[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
________________________________________________________________________

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 <a href="/cdn-cgi/l/email-protection#addfc2cfc8dfd9dec6edcec9c8df83cbc9cc83cac2db"><span class="__cf_email__" data-cfemail="fa8895989f888e8991ba999e9f88d49c9e9bd49d958c">[email protected]</span></a>, 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 <a href="/cdn-cgi/l/email-protection#34514756514674051a575651461a5250551a535b42"><span class="__cf_email__" data-cfemail="dabfa9b8bfa89aebf4b9b8bfa8f4bcbebbf4bdb5ac">[email protected]</span></a>.

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

[[Page 51072]]

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


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