[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4991 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 4991

To amend the Social Security Act, the Federal Food, Drug, and Cosmetic 
Act, and the Public Health Service Act to ensure a sufficient supply of 
                   vaccines, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            January 16, 2008

Mr. Waxman (for himself and Ms. Roybal-Allard) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Social Security Act, the Federal Food, Drug, and Cosmetic 
Act, and the Public Health Service Act to ensure a sufficient supply of 
                   vaccines, 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 ``Vaccine Shortage Preparedness Act of 
2008''.

SEC. 2. SALES FROM 6-MONTH SUPPLY.

    Section 1928(d)(6) of the Social Security Act (42 U.S.C. 
1396s(d)(6)) is amended by inserting before the last sentence the 
following: ``The Secretary may sell such quantities of vaccines from 
such supply to public health departments or back to the vaccine 
manufacturers as the Secretary determines appropriate. Proceeds 
received from such sales shall be available to the Secretary only for 
the purposes of procuring pediatric vaccine stockpiles under this 
section and shall remain available until expended.''.

SEC. 3. ONE-YEAR NOTICE ON DISCONTINUING MANUFACTURE OF VACCINE.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506C 
the following section:

``SEC. 506D. DISCONTINUANCE OF VACCINE.

    ``(a) In General.--
            ``(1) Notice to secretary.--A manufacturer of a vaccine 
        approved by the Secretary shall notify the Secretary of a 
        discontinuance of the manufacture of the vaccine at least 12 
        months prior to the date of the discontinuance.
            ``(2) Director of centers for disease control and 
        prevention.--Promptly after receiving a notice under paragraph 
        (1), the Secretary shall inform the Director of the Centers for 
        Disease Control and Prevention of the notice. Promptly after 
        determining that a reduction under subsection (b) applies with 
        respect to such a notice, the Secretary shall inform such 
        Director of the reduction.
            ``(3) Relationship to separate notice program.--In the case 
        of a vaccine that is approved by the Secretary and is a drug 
        described in section 506C(a), this section applies to the 
        vaccine in lieu of section 506C.
    ``(b) Reduction in Notification Period.--The notification period 
required under subsection (a) for a manufacturer may be reduced if the 
manufacturer certifies to the Secretary that good cause exists for the 
reduction, such as a situation in which--
            ``(1) a public health problem may result from continuation 
        of the manufacturing for the 12-month period;
            ``(2) a biomaterials shortage prevents the continuation of 
        the manufacturing for the 12-month period;
            ``(3) a liability problem may exist for the manufacturer if 
        the manufacturing is continued for the 12-month period;
            ``(4) continuation of the manufacturing for the 12-month 
        period may cause substantial economic hardship for the 
        manufacturer; or
            ``(5) the manufacturer has filed for bankruptcy under 
        chapter 7 or 11 of title 11, United States Code.
    ``(c) Distribution.--To the maximum extent practicable, the 
Secretary shall distribute information on the discontinuation of the 
manufacture of vaccines to appropriate physician and patient 
organizations.''.

SEC. 4. CERTAIN AUTHORITIES REGARDING INFLUENZA AND OTHER VACCINES.

    (a) Authorities.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended--
            (1) by redesignating section 317A as section 317A-1; and
            (2) by inserting after section 317 the following section:

``SEC. 317A. CERTAIN AUTHORITIES REGARDING INFLUENZA AND OTHER 
              VACCINES.

    ``(a) Declaration.--The Secretary may declare a public health 
emergency if--
            ``(1) there is a shortage of an approved vaccine for an 
        infectious disease; and
            ``(2) there is a significant risk of a significant outbreak 
        of such disease.
    ``(b) Requirement.--If the Secretary publishes in the Federal 
Register a declaration of a public health emergency under subsection 
(a), each person who is a manufacturer or distributor of such vaccine 
shall provide to the Secretary such information as the Secretary may 
require with respect to the location of supplies of the vaccine, 
including supplies in the possession of the person, supplies scheduled 
to be received by the person, and supplies sold by the person. Any such 
person who fails to comply with an order of the Secretary under the 
preceding sentence is liable to the United States for a civil penalty 
not exceeding $1,000 for each day for which the person is in violation 
of the order.
    ``(c) Availability to States.--
            ``(1) In general.--Subject to paragraph (2), the Secretary 
        shall, at the request of a State, provide to the State 
        information collected by the Secretary under subsection (b).
            ``(2) Restriction; confidentiality.--The Secretary may 
        provide to a State information collected by the Secretary under 
        subsection (b) only if the State agrees--
                    ``(A) to restrict its use of the information to 
                facilitating access to vaccines; and
                    ``(B) to otherwise keep such information 
                confidential.''.
    (b) Study on Reallocation of Vaccine.--Not later than 1 year after 
the date of the enactment of this Act, the Secretary of Health and 
Human Services shall complete a study and submit a report to the 
Congress on successful models and alternatives for tracking and 
facilitating, in consultation with State and local health officials, 
reallocation of vaccine at the local level in times of shortage or 
emergency.
                                 <all>