[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remain in effect until superseded by regulations or new guidance.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INFORMATION section of this document for electronic access to the draft
guidance.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]
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