[Federal Register Volume 61, Number 61 (Thursday, March 28, 1996)]
[Proposed Rules]
[Pages 13792-13793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7613]



=======================================================================
-----------------------------------------------------------------------

[[Page 13793]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314, 600, and 601

[Docket No. 95N-0329]
RIN 0910-AA57


Changes to An Approved Application; Proposed Rule and Draft 
Guidance Documents; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; notice of meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting to discuss the proposed amendments to the biologics regulations 
for reporting changes to an approved application and corresponding drug 
regulations for submitting supplements for and reporting changes to an 
application for well-characterized biotechnology products. The purpose 
of the meeting is to solicit information and views on the agency's 
proposed rule addressing reporting of changes to an approved 
application as well as discuss the material and categories set forth in 
the closely related draft guidance documents.

DATES: The public meeting will be held on Friday, April 19, 1996, from 
8 a.m. to 5 p.m. Submit written notices of participation, including a 
brief summary of the presentation and approximate time requested, by 
April 15, 1996. Written comments will be accepted until May 6, 1996.

ADDRESSES: The public meeting will be held at the National Institutes 
of Health, Bldg. 10, Masur Auditorium, 9000 Rockville Pike, Bethesda, 
MD. Attendance may be limited to 500, which is the capacity of the 
auditorium. Submit written notices of participation and comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. FDA requests that 
persons who intend to participate notify the agency in advance. To 
expedite processing, written notices of participation may also be FAXED 
to 301-827-3843. 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. Transcripts of the meeting will be available for review at 
the Dockets Management Branch (address above).

FOR FURTHER INFORMATION CONTACT: For information regarding the meeting 
or to advise FDA of an intent to participate: Margaret A. Tart, Center 
for Biologics Evaluation and Research (HFM-42), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
2000, FAX 301-827-3843.
    For information regarding this document: Tracey H. Forfa, Center 
for Biologics Evaluation and Research (HFM-630), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 29, 1996 
(61 FR 2739), FDA announced its intent to hold a public meeting during 
the pendency of the comment period that ends on April 29, 1996, for the 
proposal to amend the biologics regulations for reporting changes to an 
approved application and corresponding drug regulations for submitting 
supplements for and reporting changes to an application for well-
characterized biotechnology products (21 CFR 314.70 and 601.12). During 
this public meeting FDA is seeking comments on the proposed mechanisms 
for reporting changes to an approved application. Specifically, FDA is 
seeking comments on the three-category scheme for reporting changes in 
the product, production process, equipment, facilities, or responsible 
personnel. The three categories would include: (1) Supplement 
submission and approval prior to distribution of a product made using a 
proposed change that has a substantial potential to have an adverse 
effect on a product's safety, purity, potency, or effectiveness; (2) 
notification not less than 30 days prior to distributing a product made 
using a proposed change that has a moderate potential to have an 
adverse effect on a product's safety, purity, potency, or 
effectiveness; and (3) an annual report describing changes that have 
minimal potential to have an adverse effect on a product's safety, 
purity, potency, or effectiveness.
    Further, FDA is asking for comment on the proposed three-category 
reporting system for biological product labeling changes. A change to a 
product package label, container label, or package label would require 
one of the following: (1) Submission of a supplement with FDA approval 
required prior to product distribution; (2) submission of a supplement 
with product distribution allowed prior to FDA approval; or (3) 
submission of the final printed label in an annual report. Promotional 
labeling and advertising would be required to be submitted under 
procedures found at 21 CFR 314.81(b)(3)(i).
    In addition, FDA is seeking public comment on the draft guidance 
documents, ``Changes to An Approved Application; Draft Guidance'' and 
``Draft Guidance; Changes to An Approved Application for Well-
Characterized Therapeutic Recombinant DNA-Derived and Monoclonal 
Antibody Biotechnology Products,'' that were made available 
concurrently with the proposed rule in the Federal Register of January 
29, 1996 (61 FR 2748 and 2749). FDA is seeking comments on the 
categorization of changes in the draft guidance documents and also on 
the utility of the guidance documents to applicants. FDA is not, 
however, intending to use this forum for additional discussion of the 
agency's definition of a well-characterized therapeutic recombinant 
DNA-derived and monoclonal antibody biotechnology product that was 
originally announced in the Federal Register of December 8, 1995 (60 FR 
63048).
    The procedures governing the meeting can be found in 21 CFR part 
15. Prior to the meeting, FDA will determine the amount of time 
assigned to each person and the approximate scheduled time for each 
presentation. A schedule showing the persons making presentations will 
be filed with the Dockets Management Branch (address above), and mailed 
or FAXED to each presenter before the meeting. Interested persons 
attending the meeting who did not request an opportunity to make a 
presentation will be given the opportunity to make an oral presentation 
at the conclusion of the meeting, as time permits. However, no 
participant may interrupt the presentation of another participant.
    Comments received at the public meeting and written comments 
submitted to the Dockets Management Branch (address above) by May 6, 
1996, will be considered in the review of the proposed rule and 
guidance documents to determine whether revisions are warranted. After 
careful review of the public comments, FDA intends to revise the draft 
guidance documents, if necessary, and publish a final rule.

    Dated: March 25, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-7613 Filed 3-25-96; 4:06 pm]
BILLING CODE 4160-01-F