Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 48665-48667 [2022-17155]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
education of providers and stakeholders
with respect to health care reform and
certain provisions of the HITECH Act
enacted as part of the ARRA.
The charter will terminate on January
19, 2023, unless renewed by appropriate
action. The APOE was chartered under
42 U.S.C. 217a, section 222 of the Public
Health Service Act, as amended. The
APOE is governed by provisions of Pub.
L. 92–463, as amended (5 U.S.C.
Appendix 2), which sets forth standards
for the formation and use of advisory
committees.
In accordance with the renewed
charter, the APOE will advise the
Secretary and the CMS Administrator
concerning optimal strategies for the
following:
• Developing and implementing
education and outreach programs for
individuals enrolled in, or eligible for,
Medicare, Medicaid, the CHIP, and
coverage available through the Health
Insurance Marketplace® and other CMS
programs.
• Enhancing the federal government’s
effectiveness in informing Medicare,
Medicaid, CHIP, or the Health Insurance
Marketplace® consumers, issuers,
providers, and stakeholders, pursuant to
education and outreach programs of
issues regarding these programs,
including the appropriate use of publicprivate partnerships to leverage the
resources of the private sector in
educating beneficiaries, providers,
partners and stakeholders.
• Expanding outreach to minority and
underserved communities, including
racial and ethnic minorities, in the
context of Medicare, Medicaid, CHIP,
and the Health Insurance Marketplace®
education programs and other CMS
programs as designated.
• Assembling and sharing an
information base of ‘‘best practices’’ for
helping consumers evaluate health
coverage options.
• Building and leveraging existing
community infrastructures for
information, counseling, and assistance.
• Drawing the program link between
outreach and education, promoting
consumer understanding of health care
coverage choices, and facilitating
consumer selection/enrollment, which
in turn support the overarching goal of
improved access to quality care,
including prevention services,
envisioned under the Affordable Care
Act.
The current members of the Panel as
of June 23, 2022, are as follows:
• Julie Carter, Senior Federal Policy
Associate, Medicare Rights Center.
• Scott Ferguson, Psychotherapist,
Scott Ferguson Psychotherapy.
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
• Jean-Venable Robertson Goode,
Professor, Department of
Pharmacotherapy and Outcomes
Science, School of Pharmacy, Virginia
Commonwealth University.
• Ted Henson, Director of Health
Center Performance and Innovation,
National Association of Community
Health Centers.
• Joan Ilardo, Director of Research
Initiatives, Michigan State University,
College of Human Medicine.
• Daisy Kim, Policy Manager, Asian &
Pacific Islander American Health
Forum.
• Cheri Lattimer, Executive Director,
National Transitions of Care Coalition.
• Cori McMahon, Vice President,
Tridiuum.
• Alan Meade, Director of
Rehabilitation Services, Holston
Medical Group.
• Neil Meltzer, President and CEO,
LifeBridge Health.
• Michael Minor, National Director,
H.O.P.E. HHS Partnership, National
Baptist Convention USA, Incorporated.
• Jina Ragland, Associate State
Director of Advocacy and Outreach,
AARP Nebraska.
• Morgan Reed, Executive Director,
Association for Competitive
Technology.
• Carrie Rogers, Associate Director,
Community Catalyst.
• Margot Savoy, Senior Vice
President, American Academy of Family
Physicians.
• Congresswoman Allyson Schwartz,
Senior Advisor, FTI Consulting.
• Matthew Snider, JD, Senior Policy
Analyst, Unidos US.
• Tia Whitaker, Statewide Director,
Outreach and Enrollment, Pennsylvania
Association of Community Health
Centers.
II. Provisions of This Notice
In accordance with section 10(a) of
the FACA, this notice announces a
meeting of the APOE. The agenda for
the September 15, 2022 meeting will
include the following:
• Welcome and listening session with
CMS leadership
• Recap of the previous (June 23, 2022)
meeting
• CMS programs, initiatives, and
priorities
• An opportunity for public comment
• Meeting summary, review of
recommendations, and next steps
Individuals or organizations that wish
to make a 5-minute oral presentation on
an agenda topic should submit a written
copy of the oral presentation to the DFO
at the address listed in the ADDRESSES
section of this notice by the date listed
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
48665
in the DATES section of this notice. The
number of oral presentations may be
limited by the time available.
Individuals not wishing to make an oral
presentation may submit written
comments to the DFO at the address
listed in the ADDRESSES section of this
notice by the date listed in the DATES
section of this notice.
III. Meeting Participation
The meeting is open to the public, but
attendance is limited to registered
participants. Persons wishing to attend
this meeting must register at the website
https://www.eventbrite.com/e/apoeseptember-15-2022-virtual-meetingtickets-380357628907 or contact the
DFO at the address or number listed in
the FOR FURTHER INFORMATION CONTACT
section of this notice by the date
specified in the DATES section of this
notice. This meeting will be held
virtually. Individuals who are not
registered in advance will be unable to
attend the meeting.
IV. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping, or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Chiquita Brooks-LaSure, having
reviewed and approved this document,
authorizes Lynette Wilson, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: August 5, 2022.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare
& Medicaid Services.
[FR Doc. 2022–17185 Filed 8–9–22; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2683]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\10AUN1.SGM
10AUN1
48666
ACTION:
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
Notice.
The Food and Drug
Administration (FDA, 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 a generic
clearance to collect information to
support social and behavioral research
used by FDA about drug products.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 11, 2022.
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
October 11, 2022. 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.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
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 Docket No. FDA–2016–N–
2683 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Data To
Support Social and Behavioral Research
as Used by the Food and Drug
Administration.’’ 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, 240–402–7500.
• 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
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://
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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, 240–402–7500.
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, PRAStaff@fda.hhs.gov.
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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\10AUN1.SGM
10AUN1
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
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 decisionmaking 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
48667
Evaluation and Research, Office of the
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews and Surveys .............................................
1 There
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17155 Filed 8–9–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
khammond on DSKJM1Z7X2PROD with NOTICES
7,298
Total annual
responses
15
109,470
Average time per
response
(in hours)
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 the funding in specific
areas, particularly substance abuse (for
example, opioids and stimulants) and
COVID–19.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Patent Term
Restoration; Due Diligence Petitions;
Filing, Format, and Content of
Petitions
AGENCY:
Number of
responses per
respondent
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) 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 information
collection provisions found in our
Patent Term Restoration regulations.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
October 11, 2022.
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
October 11, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48665-48667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17155]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2683]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Social and Behavioral Research as Used
by the Food and Drug Administration
AGENCY: Food and Drug Administration, HHS.
[[Page 48666]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, 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 a generic clearance to collect
information to support social and behavioral research used by FDA about
drug products.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 11, 2022.
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 October 11, 2022. 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 Docket No. FDA-
2016-N-2683 for ``Agency Information Collection Activities; Proposed
Collection; Comment Request; Data To Support Social and Behavioral
Research as Used by the Food and Drug Administration.'' 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, 240-402-7500.
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 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, 240-402-7500.
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: 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.
[[Page 48667]]
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 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.
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 time per response (in hours) Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews and Surveys....................... 7,298 15 109,470 0.25 (15 minutes)........................ 27,368
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 the funding in specific areas, particularly substance
abuse (for example, opioids and stimulants) and COVID-19.
Dated: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17155 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P
