Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Advertisements, 11112-11114 [2014-04262]
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices
regulations at 42 CFR Part 430, Subpart
D. The overall issue in any such appeal
will be whether the Florida outpatient
hospital benefit is consistent with
Federal requirements. Any request for
such a hearing should sent to the
designated Hearing Officer. The Hearing
Officer also should be notified if you
request a hearing but cannot meet the
timeframe expressed in this notice. Your
Hearing Officer is:
Benjamin R. Cohen, Hearing Officer
Centers for Medicare & Medicaid
Services
2520 Lord Baltimore Drive, Suite L
Baltimore, MD 21244
Sincerely,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
[Docket No. FDA–2013–N–0717]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Evaluation of the Food and Drug
Administration’s General Market Youth
Tobacco Prevention Campaign
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
If the state requests a hearing but
nevertheless plans to come into
compliance with the approved state
plan, please submit within 30 days of
the date of this letter an explanation of
how the state plans to come into
compliance with Federal requirements
and the timeframe for doing so. If that
explanation is satisfactory, we may
consider postponing the timing of the
scheduled hearing (which would also
delay the imposition of the withholding
of funds). Our goal is to ensure
compliance. We are available to provide
further information or assistance on the
steps necessary to bring the state into
compliance with its approved state
plan.
Should you not request a hearing
within 30 days, a notice of withholding
will be sent to you and the withholding
of Federal funds will begin as described
above.
If you have any questions or wish to
discuss this determination further,
please contact:
Jackie Glaze
Associate Regional Administrator
Division of Medicaid and Children’s
Health Operations
CMS Atlanta Regional Office
61 Forsyth Street SW., Suite 4T20
Atlanta, GA 30303–8909
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Evaluation of the Food and Drug
Administration’s General Market Youth
Tobacco Prevention Campaign’’ has
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
On
February 7, 2014; the Agency submitted
a proposed collection of information
entitled ‘‘Evaluation of the Food and
Drug Administration’s General Market
Youth Tobacco Prevention Campaign’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0753. The
approval expires on October 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
Marilynn Tavenner,
Administrator.
(Catalog of Federal Domestic Assistance
Program No. 13.714, Medicaid Assistance
Program.)
Dated: February 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04271 Filed 2–26–14; 8:45 am]
BILLING CODE 4160–01–P
Dated: February 20, 2014.
Marilynn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–04290 Filed 2–26–14; 8:45 am]
BILLING CODE 4120–01–P
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17:58 Feb 26, 2014
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Agency Information Collection
Activities: Proposed Collection;
Comment Request; Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 https://
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,
PRAStaff@fda.hhs.gov.
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
SUMMARY:
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices
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 § 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 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.
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.
Reporting to FDA
Disclosures to the Public
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
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.
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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
mstockstill on DSK4VPTVN1PROD with NOTICES
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 ..............................
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17:58 Feb 26, 2014
Jkt 232001
Number of
responses per
respondent
Number of
respondents
21 CFR section
PO 00000
Frm 00040
Average
burden per
response
Total annual
responses
Total hours
1
1
12
12
1
1
1
2
2
1
1
1
12
12
113
Fmt 4703
1
6
678
20
13,560
Sfmt 4703
E:\FR\FM\27FEN1.SGM
27FEN1
11114
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section
Average
burden per
response
Total annual
responses
Total hours
Total ..............................................................................
1 There
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
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 ...................
Average
burden per
disclosure
Total annual
disclosures
Total hours
541
46.5
25,157
400
10,062,800
1
1
1
40
40
Total ..............................................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration Center for
Substance Abuse Prevention
Notice of Meeting
mstockstill on DSK4VPTVN1PROD with NOTICES
10,062,840
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention
(CSAP) Drug Testing Advisory Board
(DTAB) will meet on March 17, 2014,
from 9:00 a.m. to 4:30 p.m., and March
18, 2014, from 9:00 a.m. to 2:00 p.m.
E.D.T. The DTAB will convene in both
open and closed sessions on these two
days.
On March 17, 2014, from 9:00 a.m. to
4:30 p.m., the meeting will be open to
the public and will include updates on
the previously announced DTAB
recommendations, the medical review
officer resources, the custody and
control form, the Federal Drug-Free
Workplace Programs, the National
Laboratory Certification Program, and
the Division of Workplace Programssponsored research studies. The meeting
also will include drug testing updates
from the Department of Transportation,
the Department of Defense, the Nuclear
Regulatory Commission, the Federal
Drug-Free Workplace Programs, and the
Drug Testing Index®.
VerDate Mar<15>2010
17:58 Feb 26, 2014
Jkt 232001
The public is invited to attend the
open session in person or to listen via
web conference. Due to the limited
seating space and call-in capacity,
registration is requested. Public
comments are welcome. To register,
make arrangements to attend, obtain the
web conference call-in numbers and
access codes, submit written or brief
oral comments, or request special
accommodations for persons with
disabilities, please register at the
SAMHSA Advisory Committees Web
site at https://nac.samhsa.gov/
Registration/meetingsRegistration.aspx
or contact the CSAP DTAB Designated
Federal Official, Dr. Janine Denis Cook
(see contact information below).
On March 18, 2014, from 9:00 a.m. to
2:00 p.m., the Board will meet in closed
session to discuss proposed revisions to
the Mandatory Guidelines for Federal
Workplace Drug Testing Programs.
Therefore, this meeting is closed to the
public as determined by the
Administrator, SAMHSA, in accordance
with 5 U.S.C. 552b(c)(9)(B) and 5 U.S.C.
App. 2, Section 10(d).
Meeting information and a roster of
DTAB members may be obtained by
accessing the SAMHSA Advisory
Committees Web site, https://
www.nac.samhsa.gov/DTAB/
meetings.aspx, or by contacting Dr.
Cook.
Committee Name: Substance Abuse
and Mental Health Services
Administration’s Center for Substance
Abuse Prevention Drug Testing
Advisory Board.
Dates/Time/Type: March 17, 2014,
from 9:00 a.m. to 4:30 p.m. E.D.T.:
OPEN; March 18, 2014, from 9:00 a.m.
to 2:00 p.m. E.D.T.: CLOSED.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Place: Sugarloaf Conference Room,
SAMHSA Building, 1 Choke Cherry
Road, Rockville, Maryland 20850.
Contact: Janine Denis Cook, Ph.D.,
Designated Federal Official, CSAP Drug
Testing Advisory Board, 1 Choke Cherry
Road, Room 7–1043, Rockville,
Maryland 20857, Telephone: 240–276–
2600, Fax: 240–276–2610, Email:
janine.cook@samhsa.hhs.gov.
Cathy J. Friedman,
Public Health Analyst, Substance Abuse and
Mental Health Services Administration.
[FR Doc. 2014–04291 Filed 2–26–14; 8:45 am]
BILLING CODE 4162–20–P
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket Number FR- 5752–N–22]
Federal Housing Administration (FHA)
Healthcare Facility Documents:
Documents Eligible for Electronic
Submission—30-Day Notice of
Information Collection
Office of the Assistant
Secretary for Housing—Federal Housing
Commissioner, HUD.
ACTION: Notice.
AGENCY:
On March 14, 2013, HUD
published in the Federal Register a
notice that announced that FHA’s
healthcare facility documents
completed the notice and comment
processes under the Paperwork
Reduction Act of 1995 (PRA), and had
been assigned a control number, 2502–
0605, by the Office of Management and
Budget (OMB). The assignment of a
control number concluded a 10-month
process through which HUD solicited
SUMMARY:
E:\FR\FM\27FEN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Notices]
[Pages 11112-11114]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04262]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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, PRAStaff@fda.hhs.gov.
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\
----------------------------------------------------------------------------------------------------------------
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........................
-------------------------------------------------------------------------------
[[Page 11114]]
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
21 CFR section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per 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: 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
