[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19313-19314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2613]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 (PRA).

DATES: Submit written comments (including recommendations) on the 
collection of information by May 1, 2023.

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 0910-0686. 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.

Prescription Drug Advertising

OMB Control Number 0910-0686--Revision

    This information collection supports FDA implementation of Agency 
regulations and associated guidance. Section 502(n) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(n)) requires 
that manufacturers, packers, and distributors (firms) who advertise 
prescription human and animal drugs, including biological products for 
humans, disclose in advertisements certain information about the 
advertised product's uses and risks. FDA's prescription drug 
advertising regulations in Sec.  202.1 (21 CFR 202.1) describe 
requirements and standards for print and broadcast advertisements. 
Section 202.1 applies to advertisements published in journals, 
magazines, other periodicals, and newspapers, and advertisements 
broadcast through media such as radio, television, and telephone 
communication systems. Print advertisements must include a brief 
summary of each of the risk concepts from the product's approved 
package labeling (Sec.  202.1(e)(1)). Advertisements

[[Page 19314]]

that are broadcast through media such as television, radio, or 
telephone communications systems must disclose the major risks from the 
product's package labeling in either the audio or audio and visual 
parts of the presentation (Sec.  202.1(e)(1)); this disclosure is known 
as the ``major statement.'' If a broadcast advertisement omits the 
major statement, or if the major statement minimizes the risks 
associated with the use of the drug, the advertisement could render the 
drug misbranded in violation of the FD&C Act, (21 U.S.C. 352(n) and 
section 201 of the FD&C Act (21 U.S.C. 321(n))), and FDA's implementing 
regulations at Sec.  202.1(e).
    We are revising the information collection to include 
recommendations found in Agency guidance. The guidance document 
entitled, ``Presenting Quantitative Efficacy and Risk Information in 
Direct-to-Consumer [DTC] Promotional Labeling and Advertisements,'' 
provides content and format recommendations for DTC promotional 
labeling and advertisements (promotional communications) that present 
quantitative efficacy and risk information. The guidance document was 
developed consistent with Agency good guidance practices regulations in 
21 CFR 10.115, which provide for comment at any time. The draft 
guidance document, issued on October 17, 2018, is available at https://www.fda.gov/media/117573/download and in docket FDA-2018-D-2613. FDA 
also maintains a searchable guidance database at https://www.fda.gov/regulatory-information/search-fda-guidance-documents to facilitate 
access to these documents.
    The guidance document recommends specific content elements 
pertaining to the presentation of quantitative efficacy and risk 
information in DTC promotional communications. The guidance also 
discusses formatting considerations related to the use of visual aids 
that display quantitative efficacy or risk information in DTC 
promotional communications. The guidance document explains that the 
information collection applies to the third-party disclosure of 
information pertaining to FDA-regulated products that contain 
quantitative efficacy or risk information and discusses the Agency's 
current thinking with regard to this topic.
    In the Federal Register of October 17, 2018 (83 FR 52484), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received regarding FDA's 
need for the information, the accuracy of our burden estimate, or ways 
to minimize burden. Although we are preparing to finalize the guidance 
document to clarify considerations for quantitative efficacy or risk 
presentations across various media types and provide additional 
explanation regarding specific concepts and examples that were included 
in the draft guidance, none of the revisions pertain to the information 
collection recommendations discussed in our 60-day notice.
    We estimate the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                 Guidance document recommendations                      Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
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``Presenting Quantitative Efficacy and Risk Information in Direct-              465               43           19,995                2           39,990
 to-Consumer Promotional Labeling and Advertisements'' as
 recommended in Section III of the guidance........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    According to available data, approximately 465 firms prepare 49,000 
FDA-regulated DTC promotional communications annually. Of these 
communications, we assume 40 percent contain a disclosure of 
quantitative efficacy or risk information. Based on this information, 
we calculate that firms each disseminate 43 DTC promotional 
communications that contain a disclosure of quantitative efficacy or 
risk information annually. Based on our experience reviewing FDA-
regulated promotional communications for drugs, we estimate respondents 
spend an average of 2 hours to prepare a disclosure as recommended in 
the guidance. We therefore estimate 19,995 disclosures and a burden of 
39,990 hours annually.

    Dated: March 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06707 Filed 3-30-23; 8:45 am]
BILLING CODE 4164-01-P