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Public Health Service Act, section 300aa-25

From the U.S. House of Representatives Downloadable U.S. Code
[uscode.house.gov]
[Laws in effect as of January 5, 1999]

[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
    .
 
-HEAD-
    subpart c - assuring a safer childhood vaccination program in
    united states
 
-CITE-
    42 USC Sec. 300aa-25                                         01/05/99
 
-EXPCITE-
    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
 
-HEAD-
    Sec. 300aa-25. Recording and reporting of information
 
-STATUTE-
    (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.
 
-SOURCE-
    (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.)
 
-COD-
                                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.
 
-MISC3-
                                 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.
 
-SECREF-
                   SECTION REFERRED TO IN OTHER SECTIONS
      This section is referred to in section 300aa-19 of this title.


Source: http://www.fda.gov/opacom/laws/phsvcact/300aa-25.htm accessed on June 6, 2006.

This page last reviewed: Tuesday, January 05, 2016
This information is provided as technical reference material. Please contact us at cwus@cdc.gov to request a simple text version of this document.
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