[Federal Register Volume 62, Number 142 (Thursday, July 24, 1997)]
[Notices]
[Pages 39904-39906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95D-0052]
Guidance for Industry: Changes To An Approved Application:
Biological Products; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled, ``Guidance for Industry:
Changes To An Approved Application: Biological Products.'' The guidance
document is intended to assist manufacturers in determining which
reporting mechanism is appropriate for a change to an approved
application, to reduce the burden on manufacturers of reporting
changes, and to facilitate the approval process. The guidance document
applies to all licensed biological products and establishments,
including Whole Blood, blood components, Source Plasma, and Source
Leukocytes, but not including specified biotechnology and specified
synthetic biological products, or products formerly referred to as
well-characterized therapeutic recombinant DNA-derived and monoclonal
antibody biotechnology products. The guidance document announced in
this notice revises the draft guidance entitled, ``Changes To An
Approved Application; Draft Guidance,'' announced in the Federal
Register of January 29, 1996 (61 FR 2749).
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Industry: Changes To An Approved Application: Biological Products,'' to
the Office of Communication, Training and Manufacturers Assistance
(HFM-40),
[[Page 39905]]
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. The guidance document may also be obtained by mail by calling
the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or
by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-
827-3844. Submit written comments on the guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for
Biologics Evaluation and Research (HFM-630), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance document entitled, ``Guidance for Industry: Changes To An
Approved Application: Biological Products.'' The guidance document is
issued in accordance with the principles set forth in Executive Order
12866, in a continuing effort to reduce unnecessary reporting burdens
on manufacturers holding licenses approved by the Center for Biologics
Evaluation and Research (CBER) under section 351 of the Public Health
Service Act.
As announced in the Federal Register of January 9, 1995 (60 FR
2351), FDA held a public meeting on January 26, 1995, as a forum for
the public to voice their comments regarding CBER's retrospective
review of biologics regulations. In comments made to the public docket,
and at the January 26, 1995, public meeting, representatives from the
biologics industry requested that FDA modify Sec. 601.12 (21 CFR
601.12) to be more flexible and less burdensome.
FDA published the guidance document entitled, ``Changes To Be
Reported for Product and Establishment License Applications;
Guidance,'' in the Federal Register of April 6, 1995 (60 FR 17535). In
a continuing effort to reduce unnecessary reporting burdens and in
response to comments received on the April 6, 1995, guidance document,
FDA published the proposed rule entitled, ``Changes To An Approved
Application'' in the Federal Register of January 29, 1996 (61 FR 2739).
FDA proposed to amend the biologics regulations for reporting changes
to an approved application. In the same issue of the Federal Register,
FDA announced the availability of a draft guidance document entitled,
``Changes To An Approved Application; Draft Guidance.'' The draft
guidance document, issued for public comment only, set forth CBER'S
interpretation of the proposed rule to amend Sec. 601.12. In addition,
FDA announced the availability of the draft guidance document entitled,
``Draft Guidance; Changes To An Approved Application For Well-
Characterized Therapeutic Recombinant DNA-Derived and Monoclonal
Antibody Biotechnology Products,'' which applied only to well-
characterized therapeutic recombinant DNA-derived and monoclonal
antibody biotechnology products.
As announced in the Federal Register of March 28, 1996 (61 FR
13793), FDA held a public meeting on April 19, 1996, to discuss and
gather information on the proposal to amend the biologics regulations
for reporting changes to an approved application and the two closely
related draft guidance documents that were made available concurrently.
In comments received on the proposed rule and the draft guidance
documents, representatives from the biologics industry asked that a
category system of changes to be reported be implemented that would
include changes that can be made without prior approval. FDA has
considered all comments and developed a regulatory scheme in response
to the requests.
Elsewhere in this issue of the Federal Register, FDA is issuing a
final rule entitled, ``Changes To An Approved Application.'' In
addition to the guidance document announced in this notice, FDA is
announcing the availability of a guidance document entitled, ``Guidance
for Industry: Changes To An Approved Application For Specified
Biotechnology and Specified Synthetic Biological Products,'' that
revises the draft guidance document entitled, ``Draft Guidance; Changes
To An Approved Application For Well-Characterized Therapeutic
Recombinant DNA-Derived and Monoclonal Antibody Biotechnology
Products.''
The guidance document announced in this notice is intended to
assist manufacturers in determining how a change to an approved
application should be reported or documented under the revised
Sec. 601.12 for changes to a product, production process, quality
controls, equipment, facilities, responsible personnel, or labeling.
The guidance document lists the three-category scheme for reporting
biological product changes.
The guidance document includes examples of changes to be reported
under the three reporting categories applicable to all biological
products, including Whole Blood, blood components, Source Plasma, and
Source Leukocytes, but not including specified biotechnology and
specified synthetic biological products. The ``Guidance for Industry:
Changes To An Approved Application: Biological Products'' supersedes
the guidance document entitled, ``Changes To Be Reported for Product
and Establishment License Applications; Guidance'' (April 1995) and
reflects revisions made to Sec. 601.12 in the final rule.
As with other procedural guidance documents, FDA does not intend
this guidance document to be all-inclusive. Alternative approaches
might be warranted in specific situations, and certain aspects would
not be applicable to all situations. If a manufacturer believes that
the procedure described in this guidance document would be inapplicable
to a particular product and other procedures would be appropriate for
CBER's consideration, the manufacturer may wish to discuss the matter
further with the agency to prevent expenditure of money and effort on
activities that later may be determined to be unacceptable by FDA. CBER
will continue to review submissions on a case-by-case basis.
The guidance document announced in this notice represents the
agency's current thinking on changes to an approved application for all
licensed biological products, except specified biotechnology and
specified synthetic biological products listed in 21 CFR 601.2. 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.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments regarding the
guidance document. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments and requests for
copies are to be identified with the docket number found in brackets in
the heading of this document. A copy of the guidance document and
received comments are available for public examination in the office
above between 9 a.m. and 4 p.m., Monday through Friday.
Persons with access to the Internet may obtain the guidance
document by using the World Wide Web (WWW), or bounce-back e-mail. For
WWW access,
[[Page 39906]]
connect to CBER at ``http://www.fda.gov/cber/cberftp.html''. To receive
the guidance document by bounce-back e-mail, send a message to
``[email protected]''.
Received comments will be considered in determining whether further
revision of the guidance document is warranted.
Dated: May 28, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-19412 Filed 7-23-97; 8:45 am]
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