[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Notices]
[Pages 40129-40130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19897]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0545]
Draft Guidance for Industry: Recommendations for Collecting Red
Blood Cells by Automated Apheresis Methods; 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availability of a draft guidance document entitled ``Guidance for
Industry: Recommendations for Collecting Red Blood Cells by Automated
Apheresis Methods.'' The draft guidance document describes the
recommended donor suitability criteria and the licensing provisions for
the collection of red blood cells using automated methods. The draft
guidance document provides recommendations to blood establishments for
the use of FDA cleared automated blood cell separators for the
collection of both single and double units of red blood cells.
DATE: Written comments may be submitted at any time, however, comments
should be submitted by September 25, 1998, to ensure their adequate
consideration in preparation of the final document.
ADDRESSES: Submit written requests for single copies of ``Guidance for
Industry: Recommendations for Collecting Red Blood Cells by Automated
Apheresis Methods'' to the Office of Communication, Training, and
Manufacturers Assistance (HFM-40),
[[Page 40130]]
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 The draft guidance document may also be obtained by mail by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. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance.
Submit written comments on the draft guidance document to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Astrid L. Szeto, 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 guidance document
entitled ``Guidance for Industry: Recommendations for Collecting Red
Blood Cells by Automated Apheresis Methods.'' The draft guidance
document is intended to provide specific recommendations on donor
suitability criteria for allogenic and autologous red blood cell
donations, on standard operating procedures, and recordkeeping, and
describes registration and licensing procedures for the manufacture of
double units of red blood cells or single units of red blood cells plus
up to two units of fresh frozen plasma.
This draft guidance document represents the agency's current
thinking with regard to collecting red blood cells by automated
apheresis methods. 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. As with
other guidance documents, FDA does not intend this document to be all-
inclusive and cautions that not all information may be applicable to
all situations. This draft guidance document is intended to provide
information and does not set forth requirements.
II. Comments
This draft guidance 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 (address
above) written comments regarding this draft guidance document. Written
comments may be submitted at any time, however, comments should be
submitted by September 25, 1998, to ensure adequate consideration in
preparation of the final document. Two copies of any comments are to be
submitted, except that 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 this draft guidance 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 using the World Wide Web (WWW) by connecting to CBER at
``http://www.fda.gov/cber/guidelines.htm''.
Dated: July 17, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-19897 Filed 7-24-98; 8:45 am]
BILLING CODE 4160-01-F
