NIH Guide - Vol. 20, No. 29 - July 26, 1991

NOTICE OF MAILING CHANGE 0 Check here if you wish to discontinue receiving this publication 0 heck here if your address has C changed and you wish to con­ tinue receiving this publication. Make corrections below and mail this page to: NIH Guide Printing & Reproduction Branch National Institutes of Health Room B4BNO8, Building 31 Bethesda, Maryland 20892 U.S. DEPARTMENT OF HENUH AND HUMAN SERVICES OFFICIAL BI'SINES First Class Mail Postages & Fees Paid PHS/NIH/OD Penalty for Private Use, $300 The NIH Guide announces scientific initiatives and provides policy and administrative information to indivi­ duals and organizationswho need t o be kept informed ofopponunities, requirements. and changes in extramural programs administered by the National institutes of Health. V o l . 2 0 , No. 2 9 July 26, 1991 N I H G U I D E - V o l . 2 0 , N O . 2 9 , J u l y 2 6 , 1991 NOTICES OF A V A I L A B I L I T Y (RFPs AND RFAs) NATIONAL RESEARCH SERVICE AWARD--INSTITUTIONAL GRANTS (RFA HS-91-03) Agency f o r H e a l t h Care P o l i c y and R e s e a r c h I n d e x : HEALTH CARE POLICY, HEALTH CARE RESEARCH MEDTEP RESEARCH CENTERS O N M I N O R I T Y POPULATIONS (RFA HS-91-02) Agency f o r H e a l t h C a r e P o l i c y and R e s e a r c h I n d e x : HEALTH CARE P O L I C Y , HEALTH CARE RESEARCH ....... 1 ............. 3 O N G O I N G PROGRAM ANNOUNCEMENTS A N O R E X I A NERVOSA AND BULIMIA NERVOSA: BASIC B R A I N , B E H A V I O R A L , AND C L I N I C A L STUDIES (PA-91-79) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N a t i o n a l I n s t i t u t e o f Mental H e a l t h I n d e x : MENTAL HEALTH 6 ANTICANCER MODEL DEVELOPMENT (PA-91-80) N a t i o n a l Cancer I n s t i t u t e I n d e x : CANCER .................................... 8 ERRATUM PROGRAM PROJECTS ON AUTOIMMUNITY (RFA AI-91-09) ............................ N a t i o n a l I n s t i t u t e o f A l l e r g y and I n f e c t i o u s Diseases I n d e x : ALLERGY, INFECTIOUS DISEASES 11 NOTICES OF A V A I L A B I L I T Y (RFPs AND RFAs) N A T I O N A L RESEARCH SERVICE AWARD--INSTITUTIONAL GRAKTS RFA AVAILABLE: P.T. 44; K . W . HS-91-03 0 7 2 0 0 0 5 , 0730050, 1004017, 0408006 Agency f o r H e a l t h Care P o l i c y and R e s e a r c h A p p l i c a t i o n R e c e i p t Date: PURPOSE The Agency f o r H e a l t h Care P o l i c y and R e s e a r c h (AHCPR) a w a r d s N a t i o n a l R e s e a r c h S e r v i c e Award (NRSA) i n s t i t u t i o n a l g r a n t s (T32) t o e l i g i b l e i n s t i t u t i o n s t o d e v e l o p o r enhance r e s e a r c h t r a i n i n g o p p o r t u n i t i e s f o r q u a l i f i e d i n d i v i d u a l s o f t h e i n s t i t u t i o n ' s s e l e c t i o n who s e e k t o p r e p a r e f o r careers i n h e a l t h s e r v i c e s r e s e a r c h . T h i s Request f o r A p p l i c a t i o n s (RFA) a n n o u n c e s t h e a p p l i c a t i o n r e c e i p t d a t e f o r t h i s program ( O c t o b e r IO, 1991) and i d e n t i f i e s t h e t r a i n i n g areas of s p e c i a l i n t e r e s t . The p u r p o s e o f t h e s e awards i s t o a s s i s t d o m e s t i c i n s t i t u t i o n s i n s u p p o r t i n g p r e d o c t o r a l and p o s t d o c t o r a l academic t r a i n i n g . The awards a l l o w t r a i n e e s t o g a i n e x p e r i e n c e i n a p p l y i n g r e s e a r c h methods t o t h e s y s t e m a t i c a n a l y s e s and evaluation of h e a l t h s e r v i c e s . I n d i v i d u a l s a r e s e l e c t e d by i n s t i t u t i o n s on t h e b a s i s o f a d e m o n s t r a t e d i n t e r e s t and r e l e v a n t background i n h e a l t h services research. O c t o b e r 1 0 , 1991 N I H G U I D E - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 1 MECHANISM OF SUPPORT T h i s announcement i s made s u b j e c t t o a v a i l a b i l i t y o f f u n d s . AHCPR r e s e r v e s t h e r i g h t t o withdraw t h i s R e q u e s t f o r A p p l i c a t i o n s i f f u n d s d o n o t become a v a i l a b l e . T h i s i s a o n e - t i m e announcement. A p p l i c a t i o n s w i l l n o t be a c c e p t e d a f t e r O c t o b e r I O , 1991. AHCPR e x p e c t s t o f u n d no more t h a n f i v e new awards i n r e s p o n s e t o t h i s R F A . - d m LEVELS AND AREAS OF T R A I N I N G A p p l i c a n t i n s t i t u t i o n s may a p p l y f o r s u p p o r t f o r p r e d o c t o r a l s t u d e n t s , p o s t d o c t o r a l s t u d e n t s , o r a combination. A p p l i c a n t s must i n c l u d e a r a t i o n a l e f o r t h e i r c h o i c e o f s u p p o r t i n g t y p e ( s ) o f s t u d e n t s . R e s e a r c h t r a i n i n g must p r o v i d e t h e c o n c e p t u a l and m e t h o d o l o g i c a l f o u n d a t i o n f o r i n v e s t i g a t i n g some o r a l l o f t h e f o l l o w i n g h e a l t h c a re a r e a s : ( 1 ) p r i m a r y c a r e i s s u e s , i n c l u d i n g development o f t e c h n i q u e s t o measure t h e e f f e c t i v e n e s s o f managing h e a l t h c a r e c o n d i t i o n s ; ( 2 ) a p p r o p r i a t e n e s s and e f f e c t i v e n e s s o f a l t e r n a t i v e t r e a t m e n t s i n t e r m s o f p a t i e n t outcomes and u s e o f s e r v i c e s ; (3) f a c t o r s a f f e c t i n g d i s s e m i n a t i o n and a s s i m i l a t i o n o f i n f o r m a t i o n on h e a l t h c a r e t e c h n o l o g i e s and o t h e r a s p e c t s o f c l i n i c a l p r a c t i c e ; (4) a l t e r n a t i v e a p p r o a c h e s t o o r g a n i z i n g , f i n a n c i n g , and r e i m b u r s i n g f o r h e a l t h c a r e s e r v i c e s and t h e i r e f f e c t s on c o s t , q u a l i t y , and access; ( 5 ) a p p l i c a t i o n o f m e d i c a l i n f o r m a t i c s t o t h e development o f e x p e r t s y s t e m s f o r t r e a t m e n t s e l e c t i o n and d i a g n o s i s ; ( 6 ) p r a c t i c e - b a s e d r e s e a r c h , i n c l u d i n g c l i n i c a l p r a c t i c e v a r i a t i o n s and g u i d e l i n e d e v e l o p m e n t ; ( 7 ) m e d i c a l m a l p r a c t i c e and l i a b i l i t y ; ( 8 ) d e l i v e r y o f h e a l t h s e r v i c e s t o t h e medically underserved, e s p e c i a l l y i n r u r a l areas; ( 9 ) a v a i l a b i l i t y , a c c e s s i b i l i t y , and q u a l i t y o f c a r e f o r low-income g r o u p s , m i n o r i t i e s , and t h e e l d e r l y ; ( I O ) c o s t - e f f e c t i v e n e s s and c o s t - b e n e f i t a n a l y s i s , i n c l u d i n g a l l o c a t i o n of h e a l t h care r e s o u r c e s and r e l a t i o n s h i p t o h e a l t h s t a t u s ; ( 1 1 ) a l t e r n a t i v e d e l i v e r y s y s t e m s , p r o v i d e r s , and p r a c t i c e p a t t e r n s i n l o n g - t e r m c a r e , i n c l u d i n g home and community-based c a r e ; ( 1 2 ) o r g a n i z a t i o n a l s t r u c t u r e , r e s o u r c e u s e , and c o s t s o f care f o r p e r s o n s w i t h H I V - r e l a t e d i l l n e s s e s . 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 a p p l y f o r g r a n t s t o s u p p o r t r e s e a r c h t r a i n i n g programs. The a p p l i c a n t i n s t i t u t i o n must h a v e 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 p r o p o s e d program. 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 b e 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 a p p o i n t m e n t o f t r a i n e e s 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. '%d METHOD OF APPLYING A p p l i c a t i o n s must b e made on g r a n t a p p l i c a t i o n form PHS 398 ( r e v . 1 0 / 8 8 ) . This revision contains additional instructions f o r preparing i n s t i t u t i o n a l N a t i o n a l R e s e a r c h S e r v i c e Award a p p l i c a t i o n s . Completed a p p l i c a t i o n s must be mailed t o : Division of Research Grants National I n s t i t u t e s of Health Westwood B u i l d i n g , Room 240 B e t h e s d a , MD 20892** REVIEW PROCESS AND SCHEDULE The NRSA t r a i n i n g g r a n t r e c e i p t d a t e and r e v i e w c y c l e f o r a l l a p p l i c a t i o n s s u b m i t t e d i n r e s p o n s e t o t h i s RFA i s i n d i c a t e d below. Appl i c a t i o n receipt date O c t o b e r IO, 1991 I n i t i a l review group meeting November 1991 Council meeting J a n u a r y 1992 Earliest possible start date March 1992 kd A p p l i c a t i o n s w i l l b e r e v i e w e d by a n AHCPR i n i t i a l r e v i e w g r o u p ( I R G ) and t h e N a t i o n a l A d v i s o r y C o u n c i l f o r H e a l t h Care P o l i c y , R e s e a r c h , and E v a l u a t i o n . The I R G w i l l c o n s i d e r t h e f o l l o w i n g c r i t e r i a i n i t s r e v i e w : t h e g o a l s o f t h e p r o p o s e d t r a i n i n g program and t h e p r o b a b i l i t y o f a c h i e v i n g them; s u b s t a n t i v e c o n t e n t o f t h e p r o p o s e d program and i t s r e l e v a n c e t o c u r r e n t h e a l t h care c o n c e r n s ] i n c l u d i n g c o u r s e s o f f e r e d ; q u a l i f i c a t i o n s and r e s p o n s i b i l i t i e s o f t h e program d i r e c t o r ; q u a l i f i c a t i o n s o f t h e p r o g r a m ' s f a c u l t y , i n c l u d i n g o n g o i n g h e a l t h s e r v i c e s research, and commitment t o t r a c k i n g g r a d u a t e s f o l l o w i n g t r a i n i n g ; program's a b i l i t y t o r e c r u i t q u a l i f i e d t r a i n e e s ; commitment t o a d e q u a t e s p a c e , c u r r i c u l u m t i m e , f i n a n c i a l s u p p o r t , and appropriate f a c i l i t i e s ; cooperation of r e l a t e d agencies o r organizations i n p r o v i d i n g e x p e r i e n c e and r e s e a r c h t r a i n i n g s i t e s f o r t r a i n e e s ; number and t y p e s of s t u d e n t s f o r whom s u p p o r t i s r e q u e s t e d ; p r o p o s e d methods f o r m o n i t o r i n g and e v a l u a t i n g t h e p e r f o r m a n c e o f t r a i n e e s as w e l l a s t h e o v e r a l l N I H GUIDE - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 2 program; and r e a s o n a b l e n e s s o f t h e p r o p o s e d b u d g e t i n r e l a t i o n t o t h e p r o p o s e d training. I n a d d i t i o n t o t h e recommendations made by t h e I R G , t h e C o u n c i l w i l l c o n s i d e r t h e a p p l i c a n t i n s t i t u t i o n ' s p l a n s f o r (and l i k e l y s u c c e s s i n ) r e c r u i t m e n t o f i n d i v i d u a l s from u n d e r r e p r e s e n t e d m i n o r i t y g r o u p s i n t o t h e t r a i n i n g p r o g r a m . Funding d e c i s i o n s w i l l b e b a s e d on t h e r e v i e w g r o u p s ' r e c o m m e n d a t i o n s , t h e need f o r r e s e a r c h p e r s o n n e l i n s p e c i f i e d program a r e a s , and t h e a v a i l a b i l i t y of funds. INQUIRIES The AHCPR s u p p o r t s t r a i n i n g i n a l l a r e a s o f h e a l t h s e r v i c e s r e s e a r c h . I n q u i r i e s r e g a r d i n g t h i s RFA and r e q u e s t s f o r a copy o f t h e f u l l RFA may be directed t o : DonnaRae Cast i l l 0 NRSA P r o j e c t O f f i c e r Agency f o r H e a l t h Care P o l i c y and R e s e a r c h Parklawn B u i l d i n g , Room 18A-10 R o c k v i l l e , MD 20857 Telephone: ( 3 0 1 ) 443-2904 I n f o r m a t i o n on g r a n t s management i s s u e s may b e o b t a i n e d f r o m : Ralph S l o a t , C h i e f G r a n t s Management Branch Asencv f o r H e a l t h Care P o l i c v and R e s e a r c h Parklawn B u i l d i n g , Room 18A-27 R o c k v i l l e , MD 20857 Telephone: ( 3 0 1 ) 443-4033 Awards a r e made u n d e r a u t h o r i t y of s e c t i o n 487 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 ( 4 2 U S C 2 8 8 ) . T i t l e 4 2 o f t h e Code of F e d e r a l R e g u l a t i o n s , P a r t 6 6 , i s a p p l i c a b l e t o t h i s program. The program i s d e s c r i b e d u n d e r C a t a l o g o f F e d e r a l Domestic A s s i s t a n c e No. 9 3 . 2 2 5 . MEDTEP RESEARCH CENTERS ON M I N O R I T Y POPULATIONS RFA AVAILBLE: P . T . 3 4 , FF; HS-91-02 K.W. 1004017, 0730050 Agency f o r H e a l t h Care P o l i c y and R e s e a r c h L e t t e r o f I n t e n t R e c e i p t Date: August 1 2 , 1991 A p p l i c a t i o n R e c e i p t Date: November 1 2 , 1991 PURPOSE The Agency f o r H e a l t h Care P o l i c y and R e s e a r c h ( A H C P R ) i n v i t e s a p p l i c a t i o n s f o r c o o p e r a t i v e a g r e e m e n t s from n o n p r o f i t o r g a n i z a t . i o n s t o d e v e l o p and manage r e s e a r c h C e n t e r s . The c e n t e r s w i l l c o n d u c t and s u p p o r t r e s e a r c h , t e c h n i c a l a s s i s t a n c e , i n f o r m a t i o n d i s s e m i n a t i o n , and r e s e a r c h t r a i n i n g on t h e a p p r o p r i a t e n e s s and e f f e c t i v e n e s s o f h e a l t h c a r e s e r v i c e s and p r o c e d u r e s p r o v i d e d t o m i n o r i t y p o p u l a t i o n s . Support f o r t h e s e r e s e a r c h c e n t e r s w i l l be p r o v i d e d t h r o u g h t h e M e d i c a l T r e a t m e n t E f f e c t i v e n e s s Program (MEDTEP) o f t h e Department o f H e a l t h and Human S e r v i c e s . The c e n t e r s w i l l b e known a s MEDTEP R e s e a r c h C e n t e r s on M i n o r i t y P o p u l a t i o n s . F o r t h e p u r p o s e s o f t h i s announcement, m i n o r i t y p o p u l a t i o n s a r e d e f i n e d t o i n c l u d e A f r i c a n Americans, H i s p a n i c Americans, American I n d i a n s , A l a s k a N a t i v e s , A s i a n s , and P a c i f i c I s l a n d e r s . Awards a r e e x p e c t e d t o b e made i n F i s c a l Year 1992. P r e f e r e n c e w i l l b e g i v e n t o a p p l i c a n t s t h a t c u r r e n t l y d e v o t e a major p o r t i o n of t h e i r resources t o t h e t r a i n i n g of minority health care providers, employment o f m i n o r i t y h e a l t h ca r e p r o v i d e r s , and p r o v i s i o n o f h e a l t h c a r e t o minority populations. Comments on t h i s p r e f e r e n c e a r e b e i n g s o l i c i t e d t h r o u g h a s e p a r a t e n o t i c e on t h e program t h a t i s b e i n g p u b l i s h e d i n t h e FEDERAL REGISTER. A p p l i c a n t s must h a v e t h e s c i e n t i f i c , t e c h n i c a l , o r g a n i z a t i o n a l , and p h y s i c a l resources necessary t o carry out: ( 1 ) m u l t i d i s c i p l i n a r y p a t i e n t outcomes r e s e a r c h ; ( 2 ) t e c h n i c a l a s s i s t a n c e t o h e a l t h c a r e p r o v i d e r s and o t h e r s ; (3) t r a i n i n g of h e a l t h s e r v i c e s r e s e a r c h e r s ; and ( 4 ) d i s s e m i n a t i o n o f r e s e a r c h f i n d i n g s and t h e e v a l u a t i o n o f d i s s e m i n a t i o n s t r a t e g i e s . N I H G U I D E - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 3 The c e n t e r s a r e a l s o e x p e c t e d t o work w i t h t h e AHCPR on a n a l y s e s and s t u d i e s . Such j o i n t a c t i v i t i e s may i n v o l v e s y n t h e s e s o f r e s e a r c h f i n d i n g s , d a t a a n a l y s e s , o r t h e p r e p a r a t i o n o f background i n f o r m a t i o n o n v a r i o u s t o p i c s r e l a t i n g t o h e a l t h c a r e and m i n o r i t y p o p u l a t i o n s . A s p a r t of a cooperative a g r e e m e n t , t h e AHCPR w i l l a l s o h a v e s u b s t a n t i v e i n v o l v e m e n t i n t h e p l a n n i n g and c o n d u c t o f r e s e a r c h , t e c h n i c a l a s s i s t a n c e , d i s s e m i n a t i o n , and t r a i n i n g c a r r i e d o u t by e a c h c e n t e r . -J HEALTHY PEOPLE 2000 AHCPR i s committed t o a c h i e v i n g t h e h e a l t h p r o m o t i o n and d i s e a s e p r e v e n t i o n o b j e c t i v e s o f " H e a l t h y P e o p l e 2000,*1 a PHS-led n a t i o n a l a c t i v i t y f o r s e t t i n g p r i o r i t y a r e a s . T h i s announcement, 'lMEDTEP R e s e a r c h C e n t e r s on M i n o r i t y P o p u l a t i o n s , " a d d r e s s e s h e a l t h s e r v i c e s and p r o t e c t i o n o b j e c t i v e s 2 1 . 3 - 2 1 . 8 and o t h e r s p e c i a l p o p u l a t i o n s o b j e c t i v e s t a r g e t i n g m i n o r i t i e s . P o t e n t i a l a p p l i c a n t s may o b t a i n a copy o f " H e a l t h y P e o p l e 2000" ( F u l l R e p o r t : S t o c k No. 017-001-00474-0 o r Summary R e p o r t : S t o c k No. 017-001-00473-1) t h r o u g h t h e S u p e r i n t e n d e n t o f Documents, Government: P r i n t i n g O f f i c e , W a s h i n g t o n , DC 20402-9325 ( t e l e p h o n e 2 0 2 - 7 8 3 - 3 2 3 8 ) . CENTER STRUCTURE AND MECHANISM OF SUPPORT AHCPR f u n d s a r e i n t e n d e d t o p r o v i d e b a s i c s u p p o r t f o r e a c h c e n t e r . Core f u n d i n g w i l l be p r o v i d e d t h r o u g h t h e c o o p e r a t i v e a g r e e m e n t ( U O I ) g r a n t mechanism, i n which t h e r e c i p i e n t i s r e i m b u r s e d f o r a d m i n i s t r a t i v e and s t a f f s u p p o r t , t h e p r o v i s i o n o f t e c h n i c a l a s s i s t a n c e , d i s s e m i n a t i o n mechanisms s u c h as c e n t e r - s p o n s o r e d n e w s l e t t e r s , and a program o f t r a i n i n g i n p a t i e n t outcomes r e s e a r c h . R e s e a r c h p r o j e c t s may a l s o b e s u p p o r t e d i n t h e i r i n i t i a l s t a g e s w i t h c o r e f u n d s , a l t h o u g h it i s e x p e c t e d t h a t r e s e a r c h p r o j e c t s w i l l u l t i m a t e l y be s p o n s o r e d w i t h f u n d s o b t a i n e d from s o u r c e s o t h e r t h a n t h e AHCPR c o o p e r a t i v e agreement g r a n t . The c e n t e r d i r e c t o r w i l l b e r e s p o n s i b l e f o r t h e o r g a n i z a t i o n and o p e r a t i o n o f t h e c e n t e r ; l i a i s o n w i t h t h e r e s e a r c h community and o u t s i d e e n t i t i e s s u c h a s p r o f e s s i o n a l s o c i e t i e s , s u b c o n t r a c t o r s , a n d consumer g r o u p s ; a n d communication P e r s o n n e l and w i t h t h e AHCPR on s c i e n t i f i c a n d o p e r a t i o n a l m a t t e r s . i n s t i t u t i o n a l r e s o u r c e s c a p a b l e o f d e v e l o p i n g and m a i n t a i n i n g a s u b s t a n t i a l commitment t o p a t i e n t outcomes r e s e a r c h must be a v a i l a b l e . The c e n t e r may c o n s i s t o f c o r e s t a f f w i t h s i g n i f i c a n t t i m e commitments t o t h e c e n t e r a n d a f f i l i a t e s t a f f w i t h l e s s e r t i m e commitments. %d he c e n t e r may b e a c o n s o r t i u m o f o r g a n i z a t i o n s t h a t w i l l p r o v i d e c o l l a t e r a l T o r supplemental support t o t h e a p p l i c a n t i n s t i t u t i o n . A maximum o f $750,000 a n n u a l t o t a l c o s t s ( d i r e c t p l u s i n d i r e c t ) may b e r e q u e s t e d f o r f u l l c e n t e r s u p p o r t , a n d a maximum o f $ 3 , 7 5 0 , 0 0 0 i n t o t a l c o s t s may b e r e q u e s t e d p e r a p p l i c a t i o n f o r f u l l c e n t e r s f o r t h e e n t i r e p r o j e c t p e r i o d , n o t t o exceed f i v e y e a r s . A p p l i c a n t s may r e q u e s t d e v e l o p m e n t a l f u n d i n g o f up t o $400,000 t o t a l a n n u a l c o s t s f o r e a c h o f a minimum o f two y e a r s and a maximum o f t h r e e y e a r s i f t h e p r o p o s e d c e n t e r n e e d s t i m e t o d e v e l o p and i s n o t l i k e l y t o meet i n i t i a l l y a l l p e r f o r m a n c e c r i t e r i a . Funded d e v e l o p m e n t a l c e n t e r s would be e x p e c t e d t o a p p l y c o m p e t i t i v e l y f o r f u n d i n g t o become f u l l c e n t e r s by t h e end o f t h e i r developmental p e r i o d . The AHCPR e x p e c t s t o commit up t o $4 m i l l i o n i n c o m p e t i t i v e a w a r d s f o r MEDTEP R e s e a r c h C e n t e r s on M i n o r i t y P o p u l a t i o n s i n F i s c a l Year 1 9 9 2 , d e p e n d i n g upon t h e a v a i l a b i l i t y of funds. SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES I N RESEARCH STUDY POPULATIONS The AHCPR a d h e r e s t o N I H a n d ADAMHA p o l i c y r e q u i r i n g a p p l i c a n t s f o r r e s e a r c h g r a n t s t o i n c l u d e m i n o r i t i e s a n d women i n s t u d y p o p u l a t i o n s , so t h a t r e s e a r c h f i n d i n g s c a n b e o f b e n e f i t t o a l l . T h i s announcement o b v i o u s l y a d d r e s s e s t h a t p o l i c y w i t h r e g a r d t o m i n o r i t i e s . A d d i t i o n a l e m p h a s i s , however, s h o u l d b e p l a c e d on t h e n e e d t o i n c l u d e women o f all a g e s i n s t u d i e s o f d i s e a s e s , d i s o r d e r s , and c o n d i t i o n s t h a t a f f e c t t h e m . REVIEW PROCEDURES A p p l i c a t i o n s f o r t h e s e c o o p e r a t i v e a g r e e m e n t s w i l l be e v a l u a t e d by t h e AHCPR g r a n t peer review process. A p p l i c a t i o n s w i l l i n i t i a l l y b e a s s e s s e d by AHCPR 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. N o n r e s p o n s i v e a p p l i c a t i o n s w i l l be r e t u r n e d w i t h o u t f u r t h e r c o n s i d e r a t i o n . N I H GUIDE - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 4 A l l r e s p o n s i v e a p p l i c a t i o n s w i l l u n d e r g o p e e r r e v i e w f o r s c i e n t i f i c m e r i t by a n AHCPR r e v i e w c o m m i t t e e o f n o n - F e d e r a l e x p e r t s , and t h o s e recommended f o r a p p r o v a l w i l l a l s o b e r e v i e w e d by t h e N a t i o n a l A d v i s o r y C o u n c i l f o r H e a l t h Care P o l i c y , Research, and E v a l u a t i o n . ELIGIBILITY Only n o n p r o f i t o r g a n i z a t i o n s a r e e l i g i b l e t o a p p l y . n o t e l i g i b l e t o apply. Foreign i n s t i t u t i o n s are - METHOD OF APPLYING A l l a p p l i c a n t s , e x c e p t S t a t e and l o c a l g o v e r n m e n t s , must u s e a p p l i c a t i o n form PHS 398 ( r e v i s e d 10/88). S t a t e a n d l o c a l g o v e r n m e n t s may u s e form PHS 5161, A p p l i c a t i o n f o r F e d e r a l A s s i s t a n c e . These f o r m s a r e a v a i l a b l e a t most i n s t i t u t i o n a l b u s i n e s s o f f i c e s , from t h e O f f i c e o f G r a n t s I n q u i r i e s , D i v i s i o n o f R e s e a r c h G r a n t s , 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 , Room 449, Westwood B u i l d i n g , 5333 Westbard Avenue, B e t h e s d a , MD 20892, and from t h e AHCPR O f f i c e o f S c i e n t i f i c Review a t t h e a d d r e s s b e l o w . The o r i g i n a l a n d f i v e c o p i e s o f t h e c o m p l e t e d a p p l i c a t i o n PHS 398 ( o r t h e o r i g i n a l and two c o p i e s o f PHS 5161) a r e t o b e m a i l e d o r d e l i v e r e d t o : Application Receipt Office Division of Research Grants National I n s t i t u t e s of H e a l t h Westwood B u i l d i n g , Room 240 B e t h e s d a , MD 20892** Completed a p p l i c a t i o n s must b e r e c e i v e d a t t h e D i v i s i o n o f R e s e a r c h G r a n t s on o r b e f o r e November 12. L a t e a p p l i c a t i o n s w i l l b e r e t u r n e d w i t h o u t r e v i e w . P o t e n t i a l a p p l i c a n t s are r e q u e s t e d t o submit a l e t t e r of i n t e n t t o D r . M i r i a m A . K e l l y a t t h e R o c k v i l l e a d d r e s s below by August 12, 1991. A l e t t e r o f i n t e n t is n e i t h e r r e q u i r e d n o r b i n d i n g , and d o e s n o t e n t e r i n t o t h e r e v i e w of s u b s e q u e n t a p p l i c a t i o n s . The l e t t e r of i n t e n t s h o u l d i n c l u d e t h e n a m e ( s 1 o f t h e p r o p o s e d P r i n c i p a l I n v e s t i g a t o r , p r i n c i p a l c o l l a b o r a t o r s , and o r g a n i z a t i o n ( s ) involved. G r a n t a p p l i c a t i o n m a t e r i a l s may b e o b t a i n e d f r o m : O f f i c e o f S c i e n t i f i c Review O f f i c e o f P l a n n i n g a n d R e s o u r c e Management Agency f o r H e a l t h C a r e P o l i c y and R e s e a r c h Room 18A20, 5600 F i s h e r s Lane R o c k v i l l e , MD 20857 Telephone: (301) 443-3091 T I METABLE L e t t e r o f i n t e n t r e c e i p t d a t e : August 12, 1991 A p p l i c a t i o n r e c e i p t d a t e : November 12, 1991 I n i t i a l ( s c i e n t i f i c ) r e v i e w d a t e : F e b r u a r y 7, 1992 N a t i o n a l A d v i s o r y C o u n c i l m e e t i n g d a t e : May 1992 E a r l i e s t g r a n t award and s t a r t d a t e : J u l y - S e p t e m b e r 1992 F o r f u r t h e r program i n f o r m a t i o n and t o r e q u e s t a copy o f t h e RFA, w r i t e o r call : D r . M i r i a m A . Kelly Health S c i e n t i s t Administrator C e n t e r f o r Medical E f f e c t i v e n e s s Research Agency f o r H e a l t h C a r e P o l i c y a n d R e s e a r c h 6001 Montrose Road, S u i t e 704 R o c k v i l l e , MD 20852 Telephone: (301) 443-0782 F o r i n f o r m a t i o n on g r a n t s and b u s i n e s s management a s p e c t s , w r i t e o r c a l l : Ralph L . S l o a t C h i e f , G r a n t s Management B r a n c h , OPRM Aaencv f o r H e a l t h C a r e P o l i c y and R e s e a r c h 5gOO F i s h e r s Lane, Room 18A27 R o c k v i l l e , MD 20857 Telephone: (301) 443-4033 N I H G U I D E - V o l . 2 0 , No. 29, J u l y 26, 1991 - Page 5 P o t e n t i a l a p p l i c a n t s s h o u l d r e f e r t o t h e f u l l RFA f o r more d e t a i l e d i n f o r m a t i o n , i n c l u d i n g c r i t e r i a t h a t w i l l be used i n t h e review o f applications. The r e q u i r e m e n t s o f E x e c u t i v e O r d e r 12372 a r e n o t a p p l i c a b l e t o t h e AHCPR r e s e a r c h g r a n t p r o g r a m . T h i s program is d e s c r i b e d i n t h e C a t a l o g o f F e d e r a l Domestic A s s i s t a n c e number 9 3 . 1 8 0 . Funded p r o j e c t s w i l l o p e r a t e u n d e r t h e PHS G r a n t s P o l i c y S t a t e m e n t ( 1 0 / 1 / 9 0 E d i t i o n ) and 42 C F R , P a r t 6 7 , S u b p a r t A . O N G O I N G PROGRAM ANNOUNCEMENTS -J A N O R E X I A NERVOSA AND B U L I M I A NERVOSA: STUDIES PA: PA-91-79 BASIC B R A I N , B E H A V I O R A L , AND C L I N I C A L P.T. 34; K.W. 0404000, 0755030, 0785055, 1002030, 0745020, 0745027 N a t i o n a l I n s t i t u t e o f Mental H e a l t h The N a t i o n a l I n s t i t u t e o f Mental H e a l t h ( N I M H ) i n v i t e s a p p l i c a t i o n s t h a t u s e a n y o f t h e a v a i l a b l e r e s e a r c h g r a n t mechanisms f o r t h e s t u d i e s r e l e v a n t t o t h e e p i d e m i o l o g y , e t i o l o g y , t r e a t m e n t , and p r e v e n t i o n o f a n o r e x i a n e r v o s a a n d bulimia nervosa. The p u r p o s e o f t h i s announcement i s t o p l a c e a d d i t i o n a l r e s e a r c h e m p h a s i s on b e h a v i o r a l , c l i n i c a l , a n d c e n t r a l n e r v o u s s y s t e m (CNS) a s p e c t s of i n g e s t i v e b e h a v i o r s and e a t i n g d i s o r d e r s . HEALTHY PEOPLE 2000 The P u b l i c H e a l t h S e r v i c e (PHS) i s committed t o a c h i e v i n g t h e h e a l t h p r o m o t i o n and d i s e a s e p r e v e n t i o n o b j e c t i v e s o f " H e a l t h y P e o p l e 2000," a PHS-led n a t i o n a l a c t i v i t y f o r s e t t i n g p r i o r i t y a r e a s . P o t e n t i a l a p p l i c a n t s may o b t a i n a copy o f " H e a l t h y P e o p l e 2000" ( F u l l R e p o r t : S t o c k No. 017-001-00473-0) o r " H e a l t h y P e o p l e 2000" (Summary R e p o r t : S t o c k No. 017-001-00473-1) t h r o u g h t h e S u p e r i n t e n d e n t o f Documents, Government P r i n t i n g O f f i c e , W a s h i n g t o n , D . C . 20042-9325 ( t e l e p h o n e : 2 0 2 - 7 8 3 - 3 2 3 8 ) . ELIGIBILITY %* A p p l i c a t i o n s may b e s u b m i t t e d by a n y p u b l i c o r p r i v a t e , n o n p r o f i t o r f o r - p r o f i t , o r g a n i z a t i o n s such as u n i v e r s i t i e s , c o l l e g e s h o s p i t a l s , l a b o r a t o r i e s , u n i t s o f S t a t e o r l o c a l g o v e r n m e n t s , and e l i g i b l e a g e n c i e s o f t h e F e d e r a l Government. Women and m i n o r i t y i n v e s t i g a t o r s a r e e n c o u r a g e d t o apply - STUDY POPULATIONS A p p l i c a t i o n s f o r t h i s g r a n t a r e e n c o u r a g e d t o i n c l u d e b o t h women and m i n o r i t i e s i n study populations, u n l e s s s c i e n t i f i c evidence o r o t h e r j u s t i f i c a t i o n f o r n o t i n c l u d i n g them i s p r o v i d e d . T h i s r e q u i r e m e n t i s i n t e n d e d to e n s u r e t h a t t h e r e s e a r c h f i n d i n g s w i l l be o f b e n e f i t t o a l l p e r s o n s a t risk o f t h e d i s e a s e , d i s o r d e r , o r c o n d i t i o n u n d e r s t u d y . F o r t h e p u r p o s e of t h e s e p o l i c i e s , c l i n i c a l r e s e a r c h i n v o l v e s human s t u d i e s o f e t i o l o g y , t r e a t m e n t , d i a g n o s i s , p r e v e n t i o n , o r epidemiology of d i s e a s e s , d i s o r d e r s , o r c o n d i t i o n s , i n c l u d i n g b u t n o t l i m i t e d t o c l i n i c a l t r i a l s ; and m i n o r i t i e s i n c l u d e U.S. r a c i a l / e t h n i c m i n o r i t y p o p u l a t i o n s ( s p e c i f i c a l l y American I n d i a n s o r A l a s k a n N a t i v e s , A s i a n I P a c i f i c I s l a n d e r s , B l a c k s , a n d Hispanics). The A l c o h o l , Drug Abuse, a n d M e n t a l H e a l t h A d m i n i s t r a t i o n (ADAMHA) r e c o g n i z e s t h a t it may n o t be f e a s i b l e o r a p p r o p r i a t e i n a l l c l i n i c a l r e s e a r c h p r o j e c t s t o i n c l u d e r e p r e s e n t a t i o n o f t h e f u l l a r r a y o f U.S. r a c i a l / e t h n i c m i n o r i t y populations. However, a p p l i c a n t s a r e u r g e d t o a s s e s s c a r e f u l l y t h e f e a s i b i l i t y of i n c l u d i n g t h e b r o a d e s t p o s s i b l e r e p r e s e n t a t i o n of m i n o r i t y groups. A p p l i c a t i o n s should i n c l u d e a d e s c r i p t i o n of t h e composition of t h e proposed s t u d y p o p u l a t i o n by g e n d e r and r a c i a l / e t h n i c g r o u p , and t h e r a t i o n a l e f o r t h e numbers and k i n d s o f p e o p l e s e l e c t e d t o p a r t i c i p a t e . T h i s i n f o r m a t i o n s h o u l d be i n c l u d e d i n t h e PHS form 3 9 8 , S e c t i o n 2 , A-D o f t h e R e s e a r c h P l a n and summarized i n S e c t i o n 2 , E , Human S u b j e c t s . % ' r e p r e s e n t a t i o n d Applications should incorporate i n t h e i r study design gender and/or minority a p p r o p r i a t e t o t h e s c i e n t i f i c o b j e c t i v e s of t h e work p r o p o s e d . If r e p r e s e n t a t i o n o f women o r m i n o r i t i e s i n s u f f i c i e n t numbers t o p e r m i t assessment of d i f f e r e n t i a l e f f e c t s i s not f e a s i b l e o r a p p r o p r i a t e , t h e reasons N I H G U I D E - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 6 f o r t h i s must be e x p l a i n e d a n d j u s t i f i e d . The r a t i o n a l e may r e l a t e t o t h e p u r p o s e o f t h e r e s e a r c h , t h e h e a l t h of t h e s u b j e c t s , o r o t h e r c o m p e l l i n g circumstances ( e . g . , i f i n t h e only s u b j e c t population a v a i l a b l e t h e r e is a d i s p r o p o r t i o n a t e r e p r e s e n t a t i o n i n terms o f a g e d i s t r i b u t i o n , r i s k f a c t o r s , i n c i d e n c e / p r e v a l e n c e , e t c . , o f one g e n d e r o r m i n o r i t y / m a j o r i t y g r o u p ) . I f t h e required information is not contained within t h e a p p l i c a t i o n , t h e r e v i e w w i l l be d e f e r r e d u n t i l it i s c o m p l e t e . P e e r r e v i e w e r s w i l l a d d r e s s s p e c i f i c a l l y whether t h e r e s e a r c h p l a n i n t h e a p p l i c a t i o n conforms t o t h e s e policies. If g e n d e r a n d / o r m i n o r i t y representation/justification a r e j u d g e d t o be i n a d e q u a t e , t h e r e v i e w e r s w i l l c o n s i d e r t h i s a s a d e f i c i e n c y i n assigning t h e p r i o r i t y score t o the application. A l l a p p l i c a t i o n s / p r o p o s a l s f o r c l i n i c a l r e s e a r c h s u b m i t t e d t o ADAMHA/NIMH a r e r e q u i r e d t o a d d r e s s t h e s e p o l i c i e s . A D A M H A I N I M H f u n d i n g components w i l l n o t award g r a n t s t h a t d o n o t comply w i t h t h e s e p o l i c i e s . A p p l i c a n t s s h o u l d a l s o b e aware t h a t t h e D e p a r t m e n t o f H e a l t h and Human S e r v i c e s h a s 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 o f human s u b j e c t s and h a s d e v e l o p e d a d d i t i o n a l 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 o f c h i l d r e n . A copy o f t h e s e r e g u l a t i o n s , 45 CFR 46, P r o t e c t i o n o f Human S u b j e c t s , i s a v a i l a b l e from t h e O f f i c e f o r P r o t e c t i o n from R e s e a r c h R i s k s , 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 , B u i l d i n g 3 1 , Room 5B59 B e t h e s d a , Maryland 20892. REVIEW PROCEDURES A p p l i c a t i o n s w i l l b e r e c e i v e d u n d e r t h e u s u a l PHS r e c e i p t a n d r e v i e w s c h e d u l e . A p p l i c a t i o n s w i l l b e r e v i e w e d by a n i n i t i a l r e v i e w g r o u p ( I R G ) c o n s i s t i n g p r i m a r i l y of non-Federal s c i e n t i f i c and t e c h n i c a l e x p e r t s . A p p l i c a t i o n s w i l l r e c e i v e a s e c o n d - l e v e l r e v i e w by t h e a p p r o p r i a t e A d v i s o r y C o u n c i l b a s e d on policy considerations a s w e l l a s s c i e n t i f i c m e r i t . Only a p p l i c a t i o n s recommended f o r a p p r o v a l by C o u n c i l may b e c o n s i d e r e d f o r f u n d i n g . APPLICATION PROCEDURES A l l r e s e a r c h a p p l i c a n t s must u s e t h e c u r r e n t v e r s i o n o f t h e g r a n t a p p l i c a t i o n form PHS 398 ( r e v . 1 0 / 8 8 > . S u p p o r t may b e r e q u e s t e d f o r a p e r i o d o f up t o f i v e y e a r s . Annual a w a r d s w i l l b e made s u b j e c t t o c o n t i n u e d a v a i l a b i l i t y b f f u n d s and p r o g r e s s a c h i e v e d . A c o m p e t i n g s u p p l e m e n t a l a p p l i c a t i o n may b e s u b m i t t e d d u r i n g a n a p p r o v e d p e r i o d o f s u p p o r t t o expand t h e s c o p e o r p r o t o c o l o f a p r o j e c t d u r i n g t h e approved p e r i o d . A competing c o n t i n u a t i o n ( i . e . , r e n e w a l ) a p p l i c a t i o n may b e s u b m i t t e d b e f o r e t h e end o f a n a p p r o v e d p e r i o d o f support t o continue a p r o j e c t . G r a n t f u n d s may b e u s e d f o r e x p e n s e s c l e a r l y r e l a t e d and n e c e s s a r y t o c o n d u c t r e s e a r c h p r o j e c t s , i n c l u d i n g d i r e c t c o s t s t h a t can be s p e c i f i c a l l y i d e n t i f i e d w i t h t h e p r o j e c t and a l l o w a b l e i n d i r e c t c o s t s of t h e i n s t i t u t i o n . Funds may n o t b e u s e d t o e s t a b l i s h , add a component t o , o r o p e r a t e a t r e a t m e n t , r e h a b i l i t a t i o n , o r p r e v e n t i o n i n t e r v e n t i o n s e r v i c e program. Support f o r r e s e a r c h - r e l a t e d t r e a t m e n t , r e h a b i l i t a t i o n , o r p r e v e n t i o n s e r v i c e s and p r o g r a m s may b e r e q u e s t e d o n l y f o r c o s t s r e q u i r e d by t h e r e s e a r c h . T h e s e c o s t s must b e j u s t i f i e d i n t e r m s o f r e s e a r c h o b j e c t i v e s , m e t h o d s , and d e s i g n s t h a t p r o m i s e t o y i e l d g e n e r a l i z a b l e knowledge a n d / o r make s i g n i f i c a n t contribution t o t h e o r e t i c a l concepts. MECHANISMS O SUPPORT F A p p l i c a t i o n s are r e q u e s t e d under t h e t r a d i t i o n a l r e s e a r c h p r o j e c t ( R o l l , F i r s t I n d e p e n d e n t R e s e a r c h S u p p o r t and T r a n s i t i o n (FIRST) Award (R291, s m a l l g r a n t (R031, i n s t i t u t i o n a l r e s e a r c h t r a i n i n g (T321, i n d i v i d u a l f e l l o w s h i p ( p r e - and p o s t - d o c t o r a l ) ( F s e r i e s ) , c a r e e r d e v e l o p m e n t (K s e r i e s ) , and program p r o j e c t ( P O I ) mechanisms. I n F i s c a l Year 1 9 9 0 , it i s e s t i m a t e d t h a t a p p r o x i m a t e l y $6 m i l l i o n was a v a i l a b l e t o s u p p o r t 20 new and c o n t i n u a t i o n g r a n t s on a n o r e x i a n e r v o s a and b u l i m i a n e r v o s a . However, t h e amount of f u n d i n g w i l l depend upon a v a i l a b i l i t y o f f u n d s a n d program p r i o r i t i e s a t t h e t i m e o f t h e a w a r d . INQUIRIES C o p i e s o f t h i s f u l l announcement and 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 contacting : 1 N I H G U I D E - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 7 -d Susan J . B l u m e n t h a l , M . D , M.P.A. C h i e f , B e h a v i o r a l Medicine Program Basic P r e v e n t i o n and B e h a v i o r a l Medicine R e s e a r c h Branch D i v i s i o n o f Basic B r a i n and B e h a v i o r S c i e n c e s N a t i o n a l I n s t i t u t e o f Mental H e a l t h 5600 F i s h e r s Lane, Room 11C-06 R o c k v i l l e , MD 20857 Telephone: (301) 443-4337 I n f o r m a t i o n on g r a n t s management i s s u e s may b e o b t a i n e d from: S t e p h e n Hudak C h i e f , G r a n t s Management S e c t i o n G r a n t s Management Branch N a t i o n a l I n s t i t u t e o f Mental H e a l t h 5600 F i s h e r s Lane, Room 7C-26 R o c k v i l l e , MD 20857 Telephone: (301) 443-4456 Awards a r e made u n d e r a u t h o r i t y o f 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 A c t (42 U.S.C. 2411, and C a t a l o g o f F e d e r a l Domestic A s s i s t a n c e 93.242. ANTICANCER MODEL DEVELOPMENT PA: PA-91-80 P . T . 34; K . W . 0755020, 0740020, 0755010, 0760075 N a t i o n a l Cancer I n s t i t u t e Application Receipt Dates: PURPOSE Cancer t r e a t m e n t s w i t h g r e a t e r s p e c i f i c i t y f o r c a n c e r c e l l s and l e s s t o x i c i t y f o r normal t i s s u e s a r e c r i t i c a l l y n e e d e d , e s p e c i a l l y f o r common s o l i d t u m o r s t h a t a f f l i c t t h e aging p o p u l a t i o n . A s w e e n t e r an era of i n c r e a s e d u n d e r s t a n d i n g of t h e p r o c e s s o f malignancy, o p p o r t u n i t i e s are emerging f o r d e f i n i n g and e x p l o i t i n g new m o l e c u l a r t a r g e t s f o r t h e d i s c o v e r y o f more u s e f u l t h e r a p i e s . With t h e development o f a more r a t i o n a l framework f o r t h e t r e a t m e n t of c a n c e r , t h e a b i l i t y t o select t h e r a p y f o r t h e i n d i v i d u a l p a t i e n t s h o u l d a l s o i m p r o v e . The o b j e c t i v e o f t h i s announcement i s t o e n c o u r a g e r e s e a r c h i n t h e development o f models t h a t w i l l l e a d t o t h e d i s c o v e r y and u s e o f more e f f e c t i v e t h e r a p i e s . P r o j e c t s c a n be m u l t i d i s c i p l i n a r y a s l o n g a s t h e y a r e w e l l f o c u s e d and meet t h e c r i t e r i a d e s c r i b e d b e l o w . O c t o b e r 1, F e b r u a r y 1, and J u n e 1 HEALTHY PEOPLE 2 0 0 0 The P u b l i c H e a l t h S e r v i c e (PHS) is committed t o a c h i e v i n g t h e h e a l t h p r o m o t i o n and d i s e a s e p r e v e n t i o n o b j e c t i v e s o f " H e a l t h y P e o p l e 2000," a PHS-led n a t i o n a l a c t i v i t y f o r s e t t i n g p r i o r i t y a r e a s . T h i s program announcement, A n t i c a n c e r Model Development, is r e l a t e d t o t h e p r i o r i t y a r e a o f c a n c e r . Potential a p p l i c a n t s may o b t a i n a copy of " H e a l t h y P e o p l e 2000" ( F u l l R e p o r t : S t o c k No. 017-001-00474-0) o r " H e a l t h y P e o p l e 2000" (Summary R e p o r t : S t o c k No. 017-001-00473-1) t h r o u g h t h e S u p e r i n t e n d e n t o f Documents, Government P r i n t i n g O f f i c e , Washington, D . C . 20402-9325 ( t e l e p h o n e 202-783-3238). RESEARCH OBJECTIVES The D i v i s i o n applications w i l l b e more treatments. limited t o : o f Cancer T r e a t m e n t of t h e N a t i o n a l Cancer I n s t i t u t e i s s e e k i n g f o r t r a d i t i o n a l r e s e a r c h g r a n t s ( R o l l w i t h a f o c u s on models t h a t p r e d i c t i v e o f t h e c l i n i c a l u s e f u l n e s s o f new a n t i c a n c e r Examples o f s t u d i e s t h a t might b e a d d r e s s e d i n c l u d e , b u t a r e n o t o R a p i d , r e s o u r c e e f f i c i e n t and c o s t - e f f e c t i v e methods f o r e v a l u a t i n g new, p o t e n t i a l a n t i c a n c e r a g e n t s . For example, r e c e p t o r - b a s e d s c r e e n i n g t e c h n i q u e s h a v e been u s e d e f f e c t i v e l y i n o t h e r a r e a s of medicine, such as i n t h e s e a r c h f o r d r u g s t h a t lower blood c h o l e s t e r o l l e v e l s . Assays t h a t e x p l o i t r e c e n t d i s c o v e r i e s i n t h e m o l e c u l a r b i o l o g y o f tumor d e v e l o p m e n t , such as s u p p r e s s o r g e n e s , are e s p e c i a l l y a t t r a c t i v e . C e l l c u l t u r e assays with cytotoxic e n d p o i n t s t h a t d o n o t o f f e r a d i s t i n c t a d v a n t a g e o v e r models i n c u r r e n t u s e a r e n o t e n c o u r a g e d . A p p l i c a t i o n s t h a t f o c u s on s c r e e n i n g o r s c a l e - u p of e x i s t i n g p r o c e d u r e s a r e n o t e n c o u r a g e d . N I H G U I D E - Vol. 20, No. 29, J u l y 26, 1991 - Page 8 o Animal models t h a t i n c l u d e t h e d e v e l o p m e n t o f v a l i d , s u r r o g a t e e n d p o i n t s f o r s u r v i v a l . T r a n s g e n i c a n i m a l s , mice w i t h a g e n e t i c p r e d i s p o s i t i o n t o c a n c e r , and s e v e r e combined i m m u n o d e f i c i e n t (SCID) mice a r e e x a m p l e s o f models u s e d i n o t h e r f i e l d s , s u c h as c a r c i n o g e n e s i s , d i f f e r e n t i a t i o n , and tumor b i o l o g y , t h a t c o u l d b e adapted f o r t h e r a p e u t i c s t u d i e s . o Models t h a t w i l l h e l p s e l e c t t h e r a p y f o r i n d i v i d u a l p a t i e n t s . The e x p e n s e and t i m e f o r c l i n i c a l t r i a l s c o u l d b e r e d u c e d by s e l e c t i n g t h e r a p i e s with g r e a t e r p r o b a b i l i t y of e f f e c t i v e n e s s f o r a given p a t i e n t . A s s a y s now b e i n g u s e d t o d i a g n o s e c a n c e r , s u c h as t h o s e i n v o l v i n g t h e polymerase c h a i n r e a c t i o n , could be a d a p t e d f o r improved t h e r a p y s e l e c t i o n s . A p p l i c a t i o n s a r e e n c o u r a g e d w i t h a n e m p h a s i s on t h e d e v e l o p m e n t and e v a l u a t i o n o f a s s a y s up t o t h e p o i n t where t h e y c o u l d b e u s e d i n p r o s p e c t i v e c l i n i c a l t r i a l s t o v a l i d a t e t h e model. Whichever model d e v e l o p m e n t a p p r o a c h i s t a k e n , a p p l i c a n t s must p r o v i d e a r a t i o n a l e f o r how t h e model may i d e n t i f y improved t h e r a p i e s o r may e n h a n c e t h e r a p y s e l e c t i o n s and must o u t l i n e a r e s e a r c h p l a n i n v o l v i n g a t e s t a b l e hypothesis. The n a t u r e of t h e model i s l i m i t e d o n l y by t h e c r e a t i v i t y and a b i l i t y of t h e a p p l i c a n t . MECHANISM OF SUPPORT T h i s program w i l l be s u p p o r t e d t h r o u g h t h e N I H g r a n t - i n - a i d mechanism ( R o l l . T h i s program announcement i s a c o n t i n u o u s announcement u n t i l r e t r a c t e d . A p p l i c a t i o n s and f u t u r e u n s o l i c i t e d c o m p e t i n g r e n e w a l a p p l i c a t i o n s w i l l compete a s r e s e a r c h p r o j e c t a p p l i c a t i o n s w i t h a l l o t h e r i n v e s t i g a t o r - i n i t i a t e d a p p l i c a t i o n s a n d b e r e v i e w e d i n a s t a n d i n g D i v i s i o n of R e s e a r c h G r a n t s s t u d y section. 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 f u n d s w i t h a l l o t h e r a p p r o v e d applications within t h e assigned I n s t i t u t e . v ELIGIBILITY A p p l i c a t i o n s may b e s u b m i t t e d by d o m e s t i c a n d f o r e i g n , p u b l i c o r p r i v a t e , n o n p r o f i t o r f o r - p r o f i t , o r g a n i z a t i o n s s u c h as u n i v e r s i t i e s , c o l l e g e s , h o s p i t a l s , l a b o r a t o r i e s , u n i t s of S t a t e o r l o c a l governments, and e l i g i b l e a g e n c i e s o f t h e F e d e r a l Government. A p p l i c a t i o n s from m i n o r i t y i n d i v i d u a l s a n d women a r e e n c o u r a g e d . 1 REVIEW PROCEDURES A p p l i c a t i o n s w i l l be a s s i g n e d on t h e b a s i s o f e s t a b l i s h e d P u b l i c H e a l t h S e r v i c e r e f e r r a l g u i d e l i n e s . A p p l i c a t i o n s w i l l b e r e v i e w e d 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 s t u d y s e c t i o n o f t h e D i v i s i o n o f R e s e a r c h G r a n t s . Following study s e c t i o n review, t h e a p p l i c a t i o n s w i l l r e c e i v e a second-level r e v i e w by t h e a p p r o p r i a t e n a t i o n a l a d v i s o r y c o u n c i l o r b o a r d . REVIEW C R I T E R I A o S c i e n t i f i c m e r i t and o r i g i n a l i t y o f p r o p o s e d r e s e a r c h . methodology p r o p o s e d t o c a r r y o u t t h e r e s e a r c h . o A p p r o p r i a t e n e s s a n d a d e q u a c y o f t h e e x p e r i m e n t a l a p p r o a c h and o Q u a l i f i c a t i o n s o f 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 u p p o r t s t a f f i n r e g a r d t o r e s e a r c h e x p e r i e n c e , c o m p e t e n c e , commitment, a n d t i m e availability. o Adequacy o f e x i s t i n g p h y s i c a l f a c i l i t i e s and t h e r e s e a r c h environment. o Adequacy o f p r o p o s e d means f o r p r o t e c t i n g a g a i n s t a d v e r s e e f f e c t s upon humans, v e r t e b r a t e a n i m a l s , a n d t h e e n v i r o n m e n t . The r e v i e w g r o u p w i l l c r i t i c a l l y examine t h e r e q u e s t e d b u d g e t a n d w i l l recommend a n a p p r o p r i a t e b u d g e t and p e r i o d o f s u p p o r t f o r e a c h a p p l i c a t i o n recommended for f u r t h e r c o n s i d e r a t i o n . SPECIAL INSTRUCTIONS T APPLICANTS REGARDING IMPLEMENTATION OF N I H POLICIES O CONCERNING INCLUSION OF WOMEN AND MINORITIES I N C L I N I C A L RESEARCH STUDY POPULATIONS N I H a n d ADAMHA p o l i c y i s t h a t a p p l i c a n t s f o r NIH/ADAMHA c l i n i c a l r e s e a r c h g r a n t s a n d c o o p e r a t i v e a g r e e m e n t s w i l l b e r e q u i r e d . t o i n c l u d e m i n o r i t i e s and N I H GUIDE - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 9 women i n s t u d y p o p u l a t i o n s so t h a t r e s e a r c h f i n d i n g s c a n b e o f b e n e f i t t o a l l p e r s o n s a t r i s k of t h e d i s e a s e , d i s o r d e r o r c o n d i t i o n u n d e r s t u d y ; s p e c i a l e m p h a s i s s h o u l d be p l a c e d on t h e need f o r i n c l u s i o n o f m i n o r i t i e s and women i n s t u d i e s o f d i s e a s e s , d i s o r d e r s and c o n d i t i o n s which d i s p r o p o r t i o n a t e l y a f f e c t them. T h i s p o l i c y i s i n t e n d e d t o a p p l y t o males and f e m a l e s o f a l l a g e s . I f women o r m i n o r i t i e s a r e e x c l u d e d o r i n a d e q u a t e l y r e p r e s e n t e d i n c l i n i c a l r e s e a r c h , p a r t i c u l a r l y i n proposed p o p u l a t i o n - b a s e d s t u d i e s , a c l e a r c o m p e l l i n g r a t i o n a l e s h o u l d be p r o v i d e d . The c o m p o s i t i o n o f t h e p r o p o s e d s t u d y p o p u l a t i o n must be d e s c r i b e d i n terms o f g e n d e r and r a c i a l / e t h n i c g r o u p , t o g e t h e r w i t h a r a t i o n a l e f o r i t s c h o i c e . I n a d d i t i o n , g e n d e r and r a c i a l / e t h n i c i s s u e s s h o u l d b e a d d r e s s e d i n d e v e l o p i n g a r e s e a r c h d e s i g n and sample s i z e a p p r o p r i a t e f o r t h e s c i e n t i f i c o b j e c t i v e o f t h e s t u d y . T h i s i n f o r m a t i o n s h o u l d b e i n c l u d e d i n t h e form PHS 398 i n S e c t i o n 2, A - D o f t h e R e s e a r c h P l a n AND summarized i n S e c t i o n 2 , E , Human S u b j e c t s . A p p l i c a n t s / o f f e r o r s a r e u r g e d t o assess c a r e f u l l y t h e f e a s i b i l i t y o f i n c l u d i n g t h e b r o a d e s t p o s s i b l e r e p r e s e n t a t i o n o f m i n o r i t y g r o u p s . However, N I H r e c o g n i z e s t h a t it may n o t b e f e a s i b l e o r a p p r o p r i a t e i n a l l r e s e a r c h p r o j e c t s t o i n c l u d e r e p r e s e n t a t i o n of t h e f u l l a r r a y of United S t a t e s r a c i a l l e t h n i c m i n o r i t y p o p u l a t i o n s ( i . e . , N a t i v e Americans ( i n c l u d i n g American I n d i a n s o r A l a s k a n N a t i v e s ) , A s i a n / P a c i f i c I s l a n d e r s , B l a c k s , H i s p a n i c s ) . The r a t i o n a l e f o r s t u d i e s on s i n g l e m i n o r i t y p o p u l a t i o n g r o u p s s h o u l d b e p r o v i d e d . F o r t h e p u r p o s e o f t h i s p o l i c y , c l i n i c a l r e s e a r c h i n c l u d e s human b i o m e d i c a l and b e h a v i o r a l s t u d i e s o f e t i o l o g y , e p i d e m i o l o g y , p r e v e n t i o n ( a n d p r e v e n t i v e s t r a t e g i e s ) , d i a g n o s i s , o r t r e a t m e n t of d i s e a s e s , d i s o r d e r s o r c o n d i t i o n s , including but not limited t o c l i n i c a l trials. The u s u a l N I H p o l i c i e s c o n c e r n i n g r e s e a r c h on human s u b j e c t s a l s o a p p l y . Basic r e s e a r c h o r c l i n i c a l s t u d i e s i n which human t i s s u e s c a n n o t b e i d e n t i f i e d o r l i n k e d t o i n d i v i d u a l s a r e e x c l u d e d . However, e v e r y e f f o r t s h o u l d b e made t o i n c l u d e human t i s s u e s from women and r a c i a l l e t h n i c m i n o r i t i e s when it i s i m p o r t a n t t o a p p l y t h e r e s u l t s o f t h e s t u d y b r o a d l y , and t h i s s h o u l d b e a d d r e s s e d by a p p l i c a n t s . F o r f o r e i g n a w a r d s , t h e p o l i c y on i n c l u s i o n o f women a p p l i e s f u l l y ; s i n c e t h e d e f i n i t i o n o f m i n o r i t y d i f f e r s i n o t h e r c o u n t r i e s , t h e a p p l i c a n t must d i s c u s s t h e r e l e v a n c e of r e s e a r c h i n v o l v i n g f o r e i g n p o p u l a t i o n groups t o t h e United States’ populations, including minorities. “‘hd I f t h e required information is not contained within t h e application, t h e a p p l i c a t i o n w i l l be r e t u r n e d . P e e r r e v i e w e r s w i l l a d d r e s s s p e c i f i c a l l y whether t h e r e s e a r c h p l a n i n t h e a p p l i c a t i o n conforms t o t h e s e p o l i c i e s . I f t h e r e p r e s e n t a t i o n o f women or m i n o r i t i e s i n t h e s t u d y d e s i g n is i n a d e q u a t e t o answer t h e s c i e n t i f i c q u e s t i o n ( s 1 a d d r e s s e d AND t h e j u s t i f i c a t i o n f o r t h e s e l e c t e d s t u d y p o p u l a t i o n i s i n a d e q u a t e , it w i l l b e c o n s i d e r e d a s c i e n t i f i c weakness o r d e f i c i e n c y i n t h e s t u d y d e s i g n and w i l l b e r e f l e c t e d i n a s s i g n i n g t h e p r i o r i t y s c o r e t o t h e application. All a p p l i c a t i o n s f o r c l i n i c a l r e s e a r c h submitted t o N I H are r e q u i r e d t o N I H f u n d i n g components w i l l n o t award g r a n t s o r address these policies. c o o p e r a t i v e a g r e e m e n t s t h a t d o n o t comply w i t h t h e s e p o l i c i e s . METHOD OF APPLYING A p p l i c a t i o n s must b e s u b m i t t e d on t h e g r a n t a p p l i c a t i o n form PHS 398 ( r e v i s e d 10/88) and w i l l be a c c e p t e d a t t h e s t a n d a r d a p p l i c a t i o n d e a d l i n e s . A p p l i c a t i o n k i t s a r e a v a i l a b l e a t most i n s t i t u t i o n a l b u s i n e s s and g r a n t l c o n t r a c t o f f i c e s and may b e o b t a i n e d from t h e D i v i s i o n o f R e s e a r c h G r a n t s , 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 , Westwood B u i l d i n g , Room 449, B e t h e s d a , MD 20892, t e l e p h o n e ( 3 0 1 ) 496-7441. The t i t l e and number o f t h i s announcement must b e t y p e d i n l i n e 2 on t h e f a c e page o f t h e a p p l i c a t i o n . The o r i g i n a l a p p l i c a t i o n and s i x s i g n e d e x a c t p h o t o c o p i e s must b e s u b m i t t e d o r delivered t o : Di vi si on of Research Grants N a t i o n a l I n s t i t u t e s of Health Hestwood B u i l d i n g , Room 240 B e t h e s d a , MD 20892** INQUIRIES .k/ I n q u i r i e s a b o u t t h e o b j e c t i v e s o f t h i s program announcement may b e a d d r e s s e d to: N I H G U I D E - V o l . 2 0 , No. 29, J u l y 26, 1991 - Page 10 Mary K . W o l p e r t , Ph.D. Developmental T h e r a p e u t i c s Program D i v i s i o n of Cancer T r e a t m e n t N a t i o n a l Cancer I n s t i t u t e E x e c u t i v e P l a z a N o r t h , S u i t e 832 B e t h e s d a , MD 20892 Telephone: ( 3 0 1 ) 496-8783 I n q u i r i e s of a b u d g e t a r y o r a d m i n i s t r a t i v e n a t u r e s h o u l d be d i r e c t e d t o : M s . Barbara A . F i s h e r G r a n t s Management S p e c i a l i s t N a t i o n a l Cancer I n s t i t u t e E x e c u t i v e P l a z a S o u t h , Room 242 B e t h e s d a , MD 20892 Telephone: ( 3 0 1 ) 496-7800, E x t . 29 T h i s program i s d e s c r i b e d i n t h e C a t a l o g o f F e d e r a l Domestic A s s i s t a n c e No. 9 3 . 3 9 5 , Cancer T r e a t m e n t R e s e a r c h . Awards w i l l b e made u n d e r t h e a u t h o r i t y o f 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 I V , S e c t i o n s 3 0 1 , 410, and 411, P a r t A ( P u b l i c L a w 78-410, 42 USC 241 a s amended, P u b l i c L a w 99-158, 42 USC 285a) and a d m i n i s t e r e d u n d e r PHS g r a n t p o l i c i e s and F e d e r a l R e g u l a t i o n s a t 42 CFR P a r t 52 and 45 CFR P a r t 7 4 . T h i s program i s n o t s u b j e c t t o t h e i n t e r g o v e r n m e n t a l r e v i e w r e q u i r e m e n t s o f E x e c u t i v e O r d e r 12372 o r t o H e a l t h System Agency r e v i e w . Awards w i l l b e a d m i n i s t e r e d u n d e r P u b l i c H e a l t h S e r v i c e g r a n t s p o l i c y a s s t a t e d i n t h e PHS G r a n t s P o l i c y S t a t e m e n t , DHHS P u b l i c a t i o n No. (OASH) 9 0 - 5 0 , 0 0 0 , r e v i s e d O c t o b e r 1 , 1990. ERRATUM PROGRAM PROJECTS ON AUTOIMMUNITY RFA: AI-91-09 0715015, 0745027, 0745070, 0710030 P.T. 34; K . W . N a t i o n a l I n s t i t u t e o f A l l e r g y and I n f e c t i o u s Diseases The f o u r t h p a r a g r a p h u n d e r Mechanisms o f S u p p o r t o f t h e f u l l t e x t o n l i n e v e r s i o n o f t h e R e q u e s t f o r A p p l i c a t i o n s , "Program P r o j e c t s on Autoimmunity" ( N I H Guide f o r G r a n t s and C o n t r a c t s , V o l . 2 0 , No. 2 3 , J u n e 1 4 , 1991) s t a t e s t h a t s u p p o r t w i l l b e l i m i t e d t o a maximum o f f o u r y e a r s . The maximum p e r i o d o f s u p p o r t i s i n e r r o r and i s amended t o r e a d : S u p p o r t f o r a program p r o j e c t i n autoimmune mechanisms i n d i s e a s e w i l l b e l i m i t e d t o a maximum o f FIVE years. - **THE M A I L I N G ADDRESS G I V E N FOR SENDING APPLICATIONS TO THE DIVISION OF ET O D RESEARCH GRANTS OR CONTACTING PROGRAM STAFF I N THE W S W O B U I L D I N G I S THE CENTRAL M A I L I N G ADDRESS FOR THE N A T I O N A L INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A C O U R I E R SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE W S W O ET O D BUILDING IS: 5333 Westbard Avenue B e t h e s d a , Maryland 20816 N I H G U I D E - V o l . 2 0 , No. 2 9 , J u l y 2 6 , 1991 - Page 11