[Federal Register Volume 66, Number 152 (Tuesday, August 7, 2001)]
[Notices]
[Pages 41247-41248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5046]


``Guidance for Industry: Changes to an Approved Application: 
Biological Products: Human Blood and Blood Components Intended for 
Transfusion or for Further Manufacture;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry: Changes to 
an Approved Application: Biological Products: Human Blood and Blood 
Components Intended for Transfusion or for Further Manufacture'' dated 
July 2001. The guidance document provides information about reporting 
changes to licensed biological products including labeling, production 
processes, quality controls, equipment, and facilities that have been 
documented in approved license applications. The guidance document is 
intended to assist biological product manufacturers in identifying the 
kinds of changes to be reported, the category into which the change is 
to be placed, and the time to report the change to FDA.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Office of Communication, Training, and Manufacturers Assistance 
(HFM-40), 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 the office in 
processing your requests. The 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. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.
    Submit written comments on the guidance document to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Nathaniel L. Geary, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Changes to an Approved Application: Biological 
Products: Human Blood and Blood Components Intended for Transfusion or 
for Further Manufacture'' dated July 2001. CBER developed the guidance 
in response to public comments on the ``Guidance for Industry: Changes 
to an Approved Application: Biological Products'' dated July 1997 and 
public comments on the CBER Biologics Workshop on the Biologics License 
Application (BLA), December 2, 1997. The guidance applies to the 
manufacture of all licensed Whole Blood, blood components, Source 
Plasma, and Source Leukocytes. The guidance is intended to assist 
biological product manufacturers in identifying the kinds of changes to 
be reported, the category into which the change is to be placed, and 
the time to report the change to FDA.
    This guidance replaces the recommendations for the products 
mentioned above in the ``Guidance for Industry: Changes to an Approved 
Application: Biological Products'' dated July 1997 and revises and 
finalizes the draft guidance entitled ``Guidance for Industry: Changes 
to an Approved Application: Biological Products:

[[Page 41248]]

Human Blood and Blood Components Intended for Transfusion or for 
Further Manufacture'' dated January 2000 that was announced in the 
Federal Register of January 3, 2000 (65 FR 134).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This guidance document represents the agency's current thinking on 
reporting changes to an approved application for human blood and blood 
components that are intended for transfusion or for further 
manufacture. 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 requirement of the 
applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Dockets Management Branch (address above) regarding 
this guidance document. Two copies of any comments are to be submitted, 
except individuals may submit one copy. Comments should be identified 
with the docket number found in the brackets in the heading of this 
document. A copy of the document and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-19683 Filed 8-6-01; 8:45 am]
BILLING CODE 4160-01-S