[Federal Register Volume 68, Number 128 (Thursday, July 3, 2003)]
[Notices]
[Pages 39955-39956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16790]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0080]


Guidance for Industry: Streamlining the Donor Interview Process: 
Recommendations for Self-Administered Questionnaires; 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: 
Streamlining the Donor Interview Process: Recommendations for Self-
Administered Questionnaires'' dated July 2003. The guidance document 
provides guidance to blood and plasma establishments on the 
recommendations of FDA for implementing self-administered donor 
questionnaires at the predonation donor screening interview. The 
guidance document also describes the information to be included in a 
biologics license application supplement or annual report for the 
implemented changes. The guidance supersedes section I.A of FDA's 
memorandum dated April 23, 1992, entitled ``Revised Recommendations for 
the Prevention of Human Immunodeficiency Virus (HIV) Transmission by 
Blood and Blood Products,'' and finalizes the draft guidance of the 
same title dated April 2002.

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

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: Michael D. Anderson, 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 document entitled 
``Guidance for industry: Streamlining the Donor Interview Process: 
Recommendations

[[Page 39956]]

for Self-Administered Questionnaires,'' dated July 2003. The guidance 
is intended to provide recommendations to the blood and plasma 
establishments on the changes from the current predonation donor 
screening interview procedure to a self-administered format. The 
guidance also describes the information to be included in a biologics 
license application supplement or annual report for the implemented 
changes. The guidance does not address the informed consent process or 
specific screening questions, a specific questionnaire, or how to 
submit changes to the questions on a currently approved questionnaire. 
The guidance supersedes section I.A of FDA's memorandum dated April 23, 
1992, entitled ``Revised Recommendations for the Prevention of Human 
Immunodeficiency Virus (HIV) Transmission by Blood and Blood 
Products,'' and finalizes the draft guidance of the same title dated 
April 2002.
    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 requirement 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 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: June 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-16790 Filed 7-2-03; 8:45 am]
BILLING CODE 4160-01-S