[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12756-12758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5812]


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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) 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 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 regulations on prescription drug 
advertisements.

DATES: Submit written or electronic comments on the collection of 
information by May 17, 2010.

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:  Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, e-mail: 
[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 the Federal 
Register concerning each proposed 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--21 CFR 202.1 (OMB Control Number 
0910)--New

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(n)) (the act) 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 
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 act 
(21 U.S.C. 352(n) and 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 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

[[Page 12757]]

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

[[Page 12758]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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  21 CFR     Type of        No. of       Annual Frequency  per   Total Annual     Hours  per
 Section    Submission    Respondents          Response            Responses       Response        Total Hours
----------------------------------------------------------------------------------------------------------------
202.1(e)(  Waiver                    1                   1                   1              12                12
 6)         request to
            FDA
----------------------------------------------------------------------------------------------------------------
202.1(j)(  Submission                1                   1                   1               2                 2
 1)         of
            advertisem
            ent to FDA
            for prior
            approval
----------------------------------------------------------------------------------------------------------------
202.1(j)(  Providing a               1                   1                   1              12                12
 1)(iii)    program to
            FDA for
            assuring
            that
            adverse
            informatio
            n about
            the drug
            will be
            publicized
----------------------------------------------------------------------------------------------------------------
202.1(j)(  Voluntarily             155                   9.065           1,405              20            28,100
 4)         submitting
            the
            advertisem
            ent to FDA
            prior to
            publicatio
            n for
            comment
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     28,126
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           No. of        Annual Frequency       Total Annual        Hours per
      21 CFR Section           Type of  Submission       Respondents      per Disclosure         Disclosures       Disclosure          Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1                      Advertisements prepared in             355                47.324              16,800             400                6,720,000
                            accordance with Sec.
                            202.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1(j)(1)                Including information                    1                 1                       1              40                       40
                            about the drug's
                            fatalities or serious
                            damage in the
                            advertisement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                          6,720,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: March 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5812 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S