[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Notices]
[Page 64402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc02-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0428]
Draft ``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 draft document entitled ``Guidance for Industry: An
Acceptable Circular of Information for the Use of Human Blood and Blood
Components'' dated October 2002. The draft guidance document recognizes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 those manufacturers in complying with the
labeling requirements under FDA regulations.
DATES: Submit written or electronic comments on the draft guidance to
ensure their adequate consideration in preparation of the final
document by December 17, 2002. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance and the Circular to the Office of Communication, Training, and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 documents 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for electronic access to the draft guidance document.
Submit written comments on the 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: 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 draft document entitled
``Guidance for Industry: An Acceptable Circular of Information for the
Use of Human Blood and Blood Components'' dated October 2002. The draft
guidance document recognizes that the circular dated July 2002 meets
the labeling requirements in Sec. 606.122 (21 CFR 606.122), and
therefore is acceptable for use by manufacturers of blood and blood
components intended for transfusion that are subject to U.S. statutes
and regulations.
The requirements under Sec. 606.122 specify that an instruction
circular must be available for distribution with blood and blood
components intended for transfusion, and that the information in the
instruction circular must include adequate instructions for use. The
circular will assist manufacturers of blood and blood components
intended for transfusion in complying with the labeling requirements
under Sec. 606.122. 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 in the draft guidance
document.
This draft guidance document is being issued in accordance with
FDA's good guidance practices regulation (21 CFR 10.115). The draft
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
This draft document is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Dockets Management Branch (see ADDRESSES) written or
electronic comments regarding this draft guidance document. Submit
written or electronic comments to ensure adequate consideration in
preparation of the final 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 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 draft guidance
document 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 obtained at www.aabb.org.
Dated: October 10, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26612 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S