[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23574-23576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10533]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0110]


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

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 the reporting requirements, including third 
party disclosure, contained in FDA's current regulations on 
prescription drug advertisements.

DATES: Submit either electronic or written comments on the collection 
of information by July 24, 2017.

ADDRESSES: You may submit comments as follows:

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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2010-N-0110 for ``Prescription Drug Advertisements.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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

[[Page 23575]]

information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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 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 Advertisements; OMB Control Number 0910-0686--
Extension

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and 
distributors (sponsors) 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. For prescription drugs and biologics, section 502(n) of the 
FD&C Act requires advertisements to contain ``* * * a true statement * 
* *'' of certain information including ``* * * information in brief 
summary relating to side effects, contraindications, and effectiveness 
* * *'' as required by regulations issued by FDA. FDA's prescription 
drug advertising regulations at 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 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 section 502(n) of the FD&C Act, section 
201(n) of the FD&C Act (21 U.S.C. 321(n)), and FDA's implementing 
regulations at Sec.  202.1(e).
    Advertisements subject to the requirements at Sec.  202.1 are 
subject to the PRA because these advertisements disclose information to 
the public. In addition, Sec.  202.1(e)(6) and (j) include provisions 
that are subject to OMB approval under the PRA.

Reporting to FDA

    Section 202.1(e)(6) permits a person who would be adversely 
affected by the enforcement of a provision of Sec.  202.1(e)(6) to 
request a waiver from FDA for that provision. 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, 
misleading, or otherwise violative of section 502(n) of the FD&C Act.
    Section 202.1(j), which sets forth requirements for the 
dissemination of advertisements subject to the standards in Sec.  
202.1(e), contains the following information collection that is subject 
to the PRA:
    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.

Disclosures to the Public

    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.
    We estimate the burden of this collection of information as 
follows:

[[Page 23576]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                    21 CFR section or activity                            Number of        responses per   Total annual      Hours per      Total hours
                                                                         respondents        respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER:
    202.1(e)(6); waiver request...................................                     1               1               1              12              12
    202.1(j)(1); submission of advertisement......................                     1               1               1               2               2
    202.1(j)(1)(iii); assuring that adverse information be                             1               1               1              12              12
     publicized...................................................
    202.1(j)(4); voluntary submission of ad to FDA................                    71            6.97             495              20           9,900
CBER:
    202.1(e)(6); waiver request...................................                     0               0               0              12               0
    202.1(j)(1); submission of advertisement......................                     0               0               0               2               0
    202.1(j)(1)(iii); assuring that adverse information be                             0               0               0              12               0
     publicized...................................................
    202.1(j)(4); voluntary submission of ad to FDA................                     9               8              72              20           1,440
CVM:
    202.1(e)(6); waiver request...................................                     0               0               0              12               0
    202.1(j)(1); submission of advertisement......................                     0               0               0               2               0
    202.1(j)(1)(iii); assuring that adverse information be                             0               0               0              12               0
     publicized...................................................
    202.1(j)(4); voluntary submission of ad to FDA................                     5               1               5              20             100
                                                                   -------------------------------------------------------------------------------------
        Total.....................................................  ....................  ..............  ..............  ..............          11,466
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                             Number of
                    21 CFR section or activity                            Number of        responses per   Total annual      Hours per      Total hours
                                                                         respondents        respondent       responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER:
    202.1; ad prepared in accordance with 21 CFR Part 202.........                   394           105.3          41,494             400      16,597,600
    202.1(j)(1); info. included re. fatalities or serious damage..                     1               1               1              40              40
CBER:
    202.1; ad prepared in accordance with 21 CFR Part 202.........                    47            63.4           2,984             400       1,193,600
    202.1(j)(1); info. included re. fatalities or serious damage..                     0               0               0              40               0
CVM:
    202.1; ad prepared in accordance with 21 CFR Part 202.........                    25              36             900             400         360,000
    202.1(j)(1); info. included re. fatalities or serious damage..                     0               0               0              40               0
                                                                   -------------------------------------------------------------------------------------
        Total.....................................................  ....................  ..............  ..............  ..............      18,151,240
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10533 Filed 5-22-17; 8:45 am]
 BILLING CODE 4164-01-P