
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC300aa-25]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
                        SUBCHAPTER XIX--VACCINES
 
          Part 2--National Vaccine Injury Compensation Program
 
  subpart c--assuring a safer childhood vaccination program in united 
                                 states
 
Sec. 300aa-25. Recording and reporting of information


(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 300aa-14(b) of this 
    title 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 December 22, 1987. The Secretary shall 
publish in the Federal Register as soon as practicable after such date a 
notice of the reporting requirement.
    (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 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, 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.

(July 1, 1944, ch. 373, title XXI, Sec. 2125, as added Pub. L. 99-660, 
title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774; amended Pub. L. 
100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987, 101 Stat. 1330-221.)

                          Codification

    In subsec. (b)(1), (3), ``December 22, 1987'' was substituted for 
``the effective date of this subpart'' on authority of section 323 of 
Pub. L. 99-660, as amended, set out as an Effective Date note under 
section 300aa-1 of this title.


                               Amendments

    1987--Subsec. (b)(1), (3). Pub. L. 100-203 substituted ``effective 
date of this subpart'' for ``effective date of this part''.


                             Effective Date

    Subpart effective Dec. 22, 1987, see section 323 of Pub. L. 99-660, 
set out as a note under section 300aa-1 of this title.

                  Section Referred to in Other Sections

    This section is referred to in section 300aa-19 of this title.
