Notice2021-15648
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertising
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Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39033-39035]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-15648]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0363]
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) 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 August 23, 2021.
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#b9e9ebf8eacdd8dfdff9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="8cdcdecddff8edeaeacceae8eda2e4e4ffa2ebe3fa">[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--21 CFR Part 202
OMB Control Number 0910-0686--Extension
This information collection supports Agency regulations and
associated guidance. FDA protects the public health by assuring the
safety, effectiveness, and security of a wide range of products. We
also help consumers get accurate, science-based information they need
to use medicines appropriately and improve their health.
[[Page 39034]]
Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 331) prohibits the misbranding of FDA-regulated products,
including prescription drugs. Section 502 of the FD&C Act (21 U.S.C.
352) requires that manufacturers, packers, and distributors, or anyone
acting on their behalf (firms) include certain information in human
prescription drug promotional labeling and advertisements.
Our prescription drug advertising regulations in part 202 (21 CFR
part 202) 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 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).
Section 202.1(e)(6) provides for certain waivers. The waiver
request must set forth clearly and concisely the petitioner's interest
in the advertisement, the specific provision of Sec. 202.1(e)(6) from
which a waiver is sought, a complete copy of the advertisement, and a
showing that the advertisement is not false, lacking in fair balance or
otherwise misleading, or otherwise violative of section 502(n) of the
FD&C Act.
Under Sec. 202.1(j)(1), a sponsor must submit advertisements to
FDA for prior approval before dissemination if: (1) The sponsor or FDA
has received information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage; (2) FDA has notified the sponsor that the information must be
part of the advertisements for the drug; and (3) the sponsor has failed
to present to FDA a program for assuring that such information will be
publicized promptly and adequately to the medical profession in
subsequent advertisements, or if such a program has been presented to
FDA but is not being followed by the sponsor.
Under Sec. 202.1(j)(1)(iii), a sponsor must provide to FDA a
program for assuring that significant new adverse information about the
drug that becomes known (i.e., use of drug may cause fatalities or
serious damage) will be publicized promptly and adequately to the
medical profession in any subsequent advertisements. Under Sec.
202.1(j)(4), a sponsor may voluntarily submit advertisements to FDA for
comment prior to publication.
While the regulations establish requirements for prescription drug
advertisements, we have developed the guidance document entitled,
``Product Name Placement, Size, and Prominence in Promotional Labeling
and Advertisements; Guidance for Industry'' to clarify requirements for
product name placement, size, prominence, and frequency in promotional
labeling and advertisements for human and animal prescription drugs and
prescription biological products. The guidance includes recommendations
that pertain to traditional print promotional labeling and
advertisements (e.g., journal ads, detail aids, brochures), audiovisual
promotional labeling (e.g., videos shown in a healthcare provider's
office), broadcast advertisements (e.g., television advertisements,
radio advertisements), and electronic and computer-based promotions
(e.g., internet, social media, emails, CD-ROMs, DVDs). The guidance
document was issued consistent with our Good Guidance Practice
regulations in part 10.115 which provide for public comment at any
time, and is available from our website at: <a href="https://www.fda.gov/media/87202/download">https://www.fda.gov/media/87202/download</a>.
In the Federal Register of April 29, 2021 (86 FR 22686), we
published a 60-day notice requesting public comment on the proposed
collection of information. Three comments were received, all generally
supportive of FDA's drug advertising regulations; however, some
commenters suggested FDA might do more to promote truthful advertising
with regard to prescription drug products. We appreciate all comments.
No comment suggested a revision to our current estimate for the
information collection.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
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CDER Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 59 1.85 109 20 2,180
submission of ad to FDA..
CBER Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 7 2.57 18 20 360
submission of ad to FDA..
CVM Regulated Products:
202.1(e)(6); waiver 1 1 1 12 12
request..................
202.1(j)(1); submission of 1 1 1 2 2
advertisement............
202.1(j)(1)(iii); assuring 1 1 1 12 12
that adverse information
be publicized............
202.1(j)(4); voluntary 7 1 7 20 140
submission of ad to FDA..
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Total................. .............. ............... 143 ............... 2,758
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
[[Page 39035]]
Our estimate of burden we attribute to the reporting provisions in
part 202 is based on our experience with the collection and a review of
Agency data.
Table 2--Estimated Annual Third-Party Disclosure Burden 1 2
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Number of
21 CFR section; activity Number of disclosures per Total annual Burden per Total hours
respondents respondent disclosures disclosure
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202.1; ad prepared in accordance with part 202................... 670 111.08 74,425 400 29,770,000
202.1(j)(1); info. included re. fatalities or serious damage..... 1 1 1 40 40
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Total........................................................ ............... ................ 74,426 ................ 29,770,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
\2\ Numbers rounded to the nearest one/one-hundredth.
Under Sec. 202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section. Under Sec. 202.1(j)(1), if information that the use
of a prescription drug may cause fatalities or serious damage has not
been widely publicized in the medical literature, a sponsor must
include such information in the advertisements for that drug. Based on
a review of Agency data we estimate an average of 29,770,040 hours is
incurred annually by respondents in complying with third-party
disclosure requirements for prescription drug advertising. We assume a
placeholder of 1 for disclosures under Sec. 202.1(j)(1).
Table 3--Estimated Annual Disclosure Burden Discussed in Agency Guidance
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Number of Average burden
Information collection recommendations Number of disclosures per Total annual per disclosure Total hours
respondents respondent disclosures (in hours)
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Product name placement, size, and prominence in promotional 715 190.3 136,069 3 408,207
labeling and advertisements' disclosures........................
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The placement, size, prominence, and frequency of the proprietary
and established names for human prescription drugs, including
prescription biological products, and animal prescription drugs are
specified in labeling and advertising regulations (Sec. Sec. 201.10(g)
and (h); 202.1(b)-(d)). Based on Agency data, we estimate that, for
human and animal prescription drugs and prescription biological
products, an average of 715 firms disseminate approximately 136,069
advertisements and promotional pieces each year. We assume that the
burden associated with complying with the regulatory requirements
discussed in the guidance would be approximately 3 hours per response.
We have adjusted our estimate upward to reflect increases in
prescription drug advertisements and associated disclosures.
Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15648 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P
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