Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements, 4117-4119 [2011-1275]
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
substantial equivalence (21 U.S.C.
387e(j)). In a level 1 guidance document
issued under the Good Guidances
Practices regulation (21 CFR 10.115),
FDA provides recommendations
intended to assist persons submitting
reports under section 905(j) of the FD&C
Act, and explains, among other things,
FDA’s interpretation of the statutory
sections related to substantial
equivalence.
Estimation of Burden
FDA estimates the burden for this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Number of
respondents
FD&C Act sections
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
905(j) and 910(a) .................................................................
150
1
150
360
54,000
Total .....................................................................................
........................
........................
........................
........................
54,000
There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA has based these estimates on
information related to other regulated
products and FDA’s expectations
regarding the tobacco industry’s use of
the 905(j) pathway to market their
products. Table 1 of this document
describes the annual reporting burden
as a result of the implementation of the
substantial equivalence requirements of
sections 905(j) and 910(a) of the FD&C
Act (21 U.S.C. 387e(j) and 387j(a)). FDA
estimates that it will receive 150 section
905(j) reports each year and that it will
take a manufacturer approximately 360
hours to prepare a report of substantial
equivalence for a new tobacco product.
Therefore, FDA estimates the burden for
submission of substantial equivalence
information will be 54,000 hours.
Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1276 Filed 1–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
mstockstill on DSKH9S0YB1PROD with NOTICES
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
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Fax written comments on the
collection of information by February
23, 2011.
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–new and
title ‘‘Prescription Drug
Advertisements’’. Also include the FDA
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.
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
DATES:
Prescription Drug Advertisements—
(OMB Control Number 0910)—New
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
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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 FD&C
Act, (21 U.S.C. 352(n) and section 201
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. 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
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§ 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.
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
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of this information collection that FDA
would receive one advertisement
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 to prepare,
assemble, and copy the necessary
information.
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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.
In the Federal Register of March 17,
2010 (75 FR 12756), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received one comment.
The comment said that any waiver
requests FDA receives in the future
under § 202.1(e)(6) should be granted
only for extraordinary reasons because
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of the ‘‘high public interest value
associated with parties fully complying
with information requests concerning
prescription drugs.’’
FDA Response: FDA is not aware of
any request for a waiver under
§ 202.1(e)(6). If we receive such a waiver
request in the future, we will consider
this comment in determining whether or
not to grant the request.
Concerning the statement that FDA
has not received any advertisements
requiring prior approval under
§ 202.1(j)(1) in the past 10 years, the
comment said this may be indicative of
FDA’s failure to ensure compliance with
this provision, rather than simply an
indication that no advertisements are
received under § 202.1(j)(1). The
comment said that FDA should more
vigorously investigate and penalize or
otherwise sanction sponsors who fail to
ensure that significant new adverse
information about a drug that becomes
known to the sponsors is advertised in
compliance with § 202.1(j).
FDA Response: FDA properly enforces
the requirements of § 202.1(j).
Additionally, the Division of Drug
Marketing, Advertising and
Communication (DDMAC) works
closely with the Office of New Drugs
(OND) and sponsors to ensure that
information about serious and
significant risks that have not been
widely publicized is appropriately
presented in promotional labeling and
advertising. FDA regularly
communicates these requests to
sponsors through supplement letters
sent by OND review divisions and safety
update letters sent by DDMAC. DDMAC
is not aware of any drugs that have
required prior approval under
§ 202.1(j)—but DDMAC is consistently
in contact with OND and sponsors to
ensure that promotional labeling
accurately communicates serious and
significant risk information.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Type of submission
202.1(e)(6) ...........
202.1(j)(1) ............
Waiver request to FDA ......................
Submission of advertisement to FDA
for prior approval.
Providing a program to FDA for assuring that adverse information
about the drug will be publicized.
Voluntarily submitting the advertisement to FDA prior to publication
for comment.
202.1(j)(1)(iii) ........
202.1(j)(4) ............
Total ..............
1 There
Annual
frequency per
response
Number of
respondents
21 CFR section
Total annual
responses
Hours per
response
Total hours
1
1
1
1
12
2
12
2
1
1
1
12
12
155
9
1,395
20
27,900
........................
............................................................
1
1
........................
........................
........................
27,926
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Annual
frequency of
disclosure
Number of
respondents
Total annual
disclosure
Hours per
disclosure
21 CFR section
Type of submission
202.1 ....................
355
47
16,685
400
6,674,000
202.1(j)(1) ............
Advertisements prepared in accordance with § 202.1.
Including information about the
drug’s fatalities or serious damage
in the advertisement.
1
1
1
40
40
Total ..............
............................................................
........................
........................
........................
........................
6,674,040
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–1275 Filed 1–21–11; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0381]
BILLING CODE 4160–01–P
Generic Drug User Fee; Notice of
Public Meeting; Reopening of the
Comment Period
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Total hours
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA) is reopening until
February 23, 2011, the comment period
SUMMARY:
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for the notice of public meeting entitled
Generic Drug User Fee; Public Meeting;
Request for Comments, published in the
Federal Register of August 9, 2010 (75
FR 47820). In that notice, FDA
announced a public meeting that took
place on September 17, 2010, to gather
stakeholder input on the development
of a generic drug user fee program. FDA
is reopening the comment period to
permit public consideration of latereceived comments and to provide an
opportunity for all interested parties to
provide information and share views on
the matter.
Submit either electronic or
written comments by February 23, 2011.
DATES:
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]]>Agencies
[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4117-4119]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1275]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0110]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prescription Drug
Advertisements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
February 23, 2011.
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-new and
title ``Prescription Drug Advertisements''. Also include the FDA 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.
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Prescription Drug Advertisements--(OMB Control Number 0910)--New
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 the FD&C Act, (21 U.S.C. 352(n) and section
201 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. 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
[[Page 4118]]
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.
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.
In the Federal Register of March 17, 2010 (75 FR 12756), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received one comment.
The comment said that any waiver requests FDA receives in the
future under Sec. 202.1(e)(6) should be granted only for extraordinary
reasons because
[[Page 4119]]
of the ``high public interest value associated with parties fully
complying with information requests concerning prescription drugs.''
FDA Response: FDA is not aware of any request for a waiver under
Sec. 202.1(e)(6). If we receive such a waiver request in the future,
we will consider this comment in determining whether or not to grant
the request.
Concerning the statement that FDA has not received any
advertisements requiring prior approval under Sec. 202.1(j)(1) in the
past 10 years, the comment said this may be indicative of FDA's failure
to ensure compliance with this provision, rather than simply an
indication that no advertisements are received under Sec. 202.1(j)(1).
The comment said that FDA should more vigorously investigate and
penalize or otherwise sanction sponsors who fail to ensure that
significant new adverse information about a drug that becomes known to
the sponsors is advertised in compliance with Sec. 202.1(j).
FDA Response: FDA properly enforces the requirements of Sec.
202.1(j). Additionally, the Division of Drug Marketing, Advertising and
Communication (DDMAC) works closely with the Office of New Drugs (OND)
and sponsors to ensure that information about serious and significant
risks that have not been widely publicized is appropriately presented
in promotional labeling and advertising. FDA regularly communicates
these requests to sponsors through supplement letters sent by OND
review divisions and safety update letters sent by DDMAC. DDMAC is not
aware of any drugs that have required prior approval under Sec.
202.1(j)--but DDMAC is consistently in contact with OND and sponsors to
ensure that promotional labeling accurately communicates serious and
significant risk information.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Type of submission Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1(e)(6)............................... Waiver request to FDA....... 1 1 1 12 12
202.1(j)(1)............................... Submission of advertisement 1 1 1 2 2
to FDA for prior approval.
202.1(j)(1)(iii).......................... Providing a program to FDA 1 1 1 12 12
for assuring that adverse
information about the drug
will be publicized.
202.1(j)(4)............................... Voluntarily submitting the 155 9 1,395 20 27,900
advertisement to FDA prior
to publication for comment.
-------------------------------------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 27,926
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
21 CFR section Type of submission Number of frequency of Total annual Hours per Total hours
respondents disclosure disclosure disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
202.1..................................... Advertisements prepared in 355 47 16,685 400 6,674,000
accordance with Sec.
202.1.
202.1(j)(1)............................... Including information about 1 1 1 40 40
the drug's fatalities or
serious damage in the
advertisement.
-------------------------------------------------------------------------------------------------------------
Total................................. ............................ .............. .............. .............. .............. 6,674,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1275 Filed 1-21-11; 8:45 am]
BILLING CODE 4160-01-P
