Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration, 16002 [2024-04716]
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16002
Federal Register / Vol. 89, No. 45 / Wednesday, March 6, 2024 / Notices
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–2781]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Data To Support
Drug Product Communications as
Used by the Food and Drug
Administration
AGENCY:
Data To Support Drug Product
Communications as Used by the Food
and Drug Administration
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.
DATES: Submit written comments
(including recommendations) on the
collection of information by April 5,
2024.
SUMMARY:
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 0910–0695. 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
OMB Control Number 0910–0695—
Extension
This information collection supports
Agency outreach and other proactive
communication efforts. Evaluating
communication messages and
supporting materials in advance of a
communication campaign provides an
important role in improving FDA
communications as they allow for an
indepth understanding of individuals
knowledge, attitudes, beliefs,
motivations, feelings, and behaviors.
Such evaluations are critical in helping
FDA develop public health
communications that meet the needs
and desires of its many diverse target
audiences.
We intend to use the following
methods with general public health
consumers and healthcare professionals
in our efforts: individual indepth
interviews, focus group discussions,
intercept interviews, self-administered
surveys, and gatekeeper surveys, all on
a voluntary basis. The methods to be
used serve the narrowly defined need
for direct and informal opinion on a
specific topic and, as a qualitative and/
or quantitative research tools, have two
major purposes: (1) to obtain
information that is useful for developing
variables and measures for formulating
the basic objectives of risk
communication campaigns and (2) to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with their
intended audiences. We will use these
methods to test and refine our ideas and
to help develop messages and other
communications 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.
We will use this qualitative and/or
quantitative research to test messages
about regulated drug products on a
variety of subjects related to consumer,
patient, or healthcare professional
perceptions and about use of drug
products and related materials,
including but not limited to: (1) directto-consumer prescription drug
promotion; (2) labeling and information
about prescription and over-the-counter
drugs; (3) patient medication guides; (4)
safety and risk communications; (5)
online sale of medical products; and (6)
consumer and professional education.
Annually, we project about 75
communication studies using the
variety of research methods listed in
this document. FDA is requesting an
extension of these burden hours so as
not to restrict its ability to gather
information on public opinion for its
regulatory and communications
programs.
In the Federal Register of September
29, 2023 (88 FR 67311), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate 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
Average burden
per response
Total hours
Interviews/Surveys ................
45,000
1
45,000
0.75 (45 minutes)
33,750
ddrumheller on DSK120RN23PROD with NOTICES1
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our estimated
burden to allow for additional
individual collections under the
approved generic clearance. For more
detailed information regarding
individual collections conducted under
the currently approved generic
clearance, please see our supporting
statement at https://www.reginfog.gov.
We believe that increasing the frequency
of individual collections will improve
VerDate Sep<11>2014
16:57 Mar 05, 2024
Jkt 262001
our ability to timely deliver important
drug product communications to
specific populations, including
vulnerable populations that include
patients with certain medical
conditions.
PO 00000
Frm 00034
Fmt 4703
Sfmt 9990
Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04716 Filed 3–5–24; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\06MRN1.SGM
06MRN1
]]>Agencies
[Federal Register Volume 89, Number 45 (Wednesday, March 6, 2024)]
[Notices]
[Page 16002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04716]
[[Page 16002]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2781]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Data To Support Drug
Product Communications as Used by the Food and Drug Administration
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 April 5, 2024.
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 0910-0695. 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.
Data To Support Drug Product Communications as Used by the Food and
Drug Administration
OMB Control Number 0910-0695--Extension
This information collection supports Agency outreach and other
proactive communication efforts. Evaluating communication messages and
supporting materials in advance of a communication campaign provides an
important role in improving FDA communications as they allow for an
indepth understanding of individuals knowledge, attitudes, beliefs,
motivations, feelings, and behaviors. Such evaluations are critical in
helping FDA develop public health communications that meet the needs
and desires of its many diverse target audiences.
We intend to use the following methods with general public health
consumers and healthcare professionals in our efforts: individual
indepth interviews, focus group discussions, intercept interviews,
self-administered surveys, and gatekeeper surveys, all on a voluntary
basis. The methods to be used serve the narrowly defined need for
direct and informal opinion on a specific topic and, as a qualitative
and/or quantitative research tools, have two major purposes: (1) to
obtain information that is useful for developing variables and measures
for formulating the basic objectives of risk communication campaigns
and (2) to assess the potential effectiveness of messages and materials
in reaching and successfully communicating with their intended
audiences. We will use these methods to test and refine our ideas and
to help develop messages and other communications 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.
We will use this qualitative and/or quantitative research to test
messages about regulated drug products on a variety of subjects related
to consumer, patient, or healthcare professional perceptions and about
use of drug products and related materials, including but not limited
to: (1) direct-to-consumer prescription drug promotion; (2) labeling
and information about prescription and over-the-counter drugs; (3)
patient medication guides; (4) safety and risk communications; (5)
online sale of medical products; and (6) consumer and professional
education. Annually, we project about 75 communication studies using
the variety of research methods listed in this document. FDA is
requesting an extension of these burden hours so as not to restrict its
ability to gather information on public opinion for its regulatory and
communications programs.
In the Federal Register of September 29, 2023 (88 FR 67311), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate 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........................ 45,000 1 45,000 0.75 (45 minutes)........... 33,750
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our estimated burden to allow for additional
individual collections under the approved generic clearance. For more
detailed information regarding individual collections conducted under
the currently approved generic clearance, please see our supporting
statement at https://www.reginfog.gov. We believe that increasing the
frequency of individual collections will improve our ability to timely
deliver important drug product communications to specific populations,
including vulnerable populations that include patients with certain
medical conditions.
Dated: February 29, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04716 Filed 3-5-24; 8:45 am]
BILLING CODE 4164-01-P
