[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39033-39035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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--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: https://www.fda.gov/media/87202/download.
    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
----------------------------------------------------------------------------------------------------------------
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..
                               ---------------------------------------------------------------------------------
        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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                  --------------------------------------------------------------------------------------
    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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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