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: 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 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 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:// 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: 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/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]]

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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