Orphan Drug Act
PL 97-414 (H.R.5238), enacted 01/04/1983

PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2049 
Public Law 97-414 
97th Congress 
An Act 
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of 
drugs for rare diseases and conditions, and for other purposes. 
Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, 
SHORT TITLE; F I N D I N G S 
SECTION 1. (a) This Act may be cited as the "Orphan Drug Act", 
(b) The Congress finds that— 
(1) there are many diseases and conditions, such as Hunting-
ton's disease, myoclonus, ALS (Lou Gehrig's disease), Tourette 
syndrome, and muscular dystrophy which affect such small 
numbers of individuals residing in the United States that the 
diseases and conditions are considered rare in the United 
States; 
(2) adequate drugs for many of such diseases and conditions 
have not been developed; 
(3) drugs for these diseases and conditions are commonly 
referred to as "orphan drugs"; 
(4) because so few individuals are affected by any one rare 
disease or condition, a pharmaceutical company which develops 
an orphan drug may reasonably expect the drug to generate 
relatively small sales in comparison to the cost of developing 
the drug and consequently to incur a financial loss; 
(5) there is reason to believe that some promising orphan 
drugs will not be developed unless changes are made in the 
applicable Federal laws to reduce the costs of developing such 
drugs and to provide financial incentives to develop such drugs; 
and 
(6) it is in the public interest to provide such changes and 
incentives for the development of orphan drugs. 
Jan. 4, 1983 
[H.R. 5238] 
Orphan Drug 
Act. 
21 u s e 301 note. 
21 u s e 360aa 
note. 
AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 
SEC. 2. (a) Chapter V of the Federal Food, Drug, and Cosmetic Act 
is amended by adding at the end the following: 
"SUBCHAPTER B—DRUGS FOR RARE DISEASES OR CONDITIONS 
RECOMMENDATIONS FOR INVESTIGATIONS OF DRUGS FOR RARE 
DISEASES OR CONDITIONS 
"SEC. 525. (a) The sponsor of a drug for a disease or condition 
21 use 360aa. 
which is rare in the States may request the Secretary to provide 
written recommendations for the non-clinical and clinical investiga-
tions which must be conducted with the drug before— 
'' 
' ' ^ 
"(1) it may be approved for such disease or condition under 
section 505, or 
21 use 355. 
96 STAT. 2050 
PUBLIC LAW 97-414—JAN. 4, 1983 
"(2) if the drug is a biological product, before it may be 
licensed for such disease or condition under section 351 of the 
42 use 262. 
Public Health Service Act. 
If the Secretary has reason to believe that a drug for which a 
request is made under this section is a drug for a disease or 
condition which is rare in the States, the Secretary shall provide the 
.\ 
. ,, 
person making the request written recommendations for the non-
clinical and clinical investigations which the Secretary believes, on 
the basis of information available to the Secretary at the time of the 
request under this section, would be necessary for approval of such 
21 use 355. 
drug for such disease or condition under section 505 or licensing 
under section 351 of the Public Health Service Act for such disease 
or condition. 
"(b) The Secretary shall by regulation promulgate procedures for 
the implementation of subsection (a). 
21 u s e 360bb. 
"Rare disease or 
condition." 
Notice. 
DESIGNATION OF DRUGS FOR RARE DISEASES OR CONDITIONS 
"SEC. 526. (a)(1) The manufacturer or the sponsor of a drug may 
request the Secretary to designate the drug as a drug for a rare 
disease or condition. If the Secretary finds that a drug for which a 
request is submitted under this subsection is being or will be investi-
gated for a rare disease or condition and— 
"(A) if an application for such drug is approved under section 
505, or 
"(B) if the drug is a biological product, a license is issued 
under section 351 of the Public Health Service Act, 
the approval or license would be for use for such disease or condi-
tion, the Secretary shall designate the drug as a drug for such 
disease or condition. A request for a designation of a drug under this 
subsection shall contain the consent of the applicant to notice being 
given by the Secretary under subsection (b) respecting the designa-
tion of the drug. 
"(2) For purposes of paragraph (1), the term 'rare disease or 
condition' means any disease or condition which occurs so infre-
quently in the United States that there is no reasonable expectation 
that the cost of developing and making available in the United 
States a drug for such disease or condition will be recovered from 
sales in the United States of such drug. Determinations under the 
preceding sentence with respect to any drug shall be made on the 
basis of the facts and circumstances as of the date the request for 
designation of the drug under this subsection is made. 
"(b) Notice respecting the designation of a drug under subsection 
(a) shall be made available to the public. 
"(c) The Secretary shall by regulation promulgate procedures for 
the implementation of subsection (a). 
,. •, 
. 
_ 
PROTECTION FOR UNPATENTED DRUGS FOR RARE DISEASES OR 
CONDITIONS 
21 use 3
6
0
C
C
. 
"SEC. 527. (a) Except as provided in subsection (b), if the Secre-
tary— 
"(1) approves an application filed pursuant to section 505(b), 
or 
"(2) issues a license under section 351 of the Public Health 
Service Act 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2051 
for a drug designated under section 526 for a rare disease or 
Ante, p. 2050. 
condition and for which a United States Letter of Patent may not be 
issued, the Secretary may not approve another application under 
section 505(b) or issue another license under section 351 of the 
21 USC 355. 
Public Health Service Act for such drug for such disease or condi- 42 USC 262. 
tion for a person who is not the holder of such approved application 
or of such license until the expiration of seven years from the date of 
the approval of the approved application or the issuance of the 
license. Section 505(cX2) does not apply to the refusal to approve an 
application under the preceding sentence. 
"(b) If an application filed pursuant to section 505(b) is approved 
for a drug designated under section 526 for a rare disease or 
condition or a license is issued under section 351 of the Public 
Health Service Act for such a drug and if a United States Letter of 
Patent may not be issued for the drug, the Secretary may, during 
the seven-year period beginning on the date of the application 
approval or of the issuance of the license, approve another applica-
tion under section 505(b), or, if the drug is a biological product, issue 
a license under section 351 of the Public Health Service Act, for 
such drug for such disease or condition for a person who is not the 
holder of such approved application or of such license if— 
"(1) The Secretary finds, after providing the holder notice and 
opportunity for the submission of views, that in such period the 
;. 
holder of the approved application or of the license cannot 
assure the availability of sufficient quantities of the drug to 
meet the needs of persons with the disease or condition for 
which the drug was designated; or 
"(2) such holder provides the Secretary in writing the consent 
1 
of such holder for the approval of other applications or the 
issuance of other licenses before the expiration of such seven-
year period. 
"OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS FOR RARE DISEASES 
O
R CONDITIONS 
^ "SEC. 528. If a drug is designated under section 526 as a drug for a 
21 USC 360dd. 
rare disease or condition and if notice of a claimed exemption under 
section 505(i) or regulations issued thereunder is filed for such drug, 
the Secretary shall encourage the sponsor of such drug to design 
protocols for clinical investigations of the drug which may be con-
ducted under the exemption to permit the addition to the investiga-
tions of persons with the disease or condition who need the drug to 
treat the disease or condition and who cannot be satisfactorily 
treated by available alternative drugs.". 
Ot)) Chapter V of the Federal Food, Drug, and Cosmetic Act is 
amended by inserting before section 501 the following: 
"SUBCHAPTER A—DRUGS AND DEVICES.". 
ORPHAN PRODUCTS BOARD 
SEC. 3. Title II of the Public Health Service Act is amended by 
adding at the end the following: 
96 STAT. 2052 
PUBLIC LAW 97-414—JAN. 4, 1983 
"ORPHAN PRODUCTS BOARD 
Establishment. 
"SEC. 227. (a) There is established in the Department of Health 
42 use 236. 
and Human Services a board for the development of drugs (includ-
ing biologies) and devices (including diagnostic products) for rare 
diseases or conditions to be known as the Orphan Products Board. 
The Board shall be comprised of the Assistant Secretary for Health 
of the Department of Health and Human Services and representa-
tives, selected by the Secretary, of the Food and Drug Administra-
tion, the National Institutes of Health, the Centers for Disease 
Control, and any other Federal department or agency which the 
Secretary determines has activities relating to drugs and devices for 
rare diseases or conditions. The Assistant Secretary for Health shall 
chair the Board. 
"(b) The function of the Board shall be to promote the develop-
ment of drugs and devices for rare diseases or conditions and the 
coordination among Federal, other public, and private agencies in 
carrying out their respective functions relating to the development 
of such articles for such diseases or conditions. 
"(c) In the case of drugs for rare diseases or conditions the Board 
shall— 
"(Devaluate— 
- • 
"(A) the effect of subchapter B of the Federal Food, Drug, 
Ante, p. 2049. 
ii 
and Cosmetic Act on the development of such drugs, and 
"(B) the implementation of such subchapter; 
« 
"(2) evaluate the activities of the National Institutes of 
Tii Health and the Alcohol, Drug Abuse, and Mental Health 
Administration for the development of drugs for such diseases 
*ii'. or conditions, 
"(3) assure appropriate coordination among the Food and 
Drug Administration, the National Institutes of Health, the 
Alcohol, Drug Abuse, and Mental Health Administration, and 
the Centers for Disease Control in the carrying out of their 
j respective functions relating to the development of ^rugs for 
such diseases or conditions to assure that the activities of each 
agency are complementary, 
I, V 
;\ 
"(4) assure appropriate coordination among all interested 
Federal agencies, manufacturers, and organizations represent-
ing patients, in their activities relating to such drugs, 
"(5) with the consent of the sponsor of a drug for a rare 
disease or condition exempt under section 5(y5(i) of the Federal 
21 use 355. 
Food, Drug, and Cosmetic Act or regulations issued under such 
section, inform physicians and the public respecting the avail-
ability of such drug for such disease or condition and inform 
physicians and the public respecting the availability of drugs 
,; 
approved under section 505(c) of such Act or licensed under 
42 use 262. 
' •' 
section 351 of this Act for rare diseases or conditions, 
"(6) seek business entities and others to undertake the spon-
sorship of drugs for rare diseases or conditions, seek investiga-
tors to facilitate the development of such drugs, and seek 
business entities to participate in the distribution of such drugs, 
and 
"(7) recognize the efforts of public and private entities and 
'" individuals in seeking the development of drugs for rare dis-
eases or conditions and in developing such drugs. 
"(d) The Board shall consult with interested persons respecting 
the activities of the Board under this section and as part of such 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2053 
consultation shall provide the opportunity for the submission of oral 
views. 
"(e) The Board shall submit to the C!ommittee on Labor and 
Report to 
Human Resources of the Senate and the Committee on Energy and 
congressional 
Commerce of the House of Representatives an annual report— 
commi 
"(1) identifying the drugs which have been designated under 
section 526 of the Federal Food, Drug, and Cosmetic Act for a 
rare disease or condition, 
"(2) describing the activities of the Board, and 
"(3) containing the results of the evaluations carried out by 
the Board. 
The Director of the National Institutes of Health and the Adminis-
trator of the Alcohol, Drug Abuse, and Mental Health Administra-
tion shall submit to the Board for inclusion in the annual report a 
., 
. . , 
report on the rare disease and condition research activities of the 
' 
' 
Institutes of the National Institutes of Health and the Alcohol, Drug 
Abuse, and Mental Health Administration; the Secretary of the 
Treasury shall submit to the Board for inclusion in the annual 
report a report on the use of the credit against tax provided by 
section 44H of the Internal Revenue Code of 1954; and the Secretary 
infra. 
of Health and Human Services shall submit to the Board for inclu-
sion in the annual report a report on the program of assistance 
under section 5 of the Orphan Drug Act for the development of Post, p. 2056 
drugs for rare diseases and conditions. Each annual report shall be 
submitted by June 1 of each year for the preceding calendar year.". 
TAX CREDIT FOR TESTING EXPENSES FOR DRUGS FOR RARE DISEASES OR 
CONDITIONS 
SEC. 4. (a) Subpart A of part IV of subchapter A of chapter 1 of the 
Internal Revenue Code of 1954 (relating to credits allowable) is 
amended by inserting after section 44G the following new section: 
"SEC. 44H. CLINICAL TESTING EXPENSES FOR CERTAIN DRUGS FOR RARE 
26 USC 44H. 
DISEASES OR CONDITIONS. 
"(a) GENERAL RULE.—There shall be allowed as a credit against 
the tax imposed by this chapter for the taxable year an amount 
equal to 50 percent of the qualified clinical testing expenses for the 
taxable year. 
"Ot)) QUALIFIED CUNICAL TESTING EXPENSES.—For purposes of this 
section— 
"(1) QUALIFIED CLINICAL TESTING EXPENSES.— 
"(A) IN GENERAL.—Except as otherwise provided in this 
paragraph, the term 'qualified clinical testing expenses' 
means the amounts which are paid or incurred by the 
taxpayer during the taxable year which would be described 
r 
in subsection (b) of section 44F if such subsection were 
applied with the modifications set forth in subparagraph 
(B). 
"(B) MODIFICATIONS.—For purposes of subparagraph (A), 
J 
subsection (b) of section 44F shall be applied— 
"(i) by substituting 'clinical testing' for 'qualified 
research' each place it appears in paragraphs (2) and (3) 
of such subsection, and 
"(ii) by substituting '100 percent' for '65 percent' in 
'"' 
paragraph (3)(A) of such subsection. 
96 STAT. 2054 
PUBLIC LAW 97-414—JAN. 4, 1983 
SI' * 
"(C) EXCLUSION FOR AMOUNTS FUNDED BY GRANTS, ETC.— 
The term 'qualified clinical testing expenses' shall not in-
'' 
elude any amount to the extent such amount is funded by 
any grant, contract, or otherwise by another person (or any 
governmental entity). 
"(D) SPECIAL RULE.—For purposes of this paragraph, sec-
tion 44F shall be deemed to remain in effect for periods 
after December 31,1985. 
"(2) CLINICAL TESTING.— 
••f(i 
"(A) IN GENERAL.—The term 'clinical testing' means any 
human clinical testing— 
"(i) which is carried out under an exemption for a 
drug being tested for a rare disease or condition under 
section 505(i) of the Federal Food, Drug, and Cosmetic 
21 use 355. 
Act (or regulations issued under such section), 
"(ii) which occurs— 
"(I) after the date of such drug is designated 
under section 526 of such Act, and 
"(II) before the date on which an application 
with respect to such drug is approved under section 
505(b) of such Act, and 
"(iii) which is conducted by or on behalf of the tax-
payer to whom the designation under such section 526 
applies. 
"(B) TESTING MUST BE RELATED TO USE FOR RARE DISEASE OR 
CONDITION.—Human clinical testing shall be taken into 
account under subparagraph (A) only to the extent such 
* 
testing is related to the use of a drug for the rare disease or 
condition for which it was designated under section 526 of 
Ante, p. 2050. 
the Federal Food, Drug, and Cosmetic Act. 
"(c) COORDINATION WITH CREDIT FOR INCREASING RESEARCH EX-
PENDITURES.— 
"(1) IN GENERAL.—Except as provided in paragraph (2), any 
= 
••••'• 
qualified clinical testing expenses for a taxable year to which an 
election under this section applies shall not be taken into 
account for purposes of determining the credit allowable under 
section 44F for such taxable year. 
"(2) EXPENSES INCLUDED IN DETERMINING BASE PERIOD RE-
SEARCH EXPENSES.—Any qualified clinical testing expenses for 
any taxable year which are qualified research expenses (within 
i the meaning of section 44F(b)) shall be taken into account in 
determining base period research expenses for purposes of ap-
plying section 44F to subsequent taxable years. 
"(d) DEFINITION AND SPECIAL RULES.-:-
"(1) RARE DISEASE OR CONDITION.—For purposes of this section, 
the term 'rare disease or condition' means any disease or condi-
tion which occurs so infrequently in the United States that 
there is no reasonable expectation that the cost of developing 
and making available in the United States a drug for such 
disease or condition will be recovered from sales in the United 
States of such drug. Determinations under the preceding sen-
tence with respect to any drug shall be made on the basis of the 
; 
facts and circumstances as of the date such drug is designated 
under section 526 of the Federal Food, Drug, and Cosmetic Act. 
"(2) LIMITATION BASED ON AMOUNT OF TAX.—The credit al-
V lowed by this section for any taxable year shall not exceed the 
amount of the tax imposed by this chapter for the taxable year 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2055 
reduced by the sum of the credits allowable under a section of 
this subpart having a lower number or letter designation than 
this section, other than the credits allowable by sections 31, 39, 
and 43. For purposes of the preceding sentence, the term 'tax 
imposed by this chapter' shall not include any tax treated as not 
imposed by this chapter under the last sentence of section 53(a). 
(3) SPECIAL UMITATIONS ON FOREIGN TESTING.— 
"(A) IN GENERAL.—No credit shall be allowed under this 
section with respect to any clinical testing conducted out-
side the United States unless— 
1 
"(i) such testing is conducted outside the United 
States because there is an insufficient testing popula-
tion in the United States, and 
"(ii) such testing is conducted by a United States 
^ 
person or by any other person who is not related to the 
''' 
taxpayer to whom the designation under section 526 of 
the Federal Food, Drug, and Cosmetic Act applies. 
f
o e 
"(B) SPECIAL LIMITATION FOR CORPORATIONS TO WHICH SEC-
TION 934(b) O
R 936 APPUES.—No Credit shall be allowed 
under this section with respect to any clinical testing con- 
' :. 
ducted by a corporation to which section 934(b) applies or to 
which an election under section 936 applies. 
"(4) CERTAIN RULES MADE APPUCABLE.—Rules similar to 
the 
rules of paragraphs (1) and (2) of section 44F(f) shall apply for 
purposes of this section. 
"(5) ELECTION.—This section shall apply to any taxpayer for 
any taxable year only if such taxpayer elects (at such time and 
in such manner as the Secretary may bv regulations prescribe) 
to have this section apply for such taxable year. 
9 2 ; 
"(e) TERMINATION.—This section shall not apply to any amount 
paid or incurred after December 31,1987." 
(bXl) Section 280C of such Code (relating to denial of deduction for 
26 use 280C. 
portion of wages for which credit is claimed under section 40 or 44B) 
is amended by adding at the end thereof the following new 
subsection: 
"(c) CREDIT FOR QUAUFIED CUNICAL TESTING EXPENSES FOR CER-
TAIN DRUGS.— 
"(1) IN GENERAL.—No deduction shall be allowed for that 
portion of the qualified clinical testing expenses (as defined in 
section 44H(b)) otherwise allowable as a deduction for the tax-
able year which is equal to the amount of the credit allowable 
for the taxable year under section 44H (determined without 
regard to subsection (d)(2) thereof). 
- . <
•
-
"(2) SIMILAR RULE WHERE TAXPAYER CAPITAUZES RATHER THAN 
DEDUCTS EXPENSES.—If— 
"(A) the amount of the credit allowable for the taxable 
year under section 44H (determined without regard to sub-
section (d)(2) thereof), exceeds 
"(B) the amount allowable as a deduction for the taxable 
year for qualified clinical testing expenses (determined 
without regard to paragraph (1)), 
the amount chargeable to capital account for the taxable year 
for such expenses shall be reduced by the amount of such 
excess. 
"(3) CONTROLLED GROUPS.—In the case of a corporation which 
is a member of a controlled group of corporations (within the 
meaning of section 44F(f)(5)) or a trade or business which is 
96 STAT. 2056 
PUBLIC LAW 97-414—JAN. 4, 1983 
26 u s e 6096. 
26 u s e 44H 
note. 
treated as being under common control with other trades or 
business (within the meaning of section 44F(f)(l)(B)), this subsec-
tion shall be applied under rules prescribed by the Secretary 
similar to the rules applicable under subparagraphs (A) and (B) 
of section 44F(f)(l)." 
(2)(A) The section heading of section 280C of such Code is amended 
to read as follows: 
"SEC. 280C. CERTAIN EXPENSES FOR WHICH CREDITS ARE ALLOWABLE." 
(B) The table of sections for part IX of subchapter B of chapter 1 of 
such Code is amended by striking out the item relating to section 
280C and inserting in lieu thereof the following: 
"Sec. 280C. Certain expenses for which credits are allowable." 
(c)(1) The table of sections for subpart A of part IV of subchapter A 
of chapter 1 of such Code is amended by inserting after the item 
relating to section 44G the following new item: 
"Sec. 44H. Clinical testing expenses for certain drugs for rare diseases or 
conditions." 
(2) Subsection (b) of section 6096 of such Code is amended by 
striking out "and 44G" and inserting in lieu thereof "44G, and 44H . 
(d) The amendments made by this section shall apply to amounts 
paid or incurred after December 31, 1982, in taxable years ending 
after such date. 
„. 
„. .__ ,,, ,„ 
. 
21 u s e 360ee. 
'}&..} 
"Qualified 
clinical 
testing." 
Ante, p. 2050. 
21 u s e 355. 
"Rare disease or 
condition." 
GRANTS AND CONTRACTS FOR DEVELOPMENT OF DRUGS FOR RARE 
DISEASES AND CONDITIONS 
SEC. 5. (a) The Secretary may make grants to and enter into 
contracts with public and private entities and individuals to assist in 
defraying the costs of qualified clinical testing expenses incurred in 
connection with the development of drugs for rare diseases and 
conditions. 
(b) For purposes of subsection (a): 
(1) The term "qualified clinical testing" means any human 
clinical testing— 
(A) which is carried out under an exemption for a drug 
irub 
for a rare disease or condition under section 505(i) of the 
Federal Food, Drug, and Cosmetic Act (or regulations issued 
under such section), 
(B) which occurs— 
(i) after the date such drug is designated under sec-
tion 526 of such Act, and 
' ? , ) • ; ' 
(ii) before the date on which an application with 
respect to such drug is submitted under section 5050)) 
of such Act. 
(2) The term "rare disease or condition" means any disease or 
condition which occurs so infrequently in the United States that 
there is no reasonable expectation that the cost of developing 
and making available in the United States a drug for such 
disease or condition will be recovered from sales in the United 
States of such drug. Determinations under the preceding sen-
tence with respect to any drug shall be made on the basis of the 
facts and circumstances as of the date the request for designa-
tion of the drug under this subsection is made. 
zi ivjiiW'v ii5';*->niPi?<j 
iOlil} 
k> TO i'-f-
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2057 
(c) For grants and contracts under subsection (a) there are author-
ized to be appropriated $4,000,000 for fiscal year 1983 and for each of 
the next two fiscal years. 
Appropriation 
authorization. 
HOME HEALTH SERVICES 
. SEC. 6. (a) Part D of title III of the Public Health Service Act is 
amended by inserting after subpart II the following new subpart: 
:rr 
"SUBPART III—HOME HEALTH SERVICES 
O' i 
HOME HEALTH SERVICES 
i; 
"SEC. 339. (aXD For the purpose of encouraging the establishment 
and initial operation of home health programs to provide home 
health services in areas in which such services are inadequate or not 
readily accessible, the Secretary may, in accordance with the provi-
sions of this section, make grants to public and nonprofit private 
entities and loans to proprietary entities to meet the initial costs of 
establishing and operating such home health programs. Such grants 
and loans may include funds to provide training for paraprofession-
als (including homemaker home health aides) to provide home 
health services. 
"(2) In making grants and loans under this subsection, the Secre-
tary shall— 
"(A) consider the relative needs of the several States for home 
health services; 
"(B) give preference to areas in which a high percentage of 
the population proposed to be served is composed of individuals 
who are elderly, medically indigent, or disabled; and 
"(C) give special consideration to areas with inadequate 
means of transportation to obtain necessary health services. 
"(3)(A) No loan may be made to a proprietary entity under this 
section unless the application of such entity for such loan contains 
assurances satisfactory to the Secretary that— 
"(i) at the time the application is made the entity is fiscally 
sound; 
"(ii) the entity is unable to secure a loan for the project for 
which the application is submitted from non-Federal lenders at 
f 
the rate of interest prevailing in the area in which the entity is 
located; and 
, 
"(iii) during the period of the loan, such entity will remain 
fiscally sound. 
"(B) Loans under this section shall be made at an interest rate 
comparable to the rate of interest prevailing on the date the loan is 
made with respect to the marketable obligations of the United 
States of comparable maturities, adjusted to provide for administra-
tive costs. 
"(4) Applications for grants and loans under this subsection shall 
be in such form and contain such information as the Secretary shall 
prescribe. 
"(5) There are authorized to be appropriated for grants and loans 
under this subsection $5,000,000 for each of the fiscal years ending 
on September 30,1983, and September 30,1984. 
"(b)(1) The Secretary may make grants to and enter into contracts 
with public and private entities to assist them in developing appro-
Grants. 
42 use 255. 
Appropriation 
authorization. 
96 STAT. 2058 
PUBLIC LAW 97-414—JAN. 4, 1983 
Appropriation 
authorization. 
Report to 
congressional 
committees. 
42 u s e 1395x. 
Report and 
recommenda-
tions to 
Congress. 
42 u s e 255 note. 
42 u s e 255 note. 
priate training programs for paraprofessionals (including home-
maker home health aides) to provide home health services. 
"(2) Any program established with a grant or contract under this 
subsection to train homemaker home health aides shall— 
"(A) extend for at least forty hours, and consist of classroom 
instruction and at least twenty hours (in the aggregate) of 
^ • supervised clinical instruction directed toward preparing stu-
- dents to deliver home health services; 
"(B) be carried out under appropriate professional supervision 
and be designed to train students to maintain or enhance the 
personal care of an individual in his home in a manner which 
promotes the functional independence of the individual; and 
"(C) include training in— 
"(i) personal care services designed to assist an individual 
in the activities of daily living such as bathing, exercising, 
personal grooming, and getting in and out of bed; and 
"(ii) household care services such as maintaining a safe 
living environment, light housekeeping, and assisting in 
providing good nutrition (by the purchasing and prepara-
tion of food). 
"(3) In making grants and entering into contracts under this 
subsection, special consideration shall be given to entities which 
establish or will establish programs to provide training for persons 
fifty years of age and older who wish to become paraprofessionals 
(including homemaker home health aides) to provide home health 
services. 
"(4) Applications for grants and contracts under this subsection 
shall be in such form and contain such information as the Secretary 
shall prescribe. 
"(5) There are authorized to be appropriated for grants and con-
tracts under this subsection $2,000,000 for each of the fiscal years 
ending September 30,1983, and September 30,1984. 
"(c) The Secretary shall report to the Committee on Labor and 
Human Resources of the Senate and the Committee on Energy and 
Commerce of the House of Representatives on or before January 1, 
1984, with respect to— 
"(1) the impact of grants made and contracts entered into 
under subsections (a) and (b) (as such subsections were in effect 
prior to October 1,1981); 
"(2) the need to continue grants and loans under subsections 
(a) and (b) (as such subsections are in effect on the day after the 
j^. date of enactment of the Orphan Drug Act); and 
"(3) the extent to which standards have been applied to the 
training of personnel who provide home health services. 
"(d) For purposes of this section, the term 'home health services' 
has the meaning prescribed for the term by section 1861(m) of the 
Social Security Act.". 
(b) The Secretary shall report the results of studies currently 
evaluating home and community based health services, and any 
recommendations for legislative action which might improve the 
provision of such services, to the Congress prior to January 1, 1985. 
(c) The Secretary of Health and Human Services shall compile and 
analyze the results of significant studies carried out by any public or 
private entity, group, or individual, relating to current and alterna-
tive reimbursement methodologies for home health services. The 
Secretary shall make recommendations with respect to such reim-
bursement methodologies as they might be applied in health care 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2059 
programs funded in whole or in part by Federal funds, and report 
such recommendations to the Congress within 180 days after the 
date of the enactment of this Act. 
(d) The Secretary of Health and Human Services, acting through 
the Inspector General of the Department of Health and Human 
Services, shall undertake a thorough investigation of— 
(1) the methods available to stem fraud and abuse in the 
provision of home health services under medicare and medicaid; 
and 
(2) the extent to which such methods are applied in stemming 
such fraud and abuse. 
The Secretary shall report the results of the investigation to the 
Congress within 18 months after the date of the enactment of this 
Act. 
(eXD The Secretary of Health and Human Services shall develop 
and carry out demonstration projects commencing no later than 
January 1,1984, to test— 
(A) methods for identifying patients at risk of insti-
tutionalization who could be treated more cost-effectively with 
home health services and other non-institutional health serv-
ices; and 
(B) alternative reimbursement methodologies for home health 
agencies in order to determine the most cost-effective and effi-
cient way of providing home health services. 
(2) Methods for identifying patients at risk of institutionalization 
to be tested by the Secretary under paragraph (1)(A) may include, 
but not be limited to, the identification of hospitalized medicare 
patients who are candidates for early discharge due to availability of 
home health services and individuals in the community who could 
avoid institutionalization with the availability of home health 
services. 
(3) Reimbursement methodologies to be tested by the Secretary 
under paragraph (1)(B) may include but not be limited to fee sched-
ules, prospective reimbursement, and capitation payments. 
(4) The Secretary shall report to Congress his findings with regard 
to the demonstrations carried out under paragraph (1) no later than 
January 1,1985. 
(f) For purposes of this section, the term "home health services" 
has the meaning prescribed for the term by section 1861(m) of the 
Social Security Act. 
Investigation. 
42 u s e 255 note. 
Report to 
Congress. 
42 u s e 255 note. 
Report to 
Congress. 
"Home health 
services." 
42 u s e 255 note. 
42 u s e 1395x. 
ANALYSIS OF THYROID CANCER; ACTIONS BY SECRETARY 
SEC. 7. (a) In carrying out section 301 of the Public Health Service 
Act, the Secretary of Health and Human Services shall— 
(1) conduct scientific research and prepare analyses necessary 
to develop valid and credible assessments of the risks of thyroid 
cancer that are associated with thyroid doses of Iodine 131; 
(2) conduct scientific research and prepare analyses necessary 
to develop valid and credible methods to estimate the thyroid 
doses of Iodine 131 that are received by individuals from nuclear 
bomb fallout; 
(3) conduct scientific research and prepare analyses necessary 
to develop valid and credible assessments of the exposure to 
Iodine 131 that the American people received from the Nevada 
atmospheric nuclear bomb tests; and 
42 u s e 241 note. 
42 u s e 241. 
96 STAT. 2060 
PUBLIC LAW 97-414—JAN. 4, 1983 
Report to 
Congress. 
Radioepidemi-
ological tables, 
publication. 
.t,-»J* 
Update of 
tables. 
(4) prepare and transmit to the Congress within one year after 
the date of enactment of this Act a report with respect to the 
activities conducted in carrying out paragraphs (1), (2), and (3). 
(bXl) Within one year after the date of enactment of this Act, the 
Secretary of Health and Human Services shall devise and publish 
radioepidemiological tables that estimate the likelihood that persons 
who have or have had any of the radiation related cancers and who 
have received specific doses prior to the onset of such disease 
developed cancer as a result of these doses. These tables shall show a 
probability of causation of developing each radiation related cancer 
associated with receipt of doses ranging from 1 millirad to 1,000 rads 
in terms of sex, age at time of exposure, time from exposure to the 
onset of the cancer in question, and such other categories as the 
Secretary, after consulting with appropriate scientific experts, deter-
mines to be relevant. Each probability of causation shall be calcu-
lated and displayed as a single percentage figure. 
(2) At the time the Secretary of Health and Human Services 
publishes the tables pursuant to paragraph (1), such Secretary shall 
also publish— 
.. , 
(A) for the tables of each radiation related cancer, an evalua-
tion which will assess the credibility, validity, and degree of 
certainty associated with such tables; and 
T 
(B) a compilation of the formulas that yielded the probabil-
ities of causation listed in such tables. Such formulas shall be 
, , published in such a manner and together with information 
* necessary to determine the probability of causation of any 
individual who has or has had a radiation related cancer and 
has received any given dose. 
(3) The tables specified in paragraph (1) and the formulas specified 
in paragraph (2) shall be devised from the best available data that 
are most applicable to the United States, and shall be devised in 
accordance with the best available scientific procedures and exper-
tise. The Secretary of Health and Human Services shall update 
these tables and formulas every four years, or whenever he deems it 
necessary to insure that they continue to represent the best avail-
able scientific data and expertise. 
TECHNICAL AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT 
SEC. 8. (a) Section 207(a)(1) of such Act (42 U.S.C. 209(a)(1)) is 
amended by inserting "psychology," after "pharmacy,". 
(b) Section 306(1)(2) of such Act (42 U.S.C. 242k(l)(2)) is amended 
by striking out subparagraph (D) and redesignating subparagraphs 
(E), (F), and (G) as subparagraphs (D), (E), and (F), respectively. 
(c) Section 308(d) of such Act (42 U.S.C. 242m(d)) is amended (1) by 
inserting ", if an establishment or person supplying the information 
or described in it is identifiable," after "No information", and (2) by 
striking out "authorized by guidelines in effect under section 
306(1)(2) or under regulations of the Secretary" and inserting in lieu 
thereof "such establishment or person has consented (as determined 
under regulations of the Secretary) to its use for such other 
purpose". 
(d) The first sentence of section 311(c)(2) of such Act (42 U.S.C. 
243(c)(2)) is amended by striking out "forty-five days" and inserting 
instead "six months". 
(e) Section 330(d)(2) of such Act (42 U.S.C. 254c(d)(2)) is amended by 
inserting before "and the costs" the following: ", the costs of repay-
PUBLIC LAW 97-414-JAN. 4, 1983 
96 STAT. 2061 
ing loans made by the Farmers Home Administration 
for 
buildings,". 
(0 Section 337(a) of such Act (42 U.S.C. 254j(a)) is amended by 
striking out "carrying out this subpart" and inserting in lieu thereof 
"carrying out this subpart (other than section 338G)". 
» , . 
(g)(1) Section 338B(e) of the Public Health Service Act (42 U.S.C. 
254m-(e)) is amended by inserting before the period the following: 
"or under section 225 as in effect on September 30,1977". 
(2) Section 338D(b) of such Act (42 U.S.C. 294w(b)) is amended by 
42 USC 254o. 
striking out "section 338F(b)" and inserting in lieu thereof "section 
338E(d)". 
(3) Section 338E(d)(l) of such Act (42 U.S.C. 294x(d)(l)) is amended 
42 USC 254p. 
by striking out "section 338D(c)" and inserting in lieu thereof 
"section 338D(b)". 
(h) Section 340(g) of the Public Health Service Act (42 U.S.C. 
256(g)) is amended (1) by striking out "and" after "1980," in para-
graph (1) and by inserting before the period in that paragraph a 
comma and "and $3,000,000 for the fiscal year ending September 30, 
1982", and (2) by inserting "and" after "1980," in paragraph (2) and 
by striking out in that paragraph ", and $3,000,000 for the fiscal 
year ending September 30,1982". 
(i) Section 737(2) of such Act (42 U.S.C. 294jX2)) is amended by 
inserting "in a State" after "means a school". 
(j) Section 781(a)(2) of such Act (42 U.S.C. 295g-l(a)(2)) is amended 
by striking out "under area health education center programs". 
(k)(l) Section 791A(b)(3)(A) of such Act (42 U.S.C. 295h-la(b)(3)(A)) 
.,,., .,,,, 
is amended by striking out "postbaccalaureate" and inserting in lieu 
(2) Section 791(c)(2)(A) of such Act (42 U.S.C. 295h(c)(2)(A)) is 
amended to read as follows: 
"(A) such application contains assurances satisfactory to the 
Secretary that in the school year (as defined in regulations of 
the Secretary) beginning in the fiscal year for which the appli-
cant receives a grant under subsection (a) that— 
"(i) at least 25 individuals will complete the graduate 
3,f 
educational programs of the entity for which such applica-
1
^ 
tion is submitted; and 
"(ii) such entity shall expend or obligate at least $100,000 
in funds from non-Federal sources to conduct such pro-
grams; and". 
(1) Section 831(b) of such Act (42 U.S.C. 297-1(b)) is amended by 
inserting before the period a comma and the following: "$400,000 for 
the fiscal year ending September 30, 1983, and $800,000 for the fiscal 
year ending September 30,1984". 
(m) Title VIII of such Act is amended by adding at the end thereof 
the following: 
"TECHNICAL ASSISTANCE 
"SEC. 857. Funds appropriated under this title may be used by the 
42 USC 298b-4. 
Secretary to provide technical assistance in relation to any of the 
,, ,^ ,, 
authorities under this title.". 
' 
' 
(n) Sections 1001(c), 1003(b), and 1005(b) of such Act (42 U.S.C. 
300(c), 300a-l(b), 300a-3(b)) are each amended by striking out the 
comma after "1981" and inserting in lieu thereof a semicolon. 
(o) Section 1101(b) of such Act (42 U.S.C. 300ba))) (as in effect 
before its repeal by section 2193(b)(1) of the Omnibus Budget Recon-
ciliation Act of 1981 is amended by inserting a comma after "1981". 
95 Stat. 826. 
96 STAT. 2062 
PUBLIC LAW 97-414—JAN. 4, 1983 
(p) Section 1536 of such Act (42 U.S.C. 300n-5) (as amended by 
95 Stat. 571. 
scction 935 of the Omnibus Budget Reconciliation Act of 1981) is 
amended by striking out "this title and" and inserting in lieu 
thereof "this title and—". 
42 use 300q-2. 
(q) Section 1602(0(2) of such Act (42 U.S.C. 300g-2(fX2)) is amended 
by inserting after "including" the following: "selling real property 
pledged as security for such a loan or loan guarantee and". 
,^^ , 
(r)(l) The matter in section 1706(a) (42 U.S.C. 300u-5(a)) of the 
' 
'" 
Public Health Service Act preceding paragraph (1) is amended by 
striking out "Health Information, Health Promotion and Physical 
-. . , ^ 
Fitness and Sports Medicine" and inserting instead "Health 
promotion". 
(2) The section heading for section 1706 of such Act (42 U.S.C. 
300u-5) is amended to read as follows: 
"OFFICE OF HEALTH PROMOTION". 
(s) The second sentence of section 1904(a)(1)(F) of such Act (42 
U.S.C. 300w-3(aXl)(F)) is amended by striking out "equipment for 
the systems" and inserting in lieu thereof "equipment for the 
systems (other than systems with respect to which grants were made 
as prescribed by section 1905(cX2))". 
(t) Effective October 1,1982, section 1912(b) of such Act (42 U.S.C. 
300x-l(b)) is amended to read as follows: 
"(b)(1) From the remainder of the amount appropriated under 
42USC300X. 
section 1911 for any fiscal year, the Secretary shall allot to each 
State an amount which bears the same ratio to such remainder for 
that fiscal year as the amounts— 
"(A) which would have been provided by the Secretary to the 
42 use 241. 
State and entities in the State under section 301 of this Act for 
mental health services demonstrations and under the Commu-
nity Mental Health Centers Act and the Mental Health Systems 
Act for mental health services for fiscal year 1981 if the Secre-
tary had obligated all the funds for such purposes available for 
such Acts under Public Law 96-536, and 
"(B) provided by the Secretary to the State and entities in the 
State under the laws referred to in subparagraphs (D) and (E) of 
paragraph (2) for fiscal year 1980, 
bore to the total amount appropriated for mental health services 
demonstrations and mental health services for fiscal year 1981 
under Public Law 96-536 for section 301 of this Act, the Community 
42 use 2689 
Mental Health Centers Act and the Mental Health Systems Act and 
note, 9401 
^jjg ^otj^j amouut appropriated for fiscal year 1980 for the provisions 
" 
of law referred to in subparagraphs (D) and (E) of paragraph (2). 
"(2) The provisions of law referred to in paragraph (1) are the 
following provisions of law as in effect on the day before the date of 
the enactment of the Omnibus Budget Reconciliation Act of 1981: 
.-, V 
"(A) The Community Mental Health Centers Act. 
"(B) The Mental Health Systems Act. 
42 use 241. 
"(C) Section 301 of this Act. 
"(D) Sections 301 and 312 of the Comprehensive Alcohol 
Abuse and Alcoholism, Prevention, Treatment, and Rehabilita-
42 use 4571, 
tion Act of 1970. 
4578. 
"(E) Sections 409 and 410 of the Drug Abuse Prevention, 
95 Stat. 595. 
Treatment, and Rehabilitation Act. 
21 use 1176, 
"(3) For purposes of paragraph (1), the total amount appropriated 
^^^^ 
under Public Law 96-536 for mental health services demonstrations 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2063 
under section 301 of this Act shall be deemed not to exceed 
$20,000,000; and if such total amount did exceed $20,000,000, the 
amount that would have been provided to each State and entities in 
each State shall be ratably reduced for purposes of paragraph (1)(A) 
to conform to the limit prescribed by this paragraph. 
"(4) To the extent that all the funds appropriated under section 
1911 for a fiscal year and available for allotment in such fiscal year 
are not otherwise allotted to States because— 
"(A) one or more States have not submitted an application or 
description of activities in accordance with section 1915 for the 
42 USC 300x-4. 
J 
fiscal 
year; 
^ 
"(B) one or more States have notified the Secretary that they 
do not intend to use the full amount of their allotment; or 
"(C) some State allotments are offset or repaid under section 
1916(b)(3); 
42 use 300X-5. 
such excess shall be allotted among each of the remaining States in 
proportion to the amount otherwise allotted to such States for the 
fiscal year without regard to this paragraph.". 
(u)(l) section 1915(c)(5) of such Act (42 U.S.C. 300x-4(c)(5)) is 
amended (1) by inserting "procedures for" before "procedural", and 
(2) by striking out "review procedures" and inserting in lieu thereof 
"review". 
(2)(A) Section 1915(c)(6)(A)(i) of such Act (42 U.S.C. 300x-
4(c)(6)(A)(i)) is amended— 
(i) by striking out "for mental health services"; 
(ii) by inserting "for mental health services" after "fiscal year 
1981"; 
(iii) by inserting "for mental health services demonstrations 
under section 301 of this Act" before "if the Secretary"; and 
(iv) by striking out "such Acts" each place it occurs and 
inserting in lieu thereof "such provisions of law". 
(B) Section 1915(c)(6)(A)(ii) of such Act (42 U.S.C. 300x-4(c)(6)(A)(ii)) 
is amended— 
(i) by striking out "for mental health services"; 
(ii) by inserting "for mental health services" after "fiscal year 
1981"; 
(iii) by inserting "and for mental health services demonstra-
tions under section 301 of this Act" before "if the Secretary"; 
and 
(iv) by striking out "such Acts" and inserting in lieu thereof 
"such provisions of law", 
(v) Section 1932 of such Act is amended by— 
95 Stat. 559. 
(1) inserting "(a)" after "1932.", and 
42 USC 300y-ll. 
(2) adding a new subsection (b) as follows: 
"(b) The Secretary shall promulgate separate regulations govern- Regulations. 
ing the administration of this part. Such regulations shall take into 
account the distinctive features of the grant program authorized 
under this part.". 
(w) From the funds appropriated under section 419B of such Act 
42 USC 2871 
or under any other applicable provision of law, the Secretary of 
^o^usc 287" 
Health and Human Services shall provide for the development and 
support of not less than ten comprehensive centers for sickle cell 
disease. 
96 STAT. 2064 
PUBLIC LAW 97-414—JAN. 4, 1983 
MISCELLANEOUS TECHNICAL AMENDMENTS 
SEC. 9. (a) Section 931(a) of the Omnibus Budget Reconciliation Act 
95 Stat. 570. 
of 1981 is amended by striking out " '1980/ " in paragraphs (1), (2), 
42 use 300, 
and (3) and inserting in lieu thereof " '1980;' ". 
dooa-i, 300a-3. 
^^^ Section 936(b)(1) of the Omnibus Budget Reconciliation Act of 
95 Stat. 572. 
1981 is amended by striking out "300m(d)(l)(B)(ii)" and inserting in 
42 use 300m. 
ligu thereof "300m(d)(l)(B)". 
95 Stat. 573. 
(c) Section 942(i) of the Omnibus Budget Reconciliation Act of 1981 
42USC300e-l. 
ig amended by striking out "'feasible (1)'" and inserting in lieu 
thereof " 'feasible (i)' ". 
(d)(1) Section 963(b)(4) of the Omnibus Budget Reconciliation Act 
95 Stat. 593. 
of 1981 is amended by striking out "clause (2)" and inserting in lieu 
42 use 4577. 
thereof "clause (3)". 
(2) Section 311(a)(3) of the Comprehensive Alcohol Abuse and 
Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 
95 Stat. 593. 
(42 U.S.C. 4577(b)3)) is amended by striking out the period at the end 
and inserting in lieu thereof a comma. 
(e) Section 965(a) of the Omnibus Budget Reconciliation Act of 
95 Stat. 594. 
1981 is amended by striking out paragraph (A) and by redesignating 
42 use 4588. 
paragraphs (B), (C), and (D) as paragraphs (1), (2), and (3), 
respectively. 
(f) Section 2741(a)(3) of the Omnibus Budget Reconciliation Act of 
95 Stat. 922. 
1981 is amended by striking out "and 'and' ". 
42 use 295g-^. 
(g)(1) Section 709 of the Controlled Substances Act (21 U.S.C. 904) 
is amended (1) by striking out subsections (a) and (b), (2) by striking 
out "(c)", and (3) by amending the section heading to read as follows: 
"PAYMENT OF TORT CLAIMS". 
(2) The item relating to section 709 in the table of contents of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970 is 
amended by striking out "Authorizations of Appropriations" and 
inserting in lieu thereof "Payment of Tort Claims". 
Repeal. 
(h) Section 302 of the Health Planning and Resources Develop-
42 use 300t-ll 
ment Amendments of 1979 (Public Law 96-79) is repealed. 
"°*^®- 
(i) The paragraph beginning with "Service and supply fund:" 
under the heading "PUBLIC HEALTH SERVICE" in the Federal 
Security Agency Appropriation Act, 1946 (42 U.S.C. 231) is amended 
by inserting ", or in advance," after "stock furnished". 
(j)(l) Section 6(b)(1) of the Consumer Product Safety Act (15 U.S.C. 
2055(b)(1)) is amended by striking out "paragraph (2)" and inserting 
^
. 
J ,j, 
in lieu thereof "paragraph (4)". 
.^ :;: :;;ni;: 
(2) section IKC) of such Act (15 U.S.C 2060(c)) is amended by 
'' ' 
^ 
striking out "section 10(e)(4)" and inserting in lieu thereof "subsec-
tion (f)". 
- uj 1
1
.
^
3
^
^ 
(3) Section 15(g)(1) of such Act (15 U.S.C. 2064(g)(1)) is amended bv 
striking out "section 12(c)(1)" and inserting in lieu thereof "12(d)(1)'. 
(4)(A) Section 19(a)(7) of such Act (15 U.S.C. 2068(a)(7)) is amended 
by striking out "section 9(d)(2)" and inserting in lieu thereof "sec-
tion 9(g)(2)^'. 
(B) Paragraph (8) of section 19(a) of such Act is repealed and 
paragraph (9) and the first of the two paragraphs (10) are redesig-
nated as paragraphs (8) and (9), respectively. 
(5) Section 31(b)(1) of such Act (15 U.S.C. 2080(b)(1)) is amended by 
striking out "The Commission" and all that follows through "Sub-
stances Act," and inserting in lieu thereof the following: 
i'Oii 
PUBLIC LAW 97-414—JAN. 4, 1983 
96 STAT. 2065 
^ "(bXD The Commission may not issue— 
"(A) an advance notice of proposed rulemaking for a con-
sumer product safety rule, 
"(B) a notice of proposed rulemaking for a rule under section 
27(e), or 
"(C) an advance notice of proposed rulemaking for regulations 
under section 2(qXl) of the Federal Hazardous Substances 
Act,". 
15 use 1261. 
(k) Section 3(a) of the Poison Prevention Packaging Act of 1970 (15 
U.S.C. 1472(a)) is amended by striking out ", after consultation with 
the Technical Advisory Committee provided for in section 6 of this 
Act". 
(1) Section 15 of the Federal Hazardous Substances Act (15 U.S.C. 
1274) (as amended by section 1211(f)(1) of the Omnibus Budget 
Reconciliation Act of 1982) is amended by adding at the end thereof 95 Stat. 721. 
the following: 
"(e) For purposes of this section (1) the term 'manufacturer' 
"Manufacturer." 
includes an importer for resale, and (2) a dealer who sells at 
wholesale an article or substance shall with respect to that sale be 
considered the distributor of that article or substance.". 
(m) Section 1211(hX4) of the Omnibus Budget Reconciliation Act of 
1981 is amended by striking out "by inserting ', Science and Trans- 95 Stat. 721. 
portation' immediately after 'on Commerce', and". 
i^ U
S
C 2064. 
STUDY 
SEC. 10. Of the funds available under section 706 of the Energy 
Security Act, there shall be made available $800,000 for the costs of 42 use 8905. 
a grant or contract for a study of the water quality of the Quabbin 
Reservoir in Massachusetts. 
PATENT TERM EXTENSION 
SEC. 11. (a) Title 35, United States C!ode, is amended by adding the 
following new section: 
"§ 155. Patent term extension 
35 USe 155. 
"Notwithstanding the provisions of section 154, the term of a 35 use 154. 
patent which encompasses within its scope a composition of matter 
or a process for using such composition shall be extended if such 
composition or process has been subjected to a regulatory review by 
the Federal Food and Drug Administration pursuant to the Federal 
Food, Drug, and Cosmetic Act leading to the publication of regula- 21 use 301. 
tion permitting the interstate distribution and sale of such composi-
tion or process and for which there has thereafter been a stay of 
regulation of approval imposed pursuant to section 409 of the 
Federal Food, Drug, and CJosmetic Act which stay was in effect on 21 use 348. 
January 1, 1981, by a length of time to be measured from the date 
such stay of regulation of approval was imposed until such proceed-
ings are finally resolved and commercial marketing permitted. The 
patentee, his heirs, successors or assigns shall notify the Commis-
sioner of Patents and Trademarks within ninety days of the date of 
enactment of this section or the date the stay of regulation of 
approval has been removed, whichever is later, of the number of the 
patent to be extended and the date the stay was imposed and the 
date commercial marketing was permitted. On receipt of such 
notice, the CJommissioner shall promptly issue to the owner of record 
96 STAT. 2066 
PUBLIC LAW 97-414—JAN. 4, 1983 
of the patent a certificate of extension, under seal, stating the fact 
and length of the extension and identifying the composition of 
matter or process for using such composition to which such exten-
sion is applicable. Such certificate shall be recorded in the official 
file of each patent extended and such certificate shall be considered 
as part of the original patent, and an appropriate notice shall be 
'; •, J r, published in the Official Gazette of the Patent and Trademark 
Office.". 
(b) The analysis for chapter 14 of such title 35 is amended by 
adding at the end the following: 
"155. Patent term extension.". 
Approved January 4, 1983. 
..th'.p^ Y'l ^e-forii 
\n ;it , 
LEGISLATIVE HISTORY—H.R. 5238: 
HOUSE REPORT No. 97-840 Ft. I (Comm. on Energy and Commerce). 
I 
CONGRESSIONAL RECORD, Vol. 128 (1982): 
.| 
, 
Sept. 28, considered and passed House. 
*
! 
Oct. 1, considered and passed Senate, amended. 
,
^ 
Dec. 14, House concurred in Senate amendment with an amendment. 
Dec. 16, Senate concurred in House amendment. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 19, No. 1 (1983): 
I 
Jan. 4, Presidential statement.