[Federal Register: May 12, 2004 (Volume 69, Number 92)]
[Notices]               
[Page 26399]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my04-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0198]

 
Draft ``Guidance for Industry: Acceptable Full-Length Donor 
History Questionnaire and Accompanying Materials for Use in Screening 
Human Donors of Blood and Blood Components;'' 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 document entitled ``Guidance for Industry: 
Acceptable Full-Length Donor History Questionnaire and Accompanying 
Materials for Use in Screening Human Donors of Blood and Blood 
Components'' dated April 2004. The draft guidance document, when 
finalized, will recognize as acceptable for use by both licensed and 
unlicensed manufacturers that collect human blood and blood components, 
the full-length donor history questionnaire and accompanying materials 
(Version No. 1, dated April 2004) prepared by the Interorganizational 
Uniform Donor History Questionnaire Task Force. The full-length donor 
history questionnaire and accompanying materials (DHQ documents) 
provide a specific process for administering questions to donors of 
blood and blood components intended for transfusion and further 
manufacture to determine their eligibility to donate consistent with 
FDA requirements and recommendations.

DATES: Submit written or electronic comments on the draft guidance by 
August 10, 2004, to ensure their adequate consideration in preparation 
of the final guidance. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, 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 The draft guidance may also be obtained by 
mail by calling the Center for Biologics and Research Voice Information 
System at 1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.


FOR FURTHER INFORMATION CONTACT: Joseph L. Okrasinski, Jr., 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 document entitled 
``Guidance for Industry: Acceptable Full-Length Donor History 
Questionnaire and Accompanying Materials for Use in Screening Human 
Donors of Blood and Blood Components'' dated April 2004. The draft 
guidance document, when finalized, will recognize as acceptable for use 
by licensed and unlicensed manufacturers that collect blood and blood 
components the full-length donor history questionnaire and accompanying 
materials (Version No. 1, dated April 2004) prepared by the 
Interorganizational Uniform Donor History Questionnaire Task Force. The 
DHQ documents provide a specific process for administering questions to 
donors of blood and blood components to determine their eligibility to 
donate consistent with FDA requirements and recommendations. FDA 
believes the DHQ documents will assist manufacturers in complying with 
the regulations under part 640 (21 CFR part 640). The guidance also 
advises licensed manufacturers of blood and blood components how to 
report the change to implement the DHQ documents described in the 
guidance to FDA under Sec.  601.12 (21 CFR 601.12).
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection(s) of information in Sec. Sec.  601.12, 606.160, 640.3, and 
640.63 cited in the guidance have been approved by OMB under OMB 
control numbers 0910-0338 and 0910-0116.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft guidance. Submit 
written or electronic comments to ensure adequate consideration in 
preparation of the final 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
document at either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.

    Dated: May 3, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-10753 Filed 5-11-04; 8:45 am]

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