[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
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202.1(e)( Waiver 1 1 1 12 12
6) request to
FDA
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202.1(j)( Submission 1 1 1 2 2
1) of
advertisem
ent to FDA
for prior
approval
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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
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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
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Total 28,126
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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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Type of Submission Respondents per Disclosure Disclosures Disclosure Total Hours
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202.1 Advertisements prepared in 355 47.324 16,800 400 6,720,000
accordance with Sec.
202.1
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202.1(j)(1) Including information 1 1 1 40 40
about the drug's
fatalities or serious
damage in the
advertisement
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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