[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2049 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 2049

To amend the Federal Food, Drug and Cosmetic Act to include a 12 month 
notification period before discontinuing a biological product, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 21, 2002

  Mr. DeWine (for himself, Mrs. Clinton, and Mr. Dodd) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug and Cosmetic Act to include a 12 month 
notification period before discontinuing a biological product, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Childhood Vaccine Supply Act of 
2002''.

SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Inclusion of Biological Products.--Section 506C(a) of the 
Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 356c(a)) is amended--
            (1) in the matter preceding paragraph (1) by striking 
        ``that is the sole manufacturer of a drug'' and inserting ``of 
        a product regulated by the Food and Drug Administration'';
            (2) in subparagraph (C) of paragraph (1), by striking ``of 
        a debilitating disease or condition;'' and inserting ``or 
        treatment of a serious disease or condition; and'';
            (3) in paragraph (2), by striking ``; and'' and inserting 
        ``, or for which a biologics license application has been 
        approved under section 351 of the Public Health Service Act;'';
            (4) by striking paragraph (3); and
            (5) in the flush matter at the end, by striking ``of the 
        drug at least 6 months'' and inserting ``, in the case of a 
        product approved under section 505(b) or 505(j), at least 6 
        months, or in the case of a product approved under section 351 
        of the Public Health Service Act, at least 12 months''.
    (b) Reduction in Notification Period.--Section 506C(b) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c(b)) is amended--
            (1) in paragraph (1), by striking ``6-month period'' and 
        inserting ``notification period prescribed in subsection (a)'';
            (2) in paragraph (2), by striking ``6-month period'' and 
        inserting ``notification period prescribed in subsection (a)'';
            (3) in paragraph (3), by striking ``6-month period'' and 
        inserting ``notification period prescribed in subsection (a)'';
            (4) in paragraph (4), by striking ``6-month period'' and 
        inserting ``notification period prescribed in subsection (a)''; 
        and
            (5) in paragraph (6), by striking ``of the drug involved 
        for 6 months'' and inserting ``of the product approved under 
        section 505(b) or 506(j), for 6 months, or the product approved 
        under section 351 of the Public Health Service Act, for 12 
        months''.
    (c) Distribution.--Section 506C(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356c(c)) is amended by inserting ``, 
hospital,'' after ``physician''.

SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)) 
is amended by adding at the end the following:
    ``(3) The Secretary may purchase pediatric and adult vaccines for 
national stockpiles utilizing a portion of the funds made available 
under this subsection.''.
                                 <all>