[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.

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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\
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                                                                     Number of
                 Activity                        Number of         responses per       Total annual      Average burden per response      Total hours
                                                respondents         respondent           responses
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Interviews/Surveys........................             45,000                   1              45,000   0.75 (45 minutes)...........             33,750
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\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