[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availability of a draft guidance document entitled ``Guidance for 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 This draft guidance document, when finalized, is 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DATES: Written comments on the draft guidance document may be submitted 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Guidance for Industry: Revised 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 The draft guidance document may also be 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INFORMATION section for electronic access to the draft guidance 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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