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PHS/NIH/OD Permit No. G-291

VOL. 16,RO. 1 3 , 4 P R I L 10, 1987

Vol. 16, No. 13, A p r i l 10, 1987

DATED ANNOUNCEMENTS (RFPs AND RFAs AVAILABLE)

A C L I N I C A L TRIAL FOR THE USE OF NOVEL THERAPIES I N BONE MARROW TRANSPLANTATION (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 AND INFECTIOUS DISEASES

THE CONTRACEPTIVE BEHAVIOR OF TEENAGE WOMEN AND THEIR PARTNERS (RFP) ........................................................... 1

National I n s t i t u t e of Chi ld Heal th and Human DevelopmentIndex: CHILD HEALTH AND HUMAN DEVELOPMENT

SURVEY OF PHYSICIAN PRACTICE BEHAVIORS RELATED TO THE TREATMENT OF PEOPLE WITH DIABETES MELLITUS (RFP) ...................................2

National I n s t i t u t e o f Diabetes and Diges t ive and Kidney Diseases Index: DIABETES AND DIGESTIVE AND K I D N E Y DISEASES

HUMAN LIVER CELL CULTURE FACILITY ( R F P ) . . ..................................... 2 National I n s t i t u t e of Diabetes and Diges t ive and Kidney Diseases Index: DIABETES AND DIGESTIVE AND KIDNEY DISEASES

EVALUATION OF ORTHODONTIC TREATMENT STRATEGIES (RFA) National I n s t i t u t e of Dental Research Index: DENTAL

THE N C I OUTSTANDING INVESTIGATOR GRANT ........................................ 4 Nat iona l Cancer I n s t i t u t e Index: CANCER

MINORITY INSTITUTIONAL RESEARCH TRAINING PROGRAM ............................. 5 National Heart , Lung, and Blood I n s t i t u t e Index: HEART, LUNG, AND BLOOD

MINORITY SCHOOL FACULTY DEVELOPMENT AWAR D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 National Heart , Lung, and Blood I n s t i t u t e Index: HEART, LUNG, AND BLOOD

THE DIAGNOSIS OF ALZHEIMER DISEASE ............................................ 7 d Nat iona l I n s t i t u t e on AgingNational I n s t i t u t e of Mental Heal th National I n s t i t u t e o f Neurological and Communicative

Disorders and S t roke Index: A G I N G

NATIONAL INSTITUTE OF MENTAL HEALTH NEUROLOGICAL AND COMMUNICATIVE DISORDERS AND STROKE

ESTABLISHMENT OF SURVEILLANCE SYSTEM OF WOMEN UNDERGOING TREATMENT FOR INFERTILITY WITH I N VITRO FERTILIZATION -SOURCES SOUGHT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

National I n s t i t u t e o f Chi ld Health and Human DevelopmentIndex: CHILD HEALTH AND HUMAN DEVELOPMENT

ONGOING PROGRAM ANNOUNCEMENTS

PERSONS WITH MENTAL RETARDATION AND MENTAL ILLNESS ............................ 10 National I n s t i t u t e o f Mental Heal th National I n s t i t u t e of Chi ld Health and Human DevelopmentIndex: NATIONAL INSTITUTE OF MENTAL HEALTH

CHILD HEALTH AND HUMAN DEVELOPMENT

CLINICAL AND EPIDEMIOLOGIC RESEARCH ON MINORITY POPULATIONS OF THE UNITED STATES. .................................................... 11

Nat iona l I n s t i t u t e of Diabe tes and Diges t ive and Kidney Diseases Index: DIABETES AND DIGESTIVE AND KIDNEY DISEASES

ERRATUM

STUDIES OF THE OPPORTUNISTIC INFECTIONS ASSOCIATED WITH THE ACQUIRED IMMUNODEFICIENCY SYNDROME (RFA) ................................. 12

Nat ional I n s t i t u t e of Allergy and I n f e c t i o u s Diseases Index: ALLERGY AND INFECTIOUS DISEASES

DATED ANNOUNCEMENTS (RFPr; AND RFAs AVAILABLE)

A C L I N I C A L TRIAL FOR THE USE OF NOVEL THERAPIES I N BONE MARROW TRANSPLANTATION

\#' RFP-NIH-NIAID-IAIDP-87-29 - CANCELLATION

P.T. 34; K.W. 0745065, 0755015, 0705005, 0710125

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

RFP-NIH-NIAID-IAIDP-87-29, e n t i t l e d A C l in i ca l T r i a l f o r t h e Use o f Novel Therapies i n Bone Marrow T r a n s p l a n t a t i o n , a d v e r t i s e d i n t h e February 6, 1987 e d i t i o n o f t h e Guide (Vol. 16, No. 51, is hereby c a n c e l l e d . No award w i l l be made.

Rosemary L . McCabe Cont rac t ing Officer Nat iona l I n s t i t u t e o f A l l e rgy and I n f e c t i o u s Diseases

THE CONTRACEPTIVE BEHAVIOR OF TEENAGE WOMEN AND THEIR PARTNERS

RFP AVAILABLE: NICHD-DBS-87-5

P.T. 34; K.W. 0404000, 0750020, 0414000, 0730010, 0730070

Nat iona l I n s t i t u t e o f Chi ld Hea l th and Human Development

The Demographic and Behavior Sc iences Branch, Center f o r Popu la t ion Research, Nat iona l I n s t i t u t e o f Chi ld Heal th and Human Development, has a requirement f o r t h e s tudy o f t h e c o n t r a c e p t i v e behavior o f t eenage women and t h e i r p a r t n e r s . The goa l o f t h i s c o n t r a c t is t o o b t a i n recommendations r ega rd ing t h e t h e o r e t i c a l framework,s u b s t a n t i v e focus , con ten t and s t r a t e g y of a l a r g e - s c a l e d a t a c o l l e c t i o n e f f o r t focus ing on t h e c o n t r a c e p t i v e behavior o f t eenage females . S t u d i e s o f males on ly w i l l n o t be cons ide red under t h i s RFP. It is 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 RFP f o r a pe r iod o f approximately e i g h t e e n months.

hd The b a s i c o b j e c t i v e s o f t h e e f f o r t w i l l be t o review e x i s t i n g r e s e a r c h and t h e o r y i n t h e areas o f psychology, soc io logy , economics and p u b l i c h e a l t h and t o recommend con ten t and s t r a t e g y f o r a l a r g e - s c a l e d a t a c o l l e c t i o n e f f o r t i n t h e use o f c o n t r a c e p t i o n by t eenage females. The o f f e r o r w i l l a l s o be r e q u i r e d t o recommend s p e c i f i c i n s t rumen t s f o r t h i s d a t a c o l l e c t i o n e f f o r t and t o p rov ide s p e c i f i c c o s t estimates f o r such a s tudy .

Performance of t h e s p e c i f i e d p r o j e c t r e q u i r e s r e s e a r c h e r s w i th adequate t r a i n i n g and e x p e r t i s e i n t h e behav io ra l - soc ia l popu la t ion s c i e n c e s . The o f f e r o r must have demonstrated a b i l i t y i n two areas: 1 ) s u b s t a n t i v e knowledge o f r e s e a r c h i n t h e area of teenage c o n t r a c e p t i v e oehavior ; and 2) survey d e s i g n and sampling. I n a d d i t i o n t o being a b l e t o propose d i f f e r e n t sampling p l a n s and survey s t r a t e g i e s , t h e o f f e r o r must be able t o assess t h e c o s t i m p l i c a t i o n s o f d i f f e r e n t approaches.

RFP-NICHD-DBS-87-5 w i l l be i s s u e d on o r about A p r i l 20, 1987. P roposa l s w i l l be due approximately 60 days t h e r e a f t e r . Copies of t h e RFP may be ob ta ined by sending w r i t t e n r e q u e s t s t o t h e fo l lowing addres s . P l e a s e e n c l o s e a se l f - addres sed l a b e l .

Paul J . Duska, Con t rac t ing Officer Contrac t Management Sec t ion , OGC Nat iona l I n s t i t u t e o f Chi ld Heal th and Human DevelopmentLandow Bui ld ing , Room 6C25 7910 Woodmont Avenue Bethesda, Maryland 20892

1

SURVEY OF PHYSICIAN PRACTICE BEHAVIORS RELATED TO THE TREATMENT OF PEOPLE WITH DIABETES MELLITUS

RFP AVAILABLE: RFP-NIH-NIDDK-87-10

P.T. 3 4 ; K.W. 0715075, 0404021, 0415000, 0730070

Nat iona l I n s t i t u t e o f Diabe tes and Diges t ive and Kidney Di seases

The Na t iona l I n s t i t u t e o f Diabe tes and Diges t ive 27.d Kidney Diseases ( N I D D K ) , Nat iona l I n s t i t u t e s o f Heal th , is seeking an orgar , iza t ion t o perform a Survey of Phys ic i an P r a c t i c e Behaviors Re la t ed t o t h e Treatment of People With Diabe tes Me11i t u s .

T h i s a c q u i s i t i o n is under a 100% SMALL BUSINESS SET-ASIDE.

T h i s Request f o r Proposa ls , RFP NIH-NIDDK-87-10, is now a v a i l a b l e , w i t h a c l o s i n g d a t e set f o r May 11, 1987. To r e c e i v e a copy o f t h e RFP, p l e a s e supply t h i s o f f i c e with two se l f - addres sed ma i l ing l a b e l s . S ince a l i m i t e d number o f c o p i e s w i l l be n r i n t e d , r e a u e s t s s h a l l be f i l l e d on a f i r s t -come. f i r s t - s e r v e b a s i s u n t i l t h e kupply is exhaus ted . Requests f o r t h e RFP should be s e n t t o t h e fo l lowing addres s :

P a t r i c k M . S u l l i v a n , Chief Cont rac t s Management Branch Nat iona l I n s t i t u t e o f D iabe te s and D i g e s t i v e and Kidney Diseases Nat iona l I n s t i t u t e s o f Hea l th Westwood Bui ld ing , Room 602 Bethesda, Maryland 20892

T h i s adver t i sement does n o t commit t h e Government t o award a c o n t r a c t .

HUMAN LIVER CELL CULTURE FACILITY

RFP AVAILABLE: RFP-NIH-NIDDK-87-9

P.T. 34; K . W . 0780015, 0780000

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 Na t iona l I n s t i t u t e o f D iabe te s and D i g e s t i v e and Kidney Diseases ( N I D D K ) i s seek ina an o r a a n i z a t i o n t o a r o v i d e a f a c i l i t v where ( 1 1 t h e s c i e n c e o f c u l t u r i n g human r i v e r c e l l s would be h i g h l y developed &-id s t u d i e d and ( 2 ) where such ce l l s would be a v a i l a b l e f o r use by o t h e r i n v e s t i g a t o r s e i t h e r i n t h e c u l t u r e f a c i l i t y or th rough shipment o f c u l t u r e s .

T h i s Request f o r Proposa ls , RFP NIH-NIDDK-87-9, i s now a v a i l a b l e , w i th a c l o s i n g d a t e s e t f o r August 3, 1987. To r e c e i v e a copy of t h e RFP, p l e a s e supply t h i s o f f i c e wi th two self addressed ma i l ing l a b e l s . S ince a l i m i t e d number o f c o p i e s w i l l be p r i n t e d , r e q u e s t s s h a l l be f i l l e d on a f irst come, f irst serve basis u n t i l t h e supply is exhaus ted . Requests f o r t h e RFP should be s e n t t o t h e fo l lowing a d d r e s s :

P a t r i c k Y . S u l l i v a n , Chief Cont rac t s Management Branch Nat iona l I n s t i t u t e o f Diabe tes and Diges t ive and Kidney Diseases Nat iona l I n s t i t u t e s o f Heal th Westwood Bu i ld ing , Room 602 Bethesda, Maryland 20892

T h i s adver t i sement does no t commit t h e Government t o award a c o n t r a c t .

EVALUATION OF ORTHODONTIC TREATMENT STRATEGIES

RFA AVAILABLE: 87-DE-1

P.T. 34; K . W . 0785040, 0415000, 0795005

Na t iona l I n s t i t u t e o f Dental Research

App l i ca t ion Rece ip t Date: December 1 , 1987 IThe C r a n i o f a c i a l Anomalies, Pa in Cont ro l and Behaviora l Research Branch o f t h e

Na t iona l I n s t i t u t e o f Dental Research ( N I D R ) s eeks 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 t o e v a l u a t e commonly used c l i n i c a l s t r a t e g i e s f o r t r e a t i n g o r t h o d o n t i c problems i n

2

c h i l d r e n and a d u l t s . T h i s r e q u e s t i s f o r a s i n g l e compet i t ion wi th a r e c e i p t d a t e of December 1 , 1987; t h i s RFA may be r e i s s u e d a t a l a t e r d a t e .

BACKGROUND

Although c o n s i d e r a b l e r e s e a r c h h a s been c a r r i e d out on t r e a t m e n t of major c o n g e n i t a l LJ c r a n i o f a c i a l malformations such as f ac i a l c l e f t s of v a r i o u s t y p e s , t h e r e h a s been

l i t t l e o r no c l i n i c a l r e s e a r c h on p a t i e n t s undergoing t r e a t m e n t t o c o r r e c t less s e v e r e b u t n e v e r t h e l e s s important problems r e q u i r i n g o r t h o d o n t i c t r ea tmen t . The p o t e n t i a l impact of t h e s e problems is seen c l e a r l y i n t h e r e c e n t e s t i m a t e s t h a t n e a r l y f i f t y p e r c e n t of c h i l d r e n i n t h e United S t a t e s would b e n e f i t from o r t h o d o n t i c t r e a t m e n t , and t h a t about f i v e p e r c e n t o f United S t a t e s c h i l d r e n have s u f f i c i e n t l y s e v e r e o r t h o d o n t i c problems t h a t t h e y are handicapped i n t h e i r l i f e ad jus tment . An i n c r e a s i n g number o f a d u l t s are a l s o r e c e i v i n g t r e a t m e n t b o t h f o r t h e c o r r e c t i o n of p h y s i c a l l y handicapping malocclusions and a l s o as an a i d t o psychosocia l ad jus tment . I n some o r t h o d o n t i c p r a c t i c e s , between t h i r t y and s i x t y p e r c e n t o f p a t i e n t s i n t r e a t m e n t are a d u l t s . For s e v e r a l t y p e s o f o r t h o d o n t i c problems, a l t e r n a t i v e t r e a t m e n t approaches are p o s s i b l e and a r e advocated byc l i n i c i a n s . No c l i n i c a l t r i a l s have been conducted t o e v a l u a t e c l e a r l y t h e s e a l t e r n a t i v e approaches and, d e s p i t e t h e s t r o n g l y h e l d o p i n i o n s o f some c l i n i c i a n s ,d a t a do n o t e x i s t t o d i f f e r e n t i a t e c l e a r l y between t h e a l t e r n a t i v e approaches wi th r e s p e c t t o t h e i r e f f i c a c y . The o b j e c t i v e of t h i s RFA is t o s o l i c i t a p p l i c a t i o n s t o e v a l u a t e t h e outcomes and e f f i c a c y o f d i f f e r e n t o r t h o d o n t i c t r e a t m e n t s .

RESEARCH GOALS

I d e a l l y , e v a l u a t i o n o f a p a r t i c u l a r o r t h o d c n t i c t r e a t m e n t would be c a r r i e d o u t on a p r o s p e c t i v e b a s i s , and one of t h e aims of t h i s announcement is t o encourage t h e development o f p r o s p e c t i v e r e s e a r c h d e s i g n s i n t h i s area. However, because o f t h e long time span o f p r o s p e c t i v e r e s e a r c h p r o j e c t s and t h e c o n s i d e r a b l e expensea s s o c i a t e d w i t h such r e s e a r c h des igns , r e t r o s p e c t i v e a n a l y s e s o f t h e t r e a t m e n t s w i l l be cons idered f o r s u p p o r t . Outcomes o f o r t h o d o n t i c t r e a t m e n t can be e v a l u a t e d i n two ways: ( 1 ) from t h e morphologic changes produced by t h e t r e a t m e n t , comparing its r e s u l t s t o t h e i d e a l arrangement o f t h e t e e t h and t o i d e a l f a c i a l p r o p o r t i o n s ; i n t h i s sense , t h e outcome is scored i n terms o f t h e morphologic improvement producedby t h e t r e a t m e n t ; and (2 ) i n terms of t h e p a t i e n t ' s p e r c e p t i o n o f and s a t i s f a c t i o n w i t h t h e t r e a t m e n t r e s u l t . Both t y p e s o f outcome d a t a may be cons idered i n p r o j e c t ssubmit ted i n response t o t h i s RFA. E f f i c a c y o f t r e a t m e n t re la tes t o how w e l l t h e t r e a t m e n t procedure produces t h e d e s i r e d r e s u l t , and t o t h e c o s t and t i m e involved. More e f f i c a c i o u s t r e a t m e n t s should show a reduced inc idence o f compl ica t ions ,

bh/ g r e a t e r longterm s t a b i l i t y o f r e s u l t s and a g r e a t e r p r e d i c t a b i l i t y o f f a v o r a b l e r e s u l t s .

S t u d i e s could involve e i t h e r o f two s t r a t e g i e s : ( 1 ) s t u d i e s o f l a r g e groups o f p a t i e n t s wi th r e l a t i v e l y common problems o r (2) t h e d e t a i l e d s tudy of smaller groups o f p a t i e n t s w i t h more s e v e r e o r t h o d o n t i c problems. Examples o f t o p i c s f o r s tudy i n c l u d e , i n t h e f irst area: (i)comparisons of growth m o d i f i c a t i o n t r e a t m e n t s i n younger p a t i e n t s w i t h mixed d e n t i t i o n and i n o l d e r p a t i e n t s w i t h permanentd e n t i t i o n ; t h e s e t r e a t m e n t s should be aimed a t s p e c i f i c malocclusions such as mild t o moderate s k e l e t o - d e n t a l d i s c r e p a n c i e s i n t h e v e r t i c a l , t r a n s v e r s e a n d l o r s a g i t t a l planes ; (ii)comparisons o f e a r l y t r e a t m e n t involv ing e x t r a c t i o n i n t h e mixed d e n t i t i o n f o r C l a s s I crowding problems v e r s u s t r e a t m e n t involv ing e x t r a c t i o n s a f te r a l l permanent t e e t h have e r u p t e d ; (iii) comparisons o f e x t r a c t i o n v e r s u s n o n e x t r a c t i o n t r e a t m e n t p r o t o c o l s , f o r s p e c i f i c t y p e s of problems, such as crowding o r d e n t o a l v e o l a r p r o t r u s i o n ; and ( i v ) comparisons o f t h e e f f e c t i v e n e s s of d i f f e r e n t treatment s t r a t e g i e s i n a d u l t s . Examples i n t h e second area i n c l u d e : ( i) comparisons o f e a r l y v e r s u s l a t e t r e a t m e n t o f s k e l e t a l open b i t e ; and (ii)comparisons o f o r t h o d o n t i c v e r s u s o r t h o g n a t h i c s u r g i c a l t r e a t m e n t o f s e v e r e malocc lus ions .

E v a l u a t i o n s such as t h e s e r e q u i r e p r e c i s e c h a r a c t e r i z a t i o n o f t h e p r e t r e a t m e n t c o n d i t i o n , r i g o r o u s implementation o r a n a l y s i s o f t h e t r e a t m e n t p l a n , and p r e c i s e measurement of t h e outcomes. The a p p l i c a t i o n should e s t a b l i s h t h a t a s u i t a b l e , def ined , s tudy p o p u l a t i o n is a v a i l a b l e o r t h a t d a t a from such a t r e a t e d p o p u l a t i o n are a c c e s s i b l e . Study d e s i g n s must be s t a t i s t i c a l l y sound and e t h i c a l l y a c c e p t a b l e . Because sample s i z e s f o r some c o n d i t i o n s may be l i m i t e d a t any s i n g l e i n s t i t u t i o n , a p p l i c a t i o n s involv ing s e v e r a l i n s t i t u t i o n s w i l l be a c c e p t a b l e . I n p r o s p e c t i v e s t u d i e s , measures t o ensure r e t e n t i o n of s u b j e c t s t o follow-up should be c a r e f u l l y d e l i n e a t e d . P r o j e c t s should be designed so t h a t some s p e c i f i c aims can be m e t d u r i n g t h e i n i t i a l p e r i o d of suppor t (3-5 y e a r s ) ,

MECHANISM OF SUPPORT

Support f o r t h i s program w i l l be through r e s e a r c h p r o j e c t g r a n t s ( R o l l . It is a n t i c i p a t e d t h a t up t o f o u r awards w i l l be made, i f a s u f f i c i e n t number of h i g h

\-/ q u a l i t y a p p l i c a t i o n s is r e c e i v e d . Although funds have been a l l o c a t e d f o r t h i s program i n N I D R ' s p l a n s f o r f i sca l y e a r s 1988 through 1992, award o f g r a n t s

3

r e s u l t i n g from t h i s RFA is cont ingent upon r e c e i p t of appropriated funds f o r t h i s purpose. Applicants may r eques t up t o f i v e y e a r s o f support . Subsequent support w i l l be cont ingent upon progam needs and g ran tees ' performance as determined by peer review. P o l i c i e s t h a t govern r e sea rch g ran t programs o f t h e National I n s t i t u t e s o f Health w i l l p r e v a i l .

APPLICATION AND REVIEW PROCEDURES

Applicat ions i n response t o t h i s RFA w i l l be reviewed by a Spec ia l Review Committee convened by t h e N I D R ' s S c i e n t i f i c Review Branch. Secondary review w i l l be by t h e National Advisory Dental Research Council i n May 1988. Review c r i t e r i a include t h e s i g n i f i c a n c e and o r i g i n a l i t y of t h e r e sea rch goa l s and approaches; f e a s i b i l i t y of t h e r e sea rch and t h e adequacy o f t h e s tudy design; a v a i l a b i l i t y and appropriateness of t h e s tudy populat ions o r c l i n i c a l da t a ; t r a i n i n g , experience and r e sea rch competence o f t h e i n v e s t i g a t o r ( s ) ; adequacy of f a c i l i t i e s ; p rov i s ions f o r p r o t e c t i o n of human sub jec t s ; and t h e appropr i a t eness o f t h e requested budget f o r t h e work proposed.

Funding dec i s ions w i l l be based on t h e i n i t i a l review group's and t h e National Advisory Dental Research Counci l ' s recommendations concerning s c i e n t i f i c merit and program relevance, and t h e a v a i l a b i l i t y o f appropriated funds. The ear l ies t funding d a t e i s J u l y 1 , 1988.

Applicat ions should be submitted on form PHS-398, a v a i l a b l e i n t h e business o r g r a n t s o f f i c e o f most academic o r r e sea rch i n s t i t u t i o n s o r from t h e Divis ion o f Research Grants, National I n s t i t u t e s o f Heal th . Applicat ions received a f te r December 1 , 1987 and those which are deemed nonresponsive t o t h e RFA w i l l be assigned t o a Divis ion o f Research Grants Study Sect ion f o r i n i t i a l review and w i l l be considered with o t h e r n o n s o l i c i t e d g ran t a p p l i c a t i o n s received during t h a t review cyc le . The phrase "Response t o N I D R RFA: 87-DE-1, Evaluation o f Orthodontic Treatment S t r a t e g i e s " should be typed on l i n e 2 of t h e f a c e page o f t h e a p p l i c a t i o n . The o r i g i n a l and fou r cop ie s should be s e n t o r de l ive red to:

Grant Applicat ion Receipt Office Division of Research Grants National I n s t i t u t e s o f Health Westwood Building, Room 249 5333 Westbard Avenue Bethesda, Maryland 20892-4500

Two cop ies should be s e n t t o :

John D . Townsley, Ph.D. Chief, Cran io fac i a l Anomalies,Pain Control and Behavioral Research Branch National I n s i t u t e o f Dental r e sea rch Westwood Building, Room 506 Bethesda? Maryland 20892-4500 Telephone: ( 3 0 1 ) 496-7807

I n q u i r i e s concerning t h i s RFA may be addressed t o D r . Townsley.

This program is descr ibed i n t h e Catalog of Federal Assis tance No. 13.122. Awards w i l l be made under a u t h o r i z a t i o n o f t h e Publ ic Health Se rv ice A c t , T i t l e 111. Sec t ion 301 (Pub l i c Law 78-410, as amended), and administered under PHS g r a n t s p o l i c i e s and Federal Regulat ions 42 CFR P a r t 52 and 45 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 o r Health Sys terns Agency review . THE N C I OUTSTANDING INVESTIGATOR GRANT

P.T. 34; K.W. 0715035, 0710030

National Cancer I n s t i t u t e

Applicat ion Receipt Date : June 15

SUMMARY AND PURPOSE

The National Cancer I n s t i t u t e ( N C I ) w i l l cont inue t o accept a p p l i c a t i o n s f o r t h e Outstanding I n v e s t i g a t o r Grant ( O I G ) , t h e purpose o f which i s t o provide long-term support t o experienced i n v e s t i g a t o r s with outs tanding records of r e sea rch p r o d u c t i v i t y . The O I G i s intended t o encourage i n v e s t i g a t o r s t o embark on p r o j e c t so f unusual p o t e n t i a l i n cancer r e sea rch . Emphasis w i l l be placed on evidence of r e c e n t s u b s t a n t i v e c o n t r i b u t i o n s ( i . e . ? seminal i deas and innovat ive approaches t o r e s i s t a n t problems) and t h e p o t e n t i a l f o r continued work o f high c a l i b e r .

4

ELIGIBILITY

App l i ca t ions may be submi t ted only by domestic i n s t i t u t i o n s on beha l f o f i n v e s t i g a t o r s who have r e c e n t l y demonstrated ou t s t and ing r e s e a r c h p r o d u c t i v i t y f o r a t l eas t f i v e y e a r s . There are no age r e s t r i c t i o n s . Only United S t a t e s c i t i z e n s , n a t i o n a l s o r permanent r e s i d e n t s may be presented as cand ida te s f o r t h i s g r a n t .

\J Appl i ca t ions w i l l be accepted by t h e N C I on ly when t h e y a r e cance r - r e l a t ed as de f ined by t h e Div i s ion o f Research Grants ( D R G ) g r a n t referral g u i d e l i n e s . Thus, i n v e s t i g a t o r s whose c u r r e n t r e s e a r c h suppor t is der ived predominant ly from sources o t h e r t h a n t h e N C I may n o t be e l i g i b l e and are encouraged t o d i s c u s s t h e i r r e s e a r c h o b j e c t i v e s wi th a p p r o p r i a t e N C I o f f i c i a l s be fo re apply ing .

The i n s t i t u t i o n sponsor ing t h e O I G a p p l i c a t i o n is r e q u i r e d t o commit itself t o provid ing 25% of t h e i n v e s t i g a t o r ' s s a l a r y suppor t .

App l i ca t ions which do n o t meet a l l o f t h e above e l i g i b i l i t y c r i t e r i a o r which have no t had approval from t h e N C I as excep t ions t o t h e above cr i ter ia w i l l be r e t u r n e d t o t h e a p p l i c a n t .

HOW TO APPLY

o The d a t e o f r e c e i p t o f a l l O I G a p p l i c a t i o n s w i l l be June 15 o f each y e a r .They w i l l be processed f o r review a t t h e ear l ies t p o s s i b l e meeting of t h e NCAB .

o Appl ica t ion f o r t h i s award should be made on form PHS 398 i n accordance wi th i n s t r u c t i o n s i n t h i s Announcement. These a p p l i c a t i o n s are a v a i l a b l e i n t h e bus iness o r c o n t r a c t s o f f i c e s a t most academic o r r e s e a r c h i n s t i t u t i o n s , o r from:

Div i s ion o f Research Grants Nat iona l I n s t i t u t e s o f Heal th 5333 Westbard Avenue Bethesda, Maryland 20892

o The t i t l e " N C I OUTSTANDING INVESTIGATOR GRANT" should be typed i n s e c t i o n 2 on t h e first page of t h e a p p l i c a t i o n .

o A l e t t e r i n d i c a t i n g clear and con t inu ing i n s t i t u t i o n a l commitment t o t h e \& a p p l i c a n t must e i t h e r accompany t h e a p p l i c a t i o n o r be r ece ived s e p a r a t e l y

be fo re t h e NCI w i l l beg in t h e i n i t i a l review p rocess .

INQUIRIES

A l l p o t e n t i a l a p p l i c a n t s f o r t h i s award are advised t h a t t h e f u l l t e x t of t h i s Program Announcement, con ta in ing c u r r e n t l y a p p l i c a b l e g u i d e l i n e s , i s now a v a i l a b l e and should be r eques t ed p r i o r t o submi t t i ng an a p p l i c a t i o n f o r t h e June 15, 1987 r e c e i p t d a t e .

Please d i r e c t i n q u i r i e s f o r f u r t h e r in format ion , and f o r cop ie s o f t h e f u l l announcement, to:

Mrs. Barbara S. BynumD i r e c t o r Div i s ion o f Extramural A c t i v i t i e s Nat iona l Cancer I n s t i t u t e Bui ld ing 31 - Room 10A03 Bethesda, Maryland 20892 Telephone: (301) 496-5147

M l

P.T. 14, 349 FF; K.W. 0715040, 0715165

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

App l i ca t ion Receipt Date: August 24, 1987

The Nat iona l Heart , Lung and Blood I n s t i t u t e ( N H L B I ) announces a program t o suppor tf u l l t ime r e s e a r c h t r a i n i n g f o r i n v e s t i g a t i v e c a r e c r s a t minor i ty schoo l s i n areas r e l a t e d t o c a r d i o v a s c u l a r , pulmonary o r hematologic d i s e a s e s . Minori ty schoo l s seeking t h i s suppor t must have: ( 1 ) gradua te s t u d e n t s , o r ; ( 2 ) h e a l t h p r o f e s s i o n a l

5

s t u d e n t s who w i l l t a k e a minimum o f one yea r from h i s / h e r p r o f e s s i o n a l t r a i n i n g , o r ; (3) p o s t d o c t o r a l s t u d e n t s . The suppor t mechanism w i l l be t h e N I H i n s t i t u t i o n a l r e s e a r c h t r a i n i n g g r a n t . Copies of t h e program g u i d e l i n e s are c u r r e n t l y a v a i l a b l e from s ta f f o f t h e NHLBI, l i s t e d below.

Grants i n t h i s program w i l l be made t o minor i ty i n s t i t u t i o n s , each o f which w i l l coopera t e wi th a r e s e a r c h c e n t e r t h a t has a we l l - e s t ab l i shed ca rd iovascu la r , -* pulmonary, o r hematologic r e s e a r c h and r e s e a r c h t r a i n i n g programs. Each t r a i n e e w i l l be p laced wi th a mentor who is an accomplished i n v e s t i g a t o r a t t h e coope ra t ing r e s e a r c h c e n t e r and who w i l l assist t h e a d v i s o r a t t h e minor i ty i n s t i t u t i o n i n t h e t r a i n e e ' s development and r e s e a r c h p l a n .

Guidel ines f o r t h i s program may be ob ta ined from any o f t h e fo l lowing:

George A. Hayden, Ph.D. Div i s ion o f Heart and Vascular Diseases Nat iona l Heart, Lung, and Blood 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 Federa l Bui ld ing , Room 3C04 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-1724

Diane Aiken Div i s ion o f Lung Diseases Nat iona l Heart, Lung, and Blood 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 Westwood Bui ld ing , Room 640A Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-7668

T h i s program is desc r ibed i n t h e Cata log of Fede ra l Domestic Ass i s t ance numbers 13.837, 13.838, and 13.839. Award w i l l be made under t h e a u t h o r i t y of t h e Pub l i c Heal th S e r v i c e Act, T i t l e 111, Sec t ion 301 ( P u b l i c Law 78-410, as amended; 42 USC 2 4 1 ) and adminis te red under PHS gran t p o l i c i e s and Federa l Regula t ions a t 42 CFR P a r t 52 and 45 CFR P a r t 74. This program is 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 or Heal th Systems Agency review.

C h r i s t i n e Parker , Ph.D. Div i s ion o f Blood Diseases and Resources Nat iona l Heart, Lung, and Blood I n s t i t u t e Nat iona l I n s t i t u t e s of Heal th Federa l Bui ld ing , Room 5C04 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-4186

MINORITY SCHOOL FACULTY DEVELOPMENT AWARD

P.T. 14 , 34, FF; K.W. 0715040, 0715165

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

Appl i ca t ion Rece ip t Date: August 24, 1987

The Nat iona l Heart, Lung, and Blood I n s t i t u t e ( N H L B I ) announces a program t o encourage t h e development o f f a c u l t y i n v e s t i g a t o r s a t minor i ty schoo l s i n areas r e l e v a n t t o c a r d i o v a s c u l a r , pulmonary, and hematologic d i s e a s e s and r e sources . Copies o f t h e program g u i d e l i n e s are c u r r e n t l y a v a i l a b l e from t h e s t a f f o f t h e N H L B I , l i s t e d below.

Grants i n t h i s program w i l l be made t o minor i ty i n s t i t u t i o n s on beha l f o f awardees,each of which w i l l work wi th a mentor a t a nearby ( w i t h i n 100 m i l e s ) r e s e a r c h

who is recognized accomplished i n v e s t i g a t o r i n t h e r e s e a r c hc e n t e r , a s an proposed, and who w i l l p rovide guidance f o r p l a n .

Guidel ines f o r t h i s program may be ob ta ined

George A . Hayden, Ph.D. Div i s ion o f Heart and Vascular Diseases Nat iona l Hear t , Lung, and Blood I n s t i t u t e Nat iona l I n s t i t u t e s of Health Federa l Bui ld ing , Room 3C04 Bethesda, Maryland 20892 Telephone: ( 3 0 1 ) 496-1724

a r e a t h e awardee's development and r e s e a r c h

from one of t h e fo l lowing:

6

--IJ

IF&

Diane Aiken Div i s ion o f Lung Diseases Nat iona l Heart, Lung, and Blood 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 Westwood Bui ld ing , Room 640A Bethesda, Maryland 20892 Telephone: (301) 496-7668

T h i s program is desc r ibed i n t h e Cata log o f Fede ra l Domestic Ass i s t ance Nos.13.837, 13.838, and 13.839. 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 P u b l i c Heal th S e r v i c e A c t , T i t l e 111, Sec t ion 301 g r a n t p o l i c i e s and Federa l Regula t ion 42 CFR P a r t 52 and 45 CFR P a r t 74. T h i s program i s n o t s u b j e c t t o t h e in te rgovernmenta l review requi rements o f Execut ive Order 12372 o r Heal th Systems Agency review.

C h r i s t i n e Pa rke r , Ph.D. Div i s ion o f Blood Diseases and Resources Nat iona l Hea r t , Lung, and Blood 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 Federa l Bui ld ing , Room 5C04 Bethesda, Maryland 20892 Telephone (301) 496-4186

THE DIAGNOSIS OF ALZHEIMER DISEASE

P.T. 34; K.W. 0715180, 0745020, 0710085, 0706030, 0785055

Nat iona l I n s t i t u t e on AgingNat iona l I n s t i t u t e o f Mental Heal th Nat iona l I n s t i t u t e o f Neurologica l and Communicative Disorde r s and S t r o k e

BACKGROUND

Alzheimer d i s e a s e (AD) i s a p r o g r e s s i v e degene ra t ive d i s o r d e r o f i n s i d i o u s o n s e t , c h a r a c t e r i z e d by memory l o s s , confus ion , and a v a r i e t y o f c o g n i t i v e d i s a b i l i t i e s . It may occur as e a r l y as t h e age o f 40 y e a r s , bu t is most commonly seen a f t e r t h e age of 6 0 y e a r s . Its preva lence seems t o be i n c r e a s i n g as t h e average l i f e expectancy i n c r e a s e s . I n i t s e a r l y s t a g e s i n e l d e r l y persons , t h e d i a g n o s i s is d i f f i c u l t . I n i t s l a t e r s t a t e s , AD is sometimes mistaken f o r o t h e r k i n d s o f dementias and mental d i s e a s e s . I n c o r r e c t d i a g n o s i s is thought t o be common, perhapsrang ing from 1 0 p e r c e n t t o 3 0 p e r c e n t i n t h e g e n e r a l medical popu la t ion (Na t iona lI n s t i t u t e on Aging Task Force, 1980) .

E a r l y and a c c u r a t e d i a g n o s i s o f Alzheimer d i s e a s e h a s a major impact on t h e p r o g r e s sof r e s e a r c h on dementia . To addres s t h e problems involved i n AD i n i t s ea r l i e s t s t a g e s , t h e Na t iona l I n s t i t u t e on Aging, t h e American Assoc ia t ion o f R e t i r e d Persons , t h e Na t iona l I n s t i t u t e of Neurologica l and Communicative Di so rde r s and S t roke , and t h e Na t iona l I n s t i t u t e o f Mental Heal th j o i n t l y sponsored a workshop for planning r e s e a r c h . The purpose o f t h e meeting w a s t o i d e n t i f y t h e most importants c i e n t i f i c r e s e a r c h o p p o r t u n i t i e s and t h e c r u c i a l c l i n i c a l and t e c h n i c a l i s s u e s t h a t i n f l u e n c e t h e p r o g r e s s of r e s e a r c h on t h e d i a g n o s i s of AD. The recommendation o f t h e p a r t i c i p a n t s was pub l i shed as a conference r e p o r t i n t h e Archives o f Neurology.See “Diagnos is o f Alzheimer’s Disease,” 2. S . Khachatur ian, Arch. Neurol. 1985, 42: 1097-1 103.

RESEARCH GOALS AND SCOPE

The purpose o f t h i s announcement is t o s t i m u l a t e f u r t h e r r e s e a r c h focus ing on t h e s p e c i f i c s c i e n t i f i c i s s u e s i d e n t i f i e d i n t h e above-referenced conference . P rogres si n unders tanding and d iagnos ing AD w i l l most l i k e l y come about th rough amassing,e v a l u a t i n g , and comparing d a t a and m a t e r i a l from many sources . A l l d a t a c o l l e c t e d ,bo th r e t r o s p e c t i v e and p rospec t ive , w i l l be maximally u s e f u l on ly so l ong as t h e y are c a r e f u l y screened f o r accuracy o f d i a g n o s i s , r e l evance , and r e l i a b i l i t y and are comparable a c r o s s s t u d i e s .

The fo l lowing a r e some of t h e t o p i c s t h a t are o f p a r t i c u l a r programmatic i n t e r e s t to t h e t h r e e i n s t i t u t e s . These are merely an i l l u s t r a t i o n o f t o p i c s . App l i can t sshould n o t be l i m i t e d t o them.

o Diagnos t i c Screening: There is a n immediate need f o r improved d i a g n o s i s and d i a g n o s t i c s c reen ing f o r AD. However, t h e d i a g n o s i s of and sc reen ing f o r AD w i l l con t inue t o be d i f f i c u l t and sometimes i n a c c u r a t e u n t i l w e ach ieve a b e t t e r unders tanding o f t h e normal ag ing p r o c e s s . There e x i s t no c o n s i s t e n t , e s t a b l i s h e d v a l u e s f o r what c o n s t i t u t e s c o g n i t i v e impairment and memory loss wi th advancing y e a r s ; nor are t h e neu ro log ic changes, t h e neurochemical

7

changes, t h e neurophys io logica l changes, o r t h e g r o s s and f i n e anatomical changes t h a t accompany normal ag ing w e l l enough understood t o provide a f i r m base f o r determining abnormal changes. The major d i f f i c u l t y i n d iagnos ing AD invo lves t h e d e f i n i t i o n of t h e d i s e a s e i t s e l f and i ts v a r i e d and, a t t i m e s ,s u b t l e man i fe s t a t ions ; AD remains a combined c l i n i c o p a t h o l o g i c d i a g n o s i s . The r e l a t i o n s h i p between neuropsychologica l , neu ro rad io iog ica l , and neuropathologic indexes of t h e d i s e a s e is no t w e l l . understood. A con t inu inge f f o r t t o d e f i n e t h e d i s e a s e p r e c i s e l y and t o develop methods o f d e f i n i t e l yd i s t i n g u i s h i n g AD from o t h e r nervous system d i s e a s e s must remain t h e s u b s t r a t e of a l l r e s e a r c h i n t h e f i e l d .

Neuropsychological Diagnosis and Other Behaviora l Measures: There i s a need f o r t h e development o f neuropsychologic and behav io ra l tes ts and markers f o r AD. P r a c t i c a l s c reen ing f o r AD i n t h e e l d e r l y popu la t ion r e q u i r e s r e l i a b l e neuropsychologica l markers . Measures of very s u b t l e changes i n behavior t h a t are t h e first s i g n s o f a b e r r a t i o n t o be n o t i c e d by fami ly members are needed.

Neuropsychological t e s t i n g invo lv ing a b i l i t i e s o t h e r t h a n c o g n i t i v e ones maya l s o be u s e f u l and impor tan t . T e s t s o f f i r s t - o r d e r c a p a b i l i t i e s such as v i s u a l pe rcep t ion , r e a c t i o n t ime, o r motor a b i l i t y might be c l o s e r t o measuring s u b s t r a t e l e v e l s of c e n t r a l nervous system i n t e g r i t y o r d i s a b i l i t ywithout t h e compl ica t ion o f t r y i n g t o measure abs t r ac t - concep tua l - cogn i t ivebehavior .

B i o l o g i c a l and Chemical Markers: S e n s i t i v e and s p e c i f i c b i o l o g i c a l and chemical markers t o i d e n t i f y t h o s e a t h igh r i s k o f AD and t h o s e i n t h e ve rye a r l y s t a g e s o f AD are r e q u i r e d , p r e f e r a b l y de r ived from e x t r a n e u r a l sou rces such as u r i n e , s a l i v a , blood ( ce l l s o r plasma), CSF, o r f i b r o b l a s t c e l l c u l t u r e s . Before any marker is proposed o r made a v a i l a b l e , it is e s s e n t i a l t o v a l i d a t e it a g a i n s t t h e neu ropa tho log ica l d iagnoses and a l l o t h e r s i g n i f i c a n td i s e a s e s i g n s .

Techniques of molecular g e n e t i c s provide a promising new approach f o r unders tanding AD d iagnos is -e t io logy- therapy , especial ly i n view of t h e evidence t h a t t h e r e is a familial f a c t o r p r e s e n t i n t h e d i s e a s e .

Neuroimaging: There is a need t o unders tand and t o r e s o l v e t h e c o n f l i c t i n gd a t a produced by s t u d i e s u s i n g d i f f e r e n t noninvasive imaging ins t ruments ,p a r t i c u l a r l y b r a i n l o c a l i z a t i o n o f t h e imaged d a t a , and s t e r e o t a c t i c l o c a t i o n of prominent landmarks i n t h e b r a i n u s i n g methods borrowed from c u r r e n t neu rosu rg ica l t echnology.

Neuropathological Markers: The r e l a t i o n s h i p o f p laques and n e u r o f i b r i l l a r yt a n g l e s t o premortem c o g n i t i v e f u n c t i o n and t o t h e pa thogenic mechanisms o f AD must be c l a r i f i e d . While s t a n d a r d s have been e s t a b l i s h e d f o r t h e neu ropa tho log ica l d i a g n o s i s of Alzheimer d i s e a s e , ques t ions s t i l l remain. For i n s t a n c e , i f a presumptive d i a g n o s i s of dementia r e s u l t i n g from Alzheimer d i s e a s e is made pre-mortem, t h e presence of p laques and t a n g l e s a t au topsy is g e n e r a l l y cons idered conf i rmatory . However, t h e f requency of p laques and t a n g l e s i n r e p r e s e n t a t i v e popu la t ion samples of persons who were c o g n i t i v e l yi n t a c t p r i o r t o dea th is unknown.

Longi tudina l ep idemiologica l s t u d i e s wi th post-mortem i n v e s t i g a t i o n are r e q u i r e d .Longi tudina l s t u d i e s c o l l e c t i n g d e t a i l e d informat ion on i n d i v i d u a l s a l r e a d ys u f f e r i n g from AD and s t u d i e s invo lv ing g e n e r a l popu la t ions of e l d e r l y persons mayprovide informat ion on premorbid e v e n t s and c o n d i t i o n s of t h o s e who might come down wi th t h e d i s e a s e .

MECHANISMS OF SUPPORT

App l i can t s may use t h e Research P r o j e c t Grant ( R o l l , Research Program P r o j e c t ( P o l ) ,F i r s t Independent Research Support and T r a n s i t i o n Award (R291, Research Career Development Award (K01, K02, KO4 and KOS), C l i n i c a l I n v e s t i g a t o r Award (K081,Academic Award (KO7 and K081, Phys ic ian S c i e n t i s t Award ( K 1 1 and K121, and t h e Nat iona l Research S e r v i c e s Awards. P rospec t ive a p p l i c a n t s are encouraged t o communicate wi th t h e i n s t i t u t e p r o j e c t o f f i c e r l i s t e d a t t h e end o f t h e announcement r ega rd ing t h e a p p r o p r i a t e funding mechanism. Experienced s e n i o r i n v e s t i g a t o r s are p a r t i c u l a r l y encouraged t o cons ide r t h e submission of Research Program P r o j e c ta p p l i c a t i o n s .

APPLICATION AND REVIEW PROCEDURES

App l i can t s may o b t a i n informat ion and t h e a p p r o p r i a t e a p p l i c a t i o n k i t s from t h e i r i n s t i t u t i o n ' s g r a n t s o f f i c e or by c o n t a c t i n g :

8

Office o f Grants I n q u i r i e sD i v i s i o n o f Research Grants Na t iona l I n s t i t u t e s o f Heai th Bethesda, Maryland 20892 Telephone: (301) 496-7441

Although a l e t t e r o f i n t e n t i s no t a p r e r e q u i s i t e f o r apply ing , p r o s p e c t i v ecd a p p l i c a n t s are encouraged t o c o n s u l t w i th t h e p r o j e c t o f f i c e r r ega rd ing t h e

s c i e n t i f i c g o a l s , des ign and s u b j e c t popu la t ion of t h e proposed s tudy .

On i t e m 2 (Response t o a S p e c i f i c Program Announcement) o f t h e face ( f i rs t ) page of t h e a p p l i c a t i o n , a p p l i c a n t s should e n t e r : N I A Program Announcement - Diagnosis o f Alzheimer Disease.

App l i ca t ions should be submi t ted acco rd ing t o t h e r e c e i p t d e a d l i n e s f o r t h e fundingmechanism chosen.

App l i ca t ions w i l l b e r ece ived by t h e N I H D iv i s ion o f Research Grants and r e spons ivea p p l i c a t i o n s w i l l b e a s s igned t o t h e a p p r o p r i a t e I n s t i t u t e . Mul t ip l e ass ignments are p o s s i b l e . It should be recognized t h a t o t h e r N I H components, such as t h e Na t iona l I n s t i t u t e of Neurologica l and Communicative Di so rde r s and S t roke , and t h e Nat iona l I n s t i t u t e o f Mental Heal th , t h e Alcohol, Prug Abuse and Mental Heal th Adminis t ra t ion , a l s o have r e s p o n s i b i l i t y f o r suppor t ing AD r e l a t e d r e s e a r c h . App l i ca t ions w i l l be a s s igned t o t h e a p p r o p r i a t e group f o r review and w i l l be reviewed i n accordance wi th t h e u s u a l N I H pee r review procedures . The review c r i t e r i a are t h e t r a d i t i o n a l c o n s i d e r a t i o n s unde r ly ing s c i e n t i f i c merit. Followings tudy s e c t i o n review, t h e a p p l i c a t i o n s w i l l be eva lua ted by t h e Na t iona l AdvisoryCounci l . Awards w i l l be made on a compe t i t i ve b a s i s wi th a l l a p p l i c a t i o n s competingf o r N I A funding .

INQUIRIES

A l l q u e s t i o n s and cor responsences

Teresa S l u s s Radebaugh, Sc.D. Neuroscience and Neuropsychology

Aging ProgramNat iona l I n s t i t u t e on AgingBui ld ing 31, Room 5C27 9000 Rockv i l l e P ike Bethesda, Maryland 20892

‘plrrr( Telephone : (301 1 496-9350

Eugene J. O l i v e r , Ph.D. Demyelinating, A t rop ic and

Dementing Di so rde r s ProgramNat iona l I n s t i t u t e o f Neurologica l

should be d i r e c t e d t o :

Nancy Miller, Ph.D. Mental D i so rde r s o f t h e Aging

Research Branch Nat iona l I n s t i t u t e o f Mental Heal th Parklawn Bui ld ing , Room 11C03 5600 F i s h e r s Lane Rockv i l l e , Maryland 20857 Telephone: (301) 496-1185

and Communicative Di so rde r s and S t roke

Fede ra l Bui ld ing , Room 710 Bethesda, Maryland 20892 Telephone: (301) 496-1431

ESTABLISHMENT OF SURVEILLANCE SYSTEM OF WOMEN UNDERGOING TREATMENT FOR INFERTILITY WITH I N VITRO FERTILIZATION -SOURCES SOUGHT

P.T. 3 4 , 11; K . W . 0413002 , 0411005 , 1004008 , 0785055

Nat iona l I n s t i t u t e of Chi ld Heal th and Human Development

The Cont racept ive Eva lua t ion Branch, Center f o r Popula t ion Research, Na t iona l I n s t i t u t e o f Chi ld Heal th and Human Development, Nat iona l I n s t i t u t e s o f Heal th , is seek ing s m a l l b u s i n e s s o r g a n i z a t i o n s capab le o f e s t a b l i s h i n g a s u r v e i l l a n c e systemo f women undergoing t r ea tmen t f o r i n f e r t i l i t y w i th i n v i t r o f e r t i l i z a t i o n (IVF) i n t h e United S t a t e s i n o r d e r t o monitor t h e medical and l i fe t ime f e r t i l i t y s eque lae of t h e procedure . The o b j e c t i v e s o f t h i s p r o j e c t are two-fold: ( 1 ) t o mount a c e n t r a l l y coord ina ted , c o l l a b o r a t i v e e f f o r t which w i l l r e s u l t i n a n a t i o n a l r e g i s t r yof t h e s e p a t i e n t s ; and ( 2 ) t o implement t h e system e s t a b l i s h e d above i n o r d e r t o i n v e s t i g a t e t h e e x t e n t t o which t h e procedure may produce a wide spectrum o f adve r se h e a l t h e f fec ts .

9

The first phase o f t h e p r o j e c t w i l l i nco rpora t e i d e n t i f i c a t i o n and s e l e c t i o n of t h e p a r t i c i p a t i n g c l i n i c s , development of t h e d a t a c o l l e c t i o n in s t rumen t s , developmentof p a t i e n t follow-up s t ra tegies and p i l o t t e s t i n g of a l l mechanisms of t h e system. The implementation phase w i l l i nc lude e s t i m a t i o n o f r i s k o f v a r i o u s endocr inologic c o n d i t i o n s , mens t rua l d i s o r d e r s , r ep roduc t ive abnorma l i t i e s , and psychologica l sequelae , i n a d d i t i o n t o gene ra t ing and exp lo r ing new medical hypotheses .

It is a n t i c i p a t e d t h a t t h i s w i l l be a f ive -yea r p r o j e c t and w i l l r e q u i r e t h e fo l lowing personnel : a phys ic i an a t t h e coord ina t ing c e n t e r t o s e r v e as p r i n c i p a l i n v e s t i g a t o r , a systems a n a l y s t , a p r o j e c t manager and c l e r i c a l suppor t . The p a r t i c i p a t i n g c l i n i c a l s i t e s w i l l r e q u i r e p r o j e c t managers (nu r se / ep idemio log i s t s ) and t h e par t - t ime p a r t i c i p a t i o n ( adv i so ry ) o f t h e p h y s i c i a n ( s 1 performing t h e procedure.

Organiza t ions responding t o t h i s announcement should have demonstrated competency i n managing m u l t i c e n t e r c o l l a L o r a t i v e r e s e a r c h p r o j e c t s and should submit documentation t h a t i n d i c a t e s t h e i r c a p a b i l i t y o f meeting t h e fo l lowing requi rements : ( 1 ) f a m i l i a r i t y wi th t h e t e c h n i c a l a s p e c t s of fa v i t r o f e r t i l i z a t i o n procedures and a b i l i t y t o i d e n t i f y c l i n i c s wi th t h i s technology a v a i l a b l e ; ( 2 ) exper ience i n r ep roduc t ive epidemiology; (3) a b i l i t y t o t r a i n and s u p e r v i s e a p p r o p r i a t e personnel a t t h e c l i n i c a l sites; and (4)da tabase management s k i l l s i nc lud ing q u a l i t y assu rance .

This announcement is no t a r e q u e s t f o r p roposa l s (RFP) and responses should no t i nc lude p r i c i n g o r budgetary informat ion . Small bus iness o r g a n i z a t i o n s t h a t b e l i e v e t h e y can meet t h e requi rements of t h i s p r o j e c t should submit f i v e cop ie s o f t h e i r c a p a b i l i t y s t a t e m e n t s t o t h e fo l lowing addres s , c i t i n g Synopsis No. NICHD-87-03, no l a t e r t h a n May 4 , 1987. 4, 1987.

Paul J . Duska, Con t rac t ing Officer Contrac t Management Sec t ion , OGC Nat iona l I n s t i t u t e of Chi ld Heal th and Human DevelopmentLandow Bui ld ing , Room 6C25 7910 Woodmont Avenue Bethesda, Maryland 20892

O N G O I N G PROGRAM ANNOUNCEMENTS

P.T. 34; K.W. 0715095, 0715130, 0785055, 0755030, 0404000

Nat iona l I n s t i t u t e o f Mental Heal th Nat iona l I n s t i t u t e o f Chi ld Heal th and Human Development

The Nat iona l I n s t i t u t e o f Mental Heal th and t h e Nat iona l I n s t i t u t e of Chi ld Heal th and Human Development announce t h e a v a i l a b i l i t y o f suppor t f o r r e s e a r c h on Persons With Mental Re ta rda t ion and Mental I l l n e s s . Th i s r e s e a r c h i s t o e l u c i d a t e t h e epidemiology, e t i o l o g y , t r ea tmen t and p reven t ion o f mental d i s o r d e r , and behav io ra l and emotional problems i n persons of any age wi th mental r e t a r d a t i o n . App l i can t s may r e q u e s t a maximum o f 5 y e a r s o f suppor t . App l i ca t ions i n response t o t h i s announcement w i l l be accepted i n accordance wi th t h e usua l Pub l i c Heal th S e r v i c e r e c e i p t d a t e s f o r new a p p l i c a t i o n s . Fu r the r in format ion is a v a i l a b l e from one of t h e fo l lowing:

Eleanor D . Dibble , D.S.W. Parklawn Bui ld ing , Room 10-1 04 Chi ld and Adolescent D i so rde r s Research Branch Div i s ion o f C l i n i c a l Research Nat iona l I n s t i t u t e o f Mental Heal th 5600 F i s h e r s Lane Rockvi l le , Maryland 20857 Telephone: (301) 443-5944

James F. Kavanagh, Ph.D. Act ing Chief , Mental Re ta rda t ion and Developmental

D i s a b i l i t i e s Branch Nat iona l I n s t i t u t e of Chi ld Heal th

and Human DevelopmentLandow Bui l ing , Room 7C09 Nat iona l I n s t i t u t e s of Heal th Bethesda, Maryland 20892 Telephone: (301 496-1383

cr-

10

CLINICAL AND EPIDEMIOLOGIC RESEARCH ON M I N O R I T Y POPULATIONS OF THE UNITED STATES

P.T. 34; FF; K.W. 0785035, 0785050, 0785055, 0715135, 0715075, 0710095, 0715010

Na t iona l I n s t i t u t e o f Diabe tes and Diges t ive and Kidney Diseases Nat iona l I n s t i t u t e o f A r t h r i t i s and Musculoske le ta l and Sk in Diseases\ r ~

OBJECTIVES AND SCOPE

The above-named I n s t i t u t e s s o l i c i t a p p l i c a t i o n s f o r r e s e a r c h i n t h e areas o f c l i n i c a l and ep idemiologic s t u d i e s on minor i ty popu la t ions o f t h e United S t a t e s .

Areas of d e s i r e d r e s e a r c h inc lude g e n e t i c , metabol ic , phys io log ic , n u t r i t i o n a l , and ep idemiologic a s p e c t s o f d i a b e t e s , endocrinology, and metabol ic d i s e a s e s ; d i g e s t i v ed i s e a s e s , n u t r i t i o n , and o b e s i t y ; kidney, uro logy and hematologic d i s e a s e s ; and a r t h r i t i s , musculoske le ta l , and s k i n d i s e a s e s . Research is s o l i c i t e d i n normal phys io logy and pathophysiology o f t h e s e d i s e a s e s ; e t i o l o g y , r i s k f a c t o r s , and p o t e n t i a l f o r development of d i s e a s e ; t r e n d s i n inc idence , p reva lence , morbid i ty and m o r t a l i t y ; n a t u r a l h i s t o r y o f d i s e a s e ; prognos is f o r development o f d i s e a s e compl i ca t ions and s e q u e l l a e ; methods f o r p reven t ion of t h e d i s e a s e s ; and methods f o r p reven t ion o r a m e l i o r a t i o n of t h e i r compl i ca t ions .

The minor i ty popu la t ions t o be s t u d i e d inc lude but are n o t l i m i t e d t o Blacks, Hispanic Americans (Mexican Americans, Pue r to Ricans, Cuban Americans), Asian Americans (Korean, Japanese , P h i l i p p i n o , Chinese, Vietnamese o r i g i n s ) , Nat ive Americans (American Ind ians , Eskimos), and P a c i f i c I s l a n d e r s , i n c l u d i n g Hawaiians. Comparisons among t h e s e popu la t ions , w i th t h e whi te m a j o r i t y popu la t ion o f t h e United S t a t e s i n c l u d i n g e t k n i c I r e l i g i o u s s u b s e t s , and wi th popu la t ions i n t h e coun t ry o f o r i g i n would be d e s i r a b l e .

S t u d i e s on t h e g e n e r a l popu la t ion a t r i s k f o r d i s e a s e , as w e l l as on p a t i e n tpopu la t ions who have been diagnosed t o have t h e d i s e a s e , w i l l b e accep ted . Research focus may be b a s i c , c l i n i c a l o r ep idemiologic . C l i n i c a l r e s e a r c h may be o r i e n t e d t o t h e c e l l u l a r , organ, o r person l e v e l and may inc lude metabol ic s t u d i e s and comparisons. Epidemiologic r e s e a r c h des igns t h a t might be employed inc lude o b s e r v a t i o n a l and n a t u r a l h i s t o r y s t u d i e s , ca se -con t ro l s t u d i e s o f r a c i a l l e t h n i c d i f f e r e n c e s , s t u d i e s o f migrant popu la t ions i n t h e t h e U.S. v e r s u s i n t h e i r coun t ryo f o r i g i n , u r b a n l r u r a l comparisons, a c c u l t u r a t i o n o f t h e m i n o r i t i e s t o t h e U.S. l i f e s t y l e and environment, and l o n g i t u d i n a l s t u d i e s . Research d i r e c t e d toward

\& improving methodologies f o r populat ion-based s t u d i e s o f minor i ty e t h n i c I r a c i a 1 groups is a l s o encouraged.

Although new r e s e a r c h p r o j e c t s a r e d e s i r e d , t h e I n s t i t u t e s are p a r t i c u l a r l yi n t e r e s t e d i n r e c e i v i n g a p p l i c a t i o n s based i n on-going s t u d i e s t h a t may have been conceived f o r r easons o t h e r t h a n f o r r e s e a r c h on U.S. m i n o r i t i e s o r f o r s t u d i e s on t h e d i s e a s e s l i s t e d above. I n a d d i t i o n , a n a l y s e s o f e x t a n t d a t a sets t h a t c o n t a i n components on U.S. minor i ty popu la t ions are p a r t i c u l a r l y encouraged.

Some o f t h e s e e x t a n t r e s e a r c h p r o j e c t s i nc lude t h e v a r i o u s n a t i o n a l su rveys o f t h e Na t iona l Center f o r Heal th S t a t i s t i c s (Heal th and N u t r i t i o n Examination Surveys,Hispanic HANES, Heal th In t e rv i ew Survey, Hosp i t a l Discharge Survey, Na t iona l Ambulatory Medical Care Survey, Nat iona l Nursing Home Survey) and o f t h e Na t iona l Center f o r Heal th S e r v i c e s Research (Na t iona l Medical Care Expendi ture Survey) , t h e Honolulu Heart Study, t h e Pue r to Rico Heart Study, Bogalusa Heart Study, Evans County Study, E a r l y Treatment o f D i a b e t i c Ret inopathy Study, Rand Heal th Insurance Study, Medicare and Medicaid d a t a , Consol ida ted End S tage Renal Disease Data System,ARAMIS, t h e Tecumseh Study, t h e Rochester Epidemiology Program, Na t iona l Survey o f Black Americans, L ip id Research C l i n i c s Program, Meharry Cohort Study, and Kaiser Permanente Twin R e g i s t r y .

MECHANISMS OF SUPPORT, APPLICATION PROCEDURE, AND REVIEW PROCEDURE

Research suppor t mechanisms t h a t might be u t i l i z e d inc lude r e g u l a r r e s e a r c h g r a n t s( R o l l , C l i n i c a l I n v e s t i g a t o r Awards (K081, F i r s t Independent Research and T r a n s i t i o n (FIRST) Awards (R291, and I n d i v i d u a l Nat iona l Research S e r v i c e Awards (F32).S p e c i f i c a p p l i c a t i o n forms and k i t s are a v a i l a b l e i n t h e b u s i n e s s o r g r a n t s and c o n t r a c t s o f f i c e s o f most academic and r e s e a r c h i n s t i t u t i o n s o r may be ob ta ined from:

Office o f Grants I n q u i r i e sDiv i s ion o f Research Grants , N I H Westwood Bu i ld ing , Room 449 Bethesda, Maryland 20892

F - 4 Telephone: (301 1 496-7441

11

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Appl i ca t ions w i l l be accepted on an i n d e f i n i t e b a s i s i n accordance wi th t h e r e g u l a rr e c e i p t d a t e s e s t a b l i s h e d by t h e N I H D iv i s ion o f Research Grants and s p e c i f i e d i n t h e p e r t i n e n t a p p l i c a t i o n k i t s . The o r i g i n a l and s i x cop ie s of t h e a p p l i c a t i o nshould be s e n t o r d e l i v e r e d t o :

App l i ca t ion Receipt Off ice Div i s ion of Research Grants , N I H Westwood Bui ld ing , Room 240 Bethesda, Maryland 20892

Appl i ca t ions i n response t o t h i s announcement w i l l be reviewed on a nat ionwide b a s i s i n compet i t ion wi th o t h e r a p p l i c a t i o n s and i n accordance wi th t h e usua l N I H pee rreview procedures . Funding d e c i s i o n s w i l l be based on r e l a t i v e s c i e n t i f i c m e r i t , program re l evance , and a v a i l a b i l i t y of appropr i a t ed funds .

STAFF CONTACT

The fo l lowing i n d i v i d u a l s may be con tac t ed i n r ega rd t o t h e p o s s i b l e s c i e n t i f i c con ten t o f g r a n t a p p l i c a t i o n s :

Diabetes , Endocrinology, and Metabol ic Diseases : Maureen I. H a r r i s . , Ph.D., M.P.H. Epidemiology Research Program, DEMD Westwood 620 N I H , Bethesda MD 20892 Telephone: (301) 496-7595

Diges t ive Diseases, N u t r i t i o n , and Obes i ty : Jay Everha r t , M.D. Epidemiology and Data Systems, DDN Federa l 616 N I H , Bethesda MD 20892 Telephone: (301) 496-8933

Kidney, Urology, and Hematology:Anna Sandberg, Dr.P.H. C l i n i c a l T r i a l s and Epidemiology, DKUH Westwood 621 N I H , Bethesda MD 20892 Telephone: (301) 496-7133

A r t h r i t i s , Musculoskeletal and Skin Diseases: Reva Lawrence, M.P.H. Epidemiology and Data Systems, AMs Westwood 403 N I H , Bethesda MD 20892 Telephone: (301) 496-7495

ERRATUM

STUDIES OF THE OPPORTUNISTIC INFECTIONS ASSOCIATED WITH-

P.T. 34; K.W. 0715125, 0715165, 0785055, 0710075, 1002008

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

The number 87-AI-10 was used e r roneous ly f o r t h e RFA, "S tud ie s o f t h e Oppor tun i s t i cI n f e c t i o n s Assoc ia ted wi th t h e Acquired Immunodeficiency Syndrome," publ i shed i n t h e Guide f o r January 16, 1987 (Vol . 16, No. 2). The c o r r e c t number is 87-AI-07. Appl i can t s are advised t h a t t h e I n s t i t u t e is aware o f t h e problem and is t a k i n g s t e p s t o make sure t h a t a p p l i c a t i o n s are as s igned t o t h e a p p r o p r i a t e review committee.

Vu'

12