[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guidance document announced in this notice finalizes the draft guidance 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