SR-11-C (21)
CNS:BJS:sd
Counc~l Meet~ng 6/28/83
1/-(,
JUH 2 f.s 1m
Santa Mon~ca, Cal~fornia
TO: Mayor and c~ty Council
FROM: c~ty Staff
SUBJECT: Allocation of Emergency Food and Shelter Funds to Ocean
Park Community Center, Wests~ce Food Sank, and the
Nelghborhood Adult Partlc~pation ProJect
Introduct1on
Th~s re20rt transmits funding recommendations for specif1c community
organ~zatlons to lmplement emergency food and shelter programs, to
be funded from the Emergency Food and Shelter Fund, previously
approved as a part of the 1983-84 Commun~ty Development Plan w~th
addlt10nal al~ocations as spec~fled 1n th~s report.
Back9round
The 1983-84 Commun~ty Development Plan, approved by the C~ty Councll
on June 21, 1983, ~ncluded a fund ~n the amount of $61,200 for un-
speclfied emergency food and shelter programs. As ~nd1cated In the
plan, three proposals were subm~tted for1mplementation of such pro-
grams and were ranked, using fund~ng select~on crlteria, as follows:
(1) Ocean Park Community Center Homeless ProJect, (2) Wests~de
Food Bank, and (3) Ne~ghborhood Adult Part~cipat~on proJect. Sum-
mar~es of these proposals have been transm1tted to Council prev~ously.
Decisions regard~ng specif~c agency fund1ng amounts were delayed due
to the need to assess the impact of Federal fund1ng for these pro-
grams through the Federal Emergency Management Agency (FEMA). Now
that these allocations are known, staff has proceedec w1th a f1nal
analYS1S of ~hese proposals.
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JU~ 2 8 1983
Mayor and City Counc~l
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June 28, 1983
D~scuss~on
(I) Ocean Park Community Center Homeless ProJect - The Homeless
Project, sponsored by OPCC In conJunction with a number of
churches and commun~ty organ~zations, has successfully located
a facility at the F~rst Chr~stian Church and w~ll beg~n opera-
t~ons ~n July of 1983. The request for $39,567 for operat~ng
funds for 1983-84 represents 34% of the total operat~ng bud-
get with the rema~nder com~ng from private donations and fund-
raising. Slnce the submiss~on of thlS request, the City has
~nformed OPCC that the facillty must be renovated to ~nclude
a sprinkler system and I-hour flre wall In order to meet
flre and bu~ld~ng codes. G~ven the already high level of
prlvate support, lt wlll not be poss~ble to ra~se these addi-
t~ona1 funds qUlck1y enough to meet the C~ty deadllne of
August 1983 for ~nstallatlon of the spr~nklers. G~ven the
crlt~cal need for establlsh~ng an emergency shelter, the
very positive track record of the particlpat~ng agenc~es ln
provlding these serVlces, and the current commltment to ralse
well over 50% of all funds from the prlvate sector, Clty staff
recommends that additlonal funds In the amount of $20,000
be awarded, in addit~on to the $39,567, for renovat~on of the
fac~l~ty.
(2) Westslde Food Bank - The Food Bank had or~glnally requested
$17,500 for an lncreased food dlstrlbuhon program. Slnce
that t~me two factors resulted In an lncreased request of
$35,000 communicated to the Counc~l by the Food Bank at the
June 21st CounC11 meet~ng. These factors lncluded the need
to move to leased warehouse space from currently free space
Mayor and c~ty Council
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June 28, 1983
wh~ch wlll no longer be ava~lable, and the expressed need for
add~t~onal staff to handle the $63,000 FEMA allocation to be
used for dlrect food purchase for d~str~bution to co~~unity
agenc~es. In assesslng the ~ncreased request, Clty staff
revlewed comparable programs ~n the Los Angeles area includ~ng
a detailed analysls of staffing levels, volunteer usage,
amount of food distr~buted and number of part~cipatlng agenc~es
for two programs - the Long Beach Food Bank and Commun~ty
Food Resources WhlCh serves the ent~re eastern port~on of
Los Angeles County. The result of this analys~s ind~cates
the follow~ng:
o The four full-tlme staff proposed by the Westslde Food Bank
is substantially higher than staff~ng levels of the two other
programs analyzed by Clty staff. The Long Beach program
cistrlbutes approxlmately 2 ~ill~on pounds of food annually,
wlth a full-t~me staff of five, an operatlng budget of $110,000,
(85% from pr~vate sources), 1200 volunteer hours per month, and
80 particlpatlng agencies. The East Los Angeles-Pasadena
program dlstr~butes approx~mately 3.5 m~lllon pounds of food
annually, wlth a full-time staff of 9, 700 volunteer hours
per month, and an operat1ng budget of $300,000. 110 agencles
partlcipate ln the distributlon of food. The Westslde Food
Bank, a new agency ln the past year, proposes an operat~ng
budget of $72,000, 4 full-t~me staff, 17 partlclpatlng agencles
and an est~mated food distr~but~on of 1 ffillllon pounds {current
year annuallzed d~strlbut~on wlll be approx~mately 360,000 Ibs. whil~
caution must be exerclsed in maklng comparisons between agenc~es,
~t appears that successful programs can be operated wlth a
lower level of stafflng if volunteers are utilized effect~vely.
o Currently, the Wests~de Food Bank utillzes four volunteers on
an as needed bas~s. Discusslon wlth staff of the OPCC Homeless
ProJect ~nd~cates that response to that program's volunteer
recrultment has been overwhelm~ng with more volunteers than
ava~lable slots at the proJect. It appears, then, that the
potential for recruiting volunteers to flll both clerical and
warehous~ng slots, on a part-t~me basls, should be poss~ble.
o It 1S ~mportant to note that the need for increased staff was
Just~f~ed because of increased food to be distr~buted through
FE~~ fundlng. Th~s food must be purchased and d~str~buted
~n a 6-rnonth period. Therefore, staffing based on thlS level
of act~v~ty requires that the Food Bank sustaln that level
after termlnation of Federal support through ~ts own efforts.
Wh~le donations have ~ncreased In the last several months,
(26,000 pounds ln Aprll) ~t is st~ll not certa~n that thlS
hlgh level could be sustalned in the long-term. Thus, f~nal
Mayor and C~ty Councll
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June 28, 1983
staff analysls resulted ~n a "f~xed staffing level" necessary
to sUsta~n bas~c and current levels of operat~on w~th the
assumptlon that, as In other programs In the area, lncreases
~n staff need can very effectlvely be f~lled with volunteers
or staff funded from other sources.
o D1SCUSSlon wlth Food Bank staff lndlcates that the reported
pol~cy of charg~ng partlc~patlng agenc~es $.05/lb. to help
defray operatlng costs has not be put into effect and has
not been presented formally to the Board of Directors for
c~scussion. Th~s charge is of particular concern for those
agencles who channeled thelr requests for FE~m fundlng through
the Food Bank ~nstead of applY1ng d~rectly to Un1ted Way for
thlS fundlng. If a charge were requ~red, these agencies would
then be pay~ng for food that they could have purchased clrectly
w~th thelr own FE~ffi funds. It 1S therefore lmportant that
Clty fund~ng be made cont~ngent upon the Food Bank Board
approvlng a "no-charge" policy for all food d~str~buted to
participating agencles. Wh~le thlS POllCY lS utlll2ea by
other food banks in the area, these programs do not rece~ve
substant~al local government support and therefore requlre
such a contr~but~on.
Based on this analysls, staff recommends that the total CLty
contr~but~on to the Food Bank be $26,238. $2,080 of this has
be allocated ~n the context of the Communlty Development Plan.
Therefore, an addltlonal $24,158 ~s recommended from the Emergency
Food and Shelter Fund. This represents an lncrease of $6,658
over the orlglnal request to cover an add~tlonal 1/2 tlme ware-
house posltlon.
(3) Ne~ghborhood Adult Partlc~patlon ProJect - NAPP's proposal for
a Food Pantry, ~n the amount of $67,296, ~ncluded a substantlal
amount for admlnlstratlve stafflng, overhead and also food pur-
chase.
Based on fundlng selectlon cr~ter~a, the proposal d~d
not rank wlth the other two recommended programs.
However,
now that FEMA funds wlll provlde addlt~onal food to NAPP's
Santa Mon~ca Center and glven the program's ab~l~ty to serve
the P~co N21ghborhood's low-lncome, minor~ty populations, it
is reco~~ended that $4,200 ~n Emergency Food anc Shelter funds be
Mayor and C~ty Councll
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June 28, 1983
allocated to NAPP to provide part-tlme staff~ng support for
the distributlon of food to low-income lndlv~duals. ThlS alloca-
tion should be made cont~ngent on its use for direct serVlce staff
and not for adrnlnlstratlve overhead and expenses.
Fiscal Impact
These recommendations do not result in an add~tlonal lncrease ~n
appropr~at~on from the General Fund. The follow~ng appropr~at~ons
have prevlously been made by the C1ty Counc~1, in the context of the
1983-84 3udget, for support of these programs:
Vitale Gllp~n Reserves
CDBG Jobs Bill
$39,567
21,633
$61,200
Recommended allocatlons are as follows:
OPCC Homeless ProJect
OPCC Shelter Renov.
Westslde Food Bank
KAPP Food Pantry
Add~t~onal Funds Needed:
Addlt. Vitale G~lp~n
GRS Interest Income
Recommendations
$39,567
20/UOO
24,158
4,200
$87,925
26,725
20/000
6,725
Clty staff recommends that the City Council (1) transfer $20/000 from
prevlollslyapproprlatedVltala-Gllplnreserves,1ncluded ~n ~he Redevelop-
ment Agency budget, to the Emergency Food and Shelter Fund (Communlty
approprlate an additlonal $6,725
and Neighborhood Services budget); (2)
to Commun~ty SerVlces proJects from General Revenue Shar~ng ~nterest
~ncome to the Commun~ty Serv~ce ProJect budget; and (3) allocate
funds to OPCC In the amount of $59,567, Westside Food Bank ~n the
amount of $24,158 and NAPP ~n the amount of $4,200 for lmplementat~on
Mayor and City Council
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June 28, 1983
of emergency food and shelter programs.
Prepared by: Barbara Stlnchfleld, Grants Admlnistrator
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"(2) The mRking of grants under subsectIOn U1H 1 )(B) for
N arional Research Service Awards shall be subject to reYle\V
and approyal by the appropriate ad'nsory councils ~rithin the
Department of Health a.nd Human Services (A) whose activ'i-
ties relate to the research or training under the awards. or
ill) for the entity at which such research or trainIng will be
j conducted.
8 "(3) ~o gram may be made under subsection (a)(l){B)
9 unless an applicatIon therefor has been submitted to and ap~
10 proved by the Secretary. Such application shall be in such
11 fOrnlt submitted in such manner, and contain such informa-
12 tion, as the Secretary may by regulation prescribe. Subject to
13 the provisions of this section other than paragraph (1) of this
14 subsection, Sational Research ServIce Awards made under a
15 grant under subsection (a)(1)(B) shall be made in accordance
16 with such regulations as the Secretary shall prescribe.
17 "(4) The period of any ~ ational Research Service
18 Awards made to any individual under subsection (a) may not
19 exceed-
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"(A) five years m the aggregate for predoctoral
21
tr~.iniTlg, and
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"(B) three years in the aggregate for postdoctoral
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training,
24 unless the Secretary for good cause shown waives the appli~
25 cation of such limit to such individual.
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1 "(5) Xational Research Ser:lce Awards shall nroyide
2 for such stipends. tuuion. fees. and allo\vances (including
3 travel and subsIstence expenses and dependency al1owance~),
-1 adjusted periodically to retlect increases ill the cost of livmg.
;) for the recipients of the awards as the Secretary may deem
6 necessary A ~ adanal Research Service A waru made to an
i indivi.dual for research or research training at a non-Federal
8 public or nonprofit private mstitution shall also proyide for
9 payments to be made to the institution for the cost of support
10 services (including the cost of faculty salaries, supplies,
11 equipment, general research support, and related items) pro-
12 ,,"ided such indi\;dual by such institutIon. The a.mount of any
13 such payments to any institution shall be determined by the
14 Secretary and shall bear a direct relationship to the reason-
15 able costs of the institution for establishing and mamtaining
16 the quality of its biomedical and behav;oral research and
17 training programs.
18 "(c)(l) Each indh;dual who is awarded a National Re-
19 search Servi.ce Award (other than an mdividual who 1S a pre-
20 baccalaureate student who is awarded a ~ ational Research
21 Sen;ce Award for research training) shall, in accordance
22 wiih paragraph (3), engage in health research or teaching or
23 any combination thereof which is in accordance ""th the
24 usual patterns of academic employment, for a period comput-
25 ed in accordance with paragraph (2).
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1 .1(2) For each month for which an individual receives a.
0) ~ atlOnal Research Service Award \vhich is made for a nenod
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3 in excess of twelve months, such mdiv-idual shall engage ill
-! one month of health research or teaching or any combination
5 thereof which is in accordance "\,,-ith the usual patterns of J.ca-
6 demic employment.
7 1l(3) The requirement of paragraph (1) shall be complied
""
8 'vith by any individual to \vhom it applies \vithin such reason-
9 able period of time, after the completion of such inmviduar s
10 award. as the Secretary shall by regulatIOn prescribe. The
11 Secretary shall by regulation prescribe the type of research
12 and teaching in which an individual may engage to compl}~
13 \\rith such reqUIrement and such other reqUIrements respect-
.
14: ing research and teaching as the Secretary considers appro-
15 priate.
16 "(4)(A) If any indhd.dual to whom the requirement of
17 paragraph (1) is applicable fails. \\ithin the period prescribed
18 by paragraph (3), to comply with such requirements, the
19 Lmted States shall be entitled to recover from such indi\;du-
20 al an amount determmed ill accordance \\;th the formula-
A=</I(t-;l!t)
21 in which 'A' is the amount the united States is entitled to
22 recover; '~' is the sum of the total amount paid under one or
23 more National :Research Senice Awards to such individual;
24 it' is the total number of months in such individual's service
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1 obligation; and '3' is the number of months or 5uch obligation
0) served by him in accordance \vith paragraphs rJ) ,:md (2) of
3 this subsectlon.
.,t "(B) Any amount wmch the L nited States IS entitled to
D recover under subparagraph L\.) shall, w-i.rhm the three-year
6 period beginning on the date the L nited States becomes eno-
7 tled to recover such amount, be paId to the L niten States.
8 Until any amount due the Lnited States under subparagraph
9 t.\.) on account of any National Research Service A ward is
10 paid, there shall accrue to the U ruted States interest on such
11 amount at a rate fixed bv the Secretary of the Treasurv after
.; to' ....
12 tJl.king into consideration private consumer rates of interest
13 prevailing on the date the United States becomes entitled to
14 such amount.
15 "(5)(A) Any obligation of any individual under para~
16 graph (3) shall be canceled upon the death of such indiv-i.dual.
17 "(B) The Secretary shall by regulation provide for the
18 waiver or suspension ot any such obligation applicable to any
19 indiVIdual whenever compliance by such indi,,-i.dual is impOSSI~
20 hie or would involve substantial hardship to such indi,;;ridual
21 or would be against equity and good conscience.
22 "(d) There are authorized to be appropriated to make
23 payments under National Research Service Awards and
24 under grants for such awards $191,000,000 for fiscal year
25 1984, $220,000,000 for fiscal year 1985, and $251,000,000
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1 such agreements. The report shall also provi.de for recom-
') mendations to the Secretary and the Congress regarci.ing
3 changes in policies regarding grants. and regulatory and .stat-
-! utory law (including patent law) necessary to protect the
;) public interest in federall;, supported biomedical research.
6 tb) A final report of such study shall be completed no
7 later than September 30. 1985. Such report shall be submit-
8 ted to the Secretary.
9 (c)(l) The Secretary shall request the National Academy
10 of Sciences to conduct the study required by subsection (a)
11 under an arrangement under which the actual ex.penses in4
12 curred by such Academy in conducting such study ",ill be
13 pai~ by the Secretary If the ~ational Academy of SCIences
14 is willing to do so, the Secretary shall enter into such an
15 arrangement with such Academv for the conduct of such
16 study.
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17 (2) If the ~ ational Academv of Sciences is Ull",-illing to
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18 conduct such study under such an arrangement, then the See-
19 retary shall enter into a sllmlar arrangement v..;,th other ap-
20 propriate nonprofit private groups or associatIons under
21 which such groups or associations will conduct such study
22 and prepare and submit the reports thereon as provided in
23 subsection (b).
24 (3) The N adana! Academy of Sciences or other group or
25 association conducting the study required by subsection (a)
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1 shall conduct such stud\T in consultation 'With the Director at
.) ~l1f,
3 I~TERAGENCY CQlnrrTTEE O~ LEAR!'Ii""I~G DISABILITIES
-1 SEC. 8. (a) ~ot later than ninety days after the date ot
;) the enactment of this Act. the Director of the X ational Insti-
6 tutes of Health shall establish an Interagency Committee on
7 Learning Disabilities to review and assess Federal research
8 priorities, activities, and findings regarding learning disabil-
9 ities (including central neITOUS system dysfunction in clril-
10 dren).
(b) The Committee shall be composed of such repre-
sentatives as the Director may desumate, but shall include
~ ~
representanves from the :s ational Institute of ~ eurological
and Communicative Disorders and Stroke, the ~ ational Insti-
tute of Child Health and Human Development. the ~ ational
Institute of Allergy and Infectious Diseases, the National In-
stitute of Emrironmental Health Sciences, and the Division of
Research Resources of the ~ ational Institutes of Health.
(c) ~ ot later than eighteen months after the date of the
enactment of this Act, the Committee 5hall report to the
Congress on its activities under subsection (a) and shall in-
22 elude in the report-
23 (1) the number of persons affected by learning dis-
24 abilities and the demographic data which describes
25 such persons;
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1 tion, and (B) other current training programs a,.ailabIe
2 for the rrammg of such personnel:
3 0;(3) :dentiiy the kInds of research positions ayuua-
4 bIe to and held by indh--iduals completIng such pro-
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grams;
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"(4) determine, to the extent teasiblet whether the
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, programs referred to ill clause (B) of paragraph (2)
8 would be adequate to meet the needs established under
9 paragraph (1) if the programs referred to in clause (JJ
10 of paragraph (2) were terminated; and
11 "(5) determine what modifications in the programs
12 referred to in paragraph (2) are required to meet the
13 needs established under paragraph (1).
14 "(b)(l) The Secretary shall request the ~ational Acade-
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15 my of Sciences to conduct the study required by subsection
16 (a) under an arrangement under which the actual expenses
17 incurred by such Academy in conducting such study 'will be
18 paid by the Secretary. If the ~ational Academy of Sciences
19 is \\.;1llng to do so, the Secretary shall enter into such an
20 arrangement ,virh such Academv for the conduct of such
21 study.
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22 "(2) If the National _\cademy of Sciences is unwilling to
23 conduct such study under such an arrangement, then the Sec.
24 retary shall enter into a similar arrangement with other ap.
25 propriate nonprofit private groups or associations under
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1 willeh such groups or aSSOCIatIons ,vill conduct such study
~ and prepare and sUbIlllt the reports thereon as provid.ed in
3 subsectIOn lc).
4 "(3) The ~ ational Academy of Sciences or other group
5 or associatIOn conducting the study required by subsection (a)
6 shall conduct such stUdy in consultation ",th the DirectOr of
j ~"1l{,
8 "(c) A report on the results of such study shall be sub-
9 mitted by the Secretarv to the CommIttee on Ener~v and
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10 Commerce of the House or RepresentatIves and the Cornmit-
11 tee on Labor and Hwnan Resources of the Senate at least
12 once every two years.
13 "PART F-GE~RAL PROV1SIO~S
14 HINSTITrTIO~.AL REVIEW BOARDS: ETIDCS GLIDA...'WE
15 PRO GRAb I
16 "SEC. 483. (a) The Secretary shall by regulation require
17 that each entity which applies for a grant, contract, or coop-
18 erative agreement under this .Act for any project or program
19 which involves the conduct of biomedical or beha"vioral re-
20 search involving human subjects submit in or with its applica-
21 tion for such grant, contract, or cooperative agreement assur-
22 ances satisfactory to the Secretary that it has established (in
23 accordance with regulations which the Secretary shall pre-
24 scribe) a board (to be kno\vn as an 'Institutional Review
25 Board') to review biomedical and behavioral research involv-
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1 ing human subjects conducted at or supported by .such emity
') in order to protect the rights 01 the human subjects of such
3 research.
4 "(b) The Secretary shall-
5 "(1) establish a program ","ithin the Department
6 under \vhich requests ior clarification and guidance
7 with respect to ethical issues raised in connectIon ","ith
8 biomedical or behavioral research involving human suh-
9 jeets are responded to promptly and appropriately, and
10 "(2) a process for the prompt and appropriate re-
11 sponse to information provided the Director of ~1H re-
12 spectmg incidences of violations of the rights of human
13 subjects of research for which funds have been made
14 available under this Act. The process shall include pro-
15 cedures for the receiving of reports of such information
16 from recipients of funds under this Act and V~.king ap-
17 propriate action \'vith respect to such violations.
18 "PEER RE'VIEW
19 "SEC. 484. (a) The Secretary, after consultation ;,vith
20 the Director of ~, and where appropriate, the head of the
21 Division of ~ ursing of the Health Resources Administration
22 (or the successor to such entity), shall by regulation require
23 appropriate technical and scientific peer review of-
24 "(1) applications made for grants and cooperative
25 agreements under this Act for biomedical and beha,,-ior.
.
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1 al research (including research under orOlZTams of such
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') Division of ~ursing); and
3 "(2) biomedical and behavIoral research and de-
4 velopment contracts to be admmistered through the
o X ational Institutes of Health or the DiYISOn of ~ ursmg
6 of the Health Resources Admmistranon (or the succes-
7 SOl' to such entity).
8 "(b) Regulations promulgated under subsection (a) shall
9 require that the review of grants. contracts. and cooperative
10 agreements required by the regulations be conducted-
11 "(1) in a manner consistent 1,Vlth the system for
12 scientific peer rev;ew applicable on the date of the eu-
13 actment of the Health Research Act oi 1983 to grants
14 under this Act for biomedical and behavioral research,
15 and
16 "(2) to the extent practical, by peer review groups
17 performing such review on or before such date.
18 ';(c) The members of any peer review group established
19 under such regulations shall be indiv;duals who by virtue of
20 their training or expenence are eminently qualified to per-
21 form the re";ew functions of the group and not more than
22 one-fourth of the members of any peer review group estab-
23 lished under such regulations shall be officers or employees of
24 the United States.
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1
"(d) The Directof of ~W shall establish nfocedures ior
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OJ periodic, ~echmc3.l. and scientIfic peer review of research at
3 the "National Institutes of Health. Such procedures shall re-
4: quire that-
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"(1) the re\'le"\vlllg entity be provided a '....TItten
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6 descriptIon of the research to be revie,ved; and
7 "(2) the reVIewing entity provIde the advisory
8 council of the national research mstitute involved with
9 such description and the results of the review by the
10 eutin".
11 "PROTECTION AGAL'lST SCIE:fTIFIC FRAUD
12 "SEC. 485. (a) The Secreta!"}? shall by regulation require
13 that each entIty which applies ior a grant. contr~ct, or coop-
14 erative agreement under this Act for any project or program
15 which involves the conduct of biomedical or behavioral re-
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16 search submit in or with its application for such grant. COll-
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17 tract, Of cooperative agreement assurances satisfactory to the
18 Secretary that it-
19 "(1) has established (in accordance .wIth regula-
20 tiolls which the Secretary shall prescribe) an admims-
21 tr::ttive process to review reports of .scientific fraud in
22 connection with bIOmedical and beha"vioral research
23 conducted at or sponsored by such entity.
24 "(2) will report to the Secretary any investigation
25 of alleged scientific fraud which appears .substantial.
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1 "(b) The Director of )'lH ::;hall establish a process tor
.) the prompt and appropriate response to informatIOn prm...i.ded
3 the Director of ~-m respecting sCIentific fraud in connection
-! with projects ror which funds have been made available under
;) this Act. The process shall mclude procedures for ~he receiv-
6 ing of reports of such infonnanon trom recipients of funds
j under this Act and taking appropriate action \V1.th respect to
8 such fraud.
9 "RESEA.BCH A...",1) Pl.-:BLIC HEALTH EJ!ERGEXCIES
10 "SEC. 486. (a) If the Secretary detenmnes, after consul-
11 tation with the the Director of ~JH:l the CommissIOner of the
12 Food and Drug Administration, or the DIrector of the Cen-
13 ters for Disease Control, that a disease or disorder constl-
14 tutes a public health emergency, the Secretary, acting
15 through the Director of l'l1H-
16 "(1) shall expedIte the re,,;ew by advisory councils
17 under section 408 and by peer review groups under
18 section 484 of applications for grants for research on
19 such disease or disorder or proposals for contra.ctS for
20 such research;
21 "(2) shall exercise the authority in section 3709 of
22 the Revised Statutes respecting public exigencies to
23 waive the advertising requirements of such section in
24 the case of proposals for contracts for such research;
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"(3) may provide atimiTUstrative supplemental in-
creases m eXIsting grants and contracts to .support ne'\"
research relevant to such disease or disorder; and
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4:
'\4:) shall disseminate, to health professionals a.nd
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the public, information on the cause. preyentlon, and
6 treatment of such disease or disorder whICh information
.
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has been developed in research assisted under this sec-
8 cion.
9 The amount of an increase in a grant or contract provided
10 under paragraph (3) may not exceed one-half the original
11 amount of the grant or contract.
12 "(b) ~ ot later than ninety days after the expiration of a
13 fiscal vear the SecretarY shall reuon to the Committee on
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14 Energy and Commerce of the House of Representatiyes and
15 the Committee on Labor and Human Resources of the
.
16 Senate on actions taken under subsection (a) in such fiscal
<A
17 vear.
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18 dA.."'1!YIALS ~ RESEARCH
19 ;'SEC. 487. (a) The Secretary. acting through the Direc-
20 tor of ~IH, shall by regulation establish standards ror rhe
21 following:
22 "(1) The proper care or animals to be used in bio-
23 medical and behavioral research.
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"(2) The proper treatment of animals wlule being
used III such research. Standards under tms paragraph
shall requrre-
"(A) the appropriate use of tranquilizers. an-
algesIcs. anesthetics. paralytics. and euthanasia
for animals III such research: and
i "(B) appropriate pre- and post-surgical vet-
S erinarv medical and nursing care for animals in
9 such research.
10 Such standards shall not be construed to prescribe
11 methods of research.
12 "(3) The organization and operation of animal
13 care committees III accordance '"\1.th subsectIOn ro).
14 "(b)(1) Regulations of the Secretary under subsection
15 (a)(3) shall require animal care committees at each entity
16 which conducts biomedical and behavioral research with
17 funds provided under this Act (including the ~ ational Insti-
18 tutes of Health and the national research institutes) to assure
19 compliance with the standards established under subsection
20 (a).
21 "(2) Each a.nimal care committee shall be appointed by
22 the chief executive officer of the entity for which the commit-
23 tee is established, shall be composed of not fewer than three
24 members1 and shall include at least one individual who has no
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1 association with ilUch entity and at least ona doctor of veteri-
~ nary medicine.
3 "(3) Each arumal care committee of a research entIty
4: shall-
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"(A) revi.ew the care and treatment of animals in
6 all animal study areas and facilities of the research
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entity at least semi-annually to evaluate compliance
8 with applicable standards established under subsection
9 (a) for appropnate animal care and treatment;
10 "(B) keep appropriate records of reviews conduct-
11 ed under subparagraph (A), and
12 "(C) for each rev;ew conducted under 5ubpara-
13 graph (A), file w-ith the Director 01 ~IH (i) J, certllca-
14 tion that the review has been conducted, and (ii) re-
15 ports of any violations of standards established under
;
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subsection (a) or assurances required by subsection (b)
17 which were observed in such review and which have
6
18 continued after notice bv the committee to the research
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19 entity involved of the violations.
20 Reports filed under subparagraph (0) shall include any mi-
21 nority ,,;ews filed by members of the committee filing the
22 report.
23 "(c) The Director of ~lH shall by regulation require
24 each applicant for a grant or contract administered by the
25 ~ ational Institutes of Health or any national research insti-
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1 tute to include in Its application or contract proposal, submit-
2 ted after the expiration of the twelve-month penod begmning
3 on the date of the enactment of this section-
4 "(1) assurances satisfactory to the Director of
5 ~-rH that-
6 "L\.j the applicant meets the requirements 01
7 the standards established under paragraphs (1)
8 and (2) of subsection (a) and has an animal care
9 committee which meets the requirements of sub-
10 sectIOn (b); and
11 "(B) scientists, animal technicians, and other
12 personnel involved "\\i.th animal care, treatment.
13 and use by the applicant haye available to them
14 instruction or training in the humane practice of
15 animal maintenance and experimentation, and the
16 concept, availability, and use of research or test-
17 ing methods that minimize the use of animals or
18 limit animal distress; and
19 "(2) a statement of the reasons for the use of ani-
20 mals in the research to be conducted ",-ith funds pro-
21 vided under such grant or contract.
22 Notwithstanding subsection (a)(2) of section 553 of tItle 5.
23 United States Code, regulations under this subsection shall
24 be promulgated in accordance with the notice and comment
25 requirements of such section.
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1 "(d) If the Director of ~1H determmes that-
2 "(1) the conditions of arumal care, treatment. or
3 use in an entity which is receIVIng a grant or contract
4 under this title do not meet applicable standards estab-
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lished under subsection (a),
6
"(2) the entity has been notIfied by the Director
7 of :NTH of such detennination and has been given a
8 reasonable opportunity to take corrective action, and
9 "(3) no action has been taken bv the entity to
10 correct such conditions,
11 the Director of N1ll shall suspend or revoke such grant or
12 contract under such conditions as the Director determines ap-
13 propriate.
14 "DEFDUTION
15 "SEC. 488. For purposes of this title, any reference to
16 research into the prevention of disease is a reference to re-
17 search which is directly related to reducing the incidence of
18 diseases or disorders within the authority of the national re-
19 search institutes, reducing the high-risk precursors of ;mch
20 diseases or disorders, and reducing the adverse consequences
21 of such precursors and early ID3,nlfestations of such diseases
22 or disorders.
23 "USE OF APPROPRIATIONS UNDER. TillS TITLE
24 HSEC. 489. Appropriations to carry out the purposes of
25 this title shall be available for the acquisition of land or the
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1 erection of buildings only if so specified. Such appropriations.
=! unless otherwIse expressly provided, may be expended in the
3 District of Columbia for personal services, stenographic re-
4 cording and translating services; by contract It deemed neces-
;3 sary, ",-ithollt regard to section 3709 of the Re'\lsed Statutes:
6 travel expenses (including the expenses ot a.ttendance ax
7 meetings when specifically auihorized by the Secretary);
8 rental, supplies and eqUIpment, purchase and exchange of
9 medical books, books of reference, directones, periodicals.
10 newspapers, and press clippings; purchase. operation, and
11 maintenance of passenger motor vehicles; printing and hind~
12 ing (in addition to that otherwise provided by law); and for all
13 other necessary expenses in carrying out the provisions of
14 this title.
15 "GIFTS
16 "SEC. 490. The Secretary mav, ill accordance \"\<-ith sec-
oJ w
1 7 tion 501, accept conditional gifts for the ~ ational Institutes
18 of Health or a national research institute or for the acquisi-
19 tion of grounds or for the erection. equipment, or mainte-
20 nance of facilities for the ~ ational Institutes of Health or a
21 national research institute. Donations of $50,000 or over for
22 the ~ational Institutes of Health or a national research insti~
23 tute for carrying out the purposes of this title may be ac-
24 knowled2"ed bv the establishment within the ~ational Insti-
'-' ~
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1 tutes oi Health or institute of sUItable memorials to the
0) donors" .
3 CONFORMING AL\1ENDl\1ENTS
4: SEC. 3. (a) The ~ ational Adyisory Health Council es-
.
;) tablished lUlder section 217 is tenninated.
6 (b) Section 217(a) is amended-
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(1) in the first sentence-
(A) by striking out "~anoual Ad'visory
Health Council, the National Advisory ):fental
Health Council. the ~ ational Ad,,;sory Council on
Alcohol Abuse and Alcoholism, and the National
Adv;sory Dental Research Council" a.nd insertIng
in lieu thereof ;'~ ational Adt>1sory 1fental Health
Council and the ~ational .Ad'visory Council on ,Al-
cohol Abuse and Alcoholism"; and
(B) by striking out "by the Surgeon General
with the approval of the Secretary of Health,
Education, and Welfare" and inserting in lieu
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thereof "by the Secretary";
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(2) in the second sentence-
21
(A) by striking out "in the case of the N a-
tional .Adyisorv Health Council, are skilled in the
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sciences related to health, and' ~;
24
(B) by striking out Hthe ~ational Ad,;sOlj7
~ental Health Council, the National Advisory
25
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1 Council on Alcohol Abuse and _.\lcohoiism. the
2 Xational Advisory Heart Council, and the )ration-
3 al Advi.sory Dental Research Council" and m.sert-
-1: ing in lieu thereof "the ~ational Adv-1sory ~Iental
5 Health Council and the ~ational AdV-1sory Coun-
6 eil on .Alcohol Abuse and Alcoholism"; and
7 (C) by strikin.g out ". alcohol abuse and alco-
8 holism, and dental diseases and conditions" and
9 inserting in lieu thereof "and alcohol abuse and
10 alcoholism"; and
11 (3) by striking out the third sentence.
12 (c) Subsection (b) of section 217 is repealed and subsec-
13 tions (c) through (e) and subsection (g) are redesignated as
14 subsections (b) through (e), respectively.
15 (d) Section 222(c) is amended to read as follows:
16 "(c) Upon appointment of any such council or commit-
17 tee, the Secretary may delegate to such council or comm..ittee
18 such advisory functions relating to grants-in-aid for research
19 or training projects or programs, in the areas or fields .wIth
20 which such councilor committee is concerned, as the Secre-
21 tary determines to be appropriate.".
22 (e) Section 301(a) is amended-
23 (1) in paragraph (3), by striking out "as are recom-
24 mended" through "for such fiscal year" and inserting
25 in lieu thereof "as are recommended by the ad,isory
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council to the ennty of the department suPPOrting such
projects or. in the case of mental health projects. by
the :National Advi.sory Mental Health Council; and
make, upon recommendation of the adv-isory council to
the entity of the depanment involved or the X ational
6 Advisory Memal Health CouncIl. grams-in-ald to
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public or nonprofit universities~ hospitals~ laboratories~
8 and other institutions for the general support of their
9 research", and
10 (2) in paragraph (8), by striking out "recommen-
11 dations of the ~ ational Ad'nsorv Health Council"
v
12 through "such additional means" and inserting in lieu
13 thereof "recommendations of the advlsory councils to
14 the entities of the department involved or, with respect
15 to mental health~ the National Advisory ~lental Health
,~
16
17
16
Council, such additional means".
(t) Sections 305(a) and 306(a) (42 U.S.C. 242c(a),
18 242k(a)) are each amended (1) by striking out "in the De.
19 partment of Health and Human Services", and (2) by striking
:]0 out "and 5upelV~sed" and all that follows in that sectlon and
21 inserting in lieu thereof a period and the following~ "The
22 Center shall be an agency of the ~ational Institutes of
23 Health.".
24 (g) Section 309(h) (42 U.S.C. 242n(h)) is amended by
25 mserting "and" after "1981," in the first sentence and bv
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1 striking out "1982," and all that follows in that sentence and
') insertmg in lieu t:hereof a1982....
3 (h) SectlOn Sew) oi the Orphan Drug Act (PublIc L.1\V
-4: 97-414) is repealed.
5 .UIEND}-IE~TS REL.A.TI~G TO THE SATIONA.L LIBRARY OF
6 }lEDICDfE
7 SEC. 4. (a) Part I of title m of the Public Health Serv-
8 ice --\..ot is transferred to title IV of such Act (as amended by
9 section 2 of this .Act), inserted at the end of .such tItle. redes-
10 ignated as part G. and amended as follows:
11 (1) Section 381 (42 L.S.C. 275) is amended-
12 (A) by inserting "(a)" before "In order".
13 lB) by striking out "there is hereby estab-
14 lished in the Public Health Serv-ice" and inserting
15 in lieu thereof "there is established as an agency
16 of the ~ ational Institutes of Health",
17 (e) by striking out "381.01 and insening in
18 lieu thereof "485.", and
19 fD) bv amendinu: the section heading' to !ead
v _ _
20 as follows:
21 "PURPOSE. ESTA.BLISH~IENT. AND FUNCTION OF THE
22 ~ATIONAL LIBRARY OF }-IEDICINE".
23 (2) Section 382 (42 U.S.C. 276) is amended-
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(A) by stl"l1cing out "subsection (c/' in sub-
sectIOn (a) a.nd inserting ill lieu thereof .. ~ubsec-
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don (d)",
4:
(B) by stI1king out "section 383" in subsec-
tIon (c) and msertmg in lieu thereof "section
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486",
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(0) by striking out "SEC. 382. (a)" and ID-
8
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serting in lieu thereof "(b)",
10
(D) by redesignating subsections (b) and (e)
as subsections (e) and (d). respectively, and
(E) by striking out the section heading.
(3) Subsection (a) of section 388 (42 U.S.C.
11
12
In
;)
2S0a-l(a)) IS inserted Just before section 383, redesig-
nated as subsection (e), and amended by striking out
14
15
"section 397" and inserting in lieu thereof "section
.
.
16 496".
~
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(4) Sections 384 and 385 (42 L.S.C. 278, 279)
18 are inserted after the subsection mserted by paragraph
19 (3) and amended-
20 (A) by stnking out "SEC. 384." and msen-
21 ing in lieu thereof "(f)",
22 (B) by striking out the section heading of
23 section 384,
24 (C) by striking out "SEC. 385." and insert-
25 ing in lieu thereof "(g)",
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1 (D) by strikmg out the section heading of
2 section 385, and
3 (E) by SU.lking out "section 383" in section
4 385 and insertmg in lieu thereof "section 486".
D (5) Section 383 (42 U.S.C. 277) is redesignated
6 as sectIon -4:86 and is amended in subsection (a) by
7 striking out "in the Public Health Service.'.
8 (6) Section 386 (42 D.S.C. 280) is redesignated
9 as section 487.
10 (i) Section 387 (42 D.S.C. 280a) is repealed.
11 (8) Section 388 (42 D.S.C. 280a-l) is amended
12 by striking out subsection (b) and the section heaning.
13 (b) Part J of title ill of the Public Health Service Act is
14 transferred to title IV of such Act (as amended by section 2
15 of this Act and subsection (a) of this section), inserted after
16 the part inserted by subsection (a), redesignated as part H,
17 and amended as follows:
18 (1) Section-S90(c) (42 c.S.C. 280b(c)) is amended
19 by striking out "and" after "1981," and by inserting
20 before the period a comma and the following:
21 "$10,000,000 for the fiscal year ending September 30,
22 1984, $11.000,000 for the fiscal year ending Septem-
23 ber 30. 1985, and $12,000,000 for the fiscal year
24 ending September 30, 1986",
HR 2350 18
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1 (2) Section 390(c) (42 L.S.C. 280b(c}) is amended
2 by striking out "sectIOns 393. 394, 395, 396, and
3 397" and inserting in lieu thereot "sections -1:92. -k93.
4 494, 495, and 496".
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(3) Section 392 (42 L.S.C. 280b-2) is amended
(A) by striking out "section 383(a) shall. ill addition to
7 its functions prescribed under section 383" in subsec-
8 tlon (a) and insernng in lieu thereof "section 486 shall,
9 in addition to its functions prescribed under such sec-
10 tion". and (B) by striking out "sectIon 383(d)" in sub-
11 section (d) and inserting in lieu thereof "section
12 486(d)" .
13 (4) Section 393(a) (42 r.s.c. 280b-4(a)) is
14 amended by striking out "section 390(b)(2)" and msen-
.I
15 ing in lieu thereof "section 489(b)(2)".
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(5) Section 394(a) (42 U.S.C. 280b-5(a)) is
amended by striking out "section 390{b)(2)" and insert-
ing in lieu thereof "section 489(b)(2)".
(6) Section 394(b) is amended by striking out
".5ection 390(b)(3)" and insertmg in lieu thereof "sec-
tion 489\b)(3)".
(7) Section 395(a) (42 r.s.c. 280b-7(a)) is
amended by striking out "section 390(b)(4)H and insert-
ing in lieu thereof "section 489(b)(4)".
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(8) Section 396(a) (42 D.S.C. 2S0b-8(a)) is
amended by striking out '~section 390(b)(5Y~ and msert-
mg in lieu thereof "section 489(b)(5)".
(9) Section 397(a) (42 U.S.C. 280b-9(a)) is
l1.mended by striking out "section 390~b)(6)" and insert-
ing in lieu thereof "section 489(b)(6)" .
(10) Sections 390 through 399 are redesignated
as sections 489 through 498, respectively.
STUDY OF PERTUSSIS VA.CCINES
SEC. 5. (a) The Director of the National Institutes of
11 Health, in consultation with the Directors of the ~ ational
12 Institute of Child Health and Human Development, the 5a-
13 clonal Institute of .Allergy and Infectious Diseases~ and the
14 ~ational Tn~titute of Neurological and Communicative Disor-
15 ders and Stroke and with organizations of parents concerned
16 with the safety and effectiveness of pertussis vaccines~ shall
17 conduct a study of the safety and effectiveness of pertussis
18 vaccines used in the United States and of the comparative
19 safety and effectiveness of pertussis vaccines not being used
20 in the "United States. The Director of the National Institutes
21 of Health shall where appropriate request the Food and Drug
22 Administration and the Center for Disease Control to con-
23 duct parts of the study.
24 (b)(l) The Director of the National Institutes of Health
25 shall complete the study prescribed by subsection (a) and
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_t
1 make a repon on it to the Congress and the Secretary of
Health and Human Sen-ices not later than April!. 1984, or
six months after the date of the enactment of rhis Act. wmch-
ever is later. Within si.."'tty days of the report to the Congress,
the Secretary of Health and Human Services shall submit a
report to Congress describing actions proposed to be taken by
the Secretary in response to the recommendations included in
8 the report.
9 (2) The report of the Director of the ~ adonal Institutes
10 of Health shall include-
(A.) data on the extent of the reporting and rec-
ordkeeping of adverse reactions to pertussis vaccines
and recommendations respecting the actions which
should be taken to improve such reporting and record-
keeping;
(B) recommendations respecting actions which
should be taken to promote better understanrling by
physicians and parents of the possible side effects of
pertussis vaccines;
(C) recommendations respecting procedures for
identifying children who are susceptible to adverse re-
actions to pertussis vaccines and the conditions under
which pertussis vaccines should be contraindicated; and
(])) a description of the actions being taken by the
National Institutes of Health and its national research
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1 institutes and other Federal agencies to promote devel-
.") opment of effective and saier pertussis vaccmes and
3 recommendations for actions to be taken by 3uch Fed-
4: eral agencies to promote such vaccines.
5 STD'"DY OF PERSO~"'EL FOR HRA.LTH NEEDS OF Till;
6 ELDERLY
7 SEC. 6. (a) The Director of the ~ atlOnal Institute on
8 Aging shall conduct a study on the adequacy and availability
9 of personnel to meet the current and projected health needs
10 of elderly Americans through the year 2020.
11 (b) The Director shall report the results of the study to
12 the Committee on Energy and Commerce of the House of
13 Representatives and the Committee on Labor and Human
14 Resources of the Senate by March 1, 1985. The report on
15 the study shall contain recommendations on-
'"
16 (1) the nnmber of primary care physicians and
17 other health personnel needed to provide adequate care
18 for the elderly,
19 (2) the training needs of physicians {including spe-
20 cialists} and other health personnel to pro.vide care re-
21 sponsive to the particular needs of the elderly,
22 (3) necessary changes in medicare and other third
23 party reimbursement necessary to support tra.ining of
24 primary care and other physicians to meet the needs of
25 the elderly, and
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1 (4) necessary program changes m third party re-
-) imbursement programs (including changes in medicare
3 programs) to support training of other health personnel
4 in the care of the elderly.
;) CO:.\fl\'IERCIALIZATION STLDY
6 SEC. I. (a) The Secretary of Health and Human Ser;-
7 ICes shall arrange, in accordance \vith subsection (c), for a
8 study to determine-
(1) the nature of recent agreements between (.A)
individual universities and other institutions which con-
duct biomedical research, and (B) private corporations
engaged in the commercial use of the findings of bio-
medical research;
(2) the effects, both intended and inadvertent, of
such agreements on the conduct of biomedical research
by individual researchers and on the operation of uni-
versities and other institutions which conduct biomedi-
cal research; and
(3) the appropriate role for public funds in sup-
portIng biomedical research which may lead to prod-
ucts to be sold for private profit.
The report of such study shall include recommendations to
individual researchers, universities. and other institutions
which conduct biomedical research, and private corporations
concerning the most appropriate practices to be followed in
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1 such agreements. The report shall also provi.de for recom-
') mendations to the Secretary and the Congress regarci.ing
3 changes in policies regarding grants. and regulatory and .stat-
-! utory law (including patent law) necessary to protect the
;) public interest in federall;, supported biomedical research.
6 tb) A final report of such study shall be completed no
7 later than September 30. 1985. Such report shall be submit-
8 ted to the Secretary.
9 (c)(l) The Secretary shall request the National Academy
10 of Sciences to conduct the study required by subsection (a)
11 under an arrangement under which the actual ex.penses in4
12 curred by such Academy in conducting such study ",ill be
13 pai~ by the Secretary If the ~ational Academy of SCIences
14 is willing to do so, the Secretary shall enter into such an
15 arrangement with such Academv for the conduct of such
16 study.
oJ
17 (2) If the ~ ational Academv of Sciences is Ull",-illing to
w ~
18 conduct such study under such an arrangement, then the See-
19 retary shall enter into a sllmlar arrangement v..;,th other ap-
20 propriate nonprofit private groups or associatIons under
21 which such groups or associations will conduct such study
22 and prepare and submit the reports thereon as provided in
23 subsection (b).
24 (3) The N adana! Academy of Sciences or other group or
25 association conducting the study required by subsection (a)
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1 shall conduct such stud\T in consultation 'With the Director at
.) ~l1f,
3 I~TERAGENCY CQlnrrTTEE O~ LEAR!'Ii""I~G DISABILITIES
-1 SEC. 8. (a) ~ot later than ninety days after the date ot
;) the enactment of this Act. the Director of the X ational Insti-
6 tutes of Health shall establish an Interagency Committee on
7 Learning Disabilities to review and assess Federal research
8 priorities, activities, and findings regarding learning disabil-
9 ities (including central neITOUS system dysfunction in clril-
10 dren).
(b) The Committee shall be composed of such repre-
sentatives as the Director may desumate, but shall include
~ ~
representanves from the :s ational Institute of ~ eurological
and Communicative Disorders and Stroke, the ~ ational Insti-
tute of Child Health and Human Development. the ~ ational
Institute of Allergy and Infectious Diseases, the National In-
stitute of Emrironmental Health Sciences, and the Division of
Research Resources of the ~ ational Institutes of Health.
(c) ~ ot later than eighteen months after the date of the
enactment of this Act, the Committee 5hall report to the
Congress on its activities under subsection (a) and shall in-
22 elude in the report-
23 (1) the number of persons affected by learning dis-
24 abilities and the demographic data which describes
25 such persons;
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1 (2) a description of the current research findings
2 on the cause, diagnosis. treatment. and prevention of
3 learning disabilities; and
--1 (3) recommendations for legislation and adminis-
5 trative actions-
6 L.\) to increase the effectiveness of research
7 on learning disabilities and to improye the dis-
S semination of the findings of such research, and
9 (B) respecting specific priorities for research
lOin the cause, diagnosis, treatment, and prevention
11 of learning disabilities.
12 (d) The Committee shall terminate on the ninetieth day
13 following the date of the :submission of the report under sub-
14 section (c).
15 STUDY OF ~A.TIONAL RESEA.RCH INSTITUTES
16 SEC. 9. (a)(1) The Secretary of Health and Human
17 Services, through the Director of the National Institutes of
18 Health, shall in accordance with subsection (b) arrange for
19 the conduct of a study of the effectiveness of the existing
20 combinations of disease research programs ~,;vithin the individ-
21 ual national research institutes and of the standards which
22 should be followed in establishing new or realigning existing
23 national research institutes.
24 (2) The Secretary shall submit to the Committee on
01
25 Energy and Commerce of the House of Representatives and
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1 the Committee on Labor n.nd Human Resources at the
2 Senate a report on the results or the study. The report shall
3 be subnntted not later than eighteen months after the date or
4: the enactment of this Act.
tb)(I) The Secretary of Health and Human Sen,ces
shall request the ~ational Academy of Sciences, through the
Institute of }Iedicine, to conduct the study required by sub-
section (a)(1) under an arrangement under which the actual
expenses incurred by the Academy in conducting such study
",,>ill be paid by the Secretary and the AcademJ? 'will prepare
the report required by subsection (a)(2). If the ~ ational Acad-
emy of Sciences is 'willing to do so, the Secretary shall enter
into such an arrangement with the Academy for the conduct
14 of the study.
15
(2) If the National Academy of Sciences is unwilling to
16 conduct such study under such an arrangement, the Secre-
17 tary shall enter into a similar arrangement ",-;th other appro-
18 priate nonprofit private entitles.
19 (c) ~ 0 national research institute, other than the ::i ation-
20 a1 Institute of Arthritis and :Yusculoskeletal Diseases, shall
21 be established in addition to the institutes in existence on the
22 date of the enactment of this Act before the expiration of six
23 months after the submission of the report referred to in sub~
24 section (a)(2).
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1 <d) The Se~retar"': of Health and Human Se~;ices shan
0) conduct an administrutlye reVIew of the disease research pro-
3 grams 'within the ~ ational Institute of Diabetes and Diges-
4, tive and Kidney Diseases to d~termme if any of such pro-
D grams could be more effectively J,nd effiCIently managed by
6 other national research mstltutes. The Secretary shail COffi-
7 plete such review within the sixty-day period beginning on
8 the date of enactment of this Act.
9
DIET THERAPY FOR KIDNEY F.ULl..~E
.
10 SEC. 10. The Director of the X ational Institute of Dia-
11 betes and Digestive and Kidney Diseases shall conduct re-
12 search into the role of diet therapy in the treatment of end
13 stage renal disease. The Director shall report to Congress the
14 results of such research not later than January 1, 1987.
15 PAY ~j) WORK SCHl<~OL:"'LES FOR Pl:"""BLIC HEALTH
16 SERVICE ~1JRSES _-\.T Ym
17 SEC. 11. (a) ~ otwithstanding any other pro,'ision of law
18 but subject to subsections (b) and (c). if the Secretary of
19 Health and Human SeIV;ces determines it to be necessarv in
~ ~
20 order to obtain or retain the services of nurses at the health
21 care facilities of the ~ational Institutes of Health, the Secre-
22 tary-
23
(1) may increase the rates of pay for nurses in the
health care facilities of the ~ ational Institutes of
24
.,~
....0
Health, and
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(2) may extend the period ior which increased pay
is paid to such nurses to include part or all of a tour of
duty any part of which is ",;thin the period commenc-
ing at midnight Friday and ending at midnight
Saturday.
(b) An increase under subsection (a)(1) in rates oi pay-
(1) may be made at any specific heahh-care facili-
ty of the X anoual Institutes of Health in order to pro-
vide nurses. or any category of nurses, at such facility
additional pay in an amount competitive \vith, but not
exceening, the amount of the same type of pay that is
paid to the same category of nurses at non-Federal
health-care facilities in the same geographic area as
such health-care facility (based upon it reasonably rep-
resentative sampling of such non-Federal facilitIes); and
(2) may be made on a nationwide, local, or other
geographic basis if the Secretary finds that such a.n in-
crease is justified on the basis of a re1;;ew of the need
for such increase (based upon a reasonably representa-
tive sampling of non-Federal health-care facilities in
the geographic area involved).
(c)(1) An extension under subsection (a)(2) of the period
for which increased pay may be paid may be made on a na-
tion",;de, local. or other geographic basis. A..\.ny such exten-
sion shall be based on a determination by the Secretary that
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1 such extension is justified on the basis of a rev-iew of the need
2 for such extension in such geographIc area.
3 (2) The rates ot increased pay payable pursuant to an
4 extension under sub<:- on (:1)(1) shall be established as :l
~
5 percentage of the applicable hourly rates of basIc pay. Such
6 rates of pay may not exceed the lesser of the percentage ot
7 such hourly rates of basic pay that the Secretary determines
8 is necessary to be paid WIthin the geographic area involved III
9 order to obtain or retain the services of nurses.
10 CALGeLATION OF COSTS OF BIO~1EDICAL _-L~D
11 BEHAVIORAL RESEARCH
12 SEC. 12. In ID:1.king grants for biomedical and behavior~
13 al research the Secretary of Health and Human Senlces
14 shall set the amounts to be paid under such grants for direct
15 and indirect costs in accordance with the system for deter-
16 mining such costs as prescribed by the Director of the Office
17 of 11anagement and Budget in Office of Management and
18 Budget Circular A-21.
19 ~.A.TIONA.L COIVDUSSION ON ORPH.A....'f DISEASES
20 SEC. 13. (a) There is established the National Cornmis-
21 sion on Orphan Diseases.
22 (b) The Commission shall assess the activities of the ~ a-
23 tional Institutes of Health, the Alcohol, Drng Abuse, and
24 Mental Health Arlministration, and other public agenCIes, and
25 of private entities in connection with-
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(1) basic research conducted on rare diseases;
(2) the use in research on rare diseases of knowl-
edge developed in other research;
(3) applied and clinical re~earch on the pre'"en-
tion. diagnosis. and treatment of rare diseases; J.na
(4) the dissemination of knowledge developed ill
research on rare diseases and other diseases to the
public, health care professionals, researchers, and drug
and medical deVIce manuiacturers which can be used in
the prevention, diagnosis, and treatment of rare
diseases.
(c) In assessing the activities of the :National Insti~utes
of Health and the Alcohol. Drug Ahuse, and )lental Health
Administration in connection vv'ith research on rare diseases,
15 the Commission shall review-
16 (1) the appropriateness of the priorities currently
1'j placed on research on rare diseases;
18 (2) the relative effectiveness of grants and con-
19 tracts when used to fund research on rare diseases;
20 (3) the appropriateness of specific requirements
21 applicable to applications for funds for research on rare
22 diseases v:J.king into consideration the reasonable capac-
23 ity of applicants to meet such requirements;
24 (4) the adequacy of the science base for such re-
25 search, including the adequacy of the research facilities
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