Notice2023-06707
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertising
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 31, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 88 Issue 62 (Friday, March 31, 2023)</title>
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[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19313-19314]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#b1e1e3f0e2c5d0d7d7f1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="ffafadbeac8b9e9999bf999b9ed197978cd1989089">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/117573/download">https://www.fda.gov/media/117573/download</a> and in docket FDA-2018-D-2613. FDA
also maintains a searchable guidance database at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a> 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
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