[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 The draft guidance document, when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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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 The draft guidance may also be obtained by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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Division of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]
BILLING CODE 4160-01-S