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PHS/NIH/OD Permit No. G-291

N I H GUIDE FOR GRANTS Ai lD CONTRACTS Vol. 16, No. 22, June 26, 1987

Vol. 16, No. 22, June 26, 1987

NOTICES

PHS 398 GRANT APPLICATION, REVISED 9/86, NOW AVAILABLE....................... .1 National Institutes of HealthIndex: NATIONAL INSTITUTES OF HEALTH

CLARIFICATION OF ELIGIBILITY FOR THE PHYSICIAN SCIENTISTAWARD FOR DENTISTS (Kll)................................................. 1

National Institute of Dental ResearchIndex: DENTAL

DATED ANNOUNCEMENTS (RFPs AND RFAs AVAILABLE)

ESTABLISHMENT OF A SURVEILLANCE SYSTEM OF WOMEN UNDERGOINGTREATMENT FOR INFERTILITY WITH IN VITRO FERTILIZATION (RFP)...............2

National Institute of Child Health and Human DevelopmentIndex: CHILD HEALTH AND HUMAN DEVELOPMENT DIABETES CENTERS (RFA)... ..................................................... 3 National Institute of Diabetes and Digestive and Kidney DiseasesIndex: DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ONGOING PROGRAM ANNOUNCEMENTS

SUPPORT FOR SCIENTIFIC MEETINGS - NATIONAL EYE INSTITUTE (PA).................4National Eye InstituteIndex: EYE

REVISED ANNOUNCEMENT: THE FIRST INDEPENDENT RESEARCHSUPPORT AND TRANSITION (FIRST) AWARD (R-29) (PA).. ....................... 4

National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH d

NOTICES

PHS 398 GRANT APPLICATION, REVISED 9/86, NOW AVAILABLE

P.T. 34; K.W. 0710030, 1014002 L'

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

The newly r e v i s e d Pub l i c Heal th Se rv ice g r a n t a p p l i c a t i o n form (PHS 398) is now a v a i l a b l e . The new v e r s i o n r e p l a c e s t h e form p r e s e n t l y i n use , da t ed 5/82.

The new PHS 398 a p p l i c a t i o n k i t i nc ludes i n s t r u c t i o n s f o r apply ing f o r newI competing renewal, and competing supplemental r e s e a r c h g r a n t suppor t . I n a d d i t i o n , t h e new v e r s i o n i n c o r p o r a t e s t h e Nat iona l Research S e r v i c e Award (NRSA) I n s t i t u t i o n a l T ra in ing Grant form ( former ly t h e PHS 6025 form) as w e l l as supplemental i n s t r u c t i o n s f o r apply ing f o r a Research Career DevelopmentAward (RCDA). The new form should be used by NRSA I n s t i t u t i o n a l T ra in ingGrant a p p l i c a n t s s t a r t i n g wi th t h e September 10, 1987 r e c e i p t d a t e , and byr e s e a r c h g r a n t and RCDA a p p l i c a n t s s t a r t i n g with t h e October 1, 1987 r e c e i p td a t e .

Appl icant o rgan iza tons should n o t e t h a t a new assurance r e l a t e d t o misconduct i n s c i e n c e h a s been added t o t h e a p p l i c a t i o n form. Th i s assurance is r e q u i r e dunder s e c t i o n 493 o f t h e PHS A c t as amended by P.L. 99-158, t h e "Health Research Extension A c t " . That s t a t u t e r e q u i r e s t h e Department o f Heal th and Human S e r v i c e s (DHHS) t o i s s u e r e g u l a t i o n s r e q u i r i n g a p p l i c a n t o r g a n i z a t i o n s t o e s t a b l i s h an a d m i n i s t r a t i v e p rocess f o r reviewing r e p o r t s o f s c i e n t i f i c f r a u d and t o r e p o r t t o t h e S e c r e t a r y any i n v e s t i g a t i o n o f a l l e g e d s c i e n t i f i c f r a u d t h a t appea r s s u b s t a n t i a l .

PHS expec t s t o p u b l i s h a n o t i c e o f Proposed Rulemaking (NPRM) implementingt h i s requirement i n t h e nea r f u t u r e . It is important t o n o t e t h a t t h e l e g i s l a t i o n does no t r e q u i r e , and PHS does no t i n t end t o r e q u i r e , agencyapproval o f i n s t i t u t i o n a l procedures, nor is it in tended t h a t t h e r e g u l a t i o n sw i l l s p e l l ou t i n d e t a i l t h e a d m i n i s t r a t i v e requi rements f o r i n s t i t u t i o n a l procedures . Thus it would be q u i t e a p p r o p r i a t e f o r you t o check "yes" i f youri n s t i t u t i o n has procedures i n p l a c e now. However, a p p l i c a n t s w i l l n o t be r e q u i r e d t o provide t h i s c e r t i f i c a t i o n f o r t h e September 10 o r October 1

1-t a p p l i c a t i o n r e c e i p t d a t e s . Future announcements i n t h e GUIDE w i l l n o t e t h e d a t e s of t h e proposed and f i n a l r e g u l a t i o n s .

/AWARD FOR DENTISTS (IC111

P.T. 34; K.W. 0710030, 0785040, 1014002 Nat iona l I n s t i t u t e of Dental Research

The announcement d e s c r i b i n g t h e Phys ic ian S c i e n t i s t A w a r d for t h e NIH, which appeared i n t h e " N I H Guide f o r Grants and Cont rac ts" , Volume 15, No. 3,February 28, 1986, inc luded t h e Nat iona l I n s t i t u t e o f Dental Research accep t ing a p p l i c a t i o n s �or t h i s award. To t h e gene ra l N I H announcement, t h e NIDR added an e x t r a page ( # l o ) , s p e c f i c a l l y d i r e c t e d t o t h e N I D R ' s "Phys ic ianS c i e n t i s t Award Program f o r Den t i s t s " (PSA). The N I D R s p e c i f i e d t h a t it would accept a p p l i c a t i o n s only f o r t h e INDIVIDUAL award.

However, w e wish t o c l a r i f y t h e ambiguity of t h e fo l lowing sen tence , which appears i n t h e f irst paragraph of t h e N I D R page. It now reads :

"The new Phys ic ian S c i e n t i s t Award (PSA), which is r e s t r i c t e d t o t h o s e hold ing D.D.S., D . M . D . , o r o t h e r h e a l t h p r o f e s s i o n a l degrees i n t h e c l i n i c a l s c i ences , i s expected t o be h e l p f u l i n accomplishing t h i s specific a i m . "

Th i s sen tence should r ead as fo l lows:

"The new Phys ic ian S c i e n t i s t Award f o r D e n t i s t s (PSA), which is r e s t r i c t e d t o t h o s e hold ing t h e D.D.S., D . M . D . , or another equ iva len t d e n t a l degree, is expected t o be h e l p f u l i n accomplishing t h i s s p e c i f i c aim.

1-4 The remainder o f t h e t e x t of t h e o r i g i n a l N I D R announcement is unchanged.

1

DATED ANNOUNCEMENTS (RFPs AND RFAs AVAILABLE)

ESTABLISHMENT OF A SURVEILLANCE SYSTEM OF WOMEN UNDERGOING TREATMENT FOR INFERTILITY WITH I N VITRO FERTILIZATION

RFP AVAILABLE: NICHD-CE-87-06

P.T. 34; K.W. 0413002, 0785055, 1004008

Nat iona l I n s t i t u t e of Child Health and Human Development

This Procurement is t o t a l l y s e t - a s i d e f o r s m a l l bus ines s concerns . For purposes of t h i s procurement, a small bus iness concern is a concern, i nc lud ing i ts a f f i l i a t e s , which i s independently owned and opera ted , is no t dominant i n t h e f i e l d of o p e r a t i o n i n which it is proposing on government c o n t r a c t s , and whose average annual r e c e i p t s f o r t h e preceding t h r e e f i sca l y e a r s do no t exceed $3.5 m i l l i o n .

The Cont racept ive Evalua t ion Branch, Center f o r Popula t ion Research, Nat iona l I n s t i t u t e o f Child Health and Human Development, Nat iona l I n s t i t u t e s o f Heal th i s seeking small bus iness o r g a n i z a t i o n s capable of e s t a b l i s h i n g a s u r v e i l l a n c e sys t em of women undergoing t r ea tmen t f o r i n f e r t i l i t y wi th i n v i t r o f e r t i l i z a t i o n (IVF) i n t h e United S t a t e s i n o r d e r t o monitor t h e medical and l i f e t i m e f e r t i l i t y sequelae o f t h e procedure. The o b j e c t i v e s o f t h i s p r o j e c t are two-fold: ( 1 ) t o mount a c e n t r a l l y coord ina ted , c o l l a b o r a t i v e e f f o r t which w i l l r e s u l t i n a n a t i o n a l r e g i s t r y o f t h e s e p a t i e n t s and (2) t o implement t h e system e s t a b l i s h e d above i n o r d e r t o i n v e s t i g a t e t h e e x t e n t t o which t h e procedure may produce a wide spectrum o f adverse h e a l t h e f f e c t s .

The f i rs t phase of t h e p r o j e c t w i l l i nco rpora t e i d e n t i f i c a t i o n and s e l e c t i o n of t h e p a r t i c i p a t i n g c l i n i c s , development o f t h e d a t a c o l l e c t i o n ins t ruments , development of p a t i e n t follow-up s t r a t e g i e s and p i l o t t e s t i n g o f a l l mechanisms of t h e sys t em. The implementation phase w i l l i nc lude e s t i m a t i o n of r isk of v a r i o u s endocr inologic cond i t ions , menstrual d i s o r d e r s , r ep roduc t ive abnorma l i t i e s , and psychologica l sequelae i n a d d i t i o n t o gene ra t ing and exp lo r ing new medical hypotheses. It is a n t i c i p a t e d t h a t t h i s w i l l be a f i v e yea r p r o j e c t and t h a t a s i n g l e c o n t r a c t award w i l l be made. It is es t ima ted t h a t t h e p r o j e c t w i l l r e q u i r e t h e fo l lowing personnel : a phys ic i an a t t h e coord ina t ing c e n t e r t o se rve as p r i n c i p a l i n v e s t i g a t o r , a systems a n a l y s t , a p r o j e c t manager and c l e r i c a l suppor t . The p a r t i c i p a t i n g c l i n i c a l s i t e s w i l l r e q u i r e p r o j e c t managers (nu r se / ep idemio log i s t s ) and t h e par t - t ime p a r t i c i p a t i o n ( adv i so ry ) of t h e p h y s i c i a n ( s 1 performing t h e procedure.

Organiza t ions responding t o t h i s announcement should have demonstrated competency i n managing mul t i cen te r c o l l a b o r a t i v e r e s e a r c h p r o j e c t s and t h e c a p a b i l i t y o f meeting t h e fo l lowing requi rements : ( 1 ) F a m i l i a r i t y with t h e t e c h n i c a l a s p e c t s o f i n v i t r o f e r t i l i z a t i o n procedures and a b i l i t y t o i d e n t i f y c l i n i c s wi th t h i s technology a v a i l a b l e ; ( 2 ) Experience i n r ep roduc t ive epidemiology; (3) A b i l i t y t o t r a i n and supe rv i se a p p r o p r i a t e personnel a t t h e c l i n i c a l s i tes; and ( 4 ) Database management s k i l l s i nc lud ing q u a l i t y assurance .

RFP-NICHD-CE-87-06 w i l l be i s sued on o r about J u l y 1 , 1987. Proposa ls w i l l b e due approximately 6 0 days t h e r e a f t e r . Copies of t h e RFP may be obta ined bysending w r i t t e n r e q u e s t s t o t h e fo l lowing addres s . P l ease inc lude a se l f - addres sed l a b e l .

Paul J . Duska, Cont rac t ing O f f i c e r Cont rac t s Management Sec t ion , OGC Nat iona l I n s t i t u t e o f Child Health and Human DevelopmentLandow Bui ld ing , Room 6C-25 7910 Woodmont Avenue Bethesda, Maryland 20892

2

tri,

DIABETES CENTERS

RFA AVAILABLE: 87-DK-10

P.T. 04, 34; K . W . 0715075, 0785050, 0710030

Nat iona l I n s t i t u t e of Diabe tes and Diges t ive and Kidney Diseases

Appl ica t ion Rece ip t D a t e : October 13, 1987

The Nat iona l I n s t i t u t e o f Diabe tes and Diges t ive and Kidney Diseases ( N I D D K )i n v i t e s a p p l i c a t i o n s f o r a Center g r a n t t o be awarded i n F i s c a l Year 1988. N I D D K a n t i c i p a t e s t h e compet i t ive award o f one Diabe tes Endocrinology Research Center (DERC) i n F i s c a l Year 1988.

BACKGROUND

A t t h e p r e s e n t t ime, t h e N I D D K suppor t s s i x DERCs. These c e n t e r s are p a r t o f an i n t e g r a t e d program of d i a b e t e s - r e l a t e d r e s e a r c h suppor t w i th in t h e N I D D K . Centers have provided a focus f o r i n c r e a s i n g t h e e f f i c i e n c y and c o l l a b o r a t i v e e f f o r t among groups o f success fu l i n v e s t i g a t o r s a t i n s t i t u t i o n s wi th e s t a b l i s h e d comprehensive d i a b e t e s r e s e a r c h bases .

OBJECTIVES AND SCOPE

The o b j e c t i v e s of t h e DERCs are t o b r i n g t o g e t h e r i n v e s t i g a t o r s from r e l e v a n t d i s c i p l i n e s i n a manner which w i l l enhance and extend t h e e f f e c t i v e n e s s o f r e sea rch be ing conducted i n t h e f i e l d of d i a b e t e s and i t s compl ica t ions . A Diabe tes Center must be an i d e n t i f i a b l e u n i t w i th in a s i n g l e u n i v e r s i t ymedical c e n t e r o r a consortium o f coopera t ing i n s t i t u t i o n s , i nc lud ing an a f f i l i a t e d u n i v e r s i t y . The o v e r a l l goa l of t h e DERC is t o b r i n g t o g e t h e r on a coope ra t ive b a s i s , c l i n i c a l and b a s i c s c i e n c e i n v e s t i g a t o r s i n a manner which w i l l e n r i c h t h e e f f e c t i v e n e s s of d i a b e t e s r e s e a r c h . A program of exce l l ence i n biomedical r e s e a r c h i n t h e area o f d i a b e t e s and r e l a t e d metabol ic and endocr ine d i s o r d e r s i n t h e form of NIH-funded r e sea rch p r o j e c t s , programp r o j e c t s , o r o t h e r peer-reviewed r e s e a r c h must be i n e x i s t e n c e a t t h e t i m e o f submission of a Center a p p l i c a t i o n . Close coopera t ion , communication, and c o l l a b o r a t i o n among a l l involved personnel of a l l p r o f e s s i o n a l d i s c i p l i n e s are u l t i m a t e o b j e c t i v e s . Appl icants should c o n s u l t with N I D D K s ta f f concerningp l a n s f o r t h e development o f t h e Center.

The DERCs a r e based on t h e c o r e concept . Cores are de f ined as shared r e sources t h a t enhance p r o d u c t i v i t y o r i n o t h e r ways b e n e f i t a group o f i n v e s t i g a t o r s working i n d i a b e t e s o r d i a b e t e s - r e l a t e d areas t o accomplish t h e s t a t e d g o a l s of t h e Center . Two o t h e r t y p e s of a c t i v i t i e s may a l s o be suppor ted wi th c e n t e r funding - a p i l o t and f e a s i b i l i t y program and an enrichment program. The p i l o t and f e a s i b i l i t y program p rov ides modest suppor tf o r new i n i t i a t i v e s o r f e a s i b i l i t y r e s e a r c h s t u d i e s f o r new i n v e s t i g a t o r s o r f o r e s t a b l i s h e d i n v e s t i g a t o r s i n o t h e r r e s e a r c h d i s c i p l i n e s where t h e i r e x p e r t i s e may be a p p l i e d t o d i a b e t e s r e s e a r c h . The Center g r a n t may a l s o inc lude l i m i t e d funds f o r program enrichment such as seminars, v i s i t i n gs c i e n t i s t s , c o n s u l t a n t s , workshops, e tc .

MECHANISM OF SUPPORT

N I D D K expec t s to award one DERC Grant i n F i s c a l Year 1988 on a compet i t ive b a s i s . The r e c e i p t of one compet i t ive c o n t i n u a t i o n a p p l i c a t i o n i s a n t i c i p a t e d , and it w i l l be i n compet i t ion f o r t h e award t o g e t h e r wi th o t h e r a p p l i c a t i o n s r ece ived i n response t o t h i s announcement. Foreign i n s t i t u t i o n s a r e no t e l i g i b l e t o apply . The a n t i c i p a t e d award w i l l be f o r f i v e y e a r s and is cont ingent upon t h e a v a i l a b i l i t y o f appropr i a t ed funds. The RFA ( g e n e r a l d e s c r i p t i o n and Guide l ines f o r t h e DERC) and c o n s u l t a t i o n may be obta ined from :

D r . Sanford G a r f i e l d Diabetes Centers Program D i r e c t o r Diabetes , Endocrinology, and Metabolic Diseases Div i s ion Nat iona l I n s t i t u t e of Diabe tes and Diges t ive and Kidney Diseases Bethesda, Maryland 20892 Telephone: (301) 496-7418

REVIEW PROCEDURES

* r ~ Appl i ca t ions f o r a DERC g r a n t w i l l be eva lua ted i n n a t i o n a l compet i t ion by t h e N I H g r a n t pee r review p rocess . App l i ca t ions w i l l be reviewed i n i t i a l l y by a s p e c i a l review committee convened by t h e N I D D K and subsequent ly by t h e Nat iona l Diabe tes and Diges t ive and Kidney Diseases Advisory Council .

3

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METHOD OF APPLYING

P o t e n t i a l a p p l i c a n t s are urged t o submit a l e t t e r o f i n t e n t regard ing t h e i r a p p l i c a t i o n . The l e t t e r of i n t e n t is nonbinding and is no t a precondi t ion f o r an award. The l e t t e r o f i n t e n t should inc lude t h e name(s1 o f t h e p r i n c i p a l i n v e s t i g a t o r and p r i n c i p a l c o l l a b o r a t o r s , d e s c r i p t i v e t i t l e s o f t h e c o r e f a c i l i t i e s and p i l o t / f e a s i b i l i t y p r o j e c t s , and t h e o r g a n i z a t i o n ( s ) involved. -Appl ica t ions must be submit ted us ing Form 398 (Rev. 9/86) . The RFA l a b e l contained i n t h e a p p l i c a t i o n k i t must be a f f i x e d t o t h e bottom o f t h e face page o f t h e o r i g i n a l copy o f t h e a p p l i c a t i o n . F a i l u r e t o use t h i s l a b e l could r e s u l t i n delayed process ing and review o f your a p p l i c a t i o n .

Mail t h e completed a p p l i c a t i o n ( o r i g i n a l and f o u r c o p i e s ) t o :

Appl ica t ion Receipt O f f ice Divis ion o f Research Grants Room 240, Westwood Bui ld ing Nat iona l I n s t i t u t e s o f Heal th Bethesda, Maryland 20892XX

Simultaneously submit two c o p i e s t o D r . Sanford G a r f i e l d a t t h e address noted above.

The s p e c i a l s i n g l e r e c e i p t d a t e f o r submissions i n response t o t h i s announcement is October 13, 1987, wi th ear l ies t funding J u l y 1, 1988.

SUPPORT FOR SCIENTIFIC MEETINGS - NATIONAL EYE INSTITUTE

P.T. 42; K.W. 1002046, 1014002

National Eye I n s t i t u t e

Progress i n v i s i o n r e s e a r c h is f o s t e r e d by f r e q u e n t exchanges of s c i e n t i f i c information among i n v e s t i g a t o r s i n t h i s f i e l d and between v i s i o n s c i e n t i s t s and s c i e n t i s t s i n o t h e r f i e l d s . These exchanges occur informally, i n c o l l a b o r a t i o n s , i n p u b l i c a t i o n s , and i n r e g u l a r y scheduled n a t i o n a l and i n t e r n a t i o n a l meetings. The Nat ional Eye I n s t i t u t e (NE11 cont inues t o o f f e r support f o r s p e c i a l , one-time meetings, workshops, and conferences. P r e f e r e n t i a l c o n s i d e r a t i o n is given t o a p p l i c a t i o n s developed i n conjunct ionwith NE1 extramural s ta f f which address s p e c i f i c r e s e a r c h needs as i d e n t i f i e d i n "Vision Research - A Nat ional Plan: 1983-1987" and i n more r e c e n t NE1 program planning e v a l u a t i o n s . The focus o f supported meetings w i l l g e n e r a l l ybe on v i s i o n r e s e a r c h areas i n g r e a t need o f new or m u l t i d i s c i p l i n a r ys c i e n t i f i c approaches and i d e a s . I n v e s t i g a t o r s planning t o submit a p p l i c a t i o n s f o r t h e support o f s c i e n t i f i c meeting a re? t h e r e f o r e , s t r o n g l yencouraged t o d i s c u s s t h e i r a p p l i c a t i o n s i n advance wi th a p p r o p r i a t e NE1 extramural s t a f f . For f u r t h e r information, p l e a s e c o n t a c t :

Jack A. McLaughlin, Ph.D. Nat ional Eye I n s t i t u t e Bui ld ing 31, Room 6A51 Bethesda, Maryland 20892 Telephone: (301) 496-5983

REVISED ANNOUNCEMENT: THE FIRST INDEPENDENT RESEARCH SUPPORT AND TRANSITION (FIRST) AWARD (R-29)

(Th i s document r e p l a c e s t h e prev ious August 1 , 1986 announcement)

P.T. 34; K.W. 0710030, 1014002

Nat iona l I n s t i t u t e s o f Heal th

The Nat iona l I n s t i t u t e s of Heal th ( N I H ) announces t h e cont inuing a v a i l a b i l i t yo f t h e FIRST Award (R-29). Based on e a r l i e r review exper iences t h e o b j e c t i v e sand f e a t u r e s o f t h e R-29 mechanism are f u r t h e r def ined and c l a r i f i e d .

4

OBJECTIVE

The o b j e c t i v e o f t h e FIRST award is t o provide a s u f f i c i e n t pe r iod of r e s e a r c h suppor t for newly independent biomedical i n v e s t i g a t o r s t o i n i t i a t e t h e i r own r e s e a r c h and demonstrate t h e m e r i t o f t h e i r own r e s e a r c h i d e a s . These g r a n t s are intended t o underwr i te t h e first independent i n v e s t i g a t i v e e f f o r t s of an i n d i v i d u a l ; t o provide a reasonable oppor tun i ty t o demonstrate c r e a t i v i t y ,

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p r o d u c t i v i t y , and f u r t h e r promise; and t o h e l p i n t h e t r a n s i t i o n t o t r a d i t i o n a l t ypes o f N I H r e sea rch p r o j e c t g r a n t s . The award is n o t in tended f o r persons i n mid-career who may be i n t r a n s i t i o n t o another endeavor. FIRST awards g e n e r a l l y w i l l p rovide funds for 5 y e a r s dur ing which time t h e newlyindependent i n v e s t i g a t o r can e s t a b l i s h h i s or h e r own r e s e a r c h program and make s i g n i f i c a n t and innova t ive c o n t r i b u t i o n s t o l a b o r a t o r y or c l i n i c a l s c i e n c e d i s c i p l i n e s i n biomedical r e sea rch .

ELIGIBILITY

To be e l i g i b l e f o r a FIRST award, t h e proposed p r i n c i p a l i n v e s t i g a t o r ( P I ) must be genuine ly independent o f a mentor y e t a t t h e same t i m e must be a t t h e beginning s t a g e s o f h i s or h e r r e sea rch career with, f o r example, no more t h a n f i v e y e a r s r e sea rch exper ience s i n c e completing 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 or i t s e q u i v a l e n t . If t h e a p p l i c a n t i s i n t h e f i n a l s t a g e s o f t r a i n i n g , it is pe rmis s ib l e t o apply , bu t no FIRST award w i l l be made t o persons i n t r a i n i n g s t a t u s . I n a d d i t i o n , t h e proposed PI must o therwise be e l i g i b l e t o s e r v e i n t h e same c a p a c i t y on a t r a d i t i o n a l r e s e a r c h p r o j e c t g r a n t (R-01) awarded t o t h e a p p l i c a n t i n s t i t u t i o n . The a p p l i c a n t i n v e s t i g a t o r must never have been des igna ted p rev ious ly as PI on any PHS-supported r e s e a r c h p r o j e c t OTHER THAN a PHS small g r a n t (R-031, an Academic Research Enhancement Award (R-15) or c e r t a i n r e s e a r c h career awards (K series) d i r e c t e d p r i n c i p a l l y t o phys i c i ans ,d e n t i s t s or v e t e r i n a r i a n s wi th l i t t l e r e s e a r c h exper ience . (Curren t or pastResearch Career Development Awardees are no t e l i g i b l e . ) Subprojec t l e a d e r s on multicomponent awards such as Program P r o j e c t g r a n t s (P-011, Center g r a n t s(P-50) or Minority Biomedical Research Support g r a n t s (S-06) may a l s o be e l i g i b l e , however p o t e n t i a l a p p l i c a n t s i n t h e s e c a t e g o r i e s are urged t o c o n t a c t t h e a p p r o p r i a t e person from t h e awarding u n i t l i s t e d below.

An important p r i n c i p l e t o remember wi th r ega rd t o e l i g i b i l i t y is t h a t t h e more ex tens ive t h e p r i o r independent r e s e a r c h exper iences , r e g a r d l e s s of funding

LJ sources , t h e greater l i k e l i h o o d t h e r e w i l l be diminished enthusiasm amongreviewers f o r t h e FIRST award a p p l i c a t i o n .

GENERAL FEATURES

PRE-AWARD

1 Only domestic o r g a n i z a t i o n s and i n s t i t u t i o n s are e l i g i b l e t o r e c e i v e FIRST awards.

2 A FIRST award is f o r a d i s t i n c t r e s e a r c h endeavor and may n o t be used merely t o supplement or broaden an ongoing p r o j e c 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 .

3 An i n d i v i d u a l may submit only one FIRST award a p p l i c a t i o n t o t h e Pub l i c Heal th Se rv ice (PHS) f o r any p a r t i c u l a r receipt d a t e and may no t submit any o t h e r t y p e o f r e s e a r c h g r a n t a p p l i c a t i o n ( i n c l u d i n gr e s e a r c h career a p p l i c a t i o n s ) t o t h e PHS dur ing t h a t p a r t i c u l a rreview c y c l e . App l i ca t ions f o r o t h e r p r o j e c t s may be submitted while t h e FIRST award i s i n f o r c e provided t h a t t h e t i m e and e f f o r t is less t h a n 100% on t h e FIRST award.

4 FIRST award a p p l i c a t i o n s must r e q u e s t 5 y e a r s o f r e s e a r c h suppor t .App l i ca t ions submitted t o t h e N I H i n which t h e r e q u e s t is for less than 5 y e a r s o f suppor t w i l l be des igna ted as ROls and so reviewed u n l e s s t h e a p p l i c a n t withdraws t h e a p p l i c a t i o n .

5 The P I must make a commitment o f no less t h a n 50% e f f o r t t o t h e proposed p r o j e c t .

Up t o 100% e f fo r t may be requested if a greater commitment of t h e p r i n c i p a l i n v e s t i g a t o r i s r equ i r ed t o do t h e r e s e a r c h . The r e q u e s tfor e f f o r t o f t h e a p p l i c a n t i n v e s t i g a t o r w i l l be reviewed and r educ t ions may be recommended.

5

6 Appl ica t ion page l i m i t a t i o n s apply t o t h e Research Plan (Sec t ion 2)of t h e PHS 398 a p p l i c a t i o n form. S e c t i o n s A-D o f t h e Research Plan, as descr ibed on page 20 of t h e i n s t r u c t i o n s f o r t h e PHS 398 (Rev. 9/86) , a r e l i m i t e d t o a t o t a l o f 20 pages inc luding t a b l e s ,f i g u r e s and chemical s t r u c t u r e s . Appl ica t ions exceeding t h e 20-page l i m i t a t i o n w i l l be r e t u r n e d .

If appendix m a t e r i a l is submit ted, s i x c o l l a t e d s e t s must be included wi th t h e '-a p p l i c a t i o n package. I d e n t i f y each o f t h e s i x se t s wi th t h e name of t h e p r i n c i p a l i n v e s t i g a t o r and t h e p r o j e c t t i t l e . T h i s material w i l l no t be r o u t i n e l y d u p l i c a t e d and w i l l be used i n a l i m i t e d way by members o f t h e i n i t i a l review group.

7 I n very unusual c i rcumstances, FIRST awards may be recommended byt h e i n i t i a l review group o r t h e awarding I n s t i t u t e f o r p e r i o d s o f less t h a n f i v e y e a r s .

POST-AWARD

1 The t o t a l d i r e c t c o s t award f o r t h e 5-year per iod may n o t exceed $350,000. The d i r e c t c o s t award i n any budget p e r i o d should n o t exceed $100,000. I n d i r e c t c o s t s w i l l be pa id t o t h e g r a n t e ei n s t i t u t i o n i n accord with a p p l i c a b l e p o l i c y o f t h e Department o f Heal th and Human S e r v i c e s (DHHS).

The a u t h o r i t y t o c a r r y over unobl iga ted d i r e c t c o s t funds from one budgetp e r i o d t o t h e subsequent one under c e r t a i n c o n d i t i o n s w i l l be a f e a t u r e of t h i s award and may be accomplished a t t h e d i s c r e t i o n o f t h e p r i n c i p a li n v e s t i g a t o r and t h e g r a n t e e i n s t i t u t i o n . If funds have been r e s t r i c t e d by a s p e c i f i c term o r c o n d i t i o n on t h e Notice o f Grant Award, t h e y may n o t be a u t o m a t i c a l l y c a r r i e d over without t h e p r i o r approval o f t h e awarding u n i t .

Carryover is e f f e c t e d by n o t i f i c a t i o n on t h e f i n a n c i a l s t a t u s r e p o r t , which t h e g r a n t e e submits w i t h i n 90 days o f t h e t e r m i n a t i o n o f each budget p e r i o d .Upon r e c e i p t o f t h e n o t i f i c a t i o n , t h e awarding u n i t w i l l i s s u e a r e v i s e d Notice o f Grant Award, which w i l l r e f lec t t h e increased a u t h o r i z a t i o n o f d i r e c t c o s t s . I n d i r e c t c o s t s w i l l be p a i d t o t h e awardee i n s t i t u t i o n i n accord wi th a p p l i c a b l e DHHS p o l i c y .

2 FIRST awards are n o t renewable. The P I on a FIRST award may submit a t r a d i t i o n a l r e s e a r c h p r o j e c t g r a n t (R-01) a p p l i c a t i o n t o cont inue Iy

and extend t h e r e s e a r c h supported by a FIRST award.

3 Grantee I n s t i t u t i o n s may extend t h e f i n a l budget per iod o f t h e p r o j e c t one t i m e f o r a per iod up t o one year beyond t h e o r i g i n a lt e r m i n a t i o n d a t e shown on t h e Notice o f Grant Award. Such an ex tens ion may be made only when any one o f t h e fol lowing a p p l i e s :

o a d d i t i o n a l t i m e beyond t h e e s t a b l i s h e d e x p i r a t i o n d a t e is r e q u i r e d t o a s s u r e adequate completion of t h e o r i g i n a l l y approved p r o j e c t scope o r o b j e c t i v e s ;

o c o n t i n u i t y o f P u b l i c Heal th S e r v i c e (PHSI g r a n t support is requiredwhile a competing a p p l i c a t i o n is under review; o r

o t h e ex tens ion is necessary t o permit an o r d e r l y phaseout o f a p r o j e c t t h a t w i l l n o t r e c e i v e cont inued suppor t .

The fac t t h a t funds remain a t t h e e x p i r a t i o n o f t h e g r a n t is n o t i n i t s e l f s u f f i c i e n t j u s t i f i c a t i o n f o r an ex tens ion without a d d i t i o n a l funds.

The g r a n t e e i n s t i t u t i o n must n o t i f y t h e awarding u n i t of t h e ex tens ion p r i o r t o t h e e x p i r a t i o n d a t e o f t h e p r o j e c t p e r i o d . Upon n o t i f i c a t i o n , t h e awardingu n i t w i l l i s s u e a r e v i s e d Notice o f Grant Award t o change t h e t e r m i n a t i o n d a t e . Grantees may n o t extend p r o j e c t p e r i o d s p r e v i o u s l y extended by t h e awarding u n i t .

4 Replacement of t h e P I on a FIRST award w i l l n o t be approved.T r a n s f e r of t h e FIRST award wi th t h e p r i n c i p a l i n v e s t i g a t o r t o another i n s t i t u t i o n f o r t h e remaining performance per iod may be reques ted .

5 Except as i n d i c a t e d above, a l l r e l e v a n t p o r t i o n s of t h e PHS Grant P o l i c y Statement are a p p l i c a b l e t o t h e s e awards.

6

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ADDITIONAL DOCUMENTATION

The fo l lowing is t o be addressed i n a l e t t e r o r memorandum from a s u i t a b l e department head or dean and should be inc luded wi th t h e a p p l i c a t i o n .

o E l i g i b i l i t y o f proposed p r i n c i p a l i n v e s t i g a t o r independently t o l e a d a r e sea rch p r o j e c 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 . Is t h i s person o the rwise q u a l i f i e d t o be t h e P I on a t r a d i t i o n a l r e s e a r c h p r o j e c t g r a n t (R01 I ?

o D e t a i l s o f in tended commitment of t h e i n s t i t u t i o n t o t h e p r o j e c tf o r t h e f ive -yea r pe r iod .

I n a d d i t i o n , t h r e e l e t te rs of r e fe rence are needed. A t l e a s t two must be r ece ived a minimum o f t h r e e weeks before t h e i n i t i a l review, o r t h e a p p l i c a t i o n w i l l be d e f e r r e d . Such l e t t e r s are c r i t i c a l l y important when t h e i n v e s t i g a t o r ' s r e s e a r c h o r i g i n a l i t y and p o t e n t i a l for independenti n v e s t i g a t i o n are no t r e f l e c t e d i n h i d h e r r e s e a r c h exper ience . For example,when t h e a p p l i c a t i o n is from t h e i n s t i t u t i o n where t h e proposed P I r ece ived 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 , it must be made a b s o l u t e l y clear t h a t t h e FIRST award would be t o suppor t a r e s e a r c h endeavor independent of t h a t conducted i n t h e former t r a i n i n g environment.

The a p p l i c a n t is r e s p o n s i b l e f o r determining t h a t l e t t e r s be s e n t t o t h e cognizant Executive S e c r e t a r y a f te r n o t i f i c a t i o n o f Study S e c t i o n assignmentis rece ived i n t h e m a i l .

REVIEW CRITERIA

Review cr i ter ia and procedures are t h o s e o f t h e r e g u l a r N I H system of dua l pee r review: e v a l u a t i o n f o r s c i e n t i f i c and t e c h n i c a l merit by an i n i t i a l review group ( s t u d y s e c t i o n ) t a k i n g i n t o c o n s i d e r a t i o n t h e i n v e s t i g a t o r ' s s t a g e o f development and mer i t o f t h e proposed r e sea rch , followed byrecommendation of t h e cognizant n a t i o n a l adv i so ry counc i l o r board. I n a d d i t i o n , t h e P I must demonstrate t h e p o t e n t i a l t o c a r r y ou t independentr e s e a r c h and c l e a r evidence o f a b i l i t y t o develop a sound r e s e a r c h p l a n . The q u a l i t y o f educa t ion , s c i e n t i f i c t r a i n i n g , r e sea rch exper ience , commitment t o a r e s e a r c h c a r e e r as we l l as t h e i n s t i t u t i o n a l commitment w i l l be important i n t h e review p rocess .

IMPLEMENTATION

A l l awarding u n i t s o f t h e N I H are au tho r i zed t o use t h i s mechanism.

It should be noted t h a t t h e s e a p p l i c a t i o n s compete f o r funding wi th t r a d i t i o n a l t y p e s o f N I H r e s e a r c h p r o j e c t g r a n t s and t h a t t h e N I H h a s no s p e c i a l s e t - a s i d e funds f o r FIRST awards.

HOW TO APPLY

App l i can t s must use t h e PHS-398 (Rev. 9/86) a p p l i c a t i o n form and must provide r e l e v a n t in format ion on e l i g i b i l i t y . (See S e c t i o n 11 .1 The acronym "FIRST" should be typed on l i n e 2 of t h e a p p l i c a t i o n face page.

App l i ca t ions must be submitted t o t h e Div i s ion o f Research Grants ( D R G ) i n accordance wi th r e g u l a r r e c e i p t d a t e s (See below).Assignment t o t h e most a p p r o p r i a t e I n s t i t u t e and i n i t i a l review group w i l l be c a r r i e d ou t by t h e DRG accord ing t o e s t a b l i s h e d g u i d e l i n e s .

Mail t h e completed a p p l i c a t i o n ( o r i g i n a l and s i x ) cop ie s t o :

Appl ica t ion Receipt Of f i ce Div is ion of Research Grants Room 2 4 0 , Westwood Bui ld ingNat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 2 0 8 9 2 X X

7

The fo l lowing t a b l e i n d i c a t e s t h e review and award cyclei

Appl ica t ion I n i t i a l Review Nat iona l Advisory E a r l i e s t P o s s i b l e Receipt Dates Group Dates Council/Board Dates Beginning Date

February 1 , June/ J u l y September/October December 1 June 1 October/November January/February A p r i l 1 October 1 February/March May/ June J u l y 1

PARTICIPATING BUREAUS, INSTITUTES, DIVISIONS AND CENTERS OF THE NATIONAL INSTITUTES OF HEALTH

Addi t iona l in format ion may be obta ined by c o n t a c t i n g :

Nat iona l I n s t i t u t e on Aging

D r . Miriam Kel ty , Assoc ia te D i r e c t o r Off i ce o f Extramural Affairs Nat iona l I n s t i t u t e on AgingBui ld ing 3 1 , Room 5C05 Nat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-9374

Nat iona l I n s t i t u t e o f A l l e rgy and I n f e c t i o u s Diseases ( N I A I D 1

D r . Luz A. F roeh l i ch , Deputy D i r e c t o r Extramural A c t i v i t i e s ProgramNat iona l I n s t i t u t e of Al le rgy and I n f e c t i o u s Diseases Nat iona l I n s t i t u t e s of Health Westwood Bui ld ing , Room 703 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-7688

Nat iona l I n s t i t u t e of A r t h r i t i s and Musculoskeletal and Skin Diseases (NIAMS)

D r . Steven J . Hausman, Deputy D i r e c t o r Extramural A c t i v i t i e s ProgramWestwood Bui ld ing , Room 403 Nat iona l I n s t i t u t e s of Health Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-7495

Nat iona l Cancer I n s t i t u t e ( N C I )

M r . Hernon Fox, R e f e r r a l Officer Nat iona l Cancer I n s t i t u t e Westwood Bui ld ing , Room 828 Nat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-3428

Nat iona l I n s t i t u t e of Chi ld Heal th and Human Development( N I C H D 1

Mrs. Hildegard Topper,Spec ia l A s s i s t a n t t o t h e D i r e c t o r Nat iona l I n s t i t u t e of Child Health and Human DevelopmentBui ld ing 3 1 , Room 2A03 Nat iona l I n s t i t u t e s of Health Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-1848

Nat iona l I n s t i t u t e o f Dental Research ( N I D R )

D r . Marie U. Nylen, D i r e c t o r Extramural ProgramsNat iona l I n s t i t u t e of Dental Research Westwood Bui ld ing , Room 503 Nat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 20892 Telephone: (301) 496-7723

'8

8

Nat iona l I n s t i t u t e of Diabetes , and Diges t ive and KidneyDiseases ( N I D D K )

D r . Walter S. S t o l z , D i r e c t o r Divis ion o f Extramural A c t i v i t i e s Nat iona l I n s t i t u t e o f Diabetes , and Diges t ive and Kidney

\d Diseases Westwood Building, Room 657 Nat iona l I n s t i t u t e s of Health Bethesda, Maryland 20982 Telephone: (301) 496-7277

Nat iona l I n s t i t u t e o f Environmental Heal th Sc iences (NIEHS)

D r . Edward Gardner, Science Adminis t ra tor Extramural Programs, NIEHS P.O. Box 12233 Research T r i a n g l e Park, North Caro l ina 27709 Telephone: (919) 541-7724

Nat iona l Eye I n s t i t u t e (NE11

D r . J a c k A . McLaughlin, Act ing Assoc ia te D i r e c t o r Nat iona l Eye I n s t i t u t e Bui ld ing 31, Room 6A51 Nat iona l I n s t i t u t e s o f Heal th Bethesda, Maryland 20892 Telephone: (301) 496-5983

Nat iona l I n s t i t u t e o f General Medical Sc iences (NIGMS)

D r . David Wolff, Deputy Assoc ia te D i r e c t o r O f f i ce o f Program A c t i v i t i e s Nat iona l I n s t i t u t e of General Medical Sc iences Westwood Building, Room 955 Nat ional I n s t i t u t e s o f Heal th Bethesda, Maryland 20892 Telephone: (301) 496-7063

Nat iona l Heart, Lung, and Blood I n s t i t u t e L**’

D r . Henry G . Roscoe, Deputy D i r e c t o r Divis ion o f Extramural A f f a i r s National Heart, Lung, and Blood I n s t i t u t e Westwood Building, Room 7A17 Bethesda, Maryland 20892 Telephone: (301) 496-7225

Nat iona l L i b r a r y of Medicine (NLM)

M r . P e t e r A . Clepper, Program Officer B i o m e d i c a l Information Support Branch Extramural Programs

(NHLBI)

Bui ld ing 3 8 A , Room 5s-518 National Library o f Medicine Bethesda, Maryland 20894 Telephone: (301) 496-4221

National I n s t i t u t e of Neurological Disorders and St roke (NINCDS)

M r . Edward Donohue, Deputy D i r e c t o r Divis ion o f Extramural A c t i v i t i e s National I n s t i t u t e of Neurological Disorders and St roke Federal Bui lding, Room 1016 National I n s t i t u t e s o f Heal th Bethesda, Maryland 20892 Telephone: (301) 496-4188

and Communicative

and Communicative

Nat iona l Center f o r Nursing Research

D r . Doris Bloch, Act ing D i r e c t o r Divis ion o f Extramural ProgramsNational Center f o r Nursing Research Building 3 8 A , Room B2E17 National I n s t i t u t e s o f Heal th Bethesda, Maryland 20892 Telephone: (301) 496-0526

(NCNR)

9

Division of Research Resources (DRR)

Dr. James F. O'Donnell, Deputy DirectorDivision of Research Resources Building 31, Room 5B03National Institutes of HealthBethesda, Maryland 20892Telephone: (301) 496-6023

XxTHE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OFRESEARCH GRANTS IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OFHEALTH. APPLICANTS WHO USE EXPRESS MAlL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESSFOR THE WESTWOOD BUILDING IS:

5333 Westbard AvenueBethesda, Maryland 20816

PII

10 *U. S . G.P. 0. 1987-181-289: 60003