[Federal Register Volume 67, Number 77 (Monday, April 22, 2002)]
[Notices]
[Page 19578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0080]


Draft ``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availability of a draft guidance document entitled ``Guidance for 
Industry: Streamlining the Donor Interview Process: Recommendations for 
Self-Administered Questionnaires'' dated April 2002. The draft 
document, when finalized, is intended to provide guidance to blood and 
plasma collection centers on the recommendations of FDA for 
implementing self-administered donor questionnaires at the predonation 
donor screening interview. The draft guidance document also describes 
the information to be included in a biologics license application 
supplement or annual report for the implemented changes.

DATES: Submit written or electronic comments on the draft guidance 
document to ensure their adequate consideration in preparation of the 
final document by June 21, 2002. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Office of Communication, Training, and 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 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    Submit written comments on the draft guidance document to the 
Dockets Management Branch (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 draft guidance document 
entitled ``Guidance for Industry: Streamlining the Donor Interview 
Process: Recommendations for Self-Administered Questionnaires'' dated 
April 2002. The draft guidance document, when finalized, is intended to 
provide recommendations to the blood and plasma collection centers on 
the changes from the current predonation donor screening interview 
procedure to a self-administered format. The draft guidance document 
also describes the information to be included in a biologics license 
application supplement or annual report for the implemented changes. 
The draft guidance document 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 draft guidance document is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance 
document 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

    The 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 or electronic comments regarding this draft guidance 
document and on the collection of information. Submit written or 
electronic comments to ensure adequate consideration in preparation of 
the final document by June 21, 2002. 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 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 document at 
http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 12, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-9687 Filed 4-19-02; 8:45 am]
BILLING CODE 4160-01-S