81_FR_67548 81 FR 67358 - Agency Information Collection Activities; Proposed Collection; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation

81 FR 67358 - Agency Information Collection Activities; Proposed Collection; Comment Request; Donor Risk Assessment Questionnaire for the Food and Drug Administration/National Heart, Lung, and Blood Institute-Sponsored Transfusion-Transmissible Infections Monitoring System-Risk Factor Elicitation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 190 (September 30, 2016)

Page Range67358-67360
FR Document2016-23622

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information collection request regarding risk factors associated with transfusion-transmissible infections (TTI) in blood donors.

Federal Register, Volume 81 Issue 190 (Friday, September 30, 2016)
[Federal Register Volume 81, Number 190 (Friday, September 30, 2016)]
[Notices]
[Pages 67358-67360]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23622]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2836]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Donor Risk Assessment Questionnaire for the Food and 
Drug Administration/National Heart, Lung, and Blood Institute-Sponsored 
Transfusion-Transmissible Infections Monitoring System--Risk Factor 
Elicitation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on an information collection request regarding 
risk factors associated with transfusion-transmissible infections (TTI) 
in blood donors.

DATES: Submit either electronic or written comments on the collection 
of information by November 29, 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

[[Page 67359]]

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-2836 for ``Donor Risk Assessment Questionnaire for the Food 
and Drug Administration (FDA)/National Heart, Lung, and Blood Institute 
(NHLBI)-sponsored Transfusion-Transmissible Infections Monitoring 
System (TTIMS)--Risk Factor Elicitation (RFE).'' 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Donor Risk Assessment Questionnaire for the Food and Drug 
Administration (FDA)/National Heart, Lung, and Blood Institute (NHLBI)-
Sponsored Transfusion-Transmissible Infections Monitoring System 
(TTIMS)--Risk Factor Elicitation (RFE) OMB Control Number--New

    FDA intends to interview blood donors to collect risk factor 
information associated with testing positive for a TTI. This collection 
of information is part of a larger initiative called TTIMS which is a 
collaborative project funded by FDA, the NHLBI of the National 
Institutes of Health (NIH), and the Department of Health and Human 
Services (HHS) Office of the Assistant Secretary of Health with input 
from other agencies in HHS including the Centers for Disease Control 
and Prevention (CDC). FDA will use these scientific data collected 
through such interview-based risk factor elicitation of blood donors to 
monitor and help ensure the safety of the United States blood supply.
    Previous assessments of risk factor profiles among blood donors 
found to be positive for human immunodeficiency virus (HIV) were funded 
by CDC for approximately 10 years after implementation of HIV serologic 
screening of blood donors in the mid-1980s, whereas studies of 
Hepatitis C virus (HCV) seropositive donors, funded by NIH, were 
conducted in the early 1990s. Information on current risk factors in 
blood donors as assessed using analytical study designs was next 
evaluated by the Transfusion-Transmitted Retrovirus and Hepatitis Virus 
Rates and Risk Factors Study conducted by the NHLBI Retrovirus 
Epidemiology Donor Study-II (REDS-II) approved under OMB control number 
0925-0630. Through a risk factor questionnaire, this study elicited 
risk factors in blood donors who tested confirmed positive for one of 
four transfusion-transmissible infections: HIV, HCV, Hepatitis B virus 
(HBV), and Human T-cell Lymphotropic virus. The study also elicited 
risk factors from donors who did not have any infections (controls) and 
compared their responses to those of the donors with confirmed 
infection (cases). Results from the REDS-II study were published in 
2015.

[[Page 67360]]

    FDA issued a document entitled ``Revised Recommendations for 
Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood 
and Blood Products, Guidance for Industry'' dated December 2015 (http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM446580.pdf) 
which changed the blood donor criterion for men who have sex with men 
(MSM) from an indefinite (permanent) deferral to a 12-month deferral 
since last MSM contact. The impact of this change in the deferral 
criteria requires a national monitoring effort as part of TTIMS to 
assess if the relative proportions of risk factors for infection in 
blood donors have changed following the adoption of the 12-month donor 
deferral for MSM. TTIMS will use similar procedures as the ones used in 
the REDS-II study to monitor and evaluate risk factors among HIV-
positive donors and recently HCV or HBV infected donors as well as 
controls.
    This study will help identify the specific risk factors for TTI and 
their prevalence in blood donors, and help inform FDA on the proportion 
of incident (new) infections among all HIV positive blood donors. 
Donations with incident infections have the greatest potential 
transmission risk because they could be missed during routine blood 
screening. The study will help FDA evaluate the effectiveness of 
screening strategies in reducing the risk of HIV transmission from at-
risk donors and to evaluate if there are unexpected consequences 
associated with the recent change in donor deferral policy such as an 
increase in HIV incidence among donors. These data also will inform FDA 
regarding future 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, and 
to inform the design of potential studies to evaluate the feasibility 
and effectiveness of such alternative deferral options.
    TTIMS will include a comprehensive interview-based epidemiological 
study of risk factor information for viral infection-positive blood 
donors at the American Red Cross (ARC), Blood Systems, Inc. (BSI), New 
York Blood Center (NYBC), and OneBlood that will identify the current 
predominant risk factors and reasons for virus-positive donations. The 
TTIMS program establishes a new, ongoing donor hemovigilance capacity 
that currently does not exist in the United States. Using procedures 
developed by the REDS-II study, TTIMS will establish this capacity in 
greater than 50 percent of all blood donations collected in the 
country.
    As part of the TTIMS project, a comprehensive hemovigilance 
database will be created that integrates the risk factor information 
collected through donor interviews of blood donor with the resulting 
data from disease marker testing and blood components collected by 
participating organizations into a research database. Following 
successful initiation of the risk factor interviews, the TTIMS network 
is poised to be expanded to include additional blood centers and/or re-
focused on other safety threats as warranted. In this way, the TTIMS 
program will maintain standardized, statistically and scientifically 
robust processes for applying hemovigilance information across blood 
collection organizations.
    The specific objectives are to:
     Determine current behavioral risk factors associated with 
all HIV infections, incident HBV, and incident HCV infections in blood 
donors (including parenteral and sexual risks) across the participating 
blood collection organizations using a case-control study design.
     Determine infectious disease marker prevalence and 
incidence for HIV, HBV, and HCV overall and by demographic 
characteristics of donors in the majority of blood donations collected 
in the country. This will be accomplished by forming epidemiological 
databases consisting of harmonized operational data from ARC, BSI, 
NYBC, and OneBlood.
     Analyze integrated risk factor and infectious marker 
testing data concurrently because when taken together these may suggest 
that blood centers are not achieving the same degree of success in 
educational efforts to prevent donation by donors with risk behaviors 
across all demographic groups.
    The respondents will be persons who donated blood in the United 
States and these participants will be defined as cases and controls. 
The estimated number of respondents is based on an overall expected 
participation in the risk factor survey. We estimate a case to control 
ratio of 1:2 (200 to 400) with a 50 percent case enrollment.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
              Questionnaire/survey                   Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cases and controls.\2\..........................             600                1              600   0.75 (45 minutes).................             450
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Cases consist of virus-positive donations, and controls represent uninfected donors.


    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23622 Filed 9-29-16; 8:45 am]
BILLING CODE 4164-01-P



                                                  67358                       Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices

                                                  tropical disease priority review user fee               User Fees Payment Portal at https://                  1. Ridley, D.B., H.G. Grabowski, and J.L. Moe,
                                                  amount for FY 2017 that must be                         userfees.fda.gov/pay. Once you search                      ‘‘Developing Drugs for Developing
                                                  submitted with a priority review                        for your invoice, click ‘‘Pay Now’’ to be                  Countries,’’ Health Affairs, vol. 25, no. 2,
                                                                                                                                                                     pp. 313–324, 2006.
                                                  voucher for a human drug application in                 redirected to Pay.gov. Note that
                                                  FY 2017, in addition to any PDUFA fee                   electronic payment options are based on                 Dated: September 26, 2016.
                                                  that is required for such an application.               the balance due. Payments must be                     Leslie Kux,
                                                                                                          drawn on U.S bank accounts.                           Associate Commissioner for Policy.
                                                  III. Fee Schedule for FY 2017                              FDA has partnered with the U.S.                    [FR Doc. 2016–23623 Filed 9–29–16; 8:45 am]
                                                     The fee rate for FY 2017 is set out in               Department of the Treasury to use                     BILLING CODE 4164–01–P
                                                  Table 1:                                                Pay.gov, a Web-based payment
                                                                                                          application, for online electronic
                                                     TABLE    1—TROPICAL DISEASE PRI-                     payment. The Pay.gov feature is                       DEPARTMENT OF HEALTH AND
                                                     ORITY    REVIEW SCHEDULE FOR FY                      available on the FDA Web site after the               HUMAN SERVICES
                                                     2017                                                 user fee ID number is generated.
                                                                                                             The user fee identification (ID)                   Food and Drug Administration
                                                                                        Fee rate for      number should be included on the
                                                           Fee category                                                                                         [Docket No. FDA–2016–N–2836]
                                                                                         FY 2017          check, followed by the words ‘‘Tropical
                                                                                                          Disease Priority Review.’’ Payments can               Agency Information Collection
                                                  Application submitted with a                            be mailed to: Food and Drug
                                                    tropical disease priority re-                                                                               Activities; Proposed Collection;
                                                    view voucher in addition to
                                                                                                          Administration, P.O. Box 979107, St.                  Comment Request; Donor Risk
                                                    the normal PDUFA fee .....          $2,706,000        Louis, MO 63197–9000.                                 Assessment Questionnaire for the
                                                                                                             If checks are sent by a courier that               Food and Drug Administration/National
                                                                                                          requests a street address, the courier can            Heart, Lung, and Blood Institute-
                                                  IV. Implementation of Tropical Disease
                                                                                                          deliver the checks to: U.S. Bank,                     Sponsored Transfusion-Transmissible
                                                  Priority Review User Fee
                                                                                                          Attention: Government Lockbox 979107,                 Infections Monitoring System—Risk
                                                     Under section 524(c)(4)(A) of the                    1005 Convention Plaza, St. Louis, MO
                                                  FD&C Act, the priority review user fee                                                                        Factor Elicitation
                                                                                                          63101. (Note: This U.S. Bank address is
                                                  is due upon submission of a human                       for courier delivery only. If you have                AGENCY:    Food and Drug Administration,
                                                  drug application for which the priority                 any questions concerning courier                      HHS.
                                                  review voucher is used. Section                         delivery contact the U.S. Bank at 314–                ACTION:   Notice.
                                                  524(c)(4)(B) of the FD&C Act specifies                  418–4013. This telephone number is
                                                  that the application will be considered                 only for questions about courier                      SUMMARY:   The Food and Drug
                                                  incomplete if the priority review user                  delivery.) The FDA post office box                    Administration (FDA) is announcing an
                                                  fee and all other applicable user fees are              number (P.O. Box 979107) must be                      opportunity for public comment on the
                                                  not paid in accordance with FDA                         written on the check. The tax                         proposed collection of certain
                                                  payment procedures. In addition, FDA                    identification number of FDA is 53–                   information by the Agency. Under the
                                                  may not grant a waiver, exemption,                      0196965.                                              Paperwork Reduction Act of 1995 (the
                                                  reduction, or refund of any fees due and                   If paying by wire transfer, please                 PRA), Federal Agencies are required to
                                                  payable under this section of the FD&C                  reference your unique user fee ID                     publish notice in the Federal Register
                                                  Act and FDA may not collect priority                    number when completing your transfer.                 concerning each proposed collection of
                                                  review voucher fees ‘‘except to the                     The originating financial institution                 information and to allow 60 days for
                                                  extent provided in advance in                           may charge a wire transfer fee. Please                public comment in response to the
                                                  appropriation Acts.’’ Section                           ask your financial institution about the              notice. This notice solicits comments on
                                                  524(c)(4)(C) and 524(c)(5)(B). Beginning                fee and include it with your payment to               an information collection request
                                                  with FDA’s appropriation for FY 2009,                   ensure that your fee is fully paid. The               regarding risk factors associated with
                                                  the annual appropriation language states                account information is as follows: U.S.               transfusion-transmissible infections
                                                  specifically that ‘‘priority review user                Dept. of Treasury, TREAS NYC, 33                      (TTI) in blood donors.
                                                  fees authorized by 21 U.S.C. 360n                       Liberty St., New York, NY 10045,                      DATES: Submit either electronic or
                                                  (section 524 of the FD&C Act) may be                    Account Number: 75060099, Routing                     written comments on the collection of
                                                  credited to this account, to remain                     Number: 021030004, SWIFT:                             information by November 29, 2016.
                                                  available until expended.’’ (Pub. L. 111–               FRNYUS33, Beneficiary: FDA, 8455                      ADDRESSES: You may submit comments
                                                  8, Section 5, Division A, Title VI).                    Colesville Rd., 14th Floor, Silver Spring,            as follows:
                                                     The tropical disease priority review                 MD 20993–0002.
                                                  fee established in the new fee schedule                    Paying by credit card (Discover, VISA,             Electronic Submissions
                                                  must be paid for any application that is                MasterCard, American Express) is                        Submit electronic comments in the
                                                  received on or after October 1, 2016, and               available for balances less than $25,000.             following way:
                                                  submitted with a priority review                        If the balance exceeds this amount, only                • Federal eRulemaking Portal: http://
                                                  voucher. This fee must be paid in                       the ACH option is available. Payments                 www.regulations.gov. Follow the
                                                  addition to any other fee due under                     must be drawn on U.S. credit cards.                   instructions for submitting comments.
                                                  PDUFA. Payment must be made in U.S.                                                                           Comments submitted electronically,
                                                  currency by electronic check, check,                    V. Reference                                          including attachments, to http://
                                                  bank draft, wire transfer, credit card, or                The following reference is on display               www.regulations.gov will be posted to
mstockstill on DSK3G9T082PROD with NOTICES




                                                  U.S. postal money order payable to the                  in the Division of Dockets Management                 the docket unchanged. Because your
                                                  order of the Food and Drug                              (HFA–305), Food and Drug                              comment will be made public, you are
                                                  Administration. The preferred payment                   Administration, 5630 Fishers Lane, Rm.                solely responsible for ensuring that your
                                                  method is online using electronic check                 1061, Rockville, MD 20852, and is                     comment does not include any
                                                  (Automated Clearing House (ACH) also                    available for viewing by interested                   confidential information that you or a
                                                  known as eCheck). Secure electronic                     persons between 9 a.m. and 4 p.m.,                    third party may not wish to be posted,
                                                  payments can be submitted using the                     Monday through Friday.                                such as medical information, your or


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                                                                              Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices                                          67359

                                                  anyone else’s Social Security number, or                Management. If you do not wish your                   the quality, utility, and clarity of the
                                                  confidential business information, such                 name and contact information to be                    information to be collected; and (4)
                                                  as a manufacturing process. Please note                 made publicly available, you can                      ways to minimize the burden of the
                                                  that if you include your name, contact                  provide this information on the cover                 collection of information on
                                                  information, or other information that                  sheet and not in the body of your                     respondents, including through the use
                                                  identifies you in the body of your                      comments and you must identify this                   of automated collection techniques,
                                                  comments, that information will be                      information as ‘‘confidential.’’ Any                  when appropriate, and other forms of
                                                  posted on http://www.regulations.gov.                   information marked as ‘‘confidential’’                information technology.
                                                    • If you want to submit a comment                     will not be disclosed except in
                                                  with confidential information that you                                                                        Donor Risk Assessment Questionnaire
                                                                                                          accordance with 21 CFR 10.20 and other
                                                  do not wish to be made available to the                                                                       for the Food and Drug Administration
                                                                                                          applicable disclosure law. For more
                                                  public, submit the comment as a                                                                               (FDA)/National Heart, Lung, and Blood
                                                                                                          information about FDA’s posting of
                                                  written/paper submission and in the                                                                           Institute (NHLBI)-Sponsored
                                                                                                          comments to public dockets, see 80 FR
                                                  manner detailed (see ‘‘Written/Paper                                                                          Transfusion-Transmissible Infections
                                                                                                          56469, September 18, 2015, or access
                                                  Submissions’’ and ‘‘Instructions’’).                                                                          Monitoring System (TTIMS)—Risk
                                                                                                          the information at: http://www.fda.gov/
                                                                                                                                                                Factor Elicitation (RFE) OMB Control
                                                  Written/Paper Submissions                               regulatoryinformation/dockets/
                                                                                                                                                                Number—New
                                                                                                          default.htm.
                                                     Submit written/paper submissions as                     Docket: For access to the docket to                   FDA intends to interview blood
                                                  follows:                                                read background documents or the                      donors to collect risk factor information
                                                     • Mail/Hand delivery/Courier (for                    electronic and written/paper comments
                                                  written/paper submissions): Division of                                                                       associated with testing positive for a
                                                                                                          received, go to http://                               TTI. This collection of information is
                                                  Dockets Management (HFA–305), Food
                                                                                                          www.regulations.gov and insert the                    part of a larger initiative called TTIMS
                                                  and Drug Administration, 5630 Fishers
                                                                                                          docket number, found in brackets in the               which is a collaborative project funded
                                                  Lane, Rm. 1061, Rockville, MD 20852.
                                                     • For written/paper comments                         heading of this document, into the                    by FDA, the NHLBI of the National
                                                  submitted to the Division of Dockets                    ‘‘Search’’ box and follow the prompts                 Institutes of Health (NIH), and the
                                                  Management, FDA will post your                          and/or go to the Division of Dockets                  Department of Health and Human
                                                  comment, as well as any attachments,                    Management, 5630 Fishers Lane, Rm.                    Services (HHS) Office of the Assistant
                                                  except for information submitted,                       1061, Rockville, MD 20852.                            Secretary of Health with input from
                                                  marked and identified, as confidential,                 FOR FURTHER INFORMATION CONTACT: FDA                  other agencies in HHS including the
                                                  if submitted as detailed in                             PRA Staff, Office of Operations, Food                 Centers for Disease Control and
                                                  ‘‘Instructions.’’                                       and Drug Administration, Three White                  Prevention (CDC). FDA will use these
                                                     Instructions: All submissions received               Flint North, 10A63, 11601 Landsdown                   scientific data collected through such
                                                  must include the Docket No. FDA–                        St., North Bethesda, MD 20852,                        interview-based risk factor elicitation of
                                                  2016–N–2836 for ‘‘Donor Risk                            PRAStaff@fda.hhs.gov.                                 blood donors to monitor and help
                                                  Assessment Questionnaire for the Food                   SUPPLEMENTARY INFORMATION: Under the                  ensure the safety of the United States
                                                  and Drug Administration (FDA)/                          PRA (44 U.S.C. 3501–3520), Federal                    blood supply.
                                                  National Heart, Lung, and Blood                         Agencies must obtain approval from the                   Previous assessments of risk factor
                                                  Institute (NHLBI)-sponsored                             Office of Management and Budget                       profiles among blood donors found to be
                                                  Transfusion-Transmissible Infections                    (OMB) for each collection of                          positive for human immunodeficiency
                                                  Monitoring System (TTIMS)—Risk                          information they conduct or sponsor.                  virus (HIV) were funded by CDC for
                                                  Factor Elicitation (RFE).’’ Received                    ‘‘Collection of information’’ is defined              approximately 10 years after
                                                  comments will be placed in the docket                   in 44 U.S.C. 3502(3) and 5 CFR                        implementation of HIV serologic
                                                  and, except for those submitted as                      1320.3(c) and includes Agency requests                screening of blood donors in the mid-
                                                  ‘‘Confidential Submissions,’’ publicly                  or requirements that members of the                   1980s, whereas studies of Hepatitis C
                                                  viewable at http://www.regulations.gov                  public submit reports, keep records, or               virus (HCV) seropositive donors, funded
                                                  or at the Division of Dockets                           provide information to a third party.                 by NIH, were conducted in the early
                                                  Management between 9 a.m. and 4 p.m.,                   Section 3506(c)(2)(A) of the PRA (44                  1990s. Information on current risk
                                                  Monday through Friday.                                  U.S.C. 3506(c)(2)(A)) requires Federal                factors in blood donors as assessed
                                                     • Confidential Submissions—To                        Agencies to provide a 60-day notice in                using analytical study designs was next
                                                  submit a comment with confidential                      the Federal Register concerning each                  evaluated by the Transfusion-
                                                  information that you do not wish to be                  proposed collection of information                    Transmitted Retrovirus and Hepatitis
                                                  made publicly available, submit your                    before submitting the collection to OMB               Virus Rates and Risk Factors Study
                                                  comments only as a written/paper                        for approval. To comply with this                     conducted by the NHLBI Retrovirus
                                                  submission. You should submit two                       requirement, FDA is publishing notice                 Epidemiology Donor Study-II (REDS–II)
                                                  copies total. One copy will include the                 of the proposed collection of                         approved under OMB control number
                                                  information you claim to be confidential                information set forth in this document.               0925–0630. Through a risk factor
                                                  with a heading or cover note that states                   With respect to the following                      questionnaire, this study elicited risk
                                                  ‘‘THIS DOCUMENT CONTAINS                                collection of information, FDA invites                factors in blood donors who tested
                                                  CONFIDENTIAL INFORMATION.’’ The                         comments on these topics: (1) Whether                 confirmed positive for one of four
                                                  Agency will review this copy, including                 the proposed collection of information                transfusion-transmissible infections:
                                                  the claimed confidential information, in                is necessary for the proper performance               HIV, HCV, Hepatitis B virus (HBV), and
mstockstill on DSK3G9T082PROD with NOTICES




                                                  its consideration of comments. The                      of FDA’s functions, including whether                 Human T-cell Lymphotropic virus. The
                                                  second copy, which will have the                        the information will have practical                   study also elicited risk factors from
                                                  claimed confidential information                        utility; (2) the accuracy of FDA’s                    donors who did not have any infections
                                                  redacted/blacked out, will be available                 estimate of the burden of the proposed                (controls) and compared their responses
                                                  for public viewing and posted on http://                collection of information, including the              to those of the donors with confirmed
                                                  www.regulations.gov. Submit both                        validity of the methodology and                       infection (cases). Results from the
                                                  copies to the Division of Dockets                       assumptions used; (3) ways to enhance                 REDS–II study were published in 2015.


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                                                  67360                            Federal Register / Vol. 81, No. 190 / Friday, September 30, 2016 / Notices

                                                     FDA issued a document entitled                                   donors. These data also will inform FDA             the TTIMS program will maintain
                                                  ‘‘Revised Recommendations for                                       regarding future blood donor deferral               standardized, statistically and
                                                  Reducing the Risk of Human                                          policy options to reduce the risk of HIV            scientifically robust processes for
                                                  Immunodeficiency Virus Transmission                                 transmission, including the feasibility of          applying hemovigilance information
                                                  by Blood and Blood Products, Guidance                               moving from the existing time-based                 across blood collection organizations.
                                                  for Industry’’ dated December 2015                                  deferrals related to risk behaviors to                 The specific objectives are to:
                                                  (http://www.fda.gov/downloads/                                      alternate deferral options, such as the                • Determine current behavioral risk
                                                  BiologicsBloodVaccines/Guidance                                     use of individual risk assessments, and             factors associated with all HIV
                                                  ComplianceRegulatoryInformation/                                    to inform the design of potential studies           infections, incident HBV, and incident
                                                  Guidances/Blood/UCM446580.pdf)                                      to evaluate the feasibility and                     HCV infections in blood donors
                                                  which changed the blood donor                                       effectiveness of such alternative deferral          (including parenteral and sexual risks)
                                                  criterion for men who have sex with                                 options.                                            across the participating blood collection
                                                  men (MSM) from an indefinite                                           TTIMS will include a comprehensive               organizations using a case-control study
                                                  (permanent) deferral to a 12-month                                  interview-based epidemiological study               design.
                                                  deferral since last MSM contact. The                                of risk factor information for viral                   • Determine infectious disease
                                                  impact of this change in the deferral                               infection-positive blood donors at the              marker prevalence and incidence for
                                                  criteria requires a national monitoring                             American Red Cross (ARC), Blood                     HIV, HBV, and HCV overall and by
                                                  effort as part of TTIMS to assess if the                            Systems, Inc. (BSI), New York Blood                 demographic characteristics of donors
                                                  relative proportions of risk factors for                            Center (NYBC), and OneBlood that will               in the majority of blood donations
                                                  infection in blood donors have changed                              identify the current predominant risk               collected in the country. This will be
                                                  following the adoption of the 12-month                              factors and reasons for virus-positive              accomplished by forming
                                                  donor deferral for MSM. TTIMS will use                              donations. The TTIMS program                        epidemiological databases consisting of
                                                  similar procedures as the ones used in                              establishes a new, ongoing donor                    harmonized operational data from ARC,
                                                  the REDS–II study to monitor and                                    hemovigilance capacity that currently               BSI, NYBC, and OneBlood.
                                                  evaluate risk factors among HIV-positive                            does not exist in the United States.                   • Analyze integrated risk factor and
                                                  donors and recently HCV or HBV                                      Using procedures developed by the                   infectious marker testing data
                                                  infected donors as well as controls.                                REDS–II study, TTIMS will establish                 concurrently because when taken
                                                     This study will help identify the                                this capacity in greater than 50 percent            together these may suggest that blood
                                                  specific risk factors for TTI and their                             of all blood donations collected in the             centers are not achieving the same
                                                  prevalence in blood donors, and help                                country.                                            degree of success in educational efforts
                                                  inform FDA on the proportion of                                        As part of the TTIMS project, a                  to prevent donation by donors with risk
                                                  incident (new) infections among all HIV                             comprehensive hemovigilance database                behaviors across all demographic
                                                  positive blood donors. Donations with                               will be created that integrates the risk            groups.
                                                  incident infections have the greatest                               factor information collected through                   The respondents will be persons who
                                                  potential transmission risk because they                            donor interviews of blood donor with                donated blood in the United States and
                                                  could be missed during routine blood                                the resulting data from disease marker              these participants will be defined as
                                                  screening. The study will help FDA                                  testing and blood components collected              cases and controls. The estimated
                                                  evaluate the effectiveness of screening                             by participating organizations into a               number of respondents is based on an
                                                  strategies in reducing the risk of HIV                              research database. Following successful             overall expected participation in the
                                                  transmission from at-risk donors and to                             initiation of the risk factor interviews,           risk factor survey. We estimate a case to
                                                  evaluate if there are unexpected                                    the TTIMS network is poised to be                   control ratio of 1:2 (200 to 400) with a
                                                  consequences associated with the recent                             expanded to include additional blood                50 percent case enrollment.
                                                  change in donor deferral policy such as                             centers and/or re-focused on other                     FDA estimates the burden of this
                                                  an increase in HIV incidence among                                  safety threats as warranted. In this way,           collection of information as follows:

                                                                                                        TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                            Number of
                                                                                                                          Number of                            Total annual         Average burden            Total
                                                                    Questionnaire/survey                                                  responses per
                                                                                                                         respondents                            responses            per response             hours
                                                                                                                                            respondent

                                                  Cases and controls.2 ............................................          600                  1                600         0.75 (45 minutes) ..........   450
                                                     1 There   are no capital costs or operating and maintenance costs associated with this collection of information.
                                                     2 Cases   consist of virus-positive donations, and controls represent uninfected donors.


                                                    Dated: September 26, 2016.                                        DEPARTMENT OF HEALTH AND                            ACTION:   Notice.
                                                  Leslie Kux,                                                         HUMAN SERVICES
                                                  Associate Commissioner for Policy.                                                                                      SUMMARY:   The Food and Drug
                                                  [FR Doc. 2016–23622 Filed 9–29–16; 8:45 am]                         Food and Drug Administration                        Administration (FDA or the Agency) is
                                                  BILLING CODE 4164–01–P
                                                                                                                                                                          announcing the fee rate for using a rare
                                                                                                                                                                          pediatric disease priority review
mstockstill on DSK3G9T082PROD with NOTICES




                                                                                                                      [Docket No. FDA–2016–N–0007]
                                                                                                                                                                          voucher for fiscal year (FY) 2017. The
                                                                                                                      Fee for Using a Rare Pediatric Disease              Federal Food, Drug, and Cosmetic Act
                                                                                                                      Priority Review Voucher in Fiscal Year              (the FD&C Act), as amended by the Food
                                                                                                                      2017                                                and Drug Administration Safety and
                                                                                                                                                                          Innovation Act (FDASIA), authorizes
                                                                                                                      AGENCY:   Food and Drug Administration,             FDA to determine and collect rare
                                                                                                                      HHS.                                                pediatric disease priority review user


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Document Created: 2018-02-09 13:33:48
Document Modified: 2018-02-09 13:33:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by November 29, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation81 FR 67358 

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