NIH Guide - Vol. 8, No. 12 - September 26, 1979 by NIHhealth

VIEWS: 28 PAGES: 52

									                                                                                       for 6 W S
HI
N GUIDE 	                                                                           and CoWTRAcTS
                                                               ~~~wIocHuLTH.IwcAflow.Am)~LFuI

                                                                  Vol. 8 , No. 1 2 , September 26, 1979

I N THIS ISSUE:
NATIONAL RESEARCH SERVICE AWARDS 

FOR I N D I V I D U A L POSTDOCTORAL FELLOWSHIPS                                                             Page 1 

           IT O      -
I N N U T R_ I_N P a r t i c i p a t i n g I n s t i t u t e s : 

N C I , NEI, NHLBI, N I A , NIAMDD, N I D R , NINCDS

Application r e c e i p t dates: February 1, 

June 1, and October 1. 

Index: Trans-NIH 

           NRSA

NATIONAL RESEARCH SERVICE AWARDS
FOR INSTITUTIONAL GRANTS I N NUTRITION                                                                       Page 7
Participating I n s t i t u t e s : N C I , NEI,
NHLBI, N I A , NIAMDD, N I D R , NIEHS, NINCL
Application receipt 'dates: February 1,
June 1, and October 1.
Index: Trans-NIH
            NRSA

SEARCH FOR SUCRASE- ISOMALTASE 

D E F I C I E N T SUBJECTS, N I D R                                                                          Page 13 

S p e c k 2 Announcement 

Index:      NIDR 


PHYSIOLOGICAL AND PATHOPHYSIOLOGICAL 

EFFECTS O F MECHANICAL CIRCULATORY                                                                            Page 15 

SUPPORT DEVICES, NHLBI 

Application r e c e i p t dates:                March 1, 

J u l y 1, and November 1. 

Index: NHLBI 



                                                                                                              (over)


                                                RAVE YOU FOYFD?

                                If your p w e m t address differs p v m thot show on
                                                                                              I
                                                                  or
                                the RddFese label. please emd w u new addrues to:
                                Cmnts and Contmot &ids Dietributbn Centor.
                                National Inetitutee of Hedth, Roocn 838R10, Building 31,
                                Bathes&, Mhryland 20205, ad attach your d r e s s lahnl
                                t o your letter. h m p t notice of your chmge of address
                                will prcwnt your nam fFMl being removed            our
                                w i l i n g list.
                              L                                                               J
         The CUlDE i s pubziehed a t irregular intervals to announce s c i r n t i f i c initiative6 ami to prowide
      policy ami a d d n i s t m t i v e informition t o individwls and organiaotiono who need tr, be kept inj;;mzd
      of opportrmities, requirmente, and changes i granta a d cantmote notivitian addniotered l y ~I:P
                                                            n
      Ilotional Institutes of Heutth.
         ILv types of supplements are published by the mepective a m d i n g wiits. Thnss printed cn yu!row
      paper concern m t m o t a : eazioitationr of source# and m n n u n c m n t of nw~ilrrbiZit!r of requestr 1 : ~ .
      propoeale. %ee printed on blue p p e r concern invitutione fiw gmnl a p y l h t w n e i n s,ell-,!rf'roe:I
      s c i e n t i f i c areae to anompliuh specific program purponea.
                                                                                 c




REQUEST FOR RESEARCH GRANT
APPLICATIONS: RFA, N I A I D                                       Page 1 9
P r o g m Projects in Mechanisms of 

   Inmunologic Diseases 

Letter of i n t e n t due: November 15, 1979.
Application r e c e i p t d a t e : February 15, 1980.
Index: N I A I D

RESEARCH INTERESTS O F THE CHRONIC RENAL
DISEASE PROGRAM, NIAMDD                                            Page 25
Application r e c e i p t d a t e s : March 1, 

J u l y 1, and November 1. 

Index: NIAMDD 


GERONTOLOGICAL AND G E R I A T R I C
DERMATOLOGY, N I A                                                 Page 27
Letter of i n t e n t due: October 1 5 , 1979 

Application r e c e i p t d a t e f o r Research P r o j e c t 

Grants and S p e c i a l Research Awards: November 1, 

March 1, and J u l y 1. 

For a l l o t h e r mechanisms of support: February 1, 

June 1, and October 1. 

Index: N I A , K A w a r d s , NRSA 


REQUEST FOR RESEARCH GRANT A P P L I C A T I O N S :   RFA
-
NCI                                                                Page 31
Identification and Evaluation of Biophysical
  Probes Suitable for Distinguishing Ma Zignant
  Cells in Automated Instrument (Cytology Automation)
Application r e c e i p t date:    November 15, 1979.
Index: N C I

REQUEST FOR RESEARCH GRANT A P P L I C A T I O N : RFA 

BUREAU O F DRUGS 
                                                 Page 35
FOOD AND DRUG A D M I N I S T R A T I O N 

The Bioavailability and Pharmacokinetics of 

  Oral Dosage Forms in N a b o m and Infant
  Human Patients 

Letter of i n t e n t due on o r b e f o r e October 15, 1979.
A p p l i c a t i o n r e c e i p t d a t e : November 15, 1979.
Index: FDA




                                                                   (continued)
REQUEST FOR RESEARCH GRANT A P P L I C A T I O N :               RFA 

BUREAU O F DRUGS 
                                                       Page 39
FOOD AND DRUG ADMINISTRATION 

!The Pharmacokinetics and Bioavailabilitu o f 
          v   .    .

  Drugs in Disease States 

Letter of i n t e n t : October 1 5 , 1979.
A p p l i c a t i o n r e c e i p t d a t e : November 1 5 , 1979.
Index: FDA

EXTRAMURAL ASSOCIATES PROGRAM
A p p l i c a t i o n r e c e i p t d a t e : January 31, 1980.          Page 43
Index: EAP

REVISED INSTRUCTIONS FOR COMPLETION OF RESEARCH 

GRANT APPLICATIONS (Form PHS 3981 
                                      Page 4 5
Index: A p p l i c a t i o n s , instruct i o n s , r e v i s e d 


NURSING RESEARCH PROGRAM GRANTS 

NURSING RESEARCH PROJECT GRANTS 
                                        Page 47
D I V I S I O N OF NURSING 

Index: DN
        N I H G u i d e for Grants and Contracts 

             .
        V o l 8, N o . 1 2 , September 2 6 , 1979
                                                                                                         Page One 



- l
 b)     NATIONAL R�SEARCH SERVICE AWARDS

                              FOR
                              -
       I N D I V I D U A L POSTDOCTORAL FELLOWSHIPS

                         I N NUTRITION


       PARTICIPATING INSTITUTES:

          NATIONAL CANCER I N S T I T U T E 

          NATIONAL EYE I N S T I T U T E 

          NATIONAL HEART, LUNG, AND BLOOD I N S T I T U T E 

          NATIONAL I N S T I T U T E ON AGING 

          NATIONAL I N S T I T U T E O F A R T H R I T I S , METABOLISM, 

            AND D I G E S T I V E DISEASES
          NATIONAL I N S T I T U T E OF DENTAL RESEARCH
          NATIONAL I N S T I T U T E OF NEUROLOGICAL AND
            COMMUNICATIVE DISEASES AND STROKE


       The N a t i o n a l I n s t i t u t e s of H e a l t h (NIH) announces t h e c o n t i n u i n g a v a i l a b i l i t y
       of support f o r r e s e a r c h t r a i n i n g i n t h e areas of clinical and b a s i c s c i e n c e s .
       This announcement d e a l s s p e c i f i c a l l y w i t h n u t r i t i o n , emphasizing t h e areas
       d e l i n e a t e d i n t h e attachment.
'
Ic
 -
 1
       Under a u t h o r i t y of S e c t i o n 472 o f t h e P u b l i c H e a l t h S e r v i c e (PHS) A c t as
       amended (42 USC 2891-l), t h e N I H makes awards d i r e c t l y t o i n d i v i d u a l
       p o s t d o c t o r a l a p p l i c a n t s who a r e i n t e r e s t e d i n careers i n biomedical and
       b e h a v i o r a l r e s e a r c h . T i t l e 42 of t h e Code o f Federal Regulations, P a r t 66,
       i s a p p l i c a b l e t o t h e s e awards as are t h e p r o v i s i o n s of t h e PHS Grants P o l i c y
       S t a temen t .
       E l i g i b i l i t y Requirements             As of t h e beginning d a t e of t h e proposed fellow-
       ship, an a p p l i c a n t must have r e c e i v e d a Ph.D.,                   M.D., D.D.S., D.O., D.V.M.,
       Sc.D., D.Eng., D.N.S., o r e q u i v a l e n t domestic o r f o r e i g n degree. I n c a s e s
       where t h e degree has n o t been f o r m a l l y c o n f e r r e d , t h e r e must be a c e r t i f i c a ­
       t i o n , signed by an a u t h o r i z e d o f f i c i a l of t h e degree-granting i n s t i t u t i o n ,
       i n d i c a t i n g t h a t - degree requirements have been m e t .
                                     all                                                         The proposed s t u d y
       must encompass biomedical o r b e h a v i o r a l r e s e a r c h t r a i n i n g w i t h a n o p p o r t u n i t y
       t o c a r r y o u t s u p e r v i s e d r e s e a r c h and must o f f e r o p p o r t u n i t y t o r e s e a r c h
       h e a l t h s c i e n t i s t s , r e s e a r c h c l i n i c i a n s , etc., t o broaden t h e i r s c i e n t i f i c
       background, o r t o extend t h e i r p o t e n t i a l f o r r e s e a r c h i n h e a l t h - r e l a t e d
       areas. N a t i o n a l Research S e r v i c e Awards ( W A S ) are n o t made f o r s t u d y
       l e a d i n g t o t h e M.D., D.O., D.D.S., o r o t h e r similar p r o f e s s i o n a l d e g r e e s ,
       n o r may t h e s e awards support nonresearch c l i n i c a l t r a i n i n g .

       The i n d i v i d u a l t o be t r a i n e d must be e i t h e r a c i t i z e n o r a n o n c i t i z e n
       n a t i o n a l of t h e United S t a t e s o r else have been l a w f u l l y admitted f o r
       permanent r e s i d e n c e and must p o s s e s s an a l i e n r e g i s t r a t i o n c a r d 1-151 o r
       1-551 b e f o r e appointment.
  d
 % '
                                                                                                                               *



Page Two

P r i o r t o formal submission, an a p p l i c a n t must a r r a n g e f o r appointment t o
an a p p r o p r i a t e i n s t i t u t i o n and acceptance by a sponsor who w i l l s u p e r v i s e
h i s o r h e r t r a i n i n g and r e s e a r c h experience. The i n s t i t u t i o n a l s e t t i n g may
be a domestic n o n p r o f i t , p r i v a t e , o r p u b l i c i n s t i t u t i o n i n c l u d i n g t h e NIH
and ADAMHA. The a p p l i c a t i o n must document t h e a v a i l a b i l i t y of s t a f f and
f a c i l i t i e s t o p r o v i d e a s u i t a b l e environment f o r performing h i g h - q u a l i t y
r e s e a r c h . The major emphasis of t h e a p p l i c a t i o n should be t h e r e s e a r c h
t r a i n i n g e x p e r i e n c e and t h e broadening of s c i e n t i f i c competence.

Unde, e x c e p t i o n a l circumstances, when such study and o p p o r t u n i t y a r e n o t
a v a i l a b l e a t any domestic i n s t i t u t i o n , an i n d i v i d u a l may r e q u e s t s u p p o r t
f o r study abroad. .Such a p p l i c a n t w i l l be r e q u i r e d t o p r o v i d e d e t a i l e d
j u s t i f i c a t i o n based on t h e uniqueness of f a c i l i t i e s a n d / o r t r a i n i n g o p p o r t u n i t y
that are of such a n a t u r e and c a l i b e r t h a t they cannot b e found i n t h e U.S.,
and t h e p a r t i c u l a r s u i t a b i l i t y of t h e f o r e i g n , r a t h e r than t h e domestic,
s i t u a t i o n t o t h e proposed r e s e a r c h .

b c u m e n t s t o b e Submitted The a p p l i c a n t must submit: (1) an a p p l i c a t i o n
(PHS 416-1); (2) a signed a s s u r a n c e that t h e s e r v i c e o r payback requirement
w i l l be complied w i t h i f an award i s made; and ( 3 ) i f a n o n c i t i z e n , a
n o t a r i z e d statement of permanent r e s i d e n c e . S i n c e a complete a p p l i c a t i o n
i n c l u d e s t h e s p o n s o r ' s F a c i l i t i e s and Commitment Statement, that statement
(PHS 416) must b e included w i t h t h e a p p l i c a t i o n when submitted. I n a d d i t i o n ,
an a p p l i c a n t must a r r a n g e for t h e submission of r e f e r e n c e r e p o r t s (PHS 416-3)
                                         n
on h i s o r h e r b e h a l f . A i n d i v i d u a l may n o t have two competing a p p l i c a t i o n s
pending review c o n c u r r e n t l y i n t h e NRSA program. I n d i v i d u a l s are encouraged
t o review t h e e l i g i b i l i t y c r i t e r i a b e f o r e r e q u e s t i n g a p p l i c a t i o n k i t s
which may b e o b t a i n e d from:

                                       O f f i c e of Grants I n q u i r i e s
                                       D i v i s i o n ,of. Research Grants
                                       N a t i o n a l I n s t i t u t e s of H e a l t h
                                       Bethesda, Maryland 20205

A s e l f - a d d r e s s e d gummed l a b e l enclosed w i t h t h e r e q u e s t f o r k i t s w i l l
e x p e d i t e handling.

Closing d a t e s f o r r e c e i p t of a p p l i c a t i o n s a r e February 1, June 1, and
Q c t a h e r 1.

P e r i o d of Support N i n d i v i d u a l may r e c e i v e more t h a n 3 y e a r s of post-
                                    o
d o c t o r a l NRSA s u p p o r t i n t h e aggregate. Any e x c e p t i o n t o t h i s r e q u i r e s a
waiver from t h e Agency head, based on a review of t h e j u s t i f i c a t i o n submitted
by t h e a p p l i c a n t and sponsor. Although f e l l o w s h i p s are awarded f o r 12-month
p e r i o d s , a s s u r a n c e s may b e given by t h e awarding u n i t f o r continued s u p p o r t
beyond t h e f i r s t y e a r provided p r o g r e s s i s s a t i s f a c t o r y and f u n d s a r e
available.

S e l e c t i o n of Awardees A p p l i c a t i o n s w i l l be e v a l u a t e d by i n i t i a l review
groups a t t h e N I H .          The a p p l i c a t i o n w i l l be e v a l u a t e d on: p a s t academic
and r e s e a r c h r e c o r d s ; t h e r e s e a r c h t r a i n i n g p r o p o s a l ; t h e sponsor and
t h e t r a i n i n g environment; t h e a p p l i c a n t ' s r e s e a r c h g o a l s , p u b l i c a t i o n s ,
and r e f e r e n c e r e p o r t s ; and o t h e r r e l e v a n t information. N I H program interests
and t h e a v a i l a b i l i t y of funds a r e a l s o considered i n t h e f i n a l s e l e c t i o n .
         NIH Guide f o r Grants and Contracts 

         Vol . 8 , No. 1 2 , September 2 6 , 1979                                                                  Page Three 


         A c t i v a t i o n Date An awardee has 12 months from t h e i s s u e d a t e on t h e award
*hd      n o t i c e t o a c t i v a t e a new award.

         S t i p e n d s and Other T r a i n i n g Costs The c u r r e n t s t i p e n d f o r t h e f i r s t y e a r
         of support i s determined i n accordance w i t h t h e accompanying t a b l e by t h e
         number of y e a r s of p r i o r relevant p o s t d o c t o r a l e x p e r i e n c e a t time of award.
         Relevant e x p e r i e n c e may i n c l u d e r e s e a r c h experience ( i n c l u d i n g i n d u s t r i a l ) ,
         teaching, i n t e r n s h i p , r e s i d e n c y , o r o t h e r time s p e n t i n f u l l - t i m e p u r s u i t
         of a d d i t i o n a l d e g r e e s , o r f u l l - t i m e s t u d i e s i n a h e a l t h - r e l a t e d f i e l d a t
         a l e v e l beyond that of t h e q u a l i f y i n g d o c t o r a l degree. The s t i p e n d f o r
         each a d d i t i o n a l y e a r of support i s based on t h e level of t h e f i r s t year
         p l u s $400 f o r each a d d i t i o n a l y e a r under t h e NRSA. There i s no allowance
         f o r dependents.


                                              Current P o s t d o c t o r a l S t i p e n d s

         Years of r e l e v a n t
         e x p e r i e n c e a t time                                              Year of award
         of i n i t i a l award                               1st y e a r            2nd y e a r               3rd y e a r
                       0                                      $10,000                $10,400                   $10,800
                       1                                       10,800                 11,200                    11,600
                       2                                       11,500                 1 ;900
                                                                                       1                        12,300
                       3                                       12,200                 12,600                    13,000
                    4                                          12,800                 13,200                    13,600
         --         5                                          13,200                 13,600                    14,000
y'krlf
         T u i t i o n and t r a v e l may b e requested.                Tuition is l i m i t e d t o t h a t required
         f o r s p e c i f i e d c o u r s e s . The i n s t i t u t i o n may r e q u e s t t u i t i o n and f e e s
         ( i n c l u d i n g a p p r o p r i a t e medical insurance) o n l y t o t h e e x t e n t that t h e same
         r e s i d e n t o r n o n r e s i d e n t t u i t i o n and f e e s are charged t o r e g u l a r non-Federally
         supported s t u d e n t s .

         Conditions of Award 
 N f e l l o w may b e supported u n l e s s an A c t i v a t i o n Notice,
                                               o
         form PHS 416-5,and a signed Payback Agreement, form PHS 6031, i n d i c a t i n g 

         h i s o r h e r i n t e n t t o m e e t t h e service o r payback p r o v i s i o n s r e q u i r e d under
         l a w have been submitted t o N I H .                   Fellowship appointments a r e made f o r
         f u l l - t i m e r e s e a r c h and r e s e a r c h t r a i n i n g . 
 Fellows may u s e some of t h e time
         i n academic s t u d i e s and c l i n i c a l d u t i e s i f such work i s c l o s e l y r e l a t e d 

         t o t h e i r r e s e a r c h t r a i n i n g experience.

           n
         A NRSA may n o t b e held c o n c u r r e n t l y w i t h a n o t h e r F e d e r a l l y sponsored
         f e l l o w s h i p o r similar F e d e r a l award which p r o v i d e s a s t i p e n d o r o t h e r w i s e
         d u p l i c a t e s p r o v i s i o n s of t h e N'RSA. NRSA r e c i p i a n t s . m a y , however, a c c e p t
         c o n c u r r e n t e d u c a t i o n a l remuneration from t h e Veterans Administration
         (e.g. G . I . B i l l ) and l o a n s from F e d e r a l funds. Supplementation of t h e
         NRSA s t i p e n d from non-Federal funds i s p e r m i t t e d . Other F e d e r a l funds
         may be used f o r supplementation o n l y if e x p l i c i t l y a u t h o r i z e d by t h e program
         from which such funds a r e d e r i v e d . N N I H , ADAMHA, o r HRA g r a n t funds
                                                                  o
         may be used f o r supplementation. This i s n o t intended t o d i s c o u r a g e i n any
         way t h e u s e of F e d e r a l l o a n funds. Such a d d i t i o n a l s u p p o r t may be
         provided without t h e f e l l o w i n c u r r i n g any o b l i g a t i o n , o r i t may be c o n d i t i o n e d
%&Y~
         on h i s o r h e r performance of c e r t a i n services such as t e a c h i n g o r s e r v i n g
         as a l a b o r a t o r y a s s i s t a n t . Under no circumstances, however, should t h e
Page Four 


service requirements d e t r a c t from o r prolong t h e t r a i n i n g .

Within 2 y e a r s a f t e r completion of NRSA s u p p o r t , r e c i p i e n t s o f NRSAs are
expected t o engage i n continuous h e a l t h - r e l a t e d biomedical o r b e h a v i o r a l
r e s e a r c h o r teaching, o r when i n academic employment, any combination
t h e r e o f which i s i n accordance w i t h t h e u s u a l p a t t e r n s o f such employment.
A l t e r n a t i v e l y , i f t h e S e c r e t a r y , DHEW, determines t h e r e a r e no s u i t a b l e
h e a l t h research o r teaching p o s i t i o n s a v a i l a b l e t o t h e i n d i v i d u a l , t h e
following may be a u t h o r i z e d :

          (1) 	 I f t h e i n d i v i d u a l is a p h y s i c i a n , d e n t i s t , n u r s e , o r
               o t h e r w i s e t r a i n e d t o provide h e a l t h care d i r e c t l y t o
                p a t i e n t s , t h e S e c r e t a r y may a u t h o r i z e service i n t h e
                N a t i o n a l H e a l t h S e r v i c e Corps, o r s e r v i c e i n h i s o r h e r
                s p e c i a l t y i n a h e a l t h maintenance o r g a n i z a t i o n s e r v i n g
                a medically underserved population.

          (2) 	 I f t h e i n d i v i d u a l who received t h e NRSA i s n o t t r a i n e d
                t o provide h e a l t h c a r e t o p a t i e n t s , t h e Secretary
                may a u t h o r i z e t h e i n d i v i d u a l t o engage i n some o t h e r
                health-related a c t i v i t y appropriate t o h i s o r her
                e d u c a t i o n and t r a i n i n g .

For each y e a r f o r which an i n d i v i d u a l r e c e i v e s NRSA s u p p o r t , h e o r s h e w i l l
engage i n 1 y e a r of such s e r v i c e .

For i n d i v i d u a l s who f a i l t o f u l f i l l t h e i r o b l i g a t i o n through service, t h e
United S t a t e s i s e n t i t l e d t o recover an amount e q u a l t o t h e t o t a l amount
p a i d t o t h e i n d i v i d u a l p l u s i n t e r e s t . The amount i s computed i n                         .-
accordance w i t h a formula which g i v e s f u l l c r e d i t f o r each month of service
when t h e t o t a l payback o b l i g a t i o n i s n o t completely f u l f i l l e d through
service. I n t e r e s t on t h e amount begins on t h e d a t e t h e United S t a t e s
becomes e n t i t l e d t o such amount; i t i s computed a t a r a t e f i x e d by t h e
S e c r e t a r y of t h e Treasury c o n s i d e r i n g p r i v a t e consumer rates p r e v a i l i n g
on that d a t e . Payment must be completed w i t h i n 3 y e a r s . By F e d e r a l
r e g u l a t i o n , t h e r e are c e r t a i n c o n d i t i o n s under which t h e S e c r e t a r y , DHEW,
may extend t h e p e r i o d f o r undertaking s e r v i c e o r f o r repayment, permit
breaks i n service, o r o t h e r w i s e waive o r suspend t h e payback o b l i g a t i o n
of a n i n d i v i d u a l where enforcement of t h e o b l i g a t i o n would i n v o l v e substan­
t i a l h a r d s h i p and b e a g a i n s t e q u i t y and good conscience.

Fellows are n o t e n t i t l e d t o v a c a t i o n s as such, a l t h o u g h t h o s e a t academic
i n s t i t u t i o n s may t a k e t h e h o l i d a y s a t Christmas, i n t h e S p r i n g , etc., and
t h e s h o r t p e r i o d between semesters o r q u a r t e r s . The t i m e between a summer
s e s s i o n and a f a l l semester i s considered a n a c t i v e p a r t of t h e t r a i n i n g
p e r i o d . Those a t nonacademic i n s t i t u t i o n s a r e e n t i t l e d t o t h e normal
h o l i d a y and v a c a t i o n p e r i o d s of t h e i n s t i t u t i o n .

N o t i f i c a t i o n o f F i n a l Action The a p p l i c a n t w i l l b e n o t i f i e d by the
awarding u n i t of t h e f i n a l a c t i o n on t h e a p p l i c a t i o n by e i t h e r a n award
n o t i c e o r by a l e t t e r .

For a d d i t i o n a l information on t h e s e programs, w r i t e t o t h e a p p r o p r i a t e
c o n t a c t persons i n d i c a t e d i n t h e attachment. For information on i n d i v i d u a l
                                                                                                                    *F
                                                                                                                    ' I
NRSAs i n areas o t h e r than n u t r i t i o n , w r i t e t o :
NIH Guide for Grants and Contracts 

Vol. 8, No. 72, SepteRber 2 6 , 1979 
                                Page F i v e

                          Office of Research Manpower 

                          D i v i s i o n o f Research Grants 

                          National I n s t i t u t e s o f Health 

                          Bethesda, Maryland 20205 





               c 

          NIH G u i d e f o r G r a n t s a n d C o n t r a c t s                                                ATTACHMENT
          Vol . 8 , No. 12, S e p t e m b e r 26, 1979                                                           Page One

                                               N a t i o n a l I n s t i t u t e s of Health

                                                    Research A r e a L i s t f o r

                              Individual Postdoctoral Fellowshim i n Nutrition


         For purposes of assignment t o t h e a p p r o p r i a t e I n s t i t u t e and i n i t i a l review
         group, a p p l i c a t i o n s must be i d e n t i f i e d a s responding t o one o r more of t h e
         r e s e a r c h areas l i s t e d below. Therefore, a l l a p p l i c a t i o n s submitted i n
         response t o t h i s announcement should i n c l u d e t h e word "Nutrition" and t h e
         name of t h e r e l e v a n t I n s t i t u t e on t h e f i r s t page.

                       NOTE: 	 !The NH dues
                                     I            not provide individual fellowships
                                   m r d s a t the predoctoraz ZeueZ.
         NATIONAL CANCER INSTITUTE                                          5. 	 N u t r i t i o n a l epidemiology    -
                                                                                 Bio s t a ti st i c a l and epidemiologic
         The D i e t , N u t r i t i o n , and Cancer                            methods p e r t i n e n t t o d i e t a r y
         Program of t h e N C I s u p p o r t s t r a i n i n g                  s t u d i e s . Metabolic and bio­
         i n t h e broad areas o f d i e t and n u t r i ­                       chemical c h a r a c t e r i z a t i o n of
         t i o n r e s e a r c h a s t h e y may r e l a t e t o                 body f l u i d s , foods, e t c . , from
         cancer. The f o l l o w i n g areas o f                                 p o p u l a t i o n s a t low o r high
         emphasis a r e examples:                                                r i s k of c a n c e r .

*'"I1C
          1.    N u t r i t i o n a l biochemistry                          6 . 	 N u t r i t i o n a l endocrinology    -
                                                                                  The r o l e of d i e t t o v a r i o u s
          2. 	 N u t r i t i o n a l physiology         -     Factors             endocrine responses as involved
               a f f e c t i n g p r o c e s s e s of d i g e s t i o n ,         in the initiation o r inhibition
               a b s o r p t i o n , a s s i m i l a t i o n , and                of c a r c i n o g e n e s i s .
               t r a n s i t . D i e t a r y i n f l u e n c e on
               i n d u c t i o n and release of d i e t a r y               The above l i s t e d areas are given
               enzymes. Role of e n t e r o h e p a t i c                   a s examples of p r o j e c t i n t e r e s t .
               circulation.                                                 They are by no means meant t o be a l l
                                                                            inclusive.
         " 3 . 	 N u t r i t i o n a l microbiology         -
                D i e t a r y i n f l u e n c e s on g a s t r o ­          Contact person :
                i n t e s t i n a l microbial populations,
                both a e r o b i c and a n a e r o b i c .                       D r . Barney C. Lepovetsky 

                E f f e c t s of n o n - n u t r i t i v e sub-                  Chief, Research Manpower Branch 

                s t a n c e s (e.g. f i b e r ) , v i t a m i n s ,              T r a i n i n g and Education Program 

                m i n e r a l s , as w e l l a s n u t r i e n t s               D i v i s i o n o f Cancer Research 

                i n v a r i o u s combinations, i n t h e                            Resources and Centers
                formation of b a c t e r i a l degrada­                          N a t i o n a l Cancer I n s t i t u t e
                t i o n products.                                                N a t i o n a l I n s t i t u t e s of H e a l t h
                                                                                 Room 10A18, Westwood Building
          4 . 	 N u t r i t i o n a l immunology        - Effects                Bethesda, Maryland 20205
                of s p e c i f i c n u t r i e n t s on c e l l -
                mediated and humoral d e f e n s e                               Telephone:         (301) 496-7803
                systems a s they may be r e l a t e d
                t o i n h i b i t i o n of c a r c i n o g e n e s i s .
ATTACHMENT
PAGE TWO

NATIONAL N E INSTITUTE                                                    3 . 	 I d e n t i f i c a t i o n and mode of
                                                                                a c t i o n of d i e t a r y hypo­
The NE1 s u p p o r t s r e s e a r c h t r a i n i n g                         cholesterolemic f a c t o r s .
in animal and c l i n i c a l s t u d i e s i n
nutrition that relate t o the structure                                   4 . 	 B i o s t a t i c a l and epidemiologic
and f u n c t i o n of t h e eye i n h e a l t h and                            s t u d i e s concerning n u t r i t i o n a l
d i s e a s e . Such s t u d i e s i n c l u d e : t h e                        and d i e t a r y f a c t o r s r e l a t i n g
r o l e of varying l e v e l s of v i t a m i n s ,                             t o p o p u l a t i o n s a t varying r i s k
amino a c i d s , minerals, o r trace                                           of c a r d i o v a s c u l a r d i s e a s e .
elements i n t h e normal d i e t as they
r e l a t e t o normal o c u l a r f u n c t i o n                        5. 	 Behavioral and p h y s i o l o g i c a l
and t o such o c u l a r c o n d i t i o n s as                                a s p e c t s of d i etar y m o d i f i c a t i o n .
corneal, l e n t i c u l a r o r v i t r e o u s
opacities, corneal o r r e t i n a l                                      6 . 	 The r o l e of sodium and potassium
d y s t r o p h i e s , and c o r n e a l o r                                   i n t h e a c t i v i t y of v a s c u l a r
r e t i n a l degenerations; t o t h e                                          smooth muscle and i n t h e
prevention of o c u l a r symptoms                                              r e g u l a t i o n of f l u i d volumes,
through supplemental o r d e f i c i e n t                                      hormonal systems, nervous
f e e d i n g regimens; and t o t h e effects                                   system f u n c t i o n , and blood
of i n d i v i d u a l n u t r i e n t s on metabolic                           pressure.
processes involved i n the immune
response where t h e eye i s used                                         7. 	 E f f e c t s of d i e t and metabolism
as a model.                                                                    on t h e development of sodium-
                                                                               s e n s i t i v e and sodium-insensitive
Contact person:                                                                h y p e r t e n s i o n i n humans.

      D r . Thomas C. O'Brien 
                                           The r e s e a r c h areas l i s t e d above a r e
      Chief, S c i e n t i f i c Programs Branch 
                        examples o n l y and a r e n o t meant t o
      National Eye I n s t i t u t e 
                                    be a l l i n c l u s i v e .
      National I n s t i t u t e s of H e a l t h 

      Room 6A49, B u i l d i n g 31 
                                     Contact persons:
      Bethesda, Maryland 20205 

                                                                                Donald MacCanon, Ph.D.
      Telephone:            (301) 496-5303                                      D i v i s i o n of Heart and Vascular
                                                                                   Diseases
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE                                       N a t i o n a l Heart, Lung, and
                                                                                   Blood I n s t i t u t e
The NHLBI mandate i n c l u d e s r e s e a r c h and                           N a t i o n a l I n s t i t u t e s of H e a l t h
r e s e a r c h t r a i n i n g concerning d i s e a s e s of                   Room 3A-O8A, F e d e r a l Building
t h e h e a r t and blood vessels, l u n g s , and                              Bethesda, Maryland 20205
blood. Within that scope, a l l a s p e c t s
of r e s e a r c h t r a i n i n g are supported                                Telephone:          (301) 496-1724
i n c l u d i n g b a s i s , c l i n i c a l , and b e h a v i o r a l
aspects of n u t r i t i o n r e s e a r c h t r a i n i n g .                  Ms. Barbara Liu 

The following areas of emphasis are                                             D i v i s i o n of Lung Diseases 

examples :                                                                      National Heart, Lung, and 

                                                                                   Blood I n s t i t u t e
1.     D i e t a r y i n f l u e n c e s on a t h e r o g e n e s i s .         N a t i o n a l I n s t i t u t e s of Health
                                                                                Room 6A-05, Westwood Building
2 . 	 I n f l u e n c e of n u t r i e n t s (such as                           Bethesda, Maryland 20205
      c h o l e s t e r o l , carbohydrates, a l c o h o l ,
      d i e t a r y f i b e r , and t o t a l c a l o r i c                     Telephone:          (301) 496-7668
      i n t a k e ) on t h e l e v e l s of l i p i d
      transport proteins.
8




    N I H Guide f o r Grants and Contracts                                                     ATTACHMENT
        .
    Vol 8 , No. 1 2 , September 26, 1979                                                       Page Three

            Fann Harding, Ph.D.                                      Contact person:
            Division of Blood Diseases
              and Resources                                                   .
                                                                           D r Zaven Khacha t u r i a n
            National Heart, Lung, and                                      National I n s t i t u t e on Aging
              Blood I n s t i t u t e                                      National I n s t i t u t e s of Health
            National I n s t i t u t e s of Health                         Room 5C35, Building 31
            Room 514, Federal Building                                     Bethesda, Maryland 20205
            Bethesda, Maryland 20205
                                                                           Telephone:         (301) 496-1003
            Telephone:       (301) 496-1817
                                                                                         F
                                                                     NATIONAL INSTITUTE O ARTHRITIS,
    NATIONAL INSTITUTE ON AGING                                        METABOLISM, AND DIGESTIVE DISEASES

    The N I A supports research t r a i n i n g in                   The N u t r i t i o n Program, NIAMDD,
    t h e unique problems a s s o c i a t e d with                   provides support f o r research and
    c l i n i c a l n u t r i t i o n i n aging a d u l t s .        research t r a i n i n g i n b a s i c , c l i n i c a l ,
    Training g r a n t proposals submitted t o                       and behavioral science a r e a s r e l a t e d
    N I A i n response t o t h i s announcement                      t o human n u t r i t i o n . Other programs
    should be d i r e c t e d toward t h e following                 of t h e I n s t i t u t e , e s p e c i a l l y t h e
    major areas, o r areas c l o s e l y r e l a t e d               Digestive Diseases, Diabetes,
    t o them:                                                        Hematology, Endocrinology, and
                                                                     Metabolism Programs , a l s o support
    1. 	 Dietary i n t a k e , amount and type                       relevant n u t r i t i o n research t r a i n i n g .
         of food eaten, and food h a b i t s                         The following are examples of
         and t h e i r r e l a t i o n s h i p t o a c u t e         emphasis areas :
         functional d i s o r d e r s o r chronic
         degenerative change with age.                              1. Human n u t r i t i o n a l requirements
                                                                          f o r a l l s t a g e s of t h e l i f e cycle
    2 . 	 N u t r i t i o n a l requirements of (a) "normal"              and f o r various d i s e a s e condi­
          aging a d u l t s , (b) i n s t i t u t i o n a l i z e d       t i o n s ; f a c t o r s that may i n
          aged a d u l t s , (c) physically i n a c t i v e               influence d i e t a r y needs such
          and physically more a c t i v e aged                            as b i o a v a i l a b i l i t y , n u t r i e n t
          a d u l t s . I n v e s t i g a t i o n of s p e c i a l        imbalance, a c t i v i t y l e v e l ,
          n u t r i t i o n a l supplementation neces­                    stress, drugs, and environ­
          sary f o r t h e aged c l i n i c a l , s u r g i c a l ,       mental toxicants. Of s p e c i a l
          and postoperative p a t i e n t .                               interest are s t u d i e s on t h e
                                                                          need f o r trace elements, d i e t a r y
    3. 	 A s s e s s m e n t o f n u t r i t i o n a l s t a t u s        fiber, and vitamins.
          and changes in body composition;
          development of methods of measuring                       2 . 	 Study of t h e metabolic function
          t h e above; t h e i n t e r r e l a t i o n s h i p of         of n u t r i e n t s and t h e r o l e of
          n u t r i t i o n a l s t a t u s with o r a l , sensory,       n u t r i e n t s as metabolic r e g u l a t o r s
          and g a s t r o i n t e s t i n a l function and
          elimination i n t h e aged.                               3. 	 Prevention of o b e s i t y - t h e
                                                                          r e l a t i o n s h i p among genetic
    4 . 	 I n v e s t i g a t i o n of r i s k f a c t o r s of           p r e d i s p o s i t i o n , induced
          d i e t and l i f e t i m e food h a b i t s in                 metabolic change, and environ­
          old age and t r a n s f e r of t h i s informa­                 mental, physiological , and
          t i o n t o relevant h e a l t h personnel.                     behavioral f a c t o r s .
          Improved function during o l d age as a
          r e s u l t of b e n e f i c i a l changes i n
          nutrition.
ATTACHMENT
Page Four

4. 	 Supportive n u t r i t i o n of p a t i e n t s ,                  function, ulcerative diseases,
     w i t h e f f o r t s aimed toward t h e                           and t h e p o s s i b l e d e l e t e r i o u s
     development of improved method­                                    e f f e c t s of s u b c l i n i c a l d e f i c i e n c i e s
     o l o g i e s f o r t h e assessment                               on g e n e r a l o r a l h e a l t h .
     of n u t r i t i o n a l s t a t u s , and t h e
     d e l i v e r y of the proper amounts                         4 . 	 C r a n i o f a c i a l anomalies - s t u d i e s
     of t h e e s s e n t i a l n u t r i e n t s i n                    d e a l i n g w i t h requirements as
     t h e p r e v e n t i o n and t r e a t m e n t                     w e l l as biochemical and/or
     of s p e c i f i c d i s e a s e states.                            metabolic e f f e c t s of n u t r i e n t
                                                                         v a r i a b l e s which may cause
5 . 	 N u t r i t i o n a l a s p e c t s of d i g e s t i v e           a b e r r a t i o n s i n growth and
      d i s e a s e s , d i a b e t e s , anemias, and                   development of t h e f a c e and j a w s
      o t h e r metabolic d i s e a s e s .                              i n c l u d i n g developmental anomalies.

Contact person:                                                    Contact person:

      D r . Gerald F. Combs                                              D r . P a u l D. F r a z i e r
      D i r e c t o r , N u t r i t i o n Program                        Chief, S o f t T i s s u e Stomatology
      National I n s t i t u t e of A r t h r i t i s ,                      and N u t r i t i o n Program Branch
          Metabolism, and D i g e s t i v e                              N a t i o n a l I n s t i t u t e of Dental
          Diseases                                                           R e s ear ch
      National I n s t i t u t e s of H e a l t h                        N a t i o n a l I n s t i t u t e s of H e a l t h
      mom 606, Westwood Building                                         Room 510, Westwood B u i l d i n g
      Bethesda, Maryland 20205                                           Bethesda, Maryland 20205

       Telephone:           (301) 496-7823                               Telephone:           (301) 496-7807
                                                                                                                                         w-
NATIONAL INSTITUTE OF DENTAL RESEARCH                              NATIONAL INSTITUTE OF NEUROLOGICAL
                                                                     AND COMMUNICATIVE DISORDERS AND
Examples of areas i n which a p p l i c a ­                          AND STROKE
tions dealing with nutririon research
t r a i n i n g will b e a c c e p t e d by NIDR                   The NINCDS s u p p o r t s t r a i n i n g i n any
include:                                                           aspect of t h e e f f e c t s of n u t r i t i o n a l
                                                                   f a c t o r s on n e u r o l o g i c a l o r communica­
1. 	 Dental caries             -   s t u d i e s of                t i v e d i s o r d e r s ; on t h e e f f e c t of
       deffciencfes r e l a t i n g t o tooth                      m a l n u t r i t i o n on t h e developing
       development and caries r e s i s t a n c e ;                nervous system and on h e a r i n g ; on
       l a b o r a t o r y and b e h a v i o r a l s t u d i e s   c e n t r a l nervous system c o n t r o l of
       of man's p r e f e r e n c e f o r sweet;                   f e e d i n g and d r i n k i n g i n c l u d i n g hunger,
       s t u d i e s of s u g a r s u b s t i t u t e s and        t h i r s t , and water metabolism;
       c a r i o g e n i c i t y of foods.                         e f f e c t s of a d m i n i s t e r e d p r e c u r s o r s
                                                                   o r a n a l o g s o f neuro t r a n s m i t t e r s;
2. 	 P e r i o d o n t a l d i s e a s e s -
                                           studies                 and on n u t r i t i o n a l f a c t o r s i n
     of t h e need f o r trace elements                            immune d i s e a s e s of t h e nervous
     i n flanrmatory o r a l d i s e a s e ; s t u d i e s         system ( a l l e r g i c e n c e p h a l o m y e l i t i s )
     of t h e r o l e of n u t r i t i o n on o r a l              and d i s o r d e r s o f h e a r i n g and
     immune systems i n c l u d i n g c e l l -                    equilibrium.
     mediated and s e c r e t o r y immune
     mechanisms.

 3. 	 Oral s o f t t i s s u e s d i s e a s e s      -
      e f f e c t s of n u t r i t i o n v a r i a b l e s
      on e p i t h e l i a l i n t e g r i t y and
      function, s e c r e t o r y c e l l
.

     N I H Guide for Grants and Contracts             ATTACHMENT
        .
     Vol 8 , No. 1 2 , September 26, 1979             Page Five

     Contact person :

         D r . Raymond Summers
         Assistant Director for
            Manpower Programs
         Extramural A c t i v i t i e s Program
         National I n s t i t u t e of Neurological
            and Communicative Disorders and Stroke
         National I n s t i t u t e s of Health
         Room 1020A, Federal Building
         Bethesda, Maryland 20205

         Telephone:     (301) 496-9236
          NIH Guide for Grants and Contracts 

          Vol. 8, No. 12, September 26, 1979 
                                                               Page Seven 


‘liyylf   NATIONAL RESEARCH SERVICE AWARDS 

                             FOR 

                            L_




                   INSTITUTIONAL GRANTS 

                          IN NUTRITION 


          PARTICIPATING INSTITUTES: 

             NATIONAL CANCER INSTITUTE 

             NATIONAL EYE INSTITUTE 

             NATIONAL HEART, LUNG, A N D BLOOD INSTITUTE 

             NATIONAL INSTITUTE O N AGING 

             NATIONAL INSTITUTE O F ARTHRITIS, METABOLISM,

               A N D DIGESTIVE DISEASES 

             NATIONAL INSTITUTE OF DENTAL RESEARCH 

             NATIONAL INSTITUTE OF ENVIRONMENTAL 

               HEALTH SCIENCES 

             NATIONAL INSTITUTE OF NEUROLOGICAL A N D 

               COMMUNICATIVE DISEASES AND STROKE 


          The N a t i o n a l Z n s t i t u t e s of H e a l t h (NIH) announces t h e c o n t i n u i n g a v a i l a b i l i t y
          o f s u p p o r t f o r r e s e a r c h t r a i n i n g i n t h e areas of c l i n i c a l and b a s i c s c i e n c e s .
 *lJ
  IF
  .       This announcement d e a l s s p e c i f i c a l l y w i t h n u t r i t i o n , emphasizing areas
          d e l i n e a t e d i n t h e attachment.

          Under a u t h o r i t y of S e c t i o n 472 of the P u b l i c Health S e r v i c e (PHS) A c t a s
          amended ( 4 2 USC 2891-l), t h e N I H makes g r a n t s t o e l i g i b l e i n s t i t u t i o n s
          f o r r e s e a r c h t r a i n i z g programs f o r i n d i v i d u a l s , s e l e c t e d by the g r a n t e e ,
          who a r e i n t e r e s t e d i n careers i n biomedical and b e h a v i o r a l r e s e a r c h i n
          areas of n u t r i t i o n d e s c r i b e d i n t h e attachment. T i t l e 42 of t h e Code of
          F e d e r a l R e g u l a t i o n s , Part 6 6 , is a p p l i c a b l e t o t h e s e awards a s a r e t h e
          p r o v i s i o n s of t h e PHS Grants P o l i c y Statement.

          E l i g i b i l i t y Requirements Domestic n o n p r o f i t , p r i v a t e , o r p u b l i c i n s t i t u ­
          t i o n s may apply f o r g r a n t s t o s u p p o r t t r a i n i n g programs i n n u t r i t i o n r e s e a r c h .
          P r e d o c t o r a l and p o s t d o c t o r a l t r a i n e e s may b e supported i f e i t h e r o r both
          l e v e l ( s ) of t r a i n i n g a r e j u s t i f i e d i n t h e a p p l i c a t i o n and a r e approved.
          The a p p l i c a n t i n s t i t u t i o n must have, o r b e a b l e t o develop, t h e s t a f f and
          f a c i l i t i e s r e q u i r e d f o r t h e proposed programs. The t r a i n i n g program d i r e c t o r
          a t t h e i n s t i t u t i o n w i l l be r e s p o n s i b l e f o r t h e s e l e c t i o n and appointment
          of t r a i n e e s t o r e c e i v e N a t i o n a l Research S e r v i c e Awards (NRSAs) and f o r t h e
          o v e r a l l d i r e c t i o n o f t h e program.

          The proposed program must encompass s u p e r v i s e d biomedical o r b e h a v i o r a l
          r e s e a r c h i n one o r more of t h e areas s p e c i f i e d i n t h e a t t a c h m e n t , and
          o f f e r opportunity f o r research t r a i n i n g leading t o t h e research degree o r ,
Page E i g h t

f o r t h o s e who have a l r e a d y a t t a i n e d t h e r e s e a r c h degree, o p p o r t u n i t y t o
broaden t h e i r s c i e n t i f i c background. For t h o s e who have a t t a i n e d t h e h e a l t h
p r o f e s s i o n a l degree, t h e supervised r e s e a r c h should be accompanied by
t r a i n i n g i n s c i e n t i f i c methodology; t h i s may be p a r t o f a r e s e a r c h d e g r e e
program. NRSAs w i l l n o t s u p p o r t study l e a d i n g t o t h e M.D., D.O., D.D.S.,
o r o t h e r similar p r o f e s s i o n a l degrees, n o r w i l l t h e y support nonresearch
                           .
c1 n i c a l t r a i n i n g
    i

P r e d o c t o r a l t r a i n e e s must have r e c e i v e d a n a p p r o p r i a t e b a c c a l a u r e a t e degree
a s of t h e d a t e of appointment t o t h e approved t r a i n i n g program. A i n d i v i d u a l         n
a t t h e p o s t d o c t o r a l l e v e l must have r e c e i v e d , as of t h e d a t e of appointment
t o t h e approved t r a i n i n g program, a Ph.D., M.D., D.D.S., D.O., D.V.M.,
O.D., Sc.D., D.Eng., D.N.S., o r e q u i v a l e n t domestic o r f o r e i g n degree.
C e r t i f i c a t i o n by an a u t h o r i z e d o f f i c i a l of t h e degree-granting i n s t i t u t i o n
t h a t - d e g r e e requirements have been m e t i s a l s o a c c e p t a b l e .
         all

The i n d i v i d u a l t o b e t r a i n e d must be e i t h e r a c i t i z e n o r a n o n c i t i z e n n a t i o n a l
of t h e United S t a t e s o r else have been l a w f u l l y admitted f o r permanent
r e s i d e n c e and p o s s e s s an a l i e n r e g i s t r a t i o n c a r d 1-151 o r 1-551 a t t h e time
of appoi ntmen t      .
Applicants r e p r e s e n t i n g i n t e r e s t e d i n s t i t u t i o n s are a d v i s e d t o c o n t a c t
t h e person d e s i g n a t e d i n t h e attachment t o d i s c u s s any q u e s t i o n s ,
e s p e c i a l l y i f a n a p p l i c a t i o n i n c l u d i n g p r e d o c t o r a l t r a i n i n g is planned
o r i f c o m p a t i b i l i t y between i n s t i t u t i o n a l and agency t r a i n i n g a i m s i s i n
doubt.

Period of Support I n s t i t u t i o n a l g r a n t s may be made f o r p r o j e c t p e r i o d s
of up t o 5 y e a r s , and may b e renewable. N trainee may r e c e i v e more than
                                                                   o
5 y e a r s of a g g r e g a t e NRSA support a t t h e p r e d o c t o r a l l e v e l and 3 y e a r s
of a g g r e g a t e NRSA s u p p o r t a t t h e p o s t d o c t o r a l level. Any exception t o
t h i s r e q u i r e s a waiver from t h e Agency head based on review of j u s t i f i c i a ­
t i o n from t h e t r a i n e e and t h e g r a n t e e i n s t i t u t i o n .

A p p l i c a t i o n and Receipt A p p l i c a t i o n s should be made on Form PHS-6025,
which may b e o b t a i n e d from i n s t i t u t i o n a l c e n t r a l a p p l i c a t i o n c o n t r o l
o f f i c e s of from:

                                          O f f i c e of Grants I n q u i r i e s
                                          D i v i s i o n of Research Grants
                                          N a t i o n a l I n s t i t u t e s of H e a l t h
                                          Room 448, Westwood B u i l d i n g
                                          Bethesda, Maryland 20205

A s e l f - a d d r e s s e d gummed m a i l i n g l a b e l enclosed w i t h r e q u e s t s f o r a p p l i c a ­
t i o n k i t s w i l l e x p e d i t e handling.

Closing d a t e s f o r r e c e i p t of a p p l i c a t i o n s a r e February 1, June 1, and
October 1.
       N I H Guide for Grants and Contracts 

       Vol . 8 , No. 1 2 , September 2 6 , 1979                                                               Page Nine 


       Review and S e l e c t i o n NRSA i n s t i t u t i o n a l g r a n t a p p l i c a t i o n s w i l l be e v a l u a t e d 

 ­
-0     by i n i t i a l review groups a t t h e N I H and are s u b j e c t t o review and a p p r o v a l
       by t h e N a t i o n a l Advisory Council o r Board of t h e NIH i n s t i t u t e whose
       a c t i v i t i e s r e l a t e t o t h e t r a i n i n g under t h e award. The a p p l i c a t i o n w i l l
       be e v a l u a t e d on: t h e q u a l i f i c a t i o n s of p a r t i c i p a t i n g f a c u l t y , proposed
       r e s e a r c h t r a i n i n g o b j e c t i v e s and program d e s i g n , p r e v i o u s t r a i n i n g experience
       of t h e program d i r e c t o r , evidence of h i s o r h e r a b i l i t y t o a t t r a c t and
       r e t a i n h i g h c a l i b e r s t u d e n t s , i n s t i t u t i o n a l commitment, f a c i l i t i e s and
       environment, and r e l a t i o n - s h i p of t h e proposed program g o a l s t o need f o r
       r e s e a r c h personnel.

       S t i p e n d s and Other T r a i n i n g Costs S t i p e n d s and allowances are as follows:
       A t t h e p r e d o c t o r a l level, t h e annual s t i p e n d i s c u r r e n t l y $3,900. For
       p o s t d o c t o r a l awardees, t h e s t i p e n d f o r t h e f i r s t y e a r of support c u r r e n t l y
       i s determined i n accordance w i t h t h e accompanying t a b l e by t h e number of
       y e a r s of p r i o r r e l e v a n t p o s t d o c t o r a l experience a t time of appointment.
       Relevant e x p e r i e n c e may i n c l u d e r e s e a r c h experience ( i n c l u d i n g i n d u s t r i a l ) ,
       t e a c h i n g , i n t e r n s h i p , r e s i d e n c y , o r o t h e r time s p e n t i n f u l l - t i m e p u r s u i t
       of a d d i t i o n a l degrees, o r f u l l - t i m e s t u d i e s i n a h e a l t h - r e l a t e d f i e l d a t
       a l e v e l beyond that of t h e q u a l i f y i n g d o c t o r a l degree. The s t i p e n d f o r
       each a d d i t i o n a l y e a r of support i s based on t h e level o f t h e f i r s t y e a r
       p l u s $400 f o r each a d d i t i o n a l y e a r under t h e NRSA. There i s no allowance
       f o r dependents.


                                               Current P o s t d o c t o r a l S t i p e n d s

%-V”   Y e a r s of r e l e v a n t
       e x p e r i e n c e a t time                                                  Y e a r of award
       of i n i t i a l appointment                            1st y e a r              2nd y e a r             3rd y e a r
                     0                                         $10,000                  $10,400                 $10,800
                     1                                          10,800                    11,200                 11,600
                     2                                          1 ,500
                                                                 1                        11,900                 12 ,300
                   3                                            12,200                    12 ,600                13,000
                   4                                            12 ,800                   13,200                 13,600
                   5                                            13,200                    13,600                 14,000

       T u i t i o n and travel may b e r e q u e s t e d . T u i t i o n a t t h e p o s t d o c t o r a l l e v e l
       i s l i m i t e d t o that r e q u i r e d f o r s p e c i f i e d c o u r s e s . The i n s t i t u t i o n may
       r e q u e s t t u i t i o n and f e e s ( i n c l u d i n g a p p r o p r i a t e medical i n s u r a n c e ) o n l y
       t o t h e e x t e n t that t h e same r e s i d e n t o r n o n r e s i d e n t t u i t i o n and f e e s are
       charged t o r e g u l a r non-Federally supported s t u d e n t s . The i n s t i t u t i o n may
       a l s o r e q u e s t a c t u a l i n d i r e c t c o s t s , o r 8% of t o t a l a l l o w a b l e d i r e c t c o s t s
       (whichever i s less), and up t o 25% of t h e t o t a l award f o r c o s t s that a r e
       deemed e s s e n t i a l t o c a r r y o u t t h e NRSA t r a i n i n g program such a s salaries,
       equipment, r e s e a r c h s u p p l i e s , s t a f f t r a v e l , etc.

       Conditions of Award No t r a i n e e may be supported u n l e s s a Statement of
       Appointment, Form PHS-2271, and a signed Payback Agreement, Form PHS-6031,
       i n d i c a t i n g h i s o r h e r i n t e n t t o meet t h e service o r payback p r o v i s i o n s
       r e q u i r e d under l a w have been submitted t o NIH.                       T r a i n e e appointments are
       made f o r f u l l - t i m e r e s e a r c h and r e s e a r c h t r a i n i n g . T r a i n e e s may u s e some
       of t h e time i n academic s t u d i e s and c l i n i c a l d u t i e s i f such work i s
‘k‘
       c l o s e l y r e l a t e d t o t h e i r r e s e a r c h t r a i n i n g experience.
Page Ten

An NRSA may n o t be held c o n c u r r e n t l y w i t h a n o t h e r F e d e r a l l y sponsored
f e l l o w s h i p o r similar F e d e r a l award which p r o v i d e s a s t i p e n d o r o t h e r w i s e
d u p l i c a t e s p r o v i s i o n s of t h e NRSA. NRSA r e c i p i e n t s may, however, a c c e p t
concurrent e d u c a t i o n a l remuneration from t h e Veterans Administration (e.g.
G.I. B i l l ) and l o a n s from Federal funds.

Supplementation of t h e NRSA s t i p e n d from non-Federal funds i s p e r m i t t e d .
Other Federal funds may b e used f o r supplementation o n l y i f e x p l i c i t l y
a u t h o r i z e d by t h e program from which such funds are d e r i v e d . No N I H ,
ADAMHA, o r HRA g r a n t funds may b e used f o r supplementation.                               This i s n o t
intended t o d i s c o u r a g e i n any way t h e u s e of F e d e r a l l o a n funds. Such
a d d i t i o n a l support may b e provided without t h e t r a i n e e i n c u r r i n g any
o b l i g a t i o n , o r i t may be conditioned on h i s o r h e r performance of c e r t a i n
s e r v i c e s such as t e a c h i n g o r s e r v i n g as a l a b o r a t o r y a s s i s t a n t . Under no
circumstances, however, should t h e service requirements d e t r a c t from o r
prolong t h e t r a i n i n g .

Within 2 y e a r s a f t e r completion o f NRSA s u p p o r t , r e c i p i e n t s of NRSAs are
expected t o engage i n continuous h e a l t h - r e l a t e d biomedical o r b e h a v i o r a l
r e s e a r c h o r t e a c h i n g , o r any combination t h e r e o f which i s i n accordance
w i t h t h e u s u a l p a t t e r n s of academic employment. A l t e r n a t i v e l y , i f t h e
S e c r e t a r y , DHEW, determines t h e r e are no s u i t a b l e h e a l t h r e s e a r c h o r
t e a c h i n g p o s i t i o n s a v a i l a b l e t o t h e i n d i v i d u a l , t h e f o l l o w i n g may b e
authorized:

      1. 	 If t h e i n d i v i d u a l i s a p h y s i c i a n , d e n t i s t , n u r s e , o r
           o t h e r w i s e t r a i n e d t o p r o v i d e h e a l t h care d i r e c t l y t o
            p a t i e n t s , t h e S e c r e t a r y may a u t h o r i z e service i n t h e National
            H e a l t h S e r v i c e Corps, o r service i n h i s o r h e r s p e c i a l t y i n
            a h e a l t h maintenance o r g a n i z a t i o n s e r v i n g a medically
            underserved p o p u l a t i o n .

      2 . 	 I f t h e i n d i v i d u a l who r e c e i v e d t h e NRSA i s n o t t r a i n e d t o
            provide h e a l t h care t o p a t i e n t s , t h e S e c r e t a r y may a u t h o r i z e
            t h e i n d i v i d u a l t o engage i n some o t h e r h e a l t h - r e l a t e d
            a c t i v i t y a p p r o p r i a t e t o h i s o r h e r e d u c a t i o n and t r a i n i n g .

For each y e a r f o r which a n i n d i v i d u a l receives NRSA s u p p o r t , h e o r s h e
w i l l engage i n 1 y e a r o f such service.

For i n d i v i d u a l s who f a i l t o f u l f i l l t h e i r o b l i g a t i o n through service, t h e
United S t a t e s i s e n t i t l e d t o r e c o v e r a n amount e q u a l t o t h e t o t a l amount
paid t o t h e i n d i v i d u a l p l u s i n t e r e s t . The amount i s computed i n accordance
w i t h a formula which g i v e s f u l l c r e d i t f o r each month of s e r v i c e when
t h e t o t a l payback o b l i g a t i o n i s n o t completely f u l f i l l e d through s e r v i c e .
I n t e r e s t on t h e amount b e g i n s on t h e d a t e t h e United S t a t e s becomes
e n t i t l e d t o such amount; i t i s computed a t a r a t e f i x e d by t h e S e c r e t a r y
of t h e Treasury c o n s i d e r i n g p r i v a t e consumer rates p r e v a i l i n g on that date.
Payment must be completed w i t h i n 3 y e a r s . By F e d e r a l r e g u l a t i o n , t h e r e
a r e c e r t a i n c o n d i t i o n s under which t h e S e c r e t a r y , DHEW, may extend t h e
p e r i o d f o r undertaking s e r v i c e o r f o r repayment, permit breaks i n s e r v i c e ,
o r o t h e r w i s e waive o r suspend t h e payback o b l i g a t i o n of an i n d i v i d u a l where
enforcement of t h e o b l i g a t i o n would i n v o l v e s u b s t a n t i a l h a r d s h i p and be
a g a i n s t e q u i t y and good conscience.
     NIH Guide f o r Grants a n d Contracts 

     Vol . 8 , No. 12, September 26, 1979                                                           Page Eleven 


     T r a i n e e s a r e n o t e n t i t l e d t o v a c a t i o n s as such, a l t h o u g h t h o s e a t academic 

%
,#   i n s t i t u t i o n s may t a k e t h e h o l i d a y s a t Christmas, i n t h e Spring, e t c . ,
     and t h e s h o r t p e r i o d between semesters o r q u a r t e r s . The t i m e between a
     summer s e s s i o n and a f a l l semester i s considered a n a c t i v e p a r t of t h e
     t r a i n i n g p e r i o d . Those a t nonacademic i n s t i t u t i o n s a r e e n t i t l e d t o t h e
     normal h o l i d a y and v a c a t i o n p e r i o d s of t h e i n s t i t u t i o n .

     N o t i f i c a t i o n of F i n a l Action The a p p l i c a n t w i l l b e n o t i f i e d by t h e awarding
     u n i t of t h e f i n a l a c t i o n on t h e a p p l i c a t i o n by e i t h e r an award n o t i c e o r
     by a l e t t e r .

     For a d d i t i o n a l information on t h e s e programs, w r i t e t o t h e a p p r o p r i a t e
     c o n t a c t person i n d i c a t e d i n t h e attachment.
NIH Guide for Grants and Contracts                                                           ATTACH MENT
,g-l, 8, No. 12, September 2 6 , 1979                                                         Page One

                             National I n s t i t u t e s of Health

                                   Research Area L i s t f o r

                           I n s t i t u t i o n a l Grants i n Nutrition


For purposes of assignment t o t h e appropriate I n s t i t u t e and i n i t i a l review
group, a p p l i c a t i o n s must be i d e n t i f i e d as responding t o one o r more of
t h e research areas l i s t e d below. Therefore, a l l a p p l i c a t i o n s submitted
i n response t o t h i s announcement should include t h e word "Nutrition" and t h e
name of t h e relevant I n s t i t u t e on t h e f i r s t page.

NATIONAL CANCER INSTITUTE                                6 . 	 N u t r i t i o n a l endocrinology -
                                                               The r o l e of d i e t t o various endo­
The D i e t , Nutrition, and Cancer                            c r i n e responses as involved i n t h e
Program of t h e N C I supports t r a i n i n g                i n i t i a t i o n o r i n h i b i t i o n of carcino­
i n t h e broad areas of d i e t and                           genesis.
n u t r i t i o n research as they may r e l a t e
t o cancer. The following areas of                       The above l i s t e d areas are given a s
emphasis are examples:                                   examples of p r o j e c t i n t e r e s t . They are
                                                         by no means meant t o be a l l inclusive.
1.   N u t r i t i o n a l biochemistry
                                                         Contact person:
2 . 	 N u t r i t i o n a l physiology - Factors
      a f f e c t i n g processes of digestion,                D r . Barney C. Lepovetsky 

      absorption, a s s i m i l a t i o n , and                Chief, Research Manpower Branch 

      t r a n s i t . Dietary influence on                     Training and Education Program 

      induction and release of d i e t a r y                   Division of Cancer Research 

      enzymes. Role of enterohepatic                             Resources and Centers
      circulation.                                             National Cancer I n s t i t u t e
                                                               National I n s t i t u t e s of Health
3. 	 N u t r i t i o n a l microbiology - D i e t a r y        Room 10Al8, Westwood Building
      influences on g a s t r o i n t e s t i n a l            Bethesda , Maryland 20205
      microbial popuia t ions, both aerobic
      and anaerobic. E f f e c t s of non-                      Telephone: (301) 496-7803
      n u t r i t i v e substances (e.g. f i b e r ) ,
      vitamins, minerals, as w e l l as                 NATIONAL EYE INSTITUTE
      n u t r i e n t s i n various combinations,
      i n t h e formation of b a c t e r i a l          The NE1 supports research t r a i n i n g i n
      degradation products.                             animal and c l i n i c a l s t u d i e s i n n u t r i t i o n
                                                        t h a t relate t o t h e s t r u c t u r e and function
4 . 	 N u t r i t i o n a l immunology - E f f e c t s  of the eye i n h e a l t h and disease. Such
      of s p e c i f i c n u t r i e n t s on c e l l - s t u d i e s include: t h e r o l e of varying
      mediated and humoral defense system l e v e l s of vitamins, amino a c i d s , minerals,
      a s they may be r e l a t e d t o inhibi-         o r trace elements i n t h e normal d i e t as
      t i o n of carcinogenesis. 	                      they r e l a t e t o normal ocular function
                                                        and t o such o c u l a r conditions as corneal,
5. 	 N u t r i t i o n a l epidemiology - Biosta- l e n t i c u l a r o r v i t r e o u s o p a c i t i e s , corneal
      t i s t i c a l and epidemiologic methods o r r e t i n a l dystrophies, and corneal o r
      pertinent to dietary studies.                     r e t i n a l degenerations; t o t h e prevention
      Metabolic and biochemical charac-                 of ocular symptoms through supplemental
      t e r i z a t i o n of body f l u i d s , foods,  o r d e f i c i e n t feeding regimens; and t o t h e
      e t c . , from populations a t low o r            e f f e c t s of individual n u t r i e n t s on meta­
      high r i s k of cancer.                           b o l i c processes involved i n t h e immune
                                                        response where t h e e y e i s used a s a model.
ATTACHMENT
Page Two

Contact person:                                                 7.    E f f e c t s of d i e t and metabolism on
                                                                             d
                                                                      t h e 	 evelopment of sodium-
      D r . Thomas C. O'Brien 
                                       s e n s i t i v e and sodium-insensitive
      Chief, S c i e n t i f i c Programs Branch 
                    hypertension i n humans.
      N a t i o n a l Eye I n s t i t u t e 

      National I n s t i t u t e s of H e a l t h 
             The r e s e a r c h areas l i s t e d above a r e
      Room 6A49, B u i l d i n g 31 
                           examples o n l y and a r e n o t meant t o be
      Bethesda, Maryland 20205 
                                a l l inclusive.

      Telephone:           (301) 496-5303                       Contact persons:

NATIONAL HEART, LUNG, AND BLOOD                                       Donald MacCanon, Ph.D.
  INSTITUTE                                                           D i v i s i o n of Heart and Vascular
                                                                         Diseases
The NHLBI mandate i n c l u d e s r e s e a r c h                     N a t i o n a l Heart, Lung, and Blood
and r e s e a r c h t r a i n i n g concerning                           Institute
d i s e a s e s of t h e h e a r t and blood                          N a t i o n a l I n s t i t u t e s of H e a l t h
v e s s e l s , lungs, and blood. Within                              Room 3A-O8A, Federal B u i l d i n g
t h a t scope, a l l a s p e c t s of r e s e a r c h                 Bethesda, Maryland 20205
t r a i n i n g a r e supparted i n c l u d i n g
b a s i c , c l i n i c a l , and b e h a v i o r a l as­             Telephone:           (301) 496-1724
p e c t s of n u t r i t i o n research t r a i n i n g .
The following areas of emphasis                                       Ms. Barbara Liu
a r e examples:                                                       D i v i s i o n of Lung Disease2
                                                                      N a t i o n a l Heart, Lung, and Blood
1. 	 D i e t a r y i n f l u e n c e s on a t h e r o ­                  Institute
     genesis      .'                                                  N a t i o n a l I n s t i t u t e s of H e a l t h
                                                                      Room 6A-05, Westwood Building
2 . 	 I n f l u e n c e of n u t r i e n t s (such a s                Bethesda, Maryland 20205
      c h o l e s t e r o l , carbohydrates,
      a l c o h o l , d i e t a r y f i b e r , and t o t a l         Telephone:           (301) 496-7668
      c a l o r i c i n t a k e ) on t h e l e v e l s of
      l i p i d transport proteins.                                   Fann Harding, Ph.D.
                                                                      D i v i s i o n of Blood Diseases and
3. 	 I d e n t i f i c a t i o n and mode of a c t i o n                 Resources
     of d i e t a r y hypocholesterolemic                             N a t i o n a l Heart, Lung, and Blood
     factors.                                                            Institute
                                                                      N a t i o n a l I n s t i t u t e s of Health
4. 	 B i o s t a t i s t i c a l and epidemiologic                    Room 514, F e d e r a l Building
     s t u d i e s concerning n u t r i t i o n a l                   Bethesda, Maryland 20205
     and d i e t a r y f a c t o r s r e l a t i n g t o
     populations a t varying r i s k of                               Telephone:           (301) 496-1817
     cardiovascular disease.
                                                                NATIONAL INSTITUTE ON AGING
5. 	 Behavioral and p h y s i o l o g i c a l
     a s p e c t s of d i e t a r y m o d i f i c a t i o n .   The N I A s u p p o r t s r e s e a r c h t r a i n i n g i n
                                                                t h e unique problems a s s o c i a t e d w i t h
6. 	 The r o l e of sodium and potassium                        c l i n i c a l n u t r i t i o n in aging adults.
     i n t h e a c t i v i t y of v a s c u l a r               T r a i n i n g g r a n t p r o p o s a l s submitted t o
     smooth muscle and i n t h e regula­                        N I A i n response t o t h i s announcement
     t i o n of f l u i d volumes, hormonal                     should be d i r e c t e d toward t h e following
     systems, nervous system f u n c t i o n ,                  major areas, o'r areas c l o s e l y r e l a t e d
     and blood p r e s s u r e .                                t o them:
N I H Guide for Grants and Contracts                                                                     ATTACHMENT
VQl. 8 , No. 1 2 , September 26, 1979                                                                    Page Three

1. 	 Dietary intake, amount and type                             a l s o support relevant n u t r i t i o n research
     of food eaten, and food h a b i t s                         t r a i n i n g . The following a r e examples
     and t h e i r r e l a t i o n s h i p s t o a c u t e       of emphasis areas:
     functional d i s o r d e r s o r chronic
     degenerative change with age.                               1. 	 Human n u t r i t i o n a l requirements
                                                                      f o r a l l s t a g e s of t h e l i f e c y c l e
2 . 	 N u t r i t i o n a l requirements of                           and f o r various d i s e a s e conditions;
      (a) %ormal" aging a d u l t s ,                                 f a c t o r s t h a t may influence d i e t a r y
      (b) i n s t i t u t i o n a l i z e d aged a d u l t s ,        needs such a s b i o a v a i l a b i l i t y ,
      (c) physically i n a c t i v e and phys­                        n u t r i e n t imbalance, a c t i v i t y l e v e l ,
      i c a l l y more active aged a d u l t s .                      stress, drugs, and environmental
      I n v e s t i g a t i o n of s p e c i a l n u t r i ­          toxicants. Of s p e c i a l i n t e r e s t
      t i o n a l supplementation necessary                           are s t u d i e s on t h e need f o r trace
      f o r t h e aged c l i n i c a l , s u r g i c a l ,            elements, d i e t a r y f i b e r , and vitamins.
      and postoperative p a t i e n t .
                                                          2 . 	 Study of t h e metabolic function
3. 	 Assessment of n u t r i t i o n a l s t a t u s            of n u t r i e n t s and t h e r o l e of
     and changes i n body composition;                          n u t r i e n t s a s metabolic regulators.
     development of methods of measuring
     t h e above; t h e i n t e r r e l a t i o n s h i p 3. 	 Prevention of o b e s i t y - The rela­
     of n u t r i t i o n a l s t a t u s with o r a l ,        t i o n s h i p among g e n e t i c predis­
     senso ry , and gast r o i n t e s t i n a l                p o s i t i o n , induced metabolic change,
     function and elimination i n t h e                         and environmental, physiological,
     aged.                                                      and behavioral f a c t o r s .

4 . 	 I n v e s t i g a t i o n of r i s k f a c t o r s of      4 . 	 Supportive n u t r i t i o n of p a t i e n t s ,
      d i e t and l i f e t i m e food h a b i t s i n                 with e f f o r t s aimed toward t h e
      old age and t r a n s f e r of t h i s                           development of improved method­
      information t o relevant h e a l t h                             o l o g i e s f o r t h e assessment of
      personnel. Improved function                                . 	 n u t r i t i o n a l s t a t u s , and t h e
      during o l d age a s a r e s u l t of                            delivery of t h e proper amounts
      b e n e f i c i a l changes i n n u t r i t i o n .              of t h e e s s e n t i a l n u t r i e n t s i n
                                                                       t h e prevention and treatment of
Contact person:                                                        specific disease states.

      D r . Zaven Khachaturian                                   5 . 	 N u t r i t i o n a l a s p e c t s of d i g e s t i v e
      National I n s t i t u t e on Aging                              diseases, d i a b e t e s , anemias, and
      National I n s t i t u t e s of Health                           o t h e r metabolic d i s e a s e s .
      Room 5C35, Building 31
      Bethesda, Maryland 20205                                   Contact person:

      Telephone:          (301) 496-1003                               D r . Gerald F. Combs
                                                                       Director, N u t r i t i o n Program
NATIONAL INSTITUTE OF ARTHRITIS,                                       National I n s t i t u t e of AGthritis,
  METABOLISM, AND DIGESTIVE DISEASES                                     Metabolism, and Digestive Diseases
                                                                       National I n s t i t u t e s of Health
The Nutrition Program, NIAMDD, provides                                Room 606, Westwood Building
support f o r research and research                                    Bethesda, Maryland 20205
t r a i n i n g i n basic, c l i n i c a l , and
behavioral science areas r e l a t e d t o                             Telephone:           (301) 496-7823
human n u t r i t i o n . Other programs of t h e
I n s t i t u t e , e s p e c i a l l y t h e Digestive
Diseases, Diabetes, Hematology, Endco­
crinology, and Metabolism Programs,
ATTACHMENT
Page Four

NATIONAL INSTITUTE OF DENTAL RESEARCH                            NATIONAL INSTITUTE OF ENVIRONMENTAL
                                                                   HEALTH SCIENCES
Examples of areas i n which a p p l i c a ­
tions dealing with n u t r i t i o n research                    The NIEHS s u p p o r t s t h o s e f a c e t s of
t r a i n i n g w i l l be acdepted by N I D R                   n u t r i t i o n r e s e a r c h and r e s e a r c h
include:                                                         t r a i n i n g which involve:              (1) t h e
                                                                 e f f e c t s o f d i e t a r y m o d i f i c a t i o n s on
1. 	 Dental c a r i e s - S t u d i e s of                       susceptibility t o toxic agents; o r
     deficiencies relating t o tooth                             (2) t h e r e l a t i o n s h i p between n u t r i ­
     development and caries r e s i s t a n c e ;                t i o n a l states and t o x i c e f f e c t s of
     l a b o r a t o r y and b e h a v i o r a l s t u d i e s   environmental a g e n t s . Such s t u d i e s
     of man's p r e f e r e n c e f o r s w e e t ;              should emphasize m e c h a n i s t i c and
     s t u d i e s of s u g a r s u b s t i t u t e s and        metabolic i n v e s t i g a t i o n s i n an attempt
     c a r i o g e n i c i t y o f foods.                        t o d e f i n e b a s i c p r i n c i p l e s as opposed
                                                                 t o empirical observations; i.e.,
2. 	 P e r i o d o n t a l d i s e a s e s - S t u d i e s       data g a t h e r i n g .
     of t h e need f o r trace elements
     i n flammatory o r a l d i s e a s e ;                      Contact Derson:
     s t u d i e s of t h e r o l e of n u t r i t i o n
     on o r a l immune systems i n c l u d i n g                       D r . C h r i s t o p h e r 0. Schonwalder
     cell-mediated and s e c r e t o r y                               Program D i r e c t o r , Research
     immune mechanisms.                                                   Manpower S e c t ion
                                                                       Extramural Program
3. 	 Oral s o f t t i s s u e s d i s e a s e s -                      N a t i o n a l I n s t i t u t e of Environ­
     E f f e c t s of n u t r i t i o n v a r i a b l e                  mental H e a l t h S c i e n c e s
     on e p i t h e l i a l i n t e g r i t y and                      P.O. Box 12233
     f u n c t i o n , s e c r e t o r y c e l l func­                 Research T r i a n g l e Park, North
     t i o n , ulcerative d i s e a s e s , and                           Carolina 27709
     the possible deleterious effects
     of s u b c l i n i c a l d e f i c i e n c i e s                  Telephone:         (919) 755-4022
     on g e n e r a l o r a l h e a l t h .
                                                                 NATIONAL INSTITUTE OF NEUROLOGICAL
4. 	 C a r n i o f a c i a l anomalies      -
                                           Studies                 AND COMMUNICATIVE DISORDERS AND
      d e a l i n g w i t h requirements as                        STROKE
      w e l l as biochemical a n d / o r
      metabolic e f f e c t s of n u t r i e n t                 The NINCDS s u p p o r t s t r a i n i n g i n any
      v a r i a b l e s which may cause                          a s p e c t of t h e e f f e c t s of n u t r i t i o n a l
      a b e r r a t i o n s i n growth and                       f a c t o r s on n e u r l o g i c a l o r communica­
      development of t h e f a c e and j a w s                   t i v e d i s o r d e r s ; on t h e e f f e c t of
      i n c l u d i n g developmental anomalies.                 m a l n u t r i t i o n on t h e developing nervous
                                                                 system and on h e a r i n g ; on c e n t r a l
Contact person :                                                 nervous system c o n t r o l of f e e d i n g
                                                                 and d r i n k i n g i n c l u d i n g hunger, t h i r s t ,
      D r . Paul D. F r a z i e r                                and water metabolism; e f f e c t s of
      Chief, S o f t T i s s u e Stomatology                     administered precursors o r analogs
          and N u t r i t i o n Program Branch                   of n e u r o t r a n s m i t t e r s ; and on n u t r i ­
      National I n s t i t u t e of Dental                       t i o n a l f a c t o r s i n immune d i s e a s e s of
          Research                                               t h e nervous system ( a l l e r g i c encephalo­
      N a t i o n a l I n s t i t u t e s of H e a l t h         m y e l i t i s ) and d i s o r d e r s of h e a r i n g
      Room 510, Westwood Building                                and e q u i l i b r i u m .
      Bethesda, Maryland 20205

      Telephone:          (301) 496-7807
N I H Guide f o r Grants and C o n t r a c t s     ATTACHMENT
YO1. 8, No. 12, September 26, 1979                 Page F i v e

     Contact person:

     Dr. Raymond Summers
     Assistant Director f o r
       Manpower Programs
     Extramural A c t i v i t i e s Program
     National I n s t i t u t e o f Neurological
       and Communicative Disorders and
       Stroke
     National I n s t i t u t e s of Health
     Room 1020A, Federal Building
     Bethesda, Maryland 20205

     Telephone:      (301) 496-9236
NIH Guide for Grants and C o n t r a c t s
Vol . 8, No, 1 2 , September 26, 1979                                                          Page T h i r t e e n


SEARCH FOR SUCRASE-ISOMALTASE DEFICIENT SUBJECTS,                                              SPECIAL

    NATIONAL INSTITUTE           OF DENTAL RESEARCH                                         ANNOUNCEMENT


The N a t i o n a l Caries Program (NCP) of t h e N a t i o n a l I n s t i t u t e o f Dental
Research i s s e e k i n g s o u r c e s who have access t o s u c r a s e - i s o m a l t a s e d e f i c i e n t
s u b j e c t s , o r who have knowledge of t h e l o c a t i o n of such s u b j e c t s . The NCP
may be i n t e r e s t e d i n s u p p o r t i n g a d e n t a l study of t h e s e s u b j e c t s i f a
S u f f i c i e n t number of t h e s e f n d i v i d u a l s can be g e o g r a p h i c a l l y and medically
i d e n t i f i e d . h t e r e s t e d f n v e s t f g a t o r s and i n s t i t u t i o n s a r e urged t o write
o r c a l l f o r more d e t a i l e d requirements and information r e g a r d i n g t h i s
announcement :

                             D r . Andrew J. Yargosko 

                             Deputy Chief, Caries Research Grants 

                                 and C o n t r a c t s Branch
                             Natfonal Caries Program
                             Natfonal I n s t i t u t e of Dental Research
                             Room 522, Westwood Buildfng
                             Bethesda, Naryland 20205

                             Telephone:         (-301) 496-7884



                             D r , Norman S. Ikari 

                             N a t i o n a l Caries Program 

                             N a t i o n a l I n s t i t u t e of Dental Research 

                             Room 549, Westwood Building 

                             Bethesda, Maryland 20205 


                             Telephone:         (301) 496-7716

T h i s announcement does n o t commit t h e N I H t o i s s u e any Request f o r P r o p o s a l s
o r Request for A p p l t c a t i o n s , n o r does i t commtt t h e N I H t o award any c o n t r a c t s
o r g r a n t s d i r e c t e d toward t h e above d e s c r i b e d area. However, should responses
t o t h i s announcement i n d i c a t e s u f f i c i e n t i n t e r e s t and a c c e s s i b i l i t y t o such
s u b j e c t s , s u i t a b l e support mechanisms ( c o n t r a c t s a n d / o r g r a n t s ) may be
initiated     .
             N I H Guide f o r Grants and C o n t r a c t s 

                  .
             Vol 8, No. 12, September 26, 1979                                                                Page F i f t e e n 



             PHYS IOLOGICAL AND PATHOPHYSIOLOGICAL EFFECTS
%   A    d



                OF MECHANICAL CIRCULATORY SUPPORT D E V I C E S ,
                NATIONAL HEART, LUNG, AND BLOOD INSTITUTE


             The N a t i o n a l H e a r t , Lung, and Blood I n s t i t u t e i s i n t e r e s t e d A encouragingn
             i n t e r e s t e d i n v e s t i g a t o r s t o submit g r a n t a p p l i c a t i o n s t o s t u d y t h e physiology
             and pathophysiology of h o s t response t o c h r o n i c mechanical c i r c u l a t o r y s u p p o r t
             i n animals.

             I n 1964 t h e I n s t i t u t e i n i t i a t e d a t a r g e t e d r e s e a r c h and development program
             w i t h t h e g o a l of p r o v i d i n g implantable c i r c u l a t o r y support systems t o
             assist o r r e p l a c e t h e f a i l i n g h e a r t . Reports from several l a b o r a t o r i e s
             have demonstrated that mechanical c i r c u l a t o r y support i s f e a s i b l e f o r p e r i o d s
             of weeks t o months; t h i s p r o v i d e s t h e o p p o r t u n i t y t o d e s c r i b e h o s t response
             t o prolonged mechanical c i r c u l a t o r y support and s t u d y t h e u n d e r l y i n g
             mechanisms. Through t h i s program announcement, i n v e s t i g a t o r s are urged
             t o s t u d y t h e p h y s i o l o g i c a l e f f e c t s of e x i s t i n g d e v i c e s o r major components.
             T h i s announcement is n o t intended t o s t i m u l a t e t h e development of new d e v i c e s .

             The vast m a j o r i t y o f r e s e a r c h on mechanical c i r c u l a t o r y support d e v i c e s
             has u t i l i z e d " t e t h e r e d " systems i n which t h e s t a t i o n a r y d r i v e c o n s o l e ,
             c o n t r o l c i r c u i t r y , and, i n some i n s t a n c e s , t h e blood pump w e r e a l l l o c a t e d
             e x t r a c o r p o r e a l l y t o t h e animal o r p a t i e n t . Primary emphasis of t h i s new
p,ll*f
             program w i l l b e t o i n v e s t i g a t e v e n t r i c u l a r support systems o r components
             which a r e o r can b e completely implanted. I n such a system, t h e blood
             pump and t h e a c t u a t i o n / c o n t r o l mechanisms a r e a l l i n t r a c o r p o r e a l and a r e
             designed t o f u n c t i o n f o r a p e r i o d of several months without i n t e r r u p t i o n .

             I n v e s t i g a t i o n s should b e designed t o e s t a b l i s h a b e t t e r understanding of
             one o r more of t h e fundamental mechanisms r e s p o n s i b l e f o r host-device
             i n t e r a c t i o n and subsequent e v e n t s which a r e l i k e l y t o o c c u r f o l l o w i n g
             i m p l a n t a t i o n of a c i r c u l a t o r y support d e v i c e . The program is open t o a l l
             a p p l i c a n t s and encourages s t u d i e s i n such areas as: a d j u s t m e n t s of t h e
             d e v i c e t o h o s t requirements (e.g. c a r d i a c o u t p u t , p o s t u r e ) and environ­
             mental c o n d i t i o n s (e.g. ambient p r e s s u r e changes) which may be encountered
             w i t h ambulatory freedom; r i g h t v e n t r i c u l a r physiology as a f u n c t i o n of l e f t
             v e n t r i c u l a r a s s i s t a n c e ; i n f l u e n c e of c h r o n i c v e n t r i c u l a r unloading on t h e
             myocardium; p h y s i o l o g i c a l compensation d u r i n g e l e v a t e d blood pump o u t p u t ;
             e f f e c t of d e v i c e motion on surrounding t i s s u e ; p l a t e l e t physiology and t h e
             thrombotic p r o c e s s ; e f f e c t of c a l c i f i c a t i o n of d e v i c e components; and t h e
             i n f l u e n c e of mechanical c i r c u l a t o r y support on autonomic c o n t r o l mechanisms.
             This l i s t i n g i s intended t o provide examples.



             This program i s d e s c r i b e d i n t h e Catalog of F e d e r a l Domestic A s s i s t a n c e
             number 13.837. Awards w i l l be made under t h e a u t h o r i t y of t h e P u b l i c
             H e a l t h Service Act, T i t l e 1 1 S e c t i o n 301 ( P u b l i c Law 78-410, a s amended;
                                                   1 ,
             42 USC 241) and a d m i n i s t e r e d under PHS g r a n t p o l i c i e s and Federal Regulations
%#'          42 CFR P a r t 52 and 45 CFR P a r t 74.
Page S i x t e e n

I n v e s t i g a t o r s may u t i l i z e a complete assist o r replacement system, o r a
s i n g l e major component. I n v i v o a n d / o r i n v i t r o experiments may be proposed;
however, s t u d i e s should be l i m i t e d t o e x i s t i n g p u l s a t i l e d e v i c e c o n c e p t s .
Methods f o r c o r r e l a t i n g i n v i t r o r e s u l t s w i t h a n t i c i p a t e d i n v i v o r e s u l t s
should be c l e a r l y d e s c r i b e d . New animal models o r r e s e a r c h t e c h n i q u e s may
be proposed t o m e e t e x p e r i m e n t a l o b j e c t i v e s .

A p p l i c a n t s may f a b r i c a t e components o r purchase t h e r e q u i r e d components
by n e g o t i a t i o n w i t h o t h e r s o u r c e s i n c l u d i n g N I H g r a n t e e s or c o n t r a c t o r s .
The I n s t i t u t e i s p r e p a r e d t o a d v i s e p o t e n t i a l a p p l i c a n t s on t h e a v a i l a b i l i t y
of d e v i c e s o r components.

A p p l i c a t i o n s i n the areas n o t e d above do n o t p r e c l u d e t h e submission of
a p p l i c a t i o n s i n v o l v i n g o t h e r r e s e a r c h problems r e l e v a n t t o t h e g e n e r a l
s u b j e c t o f mechanically s u p p o r t i n g t h e f a i l i n g h e a r t and c i r c u l a t i o n .

A p p l i c a t i o n Submission and Review

A p p l i c a t i o n r e c e i p t d a t e s a r e March 1, 1980; J u l y 1, 1980; and November 1,
1980. A p p l i c a t i o n s may a l s o b e submitted for o t h e r r e g u l a r l y scheduled
N I H g r a n t a p p l i c a t i o n r e c e i p t d a t e s . A p p l i c a t i o n s r e c e i v e d a f t e r any one
r e c e i p t d a t e are considered and reviewed t o g e t h e r w i t h t h o s e r e c e i v e d by
t h e n e x t r e c e i p t d a t e . The earliest p o s s i b l e award d a t e i s approximately
n i n e months a f t e r t h e r e c e i p t d a t e .

A p p l i c a n t s should u s e t h e r e g u l a r r e s e a r c h g r a n t a p p l i c a t i o n form PHS 398.
A p p l i c a t i o n forms may b e o b t a i n e d a t the a p p l i c a n t ' s i n s t i t u t i o n a l g r a n t s
administration o f f i c e o r upon r e q u e s t from:
                                          O f f i c e of Grants I n q u i r i e s
                                          D i v i s i o n o f Research G r a n t s
                                          National I n s t i t u t e s of Health
                                          Room 4 4 8 , Westwood B u i l d i n g
                                          Bethesda, Maryland 20205

P l e a s e i d e n t i f y r e s p o n s e s t o t h i s announcement by w r i t i n g a t t h e t o p o f
t h e face s h e e t of t h e g r a n t a p p l i c a t i o n "SUBMITTED I N RESPONSE TO NHLBI
PROGRAM ANNOUNCEMENT ON EFFECTS OF MECHANICAL CIRCULATORY SUPPORT." The
completed a p p l i c a t i o n should be mailed t o t h e f o l l o w i n g a d d r e s s w i t h a
copy t o Chief, Devices and Technology Branch:

                                          D i v i s i o n of Research Grants
                                          N a t i o n a l I n s t i t u t e s of H e a l t h
                                          Room 2 4 0 , Westwood B u i l d i n g
                                          Bethesda, Maryland 20205

The D i v i s i o n of Research Grants w i l l a s s i g n a p p l i c a t i o n s t o s t u d y s e c t i o n s
f o r review a c c o r d i n g t o the N I H p r o c e s s f o r r e g u l a r r e s e a r c h g r a n t a p p l i c a ­
t i o n s . Approved a p p l i c a t i o n s w i l l compete f o r a v a i l a b l e funds w i t h a l l
o t h e r approved g r a n t a p p l i c a t i o n s a s s i g n e d t o t h e N a t i o n a l Heart, Lung, and
Blood I n s t i t u t e .
NIH Guide f o r Grants and Contracts 

     .
Vol 8 , No. 1 2 , September 26, 1979                                                         Page Seventeen 


A d d i t i o n a l i n f o r m a t i o n may b e o b t a i n e d by c o n t a c t i n g :

                                  D r . John T. Watson 

                                  Chief, Devices and Technology Branch 

                                  D i v i s i o n o f Heart and Vascular Diseases 

                                  N a t i o n a l Heart, Lung, and Blood I n s t i t u t e 

                                  Room 312, F e d e r a l B u i l d i n g 

                                  7550 Wisconsin Avenue 

                                  Bethesda, Maryland 20205 


                                  Telephone:           (301) 496-1586
        N I H Guide f o r Grants and Contracts 

            .
        Vol 8, No. 12, September 2 6 , 1979                                                       Page Nineteen 



        REQUEST FOR RESEARCH GRANT APPLICATIONS:                   RFA

        NIH-NIAID-79-8                                                                    # / /     / / / /       "/

        NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
                                                                                            AWkdUWCEY WT'
                                                                                          / / / / / / / /     1
                                                                                                                  ' / /



                TITLE :   PROGRAM PROJECTS I N MTCHANISH OF IM?IUIVOLOGIC DISEASES

                                 Application receipt date, February 15, 1980


        BACKGROUND INFORMATION

        The Allergy and C l i n i c a l Immunology Branch o f t h e Immunology, A l l e r g i c , and
        Immunologic Diseases Program of N I A I D i s concerned w i t h asthma, a l l e r g i c ,
        and immunologic d i s e a s e s and with r e l e v a n t mechanisms of h y p e r s e n s i t i v i t y
        and inflammation. This request f o r a p p l i c a t i o n s (RFA) i s intended t o
        encourage t h e development of proposals from c o l l a b o r a t i v e b a s i c s c i e n c e
        and c l i n i c a l i n v e s t i g a t i v e groups, and t o c o o r d i n a t e t h e submission o f new
        and renewal program p r o j e c t a p p l i c a t i o n s providing e q u i t a b l e opportunity
        f o r both t o compete f o r funds c u r r e n t l y a v a i l a b l e f o r e x i s t i n g programmatic
        a c t i v i t i e s concerned with t h e study of mechanisms of immunologic d i s e a s e s .
        A s such, t h i s program i s intended t o complement t h e Branch's A s t h m a and
        A l l e r g i c Disease Center program a s w e l l as t h e Centers f o r I n t e r d i s c i p l i n a r y
        Research i n Immunologic Diseases program.

1t.rc
        Immunologic d i s e a s e s t o g e t h e r w i t h asthma, a l l e r g i c d i s e a s e s , and hyper-
        s e n s i t i v i t y and inflammatory d i s o r d e r s c o n s t i t u t e major a r e a s of endeavor
        of t h e Allergy and C l i n i c a l Immunology Branch. The programmatic a c t i v i t y
        on immunologic diseases i s designed t o f u r t h e r i n v e s t i g a t e underlying
        mechanisms o f d i s e a s e and t o enhance b a s k knowledge r e l e v a n t t o t h e e t i o l o g y ,
        prevention, and mnagement of immunologic d i s o r d e r s . S t u d i e s are e f f e c t e d
        from e i t h e r one of two d i s c i p l i n a r y approaches: c l i n i c a l immunology o r
        h u n o p a t h o l o g y . C l i n i c a l immunology s t u d i e s are d i r e c t e d toward acquired
        and i n h e r i t e d d i s e a s e s a s s o c i a t e d with dysfunctions of t h e immune system.
        Immunopathology s t u d i e s i n c l u d e s p e c i f i c areas of g e n e t i c s , cytology,
        biochemistry, physiology, and pharmacology of t h e inrmune system and i t s
        disorders.

        The r e s e a r c h t o be supported by t h i s announcement i s concerned w i t h and
        seeks t o d e f i n e t h e e t i o l o g i c f a c t o r s , pathogenic mechanisms, development
        of c r i t i c a l d f a g n o s t i c measures and approaches t o e f f e c t i v e prevention,
        c o n t r o l , and treatment of immunologic abnormalities.

        RESEARCH GOALS AND SCOPE

        1. 	 Program p r o j e c t g r a n t s a r e awarded t o an i n s t i t u t i o n i n behalf of a
             program d i r e c t o r f o r t h e support of a broadly base, m u l t i d i s c i p l i n a r y ,


        Legislat'ive a u t h o r i t y for t h i s program i s found i n Section 301 of t h e
        P u b l i c Health S e r v i c e A c t (Public Law 78-410, 42 USC 241). The Catalog of
        Federal Domestic Assistance number i s 13.855.
Pa;e Twenty

      long-term r e s e a r c h program which has a s p e c i f i c major o b j e c t i v e o r b a s i c
      theme. A program p r o j e c t g e n e r a l l y i n v o l v e s t h e organized e f f o r t s of
      groups of i n v e s t i g a t o r s , members o f which conduct r e s e a r c h p r o j e c t s
      r e l a t e d t o t h e o v e r a l l program o b j e c t i v e . The g r a n t can p r o v i d e
      support f o r t h e p r o j e c t s and f o r c e r t a i n b a s i c r e s o u r c e s shared by
      i n d i v i d u a l s i n a program where t h e s h a r i n g f a c i l i t a t e s t h e t o t a l
      r e s e a r c h e f f o r t . Each p r o j e c t supported under a program g r a n t i s
      expected t o c o n t r i b u t e t o and be d i r e c t l y r e l a t e d t o t h e common theme
      o f t h e program; t h e p r o j e c t s under t h e d i r e c t i o n of a p r i n c i p a l
      i n v e s t i g a t o r should demonstrate a n e s s e n t i a l element o f u n i t y and
      interdependence. T h i s program does n o t p r o v i d e s u p p o r t f o r n o n r e s e a r c h
      components, such as a c l i n i c a l r e f e r r a l s e r v i c e , programs i n c o n t i n u i n g
      medical e d u c t i o n , o r programs f o r a demonstration and technology t r a n s f e r .

2. 	 It i s planned that awards w i l l be made d u r i n g f i s c a l y e a r 1981 t o
     support a t least three program p r o j e c t g r a n t s . It i s a n t i c i p a t e d t h a t
     p r o j e c t s w i l l b e i n i t i a t e d A p r i l 1, 1981.

3 . 	 P r o p o s a l s should emphasize new i d e a s and new i n i t i a t i v e s and should
      be concerned w i t h t h e c l i n i c a l r e l e v a n c e o f new knowledge t o t h e
      immune system and i t s d i s o r d e r s d e r f v i n g from s t u d i e s i n r e l a t e d
      disciplines.

4. 	 P r o t o c o l s focused on t h e s t u d y of immune mechanisms i n d i s e a s e should
     b e designed t o f a v o r i n t e g r a t i o n and c o o r d i n a t i o n of i n t r a - i n s t i t u t i o n a l
      r e s e a r c h p r o j e c t s concerned w i t h immunologic d f s o r d e r s and t h o s e i n
      b a s i c biomedical s c i e n c e s . Programs should i n c l u d e c l i n i c a l i n v e s t i ­
      g a t i v e components drawing upon immunologically r e l e v a n t endeavors i n
      medicine, p e d i a t r i c s , s u r g e r y , and t h e i r s u b s p e c i a l t i e s .

5. 	 While prQposals should be based on c l i n i c a l i n v e s t i g a t i o n as t h e major
      requlrernent, t h e v a l u e and p l a c e of experimental s t u d i e s a r e recognized.
      I n c l u s i o n of b a s i c r e s e a r c h components u t i l i z i n g samples o f human
                                      --
      s o u r c e materials i n i n v i t r o procedures and t h o s e i n v o l v i n g l a b o r a t o r y yy
      animals s e w i n g as. feas.i.ble a o d e l s f o r r e q u i r e d i n d e p t h s t u d i e s are
      a c c e p t a b l e . Such work, however, should c l e a r l y demonstrate r e l e v a n c e
      t o human d i s e a s e s .

6 . 	 P a t i e n t o r i e n t e d s t u d i e s and t h o s e i n v o l v i n g --t r o l a b o r a t o r y
                                                                                  in vi
      procedures and t h e u s e of experimental animal models should have a n
      immunologic b a s e o r d r a w upon immunologically r e l e v a n t areas i n t h e
      d k s c 2 p l i n e s of biochemistry, pharmacology, microbiology, v i r o l o g y ,
      g e n e t i c s , o r pathology.

7. 	 The p r o p o s a l s should c o n s i s t o f a number o f demonstrably i n t e g r a t e d
      p r o j e c t s u t i l f z i n g m u l t i f a c e t e d experimental approaches and i n v e s t i ­
      g a t i v e probes b e a r i n g upon e i t h e r a w e l l d e f i n e d immunologic d i s e a s e
      o r upon immune mechanisms common t o m u l t i p l e human d i s o r d e r s .

8 . 	 The p r o p o s a l should c l e a r l y e x p l a i n how t h e p r o j e c t e d m u l t i d i s c i p l i n a r y
      i n t e g r a t e d program can be expected t o accomplish t h e s t a t e d g o a l more
      e f f i c i e n t l y and e f f e c t i v e l y than a series of independent i n d i v i d u a l
      g r a n t supported s t u d i e s .
       N I H Guide f o r Grants and C o n t r a c t s 

       y o l . 8, N O , 1 2 , September 2 6 , 1979                                                           Page Twenty one 


       9. 	 Designation of a program p r o j e c t d i r e c t o r should be based upon accomplish­
            ment, e x p e r i e n c e a s a s e n i o r s c i e n t l s t , and a b i l i t y t o assume b o t h
            l e a d e r s h i p of t h e i n v e s t i g a t i v e group and r e s p o n s i b i l i t y f o r s c i e n t i f i c ,
            p r o f e s s i o n a l , and a d m i n i s t r a t i v e f u n c t i o n s , and commitment t o d e v o t i n g
            a s i g n i f i c a n t amount of h i s / h e r t i m e t o t h e p r o j e c t . Each p r o j e c t
            o r s u b p r o j e c t i n t h e program should have a d e s i g n a t e d p r i n c i p a l
            i n v e s t i g a t o r a l s o w i t h a demonstrable r e c o r d o f accomplishment i n
            c l i n i c a l immunology, immunopathology, o r one of t h e b a s i c s c i e n c e
            disciplines o r c l i n i c a l s p e c i a l t i e s relevant t o the p a r t i c u l a r subject
            of i n v e s t i g a t ion.

       MECHANISM OF SUPPORT

       Support of a program p r o j e c t i n Mechanisms of Immunologic Diseases w i l l be
       l i m i t e d t o a maximum of f i v e y e a r s . If a competing renewal a p p l i c a t i o n
       i s planned, i t should b e submitted o n l y i n r e s p o n s e t o a n RFA. Funding
       beyond t h e f i r s t and subsequent y e a r s of t h e g r a n t w i l l be c o n t i n g e n t upon
       s a t i s f a c t o r y p r o g r e s s d u r i n g t h e preceding y e a r s .

       The r e c e i p t d a t e f o r a p p l i c a t i o n s w i l l b e February 15, 1980. They w i l l
       undergo i n i t i a l review i n June by t h e A l l e r g y and Immunology Research
       Committee and subsequent review by t h e N a t i o n a l Advisory A l l e r g y and
       I n f e c t i o u s Diseases Council. i n October 1980. A p r i l 1, 1981, w i l l b e t h e
       earliest s t a r t i n g d a t e f o r successful applicants.

       Grant funds may b e u t i l i z e d t o s u p p o r t t h e r e s e a r c h a c t i v i t i e s o f s c i e n t i f i c
       and p r o f e s s i o n a l p e r s o n n e l , a d m i n i s t r a t i o n , c o n s u l t a t i o n services, c e n t r a l
9t-f
       s u p p o r t services, equipment, s u p p l i e s , t r a v e l , and p u b l i c a t i o n c o s t s .
       Support f o r r e s e a r c h - r e l a t e d c o s t s of p a t i e n t involvement and medical care
       may be a u t h o r i z e d . S i n c e t h e program cannot p r o v i d e funds f o r new c o n s t r u c ­
       t i o n , adequate p h y s i c a l f a c i l i t i e s must be a v a i l a b l e f o r t h e primary needs
       o f t h e p r o j e c t . However, moderate a l t e r a t i o n s o r r e n o v a t i o n s t o enhance
       c l i n i c a l o r l a b o r a t o r y f a c i l i t i e s may b e allowed i f t h e y are n e c e s s a r y t o
       m e e t o b j e c t i v e s o f t h e proposed program.

       REVIEW PROCEDURES AND CRITERIA

       For p r e l i m i n a r y s c r e e n i n g by N I A I D s t a f f , a " l e t t e r o f i n t e n t " must be
       submitted by t h e p r o s p e c t i v e program d i r e c t o r .

       L e t t e r s of i n t e n t should cover t h e f o l l o w i n g p o i n t s :

       1. A b r i e f d e s c r i p t i o n of the intended p r o j e c t .

       2.    A d e s c r i p t i o n of a v a i l a b l e l a b o r a t o r y f a c i l i t i e s .

       3 . 	 Ongoing b a s i c and c l i n i c a l r e s e a r c h r e l a t i n g t o immunologic d i s e a s e s ,
             i d e n t i f y i n g e x i s t i n g p r o j e c t s and s o u r c e s o f s u p p o r t .

       4 . 	 P a s t r e s e a r c h by members o f t h e proposed i n v e s t i g a t i v e group i n b a s i c
             and c l i n i c a l immunology.

       5.    A d e s c r i p t i o n of a l l c l i n i c f a c i l i t i e s a v a i l a b l e f o r u s e by t h e
1i-r         proposed p r o j e c t .
Page Twenty Two

6 . 	 S p e c i f i c information on t h e i n s t i t u t i o n ' s p r e s e n t p a t i e n t l o a d and
      p r o j e c t i o n s f o r p a t i e n t involvement i n c l i n i c a l i n v e s t i g a t i o n .

7. 	 The academic p o s i t i o n s and major r e s e a r c h i n t e r e s t s of t h e program
     d i r e c t o r and h i s p r o f e s s i o n a l s t a f f who w i l l be involved i n t h e
     work of t h e program p r o j e c t .

8. 	 C o l l a b o r a t i v e p o s s i b i l i t i e s w i t h o t h e r area l a b o r a t o r i e s and i n v e s t i g a t o r s
      and d e l i n e a t i o n of t h e r o l e s and manner of a n t i c i p a t e d p a r t i c i p a t i o n
      and i n t e r a c t i o n of t h e p r i n c i p a l i n v e s t i g a t o r s , c o n s u l t a n t s , and
      collaborators.

Letters o f i n t e n t a r e due no l a t e r than November 15, 1979, and upon r e c e i p t
w i l l b e screened by N I A I D s t a f f t o determine t h e e l i g i b i l i t y and s u i t a b i l i t y
of t h e p r o j e c t e d p r o p o s a l s f o r t h i s announcement.

I n q u i r i e s should be d i r e c t e d t o :

                  Robert G o l d s t e i n , M.D., Ph.D. 

                  Chief, A l l e r g y and C l i n i c a l Immunology Disease Program 

                  N a t i o n a l I n s t i t u t e of Allergy and I n f e c t i o u s Diseases 

                  Room 755, Westwood Building 

                  N a t i o n a l I n s t i t u t e s of Health 

                  Bethesda, Maryland 20205 


                  Telephone:           (301) 496-7104 


CONSEQUENCES OF LACK OF RESPONSIVENESS TO THE RFA OR OF LATE SUBMISSION

Based upon t h e l e t t e r o f i n t e n t , p o t e n t i a l a p p l i c a n t s w i l l be promptly
advised whether o r n o t t h e i r proposal i s found t o be w i t h i n t h e r e s e a r c h
g o a l s and scope of t h e program a s defined i n t h i s RFA. A p p l i c a n t s w i l l
then have an o p p o r t u n i t y t o c o r r e c t d e f i c i e n c i e s o r weaknesses and t o
r e s t r u c t u r e t h e i r submissions accordingly.              Formal a p p l i c a t i o n s t h a t a r e
n o t r e s p o n s i v e t o t h e RFA o r a r e n o t r e c e i v e d by February 15, 1980, w i l l
n o t be accepted f o r review and w i l l b e r e t u r n e d t o t h e a p p l i c a n t .

METHOD OF APPLYING

Before p r e p a r i n g an a p p l i c a t i o n , t h e p r o s p e c t i v e a p p l i c a n t should r e q u e s t
from N I A I D program s t a f f a copy of t h e N I A I D Information Brochure on
Program P r o j e c t s which c o n t a i n s d e t a i l s on t h e requirements f o r m u l t i -
disciplinary grant applications.

Use t h e s t a n d a r d r e s e a r c h g r a n t a p p l i c a t i o n form PHS 398. I n a d d i t i o n t o
following accompanying f o n n a t i n s t r u c t i o n s f o r t h e development of t h e
a p p l i c a t i o n , i n c l u d e expanded material l i s t e d above under t h e e i g h t p o i n t s
f o r t h e l e t t e r of i n t e n t . For purposes of i d e n t i f i c a t i o n and p r o c e s s i n g ,
t h e words P O R M PROJECT ON MECHANISMS OF IMMUNOLOGIC DISEASES should be
                     RGA
typed on t h e f a c e page of t h e a p p l i c a t i o n and a b r i e f c o v e r i n g l e t t e r
should be a t t a c h e d i n d i c a t i n g submission i s i n response t o t h i s N I A I D
announcement        .
N J H Guide for Grants a n d Contracts 

     .
Vol 8, No. 1 2 , September 26, 1979                                                                 Page Twenty Three 


A p p l i c a t i o n k i t s may b e o b t a i n e d from t h e i n s t i t u t i o n ' s a p p l i c a t i o n c o n t r o l
o f f i c e . I f n o t a v a i l a b l e t h e r e , t h e y may b e o b t a i n e d from:

                                      O f f i c e of G r a n t s I n q u i r i e s
                                      D i v i s i o n of Research G r a n t s
                                      N a t i o n a l I n s t i t u t e s of H e a l t h
                                      Room 4 4 8 , Westwood B u i l d i n g
                                      Bethesda, Maryland 20205

Forward t h e completed a p p l i c a t i o n t o :

                                      D i v i s i o n of Research G r a n t s
                                      N a t i o n a l I n s t i t u t e s of H e a l t h
                                      Room 2 4 0 , Westwood B u i l d i n g
                                      Bethesda, Maryland 20205

P l e a s e forward a copy ( n o t t h e o r i g i n a l ) of t h e c o v e r l e t t e r and t h e
a p p l i c a t i o n face page to: (1) t h e N I A I D Program D i r e c t o r i n o r d e r t o
a l e r t N I A I D t o t h e submission o f t h e p r o p o s a l , and ( 2 ) t h e C h i e f , Program
and P r o j e c t R e v i e w Branch, N I A I D , Room 703, Westwood B u i l d i n g , N a t i o n a l
I n s t i t u t e s o f H e a l t h , Rethesda, Maryland 2 0 2 0 5 .
          N I H G u i d e f o r G r a n t s and C o n t r a c t s 

          Vol. 8, NO. 12, September 26, 1979                                                               Page Twenty five 



                        RESEARCH INTERESTS OF THE

                     CHRONIC RENAL DISEASE PROGRAM,

          NATIONAL I N S T I T U T E    OF A R T H R I T I S , METABOLISM,
                          AND D I G E S T I V E DISEASES


          The Chronic Renal Disease Program of t h e N a t i o n a l I n s t i t u t e o f A r t h r i t i s ,
          Metabolism, and D i g e s t i v e Diseases has a s p e c i a l i n t e r e s t i n s t i m u l a t i n g
          i n v e s t i g a t o r - i n i t i a t e d r e s e a r c h g r a n t a p p l i c a t i o n s (ROls) i n b o t h funda­
          mental and c l i n i c a l i n v e s t i g a t i o n of end-stage r e n a l d i s e a s e , a l l a s p e c t s
          of i t s t r e a t m e n t , and pathophysiology of i t s c o m p l i c a t i o n s i n c l u d i n g i t s
          r e l a t e d causes.

          For s p e c i f i c recommendations of f u t u r e r e s e a r c h d i r e c t i o n s , p o t e n t i a l
          a p p l i c a n t s are encouraged t o r e f e r t o Research Needs i n Nephrology and
          Urology, Volume 2 , Report of t h e Coordinating Committee (DHEW P u b l i c a t i o n
          [.NIH] 78-1482), a v a i l a b l e from Nancy B. Cummings, M.D., NIAMDD, NIH,
          Room 9A-17, B u i l d i n g 31, Bethesda, Maryland 20205.

          METHOD AND CRITERIA OF REVIEW

          Assignment of A p p l i c a t i o n       -A p p l i c a t i o n s w i l l be r e c e i v e d by t h e N I H ’ s
          Division of Research Grants, r e f e r r e d t o a n a p p r o p r i a t e s t u d y s e c t i o n
‘11.117   f o r s c i e n t i f i c review, and a s s i g n e d t o t h e NIAMDD f o r p o s s i b l e funding,
          u n l e s s programmatic c o n s i d e r a t i o n s i n d i c a t e more a p p r o p r i a t e assignment
          t o a n o t h e r I n s t i t u t e . These d e c i s i o n s w i l l b e governed by normal
          programmatic c o n s i d e r a t i o n s as s p e c i f i e d i n t h e DRG Referral Guidelines.

          Review Procedures            - A p p l i c a t i o n s i n r e s p o n s e t o t h i s announcement w i l l
          be reviewed on a nationwide b a s i s i n competition w i t h each o t h e r , and i n
          accord with t h e u s u a l N a t i o n a l I n s t i t u t e s of H e a l t h p e e r review procedures.
          They will first be reviewed f o r s c i e n t i f i c and t e c h n i c a l m e r i t by a review
          group composed mostly of non-Federal s c i e n t i f i c c o n s u l t a n t s (study
          s e c t i o n ) . Following s t u d y s e c t i o n review, t h e a p p l i c a t i o n w i l l be
          e v a l u a t e d for program r e l e v a n c e by t h e NTAMDD Advisory Council. The
          review c r i t e r i a c u s t o m a r i l y employed by t h e N a t i o n a l I n s t i t u t e s of H e a l t h
          f o r regular research grant applications w i l l prevail.

          Deadline - A p p l i c a t i o n s w i l l be accepted i n accordance w i t h t h e u s u a l
          r e c e i p t d a t e s f o r new a p p l i c a t i o n s :

                    November 1                             March 1                   or            July 1


          This program i s d e s c r i b e d i n t h e Catalog of F e d e r a l Domestic A s s i s t a n c e
          number 13.849. Awards w i l l be made under t h e a u t h o r i t y of t h e P u b l i c
          Health Service Act, T i t l e 111, Section 301 ( P u b l i c Law 78-410, as amended;
          42 U C 2 4 1 ) and a d m i n i s t e r e d under PHS g r a n t p o l i c i e s and F e d e r a l
              S
          Regulations 42 CFR P a r t 52 and 45 CFR P a r t 74.
Page Twenty s i x

 EH D F
M T O O APPLYING

A p p l i c a t i o n s should be submitted on form PHS 3 9 8 , which i s a v a i l a b l e i n
t h e b u s i n e s s o r g r a n t s and c o n t r a c t s o f f i c e a t most academic and r e s e a r c h
institutions.             The p h r a s e , "PREPARED I N RESPONSE TO P O R M ANNOUNCEMENT
                                                                                  RGA
I N CHRONIC RENAL DISEASE," should be typed a c r o s s t h e t o p of t h e f i r s t
page of t h e a p p l i c a t i o n .

The o r i g i n a l and six c o p i e s of t h e a p p l i c a t i o n should be s e n t o r d e l i v e r e d t o :

                                       A p p l i c a t i o n Receipt Off i c e
                                       D i v i s i o n of Research Grants
                                       N a t i o n a l I n s t i t u t e s of Health
                                       Room 2 4 0 , Westwood B u i l d i n g
                                       Bethesda, Maryland 20205

For f u r t h e r i n f o r m a t i o n , i n v e s t i g a t o r s a r e encouraged t o c o n t a c t :

                                        R. J. Wineman, Ph.D. 

                                        Chronic Renal Disease Program 

                                        D i r e c t o r , Extramural Programs 

                                        N a t i o n a l I n s t i t u t e of A r t h r i t i s , 

                                           Metabolism, and D i g e s t i v e Diseases
                                        Room 621, Westwood Building
                                        Bethesda, Maryland 20205

                                        Telephone:           (301) 496-7458

I n o r d e r t o a l e r t t h e Immunologic Diseases Program t o t h e submission of
p r o p o s a l s w i t h primary t h r u s t d i r e c t e d t o immunopathology, immune mechanisms
o r h y p e r s e n s i t i v i t y , c o p i e s of t h e f a c e page and summary page of such
a p p l i c a t i o n s should b e forwarded under s e p a r a t e cover t o :

                                        Robert A. G o l d s t e i n , M.D.
                                        C h i e f , A l l e r g y and C l i n i c a l
                                           Immunology Branch
                                        N a t i o n a l I n s t i t u t e of A l l e r g y
                                           and I n f e c t i o u s Diseases
                                        Room 7 5 0 , Westwood B u i l d i n g
                                        Bethesda, Maryland 20205
        NIH Guide for Grants and Contracts 

        Vol . 8, No. 12, September 26, 1979                                                              Page Twenty seven 



'oy*   GERONTOLOGICAL AND GERIATRIC DERMATOLOGY,
               NATIONAL INSTITUTE ON AGING 


       I.    INTRODUCTION

             The N a t i o n a l I n s t i t u t e on Aging (NIA) w a s e s t a b l i s h e d by l a w i n 1974
             f o r t h e "conduct and support of biomedical, s o c i a l and b e h a v i o r a l
             r e s e a r c h and t r a i n i n g r e l a t e d t o t h e a g i n g p r o c e s s and t h e d i s e a s e s
             and o t h e r s p e c i a l problems and needs of t h e aged." Under t h i s broad
             mandate, i t has f o s t e r e d t h e study of a wide v a r i e t y of t o p i c s r e l a t e d
             t o aging.

             The n a t u r e of dermatologic senescence and t h e p r e v e n t i o n and t r e a t m e n t
             of problems a s s o c i a t e d w i t h a g i n g s k i n are among t h e N I A ' s areas of
             r e s e a r c h interest. The Dermatology subprogram, a p a r t of t h e Basic
             Aging Program, Biomedical Research and C l i n i c a l Medicine, N I A , i s
             s p e c i f i c a l l y concerned w i t h r e s e a r c h and t r a i n i n g i n t h i s f i e l d .

       11.   BACKGROUND

             Age-related dermatologic changes, which c a u s e c o n s i d e r a b l e p h y s i c a l
             discomfort and p s y c h o l o g i c a l d i s t r e s s , a r e well-recognized b u t poorly
             understood. Research on t h e mechanisms by which s k i n a g e s may permit
%-V
             more e f f e c t i v e management o f t h e s e changes and perhaps u l t i m a t e l y l e a d
             t o t h e i r p r e v e n t i o n . I n a d d i t i o n , i t i s s i g n i f i c a n t that a g i n g s k i n
             appears t o be an e x c e l l e n t model of senescence i n g e n e r a l .

             H i s t o r i c a l l y , t h e p u b l i c ' s i n t e r e s t s and needs a s s o c i a t e d w i t h s k i n
             aging have n o t been a d e q u a t e l y matched w i t h r e s e a r c h ; however, i n
             r e c e n t y e a r s t h e dermatologic a s p e c t s of gerontology and g e r i a t r i c s
             have r e c e i v e d i n c r e a s i n g a t t e n t i o n . Among t h e s o u r c e s of background
             information t h a t may b e u s e f u l t o i n v e s t i g a t o r s new t o t h e s t u d y o f
             dermatologic a g i n g are:

                   Behnke, J . A . , C.E. Finch and G.B. Moment ( E d i t o r s ) . 1978. 

                   The Biolopy of Aging. Plenum P r e s s , N.Y. 388 pages. 


                   Lombardo, P.C. 1979. Dermatologic D i s o r d e r s i n t h e E l d e r l y . 

                   I n : C l i n i c a l Geriatrics, (Chapter 18, pages 338-353), Rossman, I. 

                   (Editor). 

                   2nd E d i t i o n . J . B . L i p p i n c o t t Company, P h i l a d e l p h i a . 704 pages. 


        This program i s d e s c r i b e d i n t h e Catalog of F e d e r a l Domestic A s s i s t a n c e
        number 13.866. Awards w i l l b e made under t h e a u t h o r i t y of t h e P u b l i c
        H e a l t h S e r v i c e A c t , T i t l e 111, S e c t i o n 301 ( P u b l i c Law 78-410, a s amended;
        42 USC 241) and administered under PHS g r a n t p o l i c i e s and Federal Regulations
        42 CFR P a r t 52 and 45 CFR P a r t 74.
  Page Twenty e i g h t

             Proceedings of t h e 28th symposium on t h e biology of s k i n . 1979.
             Journal of I n v e s t i g a t i v e Dermatology (Special I s s u e on Aging),
             Vol. 73(1) :1-134.

111.    OL
       G A S AND SCOPE

       The goal of t h e N I A p e r t i n e n t t o t h i s announcement i s t o understand
       t h e b a s i c mechanisms of dermatologic aging and thus t o f a c i l i t a t e t h e
       prevention, diagnosis, and management of age-related s k i n d i s o r d e r s .
       This o b j e c t i v e includes t h e d i f f e r e n t i a t i o n of i n n a t e aging processes
       from t h e r e s u l t s of environmental i n s u l t s . Further, as aging s k i n
       appears t o be an e x c e l l e n t model of senescence a t t h e e x t r a c e l l u l a r
       and c e l l u l a r l e v e l s , i t s study may provide i n s i g h t i n t o human aging
       processes i n less a c c e s s i b l e organs.

 IV.   SPECIFIC OBJECTIVES

       The N I A seeks r e s e a r c h and r e s e a r c h t r a i n i n g g r a n t a p p l i c a t i o n s i n
       gerontologfcal and g e r i a t r i c dermatology. I n v e s t i g a t i o n r e l a t e d t o
       aging processes i s encouraged i n d i s c i p l i n e s ranging from b a s i c molec­
       u l a r and c e l l biology t o physiology and c l i n i c a l medicine. Among
       p o s s i b l e a proaches a r e s t u d i e s F f human s k i n , of skin-derived c e l l s
       i n c u l t u r z and of animal models, as w e l l a s t h e mathematical and
       computer simulation of biochemical and c e l l u l a r events. Appropriate
       t o p i c s include, but are n o t l i m i t e d to:

             Molecular and C e l l u l a r Bioloev

                   e.g, molecular and c e l l u l a r changes i n epidermis, dermis,
                   and subcutaneous t i s s u e ; t r a n s c r i p t i o n a l and t r a n s l a t i o n a l
                   c o n t r o l ; DNA v u l n e r a b i l i t y and r e p a i r ; c e l l u l a r growth
                   c a p a c i t y and e p i g e n e t i c i n f l u e n c e on c e l l function;
                   c o r r e l a t i o n s of --t r o and --
                                              in vi                  i n vivo c e l l u l a r aging; enzy­
                   mology.

             S t r u c t u r a l Anatomy and Pathology

                   e.g. hypertrophies, a t r o p h i e s , and changes i n pigmentation;
                   changes i n v a s c u l a r i z a t i o n , i n n e r v a t i o n , and epidermal
                   appendages; c a p i l l a r y f r a g i l i t y .




   Descriptions of NIA-sponsored resources and services are a v a i l a b l e :
   Das, N.K., Murphy, D.G. 1978. National I n s t i t u t e on Aging C e l l -
   Line Repository. Experimental Aging Research. 4 ( 4 ) , 321-331.

   Das, N.K., Murphy, D.G., and Fred, I . J . 1978. National I n s t i t u t e on
   Aging Mycoplasma Testing Service. Experimental Aging Research.
   4 (4) 333-341.

   Colonies of l a b o r a t o r y mice and r a t s f o r aging r e s e a r c h are main­
   t a i n e d by t h e N I A . Applicants i n t e r e s t e d i n using t h e s e resources
   must w r i t e t o t h e N I A ( s e e a d d r e s s below) t o i n i t i a t e n e g o t i a t i o n
   f o r p o t e n t i a l access t o animals.
NIH Guide f o r Grants a n d Contracts
Yo1.. 8, No, 12, September 26, 1979                                                            Page Twenty nine


             Immunolopy

                     e.g. changes i n function and a v a i l a b i l i t y of lymphocytes,
                     Langerhans' c e l l s , and macrophages.

             Phy s i o logy

                     e.g. thermoregulation, hormone r e s p o n s i v i t y , wound r e p a i r ,
                     s e n s a t i o n ; changes i n t h e skin as a b a r r i e r .

             C l i n i c a l Topics

                     e. g. age-related skin problems ( s t a s i s d e r m a t i t i s , p r u r i t u s ,
                     decubitus u l c e r s ) , n u t r i t i o n , response t o t h e r e p e u t i c agents,
                     v u n e r a b i l i t y t o environment.

 V. 	   MECHANISMS OF RESEARCH AND RESEARCH TRAINING SUPPORT

        The primary mechanisms f o r support of t h i s program are:

             1. 	 Research P r o j e c t Grant ( t h e t r a d i t i o n a l N I H r e s e a r c h
                  support mechanism).

              2 . 	 Postdoctoral Fellowship ( t h e I n d i v i d u a l National Research
                    Service Award).

        Additional mechanisms � o r support are:

              1. 	 Program P r o j e c t Grant* ( f o r m u l t i d i s c i p l i n a r y r e s e a r c h
                   involving several p r o j e c t s with a common focus).

              2 . 	 S p e c i a l Research Award** ( f o r a p p l i c a n t s n o t previously
                    supported a s P r i n c i p a l I n v e s t i g a t o r by a U.S. P u b l i c Health
                    S e r v i c e r e s e a r c h g r a n t ; c e i l i n g $30,000 p e r year f o r 3 y e a r s ) .

             3 . 	 C1 i n i c a l I n v e s t i g a t o r Award** (for c l i n i c a l l y trained i n v e s t i ­
                    g a t o r s ; t h r e e years of support:           salary up t o $30,000; s u p p l i e s ,
                    e t c . , up t o $10,000 annually).

             4.     Research Career Development Award.

             5. 	 I n s t i t u t i o n a l Training Grant* ( I n s t i t u t i o n a l National Research
                  Service Award) f o r c l i n i c a l r e s e a r c h t r a i n i n g only.

 * P o t e n t i a l a p p l i c a n t s should c o n t a c t N I A s t a f f .
**Write N I A (see below) f o r information and i n s t r u c t i o n s .

VI.     APPLICATION REVIEW AND FUNDING POLICY

        A l l a p p l i c a t i o n s w i l l be assigned f o r c o n s i d e r a t i o n and review by t h e
        Division of Research Grants according t o t h e N I H process f o r r e g u l a r
        r e s e a r c h g r a n t s . Approved a p p l i c a t i o n s w i l l compete f o r a v a i l a b l e
        funds with a l l o t h e r approved a p p l i c a t i o n s assigned t o t h e National
        I n s t i t u t e on Aging.
  Page T h i r t y two

          B.    Statement o f t h e Problem

                DCBD i s c u r r e n t l y s u p p o r t i n g a Cytology Automation Program
                w i t h t h e u l t i m a t e g o a l of p e r f e c t i n g automated s c r e e n i n g of                 I

                                                                                                                            .


                gynecologic s a m p l e s t o determine t h e p r e s e n c e o r absence of
                premalignant and malignant c e l l s .

                Automated s y s t e m s c u r r e n t l y undergoing development and t e s t i n g
                i n c l u d e both flow and s t a t i c high r e s o l u t i o n systems. The
                program has supported development and e v a l u a t i o n of new markers
                a p p l i c a b l e t o gynecologic specimens. S e v e r a l cytochemical markers
                have been s m e 3 . The program e f f o r t has emphasized t h e
                a p p l i c a t i o n of o p t i c a l t e c h n i q u e s such a s fluorochrome and
                a b s o r p t i o n dye s t a i n i n g of macromolecules; l i g h t s c a t t e r i n g
                t e c h n i q u e s have a l s o been s t u d i e d .

                Technology and i n s t r u m e n t a t i o n now e x i s t f o r t h e s t u d y of
                p h y s i c a l p r o p e r t i e s o f cells such a s n u c l e a r , cytoplasmic
                and membrane s t r u c t u r e and f l u i d i t y , and d e g r e e of chromatin
                condensation. These t e c h n i q u e s i n c l u d e f l u o r e s c e n s e
                d e p o l a r i z a t i o n and i n t e r and i n t r a m o l e c u l a r energy t r a n s f e r .
                New probes are d e s i r a b l e s i n c e they may r e v e a l d i s t i n c t i v e
                i n f o r m a t i o n concerning normal, premalignant, and malignant
                cells.

 11. 
 RESEARCH GOALS AND SCOPE

          It i s t h e i n t e n t of t h i s RFA t o s t i m u l a t e r e s e a r c h i n i d e n t i f i c a t i o n
          and e v a l u a t i o n of new b i o p h y s i c a l probes f o r e x i s t i n g i n s t r u m e n t a t i o n
          i n flow and s t a t i c c e l l a n a l y s i s systems. It i s hoped t h a t t h i s
          r e s e a r c h w i l l l e a d t o i n n o v a t i v e approaches t o automated system(s)
          that can be employed t o s c r e e n normal and abnormal c e l l s .

          The proposed study may employ model c e l l systems; however, i f p o s s i b l e ,
          t h e a p p l i c a n t should test developing methodology on gynecologic
          specimens.

111. 
 MECHANISM OF SUPPORT

          The s u p p o r t mechanism f o r t h i s program w i l l be t h e t r a d i t i o n a l N I H
          grant-in-aid.        S u c c e s s f u l a p p l i c a n t s w i l l p l a n and e x e c u t e t h e i r
          own programs. It i s a n t i c i p a t e d t h a t a t l e a s t t h r e e awards w i l l be
          made by t h e N a t i o n a l Cancer I n s t i t u t e and t h e p r o p o s a l should n o t
          exceed t h r e e y e a r s . The t o t a l approximate level of s u p p o r t f o r
          y e a r 1 i s $300,000; $350,000 f o r y e a r 2 ; and $400,000 f o r y e a r 3 .
          JuZy 1980 s t a r t i n g d a t e s a r e a n t i c i p a t e d .

 IV   I   REVIEW PROCEDURES AND CRITERIA

          A.    Review Method

                Upon r e c e i p t , a p p l i c a t i o n s w i l l be reviewed by t h e D i v i s i o n of
                Research Grants (DRG) and the N C I s t a f f f o r r e s p o n s i v e n e s s t o
                t h i s announcement. I f t h e a p p l i c a t i o n i s judged unresponsive,
N I H Guide for Grants and Contracts 

     .
Yo1 8, No. 1 2 , September 26. 1979                                                             Page T h i r t y t h r e e 


          t h e a p p l i c a n t w i l l be given a n o p t i o n t o withdraw t h e a p p l i c a t i o n
          o r t o submit i t f o r c o n s i d e r a t i o n i n t h e t r a d i t i o n a l g r a n t program
          of NIH.

          A p p l i c a t i o n s judged r e s p o n s i v e w i l l be reviewed i n i t i a l l y f o r
          s c i e n t i f i c merit by an N I H peer review group i n February 1980.
          T h e recommendations of t h e p e e r review group w i l l be considered
          by t h e N a t i o n a l Cancer Advisory Board i n May 1980.

     B.   Review C r i t e r i a

          The f a c t o r s c o n s i d e r e d i n e v a l u a t i n g each a p p l i c a t i o n w i l l be:

          1. 	 The s c i e n t i f i c merit of t h e proposed approach. Technical
               m e r i t i n c l u d e s adequacy and i n n o v a t i o n o f methodological
               approach, r e s e a r c h d e s i g n , and s t a t i s t i c a l a n a l y s i s .

          2. 	 The e x p e r t i s e and q u a l i f i c a t i o n s of t h e P r i n c i p a l I n v e s t i g a t o r
               and proposed s t a f f i n c l u d i n g pathology s u p p o r t .

          3. 	 Documentation of t h e adequacy of t h e f a c i l i t i e s and a p p r o p r i a t e
                c o l l a b o r a t i o n f o r c l i n i c a l specimens.

          4 . 	 E v a l u a t i o n p l a n and t i m e t a b l e f o r completion of each proposed
                task.

          5. 	 P r o v i s i o n f o r human s u b j e c t s p r o t e c t i o n and c o p i e s of informed
               consent forms a s n e c e s s a r y i f human d e r i v e d c e l l s are proposed
               t o be u s e d ,

          6. 	 Documentation of p r o p e r animal w e l f a r e p r o v i s i o n s i f i t i s
                proposed t o u s e animals.

V.   METHOD OF APPLYING

     A.   A p p l i c a t i o n Format

          A p p l i c a t i o n s should be submitted on form PHS 398. The conven­
          t i o n a l p r e s e n t a t i o n f o r g r a n t a p p l i c a t i o n s should be u t i l i z e d
          and t h e p o i n t s i d e n t i f i e d under t h e Review C r i t e r i a must be
          f u l f i l l e d . The words "IDENTIFICATION AND EVALUATION OF BIOPHYSICAL
          PROBES SUITABLE FOR DISTINGUISHING MALIGNANT CELLS I N AUTOMATED
          INSTRUMENT (CYTOLOGY AUTOMATION)" must b e typed i n bold l e t t e r s
          a c r o s s t h e t o p of t h e f a c e page of t h e a p p l i c a t i o n .

     B.   A p p l i c a t i o n Procedure

          T h e p r e s e n t RFA announcement is open t o a l l i n t e r e s t e d i n v e s t i ­
          g a t o r s . A p p l i c a t i o n s must b e r e c e i v e d no l a t e r than November 1 5 ,
          1979. 
 A p p l i c a t i o n s r e c e i v e d a f t e r t h i s d a t e w i l l be r e t u r n e d .
          The o r i g i n a l and s i x c o p i e s of t h e a p p l i c a t i o n should be s e n t
          o r delivered t o :
Page Thirty four
                                     Application Receipt 

                                     Division of Research Grants 

                                     N a t i o n a l I n s t i t u t e s of Health 

                                     Room 240, Westwood Building 

                                     Bethesda, Maryland 20205 


        A b r i e f c o v e r i n g l e t t e r should accompany t h e a p p l i c a t i o n i n d i c a t i n g
        that i t is i n response t o t h i s RF’A. A copy of t h e covering l e t t e r
        should b e s e n t to:

                                     K. RDbert McIntire, M.D. 

                                     D i r e c t o r f o r Diagnosis Program 

                                     Chief , Diagnosis Branch 

                                     D i v i s i o n of Cancer Biology and Diagnosis 

                                     N a t i o n a l Cancer I n s t i t u t e 

                                     Room 10Al0, Westwood B u i l d i n g 

                                     5333 Westbard Avenue 

                                     Bethesda, Maryland 20205 

           N I H Guide f o r Grants and C o n t r a c t s
           V o l . 8, No. 1 2 , September 26, 1979                                                          Page T h i r t y f i v e


           REQUEST FOR RESEARCH GRANT APPLICATION:                           RFA                          FDA-HFD- 79-4
1   * I
    ' L.



                  BUREAU OF DRUGS
            FOOD AND DRUG ADMINISTRATION

                  TITLE:       THE BIQAVAILABILITY AND PHARMACOKTNETICS OF ORAL
                               DOSAGE FORI@ I N NEWBORN A N D INFANT HUMN PATIENTS
                                  A p p l i c a t i o n receipt date, November 15, 1979


           I.    BACKGROUND INFORMATION

                 The Biophannaceutics Program of t h e Bureau of Drugs, FDA, i n v i t e s
                 a p p l i c a t i o n s t o b e i n i t i a t e d d u r i n g FY 1980 f o r r e s e a r c h g r a n t s f o r
                 s t u d i e s of t h e b i o a v a i l a b i l i t y and pharmacokinetics of d r u g s from
                 o r a l dosage i n newborn and i n f a n t human p a t i e n t s .

                 It has been recognized f o r some t i m e t h a t newborn i n f a n t humans
                 have unique characteristics w i t h r e g a r d t o drug d i s p o s i t i o n
                 compared t o a d u l t s . This uniqueness is due in l a r g e p a r t t o
                 d i f f e r e n c e s i n t h e physiology of t h e newborn. The g o a l of t h i s
                 program is t o p r o v i d e much needed data on t h i s . p o p u l a t i o n .

           1 .
            1    RESEARCH GOALS AND SCOPE

                 Drugs are absorbed, d i s t r i b u t e d , metabolized and e x c r e t e d a t
                 d i f f e r e n t rates and t o d i f f e r e n t e x t e n t s , o f t e n because of poorly
                 developed systems r e s p o n s i b l e f o r t h e s e p r o c e s s e s .             The bio­
                 a v a i l a b i l i t y of drugs i s a f u n c t i o n of b o t h rate and e x t e n t of
                 a b s o r p t i o n . A v a r i e t y of p h y s i o l o g i c a l f a c t o r s w i l l i n f l u e n c e
                 a b s o r p t i o n i n c l u d i n g pH, stomach volume, m o t i l i t y , blood flow, and
                 membrane composition. I n t h e f i r s t few days of l i f e , t h e g a s t r i c
                 volume is approximately l c c / k g . A c i d i t y d e c r e a s e s u n t i l a g e 1 0 days
                 and then g r a d u a l l y increases u n t i l a g e t h r e e u n t i l t h e a d u l t pH i s
                 a t t a i n e d . Membranes and p r o c e s s e s r e s p o n s i b l e f o r t r a n s p o r t of
                 drugs show marked immaturity f o r a t least t h r e e months of age.

                 These f a c t o r s may i n f l u e n c e t h e b i o a v a i l a b i l i t y o f c e r t a i n drugs,
                 i.e., drugs whose physio-chemical characteristics may l e a d t o
                 a n t i c i p a t e d b i o a v a i l a b i l i t y problems. For example, poorly s o l u b l e
                 drugs such as t h e a n t i c o n v u l s a n t s phenytoin and t e g r e t o l may be less
                 b i o a v a i l a b l e i n i n f a n t s . Highly l i p i d - s o l u b l e drugs may b e more
                 b f o a v a i l a b l e i n i n f a n t s than i n a d u l t s .

                 Considering t h e f a c t that newborns and i n f a n t s may b e more s e n s i t i v e
                 t o drug e f f e c t s , t h e amount of drug a v a i l a b l e has i n c r e a s i n g importance.

           A l l p o l i c i e s and requirements that govern t h e r e s e a r c h g r a n t s programs of
           PHS apply. This program fs supported under t h e a u t h o r i z a t i o n of
           S e c t i o n 301 of t h e P u b l i c Health S e r v i c e A c t , as amended (42 USC 241).
           The Catalog of Federal Domestic A s s i s t a n c e number is 13.103.                Cost sharing
           is required.
*u 

 t'
  Page T h i r t y s i x

       It i s f e l t s a f e t y and t h e r a p e u t i c e f f i c a c y f o r s e v e r a l drugs could
       be improved w i t h a more complete understanding o f a b s o r p t i o n p r o c e s s e s
       i n newborn and i n f a n t humans.

       The l i v e r of a newborn i n f a n t i s almost n o n f u n c t i o n a l w i t h r e s p e c t
       t o metabolism and d e t o x i f i c a t i o n . S h o r t l y a f t e r b i r t h anatomic
       changes, such as c l o s u r e o f t h e d u c t u s venosus s t i m u l a t e r a p i d develop­
       ment which i s evidenced i n a v a r i e t y of ways, i n c l u d i n g a 5- t o
       10-fold i n c r e a s e i n t y r o s i n e transaminase and i n c r e a s i n g amount of
       v i t a m i n K 1 , smooth endoplasmic r e t i c u l u m , and glucuronyl t r a n s f e r a s e .

       S t u d i e s i n t h i s a g e group p r e s e n t s p e c i a l b u t n o t insurmountable
       problems. The number and volumes of b i o l o g i c a l samples must be
       g r e a t l y reduced, I n a d d i t i o n , t h e p h y s i o l o g i c a l n a t u r e of t h e
       s t u d y p o p u l a t i o n i s changing w i t h t i m e . I n n o v a t i v e approaches
       i n a n a l y t i c a l methodology and experimental d e s i g n are t h e r e f o r e
       r e q u i r e d . For example, t h e h f o r m a t i o n r e q u i r e d could b e gained
       from r o u t i n e blood sampling f o r t h e r a p e u t i c monitoring i n l a r g e
       numbers of p a t i e n t s o v e r r e l a t i v e l y l o n g p e r i o d s of t r e a t m e n t .
       Unlike many b i o a v a i l a b i l i t y s t u d i e s , such a n approach t o conducting
       s t u d i e s would be o f immediate and t h e r a p e u t i c b e n e f i t t o t h e s t u d y
       population.

        R e c e n t s t u d i e s i n p e d i a t r i c p a t i e n t population involving a v a r i e t y
        of drugs, e.g. t h e o p h y l l i n e , phenytoin, and a s p i r i n i n d i c a t e that
        t h e metabolic c l e a r a n c e ( b i o l o g i c h a l f - l i f e ) may be a f u n c t i o n of
        age. Contrary t o e x p e c t a t i o n , metabolism i s n o t n e c e s s a r i l y slower
        i n p e d i a t r i c p a t i e n t s (e.g. t h e o p h y l l i n e ) and t h e r e f o r e t h e l a b e l i n g
        requirements for d r u g s should be based on s p e c i a l i z e d s t u d i e s i n
        infants     .
111.    MECHANISM OF SUPPORT

        A. 	   E l i g i b i l i t y These g r a n t s are a v a i l a b l e t o any p u b l i c o r p r i v a t e
               nonprofit university, college, hospital, laboratory, o r other
               i n s t i t u t i o n , i n c l u d i n g S t a t e and l o c a l u n i t s o f government.

        B.     Length o f Support The a p p l i c a t i o n may n o t r e q u e s t more t h a n t h r e e
               y e a r s of s u p p o r t . Continued support beyond t h r e e y e a r s i s s u b j e c t
               t o t h e g r a n t e e ’ s performance, t h e c o m p e t i t i v e review p r o c e s s , and
               t h e a v a i l a b i l i t y of funds.

        C. 	 Fundin P l a n The a c t u a l number of p r o j e c t s funded w i l l depend
             h      t        y of t h e a p p l i c a t i o n s r e c e i v e d . The t o t a l amount
             of funds a v a i l a b l e f o r F 1980 i s a n t i c i p a t e d t o be approximately
                                              Y
             $250,000.

 IV.    REVIEW PROCEDURES AND CRITERIA

        The r e c e i p t d a t e f o r a p p l i c a t i o n s i s November 15, 1979. They w i l l
        undergo i n i t i a l review i n February-March 1980 and subsequent review
        by a N a t i o n a l Advisory Council i n May 1980. The earliest s t a r t i n g
        d a t e f o r s u c c e s s f u l a p p l i c a t i o n s w i l l be J u l y 1, 1980.
    L




b
        t4IH Guide f o r Grants a n d Contracts 

        Vol, 8, No. 1 2 , September 26, 1979                                                         Page Thirty seven 


             Applications i n response t o t h i s i n v i t a t i o n w i l l be reviewed on a
             nationwide b a s i s i n competition with each o t h e r and i n accordance
             with t h e following c r i t e r i a :

                  t h e s c i e n t i f i c m e r i t of t h e r e s e a r c h design, approach and
                  methodology , including a thorough review of t h e l i t e r a t u r e ;

                  t h e r e s e a r c h e x p e r i e n c e , t r a i n i n g and competence of t h e
                  p r i n c i p a l i n v e s t i g a t o r and s t a f f t o c a r r y o u t t h e proposed
                  p r o j e c t . This includes published r e s e a r c h work by t h e
                  i n v e s t i g a t o r on pharmacokinetics and b i o a v a i l a b i l i t y of
                  drugs;

                  t h e academic p o s i t i o n s and major r e s e a r c h interests of t h e
                  p r o j e c t d i r e c t o r and t h e p r o f e s s i o n a l s t a f f that w i l l b e
                  involved i n t h e p r o j e c t ;

                  adequacy of t i m e ( e f f o r t ) t o b e devoted t o t h e p r o j e c t by
                  i n v e s t i g a t o r ( s 1 and t e c h n i c a l s t a f f and evidence of
                  i n s t i t u t i o n a l commitment t o t h e program;

                  s p e c i f i c information on t h e i n s t i t u t i o n ' s p r e s e n t p a t i e n t
                  load and p r o j e c t i o n s f o r p a t i e n t involvement i n c l i n i c a l
                  investigations ;

                  plan f o r complying with r e g u l a t i o n s f o r t h e p r o t e c t i o n of
                  human s u b j e c t s a s a p p l i c a b l e t o t h e proposed study, i n c l u d i n g
                  d e t a i l e d p r o t o c o l and consent form;

                  a p p r o p r i a t e n e s s of requested budget t o work proposed.

             Proposals considered by t h e Division of Research Grants, N I H , and
             FDA t o b e n o t responsive t o t h e terms o u t l i n e d i n t h e RFA w i l l b e
             returned t o t h e i n v e s t i g a t o r . Late submissions w i l l be considered
             n o t responsive t o t h i s RFA. The a p p l i c a n t may then wish t o consider
             submitting t h e a p p l t c a t i o n t o t h e Division of Research Grants, N I H ,
             as a r e g u l a r r e s e a r c h g r a n t a p p l i c a t i o n s .

        V.   METHOD OF APPLYTNG

             A.    Letter of I n t e n t

                   Prospective a p p l i c a n t s a r e requested t o submit a one-page
                   l e t t e r of i n t e n t which should include a b r i e f d e s c r i p t i o n
                   of proposed areas of r e s e a r c h t o be s t u d i e d and t h e r e s e a r c h
                   r e s o u r c e s t o be available (e.g. personnel, f a c i l i t i e s , e t c . ) .
                   These l e t t e r s should be received by no l a t e r than October 15,
                   1979, and addressed t o :

                                                 D r . Bernard Cabana 

                                                 Division of Biopharmaceutics 

                                                 Bureau of Drugs (HFD-520) 

                                                 Food and Drug Administration
                                                 Room 16-62, Parklawn Building 

                                                 5600 F i s h e r s Lane 

                                                 Rockville, Maryland 20857 

                                                 Telephone: (301) 443-4750
Page Thirty-eight

        For f u r t h e r information about t h i s program, i n v e s t i g a t o r s are
        encouraged t o c o n t a c t D r . Cabana.

        The Bureau of Drugs r e q u e s t s such l e t t e r s o n l y t o p r o v i d e a n
        i n d i c a t i o n of t h e number and scope of a p p l i c a t i o n s t o be
        reviewed. A l e t t e r of i n t e n t i s n o t b i n d i n g , and i t w i l l n o t
        e n t e r i n t o t h e r e v i e w of any a p p l i c a t i o n s u b s e q u e n t l y n o r i s
        i t a n e c e s s a r y requirement f o r a p p l i c a t i o n .

   B.   A p p l i c a t i o n Procedure

        A p p l i c a t i o n s must be s u b m i t t e d - o n t h e s t a n d a r d r e s e a r c h g r a n t
        a p p l i c a t i o n form PHS 398 which may be o b t a i n e d from:

                                        O f f i c e of Grants I n q u i r i e s
                                        D i v i s i o n of Research Grants
                                        N a t i o n a l I n s t i t u t e s of H e a l t h
                                        Room 448, Westwood B u i l d i n g
                                        Bethesda, Maryland 20205

        o r from b u s i n e s s o r g r a n t s and c o n t r a c t s o f f i c e s a t most academic
        and r e s e a r c h i n s t i t u t i o n s . A statement from c o l l a b o r a t o r s ( i f
        any) i n d i c a t i n g t h e i r w i l l i n g n e s s t o p a r t i c i p a t e i n t h e p r o j e c t
        should be ficluded.                  For purposes of i d e n t i f i c a t i o n and p r o c e s s i n g ,
        t h e words "BIOAVAILABILITY OF ORAL DOSAGE FORMS" must be typed
        on t h e f a c e page of t h e a p p l i c a t i o n and a b r i e f c o v e r i n g l e t t e r
        must be a t t a c h e d i n d i c a t i n g that t h e submission i s i n response t o
        RFA #FDA-HFD-79-4.                A copy of t h e c o v e r i n g l e t t e r must a l s o b e
        s e n t t o Dr. Cabana a t t h e above a d d r e s s .

        The o r i g i n a l - a n d six (6) c o p i e s of t h e completed a p p l i c a t i o n
        and c o v e r l e t t e r should b e sent o r d e l i v e r e d t o :

                                        D i v i s i o n of Research Grants
                                        N a t i o n a l I n s t i t u t e s of Health
                                        Room 240, Westwood B u i l d i n g
                                        5333 Westbard Avenue
                                        Bethesda, Maryland 20205

        LABEL THE OUTSIDE OF THE MAILING PACKAGE AND THE TOP OF THE FACE
        PAGE " I N RESPONSE TO RFA #FDA-HFD-79-4."

        This program i s n o t s u b j e c t to OMB C i r c u l a r A-95 c l e a r i n g h o u s e
        requirements o r H e a l t h Systems Agency review.
         c


 .           N I H Guide for Grants and C o n t r a c t s 

             Vol. 8, No. 12, September 26, 1979                                                            Page T h i r t y n i n e 



 Wfl         REQUEST FOR RESEARCH GRANT APPLICATION:                         RFA                      FDA- H FD- 7 9 - 3

                    BUREAU OF DRUGS
              FOOD AND DRUG ADMINISTRATION

                               TITLE :    THE PHARMACOUNETICS AND BIOAVAILABILITY
                                                 OF DRUG‘S I N DISEASE STATES
                                        Application receipt date, November 15, 1979


             I.    BACKGROUND INFORMATION

                   The Biopharmaceutics Program of t h e Buresu of Drugs, FDA, i n v i t e s
                   a p p l i c a t i o n s t o b e i n i t i a t e d d u r i n g Fy 1980 f o r r e s e a r c h g r a n t s
                   r e l a t e d t o s t u d i e s of t h e pharmacokinetics and b i o a v a i l a b i l i t y of
                   d r u g s i n d i s e a s e states.

                   The Bureau o f Drugs has supported pharmacokinetic and b i o a v a i l a b i l i t y
                   s t u d i e s i n t h e p a s t through t h e mechanism of t h e c o n t r a c t . T h i s RFA
                   i s t h e f i r s t a t t e m p t by F A t o s t i m u l a t e i n v e s t i g a t o r i n t e r e s t i n
                                                         D
                   t h i s area through t h e award o f g r a n t s . Each s u c c e s s f u l a p p l i c a n t
                   w i l l be expected t o p l a n , d i r e c t , and e x e c u t e h i s / h e r own r e s e a r c h
                   program.

             11.   RESEARCH GOALS AND SCOPE
,
1
%
                   B i o a v a i l a b i l i t y / b i o e q u i v a l e n c y s t u d i e s are g e n e r a l l y done i n normal
                   s u b j e c t s . Y e t , t h e drug i s u s u a l l y a d m i n i s t e r e d t o unhealthy s u b j e c t s .
                   A s a consequence, o u r knowledge of t h i s a s p e c t of t h e performance of
                   d r u g s i s d e f i c i e n t i n t h a t w e do n o t know how d i s e a s e s t a t e may
                   i n f l u e n c e performance. It i s t h e r e f o r e n e c e s s a r y t o undertake
                   bioavailabilitylbioequivalency i n i n d i v i d u a l s i n d i s e a s e s t a t e s f o r
                   which a given drug i s i n d i c a t e d as w e l l a s o t h e r d i s e a s e s t a t e s .
                   Some examples r e g a r d i n g t h e p o s s i b l e e f f e c t o f d i s e a s e s t a t e on drug
                   a b s o r p t i o n , metabolism, and a c t i o n a r e p r e s e n t e d b e l o w .

                   Renal Function Impairment                 T h i s i s probably t h e most common and most
                   important s i t u a t i o n i n which dosage adjustment i s n e c e s s a r y . The h a l f -
                   l i f e of many d r u g s that are e l i m i n a t e d from t h e body predominantly by
                   glomerular f i l t r a t i o n h a s been shown t o i n c r e a s e s e v e r a l - f o l d i n
                   oliguric patients.            For example, t e t r a c y c l i n e h a s a h a l f - l i f e of 57
                   t o 108 hours i n p a t i e n t s w i t h r e n a l d i s o r d e r s compared t o 8.5 hours
                   i n normal p a t i e n t s . Likewise, the h a l f - l i f e o f d i g o x i n i n c r e a s e s by
                   almost t h r e e - f o l d i n a n u r i c s u b j e c t s .

                   L i v e r Disease The d i s a p p e a r a n c e of many d r u g s e l i m i n a t e d mainly
                   by metabolism has been shown t o be a f f e c t e d by l i v e r d i s e a s e s . For

              All p o l i c i e s and requirements t h a t govern t h e r e s e a r c h g r a n t s programs
              of PHS w i l l apply. T h i s program i s supported under t h e a u t h o r i z a t i o n
              of S e c t i o n 301 of t h e P u b l i c H e a l t h S e r v i c e Act, a s amended ( 4 2 USC 2 4 1 ) .
wndr 	        The Catalog of F e d e r a l Domestic A s s i s t a n c e number i s 13.103.             Cost-sharing
              is required.
 Page Forty

       example, t h e h a l f - l i f e of e l i m i n a t i o n of tolbutamide i n 5 o u t of
       1 0 c i r r h o t i c p a t i e n t s w a s found t o Se 7 . 8 hours t o 1 1 . 2 hours compared
       t o an a v e r a g e of 4 . 4 hours i n p a t i e n t s w i t h normal l i v e r f u n c t i o n .
       Also, t h e e l i m i n a t i o n of chloramphenical, phenylbutazone, meprobamate,
       a m o b a r b i t a l , acetaminophen, l i d o c a i n e , and p r e d n i s o l o n e , was decreased
       i n l i v e r - d i s e a s e d p a t i e n t s . Liver d i s e a s e s a r e l i k e l y t o produce
       q u a l i t a t i v e and q u a n t i t a t i v e changes i n plasma p r o t e i n s and binding 

       of drugs. These changes may a f f e c t t h e pharmacokinetics and, subsequently, 

       t h e pharmacologic a c t i o n of drugs. For example, an a s s o c i a t i o n w a s 

       found between low serum albumin l e v e l s and a d v e r s e e f f e c t s of prednisone 

       i n 2 4 0 p a t i e n t s . P r o t e i n binding of a m y l o b a r b i t a l was reduced i n 

       p a t i e n t s w i t h abnormally low c o n c e n t r a c t i o n s o f albumin i n serum, 

       and t h e h a l f - l i f e of disappearance o f t h e drug w a s i n c r e a s e d by b e t t e r 

        than two-fold. 


       Cardiovascular The e f f e c t s of c o n g e s t i v e h e a r t f a i l u r e o c c u r s
       where decreased c a r d i a c o u t p u t r e s u l t s i n d e c r e a s e d blood p e r f u s i o n
       of many p a r t s of t h e body, i n c l u d i n g t h e g a s t r o i n t e s t i n a l t r a c t .
       Therefore, t h e r a t e and e x t e n t of a drug product may be a f f e c t e d i n
       an i n d i v i d u a l w i t h c o n g e s t i v e h e a r t f a i l u r e . For example, p a t i e n t s
       w i t h c o n g e s t i v e h e a r t f a i l u r e who were a d m i n i s t e r e d q u i n i d i n e have
       Tmax v a l u e s approximately two hours l a t e r than i n normal i n d i v i d u a l s .
       F u r t h e r , t h e estimated r a t e of drug a b s o r p t i o n i n t h e c o n g e s t i v e
       heart f a i l u r e p a t i e n t s w a s only o n e - t h i r d of that i n normal s u b j e c t s .
       A l l of t h e p r o c e s s e s involved i n drug d i s p o s i t i o n , a b s o r p t i o n ,
       d i s t r i b u t i o n , and e l i m i n a t i o n may be i n f l u e n c e d by p e r f u s i o n c o n s i d e r a ­
       t i o n s . A l t e r a t i o n s i n organ p e r f u s i o n may a r i s e because of e i t h e r
       changes i n t h e magnicude a n d / o r t h e r e g i o n a l d i s t r i b u t i o n of t h e
       c a r d i a c o u t p u t and may i n v o l v e p h y s i o l o g i c a l , p a t h o l o g i c a l , s u r g i c a l ,
       o r drug r e l a t e d e v e n t s .

111.   MECHANISM OF SUPPORT

       A . 	 E l i g i b i l i t y These g r a n t s are a v a i l a b l e t o any p u b l i c o r
             private nonprofit university, college, hospital, laboratory,
             o r o t h e r i n s t i t u t i o n , i n c l u d i n g S t a t e and l o c a l u n i t s of
             government.

       B. 	 Length o f Support                The a p p l i c a t i o n may n o t r e q u e s t more than t h r e e
              y e a r s of s u p p o r t . Continued support beyond t h r e e y e a r s i s s u b j e c t
              t o t h e g r a n t e e ’ s performance, t h e c o m p e t i t i v e review p r o c e s s , and
              t h e a v a i l a b i l i t y of funds.

       C. 	   Funding P l a n The a c t u a l number of p r o j e c t s funded will
              depend on t h e q u a l i t y of t h e a p p l i c a t i o n s r e c e i v e d . The
              t o t a l amount of funds a v a i l a b l e f o r FY 1980 is a n t i c i p a t e d
              t o be approximately $250,000.

 IV.   REVIEW PROCEDURES LID C R I T E R ~ A

       The receipt d a t e f o r a p p l i c a t i o n s i s November 1 5 , 1979. They w i l l
       undergo i n i t i a l review i n February-March 1980 and subsequent review
       by a N a t i o n a l Advisory Council i n May 1980. The earliest s t a r t i n g
       d a t e f o r s u c c e s s f u l a p p l i c a n t s w i l l be J u l y 1, 1980.
N I H Guide f o r Grants and Contracts

Vol. 8, No. 12, September 26, 1979                                                               Page f o r t y one 


     A p p l i c a t i o n s i n response t o t h i s i n v i t a t i o n w i l l be reviewed on a
     nationwide b a s i s i n competition w i t h each o t h e r and i n accordance
     with t h e following c r i t e r i a :

     0 	   t h e s c i e n t i f i c merit of t h e r e s e a r c h d e s i g n , approaches and
           methodology i n c l u d i n g a thorough review of t h e l i t e r a t u r e :

           t h e r e l e v a n c e o f t h e r e s e a r c h e x p e r i e n c e , t r a i n i n g , and competence
           of t h e p r i n c i p a l i n v e s t i g a t o r and s t a f f t o c a r r y o u t t h e proposed
           p r o j e c t . This i n c l u d e s published r e s e a r c h work by t h e i n v e s t i g a t o r
           on pharmacokinetics and b i o a v a i l a b i l i t y of d r u g s ;

           a d e s c r i p t i o n o f ongoing r e s e a r c h i n t h e area of pharmacokinetics
           and b i o a v a i l a b i l i t y of drugs;

     e 	 adequacy of t i m e ( e f f o r t ) TO be devoted t o t h e p r o j e c t by
           i n v e s t i g a t o r ( s ) and technical s t a f f and evidence of i n s t i t u t i o n a l
           commitment t o t h e program;

     e 	 s p e c i f i c information on t h e i n s t i t u t i o n ' s p r e s e n t p a t i e n t l o a d
         and p r o j e c t i o n s f o r p a t i e n t involvement i n c l i n i c a l i n v e s t i g a t i o n ;

           t h e academic p o s i t i o n s and major r e s e a r c h i n t e r e s t s of t h e
           p r o j e c t d i r e c t o r and t h e p r o f e s s i o n a l s t a f f t h a t w i l l be involved
           i n t h e p r o j ec t ;

     0	    p l a n f o r complying w i t h r e g u l a t i o n s f o r t h e p r o t e c t i o n of human
           s u b j e c t s a s a p p l i c a b l e t o t h e proposed s t u d y , i n c l u d i n g d e t a i l e d
           p r o t o c o l and consent form;

     0     a p p r o p r i a t e n e s s o f requested budget t o work proposed.

     P r o p o s a l s considered by t h e D i v i s i o n of Research Grants, N I H , and F A                D
     t o be n o t r e s p o n s i v e t o t h e RFA w i l l be r e t u r n e d t o t h e i n v e s t i g a t o r .
     The a p p l i c a n t may then wish t o c o n s i d e r s u b m i t t i n g t h e a p p l i c a t i o n t o
     .the Division of Research Grants, N I H , a s a r e g u l a r research grant
     a p p l ica tion.

V.   METHOD OF APPLYING

     A.     Letter of I n t e n t

            P r o s p e c t i v e a p p l i c a n t s are r e q u e s t e d t o submit a one-page l e t t e r
            of i n t e n t which should i n c l u d e a b r i e f d e s c r i p t i o n of t h e proposed
            areas of r e s e a r c h t o b e s t u d i e d and t h e r e s e a r c h r e s o u r c e s t o be
            a v a i l a b l e (e.g. p e r s o n n e l , f a c i l i t i e s , e t c . ) . These l e t t e r s
            should be r e c e i v e d no l a t e r t h a n O c t o b e r 1 5 , 1 9 7 9 . and addressed
            to:
Page Forty two

                                      D r . Bernard Cabana 

                                      D i v i s i o n of Biopharmaceutics 

                                      Bureau of Drugs (HFD-520) 

                                      Food and Drug A d m i n i s t r a t i o n 

                                      Room 16-62, Parklawn B u i l d i n g 

                                      5600 F i s h e r s Lane 

                                      R o c k v i l l e , Maryland 20857 


                                      Telephone:          (301) 443-4750 


        For f u r t h e r i n f o r m a t i o n about t h i s program, i n v e s t i g a t o r s a r e
        encouraged t o c o n t a c t D r . Cabana.

        The Bureau of Drugs r e q u e s t s such l e t t e r s o n l y t o p r o v i d e an
        i n d i c a t i o n of t h e number and scope of a p p l i c a t i o n s t o be r e c e i v e d .
        A l e t t e r of i n t e n t i s n o t binding, and i t w i l l n o t e n t e r i n t o
        t h e review of any a p p l i c a t i o n subsequently n o r i s i t a n e c e s s a r y
        requirement f o r a p p l i c a t i o n .

   B.   ApElication Procedure
        -

        A p p l i c a t i o n s must be submitted on t h e s t a n d a r d r e s e a r c h g r a n t
        a p p l i c a t i o n form PHS 398 which may be o b t a i n e d from:

                                      O f f i c e of Grants I n q u i r i e s
                                      D i v i s i o n of Research G r a n t s
                                      N a t i o n a l I n s t i t u t e s of H e a l t h
                                      Room 448, Westwood B u i l d i n g
                                      Bethesda, Maryland 20205

        o r from b u s i n e s s o r g r a n t s and c o n t r a c t s o f f i c e s a t most academic
        and r e s e a r c h i n s t i t u t i o n s . A s t a t e m e n t from c o l l a b o r a t o r s ( i f any)
        i n d i c a t i n g t h e i r w i l l i n g n e s s t o p a r t i c i p a t e i n t h e p r o j e c t should
        be included. For purposes of i d e n t i f i c a t i o n and p r o c e s s i n g , t h e
        words "PHARMACOKINETICS AND BIOAVAILABILITY OF DRUGS" must be
        typed on t h e f a c e page a f t h e a p p l i c a t i o n and a b r i e f covering
        l e t t e r must be a t t a c h e d i n d i c a t i n g t h a t t h e submission i s i n
        response t o RFA #FDA-HFD-79-3.                         A copy o f t h e c o v e r i n g l e t t e r
        must a l s o be s e n t t o D r . Cabana a t t h e above a d d r e s s .

        The o r i g i n a l and s i x ( 6 ) c o p i e s of t h e completed a p p l i c a t i o n and
        cover l e t t e r should be s e n t o r d e l i v e r e d t o :

                                      D i v i s i o n of Research Grants
                                      N a t i o n a l I n s t i t u t e s of H e a l t h
                                      Room 240, Westwood B u i l d i n g
                                      Bethesda, Maryland 20205

        LABEL THE OUTSIDE OF THE MAILING PACKAGE AND THE TOP OF THE FACE PAGE
        " I N RESPONSE TO RFA #FDA-HFD-79-3                   ."
        This program i s n o t s u b j e c t t o OMB C i r c u l a r A-9.5 c l e a r i n g h o u s e
        requirements o r H e a l t h S y s t e m s Agency review.
       NIH  Guide f o r Grants and Contracts 

       Yo1 , 8, No. 1 2 , September 26, 1979                                                                   Page F o r t y t h r e e 



*fl    EXTRAMURAL ASSOCIATES PROGRAM


       The N a t i o n a l I n s t i t u t e s of Health (NIH) announces a s p e c i a l program under
       t h e Intergovernmental Personnel Act (IPA) of 1970 ( P u b l i c Law 91-648) t o
       promote t h e e n t r y and p a r t i c i p a t i o n of e t h n i c m i n o r i t i e s and women i n NIH-
       supported r e s e a r c h .

       P a r t i c i p a t i o n i n NIH-supported r e s e a r c h i s f a c i l i t a t e d by a thorough
       knowledge of t h e r e s e a r c h concerns of t h e N I H , t h e support mechanisms
       through which t h i s r e s e a r c h i s being accomplished, and t h e p o l i c i e s and
       procedures which govern t h e awarding of g r a n t s and c o n t r a c t s . The IPA
       o f f e r s an o p p o r t u n i t y t o d i s s e m i n a t e needed knowledge by a u t h o r i z i n g ,
       f o r work of mutual concern and b e n e f i t , temporary appointments of employees
       between Federal e x e c u t i v e a g e n c i e s , S t a t e and l o c a l governments, i n s t i t u ­
       t i o n s of h i g h e r education, and I n d i a n t r i b a l governments.

       I n r e c e n t y e a r s , s i g n i f i c a n t numbers of personnel from academic i n s t i t u t i o n s
       have e f f e c t e d temporary assignments a t t h e N I H u s i n g t h e I P A mechanism.
       Y e t , i n s t i t u t i o n s which t r a d i t i o n a l l y c o n t r i b u t e t o t h e b a s i c p r e p a r a t i o n
       of m i n o r i t i e s and women f o r biomedical s c i e n c e are n o t u t i l i z i n g t h i s
       o p p o r t u n i t y t o an e q u a l e x t e n t . While n o t excluding any i n d i v i d u a l s o r
       i n s t i t u t i o n s from t h e a v a i l a b l e o p t i o n s under t h e IPA, t h e N I H i s 

       i n i t i a t i n g a s p e c i a l e f f o r t , t h e Extramural A s s o c i a t e s Program; i n o r d e r t o 

       r e d r e s s a n o t i c e a b l e i n e q u i t y i n t h e c u r r e n t u s e of an a v a i l a b l e o p p o r t u n i t y . 


%& 	   Under t h e Extramural A s s o c i a t e s Program, t h e N I H , i n each of two groups,
       w i l l i n v i t e up t o e i g h t key a d m i n i s t r a t o r s , involved w i t h s c i e n c e , from
       s c h o o l s which c o n t r i b u t e s i g n i f i c a n t l y t o t h e pool of m i n o r i t i e s and
       women i n s c i e n c e , t o spend s i x months i n r e s i d e n c e i n Bethesda, Maryland.
       S a l a r y , travel, and r e l a t e d expenses w i l l be reimbursed by t h e N I H t o
       t h e l i m i t allowed under t h e IPA. I n a d d i t i o n , a p e r diem allowance has
       been arranged t o cover normal c o s t of l i v i n g w h i l e i n Bethesda.

       While in the program, the Associates will work in rotating assignments 

       w i t h s e n i o r members of t h e s t a f f of t h e N I H and o t h e r F e d e r a l a g e n c i e s .
       They w i l l a t t e n d seminars, committee meetings, workshops, and s i t e v i s i t s
       and w i l l have t h e o p p o r t u n i t y t o o b t a i n , on s i t e , information about
       F e d e r a l h e a l t h - r e l a t e d programs and a s s o c i a t e d g r a n t i n g and c o n t r a c t i n g
       activities.

       The N I H e x p e c t s that such information w i l l p r i m a r i l y b e n e f i t t h e i n s t i t u t i o n s
       from which t h e A s s o c i a t e s come in t h e s e n s e t h a t , when t h e A s s o c i a t e s r e t u r n
       t o t h e i r s c h o o l s , t h e y w i l l be r e s o u r c e s from whom f a c u l t y and s t u d e n t s
       (many of whom w i l l b e m i n o r i t y and/or female), can o b t a i n information on
       NIH-funded h e a l t h - r e s e a r c h programs. The information gained w i l l a l s o
       b e n e f i t t h e A s s o c i a t e s themselves i n t h e i r p r o f e s s i o n a l development as
       a d m i n i s t r a t o r s of s c i e n c e . I n a d d i t i o n , t h e N I H e x p e c t s immediate b e n e f i t s
       from t h e s p e c i a l c o n t r i b u t i o n s t o be made by t h e s e experienced a d m i n i s t r a t o r s
       while a t t h e NIH.
Page Forty four

Nomination of a c a n d i d a t e w i l l b e accepted from t h e p r e s i d e n t or an e q u i v a l e n t
o f f i c i a l of a n e l i g i b l e i n s t i t u t i o n . I n a d d i t i o n t o t h e g e n e r a l requirements
of t h e IPA, emphasis f o r s e l e c t i o n of A s s o c i a t e s w i l l b e on t h e demonstrated
c o n t r i b u t i o n of a n i n s t i t u t i o n t o t h e advancement of ethnic m i n o r i t i e s and
women; on i t s p l a n t o u t i l i z e t h e A s s o c i a t e ' s newly gained knowledge t o
promote e n t r y o f m i n o r i t i e s o r women i n t o h e a l t h - r e l a t e d s c i e n c e s ; and on
t h e q u a l i f i c a t i o n s , e x p e r i e n c e , and i n t e r e s t of t h e nominee. Consideration
w i l l be given t o a r e p r e s e n t a t i v e d i s t r i b u t i o n of A s s o c i a t e s from among t h e
nominating c o l l e g e s and u n i v e r s i t i e s .

A l l A s s o c i a t e s w i l l b e r e q u i r e d t o p a r t i c i p a t e i n t h e program for s i x months
beginning approximately August 1, 1980, o r February 1, 1981. Nomhations and
completed a p p l i c a t i o n s a r e due by January 31, 1980; s e l e c t i o n s w i l l b e
announced by A p r i l 30, 1980.

A d d i t i o n a l information concerning t h i s program and i n s t r u c t i o n s f o r completing
t h e a p p l i c a t i o n may b e o b t a i n e d by w r i t i n g o r c a l l i n g :

                                    Adm i n ist ra t or
                                    Extramural Associates Program
                                    N a t i o n a l I n s t i t u t e s of H e a l t h
                                    Room 1Al0, Building 31
                                    Bethesda, Maryland 20205

                                    Telephone:           (301) 496-9728
      NIH Guide for Grants and Contracts
      Vol . 8 , No. 12, September 26, 1979                                                                 Page Forty f i v e

         REVISED INSTRUCTIONS 

                        -
                        FO R

                COMPLETION OF
      RESEARCH GRANT APPLICATIONS

                (Form PHS 398)

      The NIH Guide for Grants and Contracts, Vol. 8, No. 10, J u l y 23, 1979,
      e d i t i o n d e s c r i b e d c e r t a i n changes e f f e c t i v e immediately i n t h e r e s e a r c h
      g r a n t a p p l i c a t i o n form PHS 398. The page l i m i t a t i o n f o r b i o g r a p h i c a l
      s k e t c h e s w a s i n c o r r e c t l y noted as two pages i n t h e announcement. U n t i l t h e
      new form PHS 398 i t s e l f i s a v a i l a b l e , b i o g r a p h i c a l s k e t c h e s may be t h r e e
      pages i n l e n g t h . Three pages a r e needed because o t h e r r e s e a r c h support is
      c u r r e n t l y d e s c r i b e d i n t h e b i o g r a p h i c a l s e e t i o n . I n t h e new form PHS 398
      that w i l l be a v a i l a b l e i n several months, t h e b i o g r a p h i c a l s k e t c h page
                                     -
      l i m i t a t i o n w i l l b e two pages, o t h e r r e s e a r c h support w i l l b e d e s c r i b e d i n
      another section.

      F l i e r s i n c u r r e n t PHS 398 a p p l i c a t i o n k i t s d a t e d June 1979 o r August 7, 1979,
      c o r r e c t l y i n d i c a t e t h r e e pages as t h e c u r r e n t b i o g r a p h i c a l s k e t c h l i m i t a t i o n .

      Numerous i n q u i r i e s have been r e c e i v e d about a p p l i c a t i o n s that have been
      submitted o r are n e a r l y completed which used t h e "old" i n s t r u c t i o n s i n t h e
q-v                                                  -
      PHS 398 k i t s . Although PHS w i l l a c c e p t a p p l i c a t i o n s prepared u s i n g t h e
      I n s t r u c t i o n Sheet i n c u r r e n t PHS 398 k i t s dated "Rev. 2-73," a p p l i c a n t s a r e
      asked t o begin u s i n g a t t h e e a r l i e s t p o s s i b l e t i m e t h e new format s p e c i f i e d
      i n t h e J u l y 23, 1979, i s s u e of t h e Guide and f l i e r s i n t h e a p p l i c a t i o n k i t s
      e n t i t l e d Revised I n s t r u c t i o n s f o r Research Grant A p p l i c a t i o n s dated June 1979
      o r August 7, 1979.
N I H G u i d e f o r G r a n t s and C o n t r a c t s 

Vol . 8, No. 12, S e p t e m b e r 26, 1979                                         P a g e F o r t y seven 


  NURSING RESEARCH PROGRAM GRANTS
  D I V I S I O N O F NURSING


  The Division of Nursing, Health Resources Administration, today
  announced that a site visit will no longer be required prior to review
  of a Nursing Research Program Grant Application. This announcement
  is effective for all applications submitted for the November 1 review
  cycle. Nursing Research Program Grants are awarded to eligible
  institutions to stimulate the conduct of clusters of studies focused
  upon a single theme, and pre-review site visits have been required.
  A site visit will now be made only when it is essential to obtain
  additional information.

  Applicants should contact Dr. Doris Bloch early in the process of
  developing an application to determine programmatic eligibility.
  Dr. Bloch may be contacted by telephone ( 3 0 1 ) 436-6204 or by writing
  to :

                                         Research Support Section
                                         Nursing Research Branch
                                         Division of Nursing, BHM, HRA
                                         3700 East-West Highway, Room 3-50
                                         Hyattsville, Maryland 20782




  PkJRSING RESEARCH PROJECT GRANTS
  DIVISION O F NURSING 



  The Division of Nursing is continuing to accept applications for 

  Nursing Research Project Grants for individual research studies in 

  areas of interest to nursing. This long-standing program has not 

  been replaced by the "cluster of studies'' program described above. 

  Additional information may be obtained by contacting the Research 

  Support Section of the Division of Nursing. 





                                                                46 GOVERNMENT PRINTING OFFICE: lo70 28)-p,sj/o
                                                                 1                                               14

								
To top