
[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36799-36801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Prescription Drug 
Advertisements

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: Fax written comments on the collection of information by 
September 6, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 Advertisements (OMB Control Number 0910-0686--
Extension)
    This information collection supports Agency regulations. 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

[[Page 36800]]

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.
    In the Federal Register of May 23, 2017 (82 FR 23574), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. One comment was received but did not 
respond to the information collection topics solicited in the notice 
and therefore we do not discuss it here.
    FDA estimates the burden of this collection of information as 
follows:

                                 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                     1               1               1               2               2
 advertisement..................
202.1(j)(1)(iii); assuring that                1               1               1              12              12
 adverse information be
 publicized.....................
202.1(j)(4); voluntary                        71            6.97             495              20           9,900
 submission of ad to FDA........
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                                                      CBER
----------------------------------------------------------------------------------------------------------------
202.1(e)(6); waiver request.....               0               0               0              12               0
202.1(j)(1); submission of                     0               0               0               2               0
 advertisement..................
202.1(j)(1)(iii); assuring that                0               0               0              12               0
 adverse information be
 publicized.....................
202.1(j)(4); voluntary                         9               8              72              20           1,440
 submission of ad to FDA........
----------------------------------------------------------------------------------------------------------------
                                                       CVM
----------------------------------------------------------------------------------------------------------------
202.1(e)(6); waiver request.....               0               0               0              12               0
202.1(j)(1); submission of                     0               0               0               2               0
 advertisement..................

[[Page 36801]]

 
202.1(j)(1)(iii); assuring that                0               0               0              12               0
 adverse information be
 publicized.....................
202.1(j)(4); voluntary                         5               1               5              20             100
 submission of ad to FDA........
                                 -------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
   21 CFR section or activity       respondents         per         disclosures     burden per     Total  hours
                                                    respondent                      disclosure
----------------------------------------------------------------------------------------------------------------
                                                      CDER
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance             394           105.3          41,494             400      16,597,600
 with part 202..................
202.1(j)(1); info. included re.                1               1               1              40              40
 fatalities or serious damage...
----------------------------------------------------------------------------------------------------------------
                                                      CBER
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance              47            63.4           2,984             400       1,193,600
 with part 202..................
202.1(j)(1); info. included re.                0               0               0              40               0
 fatalities or serious damage...
----------------------------------------------------------------------------------------------------------------
                                                       CVM
----------------------------------------------------------------------------------------------------------------
202.1; ad prepared in accordance              25              36             900             400         360,000
 with part 202..................
202.1(j)(1); info. included re.                0               0               0              40               0
 fatalities or serious damage...
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............      18,151,240
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.


    Dated: August 2, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-16607 Filed 8-4-17; 8:45 am]
 BILLING CODE 4164-01-P


