[Federal Register: July 7, 1998 (Volume 63, Number 129)]
[Notices]
[Page 36707-36708]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy98-104]
[[Page 36707]]
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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; Request for Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for submissions.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Qualifying for
Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and
Cosmetic Act.'' FDA is also requesting the submission of proposed
pediatric study requests. This guidance is intended to assist industry
in interpreting newly enacted 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guidance will remain in effect until superseded by regulations or new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: Written comments may be submitted on the guidance by October 5,
1998. General comments on agency guidance documents are welcome at any
time. Sponsors of applications for marketed drugs that appear in the
priority section of the ``List of Approved Drugs for Which Additional
Pediatric Information May Produce Health Benefits in the Pediatric
Population'' (the list) (see Docket No. 98N-0056) (63 FR 27733) for
which any exclusivity or patent period expires on or before March 31,
1999, should submit proposed pediatric study requests to the
appropriate new drug review division with a facsimile copy to Khyati N.
Roberts (address below) on or before August 31, 1998, for expedited
consideration.
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: Khyati N. Roberts, Center for Drug
Evaluation and Research (HFD-6), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-6779, FAX 301-594-5493, e-
mail ``robertsk@cder.fda.gov'', or David W. Feigal, Center for
Biologics Evaluation and Research (HFM-6), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0376,
FAX 301-827-0440, e-mail ``feigal@cber.fda.gov''.
SUPPLEMENTARY INFORMATION:
I. Description of the Guidance
FDA is announcing the availability of a 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 (Pub. L. 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, and (11)
treatment of information submitted in support of a request for
pediatric exclusivity.
This guidance document is being implemented immediately without
prior public comment because the guidance is needed to implement the
Modernization Act. However, the agency wishes to solicit comment from
the public, and it is providing a 90-day comment period and
establishing a docket for the receipt of comments. FDA will also
consider comments on pediatric exclusivity submitted to Docket No. 98N-
0056 (containing the ``List of Approved Drugs for Which Additional
Pediatric Information May Produce Health Benefits in the Pediatric
Population'') before July 7, 1998.
This guidance document represents the agency's current thinking on
the implementation of section 505A of the 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.
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
[[Page 36708]]
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. Request for Proposed Pediatric Study Requests
Sponsors of applications for marketed drugs that appear in the
priority section of the list (see Docket No. 98N-0056) for which any
exclusivity or patent period expires on or before March 31, 1999,
should submit proposed pediatric study requests to the appropriate new
drug review division with a facsimile copy to Khyati N. Roberts
(address above) on or before August 17, 1998, for expedited
consideration. These sponsors should label their proposals ``Proposed
Pediatric Study Request--Expiration on or Before March 31, 1999.'' FDA
will endeavor to issue Written Requests on or before October 15, 1998,
for adequate proposals or as soon thereafter as possible. FDA will ask
sponsors of proposals that are submitted before August 31, 1998, and
that are not adequate to resubmit their proposal. The resubmitted
proposal will be processed based on the date of resubmission. Other
proposed pediatric study requests may also be submitted during this
period, but they will be processed in the order described in the
guidance. As FDA gains experience with this process, it may provide
additional guidance regarding the timing of a proposed pediatric study
request.
III. 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 IND regulations (21 CFR part 312)
submitted to 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.
IV. 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: June 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17876 Filed 7-6-98; 8:45 am]
BILLING CODE 4160-01-F