[Federal Register Volume 63, Number 129 (Tuesday, July 7, 1998)]
[Notices]
[Pages 36707-36708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17876]



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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guidance will remain in effect until superseded by regulations or new 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 ``[email protected]'', 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 ``[email protected]''.
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

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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