[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Notices]
[Pages 79913-79915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32250]
[[Page 79913]]
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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;
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 announcing
the availability of a document entitled ``Revised Recommendations for
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood
and Blood Products; Guidance for Industry.'' The 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 guidance document
recommends corresponding revisions to donor educational materials,
donor history questionnaires and accompanying materials, along with
revisions to donor requalification, product management, and testing
procedures. The guidance announced in this notice finalizes the draft
guidance of the same title dated May 2015 and supersedes the memorandum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). While this
guidance represents FDA's current thinking on the subject, our
recommendations may evolve over time as new scientific evidence becomes
available.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-D-1211 for ``Revised Recommendations for Reducing the Risk of
Human Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of the 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 guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
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 document entitled,
``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
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
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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
products, and by infusion of clotting factor concentrates in
individuals with hemophilia. Beginning in 1983, FDA issued
recommendations for providing donors with educational material on risk
factors for AIDS and for deferring donors at increased risk for AIDS in
an effort to prevent transmission of the agent responsible for AIDS
(later understood to be caused by HIV) by blood and blood products. MSM
(originally identified as gay or bisexual men) were deferred due to the
strong clustering of AIDS illness among MSM and the subsequent
discovery of high rates of HIV infection in that population. FDA's
recommendation for deferral of MSM was modified over time to improve
its clarity and to promote compliance, including a shift of focus from
a deferral based on group identification to a deferral based on
specific behavior (male sex with another male).
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. On April 23, 1992, FDA issued the 1992 blood
memo, which consolidated its recommendations regarding the deferral of
donors at risk of HIV, including the deferral for MSM, as well as
deferral recommendations for other persons with behaviors associated
with high rates of HIV exposure, namely commercial sex workers, those
who inject non-prescription drugs, and certain other individuals with
HIV risk factors.
The use of donor educational 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 transfusions
prior to HIV testing to a current estimated residual risk of about 1 in
1.47 million transfusions. Since the implementation in 1985 of donor
testing for antibodies to HIV, FDA and the U.S. Department of Health
and Human Services (HHS) have held a number of public meetings,
including public scientific workshops and meetings of the Blood
Products Advisory Committee and the HHS Advisory Committee on Blood
Safety and Availability (ACBSA) 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. Consistent with recommendations of
the ACBSA in June 2010, studies that might support a policy change were
carried out by the Public Health Service in 2011 to 2014. A
recommendation for 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 Commissioner of Food and Drugs in December
2014. This guidance implements that recommended policy change.
In addition, the guidance provides donor deferral recommendations
for other individuals at increased risk for transmitting HIV infection,
including commercial sex workers, non-prescription injection drug
users, women who have sex with MSM, and certain other individuals with
other risk factors. The guidance provides revised recommendations for
donor educational materials, donor history questionnaires and
accompanying materials, as well as for donor requalification and
product management procedures.
In the Federal Register of May 15, 2015 (80 FR 27973), FDA
announced the availability of the draft guidance of the same title
dated May 2015. FDA received over 700 comments on the draft guidance
and those comments were carefully considered as the guidance was
finalized. Comments were received from a variety of organizations,
including patient advocacy groups representing users of blood products;
lesbian, gay, bisexual and transgender advocacy groups; medical and
professional societies; academic institutions; human rights
organizations; local governments; members of Congress; and, the blood
industry. Comments were also received from hundreds of individual
commenters.
Approximately one-half of the comments opposed FDA's time-based
deferral policy for MSM and considered the proposed policy to be
discriminatory and lacking a scientific rationale. Many of these
comments recommended that FDA adopt an individual risk assessment based
approach, regardless of an individual's sexual orientation or gender
identity. Other comments supported a time-based deferral policy shorter
than 1year, or no deferral period at all, because of advances in blood
donor testing technologies that permit earlier detection of new HIV
infections. Comments requested that FDA commit to reexamining its
deferral policies as new technologies, such as pathogen reduction
technology are implemented and data regarding compliance with the
revised policies become available.
Most of the remaining comments advocated for the continuation of
the indefinite deferral policy for MSM and expressed concern regarding
the safety of the blood should the revised policy for MSM donors be
adopted. Opponents of the proposed change commented on the HIV
incidence and prevalence rates among MSM; the potential failure of HIV
tests to capture window-period infections; the risk of emerging
pathogens for which testing does not exist; and, the potential for
decreased compliance rates with the new deferral policy. Other comments
argued that FDA should not compromise public health and the safety of
the blood supply to satisfy special interest groups.
A smaller number of comments, including those from certain patient
advocacy organizations, supported the proposed 1-year deferral policy
for MSM predicated on the establishment of a transfusion-transmitted
infectious disease monitoring system to enhance safety monitoring and
allow rapid responses to emerging threats to the blood supply. Further,
similar comments advocated for an evaluation of the effectiveness of
the donor educational materials and donor history questionnaires prior
to the implementation of new donor deferral policies.
Finally, comments received from the blood industry were generally
supportive of the revised MSM donor deferral policy. However, some
comments noted that manufacturers of plasma for further manufacturing
use (i.e., to make injectable products), including Source Plasma,
collected in the United States and intended for further manufacturing
use in other countries, may need to retain an indefinite deferral
policy for MSM to comply with the indefinite deferral policies
established in other countries. Industry commenters also requested
revisions to certain other donor deferral criteria for HIV risk and
disagreed with FDA's proposal to include the signs and symptoms
associated with HIV infection in the donor educational materials.
Comments requested clarification regarding the eligibility of donors
with false-positive HIV tests and on recommendations for product
retrieval and notification of consignees of distributed blood
components collected from a donor who should have been deferred for HIV
risk factors. Some comments were also supportive of the additional
guidance provided by FDA regarding transgender donors.
Finally numerous commenters requested FDA to clarify the
recommendation for deferral of women who have had sex with MSM.
FDA carefully considered all of the comments received in response
to the draft guidance and the available scientific data, including the
results of
[[Page 79915]]
recent studies conducted by the Public Health Service and revised the
guidance accordingly. FDA considered several options to address the
comments in response to the revised MSM donor deferral policy. Because
evidence indicates that the indefinite deferral policy for MSM may have
become less effective over time, FDA has determined that a change in
policy is warranted at this time. Data on the limitations of nucleic
acid tests to identify antibody negative window period HIV infections
suggests that donor testing alone, absent any deferral for MSM, would
result in an unacceptable increased risk of transfusion-transmitted
HIV. Similarly, pretesting at risk donors with a rapid HIV test prior
to donation would be logistically challenging and would not necessarily
identify newly HIV-infected individuals. While individual donor
assessment for risk has been implemented in a few countries, the
implementation of this strategy in the United States would present
significant practical challenges and currently there is no validated
and accepted individual risk assessment tool or questionnaire.
Therefore, FDA concluded a time-based deferral for history of male-male
sex is the most appropriate policy to maintain the safety of the U.S.
blood supply. Scientific data regarding the effectiveness of a 1-year
deferral in Australia, a country with similar HIV epidemiology to the
United States, supports FDA's policy change to the blood donor deferral
period for MSM from indefinite deferral to 1 year since the last sexual
contact. Scientifically robust data are not available for time-based
deferrals of less than 1 year. FDA also concluded that scientific data
are not currently available that would support revisions to the
indefinite deferral policy for commercial sex workers or intravenous
drug users.
In response to comments, FDA made the following changes when
finalizing the guidance: (1) Amended the recommendations regarding the
inclusion of signs and symptoms associated with HIV in the donor
educational materials; (2) revised the recommendation for the deferral
of female donors who have had sex with MSM; (3) stated that FDA no
longer recommends deferral for individuals who have had sex with an
individual with hemophilia or related clotting deficiencies requiring
treatment with clotting factor concentrates; and (4) revised the
recommendations regarding product retrieval and consignee notification
of distributed blood products collected from a donor who should have
been deferred for HIV risk factors. In addition, FDA made the following
changes to clarify certain recommendations in the guidance, which are
consistent with current policy: (1) Clarified that donors who have been
determined to have a false-positive HIV test may be reentered according
to a requalification method found acceptable to FDA; (2) noted that
recipients of allogeneic blood transfusions (i.e., not autologous
transfusions), should be temporarily deferred; (3) provided reference
to an FDA guidance on the collection of blood components from donors at
risk of HIV infection; and (4) clarified the deferral by the
responsible physician of a blood establishment of any donor if the
donation could affect the health of the donor or the safety of the
blood component. Additionally, the background section has been expanded
to summarize FDA's evaluation of the available policy options under the
available evidence relevant to the MSM deferral policy. Minor editorial
changes have also been made to the guidance.
FDA remains committed to exploring options and engaging in public
discussions regarding enhancements to donor and public education
regarding safe blood donors and evaluating the effectiveness of the
donor history questionnaire. Further, with the implementation of a
transfusion transmitted infectious disease monitoring system, FDA will
be able to monitor donor risk factors and the safety of the blood
supply, as well as investigate and refine blood safety measures in the
future. FDA's recommendations may evolve over time as new scientific
data become available on strategies to maintain or improve blood
safety.
The guidance announced in this notice finalizes the draft guidance
dated May 2015 and supersedes the 1992 blood memo.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on recommendations for reducing the risk of HIV
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 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 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. 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: December 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32250 Filed 12-22-15; 8:45 am]
BILLING CODE 4164-01-P