Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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, 42001-42002 [2020-15009]
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<![CDATA[
Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
Donor Risk Assessment Questionnaire
for FDA/National Heart, Lung, and
Blood Institute (NHLBI)-Sponsored
Transfusion-Transmissible Infections
Monitoring System (TTIMS)—Risk
Factor Elicitation (RFE)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2836]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by August 12,
2020.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0841. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:25 Jul 10, 2020
Jkt 250001
OMB Control Number 0910–0841—
Revision
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
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 recently revised the currently
approved collection instrument for the
collection of information and have
included recently issued Agency
guidance. On April 2, 2020, FDA issued
a revised guidance document entitled
‘‘Revised Recommendations for
Reducing the Risk of Human
Immunodeficiency Virus Transmission
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
42001
by Blood and Blood Products; Guidance
for Industry’’ dated April 2020
(available at: https://www.fda.gov/
media/92490/download), which
changed the blood donor criterion for
men who have sex with men (MSM)
from a 12-month deferral to a 3-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 3-month
donor deferral for MSM. We also made
a change to the Risk Factor Assessment
interview questionnaire to keep the
TTIMS interview relevant with the
current deferral. 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
E:\FR\FM\13JYN1.SGM
13JYN1
42002
Federal Register / Vol. 85, No. 134 / Monday, July 13, 2020 / Notices
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
interviews of blood donors 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.
In the Federal Register of January 8,
2020 (85 FR 922), we published a 60day notice requesting public comment
on the proposed collection of
information. We received two comments
that were generally supportive of the
collection. One comment also contained
a specific suggestion that, in analyzing
the data after it is collected, we utilize
an ‘‘underreporting correction factor’’
identified by the commenter. The
comment did not suggest that we make
any changes to the Donor Risk
Assessment Questionnaire or the
information collection requirements. We
appreciate the commenter’s interest in
the accuracy of the TTIMS and will
consider the ‘‘underreporting correction
factor’’ identified by the commenter
when analyzing the data.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Cases and controls 2 .........................
1 There
2 Cases
Number of
responses per
respondent
Number of
respondents
Questionnaire/survey
600
Total annual
responses
1
600
Average burden per response
0.5 (30 minutes) ...............................
300
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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–15009 Filed 7–10–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1253 (formerly
FDA–1987–N–0054)]
Pentaerythritol Tetranitrate; Final
Decision on Proposal To Withdraw
Approval From New Drug Applications
and Abbreviated New Drug
Applications; Availability of Final
Decision
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing
that the initial decision of the
Administrative Law Judge (ALJ), to
withdraw approval of new drug
applications (NDAs) and abbreviated
new drug applications (ANDAs) for
pentaerythritol tetranitrate (PETN), is
the final decision of the Commissioner
of Food and Drugs (the Commissioner)
by operation of law. In the initial
decision, the ALJ found that PETN had
not been shown to be supported by
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
Total hours
VerDate Sep<11>2014
20:25 Jul 10, 2020
Jkt 250001
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
substantial evidence consisting of
adequate and well-controlled studies to
be effective for prophylactic treatment
of angina pectoris and ordered the
withdrawal of approval for all NDAs
and ANDAs. Several parties to the
hearing filed exceptions to the ALJ’s
initial decision; however, all parties
who submitted exceptions have since
voluntarily withdrawn them, or FDA
has deemed them withdrawn after their
associated NDA or ANDA was
withdrawn. Consequently, the
proceeding is in the same procedural
position as if no exceptions to the ALJ’s
initial decision had been filed.
Therefore, the ALJ’s initial decision has
become the final decision of the
Commissioner by operation of law.
Applicable Date: This notice is
applicable July 13, 2020.
ADDRESSES: For access to the docket, 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
between 9 a.m. and 4 p.m., Monday
E:\FR\FM\13JYN1.SGM
13JYN1
]]>Agencies
[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 42001-42002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15009]
[[Page 42001]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2836]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by August 12, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0841. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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--Revision
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 recently revised the currently approved collection instrument
for the collection of information and have included recently issued
Agency guidance. On April 2, 2020, FDA issued a revised guidance
document entitled ``Revised Recommendations for Reducing the Risk of
Human Immunodeficiency Virus Transmission by Blood and Blood Products;
Guidance for Industry'' dated April 2020 (available at: https://www.fda.gov/media/92490/download), which changed the blood donor
criterion for men who have sex with men (MSM) from a 12-month deferral
to a 3-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 3-
month donor deferral for MSM. We also made a change to the Risk Factor
Assessment interview questionnaire to keep the TTIMS interview relevant
with the current deferral. 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
[[Page 42002]]
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 interviews of blood donors 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.
In the Federal Register of January 8, 2020 (85 FR 922), we
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments that were generally
supportive of the collection. One comment also contained a specific
suggestion that, in analyzing the data after it is collected, we
utilize an ``underreporting correction factor'' identified by the
commenter. The comment did not suggest that we make any changes to the
Donor Risk Assessment Questionnaire or the information collection
requirements. We appreciate the commenter's interest in the accuracy of
the TTIMS and will consider the ``underreporting correction factor''
identified by the commenter when analyzing the data.
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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Cases and controls \2\........ 600 1 600 0.5 (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: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15009 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P
