[Federal Register Volume 70, Number 36 (Thursday, February 24, 2005)]
[Notices]
[Pages 9083-9084]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3592]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0056]


Guidance for Industry: Recommendations for Obtaining a Labeling 
Claim for Communicable Disease Donor Screening Tests Using Cadaveric 
Blood Specimens From Donors of Human Cells, Tissues, and Cellular and 
Tissue-Based Products; 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 document entitled ``Guidance for Industry: 
Recommendations for Obtaining a Labeling Claim for Communicable Disease 
Donor Screening Tests Using Cadaveric Blood Specimens from Donors of 
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/
Ps),'' dated November 2004. The guidance document provides medical 
device manufacturers with information about performing studies to 
support modifying the indication for use of communicable disease tests 
to include testing of cadaveric blood specimens to screen donors of 
human cells, tissues, and cellular and tissue-based products (HCT/Ps). 
The guidance document recommends a suggested protocol to modify the 
indication for use to include testing of cadaveric blood specimens.

DATES: Submit written or electronic comments on agency guidances at any 
time. In accordance with 21 CFR 10.115(g)(4)(i), FDA is immediately 
implementing this guidance.

ADDRESSES: Submit written requests for single copies of the guidance 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 may also be obtained by mail by 
calling the CBER Voice Information System at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for electronic access 
to the guidance document.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Kathleen E. Swisher, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled 
``Guidance for Industry: Recommendations for Obtaining a Labeling Claim 
for Communicable Disease Donor Screening Tests Using Cadaveric Blood 
Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-
Based Products (HCT/Ps),'' dated November 2004. The guidance document 
provides information to medical device manufacturers of communicable 
disease tests used to screen donors of HCT/Ps for communicable diseases 
who plan to perform studies to validate the use of cadaveric blood 
specimens with their tests. The guidance supercedes the May 2, 1995, 
letter issued by FDA to manufacturers of communicable disease tests 
suggesting a minimum protocol for validation of use of cadaveric blood 
specimens with their donor screening tests.
    The guidance recommends a minimum suggested protocol to validate an 
indication for use of cadaveric blood specimens with communicable 
disease tests used to screen donors of HCT/Ps. The guidance makes 
recommendations about: (1) Sensitivity and specificity studies, (2) 
reproducibility studies, (3) number of test kit lots to include in 
studies, (4) plasma dilution issues, and (5) information about specimen 
collection times to be included.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on this topic. 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.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments to the Division of Dockets Management (see ADDRESSES) 
regarding this guidance. Submit a single copy of electronic comments or 
two paper copies of any mailed comments, except

[[Page 9084]]

that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in the brackets in the heading 
of this document. A copy of the guidance and received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 16, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-3592 Filed 2-23-05; 8:45 am]
BILLING CODE 4160-01-S