[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13071-13072]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04384]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0487]
Guidance for Industry: Implementation of an Acceptable Full-
Length and Abbreviated Donor History Questionnaires and Accompanying
Materials for Use in Screening Donors of Source Plasma; 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:
Implementation of an Acceptable Full-Length and Abbreviated Donor
History Questionnaires and Accompanying Materials for Use in Screening
Donors of Source Plasma'' dated February 2013. The guidance document
recognizes the standardized full-length and abbreviated donor history
questionnaires and accompanying materials, version 1.2 dated September
2012, as an acceptable mechanism that is consistent with FDA's
requirements and recommendations for collecting Source Plasma donor
history information. The Plasma Protein Therapeutics Association (PPTA)
Source Plasma donor history questionnaires and accompanying materials
(SPDHQ documents) will provide blood establishments that collect Source
Plasma with a specific process for administering questions to Source
Plasma donors to determine their eligibility to donate. The guidance
announced in this notice finalizes the draft guidance of the same title
dated July 2011.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests.
[[Page 13072]]
The guidance may also be obtained by mail by calling CBER at 1-800-835-
4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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: Implementation of an Acceptable Full-Length
and Abbreviated Donor History Questionnaires and Accompanying Materials
for Use in Screening Donors of Source Plasma'' dated February 2013. The
guidance document recognizes the standardized full-length and
abbreviated donor history questionnaires and accompanying materials,
version 1.2 dated September 2012, prepared by the PPTA, as an
acceptable mechanism that is consistent with FDA's requirements and
recommendations for collecting Source Plasma donor history information.
The SPDHQ documents will provide blood establishments that collect
Source Plasma with a specific process for administering questions to
Source Plasma donors to determine their eligibility to donate. The
guidance also advises Source Plasma manufacturers who choose to
implement the acceptable SPDHQ documents on how to report the
manufacturing change consisting of the implementation of the SPDHQ
under 21 CFR 601.12.
In the Federal Register of July 22, 2011 (76 FR 44013), FDA
announced the availability of the draft guidance of the same title
dated July 2011. FDA received no comments on the draft guidance. A
summary of changes includes: Referencing the most current version of
the acceptable SPDHQ documents, clarifying that the full-length and
abbreviated questionnaires are designed to be implemented together, and
making a few editorial changes to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated July 2011.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA'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. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in 21 CFR 601.12 have been approved under
OMB control number 0910-0338 and the collections of information in 21
CFR 640.63 have been approved under OMB control number 0910-0116.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.
Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04384 Filed 2-25-13; 8:45 am]
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