[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Pages 27973-27975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11690]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1211]


Revised Recommendations for Reducing the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products; Draft 
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is

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announcing the availability of a draft document entitled ``Revised 
Recommendations for Reducing the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products; Draft Guidance for 
Industry.'' The draft guidance document provides blood establishments 
that collect blood or blood components, including Source Plasma, with 
revised donor deferral recommendations for individuals at increased 
risk for transmitting human immunodeficiency virus (HIV) infection. The 
draft guidance document recommends corresponding revisions to donor 
education materials, donor history questionnaires and accompanying 
materials, along with revisions to donor requalification and product 
management procedures. The document also incorporates certain other 
recommendations related to donor education materials and testing 
contained in the memorandum to blood establishments entitled, ``Revised 
Recommendations for the Prevention of Human Immunodeficiency Virus 
(HIV) Transmission by Blood and Blood Products,'' dated April 23, 1992 
(1992 blood memo). The draft guidance, when finalized, is intended to 
supersede the 1992 blood memo.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 14, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver 
Spring, MD 20993-0002. 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 240-402-7800. 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: Valerie A. Butler, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Revised Recommendations for Reducing the Risk of Human 
Immunodeficiency Virus Transmission by Blood and Blood Products; Draft 
Guidance for Industry.'' The emergence of Acquired Immune Deficiency 
Syndrome (AIDS) in the early 1980s and the recognition that it could be 
transmitted by blood and blood products had profound effects on the 
U.S. blood system. Although initially identified in men who have sex 
with men (MSM) and associated with male-to-male sexual contact, AIDS 
was soon noted to be potentially transmitted by transfusion of blood 
components, and by infusion of clotting factor concentrates in 
individuals with hemophilia. Beginning in 1983, the FDA, issued 
recommendations for providing donors with education material on risk 
factors for AIDS and for deferring donors with such risk factors in an 
effort to prevent transmission of AIDS (later understood to be caused 
by HIV) by blood and blood products.
    Since September 1985, FDA has recommended that blood establishments 
indefinitely defer male donors who have had sex with another male, even 
one time, since 1977, due to the strong clustering of AIDS illness in 
the MSM community and the subsequent discovery of high rates of HIV 
infection in that population. On April 23, 1992, FDA issued the 1992 
blood memo, which contains the current recommendations regarding the 
deferral for MSM, as well as the deferral recommendations for other 
persons with behaviors associated with high rates of HIV exposure, 
namely commercial sex workers, intravenous drug users, and certain 
other individuals with other risk factors.
    The use of donor education material, specific deferral questions 
and advances in HIV donor testing have reduced the risk of HIV 
transmission from blood transfusion from about 1 in 2500 units prior to 
HIV testing to a current estimated residual risk of about 1 in 1.47 
million transfusions. During the period from 1997 to 2014, FDA and the 
Department of Health and Human Services (HHS) held a number of public 
meetings, including scientific workshops and meetings of the Blood 
Products Advisory Committee and the HHS Advisory Committee on Blood 
Safety and Availability to further review evidence and discuss FDA's 
blood donor deferral policies to reduce the risk of transmission of HIV 
by blood and blood products. Studies that might support a policy change 
were carried out by the Public Health Service agencies in 2011-2014. A 
policy change to the blood donor deferral period for MSM from 
indefinite deferral to 1 year since the last sexual contact was 
announced by the FDA Commissioner in December 2014. The draft guidance, 
when finalized, will implement that policy change.
    In addition to providing donor deferral recommendations for 
individuals at increased risk for transmitting HIV infection, the draft 
guidance document incorporates certain recommendations contained in the 
1992 blood memo. Certain other recommendations from the 1992 blood memo 
have not been included in the draft guidance document because they have 
become outdated over time, superseded by subsequent regulations or 
guidance documents, or have been incorporated into other guidance 
documents. However, to ensure that the final guidance document provides 
comprehensive recommendations for reducing the risk of HIV transmission 
by blood and blood products, we invite comments on the recommendations 
contained in the 1992 blood memo that have not been included in the 
draft guidance. Further, the draft guidance does not provide a specific 
list of recommended signs and symptoms associated with HIV for 
inclusion in the donor education materials. We invite comments and the 
submission of data on what specific signs and symptoms associated with 
HIV infection would be most appropriate for inclusion in education 
material in the blood donor setting. The draft guidance, when 
finalized, is intended to supersede the 1992 blood memo.
    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 current thinking of FDA on ``Revised 
Recommendations for Reducing the Risk of Human Immunodeficiency Virus 
Transmission by Blood and Blood Products.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The 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

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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; the collections of information in 21 CFR 
606.171 have been approved under OMB control number 0910-0458; and the 
collections of information in 21 CFR 610.46, 630.6, 640.3 and 640.63 
have been approved under OMB control number 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 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 draft guidance 
at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11690 Filed 5-14-15; 8:45 am]
 BILLING CODE 4164-01-P