[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.
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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\
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Annual
21 CFR section Type of submission Number of frequency of Total annual Hours per Total hours
respondents disclosure disclosure disclosure
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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.
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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