[Federal Register Volume 78, Number 160 (Monday, August 19, 2013)]
[Notices]
[Pages 50421-50422]
From the Federal Register Online via the Government Printing 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 This guidance finalizes the draft 
guidance of the same title dated June 2012, and supersedes the FDA 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