Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Social and Behavioral Research as Used by the Food and Drug Administration, 28557-28559 [2019-13001]
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28557
Federal Register / Vol. 84, No. 118 / Wednesday, June 19, 2019 / Notices
Format and Content Requirements for
Over-the-Counter Drug Product
Labeling—21 CFR Part 201
OMB Control Number 0910–0340—
Extension
This information collection supports
FDA regulations at § 201.66 (21 CFR
201.66), which establish standardized
content and format requirements for the
labeling of all marketed OTC drug
products. The regulations set forth the
content and format requirements for the
Drug Facts portion of labels on OTC
drug products. These regulations require
OTC drug product labeling to include
uniform headings and subheadings,
presented in a standardized order, with
minimum standards for type size and
other graphical features.
Currently marketed OTC drug
products are already required to comply
with these labeling requirements and
will incur no further burden to comply
with Drug Facts labeling requirements
in § 201.66. Labeling modifications
already required to be in Drug Facts
format are ‘‘usual and customary’’ as
part of routine redesign practice, thus
they do not create additional burden
within the meaning of the PRA.
Therefore, burden for this information
collection is that which is necessary to
comply with the labeling requirements
in § 201.66, applicable to new OTC drug
products and OTC sunscreen drug
products introduced to the marketplace
under new drug applications,
abbreviated new drug applications, or
an OTC drug monograph. New OTC
drug products must comply with the
labeling requirements in § 201.66 as
they are introduced to the marketplace.
Based on our electronic drug
registration and listing database, we
estimate that approximately 10,463 new
OTC drug product stock keeping units
(SKUs) are introduced to the
marketplace each year. We estimate that
these SKUs are marketed by 1,416
manufacturers. We estimate that the
preparation of labeling for new OTC
drug products requires 12 hours to
prepare, complete, and review prior to
submitting the new labeling to us. Based
on this estimate, the annual reporting
burden for this type of labeling is 94,296
hours.
All currently marketed sunscreen
products are required to comply with
the Drug Facts labeling requirements in
§ 201.66, so they will incur no further
burden under the information collection
provisions in the regulation. However, a
new OTC sunscreen drug product, like
any new OTC drug product, will be
subject to a one-time burden to comply
with Drug Facts labeling requirements
in § 201.66. We estimate, based on our
electronic drug registration and listing
database, that 5,253 new SKUs of OTC
sunscreen drug products will be
marketed each year. We estimate that
these 5,253 SKUs will be marketed by
294 manufacturers. We estimate that 12
hours will be spent on each label. This
is reflected in table 1, row 1.
When determining the burden for
§ 201.66, it is also important to consider
exemptions or deferrals of the regulation
allowed products under § 201.66(e). We
receive very few requests for
exemptions or deferrals. We also
estimate that a request for deferral or
exemption requires 24 hours to
complete. This is reflected in table 1,
row 2.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR section
Number of
disclosures
per
respondent
Average
burden per
disclosure
Total hours
§ 201.66(c) and (d) for new OTC drug products .................
§ 201.66(e) ...........................................................................
855
1
9.19
1
7,858
1
12
24
94,296
24
Total ..............................................................................
........................
........................
........................
........................
94,320
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase of 82,797 hours and a
corresponding increase of 6,898
disclosures. This increase corresponds
with data obtained from our database.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Social and Behavioral Research as
Used by the Food and Drug
Administration
[FR Doc. 2019–12996 Filed 6–18–19; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2016–N–2683]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
jbell on DSK3GLQ082PROD with NOTICES
Total annual
disclosure
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
SUMMARY:
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19:06 Jun 18, 2019
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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: Submit either electronic or
written comments on the collection of
information by August 19, 2019.
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 August 19,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 19, 2019.
Comments received by mail/hand
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28558
Federal Register / Vol. 84, No. 118 / Wednesday, June 19, 2019 / Notices
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.
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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–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.
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19:06 Jun 18, 2019
Jkt 247001
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
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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.
Data To Support Social and Behavioral
Research as Used by the Food and Drug
Administration
OMB Control Number 0910–0847—
Extension
Understanding patients, consumers,
and healthcare professionals’
perceptions and behaviors plays an
important role in improving FDA’s
regulatory decisionmaking processes
and communications impacting various
stakeholders. The methods used to
achieve these goals include individual
in-depth interviews, general public
focus group interviews, intercept
interviews, self-administered surveys,
gatekeeper surveys, and focus group
interviews. The methods used serve the
narrowly defined need for direct and
informal opinion on a specific topic and
as a qualitative and quantitative
research tool, and have two major
purposes:
1. To obtain information that is useful
for developing variables and measures
for formulating the basic objectives of
social and behavioral research and
2. To assess the potential effectiveness
of FDA communications, behavioral
interventions and other materials in
reaching and successfully
communicating and addressing
behavioral change with their intended
audiences.
FDA will use these methods to test
and refine its ideas and to help develop
communication and behavioral
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Federal Register / Vol. 84, No. 118 / Wednesday, June 19, 2019 / Notices
strategies research, but 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 or
Offices 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 including, but not limited to,
social and behavioral research, decisionmaking processes, and communication
and behavioral change strategies.
28559
Annually, FDA projects about 45
social and behavioral studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Interviews/Surveys .................................................................
2,520
14.6
36,792
1 There
.25 (15 minutes).
Total hours
9,198
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, we have made no
adjustments to our burden estimate.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13001 Filed 6–18–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: The Teaching
Health Center Graduate Medical
Education Program Eligible Resident/
Fellow FTE Chart, OMB No. 0915–
0367—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 for opportunity
for public comment on proposed data
collection projects, HRSA announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this ICR should be
received no later than August 19, 2019.
SUMMARY:
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Average
burden per
response
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19:06 Jun 18, 2019
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Submit your comments to
paperwork@hrsa.gov or mail them to
HRSA Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Eligible Resident/Fellow FTE Chart,
OMB No. 0915–0367—Extension.
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
Program, Section 340H of the Public
Health Service Act, was established by
Section 5508 of Public Law 111–148.
The Bipartisan Budget Act of 2018 (Pub.
L. 115–123) provided continued funding
for the THCGME Program. The
THCGME Program awards payment for
both direct and indirect expenses to
support training for primary care
residents in community-based
ambulatory patient care settings. The
THCGME Program Eligible Resident/
Fellow Full-Time Equivalents (FTE)
Chart, published in the THCGME Notice
of Funding Opportunity (NOFO), is a
means for determining the number of
eligible resident/fellow FTE’s in an
applicant’s primary care residency
program.
Need and Proposed Use of the
Information: THCGME Program Eligible
ADDRESSES:
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Resident/Fellow FTE Chart requires
applicants to provide: (a) Data related to
the size and/or growth of the residency
program over previous academic years,
(b) the number of residents enrolled in
the program during the baseline
academic year, and (c) a projection of
the program’s proposed expansion over
the next five academic years. It is
imperative that applicants complete this
chart to quantify the total supported
residents. THCGME funding is used to
support an expanded number of
residents in a residency program, to
establish a new residency training
program, or to maintain filled positions
at existing programs. Utilization of a
chart to gather this important
information has decreased the number
of errors in the eligibility review process
resulting in a more accurate review and
funding process, and comports with the
regulatory requirement imposed by 45
CFR 75.206(a) ‘‘Standard application
requirements, including forms for
applying for HHS financial assistance,
and state plans.’’
Likely Respondents: Teaching Health
Centers applying for THCGME funding
through a THCGME NOFO process,
which may include new applicants and
existing awardees.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
E:\FR\FM\19JNN1.SGM
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Agencies
[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Pages 28557-28559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13001]
-----------------------------------------------------------------------
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.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 a generic clearance to collect information
to support social and behavioral research used by FDA about drug
products.
DATES: Submit either electronic or written comments on the collection
of information by August 19, 2019.
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 August 19, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 19, 2019. Comments
received by mail/hand
[[Page 28558]]
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-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.
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.gpo.gov/fdsys/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: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, 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.
Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration
OMB Control Number 0910-0847--Extension
Understanding patients, consumers, and healthcare professionals'
perceptions and behaviors plays an important role in improving FDA's
regulatory decisionmaking processes and communications impacting
various stakeholders. The methods used to achieve these goals include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and focus group interviews. The methods used serve the narrowly defined
need for direct and informal opinion on a specific topic and as a
qualitative and quantitative research tool, and have two major
purposes:
1. To obtain information that is useful for developing variables
and measures for formulating the basic objectives of social and
behavioral research and
2. To assess the potential effectiveness of FDA communications,
behavioral interventions and other materials in reaching and
successfully communicating and addressing behavioral change with their
intended audiences.
FDA will use these methods to test and refine its ideas and to help
develop communication and behavioral
[[Page 28559]]
strategies research, but 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 or Offices 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 including, but not
limited to, social and behavioral research, decision-making processes,
and communication and behavioral change strategies.
Annually, FDA projects about 45 social and behavioral studies using
the variety of test methods listed in this document. FDA is requesting
this burden so as not to restrict the Agency's ability to gather
information on public sentiment for its proposals in its regulatory and
communications programs.
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 per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys............................. 2,520 14.6 36,792 .25 (15 minutes)................... 9,198
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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, we have made no adjustments to our burden
estimate.
Dated: June 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13001 Filed 6-18-19; 8:45 am]
BILLING CODE 4164-01-P