[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Draft Guidance for Industry: Recommendations for Collecting Red 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availability of a draft guidance document entitled ``Guidance for 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 The draft guidance document describes the 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 The draft 
guidance document provides recommendations to blood establishments for 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 The draft guidance document may also be obtained by mail by 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electronic access to the draft guidance.

     Submit written comments on the draft guidance document to the 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