[Federal Register Volume 66, Number 20 (Tuesday, January 30, 2001)]
[Notices]
[Page 8238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2489]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0545]
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 guidance document entitled ``Guidance for Industry:
Recommendations for Collecting Red Blood Cells by Automated Apheresis
Methods'' dated January 2001. The 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. The guidance document also describes
information to be included in a licensed application or supplement. The
guidance document announced in this notice finalizes the draft guidance
document entitled ``Guidance for Industry: Recommendations for
Collecting Red Blood Cells by Automated Apheresis Methods'' dated July
1998.
DATES: Submit written comments at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance for Industry: Recommendations for
Collecting Red Blood Cells by Automated Apheresis Methods'' 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.
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.
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 guidance document entitled
``Guidance for Industry: Recommendations for Collecting Red Blood Cells
by Automated Apheresis Methods'' dated January 2001. The 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. The guidance document
includes recommendations for donor selection criteria and product
quality control and describes registration, licensing, and other
procedures. The guidance document announced in this notice has been
revised based on comments received on the draft guidance document
entitled ``Guidance for Industry: Recommendations for Collecting Red
Blood Cells by Automated Apheresis Methods'' announced in the Federal
Register of July 27, 1998 (63 FR 40129), and finalizes that draft
guidance document.
This guidance is being issued consistent with FDA's good guidance
regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). This
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 statutes
and regulations. 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 document is intended to
provide information and does not set forth requirements.
II. Comments
Interested persons may, at any time, submit written comments to the
Dockets Management Branch (address above) regarding this guidance
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 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 guidance
document at http://www.fda.gov/cber/guidelines.htm.
Dated: December 28, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-2489 Filed 1-29-01; 8:45 am]
BILLING CODE 4160-01-S