[Federal Register Volume 64, Number 169 (Wednesday, September 1, 1999)]
[Notices]
[Page 47847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22801]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2213]
Draft ``Guidance for Industry: Revised Recommendations for the
Invalidation of Test Results When Using Licensed and 510(k) Cleared
Bloodborne Pathogen Assays to Test Donors;'' 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availability of a draft guidance document entitled ``Guidance for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: Revised Recommendations for the Invalidation of Test Results
When Using Licensed and 510(k) Cleared Bloodborne Pathogen Assays to
Test Donors.'' This draft guidance document, when finalized, is
intended to provide guidance to blood establishments on invalidating
donor test results based on control reagents required by the Clinical
Laboratory Improvement Act of 1988 (CLIA). The implementation of
additional quality control procedures that involve the use of external
control reagents should enhance overall testing accuracy and blood
safety.
DATES: Written comments on the draft guidance document may be submitted
at any time, however, comments should be submitted by November 30,
1999, 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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Guidance for Industry: Revised
Recommendations for the Invalidation of Test Results When Using
Licensed and 510(k) Cleared Bloodborne Pathogen Assays to Test Donors''
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 The draft guidance document may also be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INFORMATION section for electronic access to the draft guidance
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Submit written comments on the draft guidance document to the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: 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: Revised Recommendations for the
Invalidation of Test Results When Using Licensed and 510(k) Cleared
Bloodborne Pathogen Assays to Test Donors.'' This draft guidance
document would provide recommendations for blood establishments in
integrating current CLIA requirements for invalidating donor test
results based on CLIA required control reagents. When finalized, this
draft guidance document would replace the January 3, 1994, guidance
document entitled ``Recommendations for the Invalidation of Test
Results When Using Licensed Viral Marker Assays to Screen Donors.'' FDA
has developed revised recommendations based on discussions held during
the public meetings of the Blood Products Advisory Committee (BPAC) on
September 26, 1996, and December 13, 1996, and additional discussions
among the Centers for Disease Control and Prevention (CDC), Health Care
Financing Administration (HCFA), and FDA. At this time, the draft
guidance document is being made available for comment purposes only and
is not intended for use by the industry. The agency has adopted good
guidance practices (GGP's) that set forth the agency's policies and
procedures for the development, issuance, and use of guidance documents
(62 FR 8961, February 27, 1997). This document is being issued as a
draft level 1 guidance document consistent with GGP's.
This draft guidance document represents the agency's current
thinking with regard to the invalidation of test results based on the
CLIA required external control reagents. 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. The 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 November 30, 1999, to ensure adequate consideration in
preparation of the final guidance document. Two copies of any comments
are to be submitted, except individuals may submit one copy. Comments
should be identified with the docket number found in the 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 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 by using the World Wide Web (WWW). For WWW access, connect to
CBER at ``http://www.fda.gov/cber/guidelines.htm''.
Dated: August 9, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-22801 Filed 8-31-99; 8:45 am]
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