NOTICE OF MAILING CHANGE 0Chcck hew ifyou nish to discontinue rewiving this publication 0 Check here if your address has 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 B4BN08, Building 31 Bethesda, Maryland 20892 First Class Mail Postages & Fees Paid PHS/NIH/OD Permit No. (3-291 US. DEPARTMENT OF HEAUH AND HCMAN SERVICES I'hc NIf1 Giiide announces scientific initiatives and pro\.idespdiq and administrative intimmation to indivi- duah and oqpnizatlons who need to he kept intormed ofopponunities. reqiiire.mt.na, and changes in extra miir;il prognms ;idministered by the. National Insritutes ofliealth. Vol. 19, No. 9 March 2, 1990
Transcript
NOTICE OF MAILING CHANGE 0Chcck hew ifyou nish t o
discontinue rewiving this publication
0 Check here if your address has changed and you wish to continue receiving this publication Make corrections below and mail this page to:
NIH Guide Printing & Reproduction Branch National Institutes of Health Room B4BN08, Building 3 1 Bethesda, Maryland 20892
First Class Mail Postages & Fees Paid
PHS/NIH/OD Permit No. (3-291
US. DEPARTMENTOF HEAUH AND HCMAN SERVICES
I'hc NIf1 Giiide announces scientific initiatives and pro\.idespdiq and administrative intimmation to individuah and oqpnizatlons who need t o he kept intormed ofopponunities. reqiiire.mt.na, and changes in extra miir;il prognms ;idministered by the. National Insritutes ofliealth.
Vol. 19 , No. 9 March 2 , 1990
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NIH GUIDE - Vol. 19, No. 9 , March 2, 1990
NOTICES
HUMAN LIIER CELL CULTURE FACILITY ...........................................National Institute of Diabetes and Digestive and Kidney DiseasesIndex: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
1 _i
NIH WORKSHOP ON GRANTS AND CONTRACTS PREPARATION AND ADMINISTRATION FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES ............................National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH
1
NOTICES OF AVAILABILITY (RFPs AND RFAs)
A STUDY OF TUMOR SUPPRESSOR GENES (RFP) ..................................... National Institute of Environmental Health SciencesIndex: ENVIRONMENTAL HEALTH SCIENCES
2
DESIGN OF PEDIATRIC COCHLEAR IMPLANTS (RFP) .................................National Institute on Deafness and Other Communication DisordersIndex: DEAFNESS, COMMUNICATION DISORDERS
2
STRUCTURE ACTIVITY RELATIONSHIPS FOR ANTICONVULSANT DRUG DEVELOPMENT (RFP) ., 3 National Institute of Neurological Disorders and StrokeIndex: NEUROLOGICAL DISORDERS, STROKE
COOPERATIVE AGREEMENT FOR A DRUG ABUSE TREATMENT RESEARCH DEMONSTRATION PROGRAM IN THE DISTRICT OF COLUMBIA (RFA DA-90-11) . . . . . . . . . . . . 4National Institute on Drug Abuse Index: DRUG ABUSE
U m J
AIDS CLINICAL TRIAL INFRASTRUCTURE COOPERATIVE AGREEMENT FOR MINORITY INSTITUTIONS (RFA 90-AI-04) .................................................. 6National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES
COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS(RFA 90-HD-04) .............................................................. 8 National Institute of Child Health and Human DevelopmentIndex: CHILD HEALTH, HUMAN DEVELOPMENT
COOPERATIVE MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS (RFA 90-HD-01) .............................................................. 8National Institute of Child Health and Human DevelopmentIndex: CHILD HEALTH, HUMAN DEVELOPMENT
CLINICAL DIAGNOSTIC STUDIES OF BRAIN TUMOR USING PET AND OTHER IMAGING MODALITIES (RFA 90-CA-12) ........................................... 9National Cancer Institute Index: CANCER
ONGOING PROGRAM ANNOUNCEMENTS
SHORT-TERM TRAINING FOR MEDICAL STUDENTS IN ENVIRONMENTAL/OCCUPATIONAL,.”1. m..ntnLin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . l O National Institute of Environmental Health Sciences Index: ENVIRONMENTAL HEALTH SCIENCES
RESEARCH ON THE RECOGNITION, MANAGEMENT, AND PREVENTION OF ALCOHOL l*PROBLEMS IN A PRIMARY HEALTH CARE SETTING ................................... 10 National Institute on Alcohol Abuse and AlcoholismIndex: ALCOHOL ABUSE, ALCOHOLISM
NOTICES
HUMAN L I E R CELL CULTURE FACILITY
P.T. 34; K.W. 0780015, 0780000, 1002004 Nat iona l I n s t i t u t e o f Diabe tes and D i g e s t i v e and Kidney Diseases
The N a t i o n a l I n s t i t u t e o f Diabe tes and D i g e s t i v e and Kidney Diseases ( N I D D K ) announces t h e e s t a b l i s h m e n t o f a Human L i v e r C e l l C u l t u r e F a c i l i t y a t SRI I n t e r n a t i o n a l , Menlo Park, C a l i f o r n i a , f o r t h e purpose o f making human h e p a t o c y t e s more widely a c c e s s i b l e t o r e s e a r c h e r s . The F a c i l i t y i s now prepared t o begin t h e f irst phase o f p r o v i d i n g h e p a t o c y t e s t o s e l e c t e d i n v e s t i g a t o r s .
N I D D K s u p p o r t s t h e a c q u i s i t i o n o f e x c e s s normal human l i v e r s from organt r a n s p l a n t donors and t h e i s o l a t i o n and c u l t u r e o f h e p a t o c y t e s from t h e s e t i s s u e s . Human l i v e r c e l l s i n h igh y i e l d are b e i n g r o u t i n e l y p r e p a r e d .Q u a l i t y c o n t r o l d a t a on i n i t i a l v i a b i l i t y , s u r v i v a l i n c u l t u r e , s e l e c t e d l i v e r s p e c i f i c f u n c t i o n s , and donor informat ion ( e . g . , age, sex, race, c a u s e o f d e a t h ) are a v a i l a b l e .
The human l i v e r c e l l s can b e used e i t h e r i n t h e F a c i l i t y by a v i s i t i n gi n v e s t i g a t o r who is r e s i d e n t a t t h e l a b o r a t o r y o r who comes o n l y when ce l l s are a v a i l a b l e . S e l e c t e d experiments w i t h human h e p a t o c y t e s can be conducted f o r r e s e a r c h e r s by F a c i l i t y personnel , when t i m e permi ts , b u t t h e c o s t s o f t h e s e s p e c i a l a s s a y s are n o t covered by t h e N I D D K suppor t and must be reimbursed. L i v e r c e l l s can n o t be shipped a t t h i s t i m e , a l though t e c h n i q u e sf o r t r a n s p o r t i n g v i a b l e human h e p a t o c y t e s are c u r r e n t l y under development.F a c i l i t y personnel are a l s o a v a i l a b l e t o t r a i n i n v e s t i g a t o r s i n t h e p r e p a r a t i o n and h a n d l i n g o f human h e p a t o c y t e s .
A l l Uni ted S t a t e s r e s e a r c h e r s are e l i g i b l e t o o b t a i n human h e p a t o c y t e s .However, t h o s e whose s t u d i e s can provide a d d i t i o n a l c h a r a c t e r i z a t i o n s of t h e c e l l s o r c o n t r i b u t e t o t h e f u r t h e r development o f t h i s r e s o u r c e are e s p e c i a l l yencouraged. Research r e q u e s t s are reviewed and p r i o r i t i z e d by an a d v i s o r ycommittee. To o b t a i n a p r o p o s a l form o r a d d i t i o n a l in format ion about t h e F a c i l i t y c o n t a c t :
*.cl D r . Carol E . Green SRI I n t e r n a t i o n a l 333 Ravenswood Avenue Menlo Park, CA 94025 Telephone: (415) 859-4083
N I H WORKSHOP ON GRANTS AND CONTRACTS PREPARATION AND ADMINISTRATION FOR HISTORICALLY BLACK COLLEGES AND UNIVERSITIES
P.T. 42, FC; K.W. 1014006 N a t i o n a 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 ) w i l l conduct a two-day workshop on g r a n t s and c o n t r a c t s i n A t l a n t a , Georgia, on A p r i l 18 and 19, 1990. The workshop, sponsored by t h e Morehouse School of Medicine, is f o r f a c u l t y ,r e s e a r c h e r s , and r e s e a r c h a d m i n i s t r a t o r s a t H i s t o r i c a l l y Black Col leges and U n i v e r s i t i e s ( H B C U s ) p r i m a r i l y i n Alabama, F l o r i d a , Georgia, Louis iana ,M i s s i s s i p p i , North C a r o l i n a , South C a r o l i n a , and Tennessee. Those i n t e r e s t e d a t HBCUs i n o t h e r s t a t e s are welcome t o a t t e n d .
The workshop w i l l f e a t u r e informat ion and i n s t r u c t i o n on v a r i o u s a s p e c t s o f t h e p r e p a r a t i o n and a d m i n i s t r a t i o n o f r e s e a r c h g r a n t s and c o n t r a c t s . There w i l l be p r e s e n t a t i o n s and d i s c u s s i o n s of c u r r e n t i s s u e s t h a t affect HBCU p a r t i c i p a t i o n i n t h e Federa l g r a n t and c o n t r a c t p r o c e s s . Speakers f o r t h e workshop r e p r e s e n t t h e N I H D i v i s i o n of C o n t r a c t s and Grants , t h e Office o f Extramural Research, and program and g r a n t s management s t a f f . A f t e r an overview of t h e d i f f e r e n c e s i n t h e g r a n t , c o n t r a c t , and c o o p e r a t i v e agreementaward mechanisms, t h e f i rs t day of t h e workshop w i l l c e n t e r on g r a n t s , e . g . ,t h e p r e p a r a t i o n o f an N I H a p p l i c a t i o n o r p r o p o s a l , t h e N I H p e e r review p r o c e s s , and budget p r e p a r a t i o n . The second day w i l l f e a t u r e t o p i c sa s s o c i a t e d w i t h c o n t r a c t s , e . g . , preaward and post-award a d m i n i s t r a t i o n , t h e smal l and d isadvantaged b u s i n e s s program, and c i v i l r i g h t s / c o n t r a c tcompliance.
N I H G U I D E - Vol. 19, No. 9, March 2, 1990 - Page 1
The Morehouse School o f Medicine w i l l send o u t i n v i t a t i o n s t o HBCUs i n t h e s o u t h e a s t e r n United S t a t e s . Schedules and o t h e r p e r t i n e n t in format ion w i l l be a v a i l a b l e by e a r l y March. I n t e r e s t e d persons should c o n t a c t :
D r . Roy Hunter J r . Office o f Sponsored ProgramsMorehouse School o f Medicine 720 Westview Drive, S.W. A t l a n t a , GA 30310-1495 Telephone: (404) 752-1610
NOTICES OF AVAILABILITY (RFPs AND RFAs)
A STUDY OF TUMOR SUPPRESSOR GENES
RFP AVAILABLE: NIH-ES-90-08
P.T. 34; K.W. 1002058, 0755042, 0790005
N a t i o n a l I n s t i t u t e o f Environmental Heal th S c i e n c e s
The N a t i o n a l I n s t i t u t e of Environmental Heal th S c i e n c e s (NIEHS) is s o l i c i t i n g p r o p o s a l s f o r a p r o j e c t des igned t o i d e n t i f y and u l t i m a t e l y c l o n e tumor s u p p r e s s o r genes i n r o d e n t s . The pr imary s t r a i n o f mice t o be examined i s t h e B6C3F1 mouse though o t h e r heterozygous rodent s t r a i n s may a l s o be c o n s i d e r e d . The c o n t r a c t o r w i l l b e r e q u i r e d t o : ( 1 ) i d e n t i f y polymorphic probes i n t h e B6C3F1 mouse u s i n g new o r p r e v i o u s l y d e s c r i b e d probes t h a t have been mapped t o chromosomes i n t h e mouse o r o t h e r s p e c i e s ( p r o b e s s h a l l be made a v a i l a b l e t o l a b o r a t o r i e s a s d e s i g n a t e d by t h e P r o j e c t Off icer) ; (2) i f n e c e s s a r y , mapt h e s e probes t o s p e c i f i c chromosomes i n t h e mouse and t h e human; (3) i d e n t i f y mouse chromosomes t h a t show l o s s of h e t e r o z y g o s i t y i n s p e c i f i c tumor t i s s u e DNAs u s i n g t h e s e FPLP p robes ; (4)when chromosomes t h a t show loss of h e t e r o z y g o s i t y i n tumors are i d e n t i f i e d , r e g i o n a l l y l o c a l i z e r e l e v a n t FRFLP probes i n t h e s e chromosomes; and (5) reprobe membranes wi th s e l e c t e d oncogeneprobes t o de te rmine i f c e r t a i n oncogenes are a m p l i f i e d i n tumors s t u d i e d . A f i v e - y e a r c o n t r a c t is a n t i c i p a t e d . The Government e s t i m a t e s 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 approximate ly 1 . 5 p r o f e s s i o n a l person y e a r s and 1.5 t e c h n i c a l person y e a r s p e r c o n t r a c t y e a r . 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 which s h a l l b e c o n s i d e r e d by t h e Agency.
The e s t i m a t e d i s s u a n c e d a t e o f RFP NIH-ES-90-08 is March 5, 1990, and r e s p o n s e s w i l l b e due t o b e r e c e i v e d by t h e Cont rac t S p e c i a l i s t on A p r i l 27,1990. Requests should r e f e r e n c e RFP NIH-ES-90-08 and should b e forwarded t o :
N a t i o n a l I n s t i t u t e o f Environmental Heal th S c i e n c e s ATTN: James D . Doyle, Cont rac t S p e c i a l i s t C o n t r a c t s and Procurement Management Branch, OM 79 TW Alexander Drive, 4401 Research Commons B u i l d i n a
I
P.O. Box 12874 Research T r i a n g l e Park, NC 27709
DESIGN OF PEDIATRIC COCHLEAR IMPLANTS
RFP AVAILABLE: NIH-NIDCD-90-01
P.T. 34; K.W. 0715050, 0740030
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 o f Deafness and Other Communication D i s o r d e r s ( N I D C D ) ,N I H , h a s a requirement t o have a c o c h l e a r implant des igned f o r use i n c h i l d r e n and which could be removed and r e p l a c e d without i r r e v e r s i b l e trauma t o t h e cochlea and a s s o c i a t e d t i s s u e s . T h i s implant w i l l u t i l i z e e l e c t r o d e a r r a y s .
P a s t s t u d i e s suppor ted by N I D C D and i t s p r e d e c e s s o r , t h e N a t i o n a l I n s t i t u t e o f Neurologica l and Communicative D i s o r d e r s and S t r o k e , have suppor ted t h e development o f e s s e n t i a l l y a l l components i n implanted a u d i t o r y p r o s t h e s e s .These have i n c l u d e d t h e e v a l u a t i o n o f t h e s a f e t y o f c h r o n i c i m p l a n t a t i o n , and e l ec t r i ca l s t i m u l a t i o n o f t h e c o c h l e a . For t h e most p a r t t h e s e components were des igned f o r permanent i m p l a n t a t i o n i n a d u l t s . Recent ly t h e N I D C D , w i t h t h e t e c h n i c a l a s s i s t a n c e o f t h e Neural P r o s t h e s i s Program, h a s suppor teds t u d i e s o f problems t h a t are unique t o implants i n c h i l d r e n . S p e c i f i c a l l y ,t h e e f fec ts o f head growth and r e c u r r e n t o t i t i s media have been e v a l u a t e d i n young an imals .
N I H G U I D E - Vol. 19, No. 9 , March 2, 1990 - Page 2
The r e s u l t s of t h e s e s t u d i e s i n d i c a t e t h a t f i b r o u s t i s s u e e n c a p s u l a t i o n of l e a d wires connec t ing e l e c t r o d e a r r a y s i n t h e s c a l a tympani w i t h implanted r e c e i v e r - s t i m u l a t o r s i n t h e mastoid r e g i o n can c a u s e s i g n i f i c a n t problems. Also, h i s t o p a t h o l o g i c a l examinat ions o f c o c h l e a s a f t e r c h r o n i c i m p l a n t a t i o n of e l e c t r o d e s have r e v e a l e d f i b r o u s t i s s u e , and i n some c a s e s , new bone growthoccluding t h e s c a l a tympani . Although it appears t h a t p r a c t i c a l d e s i g n s which w i l l accommodate head growth w i l l be p o s s i b l e , t h e replacement o f t h e s e d e v i c e s , should t h e y f a i l o r when improved a u d i t o r y p r o s t h e s e s become a v a i l a b l e , w i l l n o t be t r i v i a l . T h i s i s e s p e c i a l l y important i n c h i l d r e n because of t h e l o n g a n t i c i p a t e d p e r i o d o f c o c h l e a r implant use over t h e i r l i f e spans .
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 s e n t s ta f f 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.
The Request f o r P r o p o s a l s , RFP No. NIH-NIDCD-90-01, w i l l be i s s u e d on o r about February 28, 1990, w i t h responses due approximately 60 days t h e r e a f t e r . It i s a n t i c i p a t e d t h a t one award w i l l be made under t h i s Request f o r P r o p o s a l s (RFP), f o r a f i v e - y e a r p e r i o d .
To r e c e i v e a copy o f 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 and two ( 2 ) 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 t o t h e fo l lowing a d d r e s 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 o f Neurologica l D i s o r d e r s and S t r o k e , N I H F e d e r a l Bui ld ing , Room 901 7550 Wisconsin Avenue Bethesda, MD 20892
A t t e n t i o n : RFP No. NIH-NIDCD-90-01
A l l r e s p o n s i b l e s o u r c e s may submit a proposa l which s h a l l be c o n s i d e r e d by t h e Government.
STRUCTURE ACTIVITY RELATIONSHIPS FOR ANTICONVULSANT DRUG DEVELOPMENT
RFP AVAILABLE: NIH-NINDS-90-05
w P.T. 34; K.W. 0740010, 0790000, 0755018, 0755060
N a t i o n a l I n s t i t u t e o f Neurologica l D i s o r d e r s and S t r o k e
The N a t i o n a l I n s t i t u t e o f Neurologica l D i s o r d e r s and S t r o k e (NINDS) h a s a requirement t o e v a l u a t e t h e s t r u c t u r e - a c t i v i t y r e l a t i o n s h i p s (SARI f o r a n t i c o n v u l s a n t drugs screened by t h e A n t i e p i l e p t i c Drug Development ( A D D )Program o f t h e NINDS.
The E p i l e p s y Branch, D i v i s i o n of Convulsive, Developmental and Neuromuscular D i s o r d e r s , NINDS, conducts an e x t e n s i v e A n t i e p i l e p t i c Drug Development ( A D D )Program aimed a t i d e n t i f y i n g p o t e n t i a l l y new a n t i e p i l e p t i c a g e n t s t o be used i n man. The ADD program i s an ex t ramura l program r u n through t h e c o n t r a c t mechanism which was e s t a b l i s h e d as a c o l l a b o r a t i v e e f f o r t w i t h academia, government, and t h e pharmaceut ica l i n d u s t r y i n o r d e r t o develop more e f f e c t i v e and l e s s t o x i c a n t i - c o n v u l s i v e t h e r a p e u t i c a g e n t s . T h i s program employs a s tep-wise approach u t i l i z i n g a systematic ser ies o f s c r e e n i n g tests and d e c i s i o n s t e p s t o advance c a n d i d a t e compounds through t h e s t a g e s o f p r e c l i n i c a l and c l i n i c a l development. Compounds t h a t demonstrate t h e r a p e u t i ci n d i c e s are advanced t o sub-chronic o r a l t o x i c i t y . The C o n t r a c t o r w i l l be r e s p o n s i b l e f o r e s t a b l i s h i n g a d a t a b a s e t o a n a l y z e s t r u c t u r e - a c t i v i t yr e l a t i o n s h i p s f o r s y s t e m a t i c p r e d i c t i o n s of i n c r e a s i n g a c t i v i t y and/ord e c r e a s i n g t o x i c i t y . T h i s requirement r e p r e s e n t s a new component o f t h e ADD program t o conduct a n a l y s i s o f approximately 14,000 s t r u c t u r e s which w i l l be o r have been screened f o r a n t i c o n v u l s a n t a c t i v i t y .
The a n a l y s i s of q u a n t i t a t i v e s t r u c t u r e - a c t i v i t y r e l a t i o n s h i p s (QSAR) is based on c a l c u l a t i n g t h e o r e t i c a l chemical s t r u c t u r a l a t t r i b u t e s and s t a t i s t i c a l l ycomparing t h e chemical and b i o l o g i c a l d a t a . QSAR methods t h a t re la te f u n c t i o n s o f chemical s t r u c t u r e s t o measures o f b i o l o g i c a l a c t i v i t y w i l l be used t o develop t h e mathematical e q u a t i o n s o r s t r u c t u r e - a c t i v i t yr e l a t i o n s h i p s . These e q u a t i o n s w i l l be used by t h e Government t o p r e d i c ta c t i v i t y o f new a g e n t s d i r e c t l y coming i n t o t h e ADD program. Algori thms w i l l be c o n s t r u c t e d around t h e mathematical e q u a t i o n s f o r u s e on a day-to-day b a s i s t o a i d i n t h e d e s i g n and s e l e c t i o n of drugs o f h i g h e r potency and lower t o x i c i t y . The ADD program w i l l be b e n e f i t e d by i n c r e a s e d e f f i c i e n c y and b e t t e r s c i e n t i f i c a n a l y s i s of t h e s c i e n t i f i c d a t a g e n e r a t e d i n t h e program.
-N I H G U I D E - Vol. 19, No. 9 , March 2, 1990 - Page 3
F u l l i n t e g r a t i o n o f chemical and b i o l o g i c a l f i l e s f o r s t r u c t u r e - a c t i v i t y a n a l y s i s under a u s e r f r i e n d l y i n t e r f a c e w i l l b e an e s s e n t i a l requirement f o r performance. I n t e r d i s c i p l i n a r y exper ience and e x p e r t i s e i n t h e o r e t i c a l chemis t ry , neuropharmacology, neurobiochemistry and advanced s c i e n t i f i c computing are r e q u i r e d . Demonstrated e x p e r t i s e i n s t r u c t u r e - a c t i v i t y r e l a t i o n s h i p s , chemical d a t a management, neuropharmacology and d e c i s i o n suppor t systems is e s s e n t i a l .
Access t o t h e d a t a and materials used and g e n e r a t e d under t h i s c o n t r a c t w i l l b e r e s t r i c t e d , s i n c e d a t a are w i t h i n a c o n t r o l l e d c o n t r a c t o r f a c i l i t y t o which non-employees s h a l l n o t have access and non-authorized employees are reasonably r e s t r a i n e d from o p p o r t u n i t y t o u s e , manipulate , o r remove t h e d a t a from t h e f a c i l i t y .
A l l r e q u i r e d personnel , f a c i l i t i e s , computer hardware, and s o f t w a r e and o t h e r materials w i l l b e t h e r e s p o n s i b i l i t y of t h e C o n t r a c t o r . The chemical s t r u c t u r a l d a t a and t h e b i o l o g i c a l s c r e e n i n g d a t a w i l l be provided by t h e Government . Request f o r P r o p o s a l s (RFP) No. NIH-NINDS-90-05 w i l l be i s s u e d on o r about February 28, 1990, w i t h r e s p o n s e s due approximately 45 days t h e r e a f t e r . The Government a n t i c i p a t e s one c o n t r a c t award f o r a performance p e r i o d o f t h r e e (3) y e a r s .
To r e c e i v e a copv o f t h e RFP, p l e a s e submit a w r i t t e n r e a u e s t and two (2) 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 $0 t h e f o l l o w i n g a d d r e s 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 o f Neurologica l D i s o r d e r s and S t r o k e , N I H F e d e r a l B u i l d i n g , Room 901 7550 Wisconsin Avenue Bethesda, MD 20892
A l l r e s p o n s i b l e s o u r c e s may submit a proposa l which shall be considered by the Government .
COOPERATIVE AGREEMENT FOR A DRUG ABUSE TREATMENT RESEARCH DEMONSTRATION PROGRAM I N THE DISTRICT OF COLUMBIA
A p p l i c a t i o n Rece ip t Date: May 23, 1990
Purpose
The purpose o f t h i s c o o p e r a t i v e agreement i s t o suppor t a drug abuse t r e a t m e n t r e s e a r c h demonst ra t ion program i n t h e Dis t r ic t o f Columbia. T h i s program w i l l t e s t and e v a l u a t e t h e e f f e c t i v e n e s s of v a r i o u s drug abuse t r e a t m e n t approaches and combinat ions o f t r e a t m e n t methods and approaches i n o r d e r t o examine t h e i r d i f f e r e n t i a l e f f e c t i v e n e s s i n p a r t i c u l a r d i a g n o s t i c and p a t i e n t / p o p u l a t i o n subgroups. I t is a l s o expected t h a t funds a v a i l a b l e from t h i s p r o j e c t w i l l be used t o expand t r e a t m e n t c a p a c i t y and t h e number o f t r e a t m e n t s l o t s a v a i l a b l e i n t h e Distr ic t o f Columbia.
The Di s t r i c t o f Columbia was s e l e c t e d a s t h e s i t e f o r t h i s model t r e a t m e n t r e s e a r c h demonst ra t ion p r o j e c t because o f t h e e x t e n t and i n t e n s i t y o f t h e drug abuse problem, a v a i l a b i l i t y o f c l i e n t s , and because t h e combinat ion o f p a t i e n t subgroups and t y p e s o f drug abuse problems l e n d s i t s e l f t o a r e s e a r c h demonst ra t ion p r o j e c t t h a t may he a b l e t o b e r e p l i c a t e d i n o t h e r p a r t s o f t h e c o u n t r y . A s p a r t o f t h e N a t i o n a l Drug Cont ro l S t r a t e g y , r e l e a s e d i n September1989, Washington, D . C . was i d e n t i f i e d as t h e f i r s t s i t e f o r a model drug t r e a t m e n t demonst ra t ion program.
A p p l i c a t i o n s are be ing s o l i c i t e d i n t h i s Request f o r A p p l i c a t i o n s ( R F A ) f o r two components: ( 1 ) a Diagnos t ic , R e f e r r a l , and Data Management Unit and ( 2 ) two o u t p a t i e n t t r e a t m e n t programs, each o f f e r i n g a d i f f e r e n t range o f s e r v i c e s . A p p l i c a n t s f o r t h e o u t p a t i e n t t r e a t m e n t programs must propose t o o p e r a t e b o t h o u t p a t i e n t t r e a t m e n t programs. I n o r d e r t o e n s u r e t h e o p e r a t i o n a l e f f i c i e n c y of t h e demonst ra t ion program, p r o p o s a l s t o o p e r a t e o n l y one o u t p a t i e n t t r e a t m e n t program w i l l be cons idered non-responsive and w i l l n o t b e c o n s i d e r e d f o r review.
N I H G U I D E - Vol. 19, No. 9, March 2 , 1990 - Page 4
1"
rrr
A p p l i c a n t s may apply f o r one o r b o t h components. A p p l i c a n t s must submit s e p a r a t e a p p l i c a t i o n s f o r each component f o r which t h e y are r e q u e s t i n g s u p p o r t . S e p a r a t e awards w i l l be made by t h e Nat iona l I n s t i t u t e on Drug Abuse ( N I D A ) f o r each o f t h e components d e s c r i b e d below. A p p l i c a n t s a p p l y i n g f o r b o t h components should i n d i c a t e t h e programmatic and f i n a n c i a l b e n e f i t s t o t h e F e d e r a l Government of having one awardee f o r t h e two components. I n FY 1990,it is e s t i m a t e d t h a t $4-5 m i l l i o n w i l l be a v a i l a b l e t o suppor t awards f o r a l l components under t h i s RFA.-It is expec ted t h a t t h i s program w i l l be expanded i n t h e n e a r f u t u r e w i t h t h e a d d i t i o n o f a r e s i d e n t i a l t r e a t m e n t component, and a p p l i c a n t s f o r t h i s c o o p e r a t i v e agreement would be expec ted t o t h e n c o o r d i n a t e t h e i r a c t i v i t i e s w i t h t h a t component, o r o t h e r such a d d i t i o n a l components as may b e developed.The r e s i d e n t i a l t r e a t m e n t component w i l l be a j o i n t i n i t i a t i v e between N I D A and t h e Alcohol , Drug Abuse, and Mental Heal th Adminis t ra t ion (ADAMHA), Office f o r Treatment Improvement (OTI). OTI w a s e s t a b l i s h e d t o provide n a t i o n a l l e a d e r s h i p f o r t h e F e d e r a l e f f o r t t o enhance approaches and programs f o c u s i n g on t h e t r e a t m e n t o f drug a b u s e r s as w e l l as a s s o c i a t e d problems o f a lcohol i sm and mental i l l n e s s .
E l i g i b i l i t y
A p p l i c a t i o n s may b e 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 or f o r - p r o f i to r g a n i z a t i o n s i n c l u d i n g b u t n o t l i m i t e d t o u n i v e r s i t i e s , c o l l e g e s , and s e r v i c e - p r o v i d e r o r g a n i z a t i o n s .
I n c l u s i o n o f M i n o r i t i e s i n Study P o p u l a t i o n s
A p p l i c a n t s are urged t o g i v e added a t t e n t i o n (where f e a s i b l e and a p p r o p r i a t e ) t o t h e i n c l u s i o n o f 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 r e s e a r c h on c l i n i c a l s t u d i e s o f t r e a t m e n t and t r e a t m e n t outcomes. If m i n o r i t i e s a r e n o t inc luded i n a g iven s tudy , a c lear r a t i o n a l e f o r t h e i r e x c l u s i o n should be provided .
I n c l u s i o n o f Women i n Study P o p u l a t i o n s
A p p l i c a n t s are urged t o c o n s i d e r t h e i n c l u s i o n of women i n t h e s t u d yp o p u l a t i o n s f o r a l l c l i n i c a l r e s e a r c h e f f o r t s . Except ions would be s t u d i e s o f d i s e a s e s which e x c l u s i v e l y a f fec t males o r where involvement o f pregnant women may expose t h e f e t u s t o undue r i s k s . Gender d i f f e r e n c e s should be noted and e v a l u a t e d . If women are n o t be inc luded , a clear r a t i o n a l e should be provided
" I d f o r t h e i r e x c l u s i o n .
I n o r d e r t o p r o v i d e more p r e c i s e informat ion t o t h e t r e a t m e n t community, it i s recommended t h a t p u b l i c a t i o n s r e s u l t i n g from ADAMHA-supported r e s e a r c h i n which t h e s t u d y p o p u l a t i o n s w a s l i m i t e d t o one s e x f o r any reason o t h e r t h a n t h a t t h e d i s e a s e o r c o n d i t i o n s t u d i e s e x c l u s i v e l y affects t h a t s e x , should s ta te , i n t h e a b s t r a c t summary, t h e gender o f t h e p o p u l a t i o n s t u d i e s , e . g . ,"male p a t i e n t s , " "male v o l u n t e e r s r t l "female p a t i e n t s , " "female v o l u n t e e r s .
A p p l i c a t i o n Procedures
A p p l i c a n t s should u s e g r a n t a p p l i c a t i o n form PHS 398 ( rev . 10/88). The number (DA-90-11) and t i t l e of t h i s RFA, "D.C. Treatment Research Demonstration Program1' ( S p e c i f y whether a p p l y i n g f o r t h e Diagnos t ic Unit o r O u t p a t i e n t C l i n i c s ) , should be typed i n item 2 on t h e f a c e page o f PHS 398 form. A p p l i c a n t s must submit a s e p a r a t e a p p l i c a t i o n f o r each component f o r which t h e y are r e q u e s t i n g s u p p o r t . A p p l i c a n t s f o r t h e second component must propose t o o p e r a t e two o u t p a t i e n t t r e a t m e n t programs; p r o p o s a l s t o o p e r a t eo n l y one o u t p a t i e n t t r e a t m e n t program w i l l be c o n s i d e r e d non-responsive and w i l l n o t b e c o n s i d e r e d f o r review. A p p l i c a n t s must a f f i x t h e RFA l a b e l , which i s provided i n t h e PHS 398 a p p l i c a t i o n k i t , t o t h e bottom o f t h e f a c e page 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 de layed p r o c e s s i n gof t h e a p p l i c a t i o n so t h a t it may n o t r e a c h t h e review committee i n time f o r rev iew.
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 necessary 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 o f 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 source i s n o t a v a i l a b l e , t h e fo l lowing o f f i c e may be c o n t a c t e d f o r t h e n e c e s s a r y a p p l i c a t i o n material: Grants Management 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, Room 8A-54, Rockvi l le , Maryland20857; (301) 443-6710.
P r o s p e c t i v e a p p l i c a n t s a r e asked t o submit a l e t t e r of i n t e n t . T h i s should b e N d b r i e f bu t i n d i c a t e 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 Co-Inves t iga tors ; i d e n t i f y
any c o o p e r a t i n g i n s t i t u t i o n s , i f any; and t h e t y p e o f component(s) f o r which suppor t w i l l be r e q u e s t e d . The I n s t i t u t e r e q u e s t s such l e t t e r s o n l y f o r t h e purpose of p r o v i d i n g an i n d i c a t i o n o f t h e number and scope o f a p p l i c a t i o n s t o
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be r e c e i v e d and, t h e r e f o r e , u s u a l l y does n o t acknowledge t h e i r rece ip t . A l e t t e r o f i n t e n t is n o t b inding and w i l l n o t e n t e r i n t o t h e review of anya p p l i c a t i o n subsequent ly submi t ted , nor i s it a n e c e s s a r y requirement f o r a p p l i c a t i o n s . T h i s l e t t e r o f i n t e n t , which should be r e c e i v e d by A p r i l 23,1990, should be s e n t t o :
D r . Michael S . Backenheimer Acting D i r e c t o r , Office o f Extramural Program Review N a t i o n a l I n s t i t u t e on Drug Abuse Y t
5600 F i s h e r s Lane, Room 10-42 R o c k v i l l e , MD 20857
The s igned o r i g i n a l and 6 permanent, l e g i b l e c o p i e s o f t h e completed a p p l i c a t i o n should b e s e n t t o :
D i v i s i o n o f Research Grants Nat iona l I n s t i t u t e s o f Heal th Westwood Bui ld ing , Room 240 Bethesda, MD 20892zX
Consequences o f L a t e Submission - 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 May 23, 1990,w i l l n o t b e c o n s i d e r e d f o r rev iew.
Review Process
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 o f 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 RFA 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 with e s t a b l i s h e d PHS Referral G u i d e l i n e s . The I R G s , c o n s i s t i n g p r i m a r i l y o f 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 mer i t . N o t i f i c a t i o n o f 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 te r t h e i n i t i a l review. 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 Nat iona l Advisory Council on Drug Abuse whose review may be 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 a s s c i e n t i f i c m e r i t . Only a p p l i c a t i o n s recommended f o r approval by t h e Counci l m a y be cons idered f o r funding .
Contact f o r t h e f o l l o w i n g person f o r f u r t h e r in format ion:
Frank M . Tims, Ph.D. Deputy Chief , Treatment Research Branch D i v i s i o n o f C l i n i c a l Research, N I D A 5600 F i s h e r s Lane, Room 10A-20 R o c k v i l l e , MD 20857 Telephone: (301) 443-4060
AIDS CLINICAL TRIAL INFRASTRUCTURE COOPERATIVE AGREEMENT FOR MINORITY INSTITUTIONS
Nat iona 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
Let ter o f I n t e n t : March 23, 1990 A p p l i c a t i o n Rece ip t Date: A p r i l 26, 1990
The D i v i s i o n o f AIDS, Nat iona 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 D i s e a s e s ( N I A I D ) , i n v i t e s m i n o r i t y i n s t i t u t i o n s ( i n s t i t u t i o n s t h a t have more t h a n 50 p e r c e n t m i n o r i t y s t u d e n t enro l lment and t h a t award an M . D . , D.D.S., D . V . M . , o r o t h e r d o c t o r a l degree i n t h e h e a l t h p r o f e s s i o n s ~ lt o submit a p p l i c a t i o n s f o r c o o p e r a t i v e agreements t o suppor t t h e e s t a b l i s h m e n t o f an AIDS C l i n i c a l T r i a l i n f r a s t r u c t u r e f o r t h e purpose o f i n c r e a s i n g t h e p a r t i c i p a t i o n o f u n d e r r e p r e s e n t e d m i n o r i t y p o p u l a t i o n s ( i . e . , Blacks, Hispanics , Nat ive Americans, A s i a n / P a c i f i c I s l a n d e r s o r women) i n AIDS C l i n i c a l T r i a l s Group(ACTG) s t u d i e s .
I . BACKGROUND INFORMATION
I n f e c t i o n w i t h human immunodeficiency v i r u s ( H I V ) and t h e Acquired Immunodeficiency Syndrome (AIDS) c o n s t i t u t e a profound and i n c r e a s i n g h e a l t h problem f o r m i n o r i t y p o p u l a t i o n s . Recent ep idemiologic d a t a i n d i c a t e t h a t m i n o r i t i e s s u f f e r d i s p r o p o r t i o n a t e l y from AIDS. Blacks account f o r 27 p e r c e n t o f a l l a d u l t c a s e s o f AIDS and 52 p e r c e n t o f p e d i a t r i c cases, whi le Hispanics -. account f o r 15 p e r c e n t o f a l l a d u l t c a s e s and 23 p e r c e n t o f t h e p e d i a t r i c
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cases, y e t t h e s e groups comprise o n l y 12 and 8 p e r c e n t , r e s p e c t i v e l y , o f t h e p o p u l a t i o n i n t h e United S t a t e s .
S i n c e t h e i n i t i a l r e c o g n i t i o n o f AIDS i n t h e e a r l y 1980s, N I A I D h a s been f u l l ycommitted t o t h e s t r u g g l e a g a i n s t t h i s d i s e a s e . T h i s commitment h a s been c h a r a c t e r i z e d by t h e e v o l u t i o n o f a m u l t i c e n t e r network o f i n s t i t u t i o n s d e s i g n a t e d as t h e AIDS C l i n i c a l T r i a l s Group (ACTG) which i s opening new
%d avenues i n e v a l u a t i n g t h e r a p i e s and methods t o r e s t o r e immune f u n c t i o n and t o t r e a t o p p o r t u n i s t i c i n f e c t i o n s a s s o c i a t e d wi th AIDS. Although c o n s i d e r a b l e p r o g r e s s h a s been made i n b r i n g i n g ACTG r e s e a r c h t o many i n d i v i d u a l s w i t h H I V i n f e c t i o n , t h e r e h a s been i n s u f f i c i e n t p r o g r e s s i n b r i n g i n g t h e s e s t u d i e s t o m i n o r i t i e s .
The purpose o f t h i s Request f o r A p p l i c a t i o n s (RFA) i s t o provide a p e r i o d o f suppor t o f 3 y e a r s f o r m i n o r i t y i n s t i t u t i o n s t o e s t a b l i s h an AIDS C l i n i c a l T r i a l s Unit i n f r a s t r u c t u r e and t o a c q u i r e s u f f i c i e n t e x p e r t i s e i n c l i n i c a l t r i a l s f o r s u c c e s s f u l submission o f a c o o p e r a t i v e agreement t o p a r t i c i p a t e i n AIDS C l i n i c a l T r i a l s Group r e s e a r c h .
11. MECHANISMS OF SUPPORT
Support w i l l b e provided through c o m p e t i t i v e l y awarded c o o p e r a t i v e agreements .N I A I D h a s set a s i d e $3 ,632 ,000 i n t o t a l c o s t s f o r t h e i n i t i a l y e a r ’ s funding t o m i n o r i t y i n s t i t u t i o n s . The N I A I D p l a n s t o fund between 4 and 5 awards from t h i s announcement. The s t a r t i n g d a t e f o r t h e i n i t i a l annual p e r i o d w i l l be on o r b e f o r e September 1990. Awards w i l l be made f o r a p e r i o d o f 3 y e a r s w i t h y e a r l y e v a l u a t i o n i n v o l v i n g competent c o n s u l t a n t s . Awardees are expec ted t o develop an i n f r a s t r u c t u r e and c a p a b i l i t i e s f o r AIDS C l i n i c a l T r i a l s r e s e a r c h and t o submit a c o m p e t i t i v e g r a n t a p p l i c a t i o n by t h e t h i r t i e t h month o f o p e r a t i o n s under t h e award mechanism f o r conduct o f AIDS C l i n i c a l T r i a l s r e s e a r c h .
111. RESEARCH GOALS AND SCOPE
The long-term o b j e c t i v e o f t h i s RFA is t o increase t h e involvement o f under represented m i n o r i t y p o p u l a t i o n s i n AIDS C l i n i c a l T r i a l s . The immediate g o a l i s t o provide funding t o :
o P lan and develop an AIDS C l i n i c a l T r i a l Uni t i n f r a s t r u c t u r e .
o Acquire t h e n e c e s s a r y e x p e r t i s e i n c l i n i c a l t r i a l s needed f o r t h e s u c c e s s f u l submission o f a c o o p e r a t i v e agreement t o p a r t i c i p a t e i n t h e ACTG.
o Acquire t h e a d m i n i s t r a t i v e and s c i e n t i f i c t r a i n i n g and s k i l l s ,th rough s u b s t a n t i a l i n t e r a c t i o n w i t h N I A I D s ta f f , t o p a r t i c i p a t e i n AIDS C l i n i c a l T r i a l s r e s e a r c h .
o R e c r u i t p r o f e s s i o n a l and suppor t s t a f f .
o Renovate e x i s t i n g s t r u c t u r e s o r r e n t space , a t a c o s t t o be approved by N I A I D , f o r p r o v i s i o n of s u i t a b l e f a c i l i t i e s f o r conduct o f AIDS C l i n i c a l T r i a l s r e s e a r c h . NOTE: Funds w i l l n o t be provided t o e s t a b l i s h new f a c i l i t i e s ( e . g . , new v i r o l o g y o r immunology l a b o r a t o r i e s ) .
o Purchase o f equipment, a t a c o s t t o be approved by N I A I D , f o r AIDS C l i n i c a l T r i a l s r e s e a r c h .
o Support t r a v e l and t r a i n i n g a c t i v i t i e s r e l a t e d t o AIDS C l i n i c a l T r i a l s r e s e a r c h .
Long-term g o a l s are t o :
o Encourage t h e p a r t i c i p a t i o n o f m i n o r i t y i n s t i t u t i o n s and m i n o r i t yi n v e s t i g a t o r s i n ACTG r e s e a r c h and provide a b a s i s f o r i n v o l v i n gunderrepresented p o p u l a t i o n s i n AIDS C l i n i c a l T r i a l s s t u d i e s .
o I n c r e a s e t h e s c i e n t i f i c base o f unders tanding t h e unique s o c i a l and medical i s s u e s r e l a t e d t o AIDS i n m i n o r i t y p o p u l a t i o n s .
o Increase t h e unders tanding of t h e p o t e n t i a l f o r a d v e r s e drugr e a c t i o n s i n m i n o r i t y i n t r a v e n o u s drug u s i n g p a t i e n t p o p u l a t i o n s .
N I H G U I D E - Vol. 19, No. 9, March 2, 1990 - Page 7
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I V . INQUIRIES
D e t a i l s o f t h i s RFA w i l l be a v a i l a b l e by March 2 , 1990. I n q u i r i e s concern ing t h i s announcement are encouraged and should be d i r e c t e d t o :
George W . Counts, M . D . Chief , C l i n i c a l Research Management Branch D i v i s i o n o f AIDS Nat iona 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 6003 Execut ive Blvd . , Room 207P Bethesda, MD 20892 Telephone: ( 3 0 1 ) 496-8214
COOPERATIVE MULTICENTER NETWORK OF MATERNAL-FETAL MEDICINE UNITS
RFA AVAILABLE: 90-HD-04
P.T. 3 4 , FF, 11; K . W . 0785135, 0775020, 0775025, 0785035, 0745020
N a t i o n a l I n s t i t u t e o f Chi ld Heal th and Human Development
A p p l i c a t i o n Rece ip t Date: May 22, 1990
The N a t i o n a l I n s t i t u t e o f Chi ld Heal th and Human Development ( N I C H D ) i n v i t e s a p p l i c a t i o n s from i n v e s t i g a t o r s w i l l i n g t o p a r t i c i p a t e w i t h t h e N I C H D under a Coopera t ive Agreement i n an ongoing m u l t i c e n t e r c l i n i c a l s t u d y des igned t o i n v e s t i g a t e problems i n c l i n i c a l o b s t e t r i c s , p a r t i c u l a r l y t h o s e r e l a t e d t o p r e v e n t i o n o f low b i r t h weight . The o b j e c t i v e o f t h i s s t u d y is t o f a c i l i t a t e r e s o l u t i o n o f t h e s e problems by e s t a b l i s h i n g a network o f c e n t e r s t h a t , byu s i n g common p r o t o c o l s , can provide answers more r a p i d l y t h a n i n d i v i d u a l c e n t e r s a c t i n g a l o n e .
A p p l i c a n t s are encouraged t o i n c l u d e m i n o r i t i e s among s t u d y p o p u l a t i o n s . If m i n o r i t i e s are n o t inc luded , a c lear r a t i o n a l e f o r t h e i r e x c l u s i o n should be provided .
MECHANISM OF SUPPORT
The funding mechanism t o be used t o a s s i s t t h e s c i e n t i f i c community i n under tak ing t h i s sys t em of c l i n i c a l i n v e s t i g a t i o n w i l l be a Coopera t ive Agreement between t h e p a r t i c i p a t i n g u n i t s and N I C H D . The major d i f f e r e n c e between a Coopera t ive Agreement and a r e s e a r c h g r a n t i s t h a t t h e r e w i l l be s u b s t a n t i a l programmatic involvement o f N I C H D s t a f f above and beyond t h e l e v e l s r e q u i r e d f o r t r a d i t i o n a l program management o f g r a n t s . It is a n t i c i p a t e d t h a t 8-10 m e r i t o r i o u s a p p l i c a t i o n s w i l l be funded.
APPLICATIONS PROCEDURE
A p p l i c a t i o n s must be submi t ted on form PHS 398 ( r e v i s e d 10188).
ADDITIONAL INFORMATION
P o t e n t i a l a p p l i c a n t s are encouraged t o r e q u e s t a d e t a i l e d r e q u e s t for a p p l i c a t i o n by t e l e p h o n i n g :
Donald McNellis, M . D . S p e c i a l A s s i s t a n t f o r O b s t e t r i c s Pregnancy and P e r i n a t o l o g y Branch Center f o r Research f o r Mothers and C h i l d r e n N a t i o n a l I n s t i t u t e of Chi ld Heal th and Human DevelopmentExecut ive P l a z a North, Room 643 Bethesda, MD 20892 Telephone: ( 3 0 1 ) 496-5575
COOPERATIVE MULTICENTER NETWORK OF NEONATAL INTENSIVE CARE UNITS
RFA AVAILABLE: 90-HD-01
P.T. 34, FF, 11; K . W . 0775020, 0775025, 0411005, 0710030, 0785035
N a t i o n a l I n s t i t u t e o f Chi ld Heal th and Human Development A p p l i c a t i o n Rece ip t Date: May 22, 1990
The N a t i o n a l I n s t i t u t e o f Chi ld Heal th and Human Development ( N I C H D ) i n v i t e s a p p l i c a t i o n s from i n v e s t i g a t o r s w i l l i n g t o p a r t i c i p a t e wi th t h e N I C H D under a
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Coopera t ive Agreement i n an ongoing m u l t i c e n t e r c l i n i c a l s t u d y des igned t o i n v e s t i g a t e t h e s a f e t y and e f f i c a c y o f t r e a t m e n t and management s t r a t e g i e s used t o c a r e f o r i n f a n t s i n Neonatal I n t e n s i v e Care U n i t s ( N I C U ) . The o b j e c t i v e o f t h i s s t u d y is t o f a c i l i t a t e r e s o l u t i o n o f t h e s e problems bye s t a b l i s h i n g a network o f c e n t e r s t h a t , by u s i n g common p r o t o c o l s , can p r o v i d e answers more r a p i d l y t h a n i n d i v i d u a l c e n t e r s a c t i n g a l o n e .
A p p l i c a n t s are encouraged t o i n c l u d e females and m i n o r i t i e s among s t u d y p o p u l a t i o n s . If m i n o r i t i e s o r females are n o t inc luded , a clear r a t i o n a l e f o r t h e i r e x c l u s i o n should be provided .
MECHANISM OF SUPPORT
The funding mechanism t o be used t o a s s i s t t h e s c i e n t i f i c community i n under tak ing t h e s e c l i n i c a l t r i a l s w i l l be a Cooperat ive Agreement between t h e p a r t i c i p a t i n g u n i t s and N I C H D . The major d i f f e r e n c e between a Coopera t ive Agreement and a r e s e a r c h g r a n t i s t h a t t h e r e w i l l be s u b s t a n t i a l programmatic involvement o f N I C H D s ta f f above and beyond t h e l e v e l s r e q u i r e d f o r t r a d i t i o n a l program management o f g r a n t s . I t is a n t i c i p a t e d t h a t 8-10 m e r i t o r i o u s a p p l i c a t i o n s w i l l be funded.
APPLICATIONS PROCEDURE
A p p l i c a t i o n s must be submi t ted on form PHS 398 (Revised 1 0 / 8 8 ) .
ADDITIONAL INFORMATION
P o t e n t i a l a p p l i c a n t s are encouraged t o r e q u e s t a d e t a i l e d r e q u e s t f o r a p p l i c a t i o n by t e l e p h o n i n g :
Linda L . Wright, M . D . S p e c i a l A s s i s t a n t t o t h e D i r e c t o r Center f o r Research f o r Mothers and Chi ldren N a t i o n a l I n s t i t u t e o f Chi ld Heal th and Human DevelopmentExecut ive P l a z a North, Room 643 9000 R o c k v i l l e P ike Bethesda, MD 20892 Telephone: ( 3 0 1 ) 496-0430
VC,J C I N I C A L DIAGNOSTIC STUDIES OF BRAIN TUMOR USING PET AND OTHER I M A G I N G MODALITIES
A p p l i c a t i o n Rece ip t Date: May 1 8 , 1990
The R a d i a t i o n Research Program (RRP), D i v i s i o n of Cancer Treatment ( D C T ) , of t h e N a t i o n a l Cancer I n s t i t u t e ( N C I ) , announces t h e a v a i l a b i l i t y o f a RequestFor A p p l i c a t i o n s (RFA) t o advance d i a g n o s t i c c l i n i c a l r e s e a r c h u s i n g PET and o t h e r imaging m o d a l i t i e s i n e v a l u a t i n g e s s e n t i a l f e a t u r e s o f b r a i n tumor metabolism t o improve our knowledge of tumor growth, p a t i e n t t h e r a p y , p a t i e n tp r o g n o s i s and management.
Advances i n t h e l a s t decade i n imaging and imaging-related technology have p e r m i t t e d more p r e c i s e ana tomic /pa thologic d i a g n o s i s and a l s o are p r o v i d i n gf u n c t i o n a l in format ion . These advances p o t e n t i a l l y ex tend t h e c a p a c i t y o f imaging method from i t s customary r o l e o f anatomic d i a g n o s i s wi th i n f e r r e d f u n c t i o n t o d i r e c t o b s e r v a t i o n of p h y s i o l o g i c and pa thophys io logic phenomenaand are t h e d i r e c t r e s u l t o f t h e t e c h n o l o g i c a l development and c l i n i c a l use of p o s i t r o n emission tomography ( P E T ) , magnetic resonance spec t roscopy (MRS),r a d i o l a b e l e d monoclonal a n t i b o d i e s , and o t h e r imaging m o d a l i t i e s . I n view o f s u c c e s s e s of PET, MRS, and o t h e r m o d a l i t i e s i n p r o v i d i n g s i g n i f i c a n tf u n c t i o n a l in format ion about normal and malignant t i s s u e s i n v ivo , c l i n i c a l s t u d y o f b r a i n tumor metabolism become n o t o n l y p o s s i b l e b u t t i m e l y .
The o v e r a l l o b j e c t i v e o f t h i s RFA is t o advance t h e use o f PET, MRS, r a d i o l a b e l e d monoclonal a n t i b o d i e s and o t h e r m o d a l i t i e s t o e v a l u a t e e s s e n t i a l f e a t u r e s o f b r a i n tumor metabolism, improve our knowledge o f tumor growth,determine e f f ec t s o f t h e r a p y , and fo l low p a t i e n t s prognos is and management.S t a t e d i n o t h e r words, t h e aim of t h i s RFA i s t o improve our unders tanding o f pathophysiology of b r a i n f u n c t i o n i n p a t i e n t s wi th pr imary b r a i n tumors u s i n gPET and o t h e r r a d i o g r a p h i c methods a t d i a g n o s i s and d u r i n g t h e c o u r s e of t h e r a p y .
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Where f e a s i b l e and a p p r o p r i a t e , a p p l i c a t i o n s f o r t h e proposed c l i n i c a l s t u d i e s should i n c l u d e a s u i t a b l e r e p r e s e n t a t i o n o f m i n o r i t i e s and women. If t h e a p p l i c a n t cannot comply, a clear r a t i o n a l e f o r t h e i r e x c l u s i o n must be provided .
It is a n t i c i p a t e d t h a t approximately t h r e e o r p o s s i b l y f o u r s c i e n t i f i c a l l ym e r i t o r i o u s a p p l i c a t i o n s can be funded. -The l a b e l a v a i l a b l e w i t h t h e 10188 r e v i s i o n o f a p p l i c a t i o n 398 must be a f f i x e d t h e bottom o f t h e face page. 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 p r o c e s s i n g of your a p p l i c a t i o n such t h a t it may n o t r e a c h t h e review committee i n t i m e f o r rev iew. I n a d d i t i o n , t h e RFA number and t i t l e should be typed on l i n e 2 o f t h e face page o f t h e a p p l i c a t i o n form.
Request for c o p i e s of t h e complete RFA should be addressed
D r . Matti Al-Aish, Act ing Chief D i a g n o s t i c Imaging Research Branch R a d i a t i o n Research ProgramN a t i o n a l Cancer I n s t i t u t e Nat iona l I n s t i t u t e s o f Heal th Execut ive P l a z a N o r t h I S u i t e 800 Bethesda, MD 20892 Telephone: (301) 496-9531
O N G O I N G PROGRAM ANNOUNCEMENTS
t o :
SHORT-TERM TRAINING FOR MEDICAL STUDENTS I N ENVIRONMENTALIOCCUPATIONAL HEALTH
P.T. 44; K.W. 0725005, 0725020, 0720005
N a t i o n a l I n s t i t u t e o f Environmental Heal th S c i e n c e s
A p p l i c a t i o n Rece ip t Date: May 10 , 1990
The purpose o f t h i s announcement i s t o s o l i c i t a p p l i c a t i o n s f o r shor t - te rm t r a i n i n g o f medical s t u d e n t s i n d i s c i p l i n e s r e l a t e d t o environmental and o c c u p a t i o n a l medicine. Two t y p e s o f mechanisms are a v a i l a b l e .
Medical s c h o o l s a t which t h e r e i s a c u r r e n t l y a c t i v e N a t i o n a l I n s t i t u t e o f Environmental Heal th S c i e n c e s (NIEHS) I n s t i t u t i o n a l T r a i n i n g Grant (T32) maysubmit a supplemental a p p l i c a t i o n t o suppor t 3-5 medical s t u d e n t s f o r summer o r of f - te rm r e s e a r c h . The p e r i o d o f suppor t may n o t exceed t h r e e months. Those programs f o r which a c o m p e t i t i v e renewal a p p l i c a t i o n is due mayi n c o r p o r a t e such p o s i t i o n s i n t o t h e renewal . A f t e r t h i s i n i t i a l round, r e q u e s t s f o r shor t - te rm t r a i n i n g may be submi t ted o n l y a t t h e t i m e o f c o m p e t i t i v e renewal .
Medical s c h o o l s t h a t do n o t c u r r e n t l y have an NIEHS I n s t i t u t i o n a l T r a i n i n gGrant b u t t h a t have ongoing b a s i c and/or c l i n i c a l r e s e a r c h a c t i v i t i e s i n a r e a s r e l a t e d t o environmental/occupational h e a l t h may apply f o r a N a t i o n a l Research S e r v i c e Award f o r Short-Term T r a i n i n g (T35) t o suppor t 3-5 s t u d e n t s p e r y e a r as d e s c r i b e d above.
For a d d i t i o n a l in format i o n and s p e c i a l i n s t r u c t i o n s , c o n t a c t :
D r . Annet te K i r s h n e r S c i e n t i f i c Programs Branch D i v i s i o n of Extramural Research and T r a i n i n g N a t i o n a l I n s t i t u t e o f Environmental Heal th S c i e n c e s P . 0 . Box 12233 Research T r i a n g l e Park, NC 27709 Telephone: (919) 541-0488
RESEARCH ON THE RECOGNITION, MANAGEMENT, AND PREVENTION OF ALCOHOL PROBLEMS I N A PRIMARY HEALTH CARE SETTING
P.T. 34; K . W . 0404003, 0745027, 0730050
N a t i o n a l I n s t i t u t e on Alcohol Abuse and Alcoholism
PURPOSE
The N a t i o n a l I n s t i t u t e on Alcohol Abuse 2nd Alcoholism ( N I A A A ) i s s e e k i n gr e s e a r c h g r a n t a p p l i c a t i o n s t h a t propose t o s t u d y i s s u e s r e l a t e d t o t h e
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r e c o g n i t i o n , management, and p r e v e n t i o n o f a l c o h o l problems i n a pr imary care s e t t i n g .
RESEARCH OBJECTIVES
Inc luded i n t h i s i n i t i a t i v e are s t u d i e s o f s t r a t e g i e s f o r s c r e e n i n g f o r a l c o h o l problems i n pr imary c a r e ; t e c h n i q u e s f o r e a r l y i n t e r v e n t i o n i n h i g h - r i s k groups o r f o r b r i e f i n t e r v e n t i o n s i n i n d i v i d u a l s w i t h a l c o h o l problems; r o u t i n e p r e v e n t i v e i n t e r v e n t i o n s f o r young people; and methods f o r t r a i n i n g pr imary c a r e h e a l t h p r o v i d e r s t o i d e n t i f y , i n t e r v e n e wi th , and managet h e c a r e of p a t i e n t s who have a c t u a l o r p o t e n t i a l a l c o h o l problems.
MECHANISM OF SUPPORT
The mechanisms o f suppor t t o be a p p l i e d f o r t h i s announcement a r e t h e t r a d i t i o n a l r e s e a r c h p r o j e c t ( R o l l , smal l g r a n t s (R031, and t h e F i r s t Independent Research Support and T r a n s i t i o n Award (R29). Support may be r e q u e s t e d f o r a p e r i o d o f up t o 5 y e a r s ( renewable f o r subsequent p e r i o d 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 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 maybe submi t ted b e f o r e t h e end o f an approved p e r i o d o f suppor t t o c o n t i n u e a p r o j e c t . E L I G I B I L I T Y
A p p l i c a t i o n s f o r a l c o h o l r e s e a r c h g r a n t s may be made by p u b l i c o r p r i v a t en o n - r o f i t o r f o r - p r o f i t o r g a n i z a t i o n s , such as u n i v e r s i t i e s , c o l l e g e s ,h o s p i t a l s , l a b o r a t o r i e s , u n i t s o f S t a t e o r l o c a l governments, and e l i g i b l ea g e n c i e s o f t h e F e d e r a l Government. Women and m i n o r i t y i n v e s t i g a t o r s are encouraged t o a p p l y .
INCLUSION OF WOMEN AND MINORITIES I N STUDY POPULATIONS
A p p l i c a n t s are urged t o g i v e added a t t e n t i o n (where f e a s i b l e and a p p r o p r i a t e ) t o t h e i n c l u s i o n o f 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 .
APPLICATION PROCESS
A p p l i c a n t s should use t h e g r a n t a p p l i c a t i o n form PHS 398 (Rev. 1 0 1 8 8 ) . The t i t l e o f t h i s announcement, "Recogni t ion, Management, and Prevent ion o f
w Alcohol Problems i n a Primary Heal th Care S e t t i n g , " should be typed i n i t e m number 2 on t h e f a c e page o f t h e PHS 398 a p p l i c a t i o n form. Page l i m i t s and l i m i t s on s i z e o f t y p e are s t r i c t l y e n f o r c e d . Non-conforming a p p l i c a t i o n sw i l l b e r e t u r n e d wi thout b e i n g reviewed.
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 (PHS 3 9 8 ) maybe 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 o f 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 source 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 b e c o n t a c t e d f o r t h e n e c e s s a r y a p p l i c a t i o n material:
N a t i o n a l Clear inghouse f o r Alcohol and Drug Informat ion P.O. Box 2345 R o c k v i l l e , MD 20852 Telephone: ( 3 0 1 ) 468-2600
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 o f a p p l i c a t i o n should be s e n t t o :
D i v i s i o n o f Research Grants , N I H Westwood B u i l d i n g , Room 240 Bethesda, MD 20892XX
REVIEW PROCESS
t h e completed
The D i v i s i o n of Research Grants , N I H , s e r v e s as a cen t r a l p o i n t f o r r e c e i p t o f 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 PHS Referral G u i d e l i n e s . The I R G s , c o n s i s t i n gp r i m a r i l y o f 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 mer i t . N o t i f i c a t i o n o f 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 review. A p p l i c a t i o n s w i l l r e c e i v e a second-level review by an a p p r o p r i a t e N 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 w 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 approval by t h e I R G and Council may b e c o n s i d e r e d f o r funding .
N I H GUIDE - Vol. 1 9 , No. 9 , March 2 , 1990 - Page 1 1
T h i s program is d e s c r i b e d i n t h e Cata log o f F e d e r a l Domestic A s s i s t a n c e , No. 13.272. Grants w i l l be awarded under t h e a u t h o r i t y o f S e c t i o n s 301 and 510 o f t h e P u b l i c Heal th S e r v i c e A c t , a s amended (42 USC 241 and 290bb) and a d m i n i s t e r e d i n accordance w i t h t h e PHS Grants P o l i c y S ta tement and F e d e r a l R e g u l a t i o n s a t 42 CFR P a r t 52 and 45 CFR P a r t 74.
A p p l i c a t i o n s submi t ted i n response t o t h i s announcement are n o t s u b j e c t t o t h e in te rgovernmenta l review requi rements o f Execut ive Order 12372, a s implemented -th rough Department o f Heal th and Human S e r v i c e s r e g u l a t i o n s a t 45 CFR P a r t 100, and are n o t s u b j e c t t o Heal th Systems Agency rev iew.
REVIEW CRITERIA
Cri ter ia t o be used i n t h e merit review o f a l c o h o l r e s e a r c h g r a n t a p p l i c a t i o n s- - .
w i l l i n c l u d e t h e f o l l o w i n g :
1. The 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 merit of t h e proposa l and t h e adequacy o f t h e methodology t o c a r r y o u t t h e proposed r e s e a r c h .
2. The adequacy o f t h e d e s i g n f o r c o l l e c t i o n and a n a l y s i s o f d a t a ,i n c l u d i n g r e s e a r c h schemat ics , d e t a i l e d a n a l y t i c p l a n s , and proposed i n s t r u m e n t a t i o n .
3. The p o t e n t i a l o f t h e r e s e a r c h f i n d i n g s t o enhance outcome s u c c e s s ra tes i n a p p l i e d p r e v e n t i o n and t r e a t m e n t s e t t i n g s .
4. The adequacy o f t h e q u a l i f i c a t i o n s ( i n c l u d i n g l e v e l o f e d u c a t i o n and t r a i n i n g ) and r e l e v a n t 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 li n v e s t i g a t o r and key r e s e a r c h p e r s o n n e l .
5. The q u a l i t y o f t h e a p p l i c a n t ' s p a s t and p r e s e n t r e s e a r c h performance as r e l a t e d t o t h e proposed p r o j e c t .
6. The a v a i l a b i l i t y o f adequate f a c i l i t i e s , g e n e r a l environment �or t h e conduct o f t h e proposed r e s e a r c h , 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 .
7. The r e a s o n a b l e n e s s of budget e s t i m a t e s 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 .
8. Where a p p l i c a b l e , t h e adequacy o f procedures t o p r o t e c t o r minimize e f fec ts on human s u b j e c t s .
9. The demonst ra t ion o f c u l t u r a l s e n s i t i v i t y , a p p r o p r i a t e u s e o f m i n o r i t y s t a f f , and t h e o r e t i c a l c o n s i d e r a t i o n o f m i n o r i t y i s s u e s i n t h e r e s e a r c h d e s i g n .
AWARD CRITERIA AND AVAILABILITY OF FUNDS
A p p l i c a t i o n s recommended f o r approval by a 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 b a s i s o f t h e 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 merits o f t h e p r o p o s a l as determined by p e e r review, program needs and balance , and t h e a v a i l a b i l i t y o f f u n d s .
I n F i s c a l Year 1991, it is e s t i m a t e d t h a t approximate ly $500,000 t o $700,000w i l l b e a v a i l a b l e t o suppor t approximately 3 t o 5 new awards under t h i s announcement. However, t h e amount o f funding a v a i l a b l e 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 ime o f award.
INQUIRIES
P o t e n t i a l a p p l i c a n t s a r e encouraged t o s e e k p r e a p p l i c a t i o n c o n s u l t a t i o n and t o c o n t a c t t h e i n d i v i d u a l l i s t e d below when p r e p a r i n g an a p p l i c a t i o n under t h i s announcement. Direct i n q u i r i e s t o :
J a c q u e l i n e Wallen, Ph.D. P r o j e c t Officer, Treatment Research Branch D i v i s i o n o f C l i n i c a l and Prevent ion Research, N I A A A 5600 F i s h e r s Lane, Room 16C-03 R o c k v i l l e , MD 20857 Telephone: ( 3 0 1 ) 443-0796
XXTHE MAILING ADDRESS GIVEN 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 CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO n~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, MD 20816
N I H GUIDE - Vol. 19, No. 9 , March 2, 1990 - Page 12 *U.S.GOVERNHENT P R I N T I N G OFFICE:1990-261-l38:00038
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