81 FR 49673 - Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 145 (July 28, 2016)

Page Range		49673-49674
FR Document		2016-17804

The Food and Drug Administration (FDA or Agency) is establishing a public docket for comment on the Agency's blood donor deferral recommendations for reducing the risk of human immunodeficiency virus (HIV) transmission as described in the document entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry'' dated December 2015. Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.

Federal Register, Volume 81 Issue 145 (Thursday, July 28, 2016)

[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49673-49674]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-17804]

[[Page 49673]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1502]

Blood Donor Deferral Policy for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket for comment on the Agency's blood donor
deferral recommendations for reducing the risk of human
immunodeficiency virus (HIV) transmission as described in the document
entitled ``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated December 2015. Interested persons are
invited to submit comments, supported by scientific evidence such as
data from research, regarding potential blood donor deferral policy
options to reduce the risk of HIV transmission, including the
feasibility of moving from the existing time-based deferrals related to
risk behaviors to alternate deferral options, such as the use of
individual risk assessments. Additionally, comments are invited
regarding the design of potential studies to evaluate the feasibility
and effectiveness of such alternative deferral options. FDA will take
the comments received into account as it continues to reevaluate and
update blood donor deferral policies as new scientific information
becomes available.

DATES: Submit either electronic or written comments by November 25,
2016.

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-2016-N-1502 for ``Blood Donor Deferral Policy for Reducing the Risk
of Human Immunodeficiency Virus Transmission by Blood and Blood
Products; Establishment of Public Docket; Request for Comments.''
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.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, 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: In the Federal Register of December 23, 2015
(80 FR 79913), FDA announced the availability of the guidance entitled
``Revised Recommendations for Reducing the Risk of Human
Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated December 2015 (December 2015 guidance)
http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf.
The December 2015 guidance updates blood donor deferral
recommendations to reflect the most current scientific evidence. The
recommendations also help ensure continued safety of the blood supply
by reducing the risk of HIV transmission by blood and blood products.
As part of the updated blood donor deferral recommendations in the
December 2015 guidance, FDA changed the recommendation for an
indefinite deferral period for men who have sex with men (MSM) to a
deferral period of 12 months since the last sexual contact with another
man. The updated recommendations better align the deferral period for
MSM with the

[[Page 49674]]

deferral period for other men and women at increased risk for HIV
infection, such as those who had a recent blood transfusion or who have
been accidentally exposed to the blood of another individual through a
needle stick. In reviewing the Agency's recommendations to reduce the
risk of HIV transmission through blood and blood products, FDA
rigorously examined several alternative options, including individual
risk assessment. Ultimately, FDA concluded that the 12-month deferral
period is supported by the best available scientific evidence, at this
point in time, relevant to the U.S. population.
As described in the December 2015 guidance, throughout the process
of comprehensively updating blood donor deferral policies, FDA has
worked with other government Agencies, considered input from external
advisory committees, reviewed comments from stakeholders to the draft
guidance of the same title (80 FR 27973, May 15, 2015), and carefully
examined the most recent available scientific evidence. FDA also has
implemented a nationally representative transfusion-transmissible
infections monitoring system for the U.S. blood supply with assistance
from the National Heart, Lung, and Blood Institute at the National
Institutes of Health. This system provides critical information to help
inform future actions that FDA may take on blood donor policies.
When FDA issued the December 2015 guidance, it noted that while the
December 2015 guidance represents FDA's current thinking on the
subject, FDA was committed to continuing to reevaluate and update blood
donor deferral policies as new scientific information becomes
available. FDA also noted that, because the process must be data-
driven, FDA could not specify a time for when future policy changes
might occur.
As part of the effort to continue to assess its donor deferral
policies, FDA is opening this docket to provide a mechanism for the
public to submit additional information regarding potential blood donor
deferral policy options. Specifically, we invite interested persons to
submit to the docket comments supported by scientific evidence
regarding possible revisions to FDA's blood donor deferral policies to
reduce the risk of HIV transmission by blood and blood products. FDA
requests that commenters provide scientific evidence, such as data from
research, to support any suggestions. Additionally, comments are
invited regarding the design of potential studies to evaluate the
feasibility or effectiveness of such alternative deferral policy
options.
FDA recognizes that many stakeholders have expressed the desire to
move from a time-based deferral period to a deferral policy based on
individual risk assessment. An individual risk assessment would involve
asking potential donors a series of questions designed to defer donors
with high risk behaviors. In particular, we invite commenters to
address the following and provide supporting scientific evidence such
as data from research:

1. What questions would most effectively identify individuals at
risk of transmitting HIV through blood donation?
2. Are there specific questions that could be asked that might best
capture the recent risk of a donor acquiring HIV infection, such as
within the 2 to 4 weeks immediately preceding blood donation?
3. How specific can the questions be regarding sexual practices
while remaining understandable and acceptable to all blood donors?
For example, could questions about specific sexual behaviors be
asked if they helped to identify which donors should be at least
temporarily deferred because of risk factors? To the extent the
questions are explicit about sexual practices, how willing will
donors be to answer such questions accurately?
4. Under what circumstances would a short deferral period for high
risk behavior be appropriate? For each short deferral period
identified, please specify the duration of the deferral and provide
the scientific rationale.
5. What changes might be necessary within blood collection
establishments to assure that accurate, individual HIV risk
assessments are performed?
6. How best to design a potential study to evaluate the feasibility
and effectiveness of alternative deferral options such as individual
risk assessment?

FDA will consider comments and supporting scientific data received
as it continues to reevaluate and update blood donor deferral policies
as new scientific information becomes available.

Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17804 Filed 7-26-16; 11:15 am]
BILLING CODE 4164-01-P

49674 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices

deferral period for other men and the feasibility or effectiveness of such DEPARTMENT OF HEALTH AND
women at increased risk for HIV alternative deferral policy options. HUMAN SERVICES
infection, such as those who had a FDA recognizes that many
recent blood transfusion or who have Food and Drug Administration
stakeholders have expressed the desire
been accidentally exposed to the blood
to move from a time-based deferral [Docket No. FDA–2016–N–0007]
of another individual through a needle
period to a deferral policy based on
stick. In reviewing the Agency’s Prescription Drug User Fee Rates for
recommendations to reduce the risk of individual risk assessment. An
individual risk assessment would Fiscal Year 2017
HIV transmission through blood and
blood products, FDA rigorously involve asking potential donors a series AGENCY: Food and Drug Administration,
examined several alternative options, of questions designed to defer donors HHS
including individual risk assessment. with high risk behaviors. In particular, ACTION: Notice.
Ultimately, FDA concluded that the 12- we invite commenters to address the
month deferral period is supported by following and provide supporting SUMMARY: The Food and Drug
the best available scientific evidence, at scientific evidence such as data from Administration (FDA) is announcing the
this point in time, relevant to the U.S. research: rates for prescription drug user fees for
population. fiscal year (FY) 2017. The Federal Food,
1. What questions would most effectively
As described in the December 2015 Drug, and Cosmetic Act (the FD&C Act),
identify individuals at risk of
guidance, throughout the process of as amended by the Prescription Drug
transmitting HIV through blood
comprehensively updating blood donor User Fee Amendments of 2012 (PDUFA
donation?
deferral policies, FDA has worked with 2. Are there specific questions that could be
V), authorizes FDA to collect user fees
other government Agencies, considered asked that might best capture the recent
for certain applications for the review of
input from external advisory risk of a donor acquiring HIV infection,
human drug and biological products, on
committees, reviewed comments from such as within the 2 to 4 weeks establishments where the products are
stakeholders to the draft guidance of the immediately preceding blood donation? made, and on such products. This
same title (80 FR 27973, May 15, 2015), 3. How specific can the questions be notice establishes the fee rates for FY
and carefully examined the most recent regarding sexual practices while 2017.
available scientific evidence. FDA also remaining understandable and FOR FURTHER INFORMATION CONTACT:
has implemented a nationally acceptable to all blood donors? For Robert J. Marcarelli, Office of Financial
representative transfusion-transmissible example, could questions about specific Management, Food and Drug
infections monitoring system for the sexual behaviors be asked if they helped Administration, 8455 Colesville Rd.,
U.S. blood supply with assistance from to identify which donors should be at COLE–14202F, Silver Spring, MD
the National Heart, Lung, and Blood least temporarily deferred because of risk 20993–0002, 301–796–7223.
Institute at the National Institutes of factors? To the extent the questions are
Health. This system provides critical SUPPLEMENTARY INFORMATION:
explicit about sexual practices, how
information to help inform future willing will donors be to answer such I. Background
actions that FDA may take on blood questions accurately?
donor policies. Sections 735 and 736 of the FD&C Act
4. Under what circumstances would a short
When FDA issued the December 2015 (21 U.S.C. 379g and 379h, respectively)
deferral period for high risk behavior be
guidance, it noted that while the establish three different kinds of user
appropriate? For each short deferral
December 2015 guidance represents fees. Fees are assessed on the following:
period identified, please specify the
FDA’s current thinking on the subject, (1) Certain types of applications and
duration of the deferral and provide the
FDA was committed to continuing to supplements for the review of human
scientific rationale.
reevaluate and update blood donor drug and biological products; (2) certain
5. What changes might be necessary within
deferral policies as new scientific establishments where such products are
blood collection establishments to assure
information becomes available. FDA that accurate, individual HIV risk
made; and (3) certain products (section
also noted that, because the process assessments are performed?
736(a) of the FD&C Act). When certain
must be data-driven, FDA could not 6. How best to design a potential study to
conditions are met, FDA may waive or
specify a time for when future policy evaluate the feasibility and effectiveness reduce fees (section 736(d) of the FD&C
changes might occur. of alternative deferral options such as Act).
As part of the effort to continue to individual risk assessment? For FY 2013 through FY 2017, the
assess its donor deferral policies, FDA is base revenue amounts for the total
opening this docket to provide a FDA will consider comments and revenues from all PDUFA fees are
mechanism for the public to submit supporting scientific data received as it established by PDUFA V. The base
additional information regarding continues to reevaluate and update revenue amount for FY 2013, which
potential blood donor deferral policy blood donor deferral policies as new became the base amount for the
options. Specifically, we invite scientific information becomes remaining four FYs of PDUFA V, is
interested persons to submit to the available. $718,669,000, as published in the
docket comments supported by Federal Register of August 1, 2012 (77
scientific evidence regarding possible Dated: July 22, 2016. FR 45639). The FY 2013 base revenue
revisions to FDA’s blood donor deferral Leslie Kux, amount is further adjusted each year
policies to reduce the risk of HIV Associate Commissioner for Policy. after FY 2013 for inflation and
Lhorne on DSK30JT082PROD with NOTICES

transmission by blood and blood [FR Doc. 2016–17804 Filed 7–26–16; 11:15 am] workload. For FY 2017, fee revenue and
products. FDA requests that BILLING CODE 4164–01–P fees may be further adjusted by the final
commenters provide scientific evidence, year adjustment. In addition, for FY
such as data from research, to support 2017, excess collections are offset as
any suggestions. Additionally, required by the FD&C Act. Fees for
comments are invited regarding the applications, establishments, and
design of potential studies to evaluate products are to be established each year

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Document Created: 2016-07-28 01:48:00
Document Modified: 2016-07-28 01:48:00

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice; establishment of a public docket; request for comments.
Dates		Submit either electronic or written comments by November 25, 2016.
Contact		Jonathan McKnight, 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.
FR Citation		81 FR 49673

81 FR 49673 - Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Establishment of a Public Docket; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 145 (July 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration