Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Advertisements, 23574-23576 [2017-10533]
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<![CDATA[
23574
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Total/annual
number of
respondents
Instrument
Implementation interview: Additional center staff ............................................
Cost workbook .................................................................................................
Time use survey staff roster ............................................................................
Time use survey advance letter ......................................................................
Time use survey ..............................................................................................
Estimated Total Annual Burden
Hours: 954 hours.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–10525 Filed 5–22–17; 8:45 am]
BILLING CODE 4184–23–P
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
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
60
50
50
700
560
Under the Paperwork Reduction Act of
1995 (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.
Submit either electronic or
written comments on the collection of
information by July 24, 2017.
ADDRESSES: You may submit comments
as follows:
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
Average
burden
hours per
response
.5
7.5
.25
.08
.25
Annual
burden hours
30
375
13
56
140
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2010–N–0110 for ‘‘Prescription Drug
Advertisements.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
E:\FR\FM\23MYN1.SGM
23MYN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
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,
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,
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
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.
Reporting to FDA
Section 202.1(e)(6) permits a person
who would be adversely affected by the
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
23575
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, 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.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\23MYN1.SGM
23MYN1
23576
Federal Register / Vol. 82, No. 98 / Tuesday, May 23, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section or activity
CDER:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
CBER:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
CVM:
202.1(e)(6); waiver request ..............................
202.1(j)(1); submission of advertisement .........
202.1(j)(1)(iii); assuring that adverse information be publicized ..........................................
202.1(j)(4); voluntary submission of ad to FDA
Total ...........................................................
1 There
Total annual
responses
Hours per
response
Total hours
1
1
1
1
1
1
12
2
12
2
1
71
1
6.97
1
495
12
20
12
9,900
0
0
0
0
0
0
12
2
0
0
0
9
0
8
0
72
12
20
0
1,440
0
0
0
0
0
0
12
2
0
0
0
5
0
1
0
5
12
20
0
100
....................................
........................
........................
........................
11,466
are no capital costs or operating and maintenance costs associated with this collection.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
CDER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
CBER:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
CVM:
202.1; ad prepared in accordance with 21
CFR Part 202 ................................................
202.1(j)(1); info. included re. fatalities or serious damage ..................................................
Total ...........................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR section or activity
Hours per
response
Total hours
394
105.3
41,494
400
16,597,600
1
1
1
40
40
47
63.4
2,984
400
1,193,600
0
0
0
40
0
25
36
900
400
360,000
0
0
0
40
0
....................................
........................
........................
........................
18,151,240
are no capital costs or operating and maintenance costs associated with this collection.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–10533 Filed 5–22–17; 8:45 am]
[Docket No. FDA–2017–N–1848]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
Total annual
responses
Food and Drug Administration
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Cosmetic Labeling
Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing an opportunity for public
comment on the proposed collection of
SUMMARY:
VerDate Sep<11>2014
21:15 May 22, 2017
Jkt 241001
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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 information
collection provisions in FDA’s cosmetic
labeling regulations.
DATES: Submit either electronic or
written comments on the collection of
information by July 24, 2017.
ADDRESSES: You may submit comments
as follows:
E:\FR\FM\23MYN1.SGM
23MYN1
]]>Agencies
[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Notices]
[Pages 23574-23576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10533]
-----------------------------------------------------------------------
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 July 24, 2017.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2010-N-0110 for ``Prescription Drug Advertisements.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
[[Page 23575]]
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
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, 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,
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.
We estimate the burden of this collection of information as
follows:
[[Page 23576]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER:
202.1(e)(6); waiver request................................... 1 1 1 12 12
202.1(j)(1); submission of advertisement...................... 1 1 1 2 2
202.1(j)(1)(iii); assuring that adverse information be 1 1 1 12 12
publicized...................................................
202.1(j)(4); voluntary submission of ad to FDA................ 71 6.97 495 20 9,900
CBER:
202.1(e)(6); waiver request................................... 0 0 0 12 0
202.1(j)(1); submission of advertisement...................... 0 0 0 2 0
202.1(j)(1)(iii); assuring that adverse information be 0 0 0 12 0
publicized...................................................
202.1(j)(4); voluntary submission of ad to FDA................ 9 8 72 20 1,440
CVM:
202.1(e)(6); waiver request................................... 0 0 0 12 0
202.1(j)(1); submission of advertisement...................... 0 0 0 2 0
202.1(j)(1)(iii); assuring that adverse information be 0 0 0 12 0
publicized...................................................
202.1(j)(4); voluntary submission of ad to FDA................ 5 1 5 20 100
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Total..................................................... .................... .............. .............. .............. 11,466
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section or activity Number of responses per Total annual Hours per Total hours
respondents respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDER:
202.1; ad prepared in accordance with 21 CFR Part 202......... 394 105.3 41,494 400 16,597,600
202.1(j)(1); info. included re. fatalities or serious damage.. 1 1 1 40 40
CBER:
202.1; ad prepared in accordance with 21 CFR Part 202......... 47 63.4 2,984 400 1,193,600
202.1(j)(1); info. included re. fatalities or serious damage.. 0 0 0 40 0
CVM:
202.1; ad prepared in accordance with 21 CFR Part 202......... 25 36 900 400 360,000
202.1(j)(1); info. included re. fatalities or serious damage.. 0 0 0 40 0
-------------------------------------------------------------------------------------
Total..................................................... .................... .............. .............. .............. 18,151,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection.
Dated: May 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10533 Filed 5-22-17; 8:45 am]
BILLING CODE 4164-01-P
