NIH Guide - Vol. 20, No. 28 - July 19, 1991

NOTICE O MAILING F CHANGE 0 C h e c k h e r e if you wish to discontinue receiving this publication 0 heck here ifyour ddms 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 US. DEPARTMENT OF H J " H AND HUMAN SERVICES OFFICIAL BUSINESS Penalty for Private Use, $300 First Class Mail Postages & Fees Paid PHS/NIH/OD Permit No. G-291 The NIH Guide announces scientific initiatives and provides policy and administrative information to indiv­ duals and organizationswho need to b e kept informed o f opportunities. requirements, and changes in extramural propdms administered by the e. National Institutes of H & V o l . 2 0 , No. 28 July 1 9 , 1991 NIH GUIDE - Vol. 20, No. 28, July 19, 1991 NOTICES A PLAN FOR MANAGING THE COST OF BIOMEDICAL RESEARCH National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH OMB CIRCULAR NO. A-I33 - - SCHEDULE OF GRANT AWARDS National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH . ........................ ......................... 1 U 2 NOTICES OF AVAILABILITY (RFPs AND RFAs) RESEARCH SUPPORT FOR THE CLINICAL AND REGULATORY AFFAIRS PROGRAM (RFP) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES ..... 2 EMERGING PATHOGENIC MYCOPLASMAS (RFA AI-91-12) ............................. National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES ONGOING PROGRAM ANNOUNCEMENTS CLINICAL INVESTIGATOR DEVELOPMENT AWARD (PA-91-78) National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD ERRATA COOPERATIVE AGREEMENTS AS THE AWARD INSTRUMENT FOR CERTAIN NHLBI CLINICAL TRIALS AND LARGE-SCALE EPIDEMIOLOGICAL STUDIES .................... National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD PROGRAM PROJECTS ON NEW METHODS OF IMMUNE INTERVENTION (RFA AI-91-11) National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD (PA-91-77) Fogarty International Center Index: FOGARTY INTERNATIONAL CENTER 3 ......................... 6 11 W ......11 ..............11 NOTICES A PLAN FOR MANAGING THE COST OF BIOMEDICAL RESEARCH P.T. 34; K.W. 1014002, 1014006 National Institutes of Health In response to Congressional concerns expressed in the FY 1991 House and Senate Appropriations Reports, the National Institutes of Health (NIH) has prepared a financial management plan entitled, "A Plan for Managing the Cost of Biomedical Research." This document, developed by NIH in consultation with the biomedical research community and the various National Advisory Councils and Boards, outlines the principles on which the plan is based, identifies the specific goals of the plan, and discusses the cost management measures to be taken. NIH GUIDE - Vol. 20, No. 28, July 19, 1991 - Page 1 Copies of t h i s p l a n a r e a v a i l a b l e 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 Westwood B u i l d i n g , Room 449 B e t h e s d a , MD 20892 Telephone: (301 1 496-7441 OMB CIRCULAR N O . A-I33 -- SCHEDULE OF GRANT A A D WRS P . T . 34; K.W. 1014002, 1014006 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 c e n t l y , a number of u n i v e r s i t i e s and o t h e r n o n p r o f i t o r g a n i z a t i o n s have r e q u e s t e d a s s i s t a n c e from 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 ( N I H ) i n p r o v i d i n g independent a u d i t o r s w i t h a s c h e d u l e of F e d e r a l awards by major programs i d e n t i f i e d by number i n t h e C a t a l o g of F e d e r a l Domestic A s s i s t a n c e . The C a t a l o g , p u b l i s h e d a n n u a l l y by t h e O f f i c e of Management and Budget COMB), i s a Government-wide compendium of F e d e r a l programs, p r o j e c t s , s e r v i c e s , and a c t i v i t i e s t h a t p r o v i d e a s s i s t a n c e o r b e n e f i t s t o t h e American p u b l i c . According t o t h e independent a u d i t o r s , d a t a showing e x p e n d i t u r e s by C a t a l o g program codes must be o b t a i n e d t o comply w i t h a r e l a t e d r e q u i r e m e n t i n OMB C i r c u l a r No. A-133, which i s t h e c i r c u l a r t h a t e s t a b l i s h e d r e q u i r e m e n t s f o r a u d i t s of i n s t i t u t i o n s of h i g h e r e d u c a t i o n and o t h e r n o n p r o f i t o r g a n i z a t i o n s . For t h e Department of H e a l t h and Human S e r v i c e s , A-I33 h a s been implemented w i t h i n t h e r e v i s i o n s t o S e c t i o n 74.62 of T i t l e 45 Code of F e d e r a l R e g u l a t i o n s P a r t 74, A d m i n i s t r a t i o n of G r a n t s (see t h e FEDERAL REGISTER, Vol. 56, No. 41, F r i d a y , March 1 , 1 9 9 1 ) . The p o s i t i o n o f N I H on t h i s i s s u e i s as f o l l o w s . Paragraph 1 5 . c . ( l ) of A-133 s t a t e s i n d e s c r i b i n g r e p o r t c o n t e n t s t h a t "The s c h e d u l e of F e d e r a l awards s h o u l d i d e n t i f y major programs and show t h e t o t a l e x p e n d i t u r e s f o r e a c h program. I n d i v i d u a l major programs OTHER THAN RESEARCH AND DEVELOPMENT AND STUDENT A I D s h o u l d b e l i s t e d as i d e n t i f i e d i n t h e C a t a l o g of F e d e r a l Domestic Assistance." (Emphasis a d d e d . ) V i r t u a l l y a l l of t h e e x t r a m u r a l programs o f N I H can be c l a s s i f i e d under t h e h e a d i n g s of Research and Development and S t u d e n t Aid programs. Accordingly, r e c i p i e n t s a r e NOT r e q u i r e d t o f u r n i s h t h e C a t a l o g number a p p l i c a b l e t o N I H g r a n t s t o t h e a u d i t o r s engaged to perform A-I33 a u d i t s . For t h a t r e a s o n , t h e N o t i c e of Grant Award used p r e s e n t l y by t h e N I H d o e s n o t c a r r y t h e C a t a l o g number. However, on o r a b o u t October 1 , 1992, w e may b e g i n t o u s e a format f o r t h e N o t i c e o f Grant Award t h a t w i l l i d e n t i f y t h e number. If t h e r e a r e any a d d i t i o n a l q u e s t i o n s c o n c e r n i n g implementation of OMB C i r c u l a r No. A-133, p l e a s e c o n t a c t : -4 M r . R i c h a r d Powers C h i e f , F i n a n c i a l Advisory S e r v i c e s Branch D i v i s i o n of C o n t r a c t s and 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 B u i l d i n g 3 1 , Room 1B43 Bethesda, MD 20892 Telephone: (301) 496-4401 NOTICES OF A V A I L A B I L I T Y (RFPs AND RFAs) RESEARCH SUPPORT F R THE CLINICAL AND REGULATORY AFFAIRS PROGRAM O RFP AVAILABLE: NIH-NIAID-DMID-92-3 P.T. 34; K.W. 0755015, 0755018 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 The D i v i s i o n of Microbiology and I n f e c t i o u s Diseases ( D M I D ) , 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 ( N I A I D ) , 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 , i s s o l i c i t i n g p r o p o s a l s from o r g a n i z a t i o n s having t h e c a p a b i l i t i e s and f a c i l i t i e s t o p r o v i d e r e s e a r c h s u p p o r t f o r t h e C l i n i c a l and R e g u l a t o r y A f f a i r s Program w i t h a l l p h a s e s of c l i n i c a l t r i a l s u p p o r t . T h i s c o n t r a c t s u p p o r t w i l l be p r o v i d e d w i t h i n a r e s e a r c h environment and c o n s o r t i u m i n c l u d i n g c l i n i c a l i n v e s t i g a t o r s , DMID Data C e n t e r , DMID C l i n i c a l S t u d i e s Group, and t h e Food and S p e c i f i c requirements include t h e c a p a b i l i t y t o : Drug A d m i n i s t r a t i o n ( F D A ) . ( 1 ) o b t a i n n e c e s s a r y i n f o r m a t i o n t o f i l e and u p d a t e I n v e s t i g a t i o n a l N e w Drugs; -Ci' N I H GUIDE - Vol. 20, No. 28, J u l y 1 9 , 1991 - Page 2 ( 2 ) d e v e l o p and implement computerized i n f o r m a t i o n s y s t e m s ; ( 3 ) m o n i t o r c l i n i c a l i n v e s t i g a t i o n s ; and (4) p r o v i d e g e n e r a l a d m i n i s t r a t i v e and l o g i s t i c a l s u p p o r t t o t h e C l i n i c a l and R e g u l a t o r y A f f a i r s S e c t i o n , D M I D . The Request f o r P r o p o s a l s (RFP) NIH-NIAID-DMID-92-3 w i l l b e a v a i l a b l e on o r a b o u t J u l y 23, 1991. Responses a r e due by September 6 , 1991. I t is a n t i c i p a t e d t h a t one c o s t - p l u s - f e e c o n t r a c t w i l l b e awarded w i t h i n c r e m e n t a l funding over a period of f i v e y e a r s . To r e c e i v e a copy o f t h i s RFP, p l e a s e s u p p l y t h i s o f f i c e w i t h two s e l f - a d d r e s s e d m a i l i n g l a b e l s . A l l i n q u i r i e s must be i n w r i t i n g and addressed t o: M s . S y l v i a Cunningham Contracting Officer C o n t r a c t Management Branch 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 C o n t r o l Data B u i l d i n g , Room 326P 6003 E x e c u t i v e Boulevard B e t h e s d a , MD 20892 T h i s a d v e r t i s e m e n t d o e s n o t commit t h e Government t o award a c o n t r a c t . EMERGING PATHOGENIC MYCOPLASMAS RFA AVAILABLE: P.T. 34; K . W . AI-91-12 0745020, 0715125, 0710070, 0785035, 0710030, 0755010 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 L e t t e r o f I n t e n t R e c e i p t Date: September 2 , 1991 A p p l i c a t i o n R e c e i p t Date: November 8 , 1991 PURPOSE The 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 ( N I A I D ) i n v i t e s a p p l i c a t i o n s f o r r e s e a r c h on t h e b i o l o g y and n a t u r a l h i s t o r y o f members o f t h e genus Mycoplasma t h a t have r e c e n t l y been r e c o g n i z e d a s p o t e n t i a l human pathogens. 1 ELIGIBILITY REQUIREMENTS Domestic u n i v e r s i t i e s , medical c o l l e g e s , h o s p i t a l s , and o t h e r p u b l i c o r p r i v a t e r e s e a r c h i n s t i t u t i o n s , i n c l u d i n g S t a t e and l o c a l government u n i t s , a r e e l i g i b l e . Awards t o f o r e i g n i n s t i t u t i o n s under t h i s r e q u e s t w i l l be made o n l y f o r r e s e a r c h o f u n u s u a l l y h i g h m e r i t , need and promise, and i n a c c o r d a n c e w i t h P u b l i c H e a l t h S e r v i c e p o l i c y g o v e r n i n g such awards. A p p l i c a t i o n s from m i n o r i t y i n v e s t i g a t o r s and women a r e encouraged. BACKGROUND Mycoplasmas a r e known t o c a u s e a wide v a r i e t y o f diseases i n humans and d o m e s t i c a t e d a n i m a l s . Mycoplasma s p p . a r e t h e c a u s e of m a s t i t i s i n c a t t l e , s h e e p , and g o a t s , u p p e r and lower r e s p i r a t o r y t r a c t i n f e c t i o n s and a r t h r i t i s i n swine, and c h r o n i c r e s p i r a t o r y d i s e a s e i n f o w l . I n humans, Mycoplasma pneumoniae i s t h e e t i o l o g i c a g e n t o f p r i m a r y a t y p i c a l pneumonia. A g r e a t d e a l o f i n t e r e s t and c o n t r o v e r s y h a s been g e n e r a t e d by r e p o r t s o f a s p e c i e s o f mycoplasma t h a t i s a s s o c i a t e d w i t h cases o f AIDS and w i t h a small number o f f a t a l i n f e c t i o n s i n HIV-negative i n d i v i d u a l s . The o r g a n i s m s a s s o c i a t e d w i t h t h e s e cases r e c e n t l y have been d e t e r m i n e d t o be s t r a i n s o f Mycoplasma f e r m e n t a n s . P r e v i o u s l y r e g a r d e d a s a commensal organism, M . f e r m e n t a n s h a s been i s o l a t e d i n f r e q u e n t l y from humans. However, r e c e n t r e p o r t s from s e v e r a l l a b o r a t o r i e s i n d i c a t e t h a t t h i s organism i s d e t e c t a b l e i n H I V - p o s i t i v e i n d i v i d u a l s a t a much h i g h e r f r e q u e n c y t h a n i n HIV-negative i n d i v i d u a l s . P r e l i m i n a r y r e p o r t s i n d i c a t e t h a t t h e same may be t r u e f o r o t h e r s p e c i e s o f Mycoplasma, p a r t i c u l a r l y Mycoplasma g e n i t a l i u m . Although t h e r e i s c o m p e l l i n g e v i d e n c e t h a t a t l e a s t some s t r a i n s of M . f e r m e n t a n s and M . g e n i t a l i u m a r e human p a t h o g e n s , t h e c r i t i c a l h o s t and m i c r o b i o l o g i c f a c t o r s t h a t d e f i n e t h e pathogenic r e l a t i o n s h i p r e q u i r e f u r t h e r i n v e s t i g a t i o n . D e l i n e a t i o n of t h e s e f a c t o r s w i l l l e a d t o e f f e c t i v e a p p r o a c h e s i n d i a g n o s i s , t r e a t m e n t , p r e v e n t i o n , and c o n t r o l . N I H GUIDE - Vol. 20, No. 28, J u l y 1 9 , 1991 - Page 3 HEALTHY PEOPLE 2000 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 promotion 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 of "Healthy People 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 areas. T h i s Request f o r A p p l i c a t i o n s ( R F A ) , Emerging P a t h o g e n i c Mycoplasmas, is r e l a t e d t o t h e p r i o r i t y area of H I V i n f e c t i o n . 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 "Healthy People 2000" ( F u l l R e p o r t : S t o c k No. 017-001-00474-0) o r "Healthy People 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 Office, Washington, D . C . 20402-9325 ( t e l e p h o n e 202-783-3238). RESEARCH GOALS AND SCOPE The g o a l o f t h i s RFA i s t o s t i m u l a t e i n n o v a t i v e b a s i c and/or c l i n i c a l r e s e a r c h on r e l e v a n t a s p e c t s o f t h e b i o l o g y and n a t u r a l h i s t o r y o f M . f e r m e n t a n s and on h o s t r e s p o n s e s t h a t i n f l u e n c e p a t h o g e n e s i s o f human disease. Of p a r t i c u l a r i n t e r e s t a r e s t u d i e s on p a t h o g e n e s i s aimed a t c h a r a c t e r i z i n g i n t e r a c t i o n o f mycoplasmas w i t h h o s t c e l l s and w i t h t h e h o s t d e f e n s e system, p a r t i c u l a r l y s t u d i e s aimed a t c h a r a c t e r i z i n g any immunosuppressive a c t i v i t y of M . f e r m e n t a n s . A s e r i o u s impediment t o s t u d i e s on M . f e r m e n t a n s i s t h e problem o f r e c o v e r y from i n f e c t e d a n i m a l s o r p a t i e n t s . Therefore, s t u d i e s focused upon growth o f t h e s e organisms w i t h p a r t i c u l a r emphasis on p h y s i o l o g i c t r a n s i t i o n s t h a t o c c u r i n r e s p o n s e t o changes i n environment, such a s from h o s t t o t i s s u e c u l t u r e o r t o s y n t h e t i c c u l t u r e , are a l s o o f i n t e r e s t . A p p l i c a n t s are encouraged, depending upon t h e i r e x p e r t i s e , t o a d d r e s s one o r more o f t h e f o l l o w i n g r e s e a r c h areas: Epidemiologic s t u d i e s on M . f e r m e n t a n s i n f e c t i o n i n humans, e s p e c i a l l y H I V - p o s i t i v e i n d i v i d u a l s , i n c l u d i n g t r a n s m i s s i o n and natural history studies; S t u d i e s of t h e biology of M. fermentans t o include: physiology, b i o c h e m i s t r y , g e n e t i c s , and s t r u c t u r e and f u n c t i o n of s u r f a c e constituents; S t u d i e s f o c u s e d upon n o n - s p e c i f i c inflammatory and s p e c i f i c immune r e s p o n s e s t o i n f e c t i o n by M . f e r m e n t a n s ; S t u d i e s f o c u s e d upon mechanisms of v i r u l e n c e o r c o l o n i z a t i o n t h a t are i m p o r t a n t i n t h e p a t h o g e n i c a c t i v i t i e s of M. f e r m e n t a n s ; rJ Development of improved c u l t u r e t e c h n i q u e s f o r more e f f i c i e n t r e c o v e r y o f i s o l a t e s from p a t i e n t s ; Development of a s e n s i t i v e and s p e c i f i c a s s a y f o r d e t e c t i o n o f t h e p r e s e n c e o f M . f e r m e n t a n s i n t h e h o s t ; and Development o f animal models f o r i n v i v o s t u d y of p a t h o g e n e s i s and host response. A p p l i c a n t s may a l s o c o n s i d e r o t h e r avenues of i n v e s t i g a t i o n t h a t would be One o r several o f t h e above areas may b e i n c l u d e d i n a n a p p l i c a t i o n . c o n s i s t e n t w i t h t h e g o a l s of t h i s RFA. Although t h e p r i m a r y f o c u s of t h i s RFA is upon M. f e r m e n t a n s , o t h e r s p e c i e s o f Mycoplasma, p a r t i c u l a r l y M . g e n i t a l i u m , may b e c o n s i d e r e d i f t h e o b j e c t i v e s o f t h e r e s e a r c h are c o n s i s t e n t w i t h t h e o b j e c t i v e s o f t h i s RFA. MECHANISM O SUPPORT F 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 i n d i v i d u a l R e s p o n s i b i l i t y f o r p l a n n i n g , d i r e c t i o n , and e x e c u t i o n research grant ( R o l l . of t h e proposed p r o j e c t w i l l be s o l e l y t h a t of t h e a p p l i c a n t . N I A I D a n t i c i p a t e s making f i v e t o e i g h t awards, t o t a l i n g $1,000,000, as a r e s u l t of t h i s s o l i c i t a t i o n . However, t h e number o f awards made w i l l be dependent upon r e c e i p t o f a s u f f i c i e n t number of a p p l i c a t i o n s o f h i g h s c i e n t i f i c merit and upon t h e a v a i l a b i l i t y o f f u n d s . If a p p r o p r i a t e , c o l l a b o r a t i o n w i t h o t h e r i n v e s t i g a t o r s o r i n s t i t u t i o n s i s encouraged. I t i s e x p e c t e d t h a t e a c h award f o r t h e f i r s t y e a r w i l l be i n t h e r a n g e o f $125,000 t o $225,000 i n t o t a l ( d i r e c t p l u s i n d i r e c t ) c o s t s , a l t h o u g h i n d i v i d u a l awards may be s l i g h t l y h i g h e r o r l o w e r . Awards w i l l be made f o r a p r o j e c t p e r i o d of up t o f i v e y e a r s . (Awards t o f o r e i g n i n s t i t u t i o n s w i l l be l i m i t e d t o t h r e e y e a r s and w i l l n o t i n c l u d e i n d i r e c t c o s t s . ) The e a r l i e s t p o s s i b l e award d a t e i s J u l y 1 , 1992. SPECIAL INSTRUCTIONS F R INCLUSION OF WOMEN AND MINORITIES I N CLINICAL O RESEARCH STUDIES N I H GUIDE - Vol. 20, No. 28, J u l y 19, 1991 - Page 4 For p r o j e c t s i n v o l v i n g c l i n i c a l r e s e a r c h , N I H r e q u i r e s a p p l i c a n t s t o g i v e s p e c i a l a t t e n t i o n t o t h e i n c l u s i o n of women and m i n o r i t i e s i n s t u d y populations. I f women and m i n o r i t i e s a r e n o t i n c l u d e d i n t h e s t u d y populations f o r c l i n i c a l studies, a s p e c i f i c j u s t i f i c a t i o n f o r t h i s exclusion must be p r o v i d e d . A p p l i c a t i o n s w i t h o u t such documentation w i l l n o t be accepted f o r review. APPLICATION AND REVIEW PROCEDURES The 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 ( r e v i s e d 10/88) must be used i n a p p l y i n g f o r t h e s e g r a n t s . These forms 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 and from t h e 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 449, Westwood B u i l d i n g , 5333 Westbard Avenue, B e t h e s d a , MD 20892. A p p l i c a t i o n s must be r e c e i v e d by November 8 , 1991. 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 e above d a t e w i l l be r e t u r n e d w i t h o u t r e v i e w . If t h e a p p l i c a t i o n 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 s u b s t a n t i a l l y s i m i l a r t o a r e s e a r c h g r a n t a p p l i c a t i o n a l r e a d y s u b m i t t e d t o t h e N I H f o r r e v i e w , b u t h a s n o t y e t been reviewed, t h e a p p l i c a n t w i l l be asked t o withdraw e i t h e r t h e pending a p p l i c a t i o n o r t h e new o n e . Simultaneous submission of i d e n t i c a l a p p l i c a t i o n s w i l l n o t be a l l o w e d , n o r w i l l e s s e n t i a l l y i d e n t i c a l a p p l i c a t i o n s be reviewed by d i f f e r e n t r e v i e w committees. T h e r e f o r e , a n a p p l i c a t i o n c a n n o t be 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 t h a t i s e s s e n t i a l l y i d e n t i c a l t o one t h a t h a s a l r e a d y been r e v i e w e d . T h i s d o e s n o t p r e c l u d e t h e submission of s u b s t a n t i a l r e v i s i o n s o f a p p l i c a t i o n s a l r e a d y reviewed, b u t such a p p l i c a t i o n s must i n c l u d e a n introduction addressing t h e previous c r i t i q u e . 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 D i v i s i o n of Research G r a n t s (DRG) and A p p l i c a t i o n s w i l l be reviewed by N I A I D s t a f f t o d e t e r m i n e assigned t o N I A I D . a d m i n i s t r a t i v e and programmatic r e s p o n s i v e n e s s t o t h i s RFA; t h o s e judged t o be n o n - r e s p o n s i v e w i l l be r e t u r n e d t o t h e a p p l i c a n t w i t h o u t r e v i e w . By mutual agreement between t h e a p p l i c a n t and N I A I D s t a f f , a n o n - r e s p o n s i v e a p p l i c a t i o n may b e p r o c e s s e d a s a n u n s o l i c i t e d R 0 1 a p p l i c a t i o n f o r t h e n e x t r e v i e w c y c l e . Those a p p l i c a t i o n s c o n s i d e r e d r e s p o n s i v e to t h e RFA may be s u b j e c t e d t o a t r i a g e r e v i e w by an N I A I D p e e r r e v i e w group, b e f o r e o r d u r i n g t h e i n i t i a l r e v i e w committee meeting, t o d e t e r m i n e t h e i r s c i e n t i f i c m e r i t r e l a t i v e t o the o t h e r 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 e RFA. The N I A I D w i l l withdraw from c o m p e t i t i o n t h o s e a p p l i c a t i o n s judged by t h e t r i a g e p e e r review group t o be n o n c o m p e t i t i v e f o r award and w i l l n o t i f y t h e a p p l i c a n t P r i n c i p a l I n v e s t i g a t o r and t h e 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 i a l . Those a p p l i c a t i o n s judged t o be r e s p o n s i v e t o t h i s s o l i c i t a t i o n w i l l 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 r e v i e w committee convened by t h e D i v i s i o n of Extramural A c t i v i t i e s , N I A I D , d u r i n g March 1992. The second l e v e l of r e v i e w w i l l b e p r o v i d e d 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 May 1992. W L e t t e r o f 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 asked t o submit a l e t t e r o f i n t e n t by September 2 , 1991. T h i s l e t t e r s h o u l d i n c l u d e t h e name of t h e i n s t i t u t i o n any o t h e r p a r t i c i p a t i n g i n s t i t u t i o n s , 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 o t h e r key i n v e s t i g a t o r s , and a d e s c r i p t i v e t i t l e . Such a l e t t e r o f i n t e n t i s n o t b i n d i n g and 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 s u b m i t t e d , n o r i s it a n e c e s s a r y r e q u i r e m e n t f o r a p p l i c a t i o n . Letters of i n t e n t a r e r e q u e s t e d s o l e l y f o r r e v i e w p l a n n i n g p u r p o s e s . N I A I D s t a f f w i l l n o t p r o v i d e r e s p o n s e s t o such l e t t e r s . L e t t e r s of i n t e n t a r e t o b e sent t o : D r . Olivia Preble C h i e f , Microbiology and Immunology Review S e c t i o n Program and P r o j e c t Review Branch 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 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 Westwood B u i l d i n g , Room 3A10 B e t h e s d a , MD 20892 Telephone: (301) 496-8208 The f u l l RFA may be o b t a i n e d from: D r . Robert L . Quackenbush C h i e f , B a c t e r i o l o g y and Mycology Branch D i v i s i o n o f Microbiology and I n f e c t i o u 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 A l l e r g y and I n f e c t i o u s Diseases Westwood B u i l d i n g , Room 738 Bethesda, MD 20892 Telephone: ( 3 0 1 ) 496-7728 W N I H G U I D E - Vol. 20, No. 2 8 , J u l y 19, 1991 - Page 5 For f i s c a l and a d m i n i s t r a t i v e matters, c o n t a c t : C h i e f , Microbiology and I n f e c t i o u s Diseases G r a n t s Management S e c t i o n GMB. DEA 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 Westwood B u i l d i n g , Room 718 Bethesda, MD 20892 Telephone: (301) 496-7075 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. 93.856 - Microbiology and I n f e c t i o u s Disease Research. G r a n t s are awarded 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 I V , S e c t i o n 301 as amended, P u b l i c Law 78-410; P u b l i c Law 97-219; P u b l i c Law 99-158; P u b l i c Law 99-500; and Report 99-711 t o accompany HR 5233 and a d m i n i s t e r e d under PHS g r a n t s 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 42 CFR 52 and 45 CFR P a r t 74. 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 review r e q u i r e m e n t s of E x e c u t i v e Order 12372 o r H e a l t h Systems Agency r e v i e w . M r . Todd B a l l ONGOING P O R M ANNOUNCEMENTS RGA C L I N I C A L INVESTIGATOR DEVELOPMENT AWARD PA: PA-91-78 0715032, 0715040, 0715165, 0750010, 0785035 P.T. 34; K.W. N a t i o n a l Heart, Lung, and Blood I n s t i t u t e I. PURPOSE AND ELIGIBILITY The N a t i o n a l Heart, Lung, and Blood I n s t i t u t e ( N H L B I ) announces t h e a v a i l a b i l i t y o f t h e C I D A . The C I D A i n c l u d e s f e a t u r e s o f and r e p l a c e s t h e P h y s i c i a n S c i e n t i s t Award and t h e C l i n i c a l I n v e s t i g a t o r Award. The C I D A is i n t e n d e d t o a l l o w g r e a t e r f l e x i b i l i t y i n d e v e l o p i n g a program s u i t e d t o . t h e e x p e r i e n c e and c a p a b i l i t i e s of t h e c a n d i d a t e . The o b j e c t i v e s o f t h e NHLBI i n supporting t h e CIDA are t o : o encourage r e s e a r c h - o r i e n t e d p h y s i c i a n s t o d e v e l o p independent -4 r e s e a r c h s k i l l s and g a i n e x p e r i e n c e i n advanced methods and e x p e r i m e n t a l approaches i n t h e b a s i c and a p p l i e d s c i e n c e s r e l e v a n t t o h e a r t , blood v e s s e l , l u n g , blood d i s e a s e s , and t r a n s f u s i o n medicine ; o i n c r e a s e t h e pool of p h y s i c i a n i n v e s t i g a t o r s who can u s e advanced t e c h n o l o g i e s t o a d d r e s s t h e major problems i n h e a r t , blood v e s s e l , l u n g , and blood d i s e a s e s , and t r a n s f u s i o n medicine. The C I D A p r o v i d e s r e s e a r c h development o p p o r t u n i t i e s f o r p h y s i c i a n s w i t h v a r y i n g l e v e l s of r e s e a r c h e x p e r i e n c e , who a r e committed to d e v e l o p i n g into independent i n v e s t i g a t o r s . This award w i l l e n a b l e c a n d i d a t e s h o l d i n g h e a l t h p r o f e s s i o n a l d o c t o r a l d e g r e e s , such as t h e M.D., D.O., D . V . M . , o r equivalent d e g r e e , to u n d e r t a k e t h r e e t o f i v e y e a r s o f s p e c i a l s t u d y and s u p e r v i s e d r e s e a r c h w i t h t h e g o a l of d e v e l o p i n g i n t o independent i n v e s t i g a t o r s . For i n d i v i d u a l s w i t h M . D . o r D . O . d e g r e e s , it i s r e q u i r e d t h a t a t l e a s t two y e a r s have e l a p s e d s i n c e t h e g r a n t i n g of t h e d o c t o r a l d e g r e e a t t h e t i m e an award i s made. I n d i v i d u a l s d e s i r i n g s u b s p e c i a l t y t r a i n i n g may wish t o complete t h e i r c l i n i c a l f e l l o w s h i p t r a i n i n g b e f o r e s t a r t i n g t h e C I D A o r , a l t e r n a t i v e l y , by i n t e r r u p t i n g t h e award t o complete c l i n i c a l t r a i n i n g , t h e y may i n t e g r a t e t h e i r c l i n i c a l f e l l o w s h i p t r a i n i n g w i t h t h e r e s e a r c h t r a i n i n g and development provided by t h e CIDA(1). A p p l i c a t i o n s may be a c c e p t e d from t h o s e who h o l d a Ph.D. d e g r e e i n a d d i t i o n t o a h e a l t h p r o f e s s i o n a l d e g r e e i f s p e c i a l c i r c u m s t a n c e s can be shown, such a s t h e Ph.D. d e g r e e was e a r n e d i n an u n r e l a t e d f i e l d o r an i n t e r v e n i n g p e r i o d o f c l i n i c a l t r a i n i n g o r o t h e r n o n - r e s e a r c h a c t i v i t i e s o c c u r r i n g s i n c e completion o f t h e Ph.D. d e g r e e . Such a p p l i c a t i o n s w i l l be c o n s i d e r e d on a c a s e - b y - c a s e b a s i s . (1) The CIDA may n o t be used t o s u p p o r t c l i n i c a l t r a i n i n g o r d u t i e s , b u t t h e award may be i n t e r r u p t e d o r suspended t o a l l o w f o r t h e completion o r c o n t i n u a t i o n of c l i n i c a l t r a i n i n g followed by resumption of CIDA s u p p o r t for t h e completion of t h e r e s e a r c h development program. ' -+' The award i s i n t e n d e d t o s e r v e r e s e a r c h career development needs o f c l i n i c a l l y t r a i n e d i n d i v i d u a l s by p r o v i d i n g them w i t h r e s e a r c h o p p o r t u n i t i e s a p p r o p r i a t e f o r t h e i r s c h o l a s t i c background, p r e v i o u s r e s e a r c h e x p e r i e n c e , and p a s t achievements. P h y s i c i a n s who have l i t t l e r e s e a r c h e x p e r i e n c e and need guided N I H GUIDE - Vol. 20, No. 28, J u l y 19, 1991 - Page 6 c o u r s e work and s u p e r v i s e d l a b o r a t o r y e x p e r i e n c e s a r e e l i g i b l e t o a p p l y . I n d i v i d u a l s who do n o t r e q u i r e a d d i t i o n a l c o u r s e s b u t who need an i n t e n s i v e r e s e a r c h e x p e r i e n c e under t h e guidance of a n e s t a b l i s h e d s c i e n t i s t a r e a l s o e l i g i b l e t o a p p l y , a s are t r a i n e e s on 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 g r a n t s o r i n d i v i d u a l p o s t d o c t o r a l f e l l o w s h i p s from t h e N I H o r o t h e r o r g a n i z a t i o n s . Women and m i n o r i t i e s a r e encouraged t o a p p l y . C u r r e n t o r p a s t P r i n c i p a l I n v e s t i g a t o r s of an N I H g r a n t o r i t s e q u i v a l e n t a r e n o t e l i g i b l e . I n g e n e r a l , a p p l i c a n t s f o r t h e award s h o u l d have no fewer t h a n 2 y e a r s o f p o s t d o c t o r a l experience. P A l l programs s h o u l d be c a r e f u l l y t a i l o r e d t o meet i n d i v i d u a l n e e d s and must i n c l u d e a s p o n s o r ( s 1 who i s competent t o p r o v i d e a p p r o p r i a t e r e s e a r c h g u i d a n c e . The C I D A can be i n t e g r a t e d w i t h t h e r e q u i r e m e n t s f o r c l i n i c a l In order t o t r a i n i n g , and d i f f e r i n g approaches f o r d o i n g so may be proposed. a l l o w f o r t h e i n t e g r a t i o n of r e s e a r c h t r a i n i n g w i t h c l i n i c a l t r a i n i n g , a C I D A development p l a n may p r o v i d e f o r an i n t e r r u p t i o n i n g r a n t s u p p o r t and t h e r e s e a r c h development program t o a l l o w f o r a d d i t i o n a l c l i n i c a l t r a i n i n g . For example, i n d i v i d u a l s w i t h l i m i t e d c l i n i c a l and r e s e a r c h t r a i n i n g may propose a program encompassing a one- t o two-year b r e a k i n t h e program t o a l l o w f o r completion of s u b s p e c i a l t y t r a i n i n g , followed by c o n t i n u a t i o n o f t h e r e s e a r c h development program. The p e r i o d of i n t e r r u p t i o n o r l e a v e would be w i t h o u t award s u p p o r t and would n o t r e d u c e t h e t o t a l number of months o f s u p p o r t f o r which an i n d i v i d u a l i s e l i g i b l e . Other more e x p e r i e n c e d c a n d i d a t e s , may simply propose t o d e v o t e a l i m i t e d e f f o r t ( 2 0 p e r c e n t o r l e s s ) t o c l i n i c a l d u t i e s t h a t r e l a t e t o t h e o v e r a l l program d u r i n g t h e c o u r s e o f t h e C I D A . A t t h e t i m e o f a p p l i c a t i o n , i n d i v i d u a l s must be e i t h e r c i t i z e n s o r n o n c i t i z e n n a t i o n a l s of t h e United S t a t e s o r have been l a w f u l l y a d m i t t e d t o t h e United S t a t e s f o r permanent r e s i d e n c e . A i n d i v i d u a l l a w f u l l y a d m i t t e d f o r permanent n r e s i d e n c e must submit, w i t h t h e a p p l i c a t i o n , a n o t a r i z e d s t a t e m e n t i n d i c a t i n g p o s s e s s i o n of t h e A l i e n R e g i s t r a t i o n R e c e i p t Card (1-151 o r 1 - 5 5 1 ) . I n d i v i d u a l s on temporary o r s t u d e n t v i s a s are n o t e l i g i b l e . 11. 1. PROVISIONS OF THE AWARD Environment A p p l i c a t i o n s w i l l be a c c e p t e d from d o m e s t i c u n i v e r s i t i e s , medical s c h o o l s , o r comparable i n s t i t u t i o n s w i t h s t r o n g , w e l l - e s t a b l i s h e d 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 programs, a d e q u a t e numbers o f accomplished f a c u l t y i n t h e b a s i c and c l i n i c a l s c i e n c e s , and a commitment and c a p a b i l i t y t o p r o v i d e guidance t o c l i n i c a l l y t r a i n e d i n d i v i d u a l s d u r i n g t h e i r development of independent r e s e a r c h careers. Evidence of i n s t i t u t i o n a l commitment t o t h e c a n d i d a t e ' s r e s e a r c h and development must be p r o v i d e d i n a p l a n t h a t i d e n t i f i e s p e r s o n n e l and o t h e r r e s o u r c e s t o be devoted t o t h a t c a n d i d a t e . 2. Program C a n d i d a t e s must be nominated by an i n s t i t u t i o n on t h e b a s i s of q u a l i f i c a t i o n s , i n t e r e s t s , accomplishments, m o t i v a t i o n , and p o t e n t i a l f o r performing q u a l i t y r e s e a r c h . The c a n d i d a t e ' s academic background, p r e v i o u s e x p e r i e n c e , and career g o a l s s h o u l d d e t e r m i n e b o t h t h e n e c e s s a r y l e n g t h and t h e k i n d of program t h a t i s a p p r o p r i a t e . The c a n d i d a t e and s p o n s o r a r e j o i n t l y r e s p o n s i b l e f o r t h e p r e p a r a t i o n of t h e r e s e a r c h development p l a n . A l l c a n d i d a t e s must p r o v i d e a f u l l d e s c r i p t i o n of t h e r e s e a r c h and career development p l a n f o r t h e p e r i o d o f t h e award. The proposed p l a n must i n c l u d e hands-on r e s e a r c h e x p e r i e n c e , w i t h e i t h e r a c l i n i c a l o r a b a s i c f o c u s , f o r t h e e n t i r e t h r e e - t o f i v e - y e a r p e r i o d . Programs may i n c l u d e s t u d i e s and r e s e a r c h endeavors l e a d i n g t o e i t h e r a Masters d e g r e e , such a s an M.P.H. d e g r e e , o r a Ph.D. d e g r e e , i f t h e o b j e c t i v e i s t h e development o f t h e c a n d i d a t e i n t o a n independent i n v e s t i g a t o r . Awardees, i n c o n j u n c t i o n w i t h t h e i r s p o n s o r ( s 1 , a r e r e q u i r e d t o submit a d e t a i l e d annual p r o g r e s s r e p o r t . Candidate w i t h Minimal Research E x p e r i e n c e I f t h e c a n d i d a t e h a s minimal r e s e a r c h e x p e r i e n c e , t h e i n d i v i d u a l ' s program s h o u l d be d e s i g n e d t o s t a r t w i t h a c r e a t i v e and d e t a i l e d s c i e n t i f i c l e a r n i n g e x p e r i e n c e and p r o g r e s s t o an i n t e n s i v e r e s e a r c h a c t i v i t y under t h e guidance o f a q u a l i f i e d s p o n s o r ( s 1 . The f i r s t y e a r o r two of t h e program may i n c o r p o r a t e any needed c o u r s e work, an i n i t i a l hands-on r e s e a r c h e x p e r i e n c e , s e m i n a r s , and o t h e r e d u c a t i o n a l e x p e r i e n c e s n e c e s s a r y t o p r e p a r e t h e c a n d i d a t e f o r t h e subsequent r e s e a r c h program. T h i s i n i t i a l phase o f t h e program may resemble and r e p l a c e a t r a d i t i o n a l p o s t d o c t o r a l r e s e a r c h t r a i n i n g program. The remainder of t h e development p l a n must i n c l u d e an i n t e n s i v e , f u l l y - d e s c r i b e d r e s e a r c h program and p r o j e c t s t h a t can be r e a s o n a b l y completed w i t h i n t h e planned p e r i o d . During t h i s l a t t e r phase, t h e program m u s t p r o v i d e N I H GUIDE - Vol. 20, No. 28, J u l y 1 9 , 1991 - Page 7 f o r p r o g r e s s i v e development o f t h e i n d i v i d u a l i n t o an independent investigator. C a n d i d a t e w i t h P r i o r Research E x p e r i e n c e *wr If t h e c a n d i d a t e h a s a l r e a d y a c q u i r e d some r e s e a r c h e x p e r i e n c e , a s might be o b t a i n e d t h r o u g h a r e s e a r c h f e l l o w s h i p , b u t n e e d s f u r t h e r development under t h e guidance of an e s t a b l i s h e d s c i e n t i f i c s p o n s o r ( s 1 , t h e c a n d i d a t e may propose t o spend t h r e e t o f i v e y e a r s s o l e l y i n an advanced r e s e a r c h e x p e r i e n c e f o c u s i n g on a s p e c i f i c r e s e a r c h p r o j e c t . Such a c a n d i d a t e , however, may t a k e a d d i t i o n a l c o u r s e s o r engage i n s p e c i a l i n s t r u c t i o n i n research techniques i n o t h e r l a b o r a t o r i e s f o r a reasonable t i m e i f needed. I n d i v i d u a l s w i t h s i g n i f i c a n t r e s e a r c h e x p e r i e n c e i n t h e proposed f i e l d of s t u d y may n o t be e l i g i b l e f o r t h i s award and s h o u l d c o n s i d e r a p p l y i n g i n s t e a d f o r independent r e s e a r c h s u p p o r t . 3. Sponsor Each c a n d i d a t e m u s t i d e n t i f y a s p o n s o r who i s an accomplished i n v e s t i g a t o r i n t h e r e s e a r c h area proposed and h a s e x p e r i e n c e i n d e v e l o p i n g independent i n v e s t i g a t o r s . The s p o n s o r must p r o v i d e a w r i t t e n p l a n f o r t h e development of t h e c a n d i d a t e and p r o v i d e guidance d u r i n g t h e p r e p a r a t i o n of t h e r e s e a r c h p r o j e c t . A s e c o n d a r y s p o n s o r may a l s o be proposed, b u t t h e primary s p o n s o r must c o n t i n u e t o be i n v o l v e d t h r o u g h o u t t h e award p e r i o d . I n some cases c a n d i d a t e s may choose t o have b o t h a b a s i c r e s e a r c h s p o n s o r and a c l i n i c a l research sponsor. 4. Advisory Committee A committee composed of t h e c a n d i d a t e ' s s p o n s o r ( s 1 and two o r t h r e e o t h e r s e n i o r f a c u l t y members must be i d e n t i f i e d . T h i s a d v i s o r y committee must meet w i t h t h e c a n d i d a t e t o review t h e r e s e a r c h development p l a n and r e s e a r c h p r o j e c t , t o e v a l u a t e t h e awardee's p r o g r e s s , and t o p r o v i d e g u i d a n c e f o r s c i e n t i f i c career development. The committee r e p o r t must be i n c l u d e d i n t h e a n n u a l p r o g r e s s r e p o r t s u b m i t t e d w i t h t h e noncompeting c o n t i n u a t i o n application. 5. *rJ D u r a t i o n and E f f o r t The award i s g r a n t e d f o r t h r e e t o f i v e y e a r s depending upon t h e n e e d s of t h e c a n d i d a t e and t h e e v a l u a t i o n by t h e i n i t i a l r e v i e w group and t h e N a t i o n a l Heart, Lung and Blood Advisory C o u n c i l . I t i s non-renewable and n o t t r a n s f e r a b l e , b u t s u b s t i t u t i o n of a n o t h e r s p o n s o r a n d l o r a change o f i n s t i t u t i o n may be p e r m i t t e d w i t h t h e p r i o r a p p r o v a l o f t h e N H L B I . A l l f u n d s must be used on b e h a l f of t h e o r i g i n a l c a n d i d a t e . A minimum of 80 p e r c e n t e f f o r t must be d e v o t e d t o t h e r e s e a r c h program. The remainder may be d e v o t e d t o o t h e r c l i n i c a l and t e a c h i n g p u r s u i t s t h a t a r e consonant w i t h t h e program g o a l s , i . e . , t h e c a n d i d a t e ' s development i n t o an independent b i o m e d i c a l s c i e n t i s t o r t h e maintenance of t h e t e a c h i n g and c l i n i c a l s k i l l s needed f o r a n academic r e s e a r c h career. The c a n d i d a t e must have a " f u l l - t i m e " appointment a t t h e a p p l i c a n t i n s t i t u t i o n . I n g e n e r a l , c a n d i d a t e s who have V e t e r a n s A d m i n i s t r a t i o n ( V A ) appointments may n o t c o n s i d e r p a r t o f t h e VA e f f o r t toward s a t i s f y i n g t h e " f u l l - t i m e " r e q u i r e m e n t a t t h e a p p l i c a n t i n s t i t u t i o n . Although e x c e p t i o n a l cases may b e approved, any r e q u e s t t o c o u n t a p a r t of t h e VA e f f o r t toward s a t i s f a c t i o n o f t h e ' w f u l l - t i m e * ' r e s e a r c h e f f o r t r e q u i r e m e n t of t h e award must be s t r o n g l y j u s t i f i e d . A l l such e x c e p t i o n a l cases must o t h e r w i s e meet t h e i n t e n t o f t h e g u i d e l i n e s . Under no c i r c u m s t a n c e s may t h e C I D A be used t o r e i m b u r s e p a r t o f t h e VA F e d e r a l s a l a r y . It i s p e r m i s s i b l e f o r p a r t o r a l l o f t h e research program t o be conducted i n a VA l a b o r a t o r y , i f , f o r example, t h e mentor h a s a VA appointment, b u t t h e above c o n d i t i o n s must be s a t i s f i e d a s they apply t o t h e CIDA candidate. 6. Allowable C o s t s - - I n d i v i d u a l compensation i s based on t h e i n s t i t u t i o n ' s s a l a r y s c a l e f o r i n d i v i d u a l s a t an e q u i v a l e n t e x p e r i e n c e l e v e l . Funding from t h i s award f o r s a l a r y may n o t exceed $ 5 0 , 0 0 0 p e r y e a r p l u s commensurate f r i n g e b e n e f i t s f o r e s s e n t i a l l y f u l l - t i m e w i t h a t l e a s t 80 p e r c e n t e f f o r t d e v o t e d t o t h e r e s e a r c h program. N I H p o l i c y p e r m i t s s u p p l e m e n t a t i o n of s a l a r y from non-Federal s o u r c e s . a . S a l a r y -J b . Research and Development Support - - A maximum o f $15,000 p e r y e a r may be r e q u e s t e d f o r r e s e a r c h p r o j e c t r e q u i r e m e n t s and r e l a t e d s u p p o r t , e . g . , t e c h n i c a l p e r s o n n e l c o s t s , s u p p l i e s , equipment, c a n d i d a t e t r a v e l , t e l e p h o n e N I H GUIDE - Vol. 20, No. 28, J u l y 19, 1991 - Page 8 c h a r g e s , p u b l i c a t i o n c o s t s , and t u i t i o n f o r n e c e s s a r y c o u r s e s . must be 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 . A l l expenses c . I n d i r e c t C o s t s - - Reimbursement o f a c t u a l i n d i r e c t c o s t s a t a r a t e up to, b u t n o t exceeding, e i g h t p e r c e n t of t h e 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 o f e a c h award, e x c l u s i v e of t u i t i o n , f e e s , and e x p e n d i t u r e s f o r equipment. 7. Concurrent A p p l i c a t i o n s %- CIDA a p p l i c a t i o n s may n o t be s u b m i t t e d o r awarded c o n c u r r e n t l y w i t h o t h e r N I H a p p l i c a t i o n s , such a s t h e Research C a r e e r Development Award, FIRST Award, Academic Award, o r Research P r o j e c t G r a n t . 8. Subsequent A p p l i c a t i o n s f o r N I H Research Support During t h e l a t e r y e a r s o f t h e C I D A , incumbents a r e encouraged t o a p p l y f o r independent r e s e a r c h s u p p o r t , such as t h e FIRST Award o r o t h e r r e s e a r c h p r o j e c t g r a n t s . C I D A r e c i p i e n t s who a r e s u c c e s s f u l i n o b t a i n i n g N I H r e s e a r c h g r a n t s u p p o r t may e l e c t e i t h e r t o t e r m i n a t e t h e CIDA immediately and b e g i n t h e r e s e a r c h g r a n t , o r a l t e r n a t i v e l y , t o t e r m i n a t e t h e C I D A on i t s a n n i v e r s a r y d a t e and b e g i n t h e r e s e a r c h g r a n t a t t h a t t i m e . S i n c e c o n c u r r e n t s u p p o r t i s n o t p e r m i t t e d , C I D A r e c i p i e n t s who a p p l y f o r subsequent r e s e a r c h g r a n t s u p p o r t a r e encouraged t o i n c l u d e s a l a r y and a l l o t h e r r e s e a r c h needs i n t h e r e s e a r c h grant application. 111. EVALUATION Awardees w i l l be encouraged t o p r o v i d e a d e t a i l e d r e p o r t t o 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 a n n u a l l y f o r a p e r i o d of f i v e y e a r s subsequent t o completion of t h e award a b o u t academic s t a t u s a t t a i n e d , p u b l i c a t i o n a u t h o r s h i p , and r e s e a r c h g r a n t s o r c o n t r a c t s r e c e i v e d . IV. MECHANISM OF SUPPORT The mechanism of s u p p o r t for t h i s a c t i v i t y w i l l be t h e c a r e e r development g r a n t (K08). The award of g r a n t s p u r s u a n t t o t h i s announcement i s c o n t i n g e n t upon a v a i l a b i l i t y of a p p r o p r i a t e d f u n d s . V. REVIEW METHODS AND CRITERIA A p p l i c a t i o n s r e c e i v e d i n r e s p o n s e t o t h i s announcement w i l l be reviewed i n accordance w i t h t h e u s u a l N I H p e e r review p r o c e d u r e s . They w i l l be reviewed i n i t i a l l y f o r t h e p o t e n t i a l t o d e v e l o p t h e c a n d i d a t e ' s r e s e a r c h career and 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 an NHLBI review group composed mostly o f non-Federal s c i e n t i f i c c o n s u l t a n t s ( i n i t i a l review g r o u p ) . Following t h e i n i t i a l r e v i e w , t h e 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 t h e N a t i o n a l Heart, Lung, and Blood Advisory C o u n c i l . The c r i t e r i a f o r i n i t i a l review of a p p l i c a t i o n s i n c l u d e : -I . 1 . Candidate - - C a n d i d a t e ' s o v e r a l l competence a s demonstrated by academic r e c o r d and c l i n i c a l performance, p o t e n t i a l f o r a c a r e e r i n independent r e s e a r c h , and commitment o r i n t e r e s t i n p u r s u i n g an academic r e s e a r c h career. 2 . S p o n s o r ( s ) - - The s p o n s o r ' s accomplishments i n t h e s c i e n t i f i c r e s e a r c h a r e a c s ) proposed, e x p e r i e n c e and t r a c k r e c o r d i n t r a i n i n g i n v e s t i g a t o r s , and commitment f o r t h e d u r a t i o n of a c a n d i d a t e ' s r e s e a r c h development. A c u r r i c u l u m v i t a e w i t h r e l e v a n t p u b l i c a t i o n s and a l i s t of c u r r e n t and pending r e s e a r c h s u p p o r t must be i n c l u d e d f o r a l l s p o n s o r s . Sponsors must a l s o i n c l u d e a l i s t of c u r r e n t and p a s t r e s e a r c h t r a i n e e s ( n o t more t h a n t h e l a s t 10 y e a r s ) w i t h i n f o r m a t i o n on t h e i r c u r r e n t p o s i t i o n s . 3. Environment - - The i n s t i t u t i o n ' s a b i l i t y t o p r o v i d e a d e q u a t e f a c i l i t i e s , r e s o u r c e s , and o p p o r t u n i t i e s n e c e s s a r y f o r t h e c a n d i d a t e ' s t r a i n i n g ; t h e i n s t i t u t i o n a l commitment t o t h e c a n d i d a t e ; t h e q u a l i t y and e x t e n t of i n t e r a c t i o n o f t h e f a c u l t y i n t h e b a s i c and c l i n i c a l s c i e n c e s ; and t h e q u a l i t y of t h e i n s t i t u t i o n ' s 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 programs. 4 . Career Development P l a n - - The adequacy of t h e r e s e a r c h career development p l a n , based on t h e c a n d i d a t e ' s p a s t 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 career goals. 5 . Research P r o j e c t - - S c i e n t i f i c m e r i t of t h e proposed r e s e a r c h p r o j e c t and i t s a p p r o p r i a t e n e s s a s a v e h i c l e f o r d e v e l o p i n g th.e c a n d i d a t e ' s r e s e a r c h skills. 6 . Advisory Committee - - A p p r o p r i a t e n e s s of t h e a d v i s o r y committee t o meet t h e r e s e a r c h c a r e e r development needs of t h e c a n d i d a t e . N I H G U I D E - Vol. 2 0 , No. 28, J u l y 19, 1991 - Page 9 VI. APPLICATION PROCEDURES A p p l i c a t i o n s must be s u b m i t t e d on 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 ( r e v . 10/88). I f n o t a v a i l a b l e a t t h e a p p l i c a n t i n s t i t u t i o n a l o f f i c e of sponsored programs, t h e form may be r e q u e s t 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 o f Research G r a n t s National I n s t i t u t e s of Health Westwood B u i l d i n g , Room 449 B e t h e s d a , MD 20892 Telephone: ( 3 0 1 ) 496-7441 The o r i g i n a l a p p l i c a t i o n a l o n g w i t h f i v e c o p i e s must be mailed t o : D i v i s i o n o f 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 Westwood B u i l d i n g , Room 240 B e t h e s d a , MD 20892** One copy must be mailed t o : -e*’ NHLBI S c i e n t i f i c Review A d m i n i s t r a t o r NHLBI Research T r a i n i n g Review Committee Review Branch D i v i s i o n of Extramural A f f a i r s N a t i o n a l Heart, Lung, and Blood I n s t i t u t e Westwood B u i l d i n g , Room 550 Bethesda, MD 20892 Supplemental I n s t r u c t i o n s f o r c o m p l e t i n g and s u b m i t t i n g t h e a p p l i c a t i o n a r e a v a i l a b l e from t h e NHLBI c o n t a c t s l i s t e d below. Receipt d a t e s of a p p l i c a t i o n s by t h e D i v i s i o n of Research G r a n t s , N I H , a r e a s follows : Application R e c e i p t Dates February 1 June 1 October 1 NHLBI Advisory Council Review October February May Earliest S t a r t i n g Date December 1 April 1 July 1 rrJ VII. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE CONTACTS D i v i s i o n of Blood D i s e a s e s and Resources - - The D i v i s i o n s u p p o r t s r e s e a r c h career development i n b a s i c and c l i n i c a l i n v e s t i g a t i o n . C a n d i d a t e s a r e encouraged t o a c q u i r e e x p e r t i s e i n d i s c i p l i n e s such as b i o c h e m i s t r y , p h y s i o l o g y , g e n e t i c s , c e l l u l a r and m o l e c u l a r b i o l o g y , b i o p h y s i c s , e n d o c r i n o l o g y , immunology, and a l s o s t a t i s t i c s , epidemiology, and r e s e a r c h d e s i g n a s r e l a t e d t o a broad spectrum o f t o p i c s i n blood d i s e a s e s and t r a n s f u s i o n m e d i c i n e . Such t o p i c s i n c l u d e t h r o m b o s i s and thromboembolic d i s o r d e r s , h e m o s t a s i s , r e d blood c e l l diseases and t h e hemoglobinopathies, h e m a t o p o i e s i s , s i c k l e c e l l d i s e a s e , blood r e s o u r c e s , t r a n s f u s i o n t h e r a p y and t r a n s f u s i o n - t r a n s m i t t e d d i s e a s e s , g r a f t - v e r s u s - h o s t d i s e a s e , and marrow transplantation. Fann Harding, Ph.D. D i v i s i o n of Blood Diseases and Resources N a t i o n a l Heart, Lung, and Blood I n s t i t u t 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 e d e r a l B u i l d i n g , Room SA08 Bethesda, MD 20892 Telephone: (301) 496-1817 D i v i s i o n o f Heart and V a s c u l a r Diseases - - The D i v i s i o n s u p p o r t s c a r e e r development in 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 o n . Research t r a i n i n g may be i n fundamental s t u d i e s of b a s i c p r o c e s s e s and f u n c t i o n s ; b e h a v i o r a l s t u d i e s , i n c l u d i n g r i s k f a c t o r m o d i f i c a t i o n ; g e n e t i c s ( i n c l u d i n g s t u d i e s of p o p u l a t i o n s 1 ; and primary o r secondary p r e v e n t i o n o r c l i n i c a l i n v e s t i g a t i o n s d i r e c t e d toward i n c r e a s i n g o u r knowledge and u n d e r s t a n d i n g of c a r d i o v a s c u l a r d i s e a s e . Areas of s c i e n t i f i c i n t e r e s t t o t h e D i v i s i o n i n c l u d e h y p e r t e n s i o n , a r t e r i o s c l e r o s i s , c o r o n a r y h e a r t d i s e a s e , c a r d i o v a s c u l a r a s p e c t s of d i a b e t e s , a r r h y t h m i a s , h e a r t f a i l u r e and shock, c e r e b r o v a s c u l a r d i s e a s e , p e r i p h e r a l v a s c u l a r d i s e a s e , c o n g e n i t a l and r h e u m a t i c h e a r t d i s e a s e s , c a r d i o m y o p a t h i e s and i n f e c t i o n s of t h e h e a r t , c i r c u l a t o r y a s s i s t a n c e , and c a r d i o v a s c u l a r d e v i c e s and t e c h n o l o g y . ‘ I Y N I H G U I D E - Vol. 20, No. 28, J u l y 19, 1991 - Page 10 John Fakunding , Ph D . D i v i s i o n o f H e a r t and V a s c u l a r D i s e a s e s 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 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 e d e r a l B u i l d i n g , Room 3C04 Bethesda, MD 20892 Telephone: (301) 496-1724 D i v i s i o n of Lung Diseases -- The D i v i s i o n s u p p o r t s r e s e a r c h career development i n 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 o n . Research t r a i n i n g i n t h e d i s c i p l i n e s o f c e l l u l a r and m o l e c u l a r b i o l o g y , b i o c h e m i s t r y , p h y s i o l o g y , embryology, immunology, epidemiology, and b e h a v i o r a l medicine a r e encouraged. Areas of s c i e n t i f i c i n t e r e s t t o t h e D i v i s i o n i n c l u d e : c e l l u l a r and developmental b i o l o g y , p e d i a t r i c pulmonary d i s e a s e s , emphysema, asthma, f i b r o t i c and immunologic l u n g d i s e a s e s , a c u t e r e s p i r a t o r y f a i l u r e , pulmonary v a s c u l a r d i s e a s e s , pulmonary a s p e c t s of AIDS, and r e s p i r a t o r y d i s o r d e r s of sleep. Mary R e i l l y , M.S. D i v i s i o n of Lung D i s e a s e s N a t i o n a l Heart, Lung, and Blood I n s t i t u t 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 Westwood B u i l d i n g , Room 640 B e t h e s d a , MD 20892 Telephone: (301) 496-7668 w . The programs of t h e N a t i o n a l Heart, Lung, and Blood I n s t i t u t e a r e i d e n t i f i e d i n t h e C a t a l o g of F e d e r a l Domestic A s s i s t a n c e , numbers 93.837, 93.838, and 93.839. Awards w i l l be u n d e r 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, as amended, 42 P a r t 241). The r e g u l a t i o n s (Code of F e d e r a l R e g u l a t i o n s , 42 P a r t .52 and 45 P a r t 74) and p o l i c i e s t h a t govern t h e r e s e a r c h g r a n t programs of 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 w i l l p r e v a i l . 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 of E x e c u t i v e Order 12372 o r t o H e a l t h Systems Agency review. ERRATA COOPERATIVE AGREEMENTS A THE AWARD INSTRUMENT FOR CERTAIN NHLBI CLINICAL S TRIALS AND LARGE-SCALE EPIDEMIOLOGICAL STUDIES P.T. 34; K.W. 0755015, 0785055, 0715040 N a t i o n a l Heart, Lung, and Blood I n s t i t u t e T h i s n o t i c e w a s p u b l i s h e d i n t h e N I H Guide f o r G r a n t s and C o n t r a c t s on J u l y 12, 1991, Vol. 20, No. 27. The code numbers f o r t h e ' P . T . ' l i n e were i n a d v e r t a n t l y o m i t t e d and a r e i n c l u d e d i n t h i s e r r a t u m . EH D P O R M PROJECTS ON NEW M T O S OF IMMUNE INTERVENTION RGA RFA AVAILABLE: P.T. 34; K . W . AI-91-11 0710070, 0745045, 0715015, 0715110, 0715026 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 T h i s n o t i c e w a s p u b l i s h e d i n t h e N I H Guide f o r G r a n t s and C o n t r a c t s on J u l y 12, 1991, Vol. 20, No. 27. The code numbers f o r t h e ' P . T . ' l i n e were i n a d v e r t a n t l y o m i t t e d and a r e i n c l u d e d i n t h i s e r r a t u m . FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD PA: PA-91-77 0710030 P.T. 34, 48; K . W . Fogarty I n t e r n a t i o n a l Center T h i s n o t i c e was p u b l i s h e d i n t h e N I H Guide f o r G r a n t s and C o n t r a c t s on J u l y 12, 1991, Vol. 20, No. 27. The code numbers f o r t h e ' P . T . ' l i n e were i n a d v e r t a n t l y o m i t t e d and a r e i n c l u d e d i n t h i s e r r a t u m . N I H G U I D E - Vol. 20, No. 28, J u l y 19, 1991 - Page 1 1