PUBLIC HEALTH SERVICE ACT
114–255
Statute Compilation
United States House of Representatives
Office of the Legislative Counsel
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Public Health Service Act-TITLE XXI (Vaccines)
Public Health Service Act
8791
78
1944-07-01
PUBLIC HEALTH SERVICE ACT
[As Amended Through P.L. 114–255, Enacted December 13, 2016]
[Currency: This publication is a compilation of the text of title XXI of Chapter 373 of the 78th Congress. It was last amended by the public law listed in the As Amended Through note above and below at the bottom of each page of the pdf version and reflects current law through the date of the enactment of the public law listed at https://www.govinfo.gov/app/collection/comps/]
[Note: While this publication does not represent an official version of any Federal statute, substantial efforts have been made to ensure the accuracy of its contents. The official version of Federal law is found in the United States Statutes at Large and in the United States Code. The legal effect to be given to the Statutes at Large and the United States Code is established by statute (1 U.S.C. 112, 204).]
[References in brackets[] are to title 42, United States Code]
TITLE XXI—

VACCINES
subtitle 1—

National Vaccine Program

ESTABLISHMENT
Sec. 2101.
[300aa–1]
The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary.

PROGRAM RESPONSIBILITIES
Sec. 2102.
[300aa–2]
(a)
The Director of the Program shall have the following responsibilities:
(1)

Vaccine research.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for research carried out in or through the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development on means to induce human immunity against naturally occurring infectious diseases and to prevent adverse reactions to vaccines.
(2)

Vaccine development.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for activities carried out in or through the National Institutes of Health, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development to develop the techniques needed to produce safe and effective vaccines.
(3)

Safety and efficacy testing of vaccines.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for safety and efficacy testing of vaccines carried out in or through the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the Department of Defense, and the Agency for International Development.
(4)

Licensing of vaccine manufacturers and vaccines.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction for the allocation of resources in the implementation of the licensing program under section 353.
(5)

Production and procurement of vaccines.—
The Director of the Program shall, through the plan issued under section 2103, ensure that the governmental and non-governmental production and procurement of safe and effective vaccines by the Public Health Service, the Department of Defense, and the Agency for International Development meet the needs of the United States population and fulfill commitments of the United States to prevent human infectious diseases in other countries.
(6)

Distribution and use of vaccines.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the Centers for Disease Control and Prevention and assistance to States, localities, and health practitioners in the distribution and use of vaccines, including efforts to encourage public acceptance of immunizations and to make health practitioners and the public aware of potential adverse reactions and contraindications to vaccines.
(7)

Evaluating the need for and the effectiveness and adverse effects of vaccines and immunization activities.—
The Director of the Program shall, through the plan issued under section 2103, coordinate and provide direction to the National Institutes of Health, the Centers for Disease Control and Prevention, the Office of Biologics Research and Review of the Food and Drug Administration, the National Center for Health Statistics, the National Center for Health Services Research and Health Care Technology Assessment, and the Centers for Medicare & Medicaid Services in monitoring the need for and the effectiveness and adverse effects of vaccines and immunization activities.
(8)

Coordinating governmental and non-governmental activities.—
The Director of the Program shall, through the plan issued under section 2103, provide for the exchange of information between Federal agencies involved in the implementation of the Program and non-governmental entities engaged in the development and production of vaccines and in vaccine research and encourage the investment of non-governmental resources complementary to the governmental activities under the Program.
(9)

Funding of federal agencies.—
The Director of the Program shall make available to Federal agencies involved in the implementation of the plan issued under section 2103 funds appropriated under section 2106 to supplement the funds otherwise available to such agencies for activities under the plan.
(b)
In carrying out subsection (a) and in preparing the plan under section 2103, the Director shall consult with all Federal agencies involved in research on and development, testing, licensing, production, procurement, distribution, and use of vaccines.

PLAN
Sec. 2103.
[300aa–3]
The Director of the Program shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 2102. The plan shall establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines, describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their vaccine functions in consultation and coordination with the Program and in conformity with such priorities. The first plan under this section shall be prepared not later than January 1, 1987, and shall be revised not later than January 1 of each succeeding year.

NATIONAL VACCINE ADVISORY COMMITTEE
Sec. 2105.1
[300aa–5]
(a)
There is established the National Vaccine Advisory Committee. The members of the Committee shall be appointed by the Director of the Program, in consultation with the National Academy of Sciences, from among individuals who are engaged in vaccine research or the manufacture of vaccines or who are physicians, members of parent organizations concerned with immunizations, or representatives of State or local health agencies or public health organizations.
^1
Section 2104 was repealed by section 601(a)(1)(H) of Public Law 105–362.
(b)
The Committee shall—
(1)
study and recommend ways to encourage the availability of an adequate supply of safe and effective vaccination products in the States,
(2)
recommend research priorities and other measures the Director of the Program should take to enhance the safety and efficacy of vaccines,
(3)
advise the Director of the Program in the implementation of sections 2102, 2103, and 21041, and
(4)
identify annually for the Director of the Program the most important areas of government and non-government cooperation that should be considered in implementing sections 2102, 2103, and 21041.

AUTHORIZATIONS
Sec. 2106.
[300aa–6]
(a)
To carry out this subtitle other than section 2102(9) there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 and 2005.
(b)
To carry out section 2102(9) there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 and 2005.
subtitle 2—

National Vaccine Injury Compensation Program
Part A—

Program Requirements

ESTABLISHMENT OF PROGRAM
Sec. 2110.
[300aa–10]
(a)

Program Established.—
There is established the National Vaccine Injury Compensation Program to be administered by the Secretary under which compensation may be paid for a vaccine-related injury or death.
(b)

Attorney's Obligation.—
It shall be the ethical obligation of any attorney who is consulted by an individual with respect to a vaccine-related injury or death to advise such individual that compensation may be available under the program for such injury or death.
(c)

Publicity.—
The Secretary shall undertake reasonable efforts to inform the public of the availability of the Program.

PETITIONS FOR COMPENSATION
Sec. 2111.
[300aa–11]
(a)

General Rule.—
(1)
A proceeding for compensation under the Program for a vaccine-related injury or death shall be initiated by service upon the Secretary and the filing of a petition containing the matter prescribed by subsection (c) with the United States Claims Court. The clerk of the United States Claims Court shall immediately forward the filed petition to the chief special master for assignment to a special master under section 2112(d)(1).
(2)
(A)
No person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part, and no such court may award damages in an amount greater than $1,000 in a civil action for damages for such a vaccine-related injury or death, unless a petition has been filed, in accordance with section 2116, for compensation under the Program for such injury or death and—
(i)
(I)
the United States Claims Court has issued a judgment under section 2112 on such petition, and
(II)
such person elects under section 2121(a) to file such an action, or
(ii)
such person elects to withdraw such petition under section 2121(b) or such petition is considered withdrawn under such section.
(B)
If a civil action which is barred under subparagraph (A) is filed in a State or Federal court, the court shall dismiss the action. If a petition is filed under this section with respect to the injury or death for which such civil action was brought, the date such dismissed action was filed shall, for purposes of the limitations of actions prescribed by section 2116, be considered the date the petition was filed if the petition was filed within one year of the date of the dismissal of the civil action.
(3)
No vaccine administrator or manufacturer may be made a party to a civil action (other than a civil action which may be brought under paragraph (2)) for damages for a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part.2
^2
Effective October 1, 1988.
(4)
If in a civil action brought against a vaccine administrator or manufacturer before the effective date of this part2 damages were denied for a vaccine-related injury or death or if such civil action was dismissed with prejudice, the person who brought such action may file a petition under subsection (b) for such injury or death.
(5)
(A)
A plaintiff who on the effective date of this part2 has pending a civil action for damages for a vaccine-related injury or death may, at any time within 2 years after the effective date of this part2 or before judgment, whichever occurs first, petition to have such action dismissed without prejudice or costs and file a petition under subsection (b) for such injury or death.
(B)
If a plaintiff has pending a civil action for damages for a vaccine-related injury or death, such person may not file a petition under subsection (b) for such injury or death.
(6)
If a person brings a civil action after November 15, 19883 for damages for a vaccine-related injury or death associated with the administration of a vaccine before November 15, 1988, such person may not file a petition under subsection (b) for such injury or death.
^3
So in law. Probably should be followed by a comma.
(7)
If in a civil action brought against a vaccine administrator or manufacturer for a vaccine-related injury or death damages are awarded under a judgment of a court or a settlement of such action, the person who brought such action may not file a petition under subsection (b) for such injury or death.
(8)
If on the effective date of this part there was pending an appeal or rehearing with respect to a civil action brought against a vaccine administrator or manufacturer and if the outcome of the last appellate review of such action or the last rehearing of such action is the denial of damages for a vaccine-related injury or death, the person who brought such action may file a petition under subsection (b) for such injury or death.
(9)
This subsection applies only to a person who has sustained a vaccine-related injury or death and who is qualified to file a petition for compensation under the Program.
(10)
The Clerk of the United States Claims Court is authorized to continue to receive, and forward, petitions for compensation for a vaccine-related injury or death associated with the administration of a vaccine on or after October 1, 1992.
(b)

Petitioners.—
(1)
(A)
Except as provided in subparagraph (B), any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table may, if the person meets the requirements of subsection (c)(1), file a petition for compensation under the Program.
(B)
No person may file a petition for a vaccine-related injury or death associated with a vaccine administered before the effective date of this part if compensation has been paid under this subtitle for 3500 petitions for such injuries or deaths.
(2)
Only one petition may be filed with respect to each administration of a vaccine. A covered vaccine administered to a pregnant woman shall constitute more than one administration, one to the mother and one to each child (as such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.
(c)

Petition Content.—
A petition for compensation under the Program for a vaccine-related injury or death shall contain—
(1)
except as provided in paragraph (3), an affidavit, and supporting documentation, demonstrating that the person who suffered such injury or who died—
(A)
received a vaccine set forth in the Vaccine Injury Table or, if such person did not receive such a vaccine, contracted polio, directly or indirectly, from another person who received an oral polio vaccine,
(B)
(i)
if such person received a vaccine set forth in the Vaccine Injury Table—
(I)
received the vaccine in the United States or in its trust territories,
(II)
received the vaccine outside the United States or a trust territory and at the time of the vaccination such person was a citizen of the United States serving abroad as a member of the Armed Forces or otherwise as an employee of the United States or a dependent of such a citizen, or
(III)
received the vaccine outside the United States or a trust territory and the vaccine was manufactured by a vaccine manufacturer located in the United States and such person returned to the United States not later than 6 months after the date of the vaccination,
(ii)
if such person did not receive such a vaccine but contracted polio from another person who received an oral polio vaccine, was a citizen of the United States or a dependent of such a citizen,
(C)
(i)
sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table in association with the vaccine referred to in subparagraph (A) or died from the administration of such vaccine, and the first symptom or manifestation of the onset or of the significant aggravation of any such illness, disability, injury, or condition or the death occurred within the time period after vaccine administration set forth in the Vaccine Injury Table, or
(ii)
(I)
sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by a vaccine referred to in subparagraph (A), or
(II)
sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine referred to in subparagraph (A),
(D)
(i)
suffered the residual effects or complications of such illness, disability, injury, or condition for more than 6 months after the administration of the vaccine, or (ii) died from the administration of the vaccine, or (iii) suffered such illness, disability, injury, or condition from the vaccine which resulted in inpatient hospitalization and surgical intervention, and
(E)
has not previously collected an award or settlement of a civil action for damages for such vaccine-related injury or death,
(2)
except as provided in paragraph (3), maternal prenatal and delivery records, newborn hospital records (including all physicians' and nurses' notes and test results), vaccination records associated with the vaccine allegedly causing the injury, pre- and post-injury physician or clinic records (including all relevant growth charts and test results), all post-injury inpatient and outpatient records (including all provider notes, test results, and medication records), if applicable, a death certificate, and if applicable, autopsy results, and
(3)
an identification of any records of the type described in paragraph (1) or (2) which are unavailable to the petitioner and the reasons for their unavailability.
(d)

Additional Information.—
A petition may also include other available relevant medical records relating to the person who suffered such injury or who died from the administration of the vaccine.
(e)

Schedule.—
The petitioner shall submit in accordance with a schedule set by the special master assigned to the petition assessments, evaluations, and prognoses and such other records and documents as are reasonably necessary for the determination of the amount of compensation to be paid to, or on behalf of, the person who suffered such injury or who died from the administration of the vaccine.
(f)

Maternal Immunization.—
(1)

In general.—
Notwithstanding any other provision of law, for purposes of this subtitle, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine.
(2)

Definition.—
As used in this subsection, the term “child” shall have the meaning given that term by subsections (a) and (b) of section 8 of title 1, United States Code, except that, for purposes of this subsection, such section 8 shall be applied as if the term “include” in subsection (a) of such section were replaced with the term “mean”.

JURISDICTION
Sec. 2112.
[300aa–12]
(a)

General Rule.—
The United States Claims Court and the United States Claims Court special masters shall, in accordance with this section, have jurisdiction over proceedings to determine if a petitioner under section 2111 is entitled to compensation under the Program and the amount of such compensation. The United States Claims Court may issue and enforce such orders as the court deems necessary to assure the prompt payment of any compensation awarded.
(b)

Parties.—
(1)
In all proceedings brought by the filing of a petition under section 2111(b), the Secretary shall be named as the respondent, shall participate, and shall be represented in accordance with section 518(a) of title 28, United States Code.
(2)
Within 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register. The special master designated with respect to such petition under subsection (c) shall afford all interested persons an opportunity to submit relevant, written information—
(A)
relating to the existence of the evidence described in section 2113(a)(1)(B), or
(B)
relating to any allegation in a petition with respect to the matters described in section 2111(c)(1)(C)(ii).
(c)

United States Claims Court Special Masters.—
(1)
There is established within the United States Claims Court an office of special masters which shall consist of not more than 8 special masters. The judges of the United States Claims Court shall appoint the special masters, 1 of whom, by designation of the judges of the United States Claims Court, shall serve as chief special master. The appointment and reappointment of the special masters shall be by the concurrence of a majority of the judges of the court.
(2)
The chief special master and other special masters shall be subject to removal by the judges of the United States Claims Court for incompetency, misconduct, or neglect of duty or for physical or mental disability or for other good cause shown.
(3)
A special master's office shall be terminated if the judges of the United States Claims Court determine, upon advice of the chief special master, that the services performed by that office are no longer needed.
(4)
The appointment of any individual as a special master shall be for a term of 4 years, subject to termination under paragraphs (2) and (3). Individuals serving as special masters upon the date of the enactment of this subsection shall serve for 4 years from the date of their original appointment, subject to termination under paragraphs (2) and (3). The chief special master in office on the date of the enactment of this subsection shall continue to serve as chief special master for the balance of the master's term, subject to termination under paragraphs (2) and (3).
(5)
The compensation of the special masters shall be determined by the judges of the United States Claims Court, upon advice of the chief special master. The salary of the chief special master shall be the annual rate of basic pay for level IV of the Executive Schedule, as prescribed by section 5315, title 5, United States Code. The salaries of the other special masters shall not exceed the annual rate of basic pay of level V of the Executive Schedule, as prescribed by section 5316, title 5, United States Code.
(6)
The chief special master shall be responsible for the following:
(A)
Administering the office of special masters and their staff, providing for the efficient, expeditious, and effective handling of petitions, and performing such other duties related to the Program as may be assigned to the chief special master by a concurrence of a majority of the United States Claims Courts4 judges.
^4
So in law. Probably should be “United States Court of Federal Claims”.
(B)
Appointing and fixing the salary and duties of such administrative staff as are necessary. Such staff shall be subject to removal for good cause by the chief special master.
(C)
Managing and executing all aspects of budgetary and administrative affairs affecting the special masters and their staff, subject to the rules and regulations of the Judicial Conference of the United States. The Conference rules and regulations pertaining to United States magistrates shall be applied to the special masters.
(D)
Coordinating with the United States Claims Court the use of services, equipment, personnel, information, and facilities of the United States Claims Court without reimbursement.
(E)
Reporting annually to the Congress and the judges of the United States Claims Court on the number of petitions filed under section 2111 and their disposition, the dates on which the vaccine-related injuries and deaths for which the petitions were filed occurred, the types and amounts of awards, the length of time for the disposition of petitions, the cost of administering the Program, and recommendations for changes in the Program.
(d)

Special Masters.—
(1)
Following the receipt and filing of a petition under section 2111, the clerk of the United States Claims Court shall forward the petition to the chief special master who shall designate a special master to carry out the functions authorized by paragraph (3).
(2)
The special masters shall recommend rules to the Claims Court and, taking into account such recommended rules, the Claims Court shall promulgate rules pursuant to section 2071 of title 28, United States Code. Such rules shall—
(A)
provide for a less-adversarial, expeditious, and informal proceeding for the resolution of petitions,
(B)
include flexible and informal standards of admissibility of evidence,
(C)
include the opportunity for summary judgment,
(D)
include the opportunity for parties to submit arguments and evidence on the record without requiring routine use of oral presentations, cross examinations, or hearings, and
(E)
provide for limitations on discovery and allow the special masters to replace the usual rules of discovery in civil actions in the United States Claims Court.
(3)
(A)
A special master to whom a petition has been assigned shall issue a decision on such petition with respect to whether compensation is to be provided under the Program and the amount of such compensation. The decision of the special master shall—
(i)
include findings of fact and conclusions of law, and
(ii)
be issued as expeditiously as practicable but not later than 240 days, exclusive of suspended time under subparagraph (C), after the date the petition was filed.
The decision of the special master may be reviewed by the United States Claims Court in accordance with subsection (e).
(B)
In conducting a proceeding on a petition a special master—
(i)
may require such evidence as may be reasonable and necessary,
(ii)
may require the submission of such information as may be reasonable and necessary,
(iii)
may require the testimony of any person and the production of any documents as may be reasonable and necessary,
(iv)
shall afford all interested persons an opportunity to submit relevant written information—
(I)
relating to the existence of the evidence described in section 2113(a)(1)(B), or
(II)
relating to any allegation in a petition with respect to the matters described in section 2111(c)(1)(C)(ii), and
(v)
may conduct such hearings as may be reasonable and necessary.
There may be no discovery in a proceeding on a petition other than the discovery required by the special master.
(C)
In conducting a proceeding on a petition a special master shall suspend the proceedings one time for 30 days on the motion of either party. After a motion for suspension is granted, further motions for suspension by either party may be granted by the special master, if the special master determines the suspension is reasonable and necessary, for an aggregate period not to exceed 150 days.
(D)
If, in reviewing proceedings on petitions for vaccine-related injuries or deaths associated with the administration of vaccines before the effective date of this part, the chief special master determines that the number of filings and resultant workload place an undue burden on the parties or the special master involved in such proceedings, the chief special master may, in the interest of justice, suspend proceedings on any petition for up to 30 months (but for not more than 6 months at a time) in addition to the suspension time under subparagraph (C).
(4)
(A)
Except as provided in subparagraph (B), information submitted to a special master or the court in a proceeding on a petition may not be disclosed to a person who is not a party to the proceeding without the express written consent of the person who submitted the information.
(B)
A decision of a special master or the court in a proceeding shall be disclosed, except that if the decision is to include information—
(i)
which is trade secret or commercial or financial information which is privileged and confidential, or
(ii)
which are medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy,
and if the person who submitted such information objects to the inclusion of such information in the decision, the decision shall be disclosed without such information.
(e)

Action by the United States Claims Court.—
(1)
Upon issuance of the special master's decision, the parties shall have 30 days to file with the clerk of the United States Claims Court a motion to have the court review the decision. If such a motion is filed, the other party shall file a response with the clerk of the United States Claims Court no later than 30 days after the filing of such motion.
(2)
Upon the filing of a motion under paragraph (1) with respect to a petition, the United States Claims Court shall have jurisdiction to undertake a review of the record of the proceedings and may thereafter—
(A)
uphold the findings of fact and conclusions of law of the special master and sustain the special master's decision,
(B)
set aside any findings of fact or conclusion of law of the special master found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law, or
(C)
remand the petition to the special master for further action in accordance with the court's direction.
The court shall complete its action on a petition within 120 days of the filing of a response under paragraph (1) excluding any days the petition is before a special master as a result of a remand under subparagraph (C). The court may allow not more than 90 days for remands under subparagraph (C).
(3)
In the absence of a motion under paragraph (1) respecting the special master's decision or if the United States Claims Court takes the action described in paragraph (2)(A) with respect to the special master's decision, the clerk of the United States Claims Court shall immediately enter judgment in accordance with the special master's decision.
(f)

Appeals.—
The findings of fact and conclusions of law of the United States Claims Court on a petition shall be final determinations of the matters involved, except that the Secretary or any petitioner aggrieved by the findings or conclusions of the court may obtain review of the judgment of the court in the United States court of appeals for the Federal Circuit upon petition filed within 60 days of the date of the judgment with such court of appeals within 60 days of the date of entry of the United States Claims Court's5 judgment with such court of appeals.
^5
So in law. Probably should be a reference to the United States Court of Federal Claims.
(g)6

Notice.—
If—
^6
Subsection (i)(2) of section 201 of Public Law 102–168 (105 Stat. 1104), which was enacted on November 26, 1991, provided that the amendments made by subsections (d) and (f) of such section “shall take effect as if the amendments had been in effect on and after October 1, 1988”. Such subsections (d) and (f) related to actions by petitioners, and to annuities, respectively, and involved amendments to sections 2112(g), 2115(f)(4), 2116(c), and 2121(b).
(1)
a special master fails to make a decision on a petition within the 240 days prescribed by subsection (d)(3)(A)(ii) (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D), and (B) any days the petition is before a special master as a result of a remand under subsection (e)(2)(C)), or
(2)
the United States Claims Court fails to enter a judgment under this section on a petition within 420 days (excluding (A) any period of suspension under subsection (d)(3)(C) or (d)(3)(D), and (B) any days the petition is before a special master as a result of a remand under subsection (e)(2)(C)) after the date on which the petition was filed,
the special master or court shall notify the petitioner under such petition that the petitioner may withdraw the petition under section 2121(b) or the petitioner may choose under section 2121(b) to have the petition remain before the special master or court, as the case may be.

DETERMINATION OF ELIGIBILITY AND COMPENSATION
Sec. 2113.
[300aa–13]
(a)

General Rule.—
(1)
Compensation shall be awarded under the Program to a petitioner if the special master or court finds on the record as a whole—
(A)
that the petitioner has demonstrated by a preponderance of the evidence the matters required in the petition by section 2111(c)(1), and
(B)
that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition.
The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion.
(2)
For purposes of paragraph (1), the term “factors unrelated to the administration of the vaccine”—
(A)
does not include any idiopathic, unexplained, unknown, hypothetical, or undocumentable cause, factor, injury, illness, or condition, and
(B)
may, as documented by the petitioner's evidence or other material in the record, include infection, toxins, trauma (including birth trauma and related anoxia), or metabolic disturbances which have no known relation to the vaccine involved, but which in the particular case are shown to have been the agent or agents principally responsible for causing the petitioner's illness, disability, injury, condition, or death.
(b)

Matters To Be Considered.—
(1)
In determining whether to award compensation to a petitioner under the Program, the special master or court shall consider, in addition to all other relevant medical and scientific evidence contained in the record—
(A)
any diagnosis, conclusion, medical judgment, or autopsy or coroner's report which is contained in the record regarding the nature, causation, and aggravation of the petitioner's illness, disability, injury, condition, or death, and
(B)
the results of any diagnostic or evaluative test which are contained in the record and the summaries and conclusions.
Any such diagnosis, conclusion, judgment, test result, report, or summary shall not be binding on the special master or court. In evaluating the weight to be afforded to any such diagnosis, conclusion, judgment, test result, report, or summary, the special master or court shall consider the entire record and the course of the injury, disability, illness, or condition until the date of the judgment of the special master or court.
(2)
The special master or court may find the first symptom or manifestation of onset or significant aggravation of an injury, disability, illness, condition, or death described in a petition occurred within the time period described in the Vaccine Injury Table even though the occurrence of such symptom or manifestation was not recorded or was incorrectly recorded as having occurred outside such period. Such a finding may be made only upon demonstration by a preponderance of the evidence that the onset or significant aggravation of the injury, disability, illness, condition, or death described in the petition did in fact occur within the time period described in the Vaccine Injury Table.
(c)

Record Defined.—
For purposes of this section, the term “record” means the record established by the special masters of the United States Claims Court in a proceeding on a petition filed under section 2111.

VACCINE INJURY TABLE
Sec. 2114.
[300aa–14]
(a)

Initial Table.—
The following is a table of vaccines, the injuries, disabilities, illnesses, conditions, and deaths resulting from the administration of such vaccines, and the time period in which the first symptom or manifestation of onset or of the significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths is to occur after vaccine administration for purposes of receiving compensation under the Program:

VACCINE INJURY TABLE
I. | DTP; P; DTP/Polio Combination; or Any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or Partial Cell Bacteria, or Specific Pertussis Antigen(s). |
| Illness, disability, injury, or condition covered: | Time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration:
| A. Anaphylaxis or anaphylactic shock | 24 hours
| B. Encephalopathy (or encephalitis) | 3 days
| C. Shock-collapse or hypotonic-hyporesponsive collapse | 3 days
| D. Residual seizure disorder in accordance with subsection (b)(2) | 3 days
| E. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable
II. | Measles, mumps, rubella, or any vaccine containing any of the foregoing as a component; DT; Td; or Tetanus Toxoid. |
| A. Anaphylaxis or anaphylactic shock | 24 hours
| B. Encephalopathy (or encephalitis) | 15 days (for mumps, rubella, measles, or any vaccine containing any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid).
| C. Residual seizure disorder in accordance with subsection (b)(2) | 15 days (for mumps, rubella, measles, or any vaccine containing any of the foregoing as a component). 3 days (for DT, Td, or tetanus toxoid).
| D. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable
III. | Polio Vaccines (other than Inactivated Polio Vaccine). |
| A. Paralytic polio |
| —in a non-immunodeficient recipient | 30 days
| —in an immunodeficient recipient | 6 months
| —in a vaccine-associated community case | Not applicable
| B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable
IV. | Inactivated Polio Vaccine. |
| A. Anaphylaxis or anaphylactic shock | 24 hours
| B. Any acute complication or sequela (including death) of an illness, disability, injury, or condition referred to above which illness, disability, injury, or condition arose within the time period prescribed | Not applicable
(b)

Qualifications and Aids to Interpretation.—
The following qualifications and aids to interpretation shall apply to the Vaccine Injury Table in subsection (a):
(1)
A shock-collapse or a hypotonic-hyporesponsive collapse may be evidenced by indicia or symptoms such as decrease or loss of muscle tone, paralysis (partial or complete), hemiplegia or hemiparesis, loss of color or turning pale white or blue, unresponsiveness to environmental stimuli, depression of consciousness, loss of consciousness, prolonged sleeping with difficulty arousing, or cardiovascular or respiratory arrest.
(2)
A petitioner may be considered to have suffered a residual seizure disorder if the petitioner did not suffer a seizure or convulsion unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit before the first seizure or convulsion after the administration of the vaccine involved and if—
(A)
in the case of a measles, mumps, or rubella vaccine or any combination of such vaccines, the first seizure or convulsion occurred within 15 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit, and
(B)
in the case of any other vaccine, the first seizure or convulsion occurred within 3 days after administration of the vaccine and 2 or more seizures or convulsions occurred within 1 year after the administration of the vaccine which were unaccompanied by fever or accompanied by a fever of less than 102 degrees Fahrenheit.
(3)
(A)
The term “encephalopathy” means any significant acquired abnormality of, or injury to, or impairment of function of the brain. Among the frequent manifestations of encephalopathy are focal and diffuse neurologic signs, increased intracranial pressure, or changes lasting at least 6 hours in level of consciousness, with or without convulsions. The neurological signs and symptoms of encephalopathy may be temporary with complete recovery, or may result in various degrees of permanent impairment. Signs and symptoms such as high pitched and unusual screaming, persistent unconsolable crying, and bulging fontanel are compatible with an encephalopathy, but in and of themselves are not conclusive evidence of encephalopathy. Encephalopathy usually can be documented by slow wave activity on an electroencephalogram.
(B)
If in a proceeding on a petition it is shown by a preponderance of the evidence that an encephalopathy was caused by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be considered to be a condition set forth in the table. If at the time a judgment is entered on a petition filed under section 2111 for a vaccine-related injury or death it is not possible to determine the cause, by a preponderance of the evidence, of an encephalopathy, the encephalopathy shall be considered to be a condition set forth in the table. In determining whether or not an encephalopathy is a condition set forth in the table, the court shall consider the entire medical record.
(4)
For purposes of paragraphs (2) and (3), the terms “seizure” and “convulsion” include grand mal, petit mal, absence, myoclonic, tonic-clonic, and focal motor seizures and signs. If a provision of the table to which paragraph (1), (2), (3), or (4) applies is revised under subsection (c) or (d), such paragraph shall not apply to such provision after the effective date of the revision unless the revision specifies that such paragraph is to continue to apply.
(c)

Administrative Revision of the Table.—
(1)
The Secretary may promulgate regulations to modify in accordance with paragraph (3) the Vaccine Injury Table. In promulgating such regulations, the Secretary shall provide for notice and opportunity for a public hearing and at least 180 days of public comment.
(2)
Any person (including the Advisory Commission on Childhood Vaccines) may petition the Secretary to propose regulations to amend the Vaccine Injury Table. Unless clearly frivolous, or initiated by the Commission, any such petition shall be referred to the Commission for its recommendations. Following—
(A)
receipt of any recommendation of the Commission, or
(B)
180 days after the date of the referral to the Commission,
whichever occurs first, the Secretary shall conduct a rulemaking proceeding on the matters proposed in the petition or publish in the Federal Register a statement of reasons for not conducting such proceeding.
(3)
A modification of the Vaccine Injury Table under paragraph (1) may add to, or delete from, the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided or may change the time periods for the first symptom or manifestation of the onset or the significant aggravation of any such injury, disability, illness, condition, or death.
(4)
Any modification under paragraph (1) of the Vaccine Injury Table shall apply only with respect to petitions for compensation under the Program which are filed after the effective date of such regulation.
(d)

Role of Commission.—
Except with respect to a regulation recommended by the Advisory Commission on Childhood Vaccines, the Secretary may not propose a regulation under subsection (c) or any revision thereof, unless the Secretary has first provided to the Commission a copy of the proposed regulation or revision, requested recommendations and comments by the Commission, and afforded the Commission at least 90 days to make such recommendations.
(e)7

Additional Vaccines.—
^7
Section 13632(a)(3) of Public Law 103-66 (107 Stat. 646) provides as follows:
``(3) Effective date.—A revision by the Secretary under section 2114(e) of the Public Health Service Act (42 U.S.C. 300aa–14(e)) (as amended by paragraph (2)) shall take effect upon the effective date of a tax enacted to provide funds for compensation paid with respect to the vaccine to be added to the vaccine injury table in section 2114(a) of the Public Health Service Act (42 U.S.C. 300aa–14(a)).''.
(1)

Vaccines recommended before august 1, 1993.—
By August 1, 1995, the Secretary shall revise the Vaccine Injury Table included in subsection (a) to include—
(A)
vaccines which are recommended to the Secretary by the Centers for Disease Control and Prevention before August 1, 1993, for routine administration to children,
(B)
the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
(C)
the time period in which the first symptoms or manifestations of onset or other significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
(2)

Vaccines recommended after august 1, 1993.—
When after August 1, 1993, the Centers for Disease Control and Prevention recommends a vaccine to the Secretary for routine administration to children, the Secretary shall, within 2 years of such recommendation, amend the Vaccine Injury Table included in subsection (a) to include—
(A)
vaccines which were recommended for routine administration to children,
(B)
the injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines, and
(C)
the time period in which the first symptoms or manifestations of onset or other significant aggravation of such injuries, disabilities, illnesses, conditions, and deaths associated with such vaccines may occur.
(3)

Vaccines recommended for use in pregnant women.—
The Secretary shall revise the Vaccine Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and the information described in subparagraphs (B) and (C) of paragraph (2) with respect to such vaccines.

COMPENSATION
Sec. 2115.
[300aa–15]
(a)

General Rule.—
Compensation awarded under the Program to a petitioner under section 2111 for a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part8 shall include the following:
^8
Effective October 1, 1988.
(1)
(A)
Actual unreimbursable expenses incurred from the date of the judgment awarding such expenses and reasonable projected unreimbursable expenses which—
(i)
result from the vaccine-related injury for which the petitioner seeks compensation,
(ii)
have been or will be incurred by or on behalf of the person who suffered such injury, and
(iii)
(I)
have been or will be for diagnosis and medical or other remedial care determined to be reasonably necessary, or
(II)
have been or will be for rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.
(B)
Subject to section 2116(a)(2), actual unreimbursable expenses incurred before the date of the judgment awarding such expenses which—
(i)
resulted from the vaccine-related injury for which the petitioner seeks compensation,
(ii)
were incurred by or on behalf of the person who suffered such injury, and
(iii)
were for diagnosis, medical or other remedial care, rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary.
(2)
In the event of a vaccine-related death, an award of $250,000 for the estate of the deceased.
(3)
(A)
In the case of any person who has sustained a vaccine-related injury after attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded, compensation for actual and anticipated loss of earnings determined in accordance with generally recognized actuarial principles and projections.
(B)
In the case of any person who has sustained a vaccine-related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person's vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of workers in the private, non-farm sector, less appropriate taxes and the average cost of a health insurance policy, as determined by the Secretary.
(4)
For actual and projected pain and suffering and emotional distress from the vaccine-related injury, an award not to exceed $250,000.
(b)

Vaccines Administered Before the Effective Date.—
Compensation awarded under the Program to a petitioner under section 2111 for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this part9 may include the compensation described in paragraphs (1)(A) and (2) of subsection (a) and may also include an amount, not to exceed a combined total of $30,000, for—
^9
Effective October 1, 1988.
(1)
lost earnings (as provided in paragraph (3) of subsection (a)),
(2)
pain and suffering (as provided in paragraph (4) of subsection (a)), and
(3)
reasonable attorneys' fees and costs (as provided in subsection (e)10.
^{10}
So in law. Probably should be a closing parenthesis after “subsection (e)”.
(c)

Residential and Custodial Care and Service.—
The amount of any compensation for residential and custodial care and service expenses under subsection (a)(1) shall be sufficient to enable the compensated person to remain living at home.
(d)

Types of Compensation Prohibited.—
Compensation awarded under the Program may not include the following:
(1)
Punitive or exemplary damages.
(2)
Except with respect to compensation payments under paragraphs (2) and (3) of subsection (a), compensation for other than the health, education, or welfare of the person who suffered the vaccine-related injury with respect to which the compensation is paid.
(e)

Attorneys' Fees.—
(1)
In awarding compensation on a petition filed under section 2111 the special master or court shall also award as part of such compensation an amount to cover—
(A)
reasonable attorneys' fees, and
(B)
other costs,
incurred in any proceeding on such petition. If the judgment of a special master or court on such a petition does not award compensation, the special master or court may award an amount of compensation to cover petitioner's reasonable attorneys' fees and other costs incurred in any proceeding on such petition if the special master or court determines that the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.
(2)
If the petitioner, before the effective date of this part,11 filed a civil action for damages for any vaccine-related injury or death for which compensation may be awarded under the Program, and petitioned under section 2111(a)(5) to have such action dismissed and to file a petition for compensation under the Program, in awarding compensation on such petition the special master or court may include an amount of compensation limited to the costs and expenses incurred by the petitioner and the attorney of the petitioner before the effective date of this part 11 in preparing, filing, and prosecuting such civil action (including the reasonable value of the attorney's time if the civil action was filed under contingent fee arrangements).
^{11}
Effective October 1, 1988.
(3)
No attorney may charge any fee for services in connection with a petition filed under section 2111 which is in addition to any amount awarded as compensation by the special master or court under paragraph (1).
(f)

Payment of Compensation.—
(1)
Except as provided in paragraph (2), no compensation may be paid until an election has been made, or has been deemed to have been made, under section 2121(a) to receive compensation.
(2)
Compensation described in subsection (a)(1)(A)(iii) shall be paid from the date of the judgment of the United States Claims Court under section 2112 awarding the compensation. Such compensation may not be paid after an election under section 2121(a) to file a civil action for damages for the vaccine-related injury or death for which such compensation was awarded.
(3)
Payments of compensation under the Program and the costs of carrying out the Program shall be exempt from reduction under any order issued under part C of the Balanced Budget and Emergency Deficit Control Act of 1985.
(4)
(A)12
Except as provided in subparagraph (B), payment of compensation under the Program shall be determined on the basis of the net present value of the elements of the compensation and shall be paid from the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal Revenue Code of 1986 in a lump sum of which all or a portion may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner.
^{12}
See footnote for section 2112(g).
(B)
In the case of a payment of compensation under the Program to a petitioner for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this part 13 the compensation shall be determined on the basis of the net present value of the elements of compensation and paid in 4 equal annual installments of which all or a portion of the proceeds 14 may be used as ordered by the special master to purchase an annuity or otherwise be used, with the consent of the petitioner, in a manner determined by the special master to be in the best interests of the petitioner. Any reasonable attorneys' fees and costs shall be paid in a lump sum. If the appropriations under subsection (j) are insufficient to make a payment of an annual installment, the limitation on civil actions prescribed by section 2121(a) shall not apply to a civil action for damages brought by the petitioner entitled to the payment.
^{13}
Effective October 1, 1988.
^{14}
Section 201(e)(1)(B) of Public Law 102–168 (105 Stat. 1103) provided that this subparagraph is amended by striking out “paid in 4 equal installments of which all or portion of the proceeds” and inserting in lieu thereof “shall be paid from appropriations made available under subsection (j) in a lump sum of which all or a portion”. The amendment cannot be executed because the term to be struck does not appear in the law. (Compare “equal installments” with “equal annual installments” and “or portion” with “or a portion”.)
(C)
In purchasing an annuity under subparagraph (A) or (B), the Secretary may purchase a guarantee for the annuity, may enter into agreements regarding the purchase price for and rate of return of the annuity, and may take such other actions as may be necessary to safeguard the financial interests of the United States regarding the annuity. Any payment received by the Secretary pursuant to the preceding sentence shall be paid to the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal Revenue Code of 1986, or to the appropriations account from which the funds were derived to purchase the annuity, whichever is appropriate.
(g)

Program Not Primarily Liable.—
Payment of compensation under the Program shall not be made for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service (1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program (other than under title XIX of the Social Security Act), or (2) by an entity which provides health services on a prepaid basis.
(h)

Liability of Health Insurance Carriers, Prepaid Health Plans, and Benefit Providers.—
No policy of health insurance may make payment of benefits under the policy secondary to the payment of compensation under the Program and—
(1)
no State, and
(2)
no entity which provides health services on a prepaid basis or provides health benefits,
may make the provision of health services or health benefits secondary to the payment of compensation under the Program, except that this subsection shall not apply to the provision of services or benefits under title XIX of the Social Security Act.
(i)

Source of Compensation.—
(1)
Payment of compensation under the Program to a petitioner for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this part 15 shall be made by the Secretary from appropriations under subsection (j).
^{15}
Effective October 1, 1988.
(2)
Payment of compensation under the Program to a petitioner for a vaccine-related injury or death associated with the administration of a vaccine on or after the effective date of this part 15 shall be made from the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal Revenue Code of 1986.
(j)

Authorization.—
For the payment of compensation under the Program to a petitioner for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this part 15 there are authorized to be appropriated to the Department of Health and Human Services $80,000,000 for fiscal year 1989, $80,000,000 for fiscal year 1990, $80,000,000 for fiscal year 1991, $80,000,000 for fiscal year 1992, $110,000,000 for fiscal year 1993, and $110,000,000 for each succeeding fiscal year in which a payment of compensation is required under subsection (f)(4)(B). Amounts appropriated under this subsection shall remain available until expended.

LIMITATIONS OF ACTIONS
Sec. 2116.
[300aa–16]
(a)

General Rule.—
In the case of—
(1)
a vaccine set forth in the Vaccine Injury Table which is administered before the effective date of this part,15 if a vaccine-related injury or death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury or death after the expiration of 28 months after the effective date of this part 15 and no such petition may be filed if the first symptom or manifestation of onset or of the significant aggravation of such injury occurred more than 36 months after the date of administration of the vaccine,
(2)
a vaccine set forth in the Vaccine Injury Table which is administered after the effective date of this part,15 if a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury, and
(3)
a vaccine set forth in the Vaccine Injury Table which is administered after the effective date of this part,16 if a death occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such death after the expiration of 24 months from the date of the death and no such petition may be filed more than 48 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of the injury from which the death resulted.
^{16}
Effective October 1, 1988.
(b)

Effect of Revised Table.—
If at any time the Vaccine Injury Table is revised and the effect of such revision is to permit an individual who was not, before such revision, eligible to seek compensation under the Program, or to significantly increase the likelihood of obtaining compensation, such person may, notwithstanding section 2111(b)(2), file a petition for such compensation not later than 2 years after the effective date of the revision, except that no compensation may be provided under the Program with respect to a vaccine-related injury or death covered under the revision of the table if—
(1)
the vaccine-related death occurred more than 8 years before the date of the revision of the table, or
(2)
the vaccine-related injury occurred more than 8 years before the date of the revision of the table.
(c)17

State Limitations of Actions.—
If a petition is filed under section 2111 for a vaccine-related injury or death, limitations of actions under State law shall be stayed with respect to a civil action brought for such injury or death for the period beginning on the date the petition is filed and ending on the date (1) an election is made under section 2121(a) to file the civil action or (2) an election is made under section 2121(b) to withdraw the petition.
^{17}
See footnote for section 2112(g).

SUBROGRATION
Sec. 2117.
[300aa–17]
(a)

General Rule.—
Upon payment of compensation to any petitioner under the Program, the trust fund which has been established to provide such compensation shall be subrograted 18 to all rights of the petitioner with respect to the vaccine-related injury or death for which compensation was paid, except that the trust fund may not recover under such rights an amount greater than the amount of compensation paid to the petitioner.
^{18}
So in law. Probably should be “subrogated”.
(b)

Disposition of Amounts Recovered.—
Amounts recovered under subsection (a) shall be collected on behalf of, and deposited in, the Vaccine Injury Compensation Trust Fund established under section 9510 of the Internal Revenue Code of 1986.

ADVISORY COMMISSION ON CHILDHOOD VACCINES
Sec. 2119.
[300aa–19]
(a)

Establishment.—
There is established the Advisory Commission on Childhood Vaccines. The Commission shall be composed of:
(1)
Nine members appointed by the Secretary as follows:
(A)
Three members who are health professionals, who are not employees of the United States, and who have expertise in the health care of children, the epidemiology, etiology, and prevention of childhood diseases, and the adverse reactions associated with vaccines, of whom at least two shall be pediatricians.
(B)
Three members from the general public, of whom at least two shall be legal representatives of children who have suffered a vaccine-related injury or death.
(C)
Three members who are attorneys, of whom at least one shall be an attorney whose specialty includes representation of persons who have suffered a vaccine-related injury or death and of whom one shall be an attorney whose specialty includes representation of vaccine manufacturers.
(2)
The Director of the National Institutes of Health, the Assistant Secretary for Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs (or the designees of such officials), each of whom shall be a nonvoting ex officio member.
The Secretary shall select members of the Commission within 90 days of the effective date of this part.19 The members of the Commission shall select a Chair from among the members.
^{19}
Effective October 1, 1988.
(b)

Term of Office.—
Appointed members of the Commission shall be appointed for a term of office of 3 years, except that of the members first appointed, 3 shall be appointed for a term of 1 year, 3 shall be appointed for a term of 2 years, and 3 shall be appointed for a term of 3 years, as determined by the Secretary.
(c)

Meetings.—
The Commission shall first meet within 60 days after all members of the Commission are appointed, and thereafter shall meet not less often than four times per year and at the call of the chair. A quorum for purposes of a meeting is 5. A decision at a meeting is to be made by a ballot of a majority of the voting members of the Commission present at the meeting.
(d)

Compensation.—
Members of the Commission who are officers or employees of the Federal Government shall serve as members of the Commission without compensation in addition to that received in their regular public employment. Members of the Commission who are not officers or employees of the Federal Government shall be compensated at a rate not to exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Commission. All members, while so serving away from their homes or regular places of business, may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as such expenses are authorized by section 5703, title 5, United States Code, for employees serving intermittently.
(e)

Staff.—
The Secretary shall provide the Commission with such professional and clerical staff, such information, and the services of such consultants as may be necessary to assist the Commission in carrying out effectively its functions under this section.
(f)

Functions.—
The Commission shall—
(1)
advise the Secretary on the implementation of the Program,
(2)
on its own initiative or as the result of the filing of a petition, recommend changes in the Vaccine Injury Table,
(3)
advise the Secretary in implementing the Secretary's responsibilities under section 2127 regarding the need for childhood vaccination products that result in fewer or no significant adverse reactions,
(4)
survey Federal, State, and local programs and activities relating to the gathering of information on injuries associated with the administration of childhood vaccines, including the adverse reaction reporting requirements of section 2125(b), and advise the Secretary on means to obtain, compile, publish, and use credible data related to the frequency and severity of adverse reactions associated with childhood vaccines, and
(5)
recommend to the Director of the National Vaccine Program research related to vaccine injuries which should be conducted to carry out this subtitle.
Part B—

Additional Remedies

AUTHORITY TO BRING ACTIONS
Sec. 2121.
[300aa–21]
(a)

Election.—
After judgment has been entered by the United States Claims Court or, if an appeal is taken under section 2112(f), after the appellate court's mandate is issued, the petitioner who filed the petition under section 2111 shall file with the clerk of the United States Claims Court—
(1)
if the judgment awarded compensation, an election in writing to receive the compensation or to file a civil action for damages for such injury or death, or
(2)
if the judgment did not award compensation, an election in writing to accept the judgment or to file a civil action for damages for such injury or death.
An election shall be filed under this subsection not later than 90 days after the date of the court's final judgment with respect to which the election is to be made. If a person required to file an election with the court under this subsection does not file the election within the time prescribed for filing the election, such person shall be deemed to have filed an election to accept the judgment of the court. If a person elects to receive compensation under a judgment of the court in an action for a vaccine-related injury or death associated with the administration of a vaccine before the effective date of this part or is deemed to have accepted the judgment of the court in such an action, such person may not bring or maintain a civil action for damages against a vaccine administrator or manufacturer for the vaccine-related injury or death for which the judgment was entered. For limitations on the bringing of civil actions for vaccine-related injuries or deaths associated with the administration of a vaccine after the effective date of this part 20, see section 2111(a)(2).
^{20}
Effective October 1, 1988.
(b)21

Continuance or Withdrawal of Petition.22—
A petitioner under a petition filed under section 2111 may submit to the United States Claims Court a notice in writing choosing to continue or to withdraw the petition if—
^{21}
See footnote for section 2112(g).
^{22}
The amendment described in section 201(d)(3)(C) of Public Law 102–168 (105 Stat. 1103) has been executed according to the probable intent of the Congress. After redesignating former subparagraphs (A) and (B) as paragraphs (1) and (2), the amendatory instructions of the section provided that section 2121(b) is amended “by running the text of paragraph (1) into the subsection heading and making the margin of the text full measure”. The instructions were applied to portions of the matter preceding paragraph (1) as redesignated, rather than to the text of paragraph (1). (That is, the instructions were applied to the former paragraph (1).)
(1)
a special master fails to make a decision on such petition within the 240 days prescribed by section 2112(d)(3)(A)(ii) (excluding (i) any period of suspension under section 2112(d)(3)(C) or 2112(d)(3)(D), and (ii) any days the petition is before a special master as a result of a remand under section 2112(e)(2)(C)), or
(2)
the court fails to enter a judgment under section 2112 on the petition within 420 days (excluding (i) any period of suspension under section 2112(d)(3)(C) or 2112(d)(3)(D), and (ii) any days the petition is before a special master as a result of a remand under section 2112(e)(2)(C)) after the date on which the petition was filed.
Such a notice shall be filed within 30 days of the provision of the notice required by section 2112(g).
(c)

Limitations of Actions.—
A civil action for damages arising from a vaccine-related injury or death for which a petition was filed under section 2111 shall, except as provided in section 2116(c), be brought within the period prescribed by limitations of actions under State law applicable to such civil action.

STANDARDS OF RESPONSIBILITY
Sec. 2122.
[300aa–22]
(a)

General Rule.—
Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for damages for a vaccine-related injury or death.
(b)

Unavoidable Adverse Side Effects; Warnings.—
(1)
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part 23 if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
^{23}
Effective October 1, 1988.
(2)
For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A)
that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 2123(d)(2), or
(B)
by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
(c)

Direct Warnings.—
No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part 24 solely due to the manufacturer's failure to provide direct warnings to the injured party (or the injured party's legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
^{24}
Effective October 1, 1988.
(d)

Construction.—
The standards of responsibility prescribed by this section are not to be construed as authorizing a person who brought a civil action for damages against a vaccine manufacturer for a vaccine-related injury or death in which damages were denied or which was dismissed with prejudice to bring a new civil action against such manufacturer for such injury or death.
(e)

Preemption.—
No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this subtitle.

TRIAL
Sec. 2123.
[300aa–23]
(a)

General Rule.—
A civil action against a vaccine manufacturer for damages for a vaccine-related injury or death associated with the administration of a vaccine after the effective date of this part 24 which is not barred by section 2111(a)(2) shall be tried in three stages.
(b)

Liability.—
The first stage of such a civil action shall be held to determine if a vaccine manufacturer is liable under section 2122.
(c)

General Damages.—
The second stage of such a civil action shall be held to determine the amount of damages (other than punitive damages) a vaccine manufacturer found to be liable under section 2122 shall be required to pay.
(d)

Punitive Damages.—
(1)
If sought by the plaintiff, the third stage of such an action shall be held to determine the amount of punitive damages a vaccine manufacturer found to be liable under section 2122 shall be required to pay.
(2)
If in such an action the manufacturer shows that it complied, in all material respects, with all requirements under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act applicable to the vaccine and related to the vaccine injury or death with respect to which the action was brought, the manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in—
(A)
fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine under section 351,
(B)
intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or
(C)
other criminal or illegal activity relating to the safety and effectiveness of vaccines,
which activity related to the vaccine-related injury or death for which the civil action was brought.
(e)

Evidence.—
In any stage of a civil action, the Vaccine Injury Table, any finding of fact or conclusion of law of the United States Claims Court or a special master in a proceeding on a petition filed under section 2111 and the final judgment of the United States Claims Court and subsequent appellate review on such a petition shall not be admissible.
Part C—

Assuring a Safer Childhood Vaccination Program in the United States

RECORDING AND REPORTING OF INFORMATION
Sec. 2125.
[300aa–25]
(a)

General Rule.—
Each health care provider who administers a vaccine set forth in the Vaccine Injury Table to any person shall record, or ensure that there is recorded, in such person's permanent medical record (or in a permanent office log or file to which a legal representative shall have access upon request) with respect to each such vaccine—
(1)
the date of administration of the vaccine,
(2)
the vaccine manufacturer and lot number of the vaccine,
(3)
the name and address and, if appropriate, the title of the health care provider administering the vaccine, and
(4)
any other identifying information on the vaccine required pursuant to regulations promulgated by the Secretary.
(b)

Reporting.—
(1)
Each health care provider and vaccine manufacturer shall report to the Secretary—
(A)
the occurrence of any event set forth in the Vaccine Injury Table, including the events set forth in section 2114(b) which occur within 7 days of the administration of any vaccine set forth in the Table or within such longer period as is specified in the Table or section,
(B)
the occurrence of any contraindicating reaction to a vaccine which is specified in the manufacturer's package insert, and
(C)
such other matters as the Secretary may by regulation require.
Reports of the matters referred to in subparagraphs (A) and (B) shall be made beginning 90 days after the effective date of this part.25 The Secretary shall publish in the Federal Register as soon as practicable after such date a notice of the reporting requirement.
^{25}
Effective December 22, 1987.
(2)
A report under paragraph (1) respecting a vaccine shall include the time periods after the administration of such vaccine within which vaccine-related illnesses, disabilities, injuries, or conditions, the symptoms and manifestations of such illnesses, disabilities, injuries, or conditions, or deaths occur, and the manufacturer and lot number of the vaccine.
(3)
The Secretary shall issue the regulations referred to in paragraph (1)(C) within 180 days of the effective date of this part.26
^{26}
Effective December 22, 1987.
(c)

Release of Information.—
(1)
Information which is in the possession of the Federal Government and State and local governments under this section and which may identify an individual shall not be made available under section 552 of title 5, United States Code, or otherwise, to any person except—
(A)
the person who received the vaccine, or
(B)
the legal representative of such person.
(2)
For purposes of paragraph (1), the term “information which may identify an individual” shall be limited to the name, street address, and telephone number of the person who received the vaccine and of that person's legal representative and the medical records of such person relating to the administration of the vaccine, and shall not include the locality and State of vaccine administration, the name of the health care provider who administered the vaccine, the date of the vaccination, or information concerning any reported illness, disability, injury, or condition resulting from the administration of the vaccine, any symptom or manifestation of such illness, disability, injury, or condition, or death resulting from the administration of the vaccine.
(3)
Except as provided in paragraph (1), all information reported under this section shall be available to the public.

vaccine information
Sec. 2126.
[300aa–26]
(a)

General Rule.—
Not later than 1 year after the effective date of this part, the Secretary shall develop and disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child or to any other individual receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.
(b)

Development and Revision of Materials.—
Such materials shall be developed or revised—
(1)
after notice to the public and 60 days of comment thereon, and
(2)
in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration.
(c)

Information Requirements.—
The information in such materials shall be based on available data and information, shall be presented in understandable terms and shall include—
(1)
a concise description of the benefits of the vaccine,
(2)
a concise description of the risks associated with the vaccine,
(3)
a statement of the availability of the National Vaccine Injury Compensation Program, and
(4)
such other relevant information as may be determined by the Secretary.
(d)

Health Care Provider Duties.—
On and after a date determined by the Secretary which is—
(1)
after the Secretary develops the information materials required by subsection (a), and
(2)
not later than 6 months after the date such materials are published in the Federal Register,
each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child or to any other individual to whom such provider intends to administer such vaccine a copy of the information materials developed pursuant to subsection (a), supplemented with visual presentations or oral explanations, in appropriate cases. Such materials shall be provided prior to the administration of such vaccine.

MANDATE FOR SAFER CHILDHOOD VACCINES
Sec. 2127.
[300aa–27]
(a)

General Rule.—
In the administration of this subtitle and other pertinent laws under the jurisdiction of the Secretary, the Secretary shall—
(1)
promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on the effective date of this part 27 and promote the refinement of such vaccines, and
^{27}
Effective December 22, 1987.
(2)
make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.
(b)

Task Force.—
(1)
The Secretary shall establish a task force on safer childhood vaccines which shall consist of the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control.
(2)
The Director of the National Institutes of Health shall serve as chairman of the task force.
(3)
In consultation with the Advisory Commission on Childhood Vaccines, the task force shall prepare recommendations to the Secretary concerning implementation of the requirements of subsection (a).
(c)

Report.—
Within 2 years after the effective date of this part,27 and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period.

MANUFACTURER RECORDKEEPING AND REPORTING
Sec. 2128.
[300aa–28]
(a)

General Rule.—
Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after the effective date of this part—27
(1)
prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity,
(2)
if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test,
(3)
include with each such report a certification signed by a responsible corporate official that such report is true and complete, and
(4)
prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number.
(b)

Sanction.—
Any vaccine manufacturer who intentionally destroys, alters, falsifies, or conceals any record or report required under paragraph (1) or (2) of subsection (a) shall—
(1)
be subject to a civil penalty of up to $100,000 per occurrence, or
(2)
be fined $50,000 or imprisoned for not more than 1 year, or both.
Such penalty shall apply to the person who intentionally destroyed, altered, falsified, or concealed such record or report, to the person who directed that such record or report be destroyed, altered, falsified, or concealed, and to the vaccine manufacturer for which such person is an agent, employee, or representative. Each act of destruction, alteration, falsification, or concealment shall be treated as a separate occurrence.
Part D—

General Provisions

citizen's actions
Sec. 2131.
[300aa–31]
(a)

General Rule.—
Except as provided in subsection (b), any person may commence in a district court of the United States a civil action on such person's own behalf against the Secretary where there is alleged a failure of the Secretary to perform any act or duty under this subtitle.
(b)

Notice.—
No action may be commenced under subsection (a) before the date which is 60 days after the person bringing the action has given written notice of intent to commence such action to the Secretary.
(c)

Costs of Litigation.—
The court, in issuing any final order in any action under this section, may award costs of litigation (including reasonable attorney and expert witness fees) to any plaintiff who substantially prevails on one or more significant issues in the action.

JUDICIAL REVIEW
Sec. 2132.
[300aa–32]
A petition for review of a regulation under this subtitle may be filed in a court of appeals of the United States within 60 days from the date of the promulgation of the regulation or after such date if such petition is based solely on grounds arising after such 60th day.

definitions
Sec. 2133.28
[300aa–33]
For purposes of this subtitle:
^{28}
Paragraphs (3) and (5) above appear so as to reflect the probable intent of the Congress, and former paragraph (7) has been struck to reflect such intent. Sections 1714, 1715, and 1716 of Public Law 107–296 (116 Stat. 2320, 2321) made amendments to section 2133 with respect to such paragraphs. Subsequently, section 102(a) of division L of Public Law 108–7 (117 Stat. 528) was enacted, and that section indicated the intent of the Congress to nullify those amendments. That section repealed sections 1714, 1715, and 1716 rather than directly amending paragraphs (3), (5), and (7). (That section also repealed section 1717, which related to effective dates.)
Section 102(b) of Public Law 108–7 provided as follows: “The Public Health Service Act (42 U.S.C. 201 et seq.) shall be applied and administered as if the sections repealed by subsection (a) had never been enacted.”. Consistent with that provision, section 2133 is shown above to reflect the assumption that repealing a provision of law that makes a change in an Act has the effect of amending that Act so as to undo the change.
Section 102(c) of such Public Law provides as follows: “No inference shall be drawn from the enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-296), or from this repeal, regarding the law prior to enactment of sections 1714 through 1717 of the Homeland Security Act of 2002 (Public Law 107-296). Further, no inference shall be drawn that subsection (a) or (b) affects any change in that prior law, or that Leroy v. Secretary of Health and Human Services, Office of Special Master, No. 02-392V (October 11, 2002), was incorrectly decided.”.
(1)
The term “health care provider” means any licensed health care professional, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities) under whose authority a vaccine set forth in the Vaccine Injury Table is administered.
(2)
The term “legal representative” means a parent or an individual who qualifies as a legal guardian under State law.
(3)
The term “manufacturer” means any corporation, organization, or institution, whether public or private (including Federal, State, and local departments, agencies, and instrumentalities), which manufactures, imports, processes, or distributes under its label any vaccine set forth in the Vaccine Injury Table, except that, for purposes of section 2128, such term shall include the manufacturer of any other vaccine covered by that section. The term “manufacture” means to manufacture, import, process, or distribute a vaccine.
(4)
The term “significant aggravation” means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health.
(5)
The term “vaccine-related injury or death” means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine.
(6)
(A)
The term “Advisory Commission on Childhood Vaccines” means the Commission established under section 2119.
(B)
The term “Vaccine Injury Table” means the table set out in section 2114.

termination of program
Sec. 2134.
[300aa–34]
(a)

Reviews.—
The Secretary shall review the number of awards of compensation made under the program to petitioners under section 2111 for vaccine-related injuries and deaths associated with the administration of vaccines on or after the effective date of this part 29 as follows:
^{29}
Effective December 22, 1987.
(1)
The Secretary shall review the number of such awards made in the 12-month period beginning on the effective date of this part.29
(2)
At the end of each 3-month period beginning after the expiration of the 12-month period referred to in paragraph (1) the Secretary shall review the number of such awards made in the 3-month period.
(b)

Report.—
(1)
If in conducting a review under subsection (a) the Secretary determines that at the end of the period reviewed the total number of awards made by the end of that period and accepted under section 2121(a) exceeds the number of awards listed next to the period reviewed in the table in paragraph (2)—
(A)
the Secretary shall notify the Congress of such determination, and
(B)
beginning 180 days after the receipt by Congress of a notification under paragraph (1), no petition for a vaccine-related injury or death associated with the administration of a vaccine on or after the effective date of this part 29 may be filed under section 2111.
Section 2111(a) and part B shall not apply to civil actions for damages for a vaccine-related injury or death for which a petition may not be filed because of subparagraph (B).
(2)
The table referred to in paragraph (1) is as follows:
| Total number of awards
| by the end of the period
Period reviewed: | reviewed
12 months after the effective date of part | 150
13th through the 15th month after such date | 188
16th through the 18th month after such date | 225
19th through the 21st month after such date | 263
22nd through the 24th month after such date | 300
25th through the 27th month after such date | 338
28th through the 30th month after such date | 375
31st through the 33rd month after such date | 413
34th through the 36th month after such date | 450
37th through the 39th month after such date | 488
40th through the 42nd month after such date | 525
43rd through the 45th month after such date | 563
46th through the 48th month after such date | 600.