[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Notices]
[Pages 11112-11114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04262]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 April 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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

[[Page 11113]]

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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     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........................
                                 -------------------------------------------------------------------------------

[[Page 11114]]

 
    Total.......................                                                                          13,586
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
         21 CFR section              Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
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..............
                                 -------------------------------------------------------------------------------
    Total.......................                                                                      10,062,840
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: February 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04262 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P