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US. DEPARTMENT OF HENTH AND HUMAN SERVICES

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The NIH Guide announces scientific initiatives and provides policy and administrative information to indivi­duals and organizationswho need to

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NIH Guide Printing & Reproduction Branch National Institutes of Health Room B4BN08, Building 31 Bethesda, Maryland 20892

First Class Mail Postages & Fees Paid

PHS/NIH/OD Permit No. G-291

V o l . 2 0 , No. 26 J u l y 5 , 1991

NIH GUIDE - Vol. 20, NO. 26, July 5, 1991

NOTICES

ELIGIBILITY REQUIREMENTS FOR FOGARTY INTERNATIONAL CENTER FELLOWSHIPS . . . . . . 1~~

Fogarty International Center Index: FOGARTY INTERNATIONAL CENTER

DISCONTINUATION OF THE SPONSOR'S SALARY ON PHYSICIAN SCIENTIST AWARDS AND PHYSICIAN SCIENTIST PROGRAM AWARDS ..................................... 1 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH

NOTICES OF AVAILABILITY (RFPs AND RFAs)

STUDIES TO EVALUATE THE TOXIC AND CARCINOGENIC POTENTIAL OF 6 0 Hz MAGNETIC FIELDS IN LABORATORY ANIMALS (RFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 National Institute of Environmental Health Sciences Index: ENVIRONMENTAL HEALTH SCIENCES

FAMILY AND GENETICS STUDIES OF CARDIOVASCULAR DISEASE - FIELDCENTERS (RFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

2 National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD

FAMILY AND GENETICS STUDIES OF CARDIOVASCULAR DISEASE - BLOOD LABORATORY (RFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 4 National Heart, Lung, and Blood Institute Index: HEART, LUNG, BLOOD

SPEECH PROCESSORS FOR AUDITORY PROSTHESES (RFP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 National Institute on Deafness and Other Communication Disorders Index: DEAFNESS, COMMUNICATION DISORDERS

STRUCTURAL BIOLOGY AS APPLIED TO THE PROBLEM OF TARGETED DRUG DESIGN,WITH POTENTIAL APPLICABILITY TO THE TREATMENT OF AIDS (RFA GM-91-02) . . . . . . . 4 National Institute of General Medical Sciences Index: GENERAL MEDICAL SCIENCES

ONGOING PROGRAM ANNOUNCEMENTS

DRUG ABUSE PREVENTION RESEARCH GRANT ANNOUNCEMENT (PA-91-73) . . . . . . . . . . . . . . . 5 National Institute on Drug Abuse Index: DRUG ABUSE

RESEARCH ON DISABILITIES AND REHABILITATION SERVICES FOR PERSONS WITH SEVERE MENTAL DISORDERS (PA-91-74) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 National Institute of Mental Health Index: MENTAL HEALTH

ERRATA

ADULT AIDS CLINICAL TRIALS UNITS (RFA AI-91-07) ............................ 10 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES

NOTICES

I C

ELIGIBILITY REQUIREMENTS FOR FOGARTY INTERNATIONAL CENTER FELLOWSHIPS

P . T . 22; K . W . 0720005, 1014006

Fogar ty I n t e r n a t i o n a l Center

The Fogar ty I n t e r n a t i o n a l Center ( F I C ) announces a change i n e l i g i b i l i t yrequ i r emen t s f o r a l l o f t h e FIC-sponsored f e l l o w s h i p programs. FIC, i n l i n e wi th o t h e r N I H f e l l o w s h i p programs, now r e q u i r e s t h a t a l l f e l l o w s h i pr e c i p i e n t s ho ld t h e d o c t o r a l l e v e l deg ree ( e . g . , Ph.D., M . D . , D.D.S., D . V . M . ,and O . D . ) p r i o r t o award of t h e f e l l o w s h i p t h a t is u s u a l l y made w i t h i n n i n e months of submiss ion . The p r e v i o u s requi rement s t a t e d t h a t t h e deg ree must have been o b t a i n e d p r i o r t o submission of t h e f e l l o w s h i p a p p l i c a t i o n . T h i s n o t i c e a p p l i e s t o a l l a p p l i c a n t s f o r f e l l o w s h i p s sponsored by t h e FIC and i s e f f e c t i v e as of t h e d a t e o f t h i s p u b l i c a t i o n .

DISCONTINUATION OF THE SPONSOR'S SALARY ON PHYSICIAN SCIENTIST AWARDS AND PHYSICIAN SCIENTIST PROGRAM AWARDS

P.T. 34; K . W . I014006

Na t iona l I n s t i t u t e s of Hea l th

The Na t iona l I n s t i t u t e s of Hea l th ( N I H ) w i l l d i s c o n t i n u e payment of t h e s p o n s o r ' s s a l a r y on competing Phys ic i an S c i e n t i s t (K11) and Phys ic i anS c i e n t i s t Program (K12) awards beginning wi th awards from f i s c a l y e a r 1992 funds .

I n i t i a l rev iew groups w i l l be adv i sed t o d i s r e g a r d r e q u e s t s f o r a sponsor ' ss a l a r y i n Phys ic i an S c i e n t i s t Award a p p l i c a t i o n s submi t t ed f o r t h e February 1 and June 1 , 1991 r e c e i p t d a t e s . A p p l i c a t i o n s f o r Phys ic i an S c i e n t i s t Awards submi t t ed f o r t h e October 1 , 1991 and subsequent r e c e i p t d a t e s may n o t c o n t a i n a r e q u e s t f o r t h e s p o n s o r ' s s a l a r y .

The N I H w i l l c o n t i n u e t o pay e x i s t i n g commitments r e g a r d i n g t h e sponsor ' ss a l a r y on K11 and K12 awards made b e f o r e f i s c a l y e a r 1992.

NOTICES OF AVAILABILITY (RFPs AND RFAs)

STUDIES TO EVALUATE THE TOXIC AND CARCINOGENIC POTENTIAL OF 60 Hz MAGNETIC FIELDS I N LABORATORY ANIMALS

RFP AVAILABLE: NIH-ES-92-11

P.T. 34; K . W . 1007009, 1013026, 0715035

Na t iona l I n s t i t u t e o f Environmental Hea l th Sc iences

The Na t iona l I n s t i t u t e of Environmental Heal th Sc iences (NIEHS), Na t iona l I n s t i t u t e s of Hea l th ( N I H ) , is s o l i c i t i n g p r o p o s a l s f o r s t u d i e s des igned t o c h a r a c t e r i z e t h e t o x i c i t y and c a r c i n o g e n i c i t y of 60 Hz s i n u s o i d a l magnet icf i e l d s i n F i s c h e r 344 rats and B6C3F1 mice, t o de te rmine i f such f i e l d s a l t e r p i n e a l f u n c t i o n , and t o de t e rmine i f such f i e l d s cause developmental o r r e p r o d u c t i v e t o x i c i t y . T h i s p r o j e c t w i l l be s e p a r a t e d i n t o two phases . Phase 1 w i l l be a six-month p e r i o d comprised on ly of t h o s e work a c t i v i t i e s a s s o c i a t e d wi th procurement o f equipment and m a t e r i a l s needed t o c o n s t r u c t t h e exposure and moni tor ing sys tems, t h e c o n s t r u c t i o n / r e n o v a t i o n o f t h e exposureand moni tor ing sys tems, and t h e developmental e f f o r t needed t o de te rmine t h a t t h e systems f u n c t i o n a p p r o p r i a t e l y and w i l l meet t h e Na t iona l ToxicologyProgram s p e c i f i c a t i o n s . The government w i l l e v a l u a t e t h e r e s u l t s of Phase 1 and may e x e r c i s e an o p t i o n f o r Phase 2 r equ i r emen t s . Phase 2 w i l l be a f o u r - y e a r , six-month p e r i o d i n v o l v i n g t h e conduct of e ight-week and 104-week s t u d i e s i n which an imals w i l l be exposed t o magnet ic f i e l d s of s p e c i f i e di n t e n s i t i e s u s i n g t h e exposure system developed i n Phase 1 . The Government estimates t h a t Phase 1 w i l l r e q u i r e approximate ly .67 p r o f e s s i o n a l pe r son-yea r s of e f f o r t and .48 t e c h n i c a l pe r son-yea r s of e f f o r t . Phase 2 w i l l r e q u i r e approximate ly 5 . 8 p r o f e s s i o n a l pe r son-yea r s of e f f o r t and 20 .1 t e c h n i c a l p e r s o n - y e a r s of e f f o r t . A l l r e s p o n s i b l e s o u r c e s may submit a p roposa l t h a t s h a l l be cons ide red by t h e Agency.

N I H G U I D E - Vol. 20, No. 26, J u l y 5 , 1991 - Page 1

The Request f o r Proposa ls NIH-ES-92-11 w i l l be i s s u e d on J u l y 15 . Responses w i l l be due by c l o s e of b u s i n e s s September 13 . NIEHS p l a n s t o make one award from t h i s s o l i c i t a t i o n .

Requests f o r t h e Request f o r P r o p o s a l s must r e f e r e n c e RFP NIH-ES-92-11 and must be forwarded t o :

Nat iona l I n s t i t u t e of Environmental Heal th S c i e n c e s C o n t r a c t s and Procurement Management Branch, OM ATTN: M s . Mary B . Armstead, C o n t r a c t i n g O f f i c e r 79 T.W. Alexander Dr ive , 4401 Research Commons Bui ld ing P.O. Box 12874 Research T r i a n g l e Park , NC 27709 Telephone: (919) 541-7893

FAMILY AND GENETICS STUDIES OF CARDIOVASCULAR DISEASE - FIELD CENTERS

RFP AVAILABLE: NHLBI-HC-91-08

P . T . 34; K.W. 0715035, 1002019, 0411005

Nat iona l Heart, Lung, and Blood I n s t i t u t e

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 ) r e q u i r e s t h r e e t o f i v e f i e l d c e n t e r s t o i n i t i a t e a fami ly and g e n e t i c s t u d y of c a r d i o v a s c u l a r d i s e a s e (CVD 1 w i t h i n e x i s t i n g United S t a t e s p o p u l a t i o n based ep idemiologica l s t u d i e s . The c e n t e r s w i l l have a t o t a l of approximately 6000 p a r t i c i p a n t s . C e n t e r s i n t h e a r e a s of u l t r a s o u n d , e l e c t r o c a r d i o g r a p h y , and pulmonary f u n c t i o n are a n t i c i p a t e d w i t h i n t h e f i e l d c e n t e r s ' s o l i c i t a t i o n . The o b j e c t i v e of t h e proposed c o n t r a c t i s t o i d e n t i f y and e v a l u a t e g e n e t i c and nongenet ic d e t e r m i n a n t s o f f a m i l i a l a g g r e g a t i o n of c a r d i o v a s c u l a r d i s e a s e and r i s k f a c t o r s . The p e r i o d of performance i s a n t i c i p a t e d f o r f o u r y e a r s beginning i n January 1992.

T h i s is an announcement of t h e a v a i l a b i l i t y of a Request f o r P r o p o s a l s (RFP). RFP NHLBI-HC-91-08 w i l l be a v a i l a b l e on o r about J u l y 8 , 1991, w i t h p r o p o s a l s due September 9 , 1991. Three t o f i v e awards are a n t i c i p a t e d by t h e Government. O f f e r o r s o t h e r t h a n U.S. i n s t i t u t i o n s w i l l n o t be c o n s i d e r e d . W r i t t e n r e q u e s t s f o r t h i s RFP must i n c l u d e t h r e e (3) m a i l i n g l a b e l s , s e l f - a d d r e s s e d , and must c i t e RFP NHLBI-HC-91-08.

Requests f o r c o p i e s of t h e RFP must be s e n t t o :

L i s a O ' N e i l l C o n t r a c t s S p e c i a l i s t f o r ECA C o n t r a c t s S e c t i o n Nat iona l H e a r t , Lung, and Blood I n s t i t u t e Federa l B u i l d i n g , Room 200 Bethesda, MD 20892

FAMILY AND GENETICS STUDIES OF CARDIOVASCULAR DISEASE - BLOOD LABORATORY

RFP A V A I L A B L E : NHLBI-HC-91-09

P . T . 34; K.W. 0715035, 1002019, 0411005, 0750010

Nat iona l H e a r t , Lung, and Blood I n s t i t u t e

The N a t i o n a l H e a r t , Lung, and Blood I n s t i t u t e ( N H L B I ) r e q u i r e s a c e n t r a l blood l a b o r a t o r y t o perform tes ts and measurements on approximately 6000 p a r t i c i p a n t s involved i n a fami ly and g e n e t i c s t u d y of c a r d i o v a s c u l a r d i s e a s e ( C V D ) i n e x i s t i n g United S t a t e s p o p u l a t i o n based ep idemiologica l s t u d i e s . The blood t e s t s t o be performed a r e : c h o l e s t e r o l , HDL-cholesterol, t r i g l y c e r i d e s ,a p o l i p o p r o t e i n s phenotypes, L p ( a ) , f i b r i n o g e n , f a c t o r V I 1 a c t i v i t y , PAI-1, c h e m i s t r i e s ( u r e a , u r i c a c i d , c r e a t i n i n e ) , homocysteine, i n s u l i n , g l u c o s e ,r e n i n , RBC, LiINa c o u n t e r t r a n s p o r t , and hematology. The whi te ce l l s and plasma are t o be s t o r e d f o r l a t e r molecular g e n e t i c s t u d i e s . The p e r i o d of performance i s a n t i c i p a t e d t o be f o r t h r e e y e a r s , n i n e months beginning March 1992.

T h i s i s an announcement of t h e a v a i l a b i l i t y of a Request f o r P r o p o s a l s ( R F P ) .RFP NHLBI-HC-91-09 w i l l be a v a i l a b l e on o r about J u l y 17, 1991, w i t h p r o p o s a l sdue September 9 , 1991. One award i s a n t i c i p a t e d by t h e Government. O f f e r o r so t h e r t h a n U.S. i n s t i t u t i o n s w i l l n o t be c o n s i d e r e d . W r i t t e n r e q u e s t s must

W

-i n c l u d e t h r e e (3) m a i l i n g labe ls , s e l f - a d d r e s s e d , and must c i t e RFP NHLBI-HC-91-09.

N I H G U I D E - Vol. 20, No. 26, J u l y 5 , 1991 - Page 2

Requests f o r c o p i e s of t h e RFP must be s e n t

L i s a O ' N e i l l C o n t r a c t s S p e c i a l i s t f o r ECA C o n t r a c t s S e c t i o n Nat iona l Heart, Lung, and Blood I n s t i t u t e Federa l B u i l d i n g , Room 200

' -.+' Bethesda, MD 20892

SPEECH PROCESSORS FOR AUDITORY PROSTHESES

RFP AVAILABLE: NIH-NIDCD-91-02

P.T. 34; K . W . 0775005, 0740060, 0740030

t o :

N a t i o n a l I n s t i t u t e on Deafness and Other Communication D i s o r d e r s

The N a t i o n a l I n s t i t u t e of Deafness and Other Communication D i s o r d e r s ( N I D C D )h a s a requirement f o r t h e cont inued d e s i g n , development, and e v a l u a t i o n of speech p r o c e s s o r s f o r u s e wi th implanted a u d i t o r y p r o s t h e s e s i n deaf humans.

The N I D C D s u p p o r t s r e s e a r c h and development on a u d i t o r y p r o s t h e s e s f o r deaf i n d i v i d u a l s . An e s s e n t i a l component of a l l a u d i t o r y p r o s t h e s e s i s t h e speech p r o c e s s o r whose f u n c t i o n is t o c o n v e r t t h e wideband e lec t r ica l s i g n a l from t h e microphone t o an informat ion condensed s i g n a l o r se t of s i g n a l s f o r d r i v i n gt h e i n d i v i d u a l e lectr ical implant s t i m u l a t o r s i n a manner t o opt imize speechr e c o g n i t i o n by t h e implant u s e r . A t t h e p r e s e n t t i m e t h e r e are s e v e r a l d i f f e r e n t t y p e s of s i n g l e and mul t ichannel a u d i t o r y p r o s t h e s e s b e i n g used i n human s u b j e c t s . These i n c l u d e b o t h monaural and b i n a u r a l c o c h l e a r implants as w e l l as c o c h l e a r n u c l e u s i m p l a n t s . S i n c e opt imal speech p r o c e s s o r d e s i g ndepends, among o t h e r t h i n g s , upon b o t h t h e implanted e l e c t r o d e d e s i g n and t h e remaining a u d i t o r y nervous system of t h e i n d i v i d u a l , it i s impor tan t i n d e s i g n i n g speech p r o c e s s o r s t o do so f o r s p e c i f i c implant d e s i g n s and t o t e s t them w i t h a r e p r e s e n t a t i v e c r o s s s e c t i o n of u s e r s .

The N I D C D is c u r r e n t l y s u p p o r t i n g two d i f f e r e n t speech p r o c e s s o r c o n t r a c t s t o e n s u r e access t o a s u f f i c i e n t number of s u b j e c t s wi th each of t h e majora u d i t o r y p r o s t h e s e s implant d e s i g n s . Only a f e w o f t h e promising speechp r o c e s s i n g s t r a t e g i e s have been i n v e s t i g a t e d , and most of t h i s e v a l u a t i o n h a s

,~-~, been i n low background n o i s e environments . Work needs t o be extended t o permi t t h e t e s t i n g and e v a l u a t i o n of a d d i t i o n a l speech p r o c e s s i n g t e c h n i q u e si n p r e v i o u s l y implanted p a t i e n t s under a range of s i g n a l - t o - n o i s e c o n d i t i o n s .

T h i s requi rement r e p r e s e n t s a r e c o m p e t i t i o n of work c u r r e n t l y b e i n g performed under c o n t r a c t s w i t h Research T r i a n g l e I n s t i t u t e and The U n i v e r s i t y of Melbourne, C o n t r a c t Nos. N01-DC-9-2400 and N01-DC-9-2401, r e s p e c t i v e l y . I t is expec ted t h a t t h e incumbent c o n t r a c t o r s w i l l recompete .

The c o n t r a c t o r w i l l be r e q u i r e d t o come t o Bethesda, Maryland, y e a r l y t o p r e s e n t p r o g r e s s on t h e i r work a t t h e Neural P r o s t h e s i s Workshop sponsored byt h e Neural P r o s t h e s i s Program.

M u l t i p l e awards may be made, each w i t h performance p e r i o d s n o t exceeding t h r e e y e a r s .

T h i s is n o t a Request f o r P r o p o s a l s . RFP No. NIH-NIDCD-91-02 w i l l be i s s u e d on o r about J u l y 5, 1991, w i t h r e s p o n s e s due on o r about September 30, 1991.

To r e c e i v e a copy of t h e RFP, p l e a s e submit a w r i t t e n r e q u e s t t o t h e f o l l o w i n g a d d r e s s and supply 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 :

C o n t r a c t i n g Officer C o n t r a c t s Management Branch, DEA N a t i o n a l I n s t i t u t e of Neurologica l D i s o r d e r s and S t r o k e F e d e r a l B u i l d i n g , Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 A t t e n t i o n : RFP No. NIH-NIDCD-91-02

A l l r e s p o n s i b l e s o u r c e s may submit a p r o p o s a l t h a t s h a l l be c o n s i d e r e d by t h e Government.

N I H G U I D E - Vol. 20, No. 26, J u l y 5, 1991 - Page 3

STRUCTURAL B I O L O G Y AS APPLIED TO THE PROBLEM OF TARGETED DRUG DESIGN, WITH POTENTIAL APPLICABILITY TO THE TREATMENT OF AIDS

RFA AVAILABLE: GM-91-02

P.T. 34; K.W. 0715008, 0755025, 0790015

N a t i o n a l I n s t i t u t e of General Medical S c i e n c e s

A p p l i c a t i o n Rece ip t Date: March 18, 1992

PURPOSE

The N a t i o n a l I n s t i t u t e s of H e a l t h ( N I H ) announces i t s i n t e r e s t i n r e c e i v i n ga p p l i c a t i o n s t o apply modern t e c h n i q u e s of molecular s t r u c t u r e d e t e r m i n a t i o n and a n a l y s i s f o r t h e purpose of deve loping new approaches t o drug d e s i g n , w i t h p o t e n t i a l a p p l i c a b i l i t y t o t h e t r e a t m e n t of H I V i n f e c t i o n and AIDS. However, i n n o v a t i v e approaches t o t h e problem of drug d e s i g n u s i n g o t h e r a p p r o p r i a t e systems w i l l be welcomed.

BACKGROUND

I n 1987, t h e N a t i o n a l I n s t i t u t e s of General Medical S c i e n c e s (NIGMS) i n i t i a t e d a program t o s u p p o r t g roups i n t e r e s t e d i n deve loping t h e area of s t r u c t u r e - b a s e d drug d e s i g n w i t h s p e c i f i c emphasis on t h e u s e of AIDS-related sys tems. The s t r u c t u r e s of s e v e r a l p r o t e i n s , such a s t h e H I V p r o t e a s e ,R N a s e H , and t h e CD4 r e c e p t o r have now been de termined , and more w i l l soon become a v a i l a b l e . Using t h e s e s t r u c t u r e s , and suppor ted by b o t h t h e NIGMS and o t h e r funding programs, e f f o r t s are now under way i n many l a b o r a t o r i e s t o d e s i g n d r u g s e f f e c t i v e i n t h e t r e a t m e n t of H I V i n f e c t i o n and AIDS. A t N I H ,s t r u c t u r a l b i o l o g y s t u d i e s a r e p r i m a r i l y suppor ted by NIGMS; drug d e s i g nu t i l i z i n g p r o t e i n s t r u c t u r a l i n f o r m a t i o n i s suppor ted by b o t h t h e NIGMS and 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.

Notwi ths tanding t h e advances t h a t have been made, t h e number of p r o t e i n s w i t h s t r u c t u r e s de te rmined t o h i g h r e s o l u t i o n i s q u i t e small and t h e l i m i t i n g s t e pi n t h e p r o c e s s of d r u g d e s i g n remains t h e l a c k of g e n e r a l i z a b l e , e f f i c i e n t ,and r e p r o d u c i b l e approaches f o r t h e u s e of macromolecular s t r u c t u r e s . Consequent ly , w e would l i k e t o encourage a p p l i c a t i o n s from any r e s e a r c h groupsw i t h a n i n t e r e s t i n deve loping t h e c o n c e p t s and methodologies of s t r u c t u r e - b a s e d drug d e s i g n . The i n t e n t o f t h i s program remains t h e development of d r u g s f o r t h e t r e a t m e n t of H I V i n f e c t i o n and AIDS. However, because b a s i c r e s e a r c h on t a r g e t e d drug d e s i g n w i l l be b r o a d l y a p p l i c a b l e and i n f o r m a t i o n ga ined w i l l be r e l e v a n t t o t h e d e s i g n of AIDS d r u g s , anymacromolecular t a r g e t s t h a t w i l l f a c i l i t a t e t h e development of t h e s e approaches w i l l be a c c e p t a b l e .

Broadly, t h e r e s e a r c h g o a l s are t o s t i m u l a t e t h e o r g a n i z a t i o n o f m u l t i d i s c i p l i n a r y groups c e n t e r e d around s t u d i e s r e l a t e d t o s t r u c t u r a l b io logyi n o r d e r t o deve lop approaches t o t a r g e t e d drug d e s i g n . The c e n t r a l d i s c i p l i n e s are t h o s e such a s , f o r example, X-ray c r y s t a l l o g r a p h y , NMR, and t h e o r e t i c a l chemis t ry a s r e l a t e d t o molecular model l ing . To be e f f e c t i v e , t h e s e must be a i d e d and, t o some d e g r e e , guided by modern r e s e a r c h i n molecular b i o l o g y and pharmacology.

MECHANISM OF SUPPORT

The mechanism of s u p p o r t w i l l be t h e program p r o j e c t g r a n t (POI) . I t i s expec ted t h a t t h r e e o r more i n v e s t i g a t o r s , a l l p u r s u i n g independent b u t i n t e r r e l a t e d p r o j e c t s , w i l l be involved . One s c i e n t i s t must be d e s i g n a t e d byt h e a p p l i c a n t i n s t i t u t i o n a s P r i n c i p a l I n v e s t i g a t o r and must bear t h e r e s p o n s i b i l i t y f o r t h e s c i e n t i f i c and f i s c a l management of t h e program p r o j e c t g r a n t . Most of t h e c o l l a b o r a t i n g s c i e n t i s t s should be independenti n v e s t i g a t o r s . For example, t h e s u p p o r t o f one s e n i o r i n v e s t i g a t o r and s e v e r a l p o s t d o c t o r a l and r e s e a r c h - a s s o c i a t e l e v e l s c i e n t i s t s is n o t a p p r o p r i a t e as a program p r o j e c t a p p l i c a t i o n . Equipment and o t h e r c o r e r e s o u r c e s n e c e s s a r y f o r t h e accomplishment of t h e o b j e c t i v e s of t h e programp r o j e c t g r a n t may be r e q u e s t e d .

Informal i n t e r a c t i o n and exchange o f i n f o r m a t i o n between a l l groups i n t h e program is e x p e c t e d . A l l awardees are expec ted t o p a r t i c i p a t e i n a y e a r l yc o n f e r e n c e .

I t i s a n t i c i p a t e d t h a t s i x t o t e n a p p l i c a t i o n s w i l l be funded. T h i s s u p p o r tl e v e l is dependent on t h e r e c e i p t of 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 of h i g h s c i e n t i f i c m e r i t . The t o t a l p r o j e c t p e r i o d f o r a p p l i c a t i o n s submi t ted i n r e s p o n s e t o t h e RFA may n o t exceed f i v e y e a r s . The a n t i c i p a t e d award d a t e w i l l be September 1 , 1992.

N I H G U I D E - Vol. 20, No. 26, J u l y 5, 1991 - Page 4

1111”

*bJ

yuy,

To r e c e i v e t h e complete RFA p l e a s e w r i t e :

Marvin Cassman, Ph.D. Nat iona l I n s t i t u t e of General Medical S c i e n c e s Nat iona l I n s t i t u t e s of Heal th Westwood B u i l d i n g , Room 922 Bethesda, MD 20892 Telephone: (301) 496-0186

For f i s c a l and a d m i n i s t r a t i v e m a t t e r s , c o n t a c t :

M s . Ann Calure Superv isory Grants Management S p e c i a l i s t Westwood b u i l d i n g , Room 953 N a t i o n a l I n s t i t u t e of General Medical 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 s of Heal th Bethesda, MD 20892 Telephone: (301) 496-7746

T h i s program i s d e s c r i b e d i n t h e Cata log of F e d e r a l Domestic A s s i s t a n c e No. 93.821. Grants w i l l be awarded under t h e a u t h o r i t y of t h e P u b l i c Heal th 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 USC 241) 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 Federa 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 74. T h i s program is n o t s u b j e c t t o t h e in te rgovernmenta l review requi rements of Execut ive Order 12372 o r Heal th Systems Agency rev iew.

O N G O I N G PROGRAM ANNOUNCEMENTS

DRUG ABUSE PREVENTION RESEARCH GRANT ANNOUNCEMENT

PA: PA-91-73

P.T. 34; K . W . 0404009, 0745027, 0755030, 0411005

N a t i o n a l I n s t i t u t e on Drug Abuse

PURPOSE

A t t h e N a t i o n a l I n s t i t u t e on Drug Abuse ( N I D A ) , p r e v e n t i o n r e s e a r c h i n c l u d e s : (11 e t i o l o g i c r e s e a r c h t h a t s e e k s t o i d e n t i f y t h o s e b i o l o g i c , g e n e t i c ,p s y c h o s o c i a l , and environmental f a c t o r s t h a t may p l a c e i n d i v i d u a l s , families, o r communities a t r i s k f o r , o r t h a t may b u f f e r o r p r o t e c t a g a i n s t , d rug u s e o n s e t , p r o g r e s s i o n t o dependency, and t h e consequences of drug abuse; and (2)p r e v e n t i v e i n t e r v e n t i o n r e s e a r c h t h a t s e e k s t o deve lop and t e s t theory-basedp r e v e n t i o n s t r a t e g i e s t o p r e v e n t t h e o n s e t and p r o g r e s s i o n of drug u s e and abuse .

RESEARCH OBJECTIVES

The pr imary o b j e c t i v e s of t h e NIDA e t i o l o g i c r e s e a r c h program are t o : i d e n t i f y t h e common e t i o l o g i c pathways t o drug abuse and t h e c r i t i c a l f a c t o r s involved; de te rmine t h e f a c t o r s t h a t may p r e d i s p o s e o r p r o t e c t an i n d i v i d u a l from i n i t i a t i o n , e s c a l a t i o n , and maintenance of drug abuse; and develop and t e s t t h e o r i e s and models of e t i o l o g i e s of drug abuse .

The pr imary o b j e c t i v e of drug abuse p r e v e n t i v e i n t e r v e n t i o n r e s e a r c h is t o apply o u r s c i e n t i f i c unders tanding of t h e c a u s e s of drug u s e o n s e t and p r o g r e s s i o n t o t h e d e s i g n , development, and t e s t i n g of theory-based p r e v e n t i o ni n t e r v e n t i o n s focused upon t h e i n d i v i d u a l , f a m i l y , p e e r group, and community( s c h o o l , workplace, and neighborhood) .

MECHANISM OF SUPPORT

Support mechanisms i n c l u d e : Research P r o j e c t s ( R o l l and F i r s t IndependentResearch Support and T r a n s i t i o n (FIRST) Awards (R29). These s u p p o r tmechanisms r e p r e s e n t t h o s e c u r r e n t l y a u t h o r i z e d and are s u b j e c t t o r e v i s i o n and reannouncement as t h e advances i n a p a r t i c u l a r s c i e n c e d i c t a t e new and unique ways f o r advancing our knowledge b a s e . Most i n v e s t i g a t o r - i n i t i a t e dr e s e a r c h i s suppor ted by r e s e a r c h g r a n t s ( R o l l . Research g r a n t s are awarded t o i n s t i t u t i o n s on b e h a l f of P r i n c i p a l I n v e s t i g a t o r s who have des igned and w i l l d i r e c t a s p e c i f i c p r o j e c t o r se t of p r o j e c t s . For d e t a i l s on a p a r t i c u l a r s u p p o r t mechanism o r program, p l e a s e c o n t a c t t h e program s taff l i s t e d a t t h e end of t h i s announcement.

N I H G U I D E - Vol. 20, No. 26, J u l y 5, 1991 - Page 5

E L I G I B I L I T Y

A p p l i c a t i o n s may be submi t ted by 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 p r o f i t - m a k i n g , 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 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 of 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 are encouraged t o a p p l y .

APPLICATION PROCEDURES

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 of 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) . The number and t i t l e of t h i s announcement, "PA-91-73 Drug Abuse P r e v e n t i o n Research Announcement," must be typed i n i t e m number 2 of t h e f a c e page of t h e PHS 398 a p p l i c a t i o n form.

A p p l i c a t i o n k i t s c o n t a i n i n g t h e n e c e s s a r y forms and i n s t r u c t i o n s may be o b t a i n e d from b u s i n e s s o f f i c e s o r o f f i c e s of sponsored r e s e a r c h a t most u n i v e r s i t i e s , c o l l e g e s , medical s c h o o l s , and o t h e r major r e s e a r c h f a c i l i t i e s . If such a s o u r c e i s n o t a v a i l a b l e , t h e f o l l o w i n g o f f i c e may be c o n t a c t e d f o r t h e PHS 398 a p p l i c a t i o n k i t :

D i v i s i o n o f Research Grants N a t i o n a l I n s t i t u t e s of Heal th Westwood B u i l d i n g , Room 240 5333 Westbard Avenue Bethesda, MD 20852 Telephone: (301) 496-7441

The s i g n e d o r i g i n a l and s i x permanent l e g i b l e c o p i e s of t h e completeda p p l i c a t i o n must be s e n t t o :

D i v i s i o n of Research G r a n t s N a t i o n a l I n s t i t u t e s of Heal th W e s t w o o d B u i l d i n g , Room 240 Bethesda, MD 20892**

RECEIPT AND REVIEW SCHEDULE

Receip t Dates I n i t i a l Advisory Counci l Ear l ies t NewIRenewal Review Review S t a r t Date

June 1 I J u l y I* O c t .INov. J a n . /Feb. A p r i lOct . l /Nov. l* Feb./March May/ June June Feb. l /Mar. l* May/ June Sept ./ O c t December

*Amended a p p l i c a t i o n s (new o r renewal ) are t o be submi t ted on t h e s e da tes .

REVIEW PROCESS AND CRITERIA

The D i v i s i o n of Research Grants , N I H , s e r v e s as a c e n t r a l p o i n t f o r r e c e i p t of a p p l i c a t i o n s f o r most d i s c r e t i o n a r y PHS g r a n t programs. A p p l i c a t i o n s r e c e i v e d under t h i s announcement w i l l be a s s i g n e d t o an i n i t i a l review group ( I R G ) i n accordance w i t h e s t a b l i s h e d P u b l i c Heal th 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 . The 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 ,w i l l review t h e a p p l i c a t i o n s 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 . N o t i f i c a t i o n of t h e review recommendations w i l l be s e n t t o t h e a p p l i c a n t a f t e r t h e i n i t i a l rev iew. 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 review by t h e a p p r o p r i a t eN a t i o n a l Advisory Counci l whose review may be based on p o l i c y as w e l l as s c i e n t i f i c merit c o n s i d e r a t i o n s . Only a p p l i c a t i o n s recommended f o r approvalby t h e Counci l may be c o n s i d e r e d f o r f u n d i n g .

C r i t e r i a f o r s c i e n t i f i d t e c h n i c a l m e r i t r ev iew o f a p p l i c a t i o n s w i l l i n c l u d e t h e f o l l o w i n g : s i g n i f i c a n c e and o r i g i n a l i t y from a s c i e n t i f i c o r t e c h n i c a l s t a n d p o i n t o f t h e g o a l s of t h e proposed r e s e a r c h ; adequacy of t h e r e s e a r c h methodology proposed t o c a r r y o u t t h e s t u d y ; f e a s i b i l i t y of t h e proposedr e s e a r c h ; q u a l i f i c a t i o n s and r e s e a r c h e x p e r i e n c e 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 rand o t h e r key r e s e a r c h p e r s o n n e l ; a v a i l a b i l i t y of adequate f a c i l i t i e s , o t h e r r e s o u r c e s , and c o l l a b o r a t i v e arrangements n e c e s s a r y f o r t h e r e s e a r c h ; a p p r o p r i a t e n e s s of budget estimates f o r t h e proposed r e s e a r c h a c t i v i t i e s ; r e s p o n s i v e n e s s t o NIH/ADAMHA p o l i c y on 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 p o p u l a t i o n s ; and adequacy of p r o v i s i o n s f o r t h e p r o t e c t i o n of human s u b j e c t s .

N I H G U I D E - Vol. 2 0 , No. 26, J u l y 5, 1991 - Page 6

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF ADAMHA POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES I N CLINICAL RESEARCH STUDY POPULATIONS

A p p l i c a t i o n s f o r ADAMHA g r a n t s and c o o p e r a t i v e agreements are r e q u i r 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 s t u d y p o p u l 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 ,u n l e s s compell ing s c i e n t i f i c 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 e i t h e r- -*' women o r m i n o r i t i e s i s provided . T h i s requirement i s in tended t o ensure t h a t r e s e a r c h f i n d i n g s w i l l be of b e n e f i t t o a l l persons a t r i s k 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 under s t u d y . For t h e purpose 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 of 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 gb 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 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 Alaskan N a t i v e s , A s i a n l P a c i f i c I s l a n d e r s , Blacks , and H i s p a n i c s ) .

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 of t h e f u l l a r r a y of U.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 . However, a p p l i c a n t s are urged 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 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 composi t ion of t h e proposeds t u d y p o p u l a t i o n by gender and r a c i a l l e t h n i c group, 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 of people selected 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 should be inc luded i n t h e form PHS 398 i n S e c t i o n 2, A - D of t h e Research Plan 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 t i o n s should i n c o r p o r a t e i n t h e i r s t u d y d e s i g n gender a n d l o r m i n o r i t yr e p r e s e n t a t i o n 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 proposed.If r e p r e s e n t a t i o n of 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 permi t assessment o f d i f f e r e n t i a l e f f ec t s i s n o t f e a s i b l e o r i s n o t a p p r o p r i a t e , t h e r e a s o n s f o r t h i s must be expla ined and j u s t i f i e d . The r a t i o n a l e may re la te t o t h e purpose 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 compel l ingc i rcumstances ( e . g . , i f i n t h e o n l y s t u d y p o p u l a t i o n 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 of age d i s t r i b u t i o n , r i s k f a c t o r s ,inc idence /preva lence , of one gender o r m i n o r i t y l m a j o r i t y g r o u p ) .

For f o r e i g n awards, t h e p o l i c y on i n c l u s i o n of 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 of 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

1 S t a t e s ' p o p u l a t i o n s , i n c l u d i n g m i n o r i t i e s .

If t h e r e q u i r e d informat ion is n o t c o n t a i n e d w i t h i n t h e a p p l i c a t i o n , 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 . Peer 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 ywhether 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 gender and/or m i n o r i t y representation/justification are judged t o be inadequate , 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 as a d e f i c i e n c y 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 a p p l i c a t i o n .

A l l a p p l i c a t i o n s l 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 submi t ted t o ADAMHA are r e q u i r e d to a d d r e s s t h e s e policies. ADAMHA funding components will n o t a w a r d g r a n t s t h a t do n o t comply w i t h t h e s e p o l i c i e s .

AWARD C R I T E R I A

A p p l i c a t i o n s recommended f o r approval by t h e a p p r o p r i a t e N a t i o n a l Advisory Counci l w i l l be c o n s i d e r e d f o r funding on t h e basis of o v e r a l l s c i e n t i f i c and t e c h n i c a l mer i t o f t h e r e s e a r c h as determined by p e e r review, I n s t i t u t e program needs, and a v a i l a b i l i t y of funds .

INQUIRIES

F u r t h e r in format ion and c o n s u l t a t i o n on program requi rements r e l e v a n t t o p r e v e n t i o n r e s e a r c h can be o b t a i n e d from:

D r . Z i l i A m s e l Acting D i r e c t o r , D i v i s i o n of Epidemiology and P r e v e n t i o n Research

A d d i t i o n a l , r e s e a r c h program informat ion can be o b t a i n e d from:

D r . Meyer Glantz Acting Chief , Epidemiology Research Branch

and I'

N I H G U I D E - Vol. 20, No. 26, J u l y 5 , 1991 - Page 7

D r . W i l l i a m Bukoski Act ing Ch ie f , P reven t ion Research Branch Nat iona l I n s t i t u t e on Drug Abuse 5600 F i s h e r s Lane Rockwall 11, S u i t e 615 R o c k v i l l e , MD 20857 Telephone: (301) 443-1514

For a d m i n i s t r a t i v e and f i s c a l m a t t e r s , c o n t a c t :

M s . S h i r l e y McKenneyChie f , GMB Nat iona l I n s t i t u t e on Drug Abuse Parklawn B u i l d i n g , Room 8A-52 R o c k v i l l e , MD 20857 Telephone: (301) 443-6710

T h i s program is d e s c r i b e d i n t h e Ca ta log o f Fede ra l Domestic A s s i s t a n c e No. 93.279. Gran t s w i l l be awarded under t h e a u t h o r i t y of s e c t i o n 310 and 515 of t h e P u b l i c Hea l th S e r v i c e A c t , as amended (42 USC 241 and 290 cc) and admin i s t e red i n accordance wi th t h e PHS Grants P o l i c y S ta tement and Fede ra 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 74. T h i s program i s n o t s u b j e c t t o t h e in t e rgove rnmen ta l rev iew requ i r emen t s of Execut ive Order 12372 o r Hea l th Systems Agency r ev iew.

RESEARCH ON DISABILITIES AND REHABILITATION SERVICES FOR PERSONS WITH SEVERE MENTAL DISORDERS

PA: PA-91-74

P.T. 34; K . W . 0715129, 0415001, 0730050

Nat iona l I n s t i t u t e of Mental Hea l th

The Na t iona l I n s t i t u t e of Mental Hea l th ( 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 se any of 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 s t u d i e s r e l e v a n t t o r e s e a r c h on d i s a b i l i t i e s r e s u l t i n g from s e v e r e mental d i s o r d e r s as w e l l as on r e h a b i l i t a t i o n s e r v i c e s f o r pe r sons wi th s e v e r e mental d i s o r d e r s . T h i s announcement implements t h e r e s e a r c h agenda recommended i n “Caring f o r Peoplewi th Severe Mental D i s o r d e r s : A Na t iona l P l an of Research t o Improve S e r v i c e s ( N I M H Na t iona l P l a n ) .*?

A p p l i c a t i o n s may be submi t t ed by any 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 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 of 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 encouraged t o a p p l y .

A p p l i c a t i o n s f o r t h i s g r a n t are encouraged t o i n c l u d e both women and m i n o r i t i e s i n s tudy p o p u l a t i o n s , u n l e s s s c i e n t i f i c ev idence 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 is p rov ided . T h i s requi rement i s in t ended t o 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 of b e n e f i t t o a l l pe r sons 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 under s t u d y . For t h e purpose 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 invo lves human s t u d i e s of 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 , bu 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 l e t h n i c minor i ty p o p u l a t i o n s ( s p e c i f i c a l l yAmerican I n d i a n s o r Alaskan Na t ives , A s i a n I P a c i f i c I s l a n d e r s , B lacks , and Hi span ic s 1.

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 of U.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 . However, a p p l i c a n t s are urged 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 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 minor i ty g roups .

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 composi t ion of t h e proposeds t u d y p o p u l a t i o n by gender and r a c i a l l e t h n i c group, 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 of people 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 fo rma t ion should be inc luded i n t h e form PHS 398, S e c t i o n 2, A - D o f t h e Research 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 t i o n s should i n c o r p o r a t e i n t h e i r s t u d y d e s i g n gender and/or m i n o r i t yr e p r e s e n t a t i o n 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 proposed .I f r e p r e s e n t a t i o n of 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 pe rmi t assessment of d i f f e r e n t i a l e f f e c t s i s n o t f e a s i b l e o r a p p r o p r i a t e , t h e r e a s o n s f o r t h i s must be e x p l a i n e d and 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

N I H G U I D E - Vol. 20, No. 26, J u l y 5, 1991 - Page 8

U”

purpose of 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 compel l ingc i rcumstances ( e . g . , i f i n t h e only s u b j e c t p o p u l a t i o n a v a i l a b l e t h e r e i s 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 t e r m s o f age d i s t r i b u t i o n , r i s k f a c t o r s ,inc idence /preva lence , e t c . , o f one gender o r m i n o r i t y / m a j o r i t y group) .

If t h e r e q u i r e d informat ion is n o t c o n t a i n e d w i t h i n t h e a p p l i c a t i o n , t h e .,-+ review w i l l be d e f e r r e d u n t i l it i s complete . Peer r e v i e w e r s w i l l address

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 . If gender and/or m i n o r i t y representation/justification are judged t o be inadequate , 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 as a d e f i c i e n c y 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 a p p l i c a t i o n .

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 submi t ted t o ADAMHA/NIMH are 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 . ADAMHA/NIMH funding components w i l l n o t award g r a n t s t h a t do n o t comply wi th t h e s e p o l i c i e s .

Appl icants should a l s o be aware t h a t t h e Department 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 of human s u b j e c t s and h a s developed 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 of c h i l d r e n . A copy of 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 of Human S u b j e c t s , is 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 Research R i s k s , Nat iona l I n s t i t u t e s o f Heal th , Bui ld ing 31, Room 5B59, Bethesda, Maryland 20892.

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 under t h e u s u a l PHS r e c e i p t and review s c h e d u l e . A p p l i c a t i o n s w i l l be reviewed by an i n i t i a l review group ( I R G ) c o n s i s t i n gp 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 second- leve l review by t h e a p p r o p r i a t e Advisory Counci l based on p o l i c y c o n s i d e r a t i o n s a s w e l l as s c i e n t i f i c merit . Only a p p l i c a t i o n srecommended f o r approval by Council may be cons idered f o r funding .

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 of t h e g r a n t a p p l i c a t i o nform PHS 398 ( r e v . 10/88) . Support may be r e q u e s t e d f o r a p e r i o d of up t o f i v e y e a r s . Annual awards w i l l be made s u b j e c t t o cont inued a v a i l a b i l i t y o f funds and p r o g r e s s achieved . A competing supplemental a p p l i c a t i o n may be submi t ted d u r i n g an approved p e r i o d of s u p p o r t t o expand t h e scope o r p r o t o c o lof 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 . ,renewal ) a p p l i c a t i o n may be submi t ted b e f o r e t h e end of an approved p e r i o d of s u p p o r t t o c o n t i n u e a p r o j e c t .

Grant funds may be used f o r expenses c l e a r l y related and n e c e s s a r y t o conduct -,,? 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

wi th 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 o f t h e i n s t i t u t i o n . Funds may n o t be used 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 programs may be r e q u e s t e d only 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 . These c o s t s must be j u s t i f i e d i n t e r m s of r e s e a r c h o b j e c t i v e s , methods, and d e s i g n st h a t promise t o y i e l d g e n e r a l i z a b l e knowledge and/or make s i g n i f i c a n tc o n t r i b u t i o n s t o t h e o r e t i c a l concepts .

I n f i s ca l y e a r 1990, t h e S e r v i c e s Research Branch of t h e N I M H D i v i s i o n of Applied and S e r v i c e s Research funded approximately $1,500,000 i n r e h a b i l i t a t i o n s e r v i c e s and d i s a b i l i t y r e s e a r c h . During f i s c a l y e a r 1990, t h e NIMH D i v i s i o n of C l i n i c a l Research funded approximately $ 1 , 0 0 0 , 0 0 0 i n d i s a b i l i t y and r e h a b i l i t a t i o n r e s e a r c h . However, t h e amount of funding w i l l depend on a p p r o p r i a t e d funds and 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 award.

Copies of t h i s f u l l announcement and a d d i t i o n a l in format ion may be o b t a i n e d byc o n t a c t i n g :

C i l l e Kennedy, Ph.D., o r C h a r l e s Windle, Ph.D. S e r v i c e s Research Branch D i v i s i o n of Applied and S e r v i c e s Research Parklawn B u i l d i n g , Room 18C-14 Telephone: (301) 443-1330 ( D r . Kennedy)

(301) 443-4233 ( D r . Windle)

H. Alice LoweryD i v i s i o n of C l i n i c a l Research Parklawn Bui ld ing , Room IOC-06 Telephone: (301) 443-3524

N I H G U I D E - Vol. 20, No. 26, J u l y 5, 1991 - Page 9

For f u r t h e r i n f o r m a t i o n on g r a n t s management i ssue :s , a p p l i c a n t s should c o n t a c t :

Stephen J . Hudak C h i e f , Grants Management S e c t i o n Parklawn B u i l d i n g , Room 7C-23 Telephone: (301) 443-4596

The m a i l i n g a d d r e s s f o r t h e above N I M H s t a f f i s :

Nat iona l I n s t i t u t e of Mental Heal th 5600 F i s h e r s Lane R o c k v i l l e , MD 20857

Under a u t h o r i t y of S e c t i o n 301 of t h e P u b l i c Heal th S e r v i c e A c t (42 U.S.C. 2411, and Cata log of F e d e r a l Domestic A s s i s t a n c e 93.242.

ERRATA

ADULT AIDS C L I N I C A L TRIALS UNITS

RFA: AI-91-07

P.T. 34; K . W . 0715008, 0755015

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 Adult AIDS C l i n i c a l T r i a l s U n i t s ( N I H Guide f o r Grants and C o n t r a c t s , Vol. 20, No. 18, May 3 , 1991, page 3 ) s t a t e s t h a t on ly one o p t i o n a l component f o r Other C l i n i c a l Developmental Research w i l l be accepted p e r a p p l i c a t i o n . T h i s s t a t e m e n t i s amended t o read: a p p l i c a n t s f o r P a r t A w i l l be e l i g i b l e t o apply f o r two component p r o j e c t s i n Other C l i n i c a l Developmental Research ( P a r t C.6); however, t h e y must be i n d i f f e r e n t d i s c i p l i n e s ( e . g . , neurology and mycology). Each a p p l i c a t i o n i n r e s p o n s e t o P a r t C . 6 w i l l be l i m i t e d t o $100,000 i n annual d i r e c t c o s t s f o r each of t h e p r o j e c t s .

**THE M A I L I N G ADDRESS G I V E N FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF I N THE WESTWOOD B U I L D I N G I S THE '.I

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 COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD B U I L D I N G I S :

5333 Westbard Avenue Bethesda, Maryland 20816

N I H G U I D E - Vol. 20, No. 26, J u l y 5 , 1991 - Page 10