[Federal Register: August 7, 2001 (Volume 66, Number 152)]
[Notices]
[Page 41247-41248]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au01-98]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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