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+l for GRAMTS -NIH GUIDE and CONTRACTS U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE POLICY 1. PURPOSE The purpose of this issuance i s to prescribe the policies and proce- duresccountabi li ty and property management o f equipment purchased with NIH grant funds. It implements DHEW Grants Administration Manual Chapter 1-410, and supersedes all other instructions inconsistent with the present instructions. 2. APPLICABILITY Subject to such legal limitations as may be prescribed by program legislation (e.g., NIH construction programs) , this policy is applicable to all current grants administered by the National Institutes of Health. It is not applicable to NIH contracts or to grants having project periods with termination dates prior to July 1 , 1971. 3. BACKGROUND Under authority of the PHS Act (42 USC 201 e. seq.), NIH makes funds avai lable through grants for the support of approved research, training, special projects, institutional grants , and demonstration projects. Such funds may be used for the purchase of equipment necessary to the successful prosecution of the activities being supported. T i t l e t o equipment purchased from grant funds is vested in the grantee institution or organization , subject t o accountabi 1i ty to the Federal Government at the completion of the project for which the grant was made. Public Law 85-934, 42 USC f 1891 et. seq. authorizes the waiver of accountability for equipment purchased with fundsfrom research grants awarded to nonprofit insti- tutions of higher education and nonprofit organizations whose primary purpose i s the conduct of scientific research. Accountability ma not be waived f o r equipment purchased with funds from research grants awarded t o o t er t y p e s n s t i t u t i o n s nor' for equipment purchased from any type of grant other than research grants. Certain equipment i s sufficiently general in nature that it can be utilized by the grantee institution i n connection with other grant-supported or grant-el igible activities. Therefore continued retention by the grantee o f such equipment, where statutory authority exists , serves the collateral purpose of the creation or enhancement of the research and training capability of the grantee institution and furtherance of the objectives of the National Institutes of Health. 4. DEFINITIONS a. Equipment: For the purposes of this issuance, an item o f equipment i s an article of property procured or fabricated, which i s complete i n itself, i s of a durable nature, and has an expected service l i f e of more than one year. b. Su lies: Items which are consumed or expended when put to use or h v e an expected service of less thdi one year. (The pro- visions of this issuance do not apply to supplies.) - The GUIDE i s published at irregular intervals to provide policy, program, and ahinistrative infomation to individuazs and organizations who need to be kept informed of requirements and changes in grants and contracts programs administered by the National Institutes of Health.

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Page 1: -NIH GUIDE and for CONTRACTS - grants.nih.gov · 2014. 10. 3. · NIH Guide for Grants and Contracts, No. 9, July 29, 1971 Page Five b. The awarding unit will authorize a method of

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for GRAMTS-NIH GUIDE and CONTRACTS U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

POLICY 1. PURPOSE The purpose o f t h i s issuance i s t o p resc r ibe t h e p o l i c i e s and proce­d u r e s c c o u n t a b i lity and p roper t y management o f equipment purchased w i t h N I H g ran t funds. I t implements DHEW Grants Admin i s t ra t i on Manual Chapter 1-410, and supersedes a l l o t h e r i n s t r u c t i o n s i n c o n s i s t e n t w i t h the present i n s t r u c t i o n s .

2. APPLICABILITY Subject t o such l e g a l l i m i t a t i o n s as may be prescr ibed by program l e g i s l a t i o n (e.g., N I H cons t ruc t i on programs) , t h i s p o l i c y i s app l i cab le t o a l l cu r ren t g ran ts admin is tered by t h e Nat iona l I n s t i t u t e s o f Heal th. It i s n o t app l i cab le t o NIH cont rac ts o r t o g ran ts having p r o j e c t per iods w i t h te rm ina t ion dates p r i o r t o J u l y 1 , 1971.

3. BACKGROUND Under a u t h o r i t y o f t h e PHS Ac t (42 USC 201 e.seq.), N I H makes funds avai l ab le through g ran ts f o r t h e suppor t o f approved research, t r a i n i n g , spec ia l p r o j e c t s , i n s t i t u t i o n a l g ran ts , and demonstrat ion p ro jec ts . Such funds may be used f o r the purchase of equipment necessary t o the successful p rosecut ion o f t he a c t i v i t i e s be ing supported. T i t l e t o equipment purchased f r o m g r a n t funds i s vested i n t h e grantee i n s t i t u t i o n o r o rgan iza t i on , sub jec t t o accountabi 1ity t o t h e Federal Government a t t he complet ion o f t h e p r o j e c t f o r which t h e g ran t was made.

P u b l i c Law 85-934, 42 USC f 1891 e t . seq. author izes t h e waiver o f a c c o u n t a b i l i t y f o r equipment purchased w i t h f u n d s f r o m research gran ts awarded t o n o n p r o f i t i n s t i ­t u t i o n s o f h igher educat ion and n o n p r o f i t o rgan iza t i ons whose pr imary purpose i s t he conduct o f s c i e n t i f i c research. A c c o u n t a b i l i t y ma n o t be waived f o r equipmentpurchased w i t h funds from research gran ts awarded t o o t e r t y p e s n s t i t u t i o n snor' f o r equipment purchased from any t ype o f g ran t o t h e r than research gran ts .

Cer ta in equipment i s s u f f i c i e n t l y general i n na ture t h a t i t can be u t i l i z e d by t h e grantee i n s t i t u t i o n i n connect ion w i t h o t h e r grant -suppor ted o r g ran t -e l i g i b l e a c t i v i t i e s . Therefore cont inued r e t e n t i o n by t h e grantee o f such equipment, where s t a t u t o r y a u t h o r i t y e x i s t s , serves the c o l l a t e r a l purpose o f t h e c r e a t i o n o r enhancement o f t he research and t r a i n i n g c a p a b i l i t y o f t h e grantee i n s t i t u t i o n and fur therance of t h e o b j e c t i v e s o f t h e Nat iona l I n s t i t u t e s o f Heal th.

4. DEFINITIONS

a. Equipment: For t h e purposes of t h i s issuance, an i t e m o f equipment i s an a r t i c l e o f p roper t y procured o r f ab r i ca ted , which i s complete i n i t s e l f , i s o f a durable nature, and has an expected se rv i ce l i f e o f more than one year.

b. Su l i e s : Items which are consumed o r expended when p u t t o use o r h v e an expected se rv i ce o f l e s s t h d i one year. (The pro-v i s i o n s o f t h i s issuance do n o t apply t o supp l ies . )

-The GUIDE i s published a t irregular in tervals t o provide policy, program, and a h i n i s t r a t i v e in fomat ion t o individuazs and organizations who need t o be keptinformed of requirements and changes i n grants and contracts programs administered by the National I n s t i t u t e s of Health.

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c. Budget Per iod: That p o r t i o n o f a p r o j e c t p e r i o d ( u s u a l l y 12 months) so designated f o r budget ing and account ing purposes.

d. Pro 'ec t Period: The i n t e r v a l o f t ime f o r which t h e suppor t o f a M e n approved by t h e N I H as s p e c i f i e d i n t h e gran t award document. ( I n some programs, e. g. , General Research Support Grants, each y e a r l y award i s a new g ran t and awarded f o r a s i n g l e bud e t per iod . I n such programs the term " p r o j e c t pe r iod " i s not&)

e. Grantee: The u n i v e r s i t y , co l l ege , h o s p i t a l , p u b l i c agency, o t h e r n o n p r o f i t research organ iza t ion , o r an i n d i v i d u a l r e c e i v i n g a g ran t f o r suppor t o f such a c t i v i t i e s as are prescr ibed by t h e Pub l i c Hea l th Service Act.

f. T i t l e : As used here in , " t i t l e " i n d i c a t e s o r des ignates t h e r i g h t t o ownership, sub jec t t o a c c o u n t a b i l i t y requirements.

Accoun tab i l i t y : The o b l i g a t i o n o f a grantee t o r e t u r n t o the Nat iona l I n s t i t u t e s o f Hea l th t h e res idue o r res idua l value o f equipment pur­

g.

chased w i t h g ran t funds i n accordance w i t h t h e law and app l i cab le Federal regu la t ions . Such res idue inc ludes as much o f t h e equipment, o r a f a i r market value thereo f , as represented by t h e p r o p o r t i o n o f t h e i n i t i a l cos t o f t he equipment charged t o the g ran t account.

5. POLICY T i t l e t o equipment acqu i red w i t h N I H g r a n t funds i s vested i n t h e grantee i n s t i t u t i o n unless s p e c i f i c a l l y s t a t e d o therw ise on t h e No t i ce o f Grant Awarded. Grantees are expected t o app ly t o equipment acqui red w i t h NIH funds t h e same p o l i c i e s , procedures, and c o n t r o l s normal ly app l i ed t o a l l o f t h e i r o t h e r equipment, p rov ided t h a t t h e minimum management standards conta ined i n t h i s i s s u ­ance are met.

Under a u t h o r i t y o f P.L. 85-934, n o n p r o f i t i n s t i t u t i o n s o f h i g h e r educat ion and non-p r o f i t o rgan iza t ions whose pr imary purpose i s the conduct o f s c i e n t i f i c research may be exempted, i n whole o r i n p a r t , f rom the o b l i g a t i o n f o r f u r t h e r account ing t o t h e Federal Government f o r t h e res idua l value o f equipment remaining a t t h e te rm i ­n a t i o n o f a grant -suppor ted research p r o j e c t . Except i n those instances where t h e awarding u n i t sees a s p e c i f i c need t o c l a i m t i t l e t o o r t r a n s f e r c e r t a i n i tems a f t e r t he p r o j e c t pe r iod i s concluded, t h e N I H awarding u n i t w i l l waive f u r t h e r accounta­b i l i t y upon request by an e l i g i b l e grantee i n s t i t u t i o n . The rese rva t i on t o c l a i m such equipment by the N I H may be exerc ised a t any t ime up t o twelve (12) months f o l l o w i n g t h e end o f t he p r o j e c t p e r i o d b u t n o t l a t e r than such date as a formal waiver o f a c c o u n t a b i l i t y has been made by t h e appropr ia te NIH awarding u n i t .

No i n s t i t u t i o n may be r e l i e v e d o f a c c o u n t a b i l i t y f o r equipment purchased w i t h t r a i n i n g g r a n t funds o r w i t h funds from o t h e r nonresearch p r o j e c t grants.

I n those unusual instances where an i n d i v i d u a l i s t h e grantee, = w a i v e r o f t h e o b l i g a t i o n f o r such a f i n a l account ing may be made.

6 . IWLA"NTATI0N BY GRANTEE INSTITUTION

a. Inventory : The N I H w i l l n o t f o r m a l l y r e q u i r e t h e submission o f an i nven to ry f o r equipment u n t i l t h e te rm ina t ion o f t h e p r o j e c t p e r i o d dur ing which the i t em was purchased i n whole o r i n p a r t as a d i r e c t charge t o g ran t funds. The f o l l o w i n g procedures w i l l be used.:

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W

w

(1 ) Upon complet ion o f a p r o j e c t per iod , and a t t he t ime o f sub-miss ion o f t h e f i n a l r e p o r t o f expenditures f o r t h a t p r o j e c t per iod , grantees s h a l l over t h e s ignature o f an au thor ized i n d i v i d u a l submit t o t h e approp r ia te N I H awarding u n i t two (2) copies o f t h e N I H equipment r e p o r t i n g form t i t l e d "Equipment Acquired w i t h N I H Grant Funds, Accoun tab i l i t y and D ispos i t i on . " ( E x h i b i t form attached.) I n t h e event t h a t funds f rom more than one N I H g ran t have been used t o purchase an i t em o f equipment, t h a t i t e m o f equipment wi1. l be i n v e n t o r i e d t o t h e gran t which prov ided t h e l a r g e s t amount o f funds f o r i t s purchase.

(2 ) Grantees s h a l l l i s t , on t h e equipment r e p o r t i n g form, a l l equipment purchased i n whole o r i n p a r t f rom N I H g r a n t funds, where t h e i n i t i a l a c q u i s i t i o n cos t o f t h e equipment was $300 o r more, unless:

(a) t h e grantee has f o r m a l l y determined t h a t t h e equipmenti s no longer use fu l ; o r ,

(b) t h e equipment has a res idua l o r scrap va lue o f l e s s than $100; o r ,

( c ) t h e equipment has o therw ise been repor ted i n accordance w i t h paragraph a . ( l ) above; o r ,

(d) accountabi 1ity has been waived pursuant t o s t a t u t o r yau tho r i t y .

(3) Where the re i s no equipment t o be reported, grantees s h a l l submit t h e requ i red form, s t a t i n g "No accountable equipment."

(4) Grantee i n s t i t u t i o n s w i l l , on t h e equipment r e p o r t i n g form, s e l e c t a proposed method f o r s a t i s f y i n g a c c o u n t a b i l i t y as descr ibed i n paragraphs b. and c. below.

b. Waiver o f A c c o u n t a b i l i t y ( A c c o u n t a b i l i t y Requirements f o r Grants Governed by P.L. 85-934)

Where t h e grantee i s a n o n p r o f i t i n s t i t u t i o n o f h ighe r educat ion o r a n o n p r o f i t o rgan iza t i on whose pr imary purpose i s t h e conduct o f s c i e n t i f i c research, t h e o b l i g a t i o n t o account f o r t h e r e s i d u a l va lue of equipment purchased w i t h research g ran t funds may be waived as fo l l ows :

(1) The N I H awarding u n i t w i l l determine whether o r n o t the f u l l a u t h o r i t y a v a i l a b l e under P.L. 85-934 w i l l be u t i l i z e d .

(2) When an i t em o f equipment has been purchased w i t h funds f rom grants p rov ided by several N I H I n s t i t u t e s o r D iv i s ions , t h e awarding u n i t which has supp l i ed t h e l a r g e s t c o n t r i b u t i o n toward the purchase o f t h e equipment w i l l decide i t s d ispo­s i t i o n . (See 6.a.( l ) above.)

(3) When wai-ver o f a c c o u n t a b i l i t y i s n o t approved, t h e op t ions l i s t e d under paragraph c., below, w i l l be a v a i l a b l e f o r use by t h e grantee, sub jec t t o approval by the awarding u n i t .

I

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c. Accoun tab i l i t y Requirements f o r Grants Other than Those Governed by P.L . 85-934

The requirement f o r accountabi 1ity f o r equipment purchased w i t h g ran t funds may n o t be waived f o r those i n s t i t u t i o n s and gran ts n o t covered by P.L. 85-934. Thus a c c o u n t a b i l i t y f o r t h e res idua l value o f equip­ment purchased w i t h t r a i n i n g g ran t funds, nonresearch g r a n t funds, and research gran ts made t o i n s t i t u t i o n s o the r than those covered by t h e p rov i s ions o f P.L. 85-934, may be s a t i s f i e d by us ing one o r more o f

f o l 1owing op t ions :

Refund t o the N I H * an amount equ iva len t t o the f a i r market value o f t he equi pment.

Return t h e equipment t o t h e NIH**.

Retain the equipment f o r use on biomedical and h e a l t h - r e l a t e d research, t r a i n i n g , o r educat ion p r o j e c t s o f t h e grantee i n s t i t u t i o n which are w i t h i n the scope o f t h e PHS Act.

T rans fer equipment and responsi b i 1ity f o r accountabi 1ity t o another grantee o rgan iza t i on .

I f op t ion " ( 3 ) " i s au thor ized , i t must be c a r r i e d o u t under the condi­t i o n s t h a t du r ing the pe r iod o f use, no use charge f o r deprec ia t ion , amor t i za t ion , o r charge f o r o t h e r use o f t h e equipment s h a l l be made aaa ins t any Federal a r a n t o r con t rac t . (The on ly except ion t o t h i s pG l i cy i s i n c l u d e d ii t h e P r i n c i l e s of Reimbursement ior Prov ider Costs t h a t a l lows h o s p i t a l s_p_an nurs inq homes p r o v i d i n g M e d i c a r e serv ices t o deprec ia te Government-provided assets. ) A1so, i f w i t h i n the use fu l l i f e o f t h e equipment i t i s s o l d o r n o t cont inued t o be used i n hea l th - re la ted research o r t r a i n i n g , t h e f a i r market value a t t he t ime o f d i s p o s i t i o n s h a l l be payable t o t h e N I H as o u t l i n e d i n " ( 1 ) " above.

I f op t ion " ( 4 ) " i s e lec ted , grantees should f o l l o w t h e procedures prescr ibed i n Guide issuance 5603 ( t o be issued).

7. I M P L E M E N T A T I O N BY N I H A W A R D I N G U N I T

a. The awarding u n i t w i l l rev iew t h e i n fo rma t ion repo r ted on t h e equipment form and the gran tee 's proposed d i s p o s i t i o n o f t h e equipment and make a de terminat ion as t o the d i s p o s i t i o n o f each i t e m l i s t e d . The method most appropr ia te t o t h e circumstances w i l l be se lec ted by t a k i n g i n t o cons idera t ion such f a c t o r s as the na tu re and purpose of t h e g ran t , t h e ex is tence o f o t h e r heal th - re1 ated p r o j e c t s a t t h e i n s t i t u t i o n , t h e c o n d i t i o n o f t h e equipment, t he cos t o f t r a n s f e r o r shipment, and t h e p o t e n t i a l f o r e f f e c t i v e u t i l i z a t i o n a t t h e N I H o r on o t h e r research o r t r a i n i n g p r o j e c t s .

* Checks should be m d e payable t o t h e NEW, N I H , and forwarded t o t h e D i rec to r , O f f i c e o f F inanc ia l Management, NIH, Bethesda, Maryland 20014. Checks must i d e n t i f y t he re levan t g ran t account and t h e reason f o r payment.

** This o p t i o n t o be fo l lowed o n l y a f t e r r e c e i v i n g i n s t r u c t i o n s f rom the appro­p r i a t e N I H awarding u n i t .

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b. The awarding u n i t w i l l au thor ize a method o f d i s p o s i t i o n f o r each i t e m o f equipment and i n d i c a t e such d i s p o s i t i o n on t h e equipment form. One signed copy o f t he equipment r e p o r t i n g form w i l l be p laced i n t h e N I H o f f i c i a l g ran t f i l e and one copy w i l l be returned, along w i t h any spec ia l i n s t r u c t i o n s f o r d i s p o s i t i o n , t o the grantee.

8. GRANTS AWARDED TO INDIVIDUALS Determinat ion as t o t h e method o f d i s p o s i t i o n of equipment purchased w i t h g ran t funds awarded t o an i n d i v i d u a l w i l l be made by t h e N I H awarding u n i t upon te rm ina t ion o f support o f t h e p ro jec t .

9. GRANTEE MANAGEmNT REQUIREMENTS

a. Acqu is i t i on : Grantees are requ i red t o be prudent i n the a c q u i s i t i o n and management o f equipment acquired w i t h g ran t funds. Careful screening should take p lace t o assure t h a t equipment i s needed and t h a t the need cannot be met w i t h equipment a l ready i n the possession o f t he i n s t i t u t i o n . A grantee may be reimbursed f o r an i t em o f equip­ment a l ready owned by the i n s t i t u t i o n only when such equipment i s i n the i n s t i t u t i o n ' s c e n t r a l purchasing department and h e l d i n a c e n t r a l stock room f o r issuance and sa le t o a using a c t i v i t y .

For purposes of charg ing N I H g ran ts , t he cos t o f a s i n g l e i t em o r p iece o f equipme.nt inc ludes necessary accessories, du ty , exc ise and sales taxes. I f the i n s t i t u t i o n p o l i c y provides t h a t charges f o r t ranspor ta t i on , p r o t e c t i v e i n - t r a n s i t insurance, and i n s t a l l a t i o n are a p a r t o f t h e cos t o f equipment, such charges may be inc luded as d i r e c t costs o f equipment on N I H g ran ts accounts.

U b. Sale o r Trade: When equipment i s so ld by a grantee dur ing t h e p r o j e c t pe r iod i n which i t was purchased, the ne t proceeds o f sa le must be c r e d i t e d t o the g ran t account. Equipment f o r which accountabi 1ity has -n o t been waived may be disposed o f by the grantee a f t e r t e rm ina t ion o f the p r o j e c t pe r iod prov ided the g ran t account i s c r e d i t e d w i t h t h e f a i r markdva lue as o f t h e date o f d i s p o s i t i o n o f such equipment. The accounting o b l i g a t i o n s h a l l apply t o t h a t p o r t i o n o f new equipment t h a t has been purchased by us ing accountable equipment as a c r e d i t o r t r a d e - i n (This i s n o t app l i cab le t o equipment which has a res idua l value of l e s s than $100.)

c. Lost, Damaged, o r Destroyed Equipment: When a c c o u n t a b i l i t y has n o t been waived, t h e grantee w i l l be respons ib le , us ing o the r than NIH g ran t funds, f o r replacement o r r e p a i r o f , o r compensating the g ran t account fo r equipment t h a t i s l o s t , damaged, o r dest royed due t o negl igence on t h e p a r t of t h e grantee.

d. Deprec iat ion and Use Charges: Deprec ia t ion o r use charges f o r any equipment o r p o r t i o n o f such equipment acqui red w i t h Federal funds may n o t be charged aga ins t N I H funds e i t h e r as a d i r e c t o r i n d i r e c t cos t . The records o f grantee i n s t i t u t i o n s must the re fo re i d e n t i f y equipment purchased w i t h N I H funds t o assure exc lus ion o f such equipment f rom deprec ia t ion o r use charges claimed f o r Federal p a r t i c i p a t i o n . (The o n l y except ion t o t h i s p o l i c y i s inc luded i n t h e P r i n c i l e s o f Reimbursement for Prov ider Costs , which a1 lows hosp i ta s a n d n u r s i n g--+ homes p rov id ing Medicare serv ices t o deprec ia te Government-provided assets. )

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10. TRANSFER OF RESEARCH PROJECTS A l l research gran ts s h a l l be made under the c o n d i t i o n t h a t equipment acquired w i t h g r a n t funds, and f o r which the grantee i s accountable, w i l l be made a v a i l a b l e f o r t r a n s f e r upon request o f the awarding u n i t i n those cases where the p r o j e c t i s t r a n s f e r r e d t o another i n s t i t u t i o n and an N I H g ran t i s made t o the new i n s t i t u t i o n t o cont inue t h a t p r o j e c t .

11. EFFECTIVE DATE The p o l i c y s t a t e d i n t h i s issuance i s e f f e c t i v e J u l y 1, 1971.

Refer ences

(1) DHEW Grants Admin i s t ra t i on Manual Chapter 1-410, Management o f Equipment and Supplies Acquired under P r o j e c t Grants, A p r i l 2, 1969.

(2 ) Code o f Federal Regulat ions, T i t l e 42, Pub l i c Health, P a r t 52, Grants f o r Research P ro jec ts , Sect ion 52.42.

( 3 ) Pub l i c Law 85-934, 42 USC B 1891 e t . seq. (Ves t ing o f t i t l e t o equipment w i th -o u t f u r t h e r o b l i g a t i o n t o the Government.)

(4) PHS Grants f o r Research P ro jec ts , P o l i c y Statement, PHS Pub. No. 1301. (5) PHS Grants f o r T r a i n i n g Pro jec ts , P o l i c y Statement, PHS Pub. No. 1302. (6 ) OMB C i r c u l a r No. A-101, January 9, 1971, "Standard P o l i c i e s and Prac t i ces

f o r Admin i s t ra t i on o f Research P ro jec ts a t Educational I n s t i t u t i o n s i n the Uni ted States.

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I N A Y S AND ADDRLSS Or ORAN- INSTITUTION ORANT NUYaUI

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE . N A T I O N A L INSTITUTES OF HEALTH

CROJICT m I O D

EQUIPMENT ACQUIRED WITH NIH GRANT FUNDS 1 ACCOUNTABILITY AND DISPOSITION I i P R I N C I P A L INVISTIOATOR OR EQUIVALENT

NOTE: For each grant. 1i.t item. of equipment with a n initial acquimition cost of $300 or more. atill useful, and which have a residual o r acrap value of mora than $100. purchased during the above project period. Public Law 85-934 authorize. Federal agencie. t o waive accountability for equipment purchaeed under RESEARCH GRANTS. provided the grantee im a non-profit institution of higher education or a "on-profit organization whose primary purpome im the conduct of Bcientific research. For ALL OTHER TYPES OF GRANTS and grantee inatitutionm. the prantce ia accountable for equipment purchased with grant funds. Submit the oriEinal and one copy with final Report of Expenditures for each project period. If additional pages are re­.. quired. enter grant number on each page. If n o equipment was purchased. write "none..' sign, and return.

FOR USE OF GRANTEE INSTITUTION I PROPOSED BY LEAVE B U N K

-~~ CHARGED T

DESCRIPTION PURCHASE GRANT

Item-(Grantee identification code)

R E M A R K S

This is to csrtify t h t tho above nam-d institution is olioible under Public Law 85-934 (me NOTE abovo), to nquert a waivw of further accountability for equipmont purchased. (Chsck o m ) 0 Y.s 0 No

NAYC AND n n z OF AurnoRIzco INSTITUTION orricmL N I I AWAROINO U N I T A C P R O V I N O OFFICIAL

S I Q N A N R S DATE S I G N A T U R E DATE

Nil4 1754 3-71 Form Approved Office of Management and Budget No. 68-R- 1205

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N I H Guide fo r Grants and Contracts , No. 9, J u l y 29, 1971 Page Nine

GRANT SUPPORT OF SCIENTIFIC ~ETINGS QJIH 4lO5-1) POLICY 1 . PURPOSE This issuance s ta tes p o l i c y concerning the review, award, admin is t ra ­t i o n m e p o r t i n g requ i red when N I H funds are u t i l i z e d f o r t he suppor t o f domestic and i n t e r n a t i o n a l s c i e n t i fic meeti ngs . 2. APPLICABILITY These p o l i c i e s are app l i cab le to - N I H research and t r a i n i n g grants, usua l l y i d e n t i f i e d by number code p r e f i x e s R 13 and T 14. N I H awarding u n i t s , however, may a t t he t ime o f award app ly them as a d d i t i o n a l cond i t i ons t o any N I H g ran t i n support o f a s c i e n t i f i c meeting.

3. DEFINITIONS The f o l l o w i n g d e f i n i t i o n s apply t o terms used i n t h i s issuance:

I n t e r n a t i o n a l Meeting-: A meeting so designated by i t s sponsor, o r one t o which open i n v i t a t i o n s a re issued on an equal bas is t o p o t e n t i a p a r t ic i -pants i n two o r more count r ies . The meeting may be h e l d i n any count ry , in c l ud i ng the Un i ted States.

Domestic Meeting: A meeting h e l d i n t h e U.S. o r Canada p r imar i y f o r U.S.-Canadian p a r t i c i p a t i o n , b u t does no t exclude those w i t h i n v i t e d f o r e i g n speakers.

E l i g i b l e Grantee: A U.S. i n s t i t u t i o n e l i g i b l e t o rece ive research o r t r a i n i n g grants, es tab l i shed s c i e n t i f i c o r p ro fess iona l soc ie t i es , o r i n the case of an i n t e r n a t i o n a l meeting, t h e U.S. representa t ive o rgan iza t i on

-w of an es tab l i shed i n t e r n a t i o n a l s c i e n t i f i c o r p ro fess iona l soc ie ty .

Bloc Travel Grant: An award o f t r a v e l funds t o a sponsoring o rgan iza t i on who w i l l , us ing an approved mechanism, s e l e c t the i n d i v i d u a l s whose t r a v e l w i 11 be supported.

4. POLICY The Nat iona l I n s t i t u t e s o f Hea l th recognizes a r e s p o n s i b i l i t y t o a s s i s t i n t h e support of s c i e n t i f i c meetings planned f o r t he purpose o f coord ina t ing , exchanging, and d isseminat ing i n fo rma t ion when such a c t i v i t i e s a re d i r e c t e d toward ob jec t i ves c l e a r l y w i t h i n t h e areas o f N I H s c i e n t i f i c program i n t e r e s t s . The NIH p o l i c y i s t o p a r t i c i p a t e w i t h o t h e r s c i e n t i f i c o rgan iza t ions i n t h e suppor t o f meetings, where p rac t i cab le , r a t h e r than t o p rov ide t h e sole support. I n view o f the d i v e r s i t y of i n t e r e s t s o f t h e var ious awarding u n i t s , and i n o rde r t o g i v e maximum f l e x i b i l i t y , t h e N I H w i l l n o t s e t r i g i d requirements concerning t h e types o f s c i e n t i f i c meetings which may be supported, o r t h e method used f o r rev iew and approval of t h e proposal. Each awarding u n i t may e l e c t t o suppor t those meetings c l e a r l y w i t h i n i t s i n t e r e s t s and mission. The general p o l i c i e s govern ing t h e admin i s t ra t i on o f research and t r a i n i n g gran ts a re app l i cab le t o g ran ts i n suppor to f meetings.

a. The f o l l o w i n g general p o l i c y gu ide l i nes are app l i cab le i n p r o v i d i n g suppor t f o r domestic o r i n t e r n a t i o n a l meetings.

(1) For domestic meetings o r i n t e r n a t i o n a l meetings h e l d i n t h e U.S. o r Canada

Research o r t r a i n i n g g ran t funds may be awarded t o a s s i s t i n t h e general support o f se lec ted s c i e n t i f i c meetings. Research gran ts may be awarded t o e l i g i b l e grantee organ iza t ions t o p rov ide l i m i t e d b loc t r a v e l suppor t t o a t tend t h e meeting f o r i n d i v i d u a l s t o be se lec ted by the app l i can t o rgan iza t ion . T ra in ing gran ts may NOT he awarded f o r b loc t r a v e l support.

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Page Ten

( 2 ) For international meetings held outside the U.S. . and Canada

Research and t r a i n i n g grants may be used only for support of specific sc ien t i f ic aspects of an international meeting such as a selected symposium o r workshop, including the cost of planning,travel of U.S. participants, and other clearly related expenses. Bloc travel support may be provided through research g r a n t sonly. Such travel allowance may not exceed economy class fares and per diem allowance will be limited t o days of attendance a t the meeting a t a rate no higher t h a n t h a t allowed Federal emplbyees. Any other res t r ic t ions which the NIH has concerning foreign travel current a t the time of award will be followed.

5. RESPONSIBILITIES Grants received under authority of the Pub1 i c Health Service Act are i n the nature of t rus t funds and responsibility of grantees and the i r officers i n handling these funds i s similar t o t h a t of a trustee. NIH does not intend t o res t r ic t grantee organizations t o any s e t plan i n developing meetings.However, except for those costs which have received prior approval by the awardingunit, only the items that f a l l w i t h i n the categories described under Costs (para-graph 7. below) may be charged t o an NIH grant.

a . Expenditure Reports and Aud i t An expenditure report i s required from the grantee (usually the treasurer or other financial officer of the grantee organization) a t the termination of each budget period. The grant account must be maintained separately ei ther on different ledgers or different parts o f ledgers, w i t h substantiating invoices, receipts,and payrolls readily available a t a l l times for Government a u d i t . All records shall be retained for audit purposes for a period of five yearsaf te r the end of the budget period which they cover o r until a Federal a u d i t i s completed and a l l resulting questions are resolved, whichever occurs f i r s t .

b . Terminal Progress Reports A report o f the meeting must be prepared and five copies submitted t o the awarding u n i t that supported the meetingw i t h i n s ix months a f te r the termination of the g r a n t . The report should include ( a ) the g r a n t number, (b) the t i t l e of the meeting, (c ) the name of the person shown on the application as the conference director, principal investigator, o r program director, (d ) the name of the o rgan i ­zation that conducted the meeting, and (e) a l i s t of the individuals who participated as speakers o r discussants in the formally planned sessions of the meeting. Copies o f proceedings o r publications resulting from the meeting, including items (a ) t h r o u g h (e) l is ted above, may be substi­t u t e d for the final progress report, w i t h approval of the NIH awardingunit.

6. APPLICATIONS Prospective applicants are encouraged t o inquire i n advance con­cerning NIH's interest i n the proposed meeting and t o request detailed instructions for pwparation of an application.

7. COSTS Except for the specific restrictions applicable t o support of inter­nationalmeetings held outside the U.S. (see paragraph 4.a.(2) above), the cost policies below are applicable t o a l l grants in support of meetings.

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N I H Guide for Grants and Contracts, No. 9 , July 29, 1971 Page Eleven W

a . Direct Cost Expenditures Grant funds may NOT be used for a l terat ions, renovations , or the purchase of equi pment. A1 lowable expendituresand the specific policies applicable to meeting grants are l i s ted below:

(1) Salaries In accordance w t t h the policy of the granteeorganization, grant funds may be used t o provide sa la r ies , i n whole o r i n part , of professional personnel, clerical assistants , editorial ass is tants , and other nonprofessionals taff b u t only i n proport ion t o the time or effor t spentdirectly on the meeting.

( 2 ) Equipment Grant funds may be used for the rental of necessaryequipment. funds may not be used for the purchase of equipment.

( 3 ) Travel and Personal Expenses Funds requested must be restr ic ted t o those DurDoses identified bv the qrantee as required for the operation'of' the conference. Funds may NOT be used for travel unless prior approval has been obtained from the NIH awardingu n i t . Travel expenses for grantee organization employees will be paid in accordance w i t h travel regulations of the grantee organi­zation when such policies have been established. In the absence of such regulations and policies , U.S. Standardized Government Travel regulations w i 11 apply. Transportation costs f o r attendees and participants a t the meeting may not exceed economyclass fares and per diem allowance will be limited t o the days of attendance a t the meeting. In a l l cases, where available, U.S. Flag Carriers will be used.

Where meals and/or lodging are furnished without charge or a t a nominal cost (e.g., as part of the registration fee) an appropri­ate deduction will be made from the authorized per diem.

Grant funds may no t be used for visas, passport charges, enter­tainment, t i p s , bar charges, personal telephone c a l l s , o r 1aundry charges of participants or guests.

Grant f u n d s may not be used t o pay travel o r other expenses of local participants i n the conference (persons no t i n travel s ta tus) except under unusual circumstances and w i t h the prior approval of the awarding unit.

(4 ) Su l i es Grant funds may be used for the purchase of supplies for &ins, provided the supplies are received during the projectperiod.

(5 ) Conference Services Grant funds may be used for necessary record­i n g of proceedings, simultaneous translation, etc. , and subsequenttranscriptions.

(6) Publication Costs Subject t o prior approval from the NIH awardingu n i t , grant funds may be used t o cover the costs of publishing the proceedings of a scient i f ic meeting or of speci a1 papers presented.

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Page Twelve

When g ran t funds are awarded t o pay f o r e i t h e r t h e e n t i r e o r the p a r t i a l c o s t o f p u b l i c a t i o n o f proceedings o r o f a book o r pamphlet, such costs a re considered t o cover spec ia l p l a t e s , char ts , diagrams, p r i n t i n g , d i s t r i b u t i n g , m a i l i n g , postage, and general hand1ing , unless otherwise s p e c i f i e d a t t h e t ime the g r a n t i s made.

Reg is t ra t i on Fees R e g i s t r a t i o n fees may be p a i d f rom g r a n t funds, prov ided such fees cover o n l y those costs p r o p e r l y chargeable t o t h e gran t .

Dues Dues t o o rgan iza t i ons , f ede ra t i ons , o r s o c i e t i e s exc lus i ve o f r e g i s t r a t i o n fees, are NOT al lowed as a charge aga ins t t h e g r a n t . Entertainment Grant funds may NOT be used t o cover t h e cos ts o f banquets, luncheons, c o f f e e breaks, t hea te r , o r enter ta inment o f any so r t .

Federal Employees Grant funds may NOT be used t o cover any pay­ment t o a f u l l - t i m e Federal employee.

Honorar ia Honorar ia may NOT be p a i d f rom g r a n t funds.

b. I n d i r e c t Costs I n d i r e c t costs w i l l n o t be al lowed on g ran ts i n suppor t o f meetings except i n t h e most unusual circumstances and then o n l y a f t e r n e g o t i a t i o n i n advance o f t h e award between t h e a p p l i c a n t o r g a n i z a t i o n and t h e awarding u n i t .

8. PUBLICATION AND COPYRIGHT I f t h e grantee o rgan iza t i on wishes t o p u b l i s h m a t e r i a l f o r which support has been prov ided i n whole o r i n p a r t w i th NIH funds, t h e m a t e r i a l may be d i s t r i b u t e d f r e e o f charge. On t h e o t h e r hand, t h e r e may be occasions where t h e d i s t r i b u t i o n o f t h e publ ished m a t e r i a l would be l i m i t e d and t h e grantee o rgan iza t i on would p r e f e r t o make a charge f o r t h e ma te r ia l . Under these circumstances an open account must be mainta ined f o r f i v e years f rom t h e da te o f p u b l i c a t i o n . That p a r t o f t h e n e t proceeds from such sa les, up t o the p r o p o r t i o n a t e amount charged t o the g ran t f o r p u b l i s h i n g o r producing t h e m a t e r i a l , must be returned t o t h e U.S. Treasury. Specia l agreement on t h e d i s t r i b u t i o n o f publ ishedm a t e r i a l should be nego t ia ted i n advance w i t h t h e N I H awarding u n i t i n each case.

Unless otherwise s p e c i f i e d by t h e awarding u n i t , f i v e copies o f any p u b l i c a t i o n r e s u l t i n g f rom a meeting should be sent t o the awarding u n i t t h a t prov ided support f o r t h e meeting.

Acknowledgment o f NIH's support should be g iven on t h e program o f t h e meeting and on any p u b l i c a t i o n r e s u l t i n g f r o m t h e meeting. The f o l l o w i n g statement, "The N I H p a r t i c i p a t e d i n t h e support o f t h i s meet ing under g r a n t No. , from

(Awarding U n i t ) ,"w i l l s u f f i c e . R e s p o n s i b i l i t y f o r t h e conduct o r sponsorship o f t h e meeting must NOT be ascr ibed t o t h e NIH.

Unless otherwise prov ided f o r i n t h e cond i t i ons o f t h e award, t h e author i s f r e e t o arrange f o r copy r igh t o f any p u b l i c a t i o n r e s u l t i n g f rom work supported by t h e NIH. Any such copyr ighted p u b l i c a t i o n , however, s h a l l be sub jec t t o a nonexclusive, i r revocab le , roya l t y - f r e e 1icense t o the Government t o reproduce, t rans1 a te , pub1i s h , and dispose o f such mater ia l , .and t o au tho r i ze o the rs t o do so.

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NJH Guide f o r Grants and Contracts , No. 9, J u l y 29, 1971 Page Th i r teen w

9. EFFECTIVE DATE This p o l i c y i s e f f e c t i v e on date o f re lease.

-References

(1) PHS Grants f o r Research P ro jec ts , P o l i c y Statement, PHS Pub. 1301. PHS Grants f o r T r a i n i n g P ro jec ts , P o l i c y Statement, PHS Pub. 1302. N I H Grants P o l i c y Guide No. 2, June 19, 1970, pp.5-6, D i s p o s i t i o n o f Grant-Related Income ( N I H 5601).

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N I H Guide f o r Grants and Contracts , No. 9, J u l y 29, 1971 Page Fourteen

IN DIGESTIVEDISFASESAM) N U T R I T I ~ A N N O U N C E M E N T

1. The Nat iona l I n s t i t u t e o f A r t h r i t i s and Metabol ic Diseases, NIH, i s accept ing a p p l i c a t i o n s f o r awards on a n a t i o n a l compet i t ion bas is f rom those ho ld ing

sciences DO, DMD, DVM, o r ’

W

h e a l t h p ro fess iona l degrees i n t h e c l i n i c a l (MD, equ iva len t ) and whose i n t e r e s t s are i n t h e areas o f d i g e s t i v e diseases and n u t r i t i o n . A l i m i t e d number o f awards w i l l be made i n the f o l l o w i n g areas:

a. C l i n i c a l I n v e s t i g a t o r Award i n D iges t i ve Diseases and N u t r i t i o n

b. Academic Career Development Award i n D iges t i ve Diseases and N u t r i t i o n .

2. Sa la r i es f o r each award w i l l be i n d i v i d u a l l y negot ia ted between t h e sponsoring i n s t i t u t i o n and NIAMD.

3. Deadline f o r submission o f a p p l i c a t i o n s i s September 1, 1971. Add i t i ona l i n fo rma t ion regard ing t h e p o l i c i e s govern ing t h e award, i n s t r u c t i o n s f o r app ly ing and a p p l i c a t i o n forms may be ob ta ined by w r i t i n g to :

D iges t i ve Diseases and N u t r i t i o n Programs National I n s t i t u t e o f A r t h r i t i s and Metabol ic Diseases Nat iona l I n s t i t u t e s o f Hea l th Bethesda , Maryland 20014.

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N I H Guide f o r Grants and Contracts , No. 9, J u l y 29, 1971 Page F i f t e e n W

The I n s t i t u t e uses the c o n t r a c t mechanism when the i n i t i a t i v e f o r c a r r y i n g o u t a research p r o j e c t , i n c l u d i n g design, d i r e c t i o n , and methodology, o r i g i n a t e s p r i m a r i l y w i t h i n the Nat iona l I n s t i t u t e of Ch i l d Hea l th and Human Development (NICHD) o r when the research requ i res ex tens ive p a r t i c i p a t i o n by s t a f f i n i t s development. Contracts a re used (1) t o s t i m u l a t e research i n gap areas; ( 2 ) t o develop resources, methodology, ins t rumenta t ion , o r s p e c i f i c products ; ( 3 ) t o pro-v ide serv ices t o i n v e s t i g a t o r s ; ( 4 ) when s t a f f can f u n c t i o n as bo th s t i m u l a t o r f o r c o l l a b o r a t i v e e f f o r t s and coord ina tor o f research among a number o f i n v e s t i g a t o r s ; (5) t o p rov ide f o r innovat ive , c rea t i ve , p ioneer ing p r o j e c t s where an unusual i n s i g h t o r a t i m e l y o r f o r t u i t o u s oppor tun i t y may have e n o m u s payo f f t o t h e s c i e n t i f i c community i f fo l l owed through; (6) t o g i v e coherence t o a r e l a t i v e l y uns t ruc tured f i e l d ; (7) t o suppor t o rgan iza t i ona l a c t i v i t i e s such as conferences which are program o r miss ion o r e i n t e d and prov ide f o r i n fo rma t ion exchange o r t h e development o f methods.

The Center f o r Popu la t ion Research, NICHD, c u r r e n t l y has con t rac ts i n t h e fo l low in : areas :

1. Contracept ive Development

a. Development o f new cont racept ive drugs, i n c l u d i n g ob ta in ing , syn thes iz ing , and t e s t i n g o f compounds t o determine t h e ex ten t and na ture o f a n t i f e r t i l i t y a c t i v i t y .

b. Development o f systems and/or ma te r ia l s f o r un in te r rup ted admin i s t ra t i on o f a n t i f e r t i l i t y drugs; and eva lua t i on o f b i o ­l o g i c a l evidence concerning slow and constant re lease o f p o t e n t i a1 cont racept ive drugs.

c. Development o f new techniques f o r s t e r i l i z a t i o n i n bo th males and females. Design o f devices t h a t a re safe and e f f e c t i v e , reve rs ib le , e a s i l y imp lan tab le , and acceptable t o var ious popu la t ion groups; t e s t i n g and eva lua t i on o f these devices.

d. Studies o f how sperm mature and acqu i re t h e capac i t y t o f e r t i l i z e ova; f unc t i ons o f t h e male duc t system and accessory glands; f a c t o r s a f f e c t i n g t h e t r a n s p o r t o f sperm t o the s i t e o f f e r t i l i z a t i o n ; and the s u r v i v a l o f sperm i n the female t r a c t .

e. Development o f techniques f o r observ ing the normal f u n c t i o n o f segments o f t h e ov iduc t i n ovum pick-up and t r a n s p o r t , and s tud ies o f t h e e f f e c t o f hormones and phys ica l f a c t o r s on the ov iduc t .

f. Studies o f hormones invo lved i n reproduc t ion and of methods for measuring them; t h e r o l e o f hormones i n t h e i n i t i a t i o n and main­tenance o f pregnancy; f u n c t i o n o f t h e corpus luteum; and hormonal events o f t h e menstrual cycle.

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g. Studies o f t h e ovum, i n c l u d i n g format ion and ovu la t i on ; t h e phys io logy o f egg membranes and poss ib le a l t e r a t i o n o f them f o r cont racept ive purposes; biochemical f u n c t i o n o f t h e f e r t i l i z e d egg before imp lan ta t i on ; and t h e dynamics o f d e c i d u a l i z a t i o n and implantat ion.

2. Evaluat ion o f E x i s t i n g Contracept ive Methods

a. C l i n i c a l and l a b o r a t o r y s tud ies o f se lected subjects ( p a r t i c u l a r l y long-term o r a l cont racept ive users) which w i l l e l u c i d a t e elements o f excess r i s k , est imates o f e x t e n t o f r i s k , unique p r o p e r t i e s o f p r e s e n t l y a v a i l a b l e drugs, and i n t e r a c t i o n between s t e r o i d drugs and commonly used p r e s c r i p t i o n drugs.

b. I n v i t r o and i n v i v o (human and animal) s tud ies o f t h e absorpt ion, metabolism, and e x c r e t i o n o f s t e r o i d con t racep t i ve drugs.

c. Studies t o f u r t h e r c l a r i f y t h e e f f e c t s o f o r a l cont racept ives on blood pressure, in c l ud i ng e x t e n t and magnitude o f r i s k , charac­t e r i s t i c s o f h i g h - r i s k subpopulat ions; unique p r o p e r t i e s o f cer­t a i n con t racep t i ve fo rmu la t i ons ; p h y s i o l o g i c a l mechanism o f p roduc t i on o f increased b lood pressure; and des i rab le methods o f t reatment.

d. Human s tud ies which w i l l l e a d t o a more p rec i se es t ima t ion o f t h e minimal dose o f a drug which w i l l p rov ide acceptable contra­c e p t i v e e f f e c t and/or minimal b i ochemi ca l o r t o x i c e f f e c t s ; eva lua t i on o f p o t e n t i a l l y t o x i c e f f e c t s may be done i n animal models .

e. Studies o f t he e f f e c t s and mechanism o f a c t i o n o f i n t r a u t e r i n e con t racep t i ve devices.

f. Studies t o a s c e r t a i n whether vasectomy i s a r e l a t i v e l y innocuous su rg i ca l procedure o r whether i t may be associated w i t h acute adverse e f f e c t s and/or s i g n i f i c a n t long-term medical compl icat ions.

3. Soc ia l Science Research Related t o Populat ion

a. Studies o f t h e i n t e r r e l a t i o n s between s o c i a l change and popula­t i o n s i ze , s t r u c t u r e , and d i s t r i b u t i o n ; and t h e determinants and consequences o f popu la t i on change.

Analyses o f t rends i n f e r t i l i t y , age a t marr iage, d ivorce,b. abor t i on , and r e l a t e d v a r i a b l e ; s tud ies o f t h e i n t e r r e l a t i o n s o f f e r t i l i t y t rends and o t h e r socioeconomic v a r i a b l e s , such as income, educat ion, re1i g i o n , and residence.

c. Studies o f f a m i l y s t r u c t u r e , sexual behavior, and t h e r e l a t i o n between ch i l dbear ing pa t te rns and c h i l d development; dec i s ions which determine a couple 's number and spacing o f c h i l d r e n ; a t t i ­tudes toward methods o f f e r t i 1it y c o n t r o l ; and a1t e r n a t i v e s t o ch i l dbear ing which couples perce ive and how these percept ions a f f e c t f e r t i l i t y .

Eva lua t i on o f p o l i c i e s aimed a t r e g u l a t i n g popu la t i on and ofd. p o l i c i e s which i n d i r e c t l y a f f e c t popu la t i on growth o r d i s t r i ­bu t i on . Past and present p o l i c i e s - - i n c l u d i n g f a m i l y al lowances,

Y R d i r e c t i ncen t i ves , and f a m i l v p lanning programs--are evaluated f o r t h e i r impact on populat ion.

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N I H Guide f o r Grants and Contracts, No. 9, J u l y 29, 1971 Page Seventeen

'The miss ion o f t he D i v i s i o n o f B i o l o g i c s Standards (DBS) i s t h e exerc ise o f c o n t r o l s on the sa fe ty , p u r i t y , and potency o f b i o l o g i c a l products through a system o f l i c e n s i n g o f manufactur ing establ ishments and o f t h e products, as w e l l as the conduct o f research r e l a t e d t o these ob jec t i ves i n o rde r t h a t dec is ions made and ac t i ons taken can be based on sound in fo rmat ion .

To discharge i t s r e s p o n s i b i l i t y , t he D i v i s i o n es tab l i shes standards f o r a l l b i o l o g i c a l products such as vaccines, serums, blood and i t s d e r i v a t i v e s , and l i k e products. These inc lude w r i t t e n standards, even tua l l y promulgated as r e g u l a t i o n s , some o f which apply t o i n d i v i d u a l products and some t o products i n genera l ; and phys ica l standards, i .e., b i o l o g i c a l p repara t ions whose p r o p e r t i e s and q u a l i t i e s have been ex tens i ve l y character ized. The l a t t e r are issued t o manufacturers and o the r research 1abora tor ies concerned w i t h b i o l o g i c s s tandard i za t i on f o r evalu­a t i o n w i t h t h e i r products, p a r t i c u l a r l y w i t h respect t o potency, o r s t rength .

As newer vaccines and o t h e r products a re developed and t h e D i v i s i o n ' s responsi ­b i l i t i e s have increased, a c o l l a b o r a t i v e o r con t rac ts program was es tab l i shed i n 1966 i n o rde r t o per form c e r t a i n func t i ons beyond t h e c a p a b i l i t i e s o f t he i n t r a ­mural program. This program i s t r u l y an extens ion o f t h e i n t ramura l research program. It i s s e t up t o develop i n fo rma t ion concerning i n d i v i d u a l b i o l o g i c a l products i n t o t o as t o t h e i r p u r i t y , sa fe ty , and potency, and components, add i t i ves , p roduc t ion subs t ra tes and conta iners and devices f o r admin i s t ra t i on . This i n fo rma t ion i s necessary so t h a t w r i t t e n standards f o r new products can be devel oped and regu la t i ons f o r ol d products can be updated. Furthermore, newer t e s t i n g methods must cons tan t l y be developed t o improve t h e s a f e t y and usefulness o f a l l b i o l o g i c a l products. To these ends, t h e program suppor ts i n v e s t i g a t i o n si n t o :

Poss ib le oncogeni c i t y o f vaccines . Toxic and undes i rab le p r o p e r t i e s o f vaccine components and add i t i ves .

Long-term ep idemio log ic fol low-up o f r e c i p i e n t s o f b i o l o g i c a l products.

Advent i t ious ma te r ia l s present i n b i o l o g i c a l products.

P u r i f i c a t i o n and d e f i n i t i o n o f a c t i v e components of b i o l o g i c a l products.

Development o f new subs t ra tes f o r t h e produc t ion o f vaccines.

Mon i to r ing of b lood f o r presence o f c e r t a i n undes i rab le p r o p e r t i e s such as an an t igen associated w i t h serum h e p a t i t i s .

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NIH Guide for Grants and Contracts, No. 9 , July 29, 1971 Page Eighteeniwrr

bUABORATIM (hlRACT PRoGFwyls OF THE ~ T I O N A IINSTITUTEliw m SCIENCEOF ENVIRONFFNTAI S

‘ I . The col 1aborati ve research program o f the National Inst i tute o f Environmental Health Sciences (NIEHS) i s directed t o support and achievement of research effor ts and goals considered essential t o the mission of the Insti tute. Collaborative projects include b o t h research contracts and interagency agreements and are restricted t o act ivi t ies which, by virtue of required expertise o r logis t ics , l i e beyond the scope o f the Ins t i tu te ’s intramural or research grants programs.

i!. Proposals are solicited on a competitive basis through pub1 ished announcements and direct contact w i t h research groups of recognized competency. B o t h solicited and nonsolicited proposals are reviewed and evaluated i n i t i a l l y , i n terms of mission relevancy, competing pr ior i t ies , and cost , by the Scientific Directorate of the Inst i tute . Secondary evaluation involves a s i t e v i s i t by an ad hoc expert com­mittee. Final evaluation, including technical review of the s i t e v i s i t report , i s c.onducted by the Scientific Directorate.

3. The current collaborative research program of NIEHS i s of limited magnitude and includes projects in the areas of biologic effects of ionizing radiation, phyto­toxins, heavy metal toxicity, somatic mutations, and special risk groups. While

k& present plans do not call for expansion o f effor t i n the aforementioned or other areas, any future need for expanded or new collaborative research e f for t will be announced through the usual mechanisms.

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e ON HFARING I oss IN P h u ~ A N i l 0 U N C E M E N Ts

The Nat ional I n s t i t u t e o f Environmental Heal th Sciences ( N I E H S ) , Nat iona l I n s t i t u t e s o f Heal th , i s i n t e r e s t e d i n o rgan iza t i ons having t h e c a p a b i l i t y o f c a r r y i n g o u t s tud ies i n t h e area o f combined e f f e c t s o f no ise exposure and o t o t o x i c drugs, e.g., kanamycin, neomycin, e tc . on hear ing l o s s and mechanism t h e r e o f i n animals. P a r t i c ­u l a r a t t e n t i o n s h a l l be p a i d t o method o f assay o f temporary and permanent th resho ld sh i f t s and under l y ing processes which r e s u l t i n these sh i f t s . Therefore, competence i n t h e area o f measuring hear ing l e v e l s i n animals and i n fundamental cochlea processes w i l l be mandatory. Resumes are i n v i t e d f rom o rgan iza t i ons hav ing t h e above c a p a b i l i t i e s . Resumes should con ta in (1) i n fo rma t ion which w i l l c l e a r l y e s t a b l i s h t h e o rgan iza t i ons ’ q u a l i f i c a t i o n s , experience, and achievement i n t h e area, ( 2 ) i n fo rma t ion concerning personnel a v a i l a b l e f o r t h e p r o j e c t , (3) a b r i e f statement o f awareness of problems and f a c t o r s i nvo l ved i n t h e s u b j e c t p r o j e c t and ( 4 ) a d e s c r i p t i o n o f equipment and f a c i l i t i e s a v a i l a b l e f o r t h e p r o j e c t .

It i s ’ emphasized t h a t express ion of i n t e r e s t must r e l a t e t o t h e s p e c i f i c p r o j e c t which f a l l s w i t h i n t h e scope of t h e area o u t l i n e d above and inc lude a r a t i o n a l e f o r t h e p r o j e c t t h a t can be s c i e n t i f i c a l l y evaluated. Compi lat ion of o rgan iza t i ona l i-ports, C.V. Is, and general express ion o f c a p a b i l i t i e s alone w i l l n o t s u f f i c e .

Th is synopsis i s n o t a request f o r a proposal . Only those sources deemed, a f t e r a review of t h e resumes, t o be f u l l y q u a l i f i e d f o r t h i s p r o j e c t w i l l be i n v i t e d t o submit proposals. The dec i s ion t o request proposals f o r t h e conduct o f t h e p r o j e c t w i l l be based on t h e eva lua t i on by t h e NIEHS s t a f f and i t s consu l tan ts o f t h e responding o rgan iza t i ons ’ p r i o r exper ience i n t h i s f i e l d and t h e f e a s i b i l i t y and adequacy o f t h e i r o u t l i n e d approaches. Other respondents w i l l n o t be n o t i f i e d o f t he r e s u l t s o f t h e evaluat ion.

l e n copies o f t h e resume of exper ience and c a p a b i l i t i e s should be submit ted t o :

Execut ive O f f i c e r Nat ional I n s t i t u t e o f Environmental Heal th Sciences P.O. Box 12233 Research T r i a n g l e Park, N.C. 27709

before c lose o f business on August 16, 1971.

Telephone c a l l s w i l l n o t be honored and a l l i n q u i r i e s must be i n w r i t i n g and addressed t o t h e o f f i c e l i s t e d above. I n order t h a t a l l p rospec t i ve c o n t r a c t o r s be t r e a t e d on an equal bas i s , any quest ions r a i s e d by i n d i v i d u a l p rospec t i ve contrac­t o r s and t h e answer t h e r e t o w i l l be made a v a i l a b l e upon request t o a l l p o t e n t i a l cont ractors .

W

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I!FFCTS OF I ~ O I S FON DRUG ION N D kcK;f'kTABOl ISM A ii 0 U ii C E F1 E N T

The Nat iona l I n s t i t u t e o f Environmental Hea l th Sciences (NIEHS) , N I H , i s i n t e r e s t e d i n o rgan iza t ions having t h e c a p a b i l i t y o f determin ing t h e e f f e c t s o f no ise on drug d i s p o s i t i o n i n animals. Th is w i l l i n c l u d e s tud ies o f no ise e f f e c t s on t h e b io log ­i c a l h a l f - l i f e o f drugs, t he normal c i r c a d i a n rhythm o f plasma adrenal s t e r o i d hormones, drug clearances, and b io t rans format ion , and on t h e metabolism o f drugs

v i t r o by t i ssues from normal vs. noise-exposed animals. P r o v i s i o n must be madei n -t o d i f f e r e n t i a t e t h e e f f e c t s o f no ise p e r se from non-aural components and f rom genera l i zed "s t ress . I'

Evidence of demonstrated competency i n the areas o f separa t ion and q u a n t i f i c a t i o n o f drugs, s t e r o i d s and t h e i r metabol it e s i s essen t ia l . Exper t i se i n determi n i ng drug and s t e r o i d metabo l iz ing enzyme system a c t i v i t i e s i n var ious t i s s u e s i s requ i red . A pharmacologist (Ph.D.) must be a p a r t o f t h e s c i e n t i f i c personnel assigned t o t h e p r o j e c t . Knowledge o f va r iab les impor tan t t o no i se as a poss ib le e f f e c t o r o f drug d i s p o s i t i o n must be documented.

It i s emphasized t h a t express ion o f i n t e r e s t must r e l a t e t o the s p e c i f i c p r o j e c t which f a l l s w i t h i n t h e scope o f t h e area o u t l i n e d above and i n c l u d e a r a t i o n a l e f o r t h e p r o j e c t t h a t can be s c i e n t i f i c a l l y evaluated. Compi la t ion of organ iza t i ona l

w d repo r t s , C.V. Is , and general express ion o f c a p a b i l i t i e s alone w i l l n o t s u f f i c e . Only those sources deemed t o be f u l l y q u a l i f i e d t o c a r r y o u t t h e s p e c i f i c p r o j e c t of i n t e r e s t t o NIEHS w i l l be considered when proposals a re s o l i c i t e d . Other respondents w i l l n o t be n o t i f i e d o f t h e r e s u l t s o f eva lua t ion . Resul ts o f a l l s tud ies t h a t a re conducted under con t rac ts t h a t may be es tab l i shed are t o be repo r tab le t o t h e NIEHS as s p e c i f i e d by t h e P r o j e c t O f f i c e r .

Resumes a re i n v i t e d f rom organ iza t ions having t h e above c a p a b i l i t i e s . Resumes should con ta in (1 ) i n fo rma t ion which w i l l c l e a r l y e s t a b l i s h the o rgan iza t i on , q u a l i ­f i c a t i o n s , experience, and achievement i n the area, (2) i n fo rma t ion concern ingpersonnel a v a i l a b l e on the p r o j e c t , (3) a b r i e f statement o f awareness o f problems and f a c t o r s i nvo l ved i n the sub jec t p r o j e c t , and (4) a d e s c r i p t i o n o f equipment and f a c i l i t i e s a v a i l a b l e f o r t he p r o j e c t .

Th is synopsis i s no t a request f o r a proposal . Only those sources deemed, a f t e r a review o f t h e resumes, t o be f u l l y q u a l i f i e d f o r t h i s p r o j e c t w i l l be i n v i t e d t o submit proposals. Other respondents w i l l n o t be n o t i f i e d o f t h e r e s u l t s o f t h e eva l u a t ion.

Ten copies o f t h e resume o f experience and c a p a b i l i t i e s should be submi t ted t o :

Execut ive O f f i c e r Nat iona l I n s t i t u t e o f Environmental Hea l th Sciences P.O. Box 12233 Research T r i a n g l e Park, N.C. 27709

before c lose o f business on August 16, 1971.

Telephone c a l l s w i l l n o t be honored and a l l i n q u i r i e s must be i n w r i t i n g and addressed t o t h e o f f i c e l i s t e d above. I n o rde r t h a t a l l p rospec t ive con t rac to rs bew' t r e a t e d on an equal bas i s , any quest ions r a i s e d by indi v i dual p rospec t i ve contrac­t o r s and t h e answer t h e r e t o w i l l be made a v a i l a b l e t o a l l p o t e n t i a l con t rac to rs .