[Federal Register Volume 62, Number 189 (Tuesday, September 30, 1997)]
[Proposed Rules]
[Pages 51071-51072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25937]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 62, No. 189 / Tuesday, September 30, 1997 /
Proposed Rules
[[Page 51071]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 312, 314, and 601
[Docket No. 97N-0165]
RIN 0910-AB20
Regulations Requiring Manufacturers to Assess the Safety and
Effectiveness of New Drugs and Biological Products in Pediatric
Patients; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of a public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to discuss issues related to the agency's proposed rule on
regulations requiring manufacturers to assess the safety and
effectiveness of new drugs and biological products in pediatric
patients. The proposed rule, previously announced in the Federal
Register, requested written comments and proposed new regulations
requiring pediatric studies of certain new drug and biological
products. The purpose of the meeting is to provide experts in the field
and interested individuals an opportunity to discuss specific issues
raised by the proposed rule. The agency is seeking comment and specific
data on the proposed rule.
DATES: The public meeting will be held on October 27, 1997, from 9 a.m.
to 6 p.m. Please arrive no later than 8:30 a.m. to allow time for
security clearance. Written requests for oral presentations should be
received by the agency on or before October 14, 1997. Written comments
must be submitted on or before November 13, 1997.
ADDRESSES: The public meeting will be held at the Cohen Bldg.,
auditorium, 330 C St. SW., Washington, DC. Submit written requests for
oral presentations to Lisa Barclay, Office of Policy (HF-22), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. To
expedite processing, fax written requests for oral presentations to
301-594-6777. To ensure timely handling, the outer envelope or
facsimile cover sheet should be clearly marked with: Docket No. 97N-
0165, ``Pediatric Labeling Meeting,'' ATTN: Lisa Barclay. Submit
written comments to the Dockets Management Branch (HFA-305), Food and
Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
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
Elaine C. Esber, Center for Biologics Evaluation and Research (HFM-
30), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0641, FAX 301-827-0644, e-mail esber@1.cber.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of August 15, 1997 (62 FR 43900), the
agency published a proposed rule for new regulations requiring
pediatric studies of certain new drug and biological products. The
proposed rule would attempt to partially address a lack of pediatric
use information by requiring that manufacturers of a limited class of
new drug and biological products provide sufficient data and
information to support directions for pediatric use for the claimed
indications before, or soon after, approval. Manufacturers of a limited
class of already marketed drugs and biologics would also, in compelling
circumstances, have to provide such data. The proposed rule is part of
a comprehensive effort to increase the number of new drug and
biological products with clinically significant use in children that
carry adequate labeling for use in that subpopulation.
Because of the importance of ensuring the safety and effectiveness
of the medications administered to children and the need to address the
absence of pediatric labeling in the most effective manner possible,
FDA, in cooperation with the American Academy of Pediatrics, is
announcing a public meeting at which recognized experts in the field,
members of the pharmaceutical industry, and other interested parties
will have an opportunity to discuss certain issues raised by the
proposed rule. FDA will consider information presented and discussed at
the meeting and written comments submitted to the Dockets Management
Branch in the development of the final rule. There is no fee for this
public meeting.
II. Scope of Meeting
The purpose of this meeting is to complement the process for
gathering written comments and recommendations on certain issues raised
by the proposed rule. The meeting will provide recognized experts in
the field, members of the pharmaceutical industry, and other interested
parties an opportunity to discuss these issues. The agency is
specifically seeking comment and data on the following:
(1) What should be considered a ``substantial number'' of pediatric
patients?
(2) Whether the rule should be restricted to new chemical entities,
including new (never-before-approved) drugs, antibiotics and biological
products, or whether it should be applied more broadly (e.g., to
applications for chemical variations of approved products, new
indications, new dosage forms or routes of administration)?
(3) Whether the proposed grounds for waiving the pediatric study
requirement are adequate and whether additional grounds may exist?
(4) What would constitute sufficient data or an adequate pediatric
clinical trial? and
(5) How should dose and safety levels for each of the different
pediatric age groups or stages of development be established? Relevant
to this issue, the agency solicits comment on special problems
associated with studies in neonates and young infants.
III. Requests for Oral Presentations
Persons who wish to participate in the meeting must file a written
or facsimile request for oral presentation with the Office of Policy
(address and fax numbers above). The request for oral presentation
should contain the speaker's name, address, telephone and fax numbers,
title, business affiliation, if any, topic, a brief summary of the
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presentation, and approximate amount of time requested for the
presentation.
The agency requests that persons or groups having similar interests
consolidate their presentations and present them through a single
representative. Because presentations will be limited to 1 day, the
agency may not be able to accommodate all requests for oral
presentations. FDA will allocate the time available for the meeting
among the persons who properly file requests for oral presentations. If
time permits at the conclusion of the meeting, FDA may allow
participation from both interested persons attending the meeting who
did not submit a written request for an oral presentation and those who
requested an opportunity to make a presentation, but, due to the time
limitations, were not granted the request.
IV. Requests for Comments
Interested persons may, on or before November 13, 1997, submit
written comments 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. Received comments
may be seen in the office above between 9 a.m. and 4 p.m., Monday
through Friday.
V. Special Accommodations
In order to accommodate the need for space or technical support,
persons who are planning on using audiovisual equipment during their
oral presentations are urged to provide advance notice of their planned
attendance to one of the contact persons identified above. If you need
special accommodations due to a disability, please contact one of the
contact persons listed above at least 7 days in advance.
VI. Transcripts
Transcripts of the meeting may be requested in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15
working days after the meeting at a cost of 10 cents per page.
Dated: September 24, 1997,
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-25937 Filed 9-29-97; 8:45 am]
BILLING CODE 4160-01-F
