[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50421-50422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19962]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0187 (formerly Docket No. 2000D-1267)]
Guidance for Industry: Recommendations for Donor Questioning,
Deferral, Reentry, and Product Management To Reduce the Risk of
Transfusion-Transmitted Malaria; 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:
Recommendations for Donor Questioning, Deferral, Reentry and Product
Management to Reduce the Risk of Transfusion-Transmitted Malaria''
dated August 2013. The guidance document provides blood establishments
that collect blood and blood components with recommendations for
questioning and deferring donors of blood and blood components,
allowing their reentry, and product management to reduce the risk of
transfusion-transmitted malaria. This guidance finalizes the draft
guidance of the same title dated June 2012, and supersedes the FDA
memorandum to all registered blood establishments entitled
``Recommendations for Deferral of Donors for Malaria Risk'' dated July
26, 1994. The recommendations contained in the guidance are not
applicable to donors of Source Plasma.
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. 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
[[Page 50422]]
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: Melissa Reisman, 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 guidance document entitled
``Guidance for Industry: Recommendations for Donor Questioning,
Deferral, Reentry and Product Management to Reduce the Risk of
Transfusion-Transmitted Malaria'' dated August 2013. The guidance
document provides blood establishments that collect blood and blood
components with recommendations for questioning and deferring donors of
blood and blood components, and allowing their reentry, to reduce the
risk of transfusion-transmitted malaria. This guidance document also
provides recommendations for product management, including
recommendations regarding product retrieval and quarantine, and
notification of consignees of blood and blood components in the event
that a blood establishment determines that blood or blood components
have been collected from a donor who should have been deferred due to
possible malaria risk. Finally, the guidance contains recommendations
on the implementation of FDA's recommendations, including how licensed
blood establishments must report to FDA the changes made to their donor
history questionnaires to reflect the new donor deferral
recommendations.
In the Federal Register of July 6, 2012 (77 FR 40068), FDA
announced the availability of the draft guidance of the same title
dated June 2012. FDA received several comments on the draft guidance
and those comments were considered as the guidance was finalized.
Significant changes to the guidance include: revisions to the
definition of malaria-endemic area, malaria-endemic country and other
terms used to assess a donor's risk of malaria based on history of
travel or residence; and revisions to the recommendations regarding
consignee notification and reporting of biological product deviations
for acellular blood components collected from a donor at risk for
malaria. Based on the revised definition of malaria-endemic area and
current epidemiological data, donors who travel to the Mexican States
of Quintana Roo or Jalisco would be eligible for donation without any
deferral, provided the donors meet all other eligibility criteria.
However, if malaria transmission in these States changes over time, the
donor deferral recommendations would encompass donors who travel to
these areas. The guidance announced in this notice finalizes the draft
guidance dated June 2012, and supersedes the FDA memorandum to all
registered blood establishments entitled ``Recommendations for Deferral
of Donors for Malaria Risk,'' dated July 26, 1994.
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 part 640 and 21 CFR 630.6 have
been approved under OMB control number 0910-0116. The collections of
information in 21 CFR 606.171 have been approved under OMB control
number 0910-0458.
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: August 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19962 Filed 8-16-13; 8:45 am]
BILLING CODE 4160-01-P