nih guide - vol. 20, no. 43 - november 15, 1991 institute of child health and hunan developnent...

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The NIH Guide announces scientific initiatives and provides policy and administrative information t o indivi duals and organizationswho need to be kept informedofopponunities, requirements.and changes in extramuralp r o ~ d m sadministeredby the National Institutes of Health.

Vo l . 20 , N o . 4 3 N o v e m b e r 15, 1991

N I H GUIDE - Vol. 20, No. 43 - November 15, 1991

NOTICES

NATIONAL WORKSHOPS ON THE PROTECTION OF HUMAN SUBJECTS . . . . . . . . . . . . . . . . . . . . . . . . 1 National I n s t i t u t e s o f Health Food and Drug Admin is t ra t ion INDEX: NATIONAL INSTITUTES OF HEALTH, FOOD AND DRUG ADMINISTRATION

NOTICES OF AVAILABILITY (RFPs AND RFAs)

CLOSED LOOP CONTROL OF FUNCTIONAL NEUROMUSCULAR STIMULATION (NIH-NINDS-92-01) . . . . . . . . . . . . . . 2 National I n s t i t u t e o f Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE

DEVELOPMENT AND TESTING OF NEW SPERMICIDES (NICHD-BAA-92-61 . . . . . . . . . . . . . . . . . . . . . . 2 National I n s t i t u t e o f C h i l d Health and Hunan Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT

GMP FORMULATION OF PEPTIDE T (SOURCES SOUGHT1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 National I n s t i t u t e o f Mental Health INDEX: MENTAL HEALTH

BASIC RESEARCH ON GROWTH REGULATION I N BENIGN PROSTATIC HYPERPLASIA (DK-92-13 . . . . . . . . . . . . . . 3 National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES

SKIN DISEASES RESEARCH CORE CENTERS (AR-92-01) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 National I n s t i t u t e o f A r t h r i t i s and Musculoskeletal and Skin Diseases INDEX: ARTHRIT IS , MUSCULOSKELETAL, S K I N DISEASES

OBESITY/NUTRITION RESEARCH CENTERS (DK/HD-92-061 . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases National I n s t i t u t e o f C h i l d Health and Human Development INDEX: DIABETES, D IGESTIVE, KIDNEY DISEASES, CHILD HEALTH, HUMAN DEVELOPMENT

DEVELOPMENT OF BIOMARKERS OF A G I N G (AG-91-17) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 National I n s t i t u t e on Aging INDEX: AGING

NOT ICES 'd NATIONAL UORKSHWJS ON THE PROTECTIOW OF H W N SUBJECTS

P.T. 42; K.W. 0783005

Nat ional I n s t i t u t e s of Health Food and Drug Admin is t ra t ion

The Nat ional I n s t i t u t e s o f Health ( N I H ) and the Food and Drug Administrat ion (FDA) are sponsoring a ser ies of uorkshops on the r e s p o n s i b i l i t i e s o f researchers, I n s t i t u t i o n a l Review Boards (IRBs), and i n s t i t u t i o n a l o f f i c i a l s f o r the p ro tec t i on o f human subjects i n research. The uorkshops are open t o everyone wi th an i n te res t i n research i nvo l v ing human subjects. The meetings should be of special i n t e r e s t t o those persons cu r ren t l y serving o r about t o begin serv ing as a member of an IRB. Issues discussed a t these workshops are relevant t o a l l other Publ ic Health Service agencies. The current schedule incLudes the fo l l ou ing :

WEST COAST WORKSHOP

DATES: January 23 and 24, 1992 (REVISED DATES)

WORKSHOP S I T E : Los Angeles, CA

SPONSORS: Un ive rs i t y o f Southern Ca l i f o rn ia Los Angeles, CA 90089-4014

C a l i f o r n i a State Un ive rs i t y - Los Angeles 5151 State Un ive rs i t y Dr ive Los Angeles, CA 90032-8202

N I H Guide f o r Grants and Contracts - Vol. 20, No. 43 - November 15, 1991 1

REGISTRATION CONTACT: Ms. L i l y Patterson Assistant t o the D i rec to r Research and Sponsored Programs Ca l i f o rn ia State Un ive rs i t y - Los Angeles 5151 State Un ive rs i t y D r i ve Los Angeles, CA 90032-8202

bJ Telephone: (213) 343-3820

TOPIC: Uhose Research i s i t Anyway? A Uorkshop on the Protect ion o f Hunan Subjects i n Research

For fu r the r informat ion regarding these workshops and fu tu re NIH/FDA Nat ional Protect ion o f Hunan Subjects Workshops, please contact:

Ms. Darlene Marie Ross Executive Assistant f o r Education D i v i s i o n o f Human Subject Protect ions O f f i c e f o r Protect ion from Research Risks National I n s t i t u t e s o f Health 9000 Rockv i l le Pike Bui ld ing 31, Room 5B59 Bethesda, MD 20892 Telephone: (301) 496-8101

NOTICES OF AVAILABILITY (RFPs AND RFAs)

CLOSED LOOP a T R O L OF FUNCTIONAL NEURMJSCULAR STIWLATION

RFP AVAILABLE: NIH-NINDS-92-01

P.T. 34; K.U. 0745047, 0740050, 0706040, 0715140

Nat ional I n s t i t u t e o f Neurological Disorders and Stroke

The Neural Prosthesis Program of the National I n s t i t u t e o f Neurological Disorders and Stroke (NINDS), N IH , i s developing neural prostheses based on funct ional neuromuscular s t imu la t i on (FNS) f o r the res to ra t i on of quadr ip legic ind iv iduals . The p r i n c i p a l goal o f the proposed p ro jec t i s t o enhance the u t i l i t y of FNS systems f o r hand grasp. Speci f ic tasks include: developing and evaluat ing closed-loop FNS systems f o r hand grasp u t i l i z i n g external force and p o s i t i o n i n teg ra t i ng FNS wr i s t s tab i l i za t i on , FNS elbow con t ro l and surg ica l procedures such as tendon t ransfer and arthrodesis w i th an FNS hand grasp system; developing a biomechanical model o f the hand f o r use i n evaluat ing advanced FNS systems; and invest igat ing new techniques f o r programing

''cuJ o f FNS systems and f o r se lec t i on of e lectrode s i tes. A research team w i th experience i n neural prostheses, sp ina l cord rehab i l i t a t i on , hand surgery, con t ro l theory, biomechanics and physiology w i 11 be required t o successfu l ly conduct t h i s research. I t i s ant ic ipated tha t one award w i l l be made f o r a per iod o f three years i n August 1992.

This i s not a Request f o r Proposals (RFP). To receive a copy o f the RFP, submit a w r i t t e n request t o the fo l lowing address, and supply t h i s o f f i c e wi th two sel f -addressedmai l ing labels. A l l responsible sources s h a l l be considered by the agency. The RFP w i l l be issued on or about November 15, 1991, w i th proposals due on January 14, 1992.

Contracting O f f i c e r Contracts Management Branch, DEA National I n s t i t u t e of Neurological Disorders and Stroke Federal Bui ld ing, Room 901 7550 Wisconsin Avenue Bethesda, MD 20892 Attent ion: RFP No. NIH-NINDS-92-01

DEVELOF'MENT AND TESTING OF NEY SPERHICIDES

RFP AVAILABLE: NICHD-BAA-92-6

P.T. 34; K.U. 0750020, 0715182

Nat ional I n s t i t u t e of Ch i l d Health and Human Development

The Contraceptive Development Branch o f the Center f o r Population Research, Nat ional I n s t i t u t e o f Ch i l d Health and Hunan Development ( N I C H D ) , has a requirement t o develop new spermicidal products tha t w i l l incorporate e i t h e r new spermicidal drugs or new formulations o f ex i s t i ng drugs. The products must be developed as s ing le dose un i t s . The desired cha rac te r i s t i cs of the f i n a l product should include: (1) high contracept ive effectiveness, together wi th the a b i l i t y t o protect the user against STDs; (2) employ vehic les f o r rap id

N I H Guide f o r Grants and Contracts - Vol. 20, No. 43 - November 15, 1991 trr4 2

spermicide del ivery; (3) can pro tec t vaginal and cerv ica l e p i t h e l i a from i r r i t a t i o n ; and (4) are long-acting a f t e r a s ing le appl icat ion. Both p r e c l i n i c a l and c l i n i c a l studies u i t h neu products u i l l be considered. I t i s an t ic ipa ted tha t three contract auards u i l l be made f o r a m a x i m per iod o f four years each, depending upon the nature and complexity o f the proposed research.

This announcement i s not a Request f o r Proposals (RFP). The RFP u i l l be issued on o r about November 15, 1991. Proposals u i l l be due approximately four months thereafter. Copies o f the RFP may be obtained by sending u r i t t e n requests u i t h a self-addressed label to:

Paul J. Duska, Contracting O f f i ce r Contracts Management Branch, OGC National I n s t i t u t e o f Ch i l d Health and Hunan Developnent Executive Plaza North, Room 610 9000 Rockvi 1 l e Pike Bethesda, MO 20892 FAX: (301) 402-0915

W FORWLATIOW OF PEPTIDE 1

SOURCES SOUGHT

P.T. 34; K.W. 0740021, 0755010

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

The National I n s t i t u t e o f Mental Health ( N I M H ) i s cu r ren t l y involved i n the c l i n i c a l t es t i ng o f Peptide T. The NIMH i s seeking a contractor capable o f formulat ing and producing dosage forms, car ry ing out q u a l i t y con t ro l and s t a b i l i t y tests, packaging, label ing, storage and shipment o f products, and preparing documentation. The data prepared must be adequate t o support chemistry requirements o f Inves t iga t iona l Neu Drug o r Neu Drug Appl icat ions submitted by NIMH or NIMH-supported inves t iga tors t o the Food 8 Drug Administrat ion. The dosage form t o be produced includes intranasal formulations and u i l l involve compounding, s t e r i l i z i n g , and sa fe ty t es t i ng bu lk pyrogen-free aqueous so lu t ions according t o standardized pharmaceutical formulations and USP methods and the FDA Good Manufacturing Procedures (GMP). The NIMH u i l l provide bu lk drug substances, assay methodology, and reference standards. The contractor must provide uashed and s t e r i l i z e d containers (capable o f administer ing metered doses o f intranasal so lu t ion) t o be f i l l e d u i t h 20 m l o f s t e r i l i z e d peptide solut ion, cap, label, and package according t o spec i f i ca t ions provided by the Goverrment, and re f r igera te . The contractor s h a l l be responsible f o r s t e r i l i t y and bioburden test ing, HPLC analysis, storage, and shipping o f the f i n a l product. The work requires tha t the cont rac tor ' s f a c i l i t y be maintained i n accordance u i t h FDA prescribed Current Good Manufacturing and Laboratory Practices. I t i s an t ic ipa ted tha t the N I M H may s o l i c i t proposals a t a l a t e r date f o r preparat ion o f approximately 10,000 v ia ls .

In te res ted pa r t i es may submit a capab i l i t y statement tha t describes the GMP f a c i l i t i e s , technical expert ise t o provide the above services, and expected timeframe f o r completion of services. In te res ted pa r t i es are requested t o respond u i t h i n 21 days o f the date o f t h i s announcement to:

LouEllen M. Rice Contracting O f f i ce r Contracts Management Branch National I n s t i t u t e o f Mental Health 5600 Fishers Lane, Room 7C-18 Rockvi l le, MD 20857

BASIC RESEARCH ON G R W H REGULATIOll I N BENIGN PROSTATIC HYPERPLASIA

RFA AVAILABLE: DK-92-13

P.T. 34; K.W. 0715105, 0760020, 0765015, 1002004, 1002008

Nat ional I n s t i t u t e o f Diabetes and D iges t ive and Kidney Diseases

Le t te r o f I n ten t Receipt Date: November 30, 1991 App l ica t ion Receipt Date: February 18, 1992

PURPOSE

The D i v i s i o n o f Kidney, Urologic and Hematologic Diseases (DKUHD) of the National I n s t i t u t e o f Diabetes and D iges t ive and Kidney Diseases (NIDDK) announces the a v a i l a b i l i t y o f a Request f o r Appl icat ions (RFA) from new and experienced inves t iga tors f o r research tha t u i l l u t i l i z e s ta te -o f - the -a r t ce l l u la r , molecular, and genetic techniques t o e luc ida te the features o f prostate growth regu la t ion that are unique t o the development o f benign p ros ta t i c hyperplasia (BPH). The purpose of t h i s R F A i s t o gain new ins igh ts i n t o the fac to rs tha t i n i t i a t e and regulate benign hyperp las t ic growth i n normal p ros ta t i c t issues. The u t i l i z a t i o n of transgenic animal models and c e l l and t i ssue cu l tu res tha t d isp lay the features o f human BPH i s encouraged i n t h i s RFA.


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BACKGRWND

BPH i s a major cause of morbidity in the adu l t male. The diagnosis and treatment o f t h i s disorder contr ibutes s i g n i f i c a n t l y t o hea l th care expenditures worldwide. The spontaneous i n i t i a t i o n o f the benign hyperplast ic growth o f the mature pros ta te gland i s a c l i n i c a l event t ha t i s unique t o primates and a few other animals. Although i t has been amply demonstrated tha t normal and abnormal prostate growth i s dependant on the presence of androgens, the fac to rs tha t i n i t i a t e and regulate the benign hyperplast ic growth o f the mature pros ta te have not been adequately elucidated.

RESEARCH GOALS AND SCOPE

The ove ra l l goal of t h i s request i s t o increase the knowledge o f the i n i t i a t i o n and regu la t ion o f the growth o f the pros ta te gland as i t appl ies t o the development o f BPH.

The purpose of t h i s RFA i s t o fund inves t iga tors who use techniques and models t o go beyond the normal endocrine regulatory mechanisms already demonstrated f o r prostate growth and look a t the r o l e o f such fac to rs as peptide growth factors, inter leukins, oncogenes, col lagen synthesis, calmodulin, ex t race l l u la r matrix, apoptosis, and inf lamnatory mediators, i n the i n i t i a t i o n and regu la t ion o f benign hyperplast ic p ros ta te growth. Appl icat ions are not l i m i t e d t o the aforementioned fac to rs but must develop innovative approaches using proven f ind ings from other spontaneous hyperplast ic disorders such as keloids, adrenal hyperplasia, t i ssue regeneration, and mesangial c e l l hyperplasia.

A major goal o f t h i s i n i t i a t i v e i s t o fos te r extensive co l labora t ion between the various d i sc ip l i nes o f the basic sciences inc lud ing biochemistry, c e l l u l a r biology, embryology, endocrinology, molecular genetics, immunology, pharmacology and physiology and research d i sc ip l i nes i n the c l i n i c a l sciences such as dermatology, nephrology, and endocrinology, in developing new models f o r inves t iga t ing the basic science aspects o f th is s i g n i f i c a n t c l i n i c a l problem.

I t i s not the i n ten t o f t h i s i n i t i a t i v e t o fund pro jec ts tha t w i l l e lucidate s o l e l y the s t ruc tu re o f s te ro id hormone receptors i n the pros ta te c e l l o r fu r ther character ize only the r o l e o f the sex hormones i n prostate growth. APPLICATIONS THAT U T I L I Z E MALIGNANT CELL L INES OR CANCER TUMOR MODELS TO REPRESENT NORMAL OR BENIGN HYPERPLASTIC GROWTH WILL NOT BE FUNDED BY T H I S RFA.

Appl icat ions are s t rong ly encouraged tha t inves t iga te the i n te rac t i on o f the known promoters and regulators o f p ros ta te growth, such as androgens, w i th other fac to rs i n t r i n s i c and e x t r i n s i c t o the pros ta te gland, such as growth fac to rs and in te r leuk ins .

ELIGIBILITY REQUIREMENTS

Appl icat ions may be submitted by domestic and foreign, f o r - p r o f i t and non-pro f i t , pub l i c and p r i va te organizations, such as un ive rs i t i es , colleges, hospi ta ls, laboratories, and e l i g i b l e agencies o f the Federal Government. Appl icat ions from mino r i t y ind iv idua ls and from u m n are espec ia l l y encouraged.

MECHANISM OF SUPPORT

Support f o r t h i s program w i l l be through the t r a d i t i o n a l i n v e s t i g a t o r - i n i t i a t e d research grant ( R O I ) . The regulat ions and p o l i c i e s tha t govern the research programs o f the National I n s t i t u t e s o f Health w i l l p reva i l . Support w i l l be provided f o r up t o f i v e years.

FUNDS AVAILABLE

For FY 1992, $1.25 m i l l i o n i n t o t a l costs per year w i l l be comnitted t o fund app l ica t ions submitted i n response t o t h i s RFA. I t i s an t ic ipa ted tha t f i v e t o seven awards w i l l be made. Applicants must l i m i t the budget requests t o no more than $160,000 i n d i r e c t costs f o r the f i r s t year.

APPLICATION PROCEDURES

Appl icat ions must be submitted using Form PHS 398 (rev. 10/88) , ava i lab le i n the business o r grants o f f i c e s of most academic o r research i n s t i t u t i o n s and from the Of f i ce o f Grants Inquir ies, D iv i s ion o f Research Grants, National I n s t i t u t e s o f Health, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441.

Appl icat ions must be received by close o f business on February 18, 1992.

Deta i led i ns t ruc t i ons on app l i ca t i on submission are described i n the RFA.

REVIEW PROCEDURES

Appl icat ions tha t are not responsive t o the research goals and scope o f t h i s RFA w i l l be returned t o the invest igator. Acceptable appl icat ions received i n response t o t h i s RFA w i l l f i r s t be reviewed f o r s c i e n t i f i c and technical mer i t by an I n i t i a l Review Group convened by the Review Branch, D iv i s ion o f Extramural Program A c t i v i t i e s , NIDDK. A secondary review f o r p o l i c y and program relevance t o the NIDDK mission w i l l be made by the National Diabetes and Digest ive and Kidney Diseases Advisory Council.


INQUIR IES

I t i s IMPERATIVE tha t the RFA be obtained by a l l prospective appl icants p r i o r t o developing an appl icat ion. Requests f o r the RFA and any other i nqu i r i es regarding i t may be addressed to:

Leroy M. Nyberg, Jr., Ph.D., M.D. Director, Urology Program, DKUHD National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases Uestwood Bui ld ing, Room 3A-05 Bethesda, MD 20892 Telephone: (301) 496-7133 FAX: (301) 496-9721

AUTHORITY AND REGULATIONS

This program i s described i n the Catalog o f Federal Domestic Assistance No. 93.849. Awards w i l l be made under the au tho r i t y o f the Pub l ic Health Service Act, T i t l e 111, Section 301 and Section 431 (b) (Publ ic Law 78-410, as amended: 42 USC 241 and 42 USC 285c-5) and administered under PHS grants p o l i c i e s and Federal Regulations 42 CFR Par t 52 and CFR Part 74. This program i s not subject t o the i n t e r g o v e r m n t a l review requirements of Executive Order 12372 or Health Systems Agency review.

SKIN DISEASES RESEARCH CORE CENTERS

RFA AVAILABLE: AR-92-01

P.T. 04; K.W. 0715185, 0710030

National I n s t i t u t e o f A r t h r i t i s and Musculoskeletal and Skin Diseases

App l ica t ion Receipt Date: April 22, 1992

BACKGROUND

The National I n s t i t u t e o f A r t h r i t i s and Musculoskeletal and Skin Diseases (NIAMS) announces the a v a i l a b i l i t y o f a Request f o r Appl icat ions (RFA) f o r research core centers in s k i n diseases. The Skin Diseases Research Core Centers (SDRCs) w i l l provide the resources f o r a nunber o f established, cu r ren t l y funded invest igators, o f ten from d i f f e r e n t d isc ip l ines , t o adopt a mu l t i d i sc ip l i na ry approach t o c m n research problems i n sk in diseases and t o ensure greater p roduc t i v i t y through in te rac t i on among the inves t iga tors o f i n d i v i d u a l l y funded research projects. New research d i rec t i ons are encouraged through a p i l o t and f e a s i b i l i t y component.

RESEARCH GOALS AND SCOPE

Research i n s k i n diseases i s a t a stage where broad advances can be e f f e c t i v e l y fostered by research core centers. Examples o f advances include, but are not l i m i t e d to:

o s t ra tun corneun: biochemistry, structure, func t ion o epidermis: d i f f erent ia t ion, kera t in iza t ion , ce l l u l a r const i tuents o dermal-epidermal junct ion: structure, functions, diseases o s k i n as an imnunological organ o autoimnune s k i n diseases o dermis: s t ruc tu ra l components, diseases

The choice o f research problems upon which the SDRC would focus i s made by the P r inc ipa l Inves t iga tor and co l labora t ing cu r ren t l y funded invest igators.

E L I G I B I L I T Y

Appl icat ions may be submitted by domestic, nonprof i t , pub l i c and p r i va te organizations, such as un ivers i t ies , colleges, hospi ta ls, laborator ies, u n i t s o f State or loca l gove rmnts , and e l i g i b l e agencies of the Federal goverrment. Appl icat ions from minor i t y ind iv idua ls and women are encouraged.


The SDRC (P30) i s a mechanism f o r integrat ing, coordinating, and fos te r ing the i n t e r d i s c i p l i n a r y cooperation of a group of establ ished inves t iga tors conducting programs o f act ive, h igh -qua l i t y research tha t r e l a t e t o a c m n theme. The SDRC provides support fo r :

o Core resources and f a c i l i t i e s t o be used by inves t iga tors o f i n d i v i d u a l l y supported research pro jec ts i n order t o enhance and coordinate t h e i r a c t i v i t i e s . This support may include personnel, equipment, supplies, services, and f a c i l i t i e s .

o L i m i t e d funds f o r p i l o t and f e a s i b i l i t y studies.

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1

o Program enrichment a c t i v i t i e s .

The NIAMS intends t o fund two Skin Disease Research Core Centers i n FY 92, subject t o the a v a i l a b i l i t y of resources and the rece ip t o f s u f f i c i e n t l y mer i tor ious applications, each wi th a year ly d i r e c t cost budget of up t o S400,OOO. The funding per iod i s f i v e years.

SPECIAL INSTRUCTIONS FOR INCLUSION OF UOMEN AND M I N O R I T I E S I N CLINICAL RESEARCH STUDIES%,+, For p ro jec ts invo lv ing c l i n i c a l research, N l H requires appl icants t o g ive specia l a t t e n t i o n t o the inc lus ion of women and m i n o r i t i e s i n study populations. I f women or minor i t ies are not included i n the study populations fo r c l i n i c a l studies, a s p e c i f i c j u s t i f i c a t i o n f o r t h i s exclusion must be provided. Applications without such docunentation w i l l not be accepted f o r review.

APPLICATION GUIDELINES

Applicants must contact the NIAMS s t a f f f o r the de ta i led guidel ines f o r the SDRC grant appl icat ion. Appl icat ions must be submitted on Form PHS 398 (rev. 10/88), which i s ava i lab le i n the i n s t i t u t i o n ’ s business o f f i c e and f romthe O f f i c e o f Grants Inqui r ies, D i v i s i o n o f Research Grants, National I n s t i t u t e s o f Health, Room 449, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441.

A l l PHS and N I H grant p o l i c i e s governing research pro jec t grants apply t o appl icat ions received i n response t o t h i s RFA.

DEADLINES

Let te r o f I n t e n t rece ip t date: February 17, 1992 Appl icat ion receipt date: A p r i l 22, 1992 Ad Hoc S t u d y Section review: June/July 1992 NIAMS Advisory Council Review: September 1992 Ant ic ipated award date: September 1992

INQUIRIES

Further in format ion on the program, inc lud ing the guidel ines f o r the Skin Diseases Research Core Centers, may be obtained from:

J u l i a B. Freeman, Ph.D. Director , Centers Programs National I n s t i t u t e o f A r t h r i t i s and Musculoskeletal and Skin Diseases Westwood Building, Room 403

“icr( Bethesda, MD 20892 Telephone: (301)496-7495

For f i s c a l and admin is t ra t ive matters, contact:

Mary Graham Grants Management Spec ia l i s t National I n s t i t u t e o f A r t h r i t i s and Musculoskeletal and Skin Diseases Westwood Building, Room 403 Bethesda, MD 20892 Telephone: (3011 496-7495


This program i s described in the Catalog o f Federal Domestic Assistance No. 93.846. Grants are auarded under the a u t h o r i t y o f the Publ ic Health Service Act, Section 301 (42 USC 241) and administered under PHS grants p o l i c i e s and Federal Regulations, most s p e c i f i c a l l y a t 42 CFR Part 52 and 45 CFR Part 74. This program i s not subject t o the i n t e r g o v e r m n t a l review requirements o f Executive Order 12372 or review by a Health Systems Agency.

OBESITY/NUTRITIOW RESEARCH CENTERS

RFA AVAILABLE: DK/HD-92-06

P.T. 04; K.U. 0715145, 0765020, 0710095, 0710030

National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases National I n s t i t u t e o f Ch i ld Health and Hmn Development

Le t te r o f In ten t Receipt Date: January 15, 1992 Appl icat ion Receipt Date: March 25, 1992

‘uclrl, N I H Guide fo r Grants and Contracts - Vol. 20, No. 43 -

6 November 15, 1991

PURPOSE

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute of Child Health and Hunan Development (NICHD) announce the availability of a Request for Applications (RFA) entitled ooObesity/NutritionResearch Centers##for conducting basic and clinical research on obesity and in the related fields of energy metabolism, body composition, satiety, adipocyte metabolism, eating disorders, and weight management. These centers will be awarded in Fiscal Year 1992. The award of three Obesity/Nutrition Research Centers by NIDDK and one Obesity/Nutrition Research Center by NICHD is anticipated.

OBJECTIVE AND SCOPE

The objectives of the Core Center are to encourage a multidisciplinary approach to research in the nutritional sciences and to bring together, on a cooperative basis, clinical and basic science investigators in a manner that will enhance and extend the effectiveness of nutritional research being conducted in the field of obesity, eating disorders, and energy regulation. To accomplish the overall goal of these centers, there must be in existence at the applicant's institution an ongoing program of excellence in biomedical research related to the study of obesity. The research base in the nutritional sciences need not be exclusively in obesity and can include a focus on eating disorders, energy metabolism, cell biology, or nutrient metabolism. It would be highly desirable that the Principal Investigator, as well as the applicant institution, have a comnitment to the treatment and prevention of obesity. The availability of a clinic population uith adequate representation of women and minorities which can be readily utilized by investigators will play a major role in attractinginvestigators to the field of obesity research and to serve as a resource in the design of pilot and feasibility projects . SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDIES

For projects involving clinical research, N I H requires applicants to give special attention to the inclusion of women and minorities in study populations. If women or minorities are not included in the study populationsfor clinical studies, a specific justification for this exclusion must be provided. Applications without such documentation will not be accepted for review.

MECHANISM OF SUPPORI

Support of this program uill be by the Core Center Grant (P30) mechanism. An average Center may include about three to five pilot/feasibility projects and two to four core units. However, the actual cost of the Center will vary depending on the needs of the Center. In no case shall direct costs requested exceed $600,000 per year, nor shall the direct costs awarded exceed 8500,000 per year per Center. The anticipated awards uill be for five years and are contingent upon the availability of appropriated funds. Currently, funds totalling approximately 82.0 million (total costs) are available for support of this announcement. The award of three new Obesity/ Nutrition Research Centers by NIDDK and one Obesity/Nutrition Research Center by NICHD is anticipated.

METHOD OF APPLYING

Letter of Intent

Potential applicants are requested to submit a letter of intent by January 15, 1992. The letter of intent is non-binding, is not a necessary requirement for submission of an application, and is not a precondition for an award. Letters of intent are requested for review planning purposes. The NIDDK and NICHD will not specificallyrespond to such letters. Include in the letter of intent the name(s) of the Principal Investigator and principal collaborators, descriptive titles of the core facilities and pilot/feasibility projects, and the institutioncs) involved. Letters of intent are to be sent to:

Robert Hamnond, Ph.D. Chief, Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Uestwood Building, Room 406 Bethesda, MD 20892

Applications must be submitted using PHS 398 (rev. 10/88). Applications are available from the business or grants offices of most academic or research institutions and from the Office of Grants Inquiries, division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/496-7441.

INQUIRIES

I t is essential that prospective applicants obtain the RFA and the general description and guidelines for the Obesity Research/Nutrition Centers from:

NIH Guide for Grants and Contracts - Vol. 20, No. 43 - November 15, 1991 7

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Van S. Hubbard, M.D., Ph.D. Director, N u t r i t i o n a l Sciences Branch National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases Uestwood Building, Room 3A18B Bethesda, MD 20892 Telephone: (301) 496-7823 FAX: (301) 402-1278

Gilman Grave, M.D. Endocrinology, N u t r i t i o n and Growth Branch National I n s t i t u t e o f Ch i l d Health and Hunan Development Executive Plaza North, Room 637A 6130 Executive Boulevard Rockvi l le, MD 20892 Telephone: (301) 496-5593 FAX: (301) 402-2085

BUSINESS INFORMATION

Nancy Dixon Supervisory Grants Management Spec ia l i s t National I n s t i t u t e o f Diabetes and Digest ive and Kidney Diseases Uestuood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467

E. Douglas Shawver O f f i c e o f Grants and Contracts National I n s t i t u t e of Ch i l d Health and Human Development Executive Plaza North, Room 501 6130 Executive Boulevard Rockvi l le, MD 20892 Telephone: (301) 496-1303

REVIEW PROCEDURES

Appl icat ions f o r the Obes i ty /Nut r i t ion Research Center Grants w i l l be evaluated f o r s c i e n t i f i c merit by the N I H grant peer review process and subsequently by e i the r the NIDDK o r NICHD Advisory Council f o r program relevance and p o l i c y issues before awards f o r meri tor ious appl icat ions are made. The special s ing le rece ip t date f o r submissions i n response t o t h i s announcement i s March 25, 1992, wi th the e a r l i e s t funding being September 1992.

'',Wmrrf AUTHORITY AND REGULATIONS

This program i s described in the Catalog o f Federal Domestic Assistance No. 93. 848. Awards w i l l be made under the au tho r i t y of the Publ ic Health Service Act, T i t l e 111, Section 301 and Section 431 (b) (Publ ic Law 78-410, as amended: 42 USC 241 and 42 USC 285c-5) and a h i n i s t e r e d under PHS grants p o l i c i e s and Federal Regulations 42 CFR Par t 52 and CFR Par t 74. This program i s not subject t o the i n t e r g o v e r m n t a l review requirements o f Executive Order 12372 or Health Systems Agency review.

DEMLOF'MENT OF BIWRKERS OF AGING

RFA AVAILABLE: AG-91-17

P.T. 34; K.U. 0710010, 0760003, 0755018

National I n s t i t u t e on Aging

Le t te r o f I n ten t Receipt Date: December 16, 1991 Appl ica t ion Receipt Date: February 19, 1992

PURPOSE

The Biology o f Aging Program (BAP), National I n s t i t u t e on Aging (NIA) , announces the a v a i l a b i l i t y of a Request f o r Appl icat ions (RFA) f o r the development of biomarkers of aging using rodent animal models supplied by the NIA. The major goal of the research t o be supported i s t o continue the development o f a panel of rodent biomarkers of aging cons t i tu ted from the biomarkers developed i n response t o t h i s and a prev ious ly announced RFA (see Development o f B ioMrkers o f Aging, N I H GUIDE For Grants and Contracts, Vol. 16, No. 19, June 5 , 1987). To achieve t h i s goal, two separate types o f appl icat ions are s o l i c i t e d i n t h i s RFA: one type addresses the assessment of po ten t i a l biomarkers o f aging, and the other type addresses the s t a t i s t i c a l analyses o f these po ten t i a l biomarkers t o provide a panel o f s t a t i s t i c a l l y v a l i d biomarkers use fu l f o r t es t i ng fu tu re intervent ions i n the aging process.

N I H Guide f o r Grants and Contracts - Vol. 2 0 , No. 43 - November 1 5 , 1991 -4 8

ELIGIBILITY REQUIREMENTS

Appl icat ions may be submitted by domestic and foreign, f o r - p r o f i t and nonprof i t , pub l i c and pr ivate, such as un ive rs i t i es , colleges, hospi ta ls , laborator ies, u n i t s o f State o r l oca l governments, and e l i g i b l e agencies of the Federal Goverrment. Appl icat ions from mino r i t y i nd i v idua ls and women are encouraged.

For the purposes o f c o n t i n u i t y and t o receive the f u l l bene f i t o f 10 years o f focus and support i n biomarkers -’ o f aging research, appl icat ions u i l l be accepted from invest igators i n e i t h e r o f the f o l l o u i n g tuo categor ies

re la ted t o experience u i t h Biomarkers o f Aging Research: invest igators c u r r e n t l y conducting NIA-funded Biomarkers o f Aging research pro jects , or invest igators uho can demonstrate an a c t i v e research focus f o r the previous four o r m r e years on biomarkers of aging, regardless o f the source of research support, using the same rodent genotypes as are ava i l ab le from the NIA/National Center f o r Technological Research biomarker colony described below, are ab le and u i l l i n g t o use animals from the NI#/NCTR biomarker colony, and have su i tab le f a c i l i t i e s f o r housing these animals.

There are no s i m i l a r experience r e s t r i c t i o n s on the invest igators apply ing f o r the s t a t i s t i c a l analyses of biomarkers o f aging research.


This RFA u i l l use the Nat ional I n s t i t u t e s o f Health ( N I H ) research p ro jec t (R01) grant funding mechanism. Responsib i l i ty f o r the planning, d i rec t i on , and execution of the proposed p ro jec t u i l l be s o l e l y tha t o f the appl icant. Auards u i l l be adninistered under PHS grants p o l i c y as s tated in the Publ ic Health Service Po l i cy Statement, DHHS Pub l i ca t i on No. (OASH) 82-50,000, revised October 1, 1990.

FUNDS AVAILABLE

A t o t a l o f $2,000,000 i s expected t o be avai lab le f o r t h i s program i n FY 1993. Funds f o r subsequent years are expected t o range from $1,500,000 t o $2,000,000 per year. I t i s ant ic ipated tha t i nd i v idua l awards u i l l range from$75,000 t o $150,000 per year i n d i r e c t costs. Col laborat ive appl icat ions o r appl icat ions t o t e s t more than one type o f p o t e n t i a l biomarker may request more than $150,000 per year i n d i r e c t costs u i t h s u f f i c i e n t j u s t i f i c a t i o n . A maximun o f 14 awards f o r the Biomarker o f Aging Research and one auard f o r the S t a t i s t i c a l Analysis o f the Biomarkers of Aging Research are ant ic ipated.

The auard o f grants pursuant t o t h i s RFA i s contingent upon receipt o f appropriated funds f o r t h i s purpose. This RFA i s a one-time i n v i t a t i o n . There are no plans f o r f u tu re reissuance. The du ra t i on of proposed pro jects may be up t o f i v e years. The s t a r t date f o r funded pro jects u i l l be approximately Apr i l 1, 1993.

RESEARCH OBJECTIVES

This RFA i s t o encourage the continued development of research p ro jec ts tha t u t i l i z e the ava i l ab le colony o f rodents t o conduct biomarker research. Tuo types of appl icat ions u i l l be considered:

Appl icat ions f o r Biomarkers of Aging Research: The object ive of appl icat ions submitted i n response t o t h i s request must be the continued developnent and tes t i ng of one o r more biomarkers of aging using gene t i ca l l y def ined mice and/or r a t s obtained from the NIA /NCTR biomarker research colony. I n order t o a l l o u f o r the developnent o f a broadly based panel o f biomarkers, appl icat ions are s o l i c i t e d from a v ide v a r i e t y o f possible approaches.

By the f i n a l year o f the proposed pro ject , the invest igator u i l l be expected t o obta in data f o r the proposed biomarker using non- invasive methods, and the proposed biomarker must be appl icable t o the human population.

The research p lan f o r biomarker development must include evaluat ion o f each p o t e n t i a l biomarker f o r rep roduc ib i l i t y , s e n s i t i v i t y , s ign i f icance o f r a t e o f change over the l i fespan, temporal pa t te rn of changes, non - le tha l i t y , degree of invasiveness required, po ten t i a l funct ional importance t o human aging, s imp l i c i t y , and cost-ef fect iveness.

As one s tep in a p lan t o implement tes t i ng o f po ten t i a l biomarkers, the N I A , in co l l abo ra t i on u i t h the NCTR, has ava i l ab le a colony o f four mouse genotypes and three r a t genotypes as a resource f o r rodent bicnnarker research. Mice ava i l ab le i n t h i s colony include C57BL/6NNIA, DBAZ/NNIA, B6DZF1 (C56BL/6NNIA X DBAE/NNIA), B6C3F1 (C57BL/6 X C3H) ranging i n age from three t o 30 months (approximately 22,00O/year). Avai lab le r a t s include Fischer 344, Broun-Noruay, and F344 X BN hybr ids ranging i n age from three t o 24 months (approximately 6,00O/year). Both male and female rodents are avai lable. This major animal resource has provided a su i tab le t e s t populat ion f o r 14 i n v e s t i g a t o r - i n i t i a t e d biomarker research p ro jec ts over the previous four years. In order t o a l l o u t e s t i n g o f biomarker s e n s i t i v i t y t o in tervent ions tha t a l t e r l i fespan, and since d ie ta ry r e s t r i c t i o n i s the only cu r ren t l y ava i l ab le in tervent ion tha t r e l i a b l y a l t e r s l i f espan i n rodents, ad l i b i t u m fed and d i e t a r y r e s t r i c t e d animals o f each genotype u i l l be avai lable. D ie ts used i n the NIA /NCTR colony u i l l be made ava i l ab le f o r shipment t o invest igators t o assure d i e t c o n t i n u i t y f o r a l l animals. Appl icat ions must include funds f o r d i e t acqu is i t i on and shipment. A l l N IA /NCTR animals are maintained i n Speci f ic Pathogen Free b a r r i e r f a c i l i t i e s . Appl icants must demonstrate t h e i r a b i l i t y t o house animals received from t h i s colony i n s i m i l a r o r equivalent b a r r i e r condi t ions. This can be achieved e i t h e r u i t h e x i s t i n g b a r r i e r f a c i l i t i e s tha t can


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be devoted t o t h i s a c t i v i t y , o r by the use o f laminar f l o u caging i n non-barr ier rocins devoted s o l e l y t o t h i s p ro jec t . Col laborat ive research appl icat ions from invest igators u i 1 1 be accepted uhere biomarker development requires m u l t i p l e research s k i l l s not ava i l ab le i n a s ing le i n s t i t u t i o n , uhere co l l abo ra t i on enhances the value o f the research conducted a t the cooperating i n s t i t u t i o n s o r uhere m u l t i p l e use o f animals i s s c i e n t i f i c a l l y f eas ib le and a l l ous s i g n i f i c a n t research cost economies.

The appl icant i s permi t ted t o propose studies leading t o the e luc ida t i on of the physiologic o r molecular mechanism(s) by uhich the biomarker studied const i tu tes a biomarker o f aging, o r the mechanism(s) by uhich c a l o r i c r e s t r i c t i o n produces l i f espan extension i n these animals.

Appl icat ions must c l e a r l y s t a t e the type, nunber, and use schedule of a l l animals needed f o r the proposed research. Where m u l t i p l e o r shared uses o f animals are proposed, each relevant app l i ca t i on must c l e a r l y shou uhich animals are shared and uhich are not. Animals from the NIA/NCTR biomarker colony w i l l be shipped t o invest igators by p re fe r red a i r f re igh t . Only costs f o r invest igator- reared animals, i f required by the proposed research design, must be included i n the appl icat ion. Appl icat ions that include the use o f invest igator- reared animals must shou a c lea r ra t i ona le f o r using such animals i n add i t i on t o NIA/NCTR colony animals. Appl icat ions tha t do not propose biomarker o f aging research or t ha t do not include the use o f NIA/NCTR colony animals u i l l not be accepted.

Appl icat ions f o r the S t a t i s t i c a l Analysis o f Biomarkers of Aging Research: The goal o f t h i s segment o f the RFA i s t o b r i n g together the r e s u l t s o f a l l o f the research conducted as a r e s u l t o f t h i s Biomarkers of Aging Research RFA, using the procedures o f mathematical s t a t i s t i c s , t o permit a s t a t i s t i c a l l y v a l i d assessment o f the gerontologic age o f rodents o f the genotype spec i f i ed here in using a panel o f appl icable biomarkers of aging. Appl icants may obta in a descr ip t ion o f ongoing research supported by the N I A Biomarkers o f Aging program from the program administrator l i s t e d i n I N Q U I R I E S o f t h i s RFA. I t i s ant ic ipated tha t a s ing le successful appl icant v i11 be able t o accomplish t h i s task, consequently a s ing le award u i l l be made.

SPECIAL REQUIREMENTS

In order t o f a c i l i t a t e the achievement o f t h i s goal, the P r inc ipa l Invest igators of successful appl icat ions w i l l be expected t o meet annual ly t o exchange informat ion and t o address progress and problems. Appl icat ions i n response t o t h i s request should include funds f o r one t r i p each year l as t i ng approximately three days t o at tend t h i s meeting i n add i t i on t o any other t rave l requirements.

REVIEW CONSIDERATIONS

Appl icat ions w i l l be received by the N I H D iv i s ion of Research Grants (DRG) and u i l l be assigned t o the N I A . Appl icat ions responsive t o t h i s RFA u i l l be evaluated f o r s c i e n t i f i c and technical mer i t by an i n i t i a l review group tha t u i l l be convened s o l e l y t o review these appl icat ions. Appl icat ions judged by the N I A t o be non-responsive (those not d i rec ted a t the goals o f t h i s RFA) w i l l be returned t o the appl icant without review. Appl icat ions may f i r s t receive a pre l iminary review by a subcomnittee o f the review panel t o establ ish those appl icat ions deemed t o be competit ive. Those appl icat ions judged non-competit ive u i l l be so designated, and an abbreviated s m r y statement not ing the major areas of concern w i l l be sent t o the P r inc ipa l Invest igator. Appl icat ions judged t o be compet i t ive v i11 be given f u l l review. Fol louing rev ieu by the i n i t i a l review group, the appl icat ions u i l l be considered by the Nat ional Advisory Council on Aging.

The fac to rs t o be considered i n the evaluat ion of the s c i e n t i f i c mer i t o f each app l i ca t i on w i l l be the responsiveness t o the i n t e n t o f t h i s RFA, and those fac to rs used i n the rev ieu o f t r a d i t i o n a l research-project grant appl icat ions and the past record o f performance i n biomarkers of aging research. Auards u i l l be made on the basis of s c i e n t i f i c mer i t and the need t o fund appl icat ions tha t provide a broad spectrum of po ten t i a l biomarkers.

APPLICATION PROCEDURES

The research grant app l i ca t i on form PHS 398 (rev. 10/88, repr in ted 9 / 8 9 ) must be used i n apply ing f o r these grants. These forms are avai lab le a t most i n s t i t u t i o n a l business of f ices; from the O f f i c e o f Grants Inqui r ies, D i v i s i o n o f Research Grants, National I n s t i t u t e s of Health, 5333 Westbard Avenue, Room449, Bethesda, MD 20892, telephone 301/496-7441; and from the N I H program administrator named below.

The RFA label ava i l ab le i n the 10/88-9/89 rev i s ion of PHS 398 app l i ca t i on form must be a f f i x e d t o the bottom o f the face page. Fa i l u re t o use t h i s label could r e s u l t i n delayed processing o f the app l i ca t i on such that i t may not reach the rev ieu comnittee i n time f o r revieu. In addi t ion, the RFA t i t l e , Wevelopnent o f Biomarkers o f Aging" and number must be typed on l i n e 2 of the face page o f the app l i ca t i on form and check the YES box.

Subnit a signed typewr i t ten o r i g i n a l of the appl icat ion, inc lud ing the Checkl ist , and four signed, exact photocopies, i n one package to:

-4 N I H Guide f o r Grants and Contracts - Vol. 20, No. 43 - November 15, 1991 10

Div i s ion o f Research Grants National I n s t i t u t e s o f Health Uestuood Bui ld ing, Room 240 Bethesda, MD 20892 ** A t t ime o f submission, two add i t iona l copies o f the app l ica t ion must a lso be sent to:

Chief SRO/OEA National I n s t i t u t e on Aging 7201 Uisconsin Avenue Bethesda, MD 20892

Appl icat ions must be received by February 19, 1992. Ifan app l ica t ion i s received a f t e r t ha t date, o r i f i t i s incomplete, i t u i l l be returned t o the applicant. Addi t ional o r revised mater ia l u i l l not be accepted a f t e r the rece ip t date. Also, the DRG w i l l not accept any app l ica t ion i n response t o t h i s onnouncement tha t i s essen t ia l l y the same as one cu r ren t l y pending i n i t i a l review, unless the appl icant uithdraws the pending appl icat ion. Nor u i l l the DRG accept any app l ica t ion tha t i s essen t ia l l y the same as one already revieued. This does not preclude the submission of substant ia l rev is ions o f appl icat ions already reviewed, but such app l ica t ions must include an in t roduc t ion addressing the previous c r i t i que .

LETTER OF INTENT

Prospective appl icants are encouraged t o submit t o the program administrator indicated below a non-binding l e t t e r o f i n ten t t o apply, post-marked no l a t e r than December 16, 1991, tha t includes a descr ip t i ve t i t l e o f the proposed research, the name, address and telephone nunber o f the P r inc ipa l Invest igator, the i d e n t i t i e s of other key personnel and p a r t i c i p a t i n g i ns t i t u t i ons , and the nunber and t i t l e o f t h i s RFA. The l e t t e r of i n ten t i s not mandatory and does not inf luence the review o r funding decisions, but i t u i l l enable the N I A t o p lan the review.

I NPUI R I ES

U r i t t e n and telephone inqu i r i es concerning t h i s RFA are encouraged. The opportuni ty t o c l a r i f y any issues or questions from po ten t i a l appl icants i s welcome.

D irect inquiries regardi ng p r o g r a mt ic is u e s t0:

Richard L. Sprott, Ph.D. Associate D i rec tor , BAP National I n s t i t u t e on Aging 7201 Uisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-4996

Di rec t i nqu i r i es regarding f i s c a l matters to:

Ms. Mary Burton Grants Management Spec ia l i s t , GCMO National I n s t i t u t e on Aging 7201 Uisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496- 1472


This program i s described i n the Catalog o f Federal Domestic Assistance, No. 93.866, Aging Research. Awards are made under au thor iza t ion of the Publ ic Health Service Act, T i t l e I V , Part A (Publ ic Law 78-410, as amended by Publ ic Law 99-158, 42 USC 241 and 285) and administered under PHS grants p o l i c i e s and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program i s not subject t o the intergovernmental rev ieu requirements o f Executive Order 12372 or Health Systems Agency revieu.

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