[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4117-4119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1275]


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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 
February 23, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-new and 
title ``Prescription Drug Advertisements''. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850. 301-796-3792. 
Elizabeth.Berbakos@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)--New

    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 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).
    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. The information 
collection requirements in Sec.  202.1 have not previously been 
submitted to OMB for approval. With this notice, we are seeking comment 
on the proposed information collection.

Reporting to FDA

    Section 202.1(e)(6) includes a provision that is subject to the 
PRA. Section 202.1(e)(6) permits a person who would be adversely 
affected by the enforcement of a provision of

[[Page 4118]]

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.
    FDA has not received any waiver requests under Sec.  202.1(e)(6) in 
the past 10 years. However, we estimate for the purposes of this 
information collection that FDA would receive one waiver request 
annually under Sec.  202.1(e)(6). The hours per response is the 
estimated time that a respondent would spend preparing information to 
be submitted to FDA under Sec.  202.1(e)(6). Based on its experience 
reviewing other waiver requests, FDA estimates that approximately 12 
hours on average would be needed per submission, including the time it 
takes to prepare, assemble, and copy the necessary information.
    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.
    FDA has not received any advertisements requiring prior approval 
under Sec.  202.1(j)(1) in the past 10 years. However, we estimate for 
the purposes of this information collection that FDA would receive one 
advertisement requiring prior approval annually under Sec.  
202.1(j)(1). The hours per response is the estimated time that a 
respondent would spend preparing information to be submitted to FDA 
under Sec.  202.1(j)(1). Based on its experience reviewing other 
advertisements, FDA estimates that approximately 2 hours on average 
would be needed per submission, including the time it takes to prepare, 
assemble, and copy the necessary information.
    FDA has not received any program information required under Sec.  
202.1(j)(1)(iii) in the past 10 years. However, we estimate for the 
purposes of this information collection that FDA would receive one 
submission of program information annually under Sec.  
202.1(j)(1)(iii). The hours per response is the estimated time that a 
respondent would spend preparing information to be submitted to FDA 
under Sec.  202.1(j)(1)(iii). Based on its experience reviewing 
advertisement-related information, FDA estimates that approximately 12 
hours on average would be needed per submission, including the time it 
takes to prepare, assemble, and copy the necessary information.
    Based on FDA data, the Center for Drug Evaluation and Research 
(CDER) estimates that approximately 1,150 draft promotional pieces are 
received from approximately 125 companies annually for Agency comment 
prior to publication under Sec.  202.1(j)(4), the Center for Biologics 
Evaluation and Research (CBER) estimates that approximately 250 draft 
promotional pieces are received from approximately 25 companies 
annually under Sec.  202.1(j)(4), and the Center for Veterinary 
Medicine (CVM) estimates that approximately 5 draft promotional pieces 
are received from approximately 5 companies annually under Sec.  
202.1(j)(4). FDA anticipates that this submission rate will moderately 
increase in the near future. The estimated total number of submissions 
under Sec.  202.1(j)(4) is 1,405. The hours per response is the 
estimated time that a respondent would spend preparing the information 
to be submitted to FDA under Sec.  202.1(j)(4). Based on its experience 
reviewing advertisements submitted prior to publication for Agency 
comment, FDA estimates that approximately 20 hours on average would be 
needed per submission, including the time it takes to prepare, 
assemble, and copy the necessary information.

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.
    Based on FDA data, CDER estimates that approximately 15,000 
advertisements for prescription drugs, including print and broadcast 
advertisements, are prepared by approximately 300 companies under Sec.  
202.1 annually, CBER estimates that approximately 1,000 of these 
advertisements are prepared by approximately 30 companies annually, and 
CVM estimates that approximately 800 of these advertisements are 
prepared by approximately 25 companies annually. FDA anticipates that 
this estimate will moderately increase in the near future. The 
estimated total number of advertisements under Sec.  202.1 is 16,800. 
The hours per response is the estimated time that a respondent would 
spend preparing an advertisement subject to Sec.  202.1. Based on its 
experience reviewing advertisements, FDA estimates that approximately 
400 hours on average would be needed per advertisement, including the 
time it takes to prepare, assemble, and copy the necessary information.
    Under Sec.  202.1, 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 is not aware of 
any advertisements that required inclusion of information on fatalities 
or serious damage associated with use of the drug under Sec.  
202.1(j)(1) in the past 10 years. However, we estimate for the purposes 
of this information collection that one advertisement would require 
inclusion of such information annually under Sec.  202.1(j)(1). The 
hours per response is the estimated time that a respondent would spend 
preparing information to comply with Sec.  202.1(j)(1). Based on its 
experience reviewing changes to advertisements, FDA estimates that 
approximately 40 hours on average would be needed to comply with Sec.  
202.1(j)(1), including the time it takes to prepare the necessary 
information.
    In the Federal Register of March 17, 2010 (75 FR 12756), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment.
    The comment said that any waiver requests FDA receives in the 
future under Sec.  202.1(e)(6) should be granted only for extraordinary 
reasons because

[[Page 4119]]

of the ``high public interest value associated with parties fully 
complying with information requests concerning prescription drugs.''
    FDA Response: FDA is not aware of any request for a waiver under 
Sec.  202.1(e)(6). If we receive such a waiver request in the future, 
we will consider this comment in determining whether or not to grant 
the request.
    Concerning the statement that FDA has not received any 
advertisements requiring prior approval under Sec.  202.1(j)(1) in the 
past 10 years, the comment said this may be indicative of FDA's failure 
to ensure compliance with this provision, rather than simply an 
indication that no advertisements are received under Sec.  202.1(j)(1). 
The comment said that FDA should more vigorously investigate and 
penalize or otherwise sanction sponsors who fail to ensure that 
significant new adverse information about a drug that becomes known to 
the sponsors is advertised in compliance with Sec.  202.1(j).
    FDA Response: FDA properly enforces the requirements of Sec.  
202.1(j). Additionally, the Division of Drug Marketing, Advertising and 
Communication (DDMAC) works closely with the Office of New Drugs (OND) 
and sponsors to ensure that information about serious and significant 
risks that have not been widely publicized is appropriately presented 
in promotional labeling and advertising. FDA regularly communicates 
these requests to sponsors through supplement letters sent by OND 
review divisions and safety update letters sent by DDMAC. DDMAC is not 
aware of any drugs that have required prior approval under Sec.  
202.1(j)--but DDMAC is consistently in contact with OND and sponsors to 
ensure that promotional labeling accurately communicates serious and 
significant risk information.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                              Annual
              21 CFR section                     Type of submission          Number of     frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
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202.1(e)(6)...............................  Waiver request to FDA.......               1               1               1              12              12
202.1(j)(1)...............................  Submission of advertisement                1               1               1               2               2
                                             to FDA for prior approval.
202.1(j)(1)(iii)..........................  Providing a program to FDA                 1               1               1              12              12
                                             for assuring that adverse
                                             information about the drug
                                             will be publicized.
202.1(j)(4)...............................  Voluntarily submitting the               155               9           1,395              20          27,900
                                             advertisement to FDA prior
                                             to publication for comment.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............          27,926
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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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Annual
              21 CFR section                     Type of submission          Number of     frequency of    Total annual      Hours per      Total hours
                                                                            respondents     disclosure      disclosure      disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1.....................................  Advertisements prepared in               355              47          16,685             400       6,674,000
                                             accordance with Sec.
                                             202.1.
202.1(j)(1)...............................  Including information about                1               1               1              40              40
                                             the drug's fatalities or
                                             serious damage in the
                                             advertisement.
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............       6,674,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1275 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P