[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54903-54904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0265]


Guidance for Industry on Qualifying for Pediatric Exclusivity; 
Availability; Revised

AGENCY: Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised guidance for industry entitled ``Qualifying 
for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, 
and Cosmetic Act.'' FDA is publishing this revised guidance to assist 
industry in interpreting provisions of the Food and Drug Administration 
Modernization Act of 1997 (Modernization Act). This guidance will 
remain in effect until superseded by regulations or new guidance.

DATES: Comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of ``Qualifying 
for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, 
and Cosmetic Act'' to the Drug Information Branch (HFD-210), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, or the Manufacturers Assistance and 
Communications Staff (HFM-42), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist in 
processing your requests. Submit written comments on the guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY 
INFORMATION section of this document for electronic access to the draft 
guidance.

FOR FURTHER INFORMATION CONTACT: 
    Terrie L. Crescenzi, Center for Drug Evaluation and Research (HFD-
2), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-7337, FAX 301-594-6197, 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. Description of the Guidance

    FDA is announcing the availability of a revised guidance for 
industry entitled ``Qualifying for Pediatric Exclusivity Under Section 
505A of the Federal Food, Drug, and Cosmetic Act.'' 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 Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355a). Section 505A of the 
act permits certain 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. FDA plans to issue regulations 
through notice-and-comment rulemaking to implement the pediatric 
exclusivity provisions of the Modernization Act. The agency is 
publishing this procedural guidance to explain how the agency intends 
to implement section 505A of the act in the interim. The guidance will 
be updated as appropriate. This guidance will remain in effect until 
superseded by regulations or new guidance.
    This guidance describes FDA's current thinking on how sponsors may 
qualify for pediatric exclusivity under section 505A of the act. The 
guidance includes the following topics: (1) Whether studies for certain 
drugs will be requested under section 505A(a) or (c), (2) the 
definition of pediatric studies, (3) the content and format of an FDA 
request for pediatric studies, (4) how an applicant can obtain an FDA 
written request, (5) the content of a written agreement for the conduct 
of pediatric studies, (6) the definition of commonly accepted 
scientific principles, (7) the filing of reports of studies, (8) 
acceptance of studies by FDA, (9) scope and nature of pediatric 
exclusivity, (10) publication of exclusivity determinations, (11) 
treatment of information submitted in support of a request for 
pediatric exclusivity, (12) how pediatric studies required under FDA 
regulations may qualify for pediatric exclusivity, and (13) what 
happens after January 1, 2002, the sunset date for the pediatric 
exclusivity provisions of the Modernization Act.
    This level 1 guidance document is being issued consistent with 
FDA's good guidance practices (62 FR 8961, February 27, 1997). It 
represents the agency's current thinking on the implementation of 
section 505A of the

[[Page 54904]]

act and pediatric exclusivity. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). 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. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

II. Paperwork Reduction Act of 1995

    This notice contains no new collections of information. The 
information requested for proposed pediatric studies is already covered 
by the collection of information on investigational new drug 
application regulations (21 CFR part 312) submitted to the Office of 
Management and Budget (OMB) for review and clearance. In accordance 
with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), OMB 
approved the information collection and assigned OMB control number 
0910-0014. The approval expires on December 31, 1999.

III. Electronic Access

    Copies of this guidance for industry are available on the Internet 
at ``http://www.fda.gov/cder/guidance/index.htm'' and at ``http://
www.fda.gov/cber/guidelines.htm''.

    Dated: September 28, 1999.
Margaret M. Dotzel,
Acting Associate Commssioner for Policy.
[FR Doc. 99-26224 Filed 10-7-99; 8:45 am]
BILLING CODE 4160-01-F