[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22686-22688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08948]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0363]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prescription Drug Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection associated with 
prescription drug advertising.

DATES: Submit either electronic or written comments on the collection 
of information by June 28, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 28, 2021. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0363 for ``Prescription Drug Advertising.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice

[[Page 22687]]

of the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Prescription Drug Advertising--21 CFR Part 202

OMB Control Number 0910-0686--Extension

    This information collection supports Agency regulations and 
associated guidance. The Food and Drug Administration (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. 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 health care 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.
    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 request.               1               1               1              12              12
    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 request.               1               1               1              12              12
    202.1(j)(1); submission of                 1               1               1               2               2
     advertisement..............

[[Page 22688]]

 
    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 request.               1               1               1              12              12
    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.

    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                       670           111.08          74,425             400      29,770,000
 accordance with part 202......
202.1(j)(1); info. included re.               1                1               1              40              40
 fatalities or serious damage..
                                --------------------------------------------------------------------------------
    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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                                                                                      Average
     Information collection         Number of       Number of      Total annual     burden per
        recommendations            respondents   disclosures per    disclosures     disclosure      Total hours
                                                    respondent                      (in hours)
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Product name placement, size,               715            190.3         136,069               3         408,207
 and prominence in promotional
 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), (c), and (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 by 11,705,225 hours annually 
to reflect increases in prescription drug advertisements and associated 
disclosures.

    Dated: April 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08948 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P


