[Federal Register Volume 64, Number 227 (Friday, November 26, 1999)]
[Notices]
[Pages 66481-66482]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30702]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-4577]


Draft ``Guidance for Industry: Application of Current Statutory 
Authority to Nucleic Acid Testing of Pooled Plasma;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a draft 
guidance document entitled ``Guidance for Industry: Application of 
Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma.'' 
The purpose of the draft guidance document is to seek public comment on 
FDA's approach to regulating nucleic acid testing for infectious agents 
when intended for use in blood donor screening and/or manufacturing of 
blood products. FDA is issuing the draft guidance document in response 
to requests from manufacturers for guidance in the development of 
nucleic acid testing of plasma pools for infectious agents.

DATES: Written comments may be submitted at any time, however, comments 
should be submitted by January 25, 2000, to ensure their adequate 
consideration in preparation of the final document.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Application of 
Current Statutory Authority to Nucleic Acid Testing of Pooled Plasma'' 
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 that 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 The draft guidance document may also be 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

[[Page 66482]]

1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.
     Submit written comments on the draft guidance document to the 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: 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 guidance document 
entitled ``Guidance for Industry: Application of Current Statutory 
Authority to Nucleic Acid Testing of Pooled Plasma.'' The draft 
guidance document outlines FDA's approach to the development and 
implementation of nucleic acid testing of infectious agents when 
intended to screen blood donors for manufacturing of blood products. 
FDA considers nucleic acid testing of plasma pools to be donor 
screening.
     The draft guidance document represents the agency's current 
thinking regarding nucleic acid testing of pooled plasma for viral 
detection in blood and blood products. 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.

 II. Comments

     The draft guidance document is being distributed for comment 
purposes only. Interested persons may submit to the Dockets Management 
Branch (address above) written comments regarding the draft guidance 
document. Written comments may be submitted at any time, however, 
comments should be submitted by January 25, 2000, to ensure their 
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 are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
document and received comments are available for public examination in 
the Dockets Management Branch (address above) 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 at http://www.fda.gov/cber/guidelines.htm.

    Dated: November 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy,
[FR Doc. 99-30702 Filed 11-24-99; 8:45 am]
BILLING CODE 4160-01-F