Agency Information Collection Activities: Proposed Collection; Comment Request; Prescription Drug Advertisements, 12756-12758 [2010-5812]
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12756
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Form name
Number of
respondents
Number of responses per respondent
Average burden
per response
(in hours)
Total ............................
.................................................................
............................
............................
............................
Dated: March 11, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–5841 Filed 3–16–10; 8:45 am]
BILLING CODE 4163–18–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
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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 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 regulations on prescription drug
advertisements.
DATES: Submit written or electronic
comments on the collection of
information by May 17, 2010.
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:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
VerDate Nov<24>2008
15:08 Mar 16, 2010
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796–3792, e-mail:
Elizabeth.Berbakos@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 the
Federal Register concerning each
proposed 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—21
CFR 202.1 (OMB Control Number
0910)—New
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
352(n)) (the act) 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 act
requires advertisements to contain ‘‘a
PO 00000
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Sfmt 4703
Total burden
(in hours)
850
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 the act (21
U.S.C. 352(n) and 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. The
information collection requirements in
§ 202.1 have not previously been
submitted to OMB for approval. With
this notice, we are seeking comment on
the proposed information collection.
Reporting to FDA
Section 202.1(e)(6) includes a
provision that is subject to the PRA.
Section 202.1(e)(6) permits a person
who would be adversely affected by the
enforcement of a provision of
§ 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
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wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
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 act.
FDA has not received any waiver
requests under § 202.1(e)(6) in the past
10 years. However, we estimate for the
purposes of this information collection
that FDA would receive one waiver
request annually under § 202.1(e)(6).
The hours per response is the estimated
time that a respondent would spend
preparing information to be submitted
to FDA under § 202.1(e)(6). Based on its
experience reviewing other waiver
requests, FDA estimates that
approximately 12 hours on average
would be needed per submission,
including the time it takes to prepare,
assemble, and copy the necessary
information.
Section 202.1(j), which sets forth
requirements for the dissemination of
advertisements subject to the standards
in § 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.
FDA has not received any
advertisements requiring prior approval
under § 202.1(j)(1) in the past 10 years.
However, we estimate for the purposes
of this information collection that FDA
would receive one advertisement
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Jkt 220001
requiring prior approval annually under
§ 202.1(j)(1). The hours per response is
the estimated time that a respondent
would spend preparing information to
be submitted to FDA under § 202.1(j)(1).
Based on its experience reviewing other
advertisements, FDA estimates that
approximately 2 hours on average
would be needed per submission,
including the time it takes to prepare,
assemble, and copy the necessary
information.
FDA has not received any program
information required under
§ 202.1(j)(1)(iii) in the past 10 years.
However, we estimate for the purposes
of this information collection that FDA
would receive one submission of
program information annually under
§ 202.1(j)(1)(iii). The hours per response
is the estimated time that a respondent
would spend preparing information to
be submitted to FDA under
§ 202.1(j)(1)(iii). Based on its experience
reviewing advertisement-related
information, FDA estimates that
approximately 12 hours on average
would be needed per submission,
including the time it takes to prepare,
assemble, and copy the necessary
information.
Based on FDA data, the Center for
Drug Evaluation and Research (CDER)
estimates that approximately 1,150 draft
promotional pieces are received from
approximately 125 companies annually
for agency comment prior to publication
under § 202.1(j)(4), the Center for
Biologics Evaluation and Research
(CBER) estimates that approximately
250 draft promotional pieces are
received from approximately 25
companies annually under § 202.1(j)(4),
and the Center for Veterinary Medicine
(CVM) estimates that approximately 5
draft promotional pieces are received
from approximately 5 companies
annually under § 202.1(j)(4). FDA
anticipates that this submission rate will
moderately increase in the near future.
The estimated total number of
submissions under § 202.1(j)(4) is 1,405.
The hours per response is the estimated
time that a respondent would spend
preparing the information to be
submitted to FDA under § 202.1(j)(4).
Based on its experience reviewing
advertisements submitted prior to
publication for agency comment, FDA
estimates that approximately 20 hours
on average would be needed per
submission, including the time it takes
PO 00000
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Fmt 4703
Sfmt 4703
12757
to prepare, assemble, and copy the
necessary information.
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.
Based on FDA data, CDER estimates
that approximately 15,000
advertisements for prescription drugs,
including print and broadcast
advertisements, are prepared by
approximately 300 companies under
§ 202.1 annually, CBER estimates that
approximately 1,000 of these
advertisements are prepared by
approximately 30 companies annually,
and CVM estimates that approximately
800 of these advertisements are
prepared by approximately 25
companies annually. FDA anticipates
that this estimate will moderately
increase in the near future. The
estimated total number of
advertisements under § 202.1 is 16,800.
The hours per response is the estimated
time that a respondent would spend
preparing an advertisement subject to
§ 202.1. Based on its experience
reviewing advertisements, FDA
estimates that approximately 400 hours
on average would be needed per
advertisement, including the time it
takes to prepare, assemble, and copy the
necessary information.
Under § 202.1, if information that the
use of a prescription drug may cause
fatalities or serious damage has not been
widely publicized in the medical
literature, a sponsor must include such
information in the advertisements for
that drug. FDA is not aware of any
advertisements that required inclusion
of information on fatalities or serious
damage associated with use of the drug
under § 202.1(j)(1) in the past 10 years.
However, we estimate for the purposes
of this information collection that one
advertisement would require inclusion
of such information annually under
§ 202.1(j)(1). The hours per response is
the estimated time that a respondent
would spend preparing information to
comply with § 202.1(j)(1). Based on its
experience reviewing changes to
advertisements, FDA estimates that
approximately 40 hours on average
would be needed to comply with
§ 202.1(j)(1), including the time it takes
to prepare the necessary information.
FDA estimates the burden of this
collection of information as follows:
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Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Type of
Submission
21 CFR Section
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours
per Response
Total Hours
202.1(e)(6)
Waiver request to FDA
1
1
1
12
12
202.1(j)(1)
Submission of advertisement to FDA for
prior approval
1
1
1
2
2
202.1(j)(1)(iii)
Providing a program to
FDA for assuring that
adverse information
about the drug will be
publicized
1
1
1
12
12
202.1(j)(4)
Voluntarily submitting
the advertisement to
FDA prior to publication
for comment
155
1,405
20
28,100
9.065
Total
28,126
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN1
21 CFR Section
Type of
Submission
202.1
No. of
Respondents
Advertisements
prepared in accordance with
§ 202.1
202.1(j)(1)
Annual Frequency
per Disclosure
355
Including information about the
drug’s fatalities or
serious damage in
the advertisement
47.324
1
Total Annual
Disclosures
Hours per
Disclosure
Total Hours
16,800
400
6,720,000
1
40
40
1
Total
6,720,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–5812 Filed 3–16–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
[Docket No. FDA–2009–N–0380]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Product
Jurisdiction: Assignment of Agency
Component for Review of Premarket
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
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 April 16,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0523. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
3794,
Jonnalynn.capezzuto@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Product Jurisdiction: Assignment of
Agency Component for Review of
Premarket Applications—(OMB Control
Number 0910–0523)—Extension
This regulation relates to agency
management and organization and has
two purposes. The first is to implement
section 503(g) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(g)), as
added by the Safe Medical Devices Act
of 1990 (Public Law 101–629), and
amended by the Medical Device User
Fee and Modernization Act of 2002
(Public Law 107–250), by specifying
how FDA will determine the
organizational component within FDA
assigned to have primary jurisdiction for
the premarket review and regulation of
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]]>Agencies
[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12756-12758]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5812]
-----------------------------------------------------------------------
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 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 regulations on prescription drug
advertisements.
DATES: Submit written or electronic comments on the collection of
information by May 17, 2010.
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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792, e-mail:
Elizabeth.Berbakos@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 the Federal
Register concerning each proposed 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--21 CFR 202.1 (OMB Control Number
0910)--New
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 352(n)) (the act) 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
act requires advertisements to contain ``a true statement'' of certain
information including ``information in brief summary relating to side
effects, contraindications, and effectiveness'' as required by
regulations issued by FDA. FDA's prescription drug advertising
regulations at Sec. 202.1 (21 CFR 202.1) describe requirements and
standards for print and broadcast advertisements. Section 202.1 applies
to advertisements published in journals, magazines, other periodicals,
and newspapers, and advertisements broadcast through media such as
radio, television, and telephone communication systems. Print
advertisements must include a brief summary of each of the risk
concepts from the product's approved package labeling (Sec.
202.1(e)(1)). Advertisements that are broadcast through media such as
television, radio, or telephone communications systems must disclose
the major risks from the product's package labeling in either the audio
or audio and visual parts of the presentation (Sec. 202.1(e)(1)); this
disclosure is known as the ``major statement.'' If a broadcast
advertisement omits the major statement, or if the major statement
minimizes the risks associated with the use of the drug, the
advertisement could render the drug misbranded in violation of the act
(21 U.S.C. 352(n) and 321(n)), and FDA's implementing regulations at
Sec. 202.1(e).
Advertisements subject to the requirements at Sec. 202.1 are
subject to the PRA because these advertisements disclose information to
the public. In addition, Sec. 202.1(e)(6) and (j) include provisions
that are subject to OMB approval under the PRA. The information
collection requirements in Sec. 202.1 have not previously been
submitted to OMB for approval. With this notice, we are seeking comment
on the proposed information collection.
Reporting to FDA
Section 202.1(e)(6) includes a provision that is subject to the
PRA. Section 202.1(e)(6) permits a person who would be adversely
affected by the enforcement of a provision of 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
[[Page 12757]]
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 act.
FDA has not received any waiver requests under Sec. 202.1(e)(6) in
the past 10 years. However, we estimate for the purposes of this
information collection that FDA would receive one waiver request
annually under Sec. 202.1(e)(6). The hours per response is the
estimated time that a respondent would spend preparing information to
be submitted to FDA under Sec. 202.1(e)(6). Based on its experience
reviewing other waiver requests, FDA estimates that approximately 12
hours on average would be needed per submission, including the time it
takes to prepare, assemble, and copy the necessary information.
Section 202.1(j), which sets forth requirements for the
dissemination of advertisements subject to the standards in Sec.
202.1(e), contains the following information collection that is subject
to the PRA:
Under Sec. 202.1(j)(1), a sponsor must submit advertisements to
FDA for prior approval before dissemination if: (1) The sponsor or FDA
has received information that has not been widely publicized in medical
literature that the use of the drug may cause fatalities or serious
damage; (2) FDA has notified the sponsor that the information must be
part of the advertisements for the drug; and (3) the sponsor has failed
to present to FDA a program for assuring that such information will be
publicized promptly and adequately to the medical profession in
subsequent advertisements, or if such a program has been presented to
FDA but is not being followed by the sponsor. Under Sec.
202.1(j)(1)(iii), a sponsor must provide to FDA a program for assuring
that significant new adverse information about the drug that becomes
known (i.e., use of drug may cause fatalities or serious damage) will
be publicized promptly and adequately to the medical profession in any
subsequent advertisements.
Under Sec. 202.1(j)(4), a sponsor may voluntarily submit
advertisements to FDA for comment prior to publication.
FDA has not received any advertisements requiring prior approval
under Sec. 202.1(j)(1) in the past 10 years. However, we estimate for
the purposes of this information collection that FDA would receive one
advertisement requiring prior approval annually under Sec.
202.1(j)(1). The hours per response is the estimated time that a
respondent would spend preparing information to be submitted to FDA
under Sec. 202.1(j)(1). Based on its experience reviewing other
advertisements, FDA estimates that approximately 2 hours on average
would be needed per submission, including the time it takes to prepare,
assemble, and copy the necessary information.
FDA has not received any program information required under Sec.
202.1(j)(1)(iii) in the past 10 years. However, we estimate for the
purposes of this information collection that FDA would receive one
submission of program information annually under Sec.
202.1(j)(1)(iii). The hours per response is the estimated time that a
respondent would spend preparing information to be submitted to FDA
under Sec. 202.1(j)(1)(iii). Based on its experience reviewing
advertisement-related information, FDA estimates that approximately 12
hours on average would be needed per submission, including the time it
takes to prepare, assemble, and copy the necessary information.
Based on FDA data, the Center for Drug Evaluation and Research
(CDER) estimates that approximately 1,150 draft promotional pieces are
received from approximately 125 companies annually for agency comment
prior to publication under Sec. 202.1(j)(4), the Center for Biologics
Evaluation and Research (CBER) estimates that approximately 250 draft
promotional pieces are received from approximately 25 companies
annually under Sec. 202.1(j)(4), and the Center for Veterinary
Medicine (CVM) estimates that approximately 5 draft promotional pieces
are received from approximately 5 companies annually under Sec.
202.1(j)(4). FDA anticipates that this submission rate will moderately
increase in the near future. The estimated total number of submissions
under Sec. 202.1(j)(4) is 1,405. The hours per response is the
estimated time that a respondent would spend preparing the information
to be submitted to FDA under Sec. 202.1(j)(4). Based on its experience
reviewing advertisements submitted prior to publication for agency
comment, FDA estimates that approximately 20 hours on average would be
needed per submission, including the time it takes to prepare,
assemble, and copy the necessary information.
Disclosures to the Public
Under Sec. 202.1, advertisements for human and animal prescription
drug and biological products must comply with the standards described
in that section.
Based on FDA data, CDER estimates that approximately 15,000
advertisements for prescription drugs, including print and broadcast
advertisements, are prepared by approximately 300 companies under Sec.
202.1 annually, CBER estimates that approximately 1,000 of these
advertisements are prepared by approximately 30 companies annually, and
CVM estimates that approximately 800 of these advertisements are
prepared by approximately 25 companies annually. FDA anticipates that
this estimate will moderately increase in the near future. The
estimated total number of advertisements under Sec. 202.1 is 16,800.
The hours per response is the estimated time that a respondent would
spend preparing an advertisement subject to Sec. 202.1. Based on its
experience reviewing advertisements, FDA estimates that approximately
400 hours on average would be needed per advertisement, including the
time it takes to prepare, assemble, and copy the necessary information.
Under Sec. 202.1, if information that the use of a prescription
drug may cause fatalities or serious damage has not been widely
publicized in the medical literature, a sponsor must include such
information in the advertisements for that drug. FDA is not aware of
any advertisements that required inclusion of information on fatalities
or serious damage associated with use of the drug under Sec.
202.1(j)(1) in the past 10 years. However, we estimate for the purposes
of this information collection that one advertisement would require
inclusion of such information annually under Sec. 202.1(j)(1). The
hours per response is the estimated time that a respondent would spend
preparing information to comply with Sec. 202.1(j)(1). Based on its
experience reviewing changes to advertisements, FDA estimates that
approximately 40 hours on average would be needed to comply with Sec.
202.1(j)(1), including the time it takes to prepare the necessary
information.
FDA estimates the burden of this collection of information as
follows:
[[Page 12758]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR Type of No. of Annual Frequency per Total Annual Hours per
Section Submission Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
202.1(e)( Waiver 1 1 1 12 12
6) request to
FDA
----------------------------------------------------------------------------------------------------------------
202.1(j)( Submission 1 1 1 2 2
1) of
advertisem
ent to FDA
for prior
approval
----------------------------------------------------------------------------------------------------------------
202.1(j)( Providing a 1 1 1 12 12
1)(iii) program to
FDA for
assuring
that
adverse
informatio
n about
the drug
will be
publicized
----------------------------------------------------------------------------------------------------------------
202.1(j)( Voluntarily 155 9.065 1,405 20 28,100
4) submitting
the
advertisem
ent to FDA
prior to
publicatio
n for
comment
----------------------------------------------------------------------------------------------------------------
Total 28,126
----------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Type of Submission Respondents per Disclosure Disclosures Disclosure Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1 Advertisements prepared in 355 47.324 16,800 400 6,720,000
accordance with Sec.
202.1
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1(j)(1) Including information 1 1 1 40 40
about the drug's
fatalities or serious
damage in the
advertisement
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 6,720,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5812 Filed 3-16-10; 8:45 am]
BILLING CODE 4160-01-S
