NIH Guide - Vol. 17, No. 5 - February 12, 1988

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Vol. 17, l o . 5

February 12, 1988

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Vol. 17, No.

5,

February

12, 1988

NOTICES

AVAILABILITY OF FISH OIL TEST MATERIALS .....................................

National Institutes of Health

Index: NATIONAL INSTITUTES OF HEALTH

THE NATIONAL INSTITUTES OF HEALTH ESTABLISHES THE NIH REVIEWERS RESERVE .....

National Institutes of Health

Index: NATIONAL INSTITUTES OF HEALTH

NOTICE OF MEETING - ANIMAL CARE & RESEARCH: INSTITUTIONAL

RESPONSIBILITY VS. PUBLIC ACCOUNTABILITY ....................................

Public Responsibility in Medicine and Research (PRIM&R)

Index: PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH

1

2

2

DATED ANNOUNCEMENTS (RFPs AND RFAs AVAILABLE)

FLOW CYTOMETRY QUALITY CONTROL (RFP)........................................

National Institute of Allergy and Infectious Diseases

Index: ALLERGY AND INFECTIOUS DISEASES

2

CLINICAL TRIAL OF COMBINATION THERAPY OF PAPILLOMAVIRUS INFECTIONS (RFP).... 3

National Institute of Allergy and Infectious Diseases

Index: ALLERGY AND INFECTIOUS DISEASE5

ANTIVIRAL SCREEN FOR HEPADNAVIRUSES, HERPESVIRUSES AND

RESPIRATORY VIRUSES (RFP)...................................................3

National Institute of Allergy and Infectious Diseases

Index: ALLERGY AND INFECTIOUS DISEASES

INTERNATIONAL COLLABORATIVE STUDY OF ORAL HEALTH OUTCOMES;

U.S.A. REPLICATION (RFP)....................................................

National Institute of Dental Research

Index: DENTAL RESEARCH

VIROLOGY QUALITY CONTROL (RFP)..............................................

National Institute of Allergy and Infectious Diseases

Index: ALLERGY AND INFECTIOUS DISEASES

4

4

ACQUISITION OF DATA FOR DEVELOPING IMPROVED STRATEGIES FOR CONDITIONS

OF BONE MARROW AND TO FACILITATE THE TRANSPLANTATION OF IMMUNE

CELL DEPLETED MARROW GRAFTS (RFP)...........................................

National Institute of Allergy and Infectious Diseases

Index: ALLERGY AND INFECTIOUS DISEASES

5

ESTABLISHMENT AND MAINTENANCE OF A SPECIFIC PATHOGEN FREE RHESUS MONKEY

BREEDING AND RESEARCH PROGRAM (RFA).........................................

Division of Research Resources

Index: RESEARCH RESOURCES

6

IN VITRO TRANSFORMATION OF HUMAN AND ANIMAL MAMMARY EPITHELIAL CELLS BY

CHEMICAL OR PHYSICAL CARCINOGENS (RFA)......................................

National Cancer Institute

Index: CANCER

7

SMALL GRANTS TO FACILITATE USE OF NEW TECHNIQUES OF MOLECULAR

AND CELL BIOLOGY AND GENETICS BY RESEARCHERS IN DIABETES,

ENDOCRINOLOGY AND METABOLIC DISEASES (RFA)..................................

National Institute of Diabetes and Digestive and Kidney Diseases

Index: DIABETES AND DIGESTIVE AND KIDNEY DISEASES

8

,

I

NOTICES

AVAILABILITY OF FISH O I L TEST MATERIALS

U

'*,

P.T. 34;

K.W.

0780010

National I n s t i t u t e s of Health

SUMMARY AND PURPOSE

The F i s h O i l T e s t Materials Program h a s been e s t a b l i s h e d t h r o u g h t h e

c o o p e r a t i o n of t h e N a t i o n a l I n s t i t u t e s of H e a l t h , t h e A l c o h o l , Drug Abuse, and

Mental H e a l t h A d m i n i s t r a t i o n and t h e N a t i o n a l Oceanic and Atmospheric

Administration-Department o f Commerce. T h i s program h a s been d e s i g n e d t o

p r o v i d e a long-term, c o n s i s t e n t s u p p l y o f quality-assuredlquality-controlled

t e s t materials t o researchers i n order t o facilitate t h e evaluation of t h e

r o l e t h a t omega-3 f a t t y a c i d s p l a y i n h e a l t h and d i s e a s e .

TEST MATERIALS CURRENTLY AVAILABLE

o n-3 e t h y l e s t e r c o n c e n t r a t e

The n-3 e s t e r c o n c e n t r a t e i s p r e p a r e d from vacuum-deodorized menhaden o i l

u s i n g t r a n s e s t e r i f i c a t i o n , u r e a a d d u c t i o n and s h o r t - p a t h d i s t i l l a t i o n ; t h e

c o n c e n t r a t e c o n t a i n s a p p r o x i m a t e l y 80 p e r c e n t n-3 e t h y l e s t e r s , 3 p e r c e n t C18

( o t h e r t h a n n-31, 6 p e r c e n t C16 and t h e remainder a s o t h e r e s t e r s . I t i s

a v a i l a b l e w i t h a n t i o x i d a n t a d d i t i o n s and packaged i n q u a n t i t i e s s u i t a b l e t o

t h e i n v e s t i g a t o r s r needs.

o E n c a p s u l a t e d p u r i f i e d steam-deodorized menhaden o i l

o E n c a p s u l a t e d commercial p r e p a r a t i o n s o f c o r n , o l i v e , and

safflower o i l

These c a p s u l e s a r e 1-gram opaque g e l c a p s u l e s , packaged 1 0 0 p e r b o t t l e i n

tamper-proof s e a l e d brown g l a s s b o t t l e s . Alpha-tocopherol and TBHQ

a n t i o x i d a n t s have been added t o t h e s e menhaden o i l c a p s u l e s . The v e g e t a b l e

o i l c a p s u l e s have had no a n t i o x i d a n t s added. However, t h e s e o i l s do c o n t a i n

endogenous t o c o p h e r o l s .

'

--I,'

o E n c a p s u l a t e d p u r i f i e d steam-deodorized menhaden o i l

o E n c a p s u l a t e d commercial p r e p a r a t i o n o f c o r n o i l

These c a p s u l e s a r e 1 gram c l e a r s o f t g e l , packaged 100 p e r b o t t l e i n

tamper-proof s e a l e d brown g l a s s b o t t l e s . The a n t i o x i d a n t c o n t e n t o f t h e

menhaden o i l c a p s u l e s and t h e a n t i o x i d a n t c o n t e n t o f t h e c o r n o i l c a p s u l e s

have been b a l a n c e d f o r a l p a - and gamma-tocopherol and TBHQ. These b a l a n c e d

l e v e l s were o b t a i n e d by a d d i n g Eastman Kodak Vitamin E 5-67, GT-1 and Tenox

20A.

o Bulk vacuum-deodorized menhaden o i l

The b u l k menhaden o i l h a s been w i n t e r i z e d , a l k a l i r e f i n e d and vacuum

I t is a v a i l a b l e w i t h o r w i t h o u t a n t i o x i d a n t a d d i t i o n s and is

deodorized.

packaged i n q u a n t i t i e s s u i t a b l e t o t h e i n v e s t i g a t o r s ' n e e d s , Corn oil m a y be

p u r c h a s e d by t h e r e s e a r c h e r ; p r o v i s i o n t o q u a l i t y assure t h e a d d i t i o n of

a n t i o x i d a n t s by t h e r e s e a r c h e r w i l l b e made.

A l l p r o d u c t s were p r e p a r e d u n d e r a n i t r o g e n b l a n k e t and w i l l b e s u p p l i e d w i t h

d e t a i l e d q u a l i t y assurance data.

I n a c c o r d a n c e w i t h f e d e r a l r e g u l a t i o n s , a n I N D number w i l l be e e q u i r e d for t h e

u s e of t h e s e m a t e r i a l s i n human s t u d i e s . The F i s h O i l T e s t M a t e r i a l s Advisory

Committee (FOTMAC) w i l l e s t a b l i s h a d r u g m a s t e r f i l e a t t h e Food and Drug

A d m i n i s t r a t i o n which w i l l i n c l u d e m a n u f a c t u r i n g , c h e m i c a l c o m p o s i t i o n and

t o x i c o l o g i c a l d a t a r e l e v a n t t o t h e s e p r o d u c t s . I n v e s t i g a t o r s awarded t h e s e

m a t e r i a l s from t h e FOTMAC may t h e n r e f e r e n c e t h i s f i l e i n o r d e r t o e x p e d i t e

t h e i r I N D r e q u e s t s . A p p l i c a t i o n s f o r omega-3 r e s e a r c h m a t e r i a l s f o r b o t h

human and animal s t u d i e s w i l l b e a c c e p t e d and p r o c e s s e d .

INQUIRIES AND APPLICATIONS

A c t i v e i n v e s t i g a t o r s may a p p l y f o r a v a i l a b l e materials t o b e u s e d f o r r e l e v a n t

s t u d i e s by r e q u e s t i n g a n a p p l i c a t i o n form from:

Nancy H e n s l e r , Program A s s i s t a n t

F i s h O i l T e s t M a t e r i a l s Program

B u i l d i n g 31, Room 4B63

N u t r i t i o n C o o r d i n a t i n g Committee

National I n s t i t u t e s of Health

Bethesda, Maryland 20892

(301) 496-2323

Telephone:

1

THE NATIONAL INSTITUTES OF HEALTH ESTABLISHES THE N I H REVIEWERS RESERVE

P.T. 34;

K.W. 1014002, 0710030

National I n s t i t u t e s of Health

The N a t i o n a l I n s t i t u t e s o f H e a l t h i s e s t a b l i s h i n g t h e N I H Reviewers R e s e r v e

( N R R ) , which i s e x p e c t e d t o become o p e r a t i o n a l i n J u l y . S e l e c t e d as needed,

members of t h i s R e s e r v e w i l l b e a b l e t o p a r t i c i p a t e f u l l y i n m e e t i n g s o f N I H ' s

c h a r t e r e d s c i e n t i f i c r e v i e w committees t h a t e v a l u a t e g r a n t and c o o p e r a t i v e

agreement a p p l i c a t i o n s and r e s e a r c h and development c o n t r a c t p r o p o s a l s .

The D i v i s i o n o f R e s e a r c h G r a n t s (DRG) w i l l manage t h e R e s e r v e f o r trans-NIH

u s e . Nominations t o t h e R e s e r v e w i l l b e made by t h e v a r i o u s N I H components,

p r i m a r i l y from among t h e p o o l o f r e t i r e d members o f c h a r t e r e d NIIf review

committees.

On b e h a l f o f t h e D i r e c t o r o f N I H , t h e DRG D i r e c t o r w i l l s e l e c t ,

i n v i t e , and a p p o i n t h i g h l y q u a l i f i e d s c i e n t i s t s and o t h e r t e c h n i c a l e x p e r t s t o

s e r v e on t h e R e s e r v e . Appointment t o t h e R e s e r v e may b e f o r up t o f o u r y e a r s

a s l o n g a s members f i l e and m a i n t a i n c u r r e n t Form HHS 474 ( S t a t e m e n t o f

Employment and F i n a n c i a l I n t e r e s t ) and do n o t a c c e p t appointment t o any

c h a r t e r e d Department o f H e a l t h and Human S e r v i c e s p u b l i c a d v i s o r y committee.

During any one g r a n t r e v i e w c y c l e , R e s e r v e members may e a c h p a r t i c i p a t e w i t h

up t o 2 c h a r t e r e d s c i e n t i f i c r e v i e w committees, a t t h e r e q u e s t o f t h e

c o m m i t t e e ' s E x e c u t i v e S e c r e t a r y . The number o f R e s e r v e members t h a t may

p a r t i c i p a t e i n t h i s c a p a c i t y a t a g i v e n c h a r t e r e d r e v i e w committee m e e t i n g i s

l i m i t e d t o no more t h a n o n e - h a l f o f t h e committee's quorum.

As i n t h e p a s t ,

Committee E x e c u t i v e S e c r e t a r i e s may a l s o a s k ad hoc s p e c i a l

i n d i v i d u a l r e v i e w e r s t o p r o v i d e a d v i c e and c o u n s e l t o c h a r t e r e d review

committees; a d hoc s p e c i a l r e v i e w e r s do n o t have t h e r i g h t s , p r i v i l e g e s , n o r

o b l i g a t i o n s o r a p p o i n t e d committee o r R e s e r v e members and do n o t o f f e r o r v o t e

on motions n o r a s s i g n p r i o r i t y r a t i n g s .

The r o s t e r o f r e v i e w e r s p r o v i d e d a s p a r t o f t h e summary s t a t e m e n t ( p i n k s h e e t )

w i l l l i s t and s p e c i f y a p p o i n t e d committee and NRR members and a d hoc

consultants.

NOTICE OF MEETING

-

ANIMAL CARE & RESEARCH:

PUBLIC ACCOUNTABILITY

P.T. 42;

INSTITUTIONAL RESPONSIBILITY VS.

K.W. 0201011, 1014003

P u b l i c R e s p o n s i b i l i t y i n Medicine and R e s e a r c h (PRIM&R)

P u b l i c R e s p o n s i b i l i t y i n Medicine and R e s e a r c h (PRIM&R) and T u f t s U n i v e r s i t y

School o f V e t e r i n a r y Medicine a r e c o - s p o n s o r i n g a m e e t i n g i n Boston on March

24-25, 1988, e n t i t l e d "Animal Care & R e s e a r c h : I n s t i t u t i o n a l R e s p o n s i b i l i t y

v s . P u b l i c Accountability.11 Topics t o be addressed include: ordinances (such

a s t h e Cambridge o r d i n a n c e ) which p r o p o s e t o s e v e r e l y l i m i t o r r e s t r i c t animal

r e s e a r c h ; s u n s h i n e laws which r e g u l a t e a n i m a l c a r e committee p r o c e e d i n g s ;

i n s t i t u t i o n a l p o l i c i e s a f f e c t i n g a r e a s such a s who c a n a t t e n d m e e t i n g s , r e c o r d

k e e p i n g and i n g e n e r a l t h e i n c r e a s i n g l y complex q u e s t i o n a s t o how

i n s t i t u t i o n a l r e s p o n s i b i l i t y and p u b l i c a c c o u n t a b i l i t y c a n b e b a l a n c e d .

For f u r t h e r i n f o r m a t i o n p l e a s e c o n t a c t :

PRIM&R

132 B o y l s t o n S t r e e t

Boston, M a s s a c h u s e t t s 02116

Telephone:

( 6 1 7 ) 423-4112 o r 423-1099

DATED ANNOUNCEMENTS (RFPs AND RFAs AVAILABLE)

FLOW CYTOMETRY QUALITY CONTROL

RFP AVAILABLE:

P.T. 34;

NIAID-AIDSP-88-26

K.W. 0735005, 0 7 6 0 0 0 0

N a t i o n a l I n s t i t u t e of A l l e r g y and I n f e c t i o u s Diseases

The Epidemiology Branch, AIDS Program, N a t i o n a l I n s t i t u t e of A l l e r g y and

I n f e c t i o u s D i s e a s e s , N I H , h a s a requirement f o r t h e q u a l i t y c o n t r o l o f

lymphocyte p h e n o t y p i n g s t u d i e s which a r e performed a t e x t r a m u r a l s i t e s

p a r t i c i p a t i n g i n c o l l a b o r a t i v e AIDS c l i n i c a l t r i a l s and n a t u r a l h i s t o r y

studies.

2

'

I

S p e c i f i c a l l y , t h e c o n t r a c t o r s h a l l be r e s p o n s i b l e f o r t h e development and

implementation o f a q u a l i t y c o n t r o l program f o r s t a n d a r d i z a t i o n o f lymphocyte

c o u n t s and s t a n d a r d i z a t i o n o f flow c y t o m e t r y conducted a t t h e r e s e a r c h s i t e s .

The c o n t r a c t o r s h a l l a l s o b e r e s p o n s i b l e f o r r e l a t e d a c t i v i t i e s n e c e s s a r y t o

s u p p o r t a r i g o r o u s q u a l i t y a s s u r a n c e program i n c l u d i n g shipment o f specimens,

d a t a e n t r y and a n a l y s i s , and m o n i t o r i n g and review o f performance a t t h e

research sites.

RFP NIH-NIAID-AIDSP-88-26 w i l l b e a v a i l a b l e on o r a b o u t F e b r u a r y 19, 1988.

Responses w i l l b e due on o r a b o u t A p r i l 4, 1988.

It i s e x p e c t e d

One c o n t r a c t w i l l b e awarded a s a r e s u l t o f t h i s s o l i c i t a t i o n .

t h a t t h e c o n t r a c t w i l l have a f i v e - y e a r p e r i o d o f p e r f o r m a n c e . A l l

r e s p o n s i b l e s o u r c e s may submit a p r o p o s a l which w i l l b e c o n s i d e r e d by t h e

Government.

To r e c e i v e a copy o f t h i s RFP, p l e a s e s e n d 2 s e l f a d d r e s s e d m a i l i n g l a b e l s t o :

J a c q u e l i n e C . Holden, C o n t r a c t i n g Officer

C o n t r a c t Management Branch, N I A I D

National I n s t i t u t e s of Health

Westwood B l d g . , Room 707

5333 Westbard Avenue

B e t h e s d a , Maryland 20892

T h i s a d v e r t i s e m e n t d o e s n o t commit t h e Government t o make a n award.

CLINICAL TRIAL OF COMBINATION THERAPY OF PAPILLOMAVIRUS INFECTIONS

RFP AVAILABLE:

P.T. 34;

K.W.

NIAID-MIDP-88-30

0755015, 0415000, 0715125

N a t i o n a l I n s t i t u t e o f A l l e r g y and I n f e c t i o u s Diseases

a-&

The A n t i v i r a l S u b s t a n c e s Program, Microbiology and I n f e c t i o u s Diseases Program

o f t h e N a t i o n a l I n s t i t u t e o f A l l e r g y and I n f e c t i o u s D i s e a s e s is s e e k i n g an

o r g a n i z a t i o n t o conduct s e v e r a l Phase 1/11 s t u d i e s o f t h e e f f i c a c y o f

c o m b i n a t i o n t h e r a p y f o r t h e c o n t r o l o f condylomata acuminatum i n f e c t i o n s . The

s u c c e s s f u l o f f e r o r s h o u l d be q u a l i f i e d t o s e r v e as t h e s o l e C o n t r a c t i n g U n i t

o r a s t h e C e n t r a l U n i t o f a c o l l a b o r a t i v e t r i a l . The s u c c e s s f u l o f f e r o r

should be a b l e t o demonstrate e x p eri en ce i n t h e c l i n i c a l e v a l u a t i o n o f

a n t i v i r a l s and d e m o n s t r a t e a c a p a c i t y t o o r g a n i z e and a d m i n i s t e r a

collaborative c l i n i c a l study.

T h i s announcement i s a new s o l i c i t a t i o n . The i s s u a n c e o f t h e RFP w i l l b e on

F e b r u a r y 29, 1988, and p r o p o s a l s w i l l b e due a t COB on A p r i l 29, 1988.

The r e q u e s t f o r t h e RFP s h o u l d b e a d d r e s s e d t o :

C h i e f , C o n t r a c t Management Branch

N a t i o n a l I n s t i t u t e of A l l e r g y and I n f e c t i o u s Diseases

National I n s t i t u t e s o f Health

Westwood B u i l d i n g , Room 707

B e t h e s d a , Maryland 20892

P l e a s e p r o v i d e t h i s o f f i c e w i t h two s e l f - a d d r e s s e d m a i l i n g l a b e l s .

T h i s a d v e r t i s e m e n t d o e s n o t commit t h e government t o award a c o n t r a c t .

ANTIVIRAL SCREEN FOR HEPADNAVIRUSES, HERPESVIRUSES AND RESPIRATORY VIRUSES

RFP AVAILABLE:

P.T. 34;

NIAID-MIDP-88-31

K.W. 0715125, 1002045, 0760035

N a t i o n a l I n s t i t u t e o f A l l e r g y and I n f e c t i o u s Diseases

Y '

The Development and A p p l i c a t i o n s Branch, N a t i o n a l I n s t i t u t e o f A l l e r g y and

I n f e c t i o u s Diseases, seeks a n o r g a n i z a t i o n t o perform i n v i t r o s c r e e n i n g o f

compounds f o r t h e i r a b i l i t y t o i n h i b i t t h e growth a n d / o r r e p l i c a t i o n o f

h e p a d n a v i r u s e s , h e r p e s v i r u s e s (HSV, CMV, VZV) and r e s p i r a t o r y v i r u s e s

( i n f l u e n z a , p a r a i n f l u e n z a , and r e s p i r a t o r y s y n c y t i a l v i r u s e s ) . The s u c c e s s f u l

o f f e r o r ( s 1 w i l l p r o v i d e t h e n e c e s s a r y equipment, p e r s o n n e l , f a c i l i t i e s , and

m a t e r i a l s t o s c r e e n a n n u a l l y 200 compounds f o r h e r p e s v i r u s e s and 100 e a c h f o r

h e p a d n a v i r u s e s and r e s p i r a t o r y v i r u s e s . The s u c c e s s f u l o f f e r o r ( s 1 w i l l b e

3

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