[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Notices]
[Pages 40068-40069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16528]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0187 Formerly Docket No. 2000D-1267]


Draft Guidance for Industry: Recommendations for Donor 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance document entitled ``Guidance for 
Industry: Recommendations for Donor Questioning, Deferral, Reentry and 
Product Management to Reduce the Risk of Transfusion-Transmitted 
Malaria'' dated June 2012. The draft guidance document provides blood 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 replaces the 
draft guidance entitled ``Guidance for Industry: Recommendations for 
Donor Questioning Regarding Possible Exposure to Malaria'' dated June 
2000. The draft guidance, when finalized, will supersede the FDA 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 The recommendations contained in the draft guidance are not 
applicable to donors of Source Plasma.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 4, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-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 The draft guidance may also be obtained by 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 draft 
guidance document.
    Submit electronic comments on the draft 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 draft guidance document 
entitled ``Guidance for Industry: Recommendations for Donor 
Questioning, Deferral, Reentry and Product Management to Reduce the 
Risk of Transfusion-Transmitted Malaria'' dated June 2012. The draft 
guidance document provides blood establishments that collect blood and

[[Page 40069]]

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 draft 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 draft guidance 
revises FDA's policy regarding donors who are residents of non-endemic 
countries and who have traveled to the Mexican states of Quintana Roo 
or Jalisco, and allows for donation without any deferral for malaria 
risk, provided the donor meets all other donor eligibility criteria.
    The draft guidance replaces the draft guidance entitled ``Guidance 
for Industry: Recommendations for Donor Questioning Regarding Possible 
Exposure to Malaria'' dated June, 2000, and, when finalized, will 
supersede the FDA memorandum to all registered blood establishments 
entitled ``Recommendations for Deferral of Donors for Malaria Risk,'' 
dated July 26, 1994. Since publication of these documents, FDA convened 
a scientific workshop on ``Testing for Malarial Infections in Blood 
Donors'' in July 2006, and also discussed the issue of blood donor 
deferral for malaria risk with the FDA Blood Products Advisory 
Committee (BPAC) on several occasions. The recommendations contained in 
the draft guidance are based, in part, on recommendations from BPAC, 
the public comments received on the earlier documents, and the comments 
received during the scientific workshop. In addition, FDA is aware that 
dengue viruses are endemic in Quintana Roo and Jalisco. FDA is 
currently evaluating the risk of dengue virus infections in U.S. blood 
donors that are acquired either locally or elsewhere in the world, 
including in Mexico, and may address this issue in future guidance.
    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 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 requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    This draft 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 have been approved under 
OMB control number 0910-0116. The collections of information in 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

    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) either 
electronic or written comments regarding this document. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: June 26, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16528 Filed 7-5-12; 8:45 am]
BILLING CODE 4160-01-P