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, 922-924 [2020-00047]
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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Office of
Policy, Bldg. 32, Rm. 4248, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Jarilyn Dupont, Office of Policy, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 4248,
Silver Spring, MD 20993–0002, 301–
796–4850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November
25, 2019 (84 FR 64906), FDA published
a notice with a 45-day comment period
to request comments on the draft
guidance for industry and staff entitled
‘‘Certificates of Confidentiality;
Guidance for Sponsors, SponsorInvestigators, Researchers, Industry, and
Food and Drug Administration Staff.’’
FDA is extending the comment period,
in response to a request from a
stakeholder, until January 24, 2020. The
Agency believes the extension allows
adequate time for interested persons to
submit comments without significantly
delaying publication of the final version
of the guidance.
II. Electronic Access
jbell on DSKJLSW7X2PROD with NOTICES
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Regulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00070 Filed 1–7–20; 8:45 am]
BILLING CODE 4164–01–P
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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 InstituteSponsored Transfusion-Transmissible
Infections Monitoring System—Risk
Factor Elicitation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing an opportunity for
public comment on the proposed
collection of certain information by the
Agency. Under the Paperwork
Reduction Act of 1995 (PRA), Federal
Agencies are required to publish notice
in the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing 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 transfusiontransmissible infections (TTI) in blood
donors.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by March 9, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 9,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 9, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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 ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Donor
Risk Assessment Questionnaire for
FDA/National Heart, Lung, and Blood
Institute-Sponsored TransfusionTransmissible Infections Monitoring
System—Risk Factor Elicitation.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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,
including each proposed extension of an
existing 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
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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 FDA/National Heart, Lung, and
Blood Institute (NHLBI)-Sponsored
Transfusion-Transmissible Infections
Monitoring System (TTIMS)—Risk
Factor Elicitation (RFE)
OMB Control Number 0910–0841—
Extension
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 U.S. 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 mid1980s, 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 TransfusionTransmitted 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
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923
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.
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
(available at: https://www.fda.gov/
media/92490/download), 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
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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
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 refocused 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 caseto-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
Questionnaire/survey
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per response
Total hours
Cases and controls 2 .........................
600
1
600
0.50 (30 minutes) .............................
300
1 There
2 Cases
are no capital costs or operating and maintenance costs associated with this collection of information.
consist of virus-positive donations, and controls represent uninfected donors.
We have adjusted our burden
estimate, which has resulted in a
decrease to the currently approved
burden. Based on experience with this
survey, we decreased the average
burden per response from 45 to 30
minutes, resulting in a change from 450
to 300 total hours.
Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00047 Filed 1–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5799]
Modernizing the Food and Drug
Administration’s Data Strategy; Public
Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
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HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
meeting entitled ‘‘Modernizing FDA’s
SUMMARY:
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Data Strategy.’’ The purpose of the
public meeting and the request for
comments is to discuss possible Agency
level approaches to modernizing FDA’s
data strategy, including approaches to
data quality, data stewardship, data
exchange, and data analytics.
DATES: The public meeting will be held
on March 27, 2020, from 9 a.m. to 5 p.m.
Eastern time. The public meeting may
be extended or may end early. Submit
electronic or written comments on this
public meeting by April 30, 2020. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room
(Rooms 1503B/C), Silver Spring, MD
20993–0002. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/about-fda/white-oakcampus-information/public-meetingsfda-white-oak-campus.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
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on or before April 30, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
April 30, 2020. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
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
E:\FR\FM\08JAN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 922-924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00047]
-----------------------------------------------------------------------
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, the Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing 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 March 9, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 9, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 9, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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 ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Donor Risk Assessment
Questionnaire for FDA/National Heart, Lung, and Blood Institute-
Sponsored Transfusion-Transmissible Infections Monitoring System--Risk
Factor Elicitation.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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
[[Page 923]]
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 Dockets Management Staff. 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, including
each proposed extension of an existing 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 FDA/National Heart, Lung, and
Blood Institute (NHLBI)-Sponsored Transfusion-Transmissible Infections
Monitoring System (TTIMS)--Risk Factor Elicitation (RFE)
OMB Control Number 0910-0841--Extension
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 U.S. 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.
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
(available at: https://www.fda.gov/media/92490/download), 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
[[Page 924]]
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
refocused 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 0.50 (30 minutes)................. 300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Based on experience with
this survey, we decreased the average burden per response from 45 to 30
minutes, resulting in a change from 450 to 300 total hours.
Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00047 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P
