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, 49673-49674 [2016-17804]

Download as PDF Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices 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. Notice; establishment of a public docket; request for comments. ACTION: 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. SUMMARY: ADDRESSES: You may submit comments as follows: Lhorne on DSK30JT082PROD with NOTICES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 VerDate Sep<11>2014 14:44 Jul 27, 2016 Jkt 238001 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 https://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 https://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 https:// PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 49673 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: https://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 https:// 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) https:// www.fda.gov/downloads/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/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 E:\FR\FM\28JYN1.SGM 28JYN1 Lhorne on DSK30JT082PROD with NOTICES 49674 Federal Register / Vol. 81, No. 145 / Thursday, July 28, 2016 / Notices 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 12month 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 VerDate Sep<11>2014 14:44 Jul 27, 2016 Jkt 238001 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 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0007] Prescription Drug User Fee Rates for Fiscal Year 2017 AGENCY: Food and Drug Administration, HHS ACTION: Notice. The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2017. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2017. SUMMARY: FOR FURTHER INFORMATION CONTACT: Robert J. Marcarelli, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE–14202F, Silver Spring, MD 20993–0002, 301–796–7223. SUPPLEMENTARY INFORMATION: I. Background Sections 735 and 736 of the FD&C Act (21 U.S.C. 379g and 379h, respectively) establish three different kinds of user fees. Fees are assessed on the following: (1) Certain types of applications and supplements for the review of human drug and biological products; (2) certain establishments where such products are made; and (3) certain products (section 736(a) of the FD&C Act). When certain conditions are met, FDA may waive or reduce fees (section 736(d) of the FD&C Act). For FY 2013 through FY 2017, the base revenue amounts for the total revenues from all PDUFA fees are established by PDUFA V. The base revenue amount for FY 2013, which became the base amount for the remaining four FYs of PDUFA V, is $718,669,000, as published in the Federal Register of August 1, 2012 (77 FR 45639). The FY 2013 base revenue amount is further adjusted each year after FY 2013 for inflation and workload. For FY 2017, fee revenue and fees may be further adjusted by the final year adjustment. In addition, for FY 2017, excess collections are offset as required by the FD&C Act. Fees for applications, establishments, and products are to be established each year E:\FR\FM\28JYN1.SGM 28JYN1

Agencies

[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49673-49674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17804]

[[Page 49673]]

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

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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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)
https://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

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