
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32554-32555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13015]


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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 July 7, 
2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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

    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 Paperwork Reduction Act of 1995 (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 or 
otherwise 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 February 27, 2014 (79 FR 11112), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 32555]]



                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR Section              Number of    responses  per   Total annual     burden per      Total hours
                                    respondents      respondent      responses       response
----------------------------------------------------------------------------------------------------------------
202.1(e)(6)--Waiver request to                 1               1               1              12              12
 FDA............................
202.1(j)(1)--Submission of                     1               1               1               2               2
 advertisement to FDA for prior
 approval.......................
202.1(j)(1)(iii)--Providing a                  1               1               1              12              12
 program to FDA for assuring
 that adverse information about
 the drug will be publicized....
202.1(j)(4)--Voluntarily                     113               6             678              20          13,560
 submitting the advertisement to
 FDA prior to publication for
 comment........................
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    Total.......................  ..............  ..............  ..............  ..............          13,586
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                           Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                     Number of
                                     Number of      disclosures    Total  annual      Average
         21 CFR Section             respondents         per         disclosures     burden per      Total hours
                                                    respondent                      disclosure
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202.1--Advertisements prepared               541            46.5          25,157             400      10,062,800
 in accordance with Sec.   202.1
202.1(j)(1)--Including                         1               1               1              40              40
 information about the drug's
 fatalities or serious damage in
 the advertisement..............
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    Total.......................  ..............  ..............  ..............  ..............      10,062,840
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: May 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13015 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P


