[Federal Register: November 26, 1999 (Volume 64, Number 227)]
[Notices]
[Page 66481-66482]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no99-79]

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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SUMMARY: The Food and Drug Administration (FDA) is issuing a draft
guidance document entitled ``Guidance for Industry: Application of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The purpose of the draft guidance document is to seek public comment on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 FDA is issuing the draft guidance document in response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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Application of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 The draft guidance document may also be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section for electronic access to the draft guidance document.
     Submit written comments on the draft guidance document to the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