[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this notice revises the draft guidance entitled, ``Changes To An 
Approved Application; Draft Guidance,'' announced in the Federal 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),

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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,

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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]
BILLING CODE 4160-01-F