An Act to amend the Public Health Service Act to authorize the establishment and implementation of an emergency national swine flu immunization program and to provide an exclusive remedy for personal injury or death arising out of the manufacture, distribution, or administration of the swine flue vaccine under such program.
PL 94-380 (S.3735), enacted 08/12/1976

PUBLIC LAW 94-380—AUG. 12, 1976 
90 STAT. 1113 
Public Law 94-380 
94th Congress 
An Act 
To amend the Public Health Service Act to authorize the establishment and 
implementation of an emergency national swine flu immunization program 
and to provide an exclusive remedy for personal injury or death arising out 
of the manufacture, distribution, or administration of the swine flu vaccine 
under such program. 
Be it enacted hy the Senate and House of Repr'esentatives of the 
United States of America in Congress assembled^ That this Act may 
be cited as the "National Swine Flu Immunization Program of 1976". 
SEC. 2. Section 317 of the Public Health Service Act (42 U.S.C. 
247b) is amended by inserting after subsection (i) the following new 
subsections: 
"(j)(l) The Secretary is authorized to establish, conduct, and 
support (by grant or contract) needed activities to carry out a national 
swine flu immunization program until August 1, 1977 (hereinafter 
in this section referred to as the 'swine flu program'). The swine flu 
program shall be limited to the following: 
" (A) The development of a safe and effective swine flu vaccine. 
"(B) The preparation and procurement of such vaccine in 
sufficient quantities for the immunization of the population of 
the States. 
"(C) The making of grants to State health authorities to assist 
in meeting their costs in conducting or supporting, or both, pro-
grams to administer such vaccine to their populations, and the 
furnishing to State health authorities of sufficient quantities of 
such swine flu vaccine for such programs. 
"(D) The furnishing to Federal health authorities of appro-
priate quantities of such vaccine. 
"(E) The conduct and support of training of personnel for 
immunization activities described in subparagraphs (C) and (D) 
of this paragraph and the conduct and support of research on 
the nature, cause, and effect of the influenza against which the 
swine flu vaccine is designed to immunize, the nature and effect 
of such vaccine, immunization against and treatment of such 
influenza, and the cost and effectiveness of immunization programs 
against such influenza. 
"(F) The development, in consultation with the National 
Commission for the Protection of Human Subjects of Biomedical 
and Behavioral Research, and implementation of a written 
informed consent form and procedures for assuring that the risks 
and benefits from the swine flu vaccine are fully explained to 
each individual to whom such vaccine is to be administered. Such 
consultation shall be completed within two weeks after enactment 
of this Act, or by September 1, 1976, whichever is sooner. Such 
procedures shall include the information necessary to advice indi-
viduals with respect to their rights and remedies arising out of 
the administration of such vaccine. 
"(G) Such other activities as are necessary to implement the 
swine flu program. 
Aug. 12, 1976 
[S. 3735] 
National Swine 
Flu Immuniza-
tion Program of 
1976. 
42 u s e 201 note. 
Grants. 
Informed consent 
form and 
procedures. 
90 STAT. 1114 
PUBLIC LAW 94-380—AUG. 12, 1976 
Reports to 
Congress. 
Contracts. 
Insurance 
premium 
amounts, refund. 
Ante, p. 362. 
Claims against 
the United States. 
I«*?s: 
42 u s e 201 note. 
"(2) The Secretary shall submit quarterly reports to the Congress 
on the administration of the swine flu program. Each such report shall 
provide information on— 
"(A) the current supply of the swine flu vaccine to be used in 
the program; 
"(B) the number of persons inoculated with such vaccine since 
the last report was made under this paragraph and the immune 
status of the population; 
"(C) the amount of funds expended for the swine flu program 
by the United States, each State, and any other entity partici-
pating in the program and the costs of each such participant which 
are associated with the program, during the period with respect 
to which the report is made; and 
"(D) the epidemiology of influenza in the United States during 
such period. 
"(3) Any contract for procurement by the United States of swine 
flu vaccine from a manufacturer of such vaccine shall (notwithstanding 
any other provision of law) be subject to renegotiation to eliminate 
any profit realized from such procurement (except that with respect to 
vaccine against the strain of influenza virus known as influenza 
A/Victoria/75 profit shall be allowed but limited to an amount not 
exceeding a reasonable profit), as determined pursuant to criteria 
prescribed by the Secretary, and the contract shall expressly so pro-
vide. Such criteria shall specify that any insurance premium amount 
which is included in the price of such procurement contract and 
which is refunded to the manufacturer under any retrospective, 
experience-rating plan or similar rating plan shall in turn be refunded 
to the United States. 
"(4) No funds are authorized to be appropriated to carry out the 
activities of the swine flu program authorized in subparagraphs (A), 
(B), (D), ( E ) , and (F) of paragraph (1) of this subsection in addi-
tion to the funds appropriated by Public Law 94—266. 
" ( k ) ( l ) ( A ) The Congress finds that— 
"(i) in order to achieve the participation in the program of 
the agencies, organizations, and individuals who will manufacture, 
distribute, and administer the swine flu vaccine purchased and 
used in the swine flu program and to assure the availability of 
such vaccine in interstate commerce, it is necessary to protect such 
agencies, organizations, and individuals against liability 
for 
other than their own negligence to persons alleging personal 
injury or death arising out of the administration of such vaccine; 
"(ii) to provide such protection and to establish an orderly 
procedure for the prompt and equitable handling of claims by 
persons alleging such injury or death, it is necessary that an 
exclusive remedy for such claimants be provided against the 
United States because of its unique role in the initiation, planning, 
and administration of the swine flu program; and 
"(iii) in order to be prepared to meet the potential emergency 
of a swine flu epidemic, it is necessary that a procedure be insti-
tuted for the handling of claims by persons alleging such injury 
or death until Congress develops a permanent approach for 
handling claims arising under programs of the Public Health 
Service Act. 
PUBLIC LAW 94-380—AUG. 12, 1976 
90 STAT. 1115 
"(B) To— 
"(i) assure an orderly procedure for the prompt and equitable 
handling of any claim for personal injury or death arising out 
of the administration of such vaccine; and 
"(ii) achieve the participation in the swine flu program of 
(I) the manufacturers and distributors of the swine flu vaccine, 
(II) public and private agencies or organizations that provide 
inoculations without charge for such vaccine or its administration 
and in compliance with the informed consent form and procedures 
requirements prescribed pursuant to subparagraph (F) of para-
graph (1) of this subsection, and (III) medical and other health 
personnel who provide or assist in providing inoculations without 
charge for such vaccine or its administration and in compliance 
with such informed consent form and procedures requirements, 
it is the purpose of this subsection to establish a procedure under 
which all such claims will be asserted directly against the United 
States under section 1346(b) of title 28, United States Code, and 
chapter 171 of such title (relating to tort claims procedure) except 28 USC 2671 et 
as otherwise specifically provided in this subsection. 
seq. 
"(2) (A) The United States shall be liable with respect to claims Liability, 
submitted after September 30, 1976 for personal injury or death 
arising out of the administration of swine flu vaccine under the swine 
flu program and based upon the act or omission of a program par-
ticipant in the same manner and to the same extent as the United 
States would be liable in any other action brought against it under 
such section 1346(b) and chapter 171, except that— 
"(i) the liability of the United States arising out of the act 
or omission of a program participant may be based on any theory 
of liability that would govern an action against such program 
participant under the law of the place where the act or omission 
occurred, including negligence, strict liability in tort, and breach 
of warranty; 
"(ii) the exceptions specified in section 2680(a) of title 28, 
United States Code, shall not apply in an action based upon the 
act or omission of a program participant; and 
"(iii) notwithstanding section 2401(b) of title 28, United 
States Code, if a civil action or proceeding for personal injury 
or death arising out of the administration of swine flu vaccine 
under the swine flu program is brought within two years of the 
date of the administration of such vaccine and is dismissed because 
the plaintiff in such action or proceeding did not file an admin-
istrative claim with respect to such injury or death as required 
by such chapter 171, the plaintiff in such action or proceeding 
shall have 30 days from the date of such dismissal or tAvo years 
from the date the claim arose, whichever is later, in which to file 
such administrative claim. 
"(B) For purposes of this subsection, the term 'program par- "Program 
ticipant' as to any particular claim means the manufacturer or dis- participant." 
tributor of the swine flu vaccine used in an inoculation under the 
swine flu program, the public or private agency or organization that 
provided an inoculation under the swine flu program without charge 
for such vaccine or its administration and in compliance with the 
Administrative 
claim, filing 
deadline. 
90 STAT. 1116 
PUBLIC LAW 94-380—AUG. 12, 1976 
Attorney 
General, civil 
action defense. 
informed consent form and procedures requirements prescribed pur-
suant to subparagraph (F) of paragraph (1) of this subsection, and 
the medical and other health personnel who provided or assisted in 
providing an inoculation under the swine flu program without charge 
for such vaccine or its administration and in compliance with such 
informed consent form and procedures requirements. 
"(3) The remedy against the United States prescribed by para-
graph (2) of this subsection for personal injury or death arising out 
of the administration of the swine flu vaccine under the swine flu 
program shall be exclusive of any other civil action or proceeding for 
such personal injury or death against any employee of the Govern-
ment (as defined in section 2671 of title 28, United States Code) or 
program participant whose act or omission gave raise to the claim. 
" (4) The Attorney General shall defend any civil action or proceed-
ing brought in any court against any employee of the Government 
(as defined in such section 2671) or program participant (or any 
liability insurer thereof) based upon a claim alleging personal injury 
or death arising out of the administration of vaccine under the swine 
flu program. Any such person against whom such civil action or pro-
ceeding is brought shall deliver all process served upon him (or an 
attested true copy thereof) to whoever is designated by the Secretary 
to receive such papers, and such person shall promptly furnish copies 
of the pleadings and process therein to the United States attorney for 
the district embracing the place wherein the civil action or proceeding 
is brought, to the Attorney General, and to the Secretary. 
"(5) (A) Upon certification by the Attorney General that a civil 
action or proceeding brought in any court against any employee of 
the Government (as defined in such section 2671) or program partic-
ipant is based upon a claim alleging personal injury or death arising 
out of the administration of vaccine under the swine flu program, such 
action or proceeding shall be deemed an action against the United 
States under the provisions of title 28, United States Code, and all 
references thereto. If such action or proceeding is brought in a district 
court of the United States, then upon such certification the United 
States shall be substituted as the party defendant. 
"(B) Upon a certification by the Attorney General under subpara-
graph (A) of this paragraph with respect to a civil action or proceed-
ing commenced in a State court, such action or proceeding shall be 
removed, without bond at any time before trial, by the Attorney 
General to the district court of the United States of the district and 
division embracing the place wherein it is pending and be deemed an 
action brought against the United States under the provisions of title 
28, United States Code, and all references thereto; and the United 
States shall be substituted as the party defendant. The certification 
of the Attorney General with respect to program participant status 
shall conclusively establish such status for purposes of such initial 
removal. Should a district court of the United States determine on a 
hearing on a motion to remand held before a trial on the merits that 
an action or proceeding is not one to which this subsection applies, the 
case shall be remanded to the State court. 
"(C) Where an action or proceeding under this subsection is pre-
cluded because of the availability of a remedy through proceedings 
for compensation or other benefits from the United States as provided 
PUBLIC LAW 94-380—AUG. 12, 1976 
90 STAT. 1117 
by any other law, the action or proceeding shall be dismissed, but in 
that event the running of any limitation of time for commencing, or 
filing an application or claim in, such proceedings for compensation 
or other benefits shall be deemed to have been suspended during the 
pendency of the civil action or proceeding under this subsection. 
"(6) A program participant shall cooperate with the United States Cooperation, 
in the processing or defense of a claim or suit under such section 
1346(b) and chapter 171 based upon alleged acts or omissions of the 28 USC 1346, 
program participant. Upon the motion of the United States or any 2671 et seq. 
other party, the status as a program participant shall be revoked by 
the district court of the United States upon finding that the program 
participant has failed to so cooperate, and the court shall substitute 
such former participant as the party defendant in place of the United 
States and, upon motion, remand any such suit to the court in which 
it was instituted. 
" (7) Should payment be made by the United States to any claimant Payment, 
bringing a claim under this subsection, either by way of administrative 
settlement or court judgment, the United States shall have, notwith-
standing any provision of State law, the right to recover for that 
portion of the damages so awarded or paid, as well as any costs of 
litigation, resulting from the failure of any program participant 
to carry out any obligation or responsibility assumed by it under a 
contract with the United States in connection with the program or 
from any negligent conduct on the part of any program participant 
,in carrying out any obligation or responsibility in connection with 
the swine flu program. The United States may maintain such action 
against such program participant in the district court of the United 
States in which such program participant resides or has its principal 
place of business. 
"(8) Within one year of the date of the enactment of the National Report to 
Swine Flu Immunization Program of 1976, and semiannually there- Congress, 
after, the Secretary shall submit to the Congress a report on the con-
duct of settlement and litigation activities under this subsection, 
specifying the number, value, nature, and status of all claims made 
thereunder, including the status of claims for recovery made under 
paragraph (7) of this subsection and a detailed statement of the 
reasons for not seeking such recovery. 
"(1) For the purposes of subsections (j) and (k) of this section— Definitions. 
"(1) the phrase 'arising out of the administration' with refer-
ence to a claim for personal injury or death under the swine flu 
program includes a claim with respect to the manufacture or 
distribution of such vaccine in connection with the provision of 
an inoculation using such vaccine under the swine flu program; 
"(2) the term'State'includes the District of Columbia, Puerto 
Rico, the Virgin Islands, Guam, American Samoa, and the Trust 
; Territory of the Pacific Islands; and 
"(3) the term 'swine flu vaccine' means the vaccine against the 
strain of influenza virus known as influenza A/New Jersey/76 
(Hsw INl), or a combination of such vaccine and the vaccine 
against the strain of influenza virus known i as influenza 
A/Victoria/75.". 
90 STAT. 1118 
^ 
PUBLIC LAW 94-380—AUG. 12, 1976 
Study. 
SEC. 3. The Secretary of Health, Education, and Welfare shall con-
42 use 247b 
duct, or provide for the conduct of, a study of the scope and extent 
°°*®' 
of liability for personal injuries or death arising out of immunization 
programs and of alternative approaches to providing protection 
against such liability (including a compensation system) for such 
Report to 
injuries. Within one year of the date of the enactment of this Act, 
Congress. 
the Secretary shall report to the Congress the findings of such study 
and such recommendations for legislation (including proposed drafts 
to 
carry 
out 
such 
recommendations) 
as the 
Secretary 
deems 
appropriate. 
Approved August 12, 1976. 
rorJ«u 
LEGISLATIVE HISTORY: 
. 
SENATE REPORT No. 94-1147 (Comm. on Appropriations). 
CONGRESSIONAL RECORD, Vol. 122 (1976): 
Aug. 10, considered and passed Senate and House. 
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, VoL 12, No. 33: 
Aug. 12, Presidential statement.