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'W Vol. 18, No. 2, January 20, 1989

NOTXCES

EXTRAMURAL RESEARCHERS' FINANCIAL CONFLICTS OF INTEREST .................... 1 National I n s t i t u t e s of Health Index: NATIONAL INSTITUTES OF HEALTH

ANALYTICAL CHEMISTRY OF CHEMICALS AND PHARMACEUTICAL PRODUCTS FOR TREATMENT OF INFECTIOUS DISEASES (RFP) ................................. 1 National I n s t i t u t e o f Al le rgy and I n f e c t i o u s Diseases Index: ALLERGY, INFECTIOUS DISEASES

DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS WITH POTENTIAL FOR TREATING INFECTIOUS DISEASES (RFP) ........................... 2 National I n s t i t u t e o f Allergy and I n f e c t i o u s Diseases Index: ALLERGY, INFECTIOUS DISEASES

NOTICE - SURVEILLANCE EPIDEMIOLOGY AND END RESULTS (SEER) (RFP) ............ 2 National Cancer I n s t i t u t e Index: CANCER

ACADEMIC RESEARCH ENHANCEMENT AWARD ........................................ 3 National I n s t i t u t e s o f Health Index: NATIONAL INSTITUTES OF HEALTH

W

CORE GRANTS FOR CLINICAL NUTRITION RESEARCH UNITS (CNRUs) (RFA) ............ 4 National I n s t i t u t e of Diabetes and Diges t ive and Kidney Diseases National I n s t i t u t e on AgingIndex: DIABETES, DIGESTIVE AND KIDNEY DISEASES, A G I N G

MENTAL HEALTH SERVICES RESEARCH DEMONSTRATION GRANTS (RFA) ................ 6 National I n s t i t u t e of Mental Heal th Index: MENTAL HEALTH

NEW APPROACHES TO STUDYING EPSTEIN-BARR VIRUS ONCOGENESIS (RFA) ............ 6 National Cancer I n s t i t u t e Index: CANCER

DEVELOPMENT OF SOMATIC CELL GENE THERAPY APPROACHES FOR SPECIFIC I N B O R N METABOLIC DISEASES (RFA) ............................................ 8 National I n s t i t u t e of Diabetes and Diges t ive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES

W

* -

NOTICES

EXTRAMURAL RESEARCHERS' FINANCIAL CONFLICTS OF INTEREST

P.T. 34; K.W. 1014004, 1014006 W

National I n s t i t u t e s o f Heal th

Growing express ions o f p u b l i c concerns suggest t h a t N I H act t o l i m i t p o s s i b i l i t i e s f o r a c t u a l or apparent f i n a n c i a l c o n f l i c t s of i n t e r e s t byi n v e s t i g a t o r s i n r e sea rch and development p r o j e c t s funded by N I H extramural awards. O f p a r t i c u l a r concern are circumstances t h a t might affect i n v e s t i g a t o r s ' o b j e c t i v i t y , or where r e sea rche r s might unduly inf luence , or might be perceived t o in f luence r NIH-funded R&D p r o j e c t s i n d i r e c t i o n s favorable t o personal f i n a n c i a l i n t e r e s t s o f themselves, t h e i r spouses, c h i l d r e n , c l o s e p ro fes s iona l a s s o c i a t e s , or organ iza t ions where they have appointments or o t h e r r e l a t i o n s h i p s .

N I H expec ts t h a t p a r t i c i p a t i n g i n v e s t i g a t o r s and c o n s u l t a n t s w i l l no t have f i n a n c i a l i n t e r e s t s i n o rgan iza t ions or e n t i t i e s t h a t produce drugs, devices , or o t h e r i n t e r v e n t i o n s s t u d i e d i n a c o n t r o l l e d c l i n i c a l t r i a l . N I H t h e r e f o r e i n t ends t o t a k e s t e p s t o develop appropr i a t e guidance f o r such r e l a t i o n s h i p s . Guidel ines would seek t o o u t l i n e p e r t i n e n t t ypes o f r e sea rch s i t u a t i o n s and personal f i n a n c i a l i n t e r e s t s , i n accord with t h e PHS Grants Pol icy Statement, January 1, 1987, r e v i s i o n , concerning Standards of Conduct f o r Employees f o r awardee o rgan iza t ions , and t o de f ine appropr i a t e d i s t r i b u t i o n s o f governancebetween N I H and awardee o rgan iza t ions . Guidel ines should a l s o recognize s p e c i a l cond i t ions under which r e s t r i c t i o n s should be waived t o permit i n v e s t i g a t o r s with unusual s k i l l s and e x p e r t i s e t o conduct s t u d i e s which mightotherwise be p rosc r ibed . (These gu ide l ines should not concern f i n a n c i a l b e n e f i t s r e s u l t i n g from l o g i c a l s t e p s i n product research/development/testingunder N I H awards, e .g . , Small Business Innovat ion Research.)

N I H encourages pre l iminary comments from p a r t i e s wishing t o suggest p o i n t s t o be included i n t h i s f u t u r e guidance. P lease address your remarks wi th in 30 days o f t h i s p u b l i c a t i o n t o :

D r . Kather ine L . Bick Deputy Di rec to r f o r Extramural Research National I n s t i t u t e s of Heal th Shannon Building, Room 144 Bethesda, Maryland 20892

Fur ther oppor tuni ty f o r comments w i l l be provided fo l lowing subsequent n o t i c e s i n t h e N I H Guide f o r Grants and Cont rac ts .

DATED ANNOUNCEMENTS (RFPs AND RFAs)

ANALYTICAL CHEMISTRY OF CHEMICALS AND PHARMACEUTICAL PRODUCTSFOR TREATMENT OF INFECTIOUS DISEASES

RFP AVAILABLE: RFP-NIH-NIAID-AIDSP 89-14

P.T. 34; K.W. 1003008, 0740025

National I n s t i t u t e of Allergy and I n f e c t i o u s Diseases

The purpose of t h e s o l i c i t a t i o n is t o provide a n a l y t i c a l chemistry support t o t h e drug d iscovery e f f o r t f o r t h e t rea tment o f i n f e c t i o u s d i s e a s ? s i n t h e areas of method development and c o n t r o l of chemical and pharmaceutical q u a l i t y . R e s p o n s i b i l i t i e s o f t h e c o n t r a c t o r w i l l inc lude : c h a r a c t e r i z a t i o n of t h e i d e n t i t y of t h e drug substance; preformulat ion de te rmina t ions of compound s o l u b i l i t y and s t a b i l i t y ; a n a l y s i s of pharmaceutical dosage forms;and ex tens ions of t h e methodologies t o t h e d e t e c t i o n of t h e drug i n s e l e c t e d b i o l o g i c a l f l u i d s .

This announcement is a new s o l i c i t a t i o n . The i ssuance o f t h e RFP w i l l be on January 26 , 1989, and proposa ls w i l l be due COB on March 29 , 1989.

This NIAID-sponsored p r o j e c t w i l l t a k e approximately f i v e yea r s t o complete. A cost-reimbursement c o n t r a c t is a n t i c i p a t e d and t h e I n s t i t u t e expec ts t o make

W one award.

Vol. 18, No. 2 , January 2 0 , 1989 - Page 1

, . . . Requests f o r t h e RFP should be d i r e c t e d i n w r i t i n g t o :

M r . Charles HayesContract Management Branch Westwood Building, 5333 Westbard Avenue, Room 707 National I n s t i t u t e o f Al le rgy and I n f e c t i o u s Diseases National I n s t i t u t e s o f Heal th Bethesda, Maryland 20892 Telephone: (301) 496-0349

-To rece ive a copy o f t h e RFP, p l ease supply t h i s o f f i c e with two ( 2 ) se l f -addressed mai l ing l a b e l s . A l l r e spons ib l e sources may submit a proposal which w i l l be considered.

This advert isement does no t commit t h e Government t o award a c o n t r a c t .

DEVELOPMENT AND MANUFACTURE OF DOSAGE FORMS OF COMPOUNDS WITH POTENTIAL FOR TREATING INFECTIOUS DISEASES

RFP AVAILABLE: RFP-NIH-NIAID-AIDSP-89-12 P.T. 34; K.W. 0740025, 0740020

National I n s t i t u t e o f Al le rgy and I n f e c t i o u s Diseases

The purpose of t h i s s o l i c i t a t i o n i s t o provide a pharmaceutical r e sea rch and development c a p a b i l i t y t o permit f u r t h e r eva lua t ion o f compounds i n animal models o f i n f e c t i o u s d i seases , i n pharmacological d i s p o s i t i o n s t u d i e s i n l a b o r a t o r y animals, i n t o x i c o l o g i c a l i n v e s t i g a t i o n s and i n c l i n i c a l t r i a l . Dosage form development and manufacturing c a p a b i l i t i e s w i l l be needed f o r s t e r i l e small volume p a r e n t e r a l f r e e z e d r i e d and l i q u i d dosage forms, t a b l e t s , and capsu le s . Q u a l i t y c o n t r o l t e s t i n g of i ng red ien t s i n t h e formulat ion and of t h e f i n a l product w i l l be r equ i r ed , Manufactured ba tches w i l l be prepared i n accord wi th FDA’s c u r r e n t good manufacturing p r a c t i c e r e g u l a t i o n s . Ant ic ipa t ed annual requirements are one or two drugs r e q u i r i n g development o f i n j e c t a b l e and o f o r a l dosage forms, one or two i n j e c t a b l e ba tches o f about 4000 v i a l s each, and two o f t h r e e t ab le / capsu le ba tches o f 50 ,000 u n i t s l l o t . - This announcement is a new s o l i c i t a t i o n . The i ssuance o f t h e RFP w i l l be on January 25, 1989, and proposa ls w i l l be due COB March 28, 1989.

This N I A I D sponsored p r o j e c t w i l l t a k e approximately f i v e y e a r s t o complete. A cost-reimbursement c o n t r a c t is a n t i c i p a t e d and t h e I n s t i t u t e expec ts t o make one award.

Requests for t h e RFP should be d i r e c t e d i n w r i t i n g t o t

M s . Mary Anne Gl i tz Contract Management Branch Westwood Building, 5333 Westbard Avenue, Room 707 National I n s t i t u t e of A l l e r g y and I n f e c t i o u s Diseases Nat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 20892 Telephone: (301) 496-1642

To rece ive a copy o f t h e RFP, p l ease supply t h i s o f f i c e wi th two ( 2 ) se l f -addressed mail ing l a b e l s . A l l r e spons ib l e sources may submit a proposa l which w i l l be cons idered .

This advert isement does no t commit t h e Government t o award a c o n t r a c t .

N)

NCI-CN-95112, NCI-CN-95113, NCI-CN-95114, NCI-CN-95115, NCI-CN-95116,NCI-CN-95117, NCI-CN-95118, NCI-CN-95119, NCI-CN-95120, NCI-CN-95121,NCI-CN-95122

P.T. 34; K.W. 0785055, 0755018, 0715035

Nat ional Cancer I n s t i t u t e

The Div is ion o f Cancer Prevent ion and Control , Nat ional Cancer I n s t i t u t e ,V i n t ends t o n e g o t i a t e wi th t h e Connecticut Department o f Heal th Sorv ices , t h e

Commonwealth o f Puerto Rico Department of Heal th , Emory Univers i ty , Fred !

I Hutchinson Cancer Research Center , Michigan Cancer Foundation, New J e r s e yDept. of Heal th , Northern C a l i f o r n i a Cancer Center, Research Corporat ion o f

Vol. 18, No. 2, January 20, 1989 - Page 2

. . t h e Univers i ty of H a w a i i , Univers i ty o f Iowa, Univers i ty of N e w Mexico, and t h e Univers i ty o f Utah f o r a seven-year con t inua t ion c o n t r a c t f o r t h e Surve i l l ance , Epidemiology and End Resu l t s (SEER) Program. The p r o j e c tinc ludes c o l l e c t i n g and r e p o r t i n g on population-based cancer incidence, t rea tment and s u r v i v a l d a t a f o r t h e United S t a t e s . (Author i ty : 41 U.S.C. 253 ( c ) (11 , as s e t f o r t h i n FAR 6.302-1 and HHSAR 306.302. -1 . ) Only one

c1, r e spons ib l e source and no o t h e r supp l i e s or s e r v i c e s w i l l s a t i s f y agencyrequirements . I n accordance with FAR 6.302-1 (a ) ( 2 ) (ii)and HHSAR 306.302(a) ( 2 ) (ii),s e r v i c e s may be deemed t o be a v a i l a b l e only from t h e o r i g i n a l sources f o r follow-on c o n t r a c t s f o r continued development. Inherent dup l i ca t ion o f c o s t t o t h e Government and unacceptable de l ays i n completing t h i s follow-up p r o j e c t make competi t ion un feas ib l e f o r t h i s p r o j e c t . The above named o rgan iza t ions have t h e p r e r e q u i s i t e knowledge, experience and f a c i l i t i e s f o r cont inued performance of t h e proposed t a s k s by v i r t u e o f t h e i r pre l iminary and c u r r e n t work on t h e s e p r o j e c t s . For Informat iona l Purposes Only. RFP is no t a v a i l a b l e . For f u r t h e r information con tac t :

S h i r l e y KyleContrac t ing Officer Prevent ion and Cancer Control Sec t ion , RCB National Cancer I n s t i t u t e , N I H Executive P laza South, S u i t e 635 Bethesda, Maryland 20892 Telephone: (301) 496-8603

ACADEMIC RESEARCH ENHANCEMENT AWARD

P.T. 34; K.N. 0710030, 1014002, 1014006

Nat iona l I n s t i t u t e s of Health

Appl ica t ion Receipt Date: June 22, 1989

The Nat ional I n s t i t u t e s o f Heal th ( N I H ) is making a s p e c i a l e f f o r t t o s t i m u l a t e r e sea rch i n educa t iona l i n s t i t u t i o n s which provide t h e bacca laurea te t r a i n i n g f o r a s i g n i f i c a n t number o f our na t ion ’ s r e sea rch s c i e n t i s t s bu t which h i s t o r i c a l l y have no t been major r e c i p i e n t s of N I H suppor t . S ince F i s c a l Year (FYI 1985, Congressional appropr i a t ions f o r t h e N I H have included funds f o r t h i s i n i t i a t i v e , which N I H has implemented through t h e Academic

w Research Enhancement Award (AREA) Program. I n FY 85, t h e N I H made 75 awards,t o t a l l i n g $5 m i l l i o n . I n FY 86, 146 such g r a n t s were awarded, amounting t o $9.57 m i l l i o n . I n FY 87, a t o t a l o f 152 AREA g r a n t s were awarded from t h e Congressional appropr i a t ion o f $10 m i l l i o n . I n FY 88, 173 awards were made,t o t a l l i n g approximately $11 m i l l i o n .

Th i s award is designed t o enhance t h e r e sea rch environment o f educa t iona l i n s t i t u t i o n s t h a t have no t been t r a d i t i o n a l r e c i p i e n t s o f N I H r e sea rch funds. The AREA funds are intended t o support new re sea rch p r o j e c t s or expand ongoingresea rch a c t i v i t i e s proposed by f a c u l t y members of t h e s e i n s t i t u t i o n s i n areas r e l a t e d t o t h e h e a l t h sc i ences . Appl ica t ions for FY 1989 AREA g r a n t s are c u r r e n t l y undergoing r e v i e w f o r s c i e n t i f i c m e r i t . S ince it i s a n t i c i p a t e dt h a t a d d i t i o n a l funds w i l l be a v a i l a b l e next year , t h e N I H is i n v i t i n g g r a n ta p p l i c a t i o n s for t h e FY 1990 competi t ion f o r AREA g r a n t s .

E l i g i b i l i t y requirements o f t h e AREA Program inc lude t h e fol lowing:

Applicant I n s t i t u t i o n s

o A l l domestic i n s t i t u t i o n s o f f e r i n g bacca laurea te or advanced degrees i n t h e sc i ences r e l a t e d t o h e a l t h are e l i g i b l e , except t hose t h a t have rece ived an N I H Biomedical Research Support Grant (BRSG) o f $20,000 or more per year f o r fou r or more yea r s dur ing t h e pe r iod from FY 1982 through FY 1988.

o Health p ro fes s iona l schools ( e . g . , schools o f medicine, d e n t i s t r y , nurs ing ,osteopathy, pharmacy, v e t e r i n a r y medicine, p u b l i c h e a l t h , a l l i e d h e a l t h and optometry) as wel l as o r g a n i z a t i o n a l l y d i s c r e t e campuses of a u n i v e r s i t ysystem are e l i g i b l e i f they meet t h e above c r i t e r i o n .

o Mul t ip le a p p l i c a t i o n s proposing d i f f e r e n t r e sea rch p r o j e c t s may be submit ted by an a p p l i c a n t i n s t i t u t i o n .

Applicant P r i n c i p a l I n v e s t i g a t o r s

w o Must no t have a c t i v e r e sea rch g ran t support ( i nc lud ing an AREA) from e i t h e r N I H or t h e Alcohol, Drug Abuse and Mental Heal th Adminis t ra t ion (ADAMHA) a t

I

I t h e a p p l i c a n t i n s t i t u t i o n a t t h e time of award o f an AREA g r a n t .


W

-

w

o May no t submit a r e g u l a r N I H or ADAMHA r e sea rch g ran t a p p l i c a t i o n f o r e s s e n t i a l l y t h e same p r o j e c t as a pending AREA a p p l i c a t i o n .

o A r e expected t o conduct t h e major i ty o f t h e i r r e sea rch a t t h e i r own i n s t i t u t i o n , a l though l i m i t e d access t o s p e c i a l f a c i l i t i e s or equipment a t another i n s t i t u t i o n is permi t ted .

o May no t be awarded more than one AREA g ran t a t a t i m e nor be awarded a second AREA g ran t t o cont inue t h e r e sea rch i n i t i a t e d under t h e first AREA g r a n t .

Those i n doubt about e l i g i b i l i t y should consu l t t h e i r i n s t i t u t i o n ' s Office of Sponsored Research, or t h e Di rec to r , Spec ia l Programs and I n i t i a t i v e s (Building 31 , Room 1B54, N I H , Bethesda, MD 20892, 3011496-1968).

Funding dec i s ions w i l l be based on t h e proposed r e sea rch p r o j e c t ' s s c i e n t i f i c mer i t and re levance t o N I H programs, and t h e i n s t i t u t i o n ' s c o n t r i b u t i o n t o t h e undergraduate p repa ra t ion o f doc to ra l - l eve l h e a l t h p r o f e s s i o n a l s . Amongp r o j e c t s of e s s e n t i a l l y equiva len t s c i e n t i f i c merit and program relevance,preference w i l l be given t o those submit ted by i n s t i t u t i o n s t h a t have grantedbacca lau rea t e degrees t o 25 or more ind iv idua l s who, during t h e per iod1978-1988, obta ined academic or pro fes s iona l doc to ra l degrees i n t h e h e a l t h r e l a t e d sc i ences .

W A S are awarded on a compet i t ive b a s i s . Applicants may reques t support f o r up t o a t o t a l of $75,000 i n d i r e c t c o s t s ( p l u s app l i cab le i n d i r e c t c o s t s ) f o r a per iod no t t o exceed 36 months. Although t h i s award is non-renewable, it w i l l enable q u a l i f i e d ind iv idua l s c i e n t i s t s wi th in t h e e l i g i b l e i n s t i t u t i o n s t o r ece ive support f o r f e a s i b i l i t y s t u d i e s , p i l o t s t u d i e s and o t h e r smal l - sca le r e sea rch p r o j e c t s prepara tory t o seeking more s u b s t a n t i a l fundingfrom t h e r e g u l a r N I H r e sea rch g ran t programs.

Appl ica t ions f o r t h i s award w i l l be accepted under t h e r e g u l a r a p p l i c a t i o nsubmission procedures o f t h e Div is ion o f Research Grants ( D R G ) of N I H . Grant a p p l i c a t i o n s must be prepared and submit ted on Form PHS 398 (Rev. 9 / 8 6 ) . An abbrevia ted format and s i m p l i f i e d i n s t r u c t i o n s w i l l be provided upon r eques tt o t h e Office o f Grants I n q u i r i e s (see address below) f o r use i n prepar ingt h e s e a p p l i c a t i o n s . The r e c e i p t d a t e is June 22 , 1989.

Those i n d i v i d u a l s and i n s t i t u t i o n s meeting e l i g i b i l i t y requirements and wishing t o receive f u r t h e r information and/or a p p l i c a t i o n materials should w r i t e t o :

AREA Of f i ce o f Grants I n q u i r i e sDivis ion of Research Grants Nat ional I n s t i t u t e s of Heal th Westwood Building, Room 449 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-7441

CORE GRANTS FOR CLINICAL NUTRITION RESEARCH UNITS (CNRUs)

RFA AVAILABLE: 89-DK-02

P.T. 34; K.W. 0710095, 0710030

National I n s t i t u t e o f Diabetes and Diges t ive and Kidney Diseases Nat ional I n s t i t u t e on Aging

Appl ica t ion Receipt Date: A p r i l 12 , 1989

The Nat ional I n s t i t u t e o f Diabetes and Diges t ive and Kidney Diseases (NIDDK)and t h e Nat ional I n s t i t u t e on Aging ( N I A ) i n v i t e a p p l i c a t i o n s f o r C l i n i c a l N u t r i t i o n Research Unit (CNRU) g r a n t s t o be awarded i n F i s c a l Year 1990. The award o f up t o two CNRU g r a n t s is a n t i c i p a t e d i n F i s c a l Year 1990.

A CNRU is an i n t e g r a t e d a r r a y o f r e sea rch , educa t iona l , and s e r v i c e a c t i v i t i e s t h a t is o r i e n t e d toward human n u t r i t i o n i n h e a l t h and d i s e a s e . A r e sea rch co re c e n t e r g ran t is awarded t o f a c i l i t a t e t h e planning and coord ina t ion of t h e a c t i v i t i e s of t h e CNRU p r imar i ly by providing funding f o r co re f a c i l i t i e s and a s s o c i a t e d staff t h a t s e rve t h e va r ious p r o j e c t s of t h e CNRU on a shared b a s i s .

I

Vol. 18, No. 2 , January 20 , 1989 - Page 4

ESSENTIAL COMPONENTS OF A CNRU

A CNRU, a t a minimum, must comprise t h e fo l lowing seven components which a l s o should have o t h e r sources o f support such as a r e g u l a r N I H r e sea rch g r a n t(Ro l l , N I H FIRST Award (R291, N I H Program P r o j e c t ( P o l ) , N I H Ind iv idua l Fellowship (F321, and t h e N I H I n s t i t u t i o n a l Nat ional Research Se rv ice Award (T32) or o t h e r Federa l and non-federal sources :-1 . Research wi th human s u b j e c t s and popula t ions ;

2 . Laboratory i n v e s t i g a t i o n s ;

3. Research t r a i n i n g (funds t o be der ived from o t h e r sourcesx);

4. Shared f a c i l i t i e s and r e sea rch se rv ices ;

5 . Education programs f o r medical s tuden t s , house s t a f f , p r a c t i c i n gphys ic ians , and a l l i e d h e a l t h personnel ( funds t o be der ived from o t h e r sourcesx) ;

6 . Research components o f n u t r i t i o n a l support s e rv i ces ; and

7. Publ ic information a c t i v i t i e s ( funds t o be der ived from o t h e r sourcesn) .

)c Funds t o support t h e s e components may n o t be reques ted as p a r t o f an a p p l i c a t i o n i n response t o t h i s announcement.

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 le t te r o f i n t e n t t h a t p rovides a d e s c r i p t i v e t i t l e , names o f i n v e s t i g a t o r s involved and o t h e r p a r t i c i p a t i n gi n s t i t u t i o n s 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 o f i n t e n t is non-bindingand is not a precondi t ion for an award and should be submit ted by February 15,1989, t o D r . Bain a t t h e address below. I n add i t ion , t h e genera l d e s c r i p t i o no f a Core Center, copies of Core Center Guidel ines , a more d e t a i l e d RFA and c o n s u l t a t i o n may be obta ined from:

Van S. Hubbard, M.D. , Ph.D. Ralph L. Bain, Ph.D. Di rec to r , C 1 i n i c a l N u t r i t i o n Program Di rec to r f o r Diges t iveResearch Un i t s Diseases Centers Program and Westwood Building, Room 3A18B A s s i s t a n t Program Di rec to r f o r CNRU 5333 Westbard Avenue Westwood Building, Room 3A16 Bethesda, Maryland 20892 5333 Westbard Avenue Telephone: (301) 496-7823 Bethesda, Maryland 20892

Telephone: (301) 496-6045

-For information concerning N I A r e sea rch i n t e r e s t s i n n u t r i t i o n con tac t :

Ann Sorenson, Ph.D. Program Di rec to r f o r t h e N I A N u t r i t i o n ProgramBuilding 31, Room 5C-21 9000 Rockvi l le Pike Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-1033

Appl ica t ions for t h e CNRU Core Center g ran 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 ran t peer review process . The r e c e i p t o f two compet i t ive con t inua t ion a p p l i c a t i o n s is a n t i c i p a t e d . Appl ica 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 ional Diabetes and Diges t ive and Kidney Diseases Advisory Council and/or t h e Nat ional I n s t i t u t e on Aging's Advisory Council . 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 Apr i l 12, 1989, with ear l ies t funding December 1989. Appl ica t ions are u n l i k e l y t o be reviewed by a s i te v i s i t team; t h e r e f o r e , t h e w r i t t e n a p p l i c a t i o n should be complete so as t o f a c i l i t a t e review without a s i t e v i s i t . Extensive a d d i t i o n a l material submit ted subsequent t o t h e s t a t e d r e c e i p t d a t e will no t be accepted .

The RFA l a b e l a v a i l a b l e i n t h e 9/86 r e v i s i o n o f Appl ica t ion Form 398 must be a f f i x e d t o 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 process ing o f your a p p l i c a t i o n such t h a t it may no t reach t h e review committee i n t i m e f o r review. Complete l i n e 2 of the a p p l i c a t i o nf a c e page with t h e t i t l e of t h i s RFA, "Core Grants for C l i n i c a l N u t r i t i o n Research Un i t s ( C N R U s ) , " and t h e RFA number 89-DK-02.

W

,


RFA AVAILABLE: MH-88-11

w P.T. 34; K.W. 0715095, 0403004

Nat ional I n s t i t u t e o f Mental Heal th

Appl ica t ion Receipt Date: A p r i l 10, 1989

The Nat ional I n s t i t u t e o f Mental Heal th ( N I M H ) r eques t s a p p l i c a t i o n s for r e sea rch demonstrat ion g r a n t s t o eva lua te t h e e f f e c t i v e n e s s and g e n e r a l i z a b i l i t y o f va r ious approaches t o case management s e r v i c e s , communityc r i s i s - r e sponse s e r v i c e s , and p s y c h i a t r i c r e h a b i l i t a t o n s e r v i c e s . The purposeis t o gene ra t e new knowledge on e f f e c t i v e , r e p l i c a b l e approaches t o provid ingt h e t h r e e s e r v i c e components and t o begin bu i ld ing t h e i n f r a s t r u c t u r e r equ i r edt o conduct f u t u r e sys temat ic r e sea rch on community support s e r v i c e s . OnlyS t a t e mental h e a l t h a u t h o r i t i e s are e l i g i b l e t o apply; t hey may submit on ly one a p p l i c a t i o n f o r one p r o j e c t under t h i s RFA. I n 1989, it is es t imated t h a t t h e community support program w i l l fund a t o t a l o f approximately 8-12 p r o j e c t saveraging $250-350,000 pe r year i n t h e t h r e e s e r v i c e areas.

NIMH w i l l accept a p p l i c a t i o n s i n response t o t h i s RFA under t h e r e c e i p t d a t e o f A p r i l 10, 1989.

P o t e n t i a l a p p l i c a n t s wishing t o seek f u r t h e r information should con tac t :

N e i l Brown, Chief ,Community Support and Advocacy Branch or Jacque l ine P a r r i s h , Program Di rec to r Community Support ProgramDivis ion o f Education and Se rv ice Systems Lia ison Nat ional I n s t i t u t e o f Mental Heal th Parklawn Bulding, Room 11C-22 5600 F i s h e r s Lane Rockvi l le , Maryland 20857 Telephone: (301) 443-3653

u PEW APPROACHES TO STUDYING EPSTEIN-BARR VIRUS ONCOGENESIS

RFA AVAILABLE: 89-CA-08

P.T. 34; K.W. 0715035, 0715125, 1002045r 1002008r 0760045

Nat iona l Cancer I n s t i t u t e

Appl ica t ion Receipt Date: August 3, 1989 L e t t e r o f I n t e n t Receipt Date: June 3, 1989

I. INTRODUCTION

Epstein-Barr v i r u s (EBV) has been a s soc ia t ed wi th s e v e r a l neop las i a s ,inc luding B u r k i t t ' s lymphoma and nasopharyngeal carcinoma and wi th s e v e r a l i n f e c t i o u s d i seases , inc luding i n f e c t i o u s mononucleosis and seve re chronic i n f e c t i o u s mononucleosis. Recent evidence appears t o l i n k EBV with p a r o t i dgland tumors and B - c e l l lymphomas i n immunosuppressed ind iv idua l s . I n v ivo s t u d i e s o f EBV oncogenesis are complicated by t h e long i n t e r v a l between primary i n f e c t i o n and t h e occurrence o f neoplas ia ; and by t h e high prevalenceof EBV i n f e c t i o n i n geographic areas where a high frequency o f EBV-associated neop las i a s occurs : e .g . , i n t h e malaria b e l t i n Af r i ca i n t h e case o f B u r k i t t ' s lymphoma, and i n t h e Far E a s t i n t h e case o f nasopharyngealcarcinoma. I n v i t r o s t u d i e s o f EBV have been hampered by t h e l a c k of a l y t i ci n f e c t i o n system. S t u d i e s have focused on lymphocytes which have been immortalized/transformed by EBV i n f e c t i o n and i n which a l i m i t e d set o f v i r a l gene products are expressed. The a p p l i c a t i o n o f recombinant DNA technology t o t h i s system has l e d t o progress i n e l u c i d a t i n g t h e s t r u c t u r e of t h e v i r a l genome, f u r t h e r d e f i n i t i o n o f v i r a l gene products , and i d e n t i f i c a t i o n o f s e v e r a l r egu la to ry reg ions of t h e v i r a l genome. However, t h e v i r a l and hos t f a c t o r s determining t h e d i s e a s e man i fe s t a t ions and c l i n i c a l outcomes f o r EBV i n f e c t i o n s are as y e t undefined. Addi t iona l ly , both B-cells and e p i t h e l i a lcel ls appear t o be s i tes o f v i r a l l a t ency and r e p l i c a t i o n . While a number of i n v e s t i g a t o r s are s tudying s p e c i f i c a s p e c t s o f EBV r e p l i c a t i o n and tumorigenesis , d e l i n e a t i o n o f v i r a l and hos t f a c t o r s which may determine t h e

, outcome o f i nd iv idua l EBV i n f e c t i o n s has been d i f f i c u l t t o approach d i r e c t l y .

"


. The p resen t RFA is f o r a s i n g l e competi t ion with a deadl ine o f August 3, 1989 f o r r e c e i p t o f a p p l i c a t i o n s , and June 3, 1989 f o r receipt o f l e t t e r s o f i n t e n t . Appl ica t ions should be prepared and submit ted i n accordance with t h e aims and requirements descr ibed i n t h e complete RFA document which may be obtained from t h e program d i r e c t o r l i s t e d i n Sec t ion I V below.- 11. RESEARCH GOALS AND SCOPE

The o v e r a l l t h r u s t o f t h i s RFA is t o s t i m u l a t e r e sea rch on t h e mechanism(s1 o f EBV oncogenesis by developing and us ing new methodological approaches t o overcome t h e d i f f i c u l t i e s inherent i n EBV r e sea rch . Examples o f r e sea rch o b j e c t i v e s (which are not a l l i n c l u s i v e ) would inc lude t h e fol lowing: (i)use of novel methods and probes t o d e f i n e RNA t r a n s c r i p t s unique t o or with c l i n i c a l s i g n i f i c a n c e f o r d i f f e r e n t EBV neoplas ias ; (ii)use o f new approachest o a l t e r (muta te ) t h e v i r a l genome followed by t h e s tudy o f t h e effect o f a l t e r e d genes on v i r a l oncogenesis; (iii)use of c e l l l i n e s express ingind iv idua l EBV gene products (both s t r u c t u r a l and r egu la to ry ) t o d e f i n e v i r a l genes and assess t h e i r r o l e i n t h e n e o p l a s t i c process; ( i v ) use of s p e c i f i c r eagen t s such as monoclonal an t ibod ie s t o v i r a l gene products t o determine t h e r o l e o f r egu la to ry and s t r u c t u r a l EBV p r o t e i n s i n t h e n e o p l a s t i c process; ( V Imeasurement o f hos t response t o ind iv idua l v i r a l p r o t e i n s with t h e goa l o f d e l i n e a t i n g d i f f e r e n c e s i n t h e hos t response i n s p e c i f i c EBV-associated neop las i a s ; ( v i ) d e l i n e a t i o n o f d i f f e r e n c e s i n cel l -mediated responses i n i n d i v i d u a l s wi th d i f f e r e n t EBV neoplas ias ; and ( v i i ) e x p l o i t a t i o n o f EBV's unique pa thologic a spec t s , such as t h e use o f t h e CR-2 r ecep to r and t h e a c t i v a t i o n of B-cells during t h e i n f e c t i o u s process , t o develop approaches t o a l t e r t h e s e unique a s p e c t s o f EBV pathogenesis wi th t h e u l t i m a t e a i m o f prevent ing or r e v e r s i n g n e o p l a s t i c conversion.

Where appropr i a t e , c o l l a b o r a t i v e arrangements t o f ac i l i t a t e t h e achievement o f r e sea rch goa l s should be considered.

Appl ica t ions should con ta in as goa l s both methodological development and a p p l i c a t i o n t o a s p e c i f i c area o f EBV oncogenesis; b a s i c and/or c l i n i c a l i s s u e s are considered as appropr i a t e s u b j e c t s f o r t h i s RFA.

Furthermore, i n s t u d i e s involving d i f f e r e n c e s between va r ious EBV-associated neop las i a s , i n v e s t i g a t o r s should cons ider no t only t h e c lass ical EBV-associated neop las i a s , such as B u r k i t t ' s lymphoma and nasopharyngealcarcinoma, but a l s o g ive some emphasis t o newer EBV-related neop las i a s such as EBV lymphomas i n immunocompromised ind iv idua l s , EBV tumors i n o t h e r areas o f t h e oropharynx such as t h e p a r o t i d gland, and o t h e r new EBV-associated d i s e a s e s such as h a i r y leukoplakia .

111. MECHANISM OF SUPPORT

Th i s RFA w i l l use t h e Nat ional I n s t i t u t e s o f Heal th ( N I H ) g ran t - in-a id .Respons ib i l i t y for t h e planning, d i r e c t i o n and execut ion of t h e proposedp r o j e c t w i l l be s o l e l y t h a t of t h e a p p l i c a n t . Except as s t a t e d i n t h i s RFA,awards w i l l be adminis te red under PHS g r a n t s p o l i c y as s t a t e d i n t h e Publ ic Heal th Se rv ice Grants Pol icy Statement, DHHS Pub l i ca t ion No. (OASH) 82-50,000,revised January 1 , 1987.

This RFA is a one-time s o l i c i t a t i o n . General ly f u t u r e u n s o l i c i t e d competingrenewal a p p l i c a t i o n s w i l l compete as r e sea rch p r o j e c t a p p l i c a t i o n s with a l l o t h e r i n v e s t i g a t o r - i n i t i a t e d a p p l i c a t i o n s and be reviewed i n a s t and ingDivis ion o f Research Grants s tudy s e c t i o n . However, should t h e N C I determine t h a t t h e r e i s a s u f f i c i e n t cont inuing program need, N C I may announce a r eques tf o r renewal a p p l i c a t i o n s .

Approximately $ 850,000 i n t o t a l c o s t s pe r year f o r f i v e ( 5 ) yea r s w i l l be committed t o s p e c i f i c a l l y fund a p p l i c a t i o n s which are submit ted i n response t o t h i s RFA. It is a n t i c i p a t e d t h a t fou r ( 4 ) t o f i v e ( 5 ) awards w i l l be made. This funding l e v e l is dependent on t h e r e c e i p t of a s u f f i c i e n t number o f a p p l i c a t i o n s o f high s c i e n t i f i c merit. The t o t a l p r o j e c t per iod f o r a p p l i c a t i o n s submit ted i n response t o t h e p re sen t RFA should no t exceed f i v e (5) yea r s . The ear l ies t f e a s i b l e s tar t d a t e f o r t h e i n i t i a l awards w i l l be A p r i l 1 , 1989. Although t h i s program is provided f o r i n t h e f i n a n c i a l p l anso f t h e Nat ional Cancer I n s t i t u t e ( N C I ) , award of g r a n t s pursuant t o t h i s RFA is a l s o cont ingent upon t h e a v a i l a b i l i t y o f funds f o r t h i s purpose.Non-profit and f o r - p r o f i t i n s t i t u t i o n s are e l i g i b l e t o apply. Foreign as w e l l as domestic i n s t i t u t i o n s are e l i g i b l e .

W I V . INQUIRIES

A copy o f t h e complete RFA desc r ib ing t h e r e sea rch goa l s and scope, t h e review c r i te r ia , and t h e method o f applying can be obtained by con tac t ing :


. D r . Susan B. Spring Program Di rec to r DNA Virus S t u d i e s I Bio log ica l Carcinogenesis Branch Divis ion of Cancer Et io logy National Cancer I n s t i t u t e Executive P laza North, Room 540 Bethesda, Maryland 20892 Telephone: (301) 496-4533

Writ ten or t e lephone i n q u i r i e s concerning t h e o b j e c t i v e s and scope of t h i s RFA or i n q u i r i e s about whether or not s p e c i f i c proposed research would be responsive are encouraged and should be d i r e c t e d t o D r . Susan B. Spring a t t h e above addres s . The program d i r e c t o r welcomes t h e oppor tuni ty t o c l a r i f y anyi s s u e s or ques t ions from p o t e n t i a l app l i can t s .

DEVELOPMENT OF SOMATIC CELL GENE THERAPY APPROACHES FOR SPECIFIC INBORN METABOLIC DISEASES

RFA AVAILABLE: 89-DK-04

P.T. 34; K.W. 0715135, 1002058, 0780015, 0755020

Nat iona l I n s t i t u t e o f Diabetes and Diges t ive and Kidney Diseases

Appl ica t ion Receipt Date: J u l y 15, 1989

INTRODUCTION AND BACKGROUND

The Metabolic Diseases and t h e Cys t ic F i b r o s i s Research Programs, Div is ion o f Diabetes , Endocrinology and Metabolic Diseases, support b a s i c and c l i n i c a l r e sea rch and r e sea rch t r a i n i n g r e l a t e d t o t h e e t io logy , d iagnos is , p revent ion and t rea tment o f inborn metabol ic d i s e a s e s such as: c y s t i c f i b r o s i s (CF),o t h e r d i s e a s e s o f t r a n s p o r t , aminoacidemias, o rganic a c i d u r i a s , lysosomal s t o r a g e d i s e a s e s , d i s e a s e s o f pur ine and pyrimidine metabolism, glycogen s to rage d i seases , d i s e a s e s o f copper metabolism, h e r e d i t a r y amyloidosis, etc. This i n i t i a t i v e is an important component o f a broad program f o r t h e development or improvement o f t h e r a p i e s f o r orphan d i seases . This i n i t i a t i v e is intended t o encourage q u a l i f i e d s c i e n t i s t s t o submit r egu la r r e sea rch p r o j e c t g ran t (Rol l or program p r o j e c t g ran t (PO11 a p p l i c a t i o n s which propose novel s t u d i e s t o f a c i l i t a t e development o f approaches t o somatic c e l l genetherapy . For t h e purposes o f t h i s program gene therapy is def ined as a molecular g e n e t i c t h e r a p e u t i c approach t h a t u t i l i z e s somatic ce l l genet r a n s f e r t o c o r r e c t or amel io ra t e t h e inborn error.

-OBJECTIVES AND SCOPE

This program is intended t o encourage submission o f proposa ls t o develop approaches t o human gene therapy f o r inborn metabol ic d i s e a s e s . Areas of r e sea rch inc lude but are no t l i m i t e d t o t h e fol lowing: development of more e f f i c i e n t and more r a p i d approaches t o chromosomal l o c a l i z a t i o n of r e l e v a n t genes; i d e n t i f i c a t i o n and c h a r a c t e r i z a t i o n o f r e t r o v i r a l and o t h e r v e c t o r s s u i t a b l e for gene t r a n s f e c t i o n ; development o f e f f i c i e n t gene t r a n s f e c t i o n t echniques ; development o f techniques f o r homologous recombination of t r a n s f e c t e d gene/s and t h e hos t chromosome i n ce l l s , or m i c e or o t h e r animals t h a t s e rve as models f o r s p e c i f i c metabol ic d i seases ; development o f c e l l l i n e s and/or mouse models s u i t a b l e f o r gene therapy s t u d i e s ; development o f t echniques for i s o l a t i o n and maintenance o f hos t c e l l s s u i t a b l e f o r genetherapy; and in t roduc t ion o f t h e t r a n s f e c t e d ce l l i n t o t h e r e l evan t t a r g e t organs o f an animal model and t h e s tudy o f i n v ivo express ion o f t h e f u n c t i o n a l p r o t e i n .

This program is intended t o s t i m u l a t e b a s i c r e sea rch and development o f t echniques focused on achiev ing success fu l human gene therapy . I n t h i s regard , s t u d i e s on t h e gene ra l mechanisms o f recombination and t r a n s f e c t i o n are no t s u i t a b l e .

MECHANISM OF SUPPORT

- The mechanism o f support for t h i s program w i l l be t h e grant- in-aid ( R o l l and t h e program p r o j e c t g ran t ( P o l ) . Although t h i s s o l i c i t a t i o n is included i n t h e funding p l ans f o r F i s c a l Year 1990 f o r N I D D K , support is cont ingent upona c t u a l a v a i l a b i l i t y o f appropr ia ted funds. The N I D D K p l ans t o des igna te a t o t a l o f $2.0 m i l l i o n ( d i r e c t and i n d i r e c t c o s t s ) f o r t h e support o f a p p l i c a t i o n s submit ted i n response t o t h i s s o l i c i t a t i o n ; however, t h e amounts t o be awarded w i l l depend upon t h e o v e r a l l m e r i t , budget, and scope of t h e


* '. - . L

a p p l i c a t i o n s rece ived . It is a n t i c i p a t e d t h a t approximately 5 t o 10 g r a n t sw i l l be awarded under t h i s s o l i c i t a t i o n .

APPLICATION AND REVIEW PROCEDURES

Appl ica t ions must be submitted on Form PHS 398 ( r ev i sed 9/86), a v a i l a b l e a t* most i n s t i t u t i o n a l bus iness o f f i c e s or from t h e Div is ion o f Research Grants,N I H . To i d e n t i f y t h e a p p l i c a t i o n as a response t o t h i s RFA, p l ease check "Yes" on i t e m two o f page one o f t h e a p p l i c a t i o n and e n t e r "NIDDK-RFA-89-DK-04 on "Somatic C e l l Gene Therapy Approaches". The RFA l a b e l (found i n t h e 9/86r e v i s i o n o f a p p l i c a t i o n form PHS 398) must be a f f i x e d t o t h e bottom of t h e f ace page o f t h e o r g i n a l copy o f t h e a p p l i c a t i o n . Appl ica t ions rece ived i n response t o t h i s s o l i c i t a t i o 9 w i l l be reviewed i n accord with t h e usua l N I H peer review procedures . It is expected t h a t s i t e v i s i t s w i l l no t be conducted and t h e r e f o r e t h e submit ted a p p l i c a t i o n s should be complete and s t and a lone f o r purposes o f review.

If an a p p l i c a t i o n submit ted i n reponse t o t h i s RFA is i d e n t i c a l t o a r e sea rch g ran t a p p l i c a t i o n a l r eady submit ted t o t h e N I H f o r review, t h e a p p l i c a n t w i l l be asked t o withdraw t h e pending a p p l i c a t i o n before t h e new one is accepted.Simultaneous submission o f i d e n t i c a l a p p l i c a t i o n s w i l l no t be allowed. Both a PO1 a p p l i c a t i o n and t h e p r o j e c t s which are components of t h i s PO1 may no t be submit ted s imultaneously i n response t o t h i s RFA.

A s i n g l e r e p l y d a t e of J u l y 15, 1989, w i l l be s t r i c t l y enforced. An a n t i c i p a t e d schedule f o r review and award is d e t a i l e d below:

APPLICATION INITIAL COUNCIL EARLIEST RECEIPT REVIEW REVIEW START DATE

J u l y 15, 1989 Oct/Nov 1989 Feb. 1990 Apr i l 1990

The o r i g i n a l and fou r cop ie s o f t h e a p p l i c a t i o n should be s e n t t o :

Div is ion o f Research Grants Nat ional I n s t i t u t e s o f Health Westwood Building, Room 240 Bethesda, Maryland 20892XX

Two a d d i t i o n a l copies o f t h e a p p l i c a t i o n are t o be s e n t t o :

Review Branch Nat ional I n s t i t u t e of Diabetes and Diges t ive

and Kidney Diseases, N I H Westwood Building, Room 406 Bethesda, Maryland 20892

CONSULTATION WITH PROGRAM STAFF

Prospec t ive a p p l i c a n t s are encouraged t o reques t a copy o f t h e complete RFA and t o d i s c u s s t h e i r i d e a s wi th Program s t a f f (see below) t o determine whether t h e y f i t g u i d e l i n e s of t h i s RFA. Appl icants who in t end t o submit PO1 a p p l i c a t i o n s should r eques t a copy o f N I D D K ' s gu ide l ines f o r program p r o j e c tg r a n t s .

Robert Katz, Ph.D. Nancy Lamontagne, Ph.D. Di rec to r , Metabolic Diseases Di rec to r , Cys t i c F i b r o s i s

Research Program, N I D D K Program, N I D D K Westwood Building, Room 607A Westwood Building, Room 607 Bethesda, Maryland 20892 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-7997 Telephone: ( 3 0 1 ) 496-4980

This program is descr ibed i n t h e Catalog o f Federa l Domestic Ass is tance ,No.13.847, Diabetes , Endocrinology, and Metabolic Diseases. Awards w i l l be made under t h e a u t h o r i t y o f t h e Publ ic Heal th Se rv ice A c t , T i t l e 111, Sec t ion 301, (Pub l i c Law 78-4101, as amended; 42 USC 241) and adminis tered under PHS g ran t p o l i c i e s and Federa l Regulat ions, most s p e c i f i c a l l y a t 42 CFR Pa r t 52 and CFR P a r t 74. This program is not s u b j e c t t o t h e intergovernmental review requirements o f Executive Order 12372 or Health Systems Agency review.

XXTHE HAILING ADDRESS G I V E N FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF I N THE WESTWOOD BUILDING I S THE CENTRAL M A I L I N G ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S

W REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS : 5333 Westbard Avenue

, Bethesda, Maryland 20816


nih guide - vol. 18, no. 2 - january 20, 1989'w vol. 18, no. 2, january 20, 1989 ......

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