Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 68173-68174 [2022-24693]
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BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2683]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 December
14, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Nov 10, 2022
Jkt 259001
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
Data To Support Social and Behavioral
Research as Used by the Food and Drug
Administration
OMB Control Number 0910–0847—
Extension
This information collection is
intended to support FDA-conducted
research. Understanding patients,
consumers, and healthcare
professionals’ perceptions and
behaviors plays an important role in
improving FDA’s regulatory decision-
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
making processes and communications
that affect various stakeholders. FDA
uses the following methods to achieve
these goals: (1) individual indepth
interviews, (2) general public focus
group interviews, (3) intercept
interviews, (4) self-administered
surveys, (5) gatekeeper surveys, and (6)
focus group interviews. These methods
serve the narrowly defined need for
direct and informal opinion on a
specific topic and serve as a qualitative
and quantitative research tool having
two major purposes:
• Obtaining useful information for the
development of variables and measures
for formulating the basic objectives of
social and behavioral research and
• successfully communicating and
addressing behavioral changes with
intended audiences to assess the
potential effectiveness of FDA
communications, behavioral
interventions, and other materials.
While FDA will use these methods to
test and refine its ideas and help
develop communication and behavioral
strategies research, the Agency will
generally conduct further research
before making important decisions
(such as adopting new policies and
allocating or redirecting significant
resources to support these policies).
FDA’s Center for Drug Evaluation and
Research, Center for Biologics
Evaluation and Research, Office of the
E:\FR\FM\14NON1.SGM
14NON1
EN14NO22.013</GPH>
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 0910–0847. Also include
the FDA docket number found in
brackets in the heading of this
document.
[FR Doc. 2022–24670 Filed 11–10–22; 8:45 am]
68173
Addendum XV: FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials (July through September 2022)
There were no FDG-PET for Dementia and Neurodegenerative
Diseases Clinical Trials published in the 3-month period.
This information is available on our website at
www.ems.gov/MedicareApprovedFacilitie/PETDT/list.asp#TopOfPage.
For questions or additional information, contact David Dolan, MBA (410786-3365).
There were no additions, deletions, or editorial changes to
Medicare-approved facilities that meet CMS' minimum facility standards
for bariatric surgery that have been certified by ACS and/or ASMBS in the
3-month period. This information is available at
www.ems.gov/MedicareApprovedFacilitie/BSF/list.asp#TopOfPage. For
questions or additional information, contact Sarah Fulton, MHS
(410-786-2749).
Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices
68174
Federal Register / Vol. 87, No. 218 / Monday, November 14, 2022 / Notices
Commissioner, and any other Centers
will use this mechanism to test
communications and social and
behavioral methods about regulated
drug products on a variety of subjects
related to consumer, patient, or
healthcare professional perceptions,
beliefs, attitudes, behaviors, and use of
drug and biological products and related
materials. These subjects include social
and behavioral research, decisionmaking processes, and communication
and behavioral change strategies.
Annually, FDA projects about 25
social and behavioral studies using the
variety of test methods listed in this
document. FDA is revising this burden
to account for the number of studies we
have received in the last 3 years and to
better reflect the scope of the
information collection.
In the Federal Register of August 10,
2022 (87 FR 48665), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Three comments were
received. The first comment was not
responsive. The second comment
requested that participants be informed
that participation is voluntary and can
withdraw at any time. Prior to beginning
the interview and several times
throughout, participants are informed
that their participation is voluntary and
that they can withdraw at any time. We
believe no further clarification to the
survey instruments are necessary. The
third comment expressed concerns
regarding the potential misuse of
information from the collection. We
have previously outlined the scope and
purpose of the information collection,
and we do not believe further
elaboration is necessary. Further, as
outlined in the supporting statement, all
information collections must be noncontroversial, must not retain Personally
Identifiable Information, and ‘‘will not
be used for substantially informing
influential policy decisions.’’
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Interviews and Surveys .....................
1 There
109,470
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–24693 Filed 11–10–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
1
Total annual
responses
109,470
Average burden per response
0.25 (15 minutes) .............................
Total hours
27,368
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, our burden estimate for
this information collection reflects an
overall increase of 35,886 responses
with a corresponding increase of 8,972
hours. We attribute this adjustment to
an increase in funding and need to
obtain additional information in specific
areas, particularly substance abuse (for
example, opioids and stimulants) and
COVID–19. In addition, we attribute the
increase in the number of respondents
(from 7,298 to 109,470) and decrease in
the number of responses per respondent
(from 15 to 1) to an inadvertent
administrative error reflected in the 60day notice. These changes, however, do
not impact the estimated total annual
responses or burden hours.
[Docket No. FDA–2019–E–2271]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PREVYMIS IV Solution, New
Drug Application 209940
AGENCY:
Number of
responses per
respondent
Number of
respondents
Activity
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:30 Nov 10, 2022
Jkt 259001
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PREVYMIS IV Solution, new drug
application (NDA) 209940, and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by January 13, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
May 15, 2023. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 13, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
timely if they are received 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
E:\FR\FM\14NON1.SGM
14NON1
]]>Agencies
[Federal Register Volume 87, Number 218 (Monday, November 14, 2022)]
[Notices]
[Pages 68173-68174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24693]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2683]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support
Social and Behavioral Research as Used by the Food and Drug
Administration
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 December 14, 2022.
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 0910-0847. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration
OMB Control Number 0910-0847--Extension
This information collection is intended to support FDA-conducted
research. Understanding patients, consumers, and healthcare
professionals' perceptions and behaviors plays an important role in
improving FDA's regulatory decision-making processes and communications
that affect various stakeholders. FDA uses the following methods to
achieve these goals: (1) individual indepth interviews, (2) general
public focus group interviews, (3) intercept interviews, (4) self-
administered surveys, (5) gatekeeper surveys, and (6) focus group
interviews. These methods serve the narrowly defined need for direct
and informal opinion on a specific topic and serve as a qualitative and
quantitative research tool having two major purposes:
Obtaining useful information for the development of
variables and measures for formulating the basic objectives of social
and behavioral research and
successfully communicating and addressing behavioral
changes with intended audiences to assess the potential effectiveness
of FDA communications, behavioral interventions, and other materials.
While FDA will use these methods to test and refine its ideas and
help develop communication and behavioral strategies research, the
Agency will generally conduct further research before making important
decisions (such as adopting new policies and allocating or redirecting
significant resources to support these policies).
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the
[[Page 68174]]
Commissioner, and any other Centers will use this mechanism to test
communications and social and behavioral methods about regulated drug
products on a variety of subjects related to consumer, patient, or
healthcare professional perceptions, beliefs, attitudes, behaviors, and
use of drug and biological products and related materials. These
subjects include social and behavioral research, decision-making
processes, and communication and behavioral change strategies.
Annually, FDA projects about 25 social and behavioral studies using
the variety of test methods listed in this document. FDA is revising
this burden to account for the number of studies we have received in
the last 3 years and to better reflect the scope of the information
collection.
In the Federal Register of August 10, 2022 (87 FR 48665), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received. The first
comment was not responsive. The second comment requested that
participants be informed that participation is voluntary and can
withdraw at any time. Prior to beginning the interview and several
times throughout, participants are informed that their participation is
voluntary and that they can withdraw at any time. We believe no further
clarification to the survey instruments are necessary. The third
comment expressed concerns regarding the potential misuse of
information from the collection. We have previously outlined the scope
and purpose of the information collection, and we do not believe
further elaboration is necessary. Further, as outlined in the
supporting statement, all information collections must be non-
controversial, must not retain Personally Identifiable Information, and
``will not be used for substantially informing influential policy
decisions.''
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Interviews and Surveys........ 109,470 1 109,470 0.25 (15 27,368
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on a review of the information collection since our last
request for OMB approval, our burden estimate for this information
collection reflects an overall increase of 35,886 responses with a
corresponding increase of 8,972 hours. We attribute this adjustment to
an increase in funding and need to obtain additional information in
specific areas, particularly substance abuse (for example, opioids and
stimulants) and COVID-19. In addition, we attribute the increase in the
number of respondents (from 7,298 to 109,470) and decrease in the
number of responses per respondent (from 15 to 1) to an inadvertent
administrative error reflected in the 60-day notice. These changes,
however, do not impact the estimated total annual responses or burden
hours.
Dated: November 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24693 Filed 11-10-22; 8:45 am]
BILLING CODE 4164-01-P
