[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]
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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,
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\
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Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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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........................
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[[Page 11114]]
Total....................... 13,586
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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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Number of
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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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..............
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Total....................... 10,062,840
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\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