Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements, 32554-32555 [2014-13015]
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32554
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
communication, quicker interaction
between citizen petitioners and FDA,
and easier access to FDA to seek input
through the citizen petition process.
Dated: May 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13037 Filed 6–4–14; 8:45 am]
BILLING CODE 4160–01–P
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.
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 July 7,
2014.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0686. Also
include the FDA 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
rmajette on DSK2TPTVN1PROD with NOTICES
SUMMARY:
Prescription Drug Advertisements—
(OMB Control Number 0910–0686)—
Extension
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
VerDate Mar<15>2010
14:59 Jun 04, 2014
Jkt 232001
(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 § 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 (§ 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 (§ 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
§ 202.1(e).
Advertisements subject to the
requirements at § 202.1 are subject to
the Paperwork Reduction Act of 1995
(the PRA) because these advertisements
disclose information to the public. In
addition, § 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
§ 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
§ 202.1(e)(6) from which a waiver is
sought, a complete copy of the
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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 § 202.1(e), contains the following
information collection that is subject to
the PRA:
Under § 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
§ 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 § 202.1(j)(4), a
sponsor may voluntarily submit
advertisements to FDA for comment
prior to publication.
Disclosures to the Public
Under § 202.1, advertisements for
human and animal prescription drug
and biological products must comply
with the standards described in that
section.
Under § 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.
In the Federal Register of February
27, 2014 (79 FR 11112), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05JNN1.SGM
05JNN1
32555
Federal Register / Vol. 79, No. 108 / Thursday, June 5, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
202.1(e)(6)—Waiver request to FDA ...................................
202.1(j)(1)—Submission of advertisement to FDA for prior
approval ............................................................................
202.1(j)(1)(iii)—Providing a program to FDA for assuring
that adverse information about the drug will be publicized ................................................................................
202.1(j)(4)—Voluntarily submitting the advertisement to
FDA prior to publication for comment ..............................
Total ..............................................................................
1 There
Number of
responses
per
respondent
Number of
respondents
21 CFR Section
Average
burden per
response
Total annual
responses
Total hours
1
1
1
12
12
1
1
1
2
2
1
1
1
12
12
113
6
678
20
13,560
........................
........................
........................
........................
13,586
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
21 CFR Section
Total
annual
disclosures
Average
burden per
disclosure
Total hours
202.1—Advertisements prepared in accordance with
§ 202.1 ..............................................................................
202.1(j)(1)—Including information about the drug’s fatalities or serious damage in the advertisement ...................
541
46.5
25,157
400
10,062,800
1
1
1
40
40
Total ..............................................................................
........................
........................
........................
........................
10,062,840
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–13015 Filed 6–4–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0444]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 July 7,
2014.
rmajette on DSK2TPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:59 Jun 04, 2014
Jkt 232001
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0497. Also
include the FDA 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, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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.
ADDRESSES:
Focus Groups as Used by the Food and
Drug Administration (All FDARegulated Products)—(OMB Control
Number 0910–0497)—Extension
FDA conducts focus group interviews
on a variety of topics involving FDAregulated products, including drugs,
biologics, devices, food, tobacco, and
veterinary medicine.
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
• To better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use focus group findings to
test and refine ideas but will generally
conduct further research before making
important decisions such as adopting
new policies and allocating or
redirecting significant resources to
support these policies.
In the Federal Register of February
18, 2014 (79 FR 9222), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\05JNN1.SGM
05JNN1
]]>Agencies
[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Notices]
[Pages 32554-32555]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13015]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 July 7,
2014.
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 emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0686.
Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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 0910-0686)--
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 Paperwork Reduction Act of 1995 (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.
In the Federal Register of February 27, 2014 (79 FR 11112), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 32555]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 13,586
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
21 CFR Section respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
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..............
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,062,840
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: May 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13015 Filed 6-4-14; 8:45 am]
BILLING CODE 4160-01-P
