[Federal Register: December 10, 2003 (Volume 68, Number 237)]
[Notices]
[Page 68931-68932]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de03-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0428]
Guidance for Industry: An Acceptable Circular of Information for
the Use of Human Blood and Blood Components; 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: An
Acceptable Circular of Information for the Use of Human Blood and Blood
Components'' dated December 2003. The guidance document recognizes the
``Circular of Information for the Use of Human Blood and Blood
Components'' (the circular) dated July 2002 as acceptable for use by
manufacturers of blood and blood components intended for transfusion.
The circular will assist manufacturers in complying with the labeling
requirements under FDA regulations. The guidance announced in this
notice finalizes the draft guidance of the same title dated October
2002.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40),
[[Page 68932]]
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 guidance may also be obtained by mail by calling the CBER
Voice Information System at 1-800-835-4709 or 301-827-1800. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
Submit written comments on the guidance to the Division of Dockets
Management (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: Valerie A. Butler, 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: An Acceptable Circular of Information for the
Use of Human Blood and Blood Components'' dated December 2003. The
guidance recognizes that the circular dated July 2002 meets the
labeling requirements in Sec. 606.122 (21 CFR 606.122) and is
acceptable for use by manufacturers of blood and blood components
intended for transfusion that are subject to U.S. statutes and
regulations. The circular was prepared jointly by the American
Association of Blood Banks, America's Blood Centers, and the American
National Red Cross. A copy of the circular is included as an attachment
in the guidance document. The guidance announced in this notice
finalizes the draft guidance of the same title, dated October 2002 (67
FR 64402, October 18, 2002).
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance document represents
the agency's current thinking on this topic. 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 submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except individuals may submit one paper copy. Comments
should be identified with the docket number found in brackets in the
heading of this document. A copy of the guidance and received comments
are available for public examination in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the guidance and the
circular at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.
The circular may also be
rcular may also be
address, but we are not responsible for subsequent changes to the Web
site after this document publishes in the Federal Register.)
Dated: December 1, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-30644 Filed 12-9-03; 8:45 am]
BILLING CODE 4160-01-S