Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications, as Used by the Food and Drug Administration, 6800-6801 [2011-2663]
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Federal Register / Vol. 76, No. 26 / Tuesday, February 8, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents 4
21 CFR section/FDA form No.
514.8(b) ............................................................
514.8(c)(1) ........................................................
514.8(c)(2) and (c)(3) .......................................
514.11 ..............................................................
558.5(i) .............................................................
514.1(b)(8) and 514.8(c)(1) 3 ...........................
FDA Form 356V ...............................................
Annual frequency
per respondent
154
154
154
154
154
154
154
Total annual
responses
2.84
.1
.7
.2
.01
.21
5.1
Hours per
response
437.36
15.4
107.8
30.8
1.54
32.34
785.4
35
71
20
1
5
90
5
Total ..........................................................
1 There
Total hours
15,308
1,093
2,156
31
8
2,911
3,927
33,319
are no capital costs or operating and maintenance costs associated with this collection of information.
Evidence—Because 21 CFR 514.4 only defines substantial evidence, it should not be viewed as creating additional collection bur-
2 Substantial
den.
3 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
4 Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 154 annual respondents
during the 5 fiscal years, from October 1, 2005, through September 30, 2010, on which these estimates were made. We use this estimate consistently throughout the table and calculate the ‘‘annual frequency per respondent’’ by dividing the total annual responses by the number of
respondents.
Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2664 Filed 2–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0067]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Data To Support
Drug Product Communications, as
Used by the Food and Drug
Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
a generic clearance to collect
information to support communications
used by FDA about drug products. This
data collection will informally gauge
public opinion on a variety of subjects
related to consumer, patient, or
healthcare professional perceptions and
use of drug and biological products and
related materials, including, but not
limited to, direct-to-consumer
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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18:16 Feb 07, 2011
Jkt 223001
prescription drug promotion, physician
labeling of prescription drugs,
Medication Guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sales of medical products, and
consumer and professional education.
DATES: Submit either electronic or
written comments on the collection of
information by April 11, 2011.
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,
Elizabeth.Berbakos@fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
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.
Data to Support Drug Products
Communications, as Used by the Food
and Drug Administration (OMB Control
Number 0910–New)
Testing of communication messages
in advance of a communication
campaign provides an important role in
improving FDA communications as they
allow for an in-depth understanding of
individuals’ attitudes, beliefs,
motivations, and feelings. The methods
to be employed include individual indepth interviews, general public focus
group interviews, intercept interviews,
self-administered surveys, gatekeeper
surveys, and professional clinician
focus group interviews. The methods to
be used serve the narrowly defined need
for direct and informal opinion on a
E:\FR\FM\08FEN1.SGM
08FEN1
6801
Federal Register / Vol. 76, No. 26 / Tuesday, February 8, 2011 / Notices
specific topic and as a qualitative
research tool have two major purposes:
• To obtain information that is useful
for developing variables and measures
for formulating the basic objectives of
risk communication campaigns, and
• To assess the potential effectiveness
of messages and materials in reaching
and successfully communicating with
their intended audiences.
FDA will use these methods to test
and refine its ideas and to help develop
messages and other communications,
but will generally conduct further
research before making important
decisions such as adopting new policies
and allocating or redirecting significant
resources to support these policies.
FDA’s Center for Drug Evaluation and
Research, Center for Biologics
Evaluation and Research, Office of the
Commissioner, and any other Centers or
Offices will use this mechanism to test
messages about regulated drug products
on a variety of subjects related to
consumer, patient, or health care
professional perceptions and about use
of drug products and related materials,
including but not limited to, direct-toconsumer prescription drug promotion,
physician labeling of prescription drugs,
Medication Guides, over-the-counter
drug labeling, emerging risk
communications, patient labeling,
online sale of medical products, and
consumer and professional education.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Annual
frequency per
response
Number of respondents
19,822 ..............................................................................................................
1 There
Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–2663 Filed 2–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0493]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Additional Criteria
and Procedures for Classifying Overthe-Counter Drugs as Generally
Recognized as Safe and Effective and
Not Misbranded
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 10,
2011.
SUMMARY:
srobinson on DSKHWCL6B1PROD with NOTICES
1
19,822
Hours per
response
0.24
Total hours
4,757
are no capital costs or operating and maintenance costs associated with this collection of information.
Annually, FDA projects about 45
communication studies using the
variety of test methods listed previously
in this document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
AGENCY:
Total annual
responses
VerDate Mar<15>2010
18:16 Feb 07, 2011
Jkt 223001
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 ‘‘Additional Criteria and Procedures
for Classifying Over-the-Counter Drugs
as Generally Recognized as Safe and
Effective and Not Misbranded.’’ 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.
ADDRESSES:
Additional Criteria and Procedures for
Classifying Over-the-Counter Drugs as
Generally Recognized as Safe and
Effective and Not Misbranded—(OMB
Control Number 0910—New)
In the Federal Register of January 23,
2002 (67 FR 3060), we established
regulations in § 330.14 (21 CFR 330.14)
providing additional criteria and
procedures for classifying over-thecounter (OTC) drugs as generally
recognized as safe and effective and not
misbranded (2002 time and extent
application (TEA) final rule). The
regulations in § 330.14 state that OTC
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
drug products introduced into the U.S.
market after the OTC drug review began
and OTC drug products without any
marketing experience in the United
States can be evaluated under the
monograph process if the conditions
(e.g., active ingredients) meet certain
‘‘time and extent’’ criteria outlined in
§ 330.14(b). The regulations allow a TEA
to be submitted to us by any party for
our consideration to include new
conditions in the OTC drug monograph
system. TEAs must provide evidence
described in § 330.14(c) demonstrating
that the condition is eligible for
inclusion in the monograph system.
(Section 330.14(d) specifies the number
of copies and address for submission of
a TEA.) If a condition is found eligible,
any interested parties can submit safety
and effectiveness information as
explained in § 330.14(f). Safety and
effectiveness data include not only the
data and information listed in 21 CFR
330.10(a)(2) (§ 330.14(f)(1)), but also a
listing of all serious adverse drug
experiences that may have occurred
(§ 330.14(f)(2)) as well as an official or
proposed compendial monograph
(§ 330.14(i)).
In the Federal Register of October 8,
2010 (75 FR 62404), we published a 60day notice requesting public comment
on the proposed collection of
information. In that notice, we stated
that we considered our estimate, in the
2002 TEA final rule, of 480 hours to
prepare a TEA and 800 hours to prepare
and submit safety and effectiveness data
to continue to be valid (75 FR 62404 at
62405). In the same document, we
stated that, based on the number of
submissions we had received in the 8
years following publication of the TEA
final rule, we expected to receive an
E:\FR\FM\08FEN1.SGM
08FEN1
]]>Agencies
[Federal Register Volume 76, Number 26 (Tuesday, February 8, 2011)]
[Notices]
[Pages 6800-6801]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0067]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Drug Product Communications, as Used
by the Food and Drug Administration
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 a generic clearance to collect information
to support communications used by FDA about drug products. This data
collection will informally gauge public opinion on a variety of
subjects related to consumer, patient, or healthcare professional
perceptions and use of drug and biological products and related
materials, including, but not limited to, direct-to-consumer
prescription drug promotion, physician labeling of prescription drugs,
Medication Guides, over-the-counter drug labeling, emerging risk
communications, patient labeling, online sales of medical products, and
consumer and professional education.
DATES: Submit either electronic or written comments on the collection
of information by April 11, 2011.
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,
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.
Data to Support Drug Products Communications, as Used by the Food and
Drug Administration (OMB Control Number 0910-New)
Testing of communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an in-depth understanding of individuals' attitudes,
beliefs, motivations, and feelings. The methods to be employed include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and professional clinician focus group interviews. The methods to be
used serve the narrowly defined need for direct and informal opinion on
a
[[Page 6801]]
specific topic and as a qualitative research tool have two major
purposes:
To obtain information that is useful for developing
variables and measures for formulating the basic objectives of risk
communication campaigns, and
To assess the potential effectiveness of messages and
materials in reaching and successfully communicating with their
intended audiences.
FDA will use these methods to test and refine its ideas and to help
develop messages and other communications, but will generally conduct
further research before making important decisions such as adopting new
policies and allocating or redirecting significant resources to support
these policies.
FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and any other
Centers or Offices will use this mechanism to test messages about
regulated drug products on a variety of subjects related to consumer,
patient, or health care professional perceptions and about use of drug
products and related materials, including but not limited to, direct-
to-consumer prescription drug promotion, physician labeling of
prescription drugs, Medication Guides, over-the-counter drug labeling,
emerging risk communications, patient labeling, online sale of medical
products, and consumer and professional education.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual
Number of respondents frequency per Total annual Hours per Total hours
response responses response
----------------------------------------------------------------------------------------------------------------
19,822.......................................... 1 19,822 0.24 4,757
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Annually, FDA projects about 45 communication studies using the
variety of test methods listed previously in this document. FDA is
requesting this burden so as not to restrict the Agency's ability to
gather information on public sentiment for its proposals in its
regulatory and communications programs.
Dated: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2663 Filed 2-7-11; 8:45 am]
BILLING CODE 4160-01-P
