[Federal Register Volume 66, Number 133 (Wednesday, July 11, 2001)]
[Notices]
[Pages 36288-36289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17255]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2213]


Guidance for Industry: Revised Recommendations Regarding 
Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne 
Pathogen Assays Used to Test Donors; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
Revised Recommendations Regarding Invalidation of Test Results of 
Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test 
Donors'' dated July 2001. The guidance document provides guidance to 
blood establishments on when to invalidate 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. The guidance 
document announced in this notice finalizes the draft guidance document 
entitled ``Draft Guidance for Industry: Revised Recommendations for the 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'' dated September 1999.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry: Revised Recommendations 
Regarding Invalidation of Test Results of Licensed and 510(k) Cleared 
Bloodborne Pathogen Assays Used 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 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 guidance document.
    Submit written comments on the 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 guidance document entitled 
``Guidance for Industry: Revised

[[Page 36289]]

Recommendations Regarding Invalidation of Test Results of Licensed and 
510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors'' dated 
July 2001. The guidance document provides recommendations for blood 
establishments in integrating current CLIA requirements for when to 
invalidate donor test results based on CLIA required control reagents. 
The guidance document announced in this notice finalizes 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'' 
announced in the Federal Register of September 1, 1999 (64 FR 47847). 
The guidance document also supersedes the January 3, 1994 guidance 
document entitled ``Recommendations for the Invalidation of Test 
Results When Using Licensed Viral Marker Assays to Screen Donors.''
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). 
This guidance document represents the agency's current thinking with 
regard to the invalidation of test results based on the CLIA required 
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 statutes and regulations. 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

    Interested persons may, at any time, submit to the Dockets 
Management Branch (address above) written comments regarding this 
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 this 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 guidance 
document at http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm

    Dated: June 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17255 Filed 7-10-01; 8:45 am]
BILLING CODE 4160-01-S