[Federal Register Volume 65, Number 88 (Friday, May 5, 2000)]
[Notices]
[Pages 26217-26218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11328]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1266]


Report to Congress on Pediatric Exclusivity; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
on the pediatric exclusivity program established by the Food and Drug 
Administration Modernization Act of 1997 (the Modernization Act). This 
action is being taken to assist the agency in preparing a report to 
Congress on

[[Page 26218]]

pediatric exclusivity as required by the Federal Food, Drug, and 
Cosmetic Act (the act). FDA is seeking public input on the pediatric 
exclusivity program.

DATES: Submit written comments on the pediatric exclusivity program by 
June 5, 2000.

ADDRESSES: Submit written comments on the pediatric exclusivity program 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Copies of this notice are available on the Internet at http://www.fda.gov/cder/pediatrics.

FOR FURTHER INFORMATION CONTACT:
    Terrie L. Crescenzi, Center for Drug Evaluation and Research (HFD-
104), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-7337, FAX 301-827-2520, e-mail: [email protected], 
or
    Elaine C. Esber, Center for Biologics Evaluation and Research (HFM-
30), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-0641, FAX 301-827-0644, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is seeking public comment on the pediatric exclusivity program. 
Section 111 of the Modernization Act (Public Law 105-115), signed into 
law by President Clinton on November 21, 1997, created section 505A of 
the act (21 U.S.C. 355a). Section 505A of the act permits certain new 
drug applications to obtain an additional 6 months of marketing 
exclusivity if, in accordance with the requirements of the statute, the 
sponsor submits information relating to the use of the drug in the 
pediatric population.
    Under section 505A(k) of the act, FDA must submit a report to 
Congress on the pediatric exclusivity program.

II. Description of the Report

    Under section 505A(k) of the act, FDA must conduct a study and 
report to Congress not later than January 1, 2001, on the experience 
under the pediatric exclusivity provisions of the act. The study and 
report must examine all relevant issues, including:
    1. The effectiveness of the program in improving information about 
important pediatric uses for approved drugs;
    2. The adequacy of the pediatric exclusivity incentive;
    3. The economic impact of the pediatric exclusivity program on 
taxpayers and consumers and the impact of the lack of lower cost 
generic drugs on patients, including on lower income patients; and
    4. Any suggestions for modification.

III. Request for Comments

    FDA invites all interested parties to address the specific topics 
that will be included in the report or any other general issue 
appropriate for this report relevant to the pediatric exclusivity 
provision of the act. Interested persons may submit to the Dockets 
Management Branch (address above) written comments on the pediatric 
exclusivity program by June 5, 2000. Two copies of any comments are to 
be submitted, except that individuals may submit one copy. Comments are 
to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 28, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-11328 Filed 5-4-00; 8:45 am]
BILLING CODE 4160-01-F