[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]
-----------------------------------------------------------------------
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Immunodeficiency Virus Transmission by Blood and Blood Products; Draft
Guidance for Industry; Availability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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
[[Page 27974]]
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Transmission by Blood and Blood Products; Draft Guidance for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 The draft guidance document provides blood establishments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draft guidance document recommends corresponding revisions to donor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 The draft guidance, when finalized, is intended to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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 14, 2015.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Outreach and Development,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
[[Page 27975]]
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