Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration Regulated Products), 74061-74062 [2010-30037]
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Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30038 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0594]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
focus groups as used by FDA to gauge
public opinion on all FDA-regulated
products.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by January 31, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
DATES:
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail:
Jonnalynn.capezzuto@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,
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
74061
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.
Focus Groups as Used by the Food and
Drug Administration (All FDARegulated Products)—(OMB Control
Number 0910–0497)—Extension
FDA conducts focus group interviews
on a variety of topics involving FDAregulated products, including drugs,
biologics, devices, food, tobacco, and
veterinary medicine.
Focus groups provide an important
role in gathering information because
they allow for a more indepth
understanding of consumers’ attitudes,
beliefs, motivations, and feelings than
do quantitative studies. Focus groups
serve the narrowly defined need for
direct and informal opinion on a
specific topic and as a qualitative
research tool have three major purposes:
• To obtain consumer information
that is useful for developing variables
and measures for quantitative studies,
• To better understand consumers’
attitudes and emotions in response to
topics and concepts, and
• To further explore findings
obtained from quantitative studies.
FDA will use focus group findings to
test and refine their ideas 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 estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
Number of
respondents
Annual
frequency per
response
Total annual
responses
Hours per
response
Total hours
Focus Group Interviews .......................................................
1,440
1
1,440
1.75
2,520
jdjones on DSK8KYBLC1PROD with NOTICES
1 There
are no capital or operating and maintenance costs associated with this collection of information.
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15:13 Nov 29, 2010
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74062
Federal Register / Vol. 75, No. 229 / Tuesday, November 30, 2010 / Notices
Annually, FDA projects about 20
focus group studies using 160 focus
groups with an average of 9 persons per
group, and lasting an average of 1.75
hours each. FDA is requesting this
burden for unplanned focus groups so
as not to restrict the Agency’s ability to
gather information on public sentiment
of its proposals in its regulatory and
communications programs.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–30037 Filed 11–29–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0588]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exceptions or
Alternatives to Labeling Requirements
for Products Held by the Strategic
National Stockpile
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
for FDA regulations related to the
exceptions or alternatives to labeling
requirements for products held by the
Strategic National Stockpile (SNS).
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 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.
jdjones on DSK8KYBLC1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:13 Nov 29, 2010
Jkt 223001
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
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.
SUPPLEMENTARY INFORMATION:
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile—(OMB
Control Number 0910–0614)—Extension
Under the Public Health Service Act
(the PHS Act), the Department of Health
and Human Services stockpiles medical
products that are essential to the health
security of the Nation (see section 319F–
2 of the PHS Act (42 U.S.C. 247d-6b)).
This collection of medical products for
use during national health emergencies,
known as the SNS, is to ‘‘provide for the
emergency health security of the United
States, including the emergency health
security of children and other
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
vulnerable populations, in the event of
a bioterrorist attack or other public
health emergency.’’
It may be appropriate for certain
medical products that are or will be
held in the SNS to be labeled in a
manner that would not comply with
certain FDA labeling regulations given
their anticipated circumstances of use in
an emergency. However, noncompliance
with these labeling requirements could
render such products misbranded under
section 502 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352).
In the Federal Register of December
28, 2007 (72 FR 73589), FDA published
an interim final rule entitled
‘‘Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile.’’ In the
interim final rule, FDA issued
regulations under §§ 201.26, 610.68,
801.128, and 809.11 (21 CFR 201.26,
610.68, 801.128, and 809.11), which
allow the appropriate FDA Center
Director to grant a request for an
exception or alternative to certain
regulatory provisions pertaining to the
labeling of human drugs, biological
products, medical devices, and in vitro
diagnostics that currently are or will be
included in the SNS if certain criteria
are met. The appropriate FDA Center
Director may grant an exception or
alternative to certain FDA labeling
requirements if compliance with these
labeling requirements could adversely
affect the safety, effectiveness, or
availability of products that are or will
be included in the SNS. An exception
or alternative granted under the
regulations may include conditions or
safeguards so that the labeling for such
products includes appropriate
information necessary for the safe and
effective use of the product given the
product’s anticipated circumstances of
use. Any grant of an exception or
alternative will only apply to the
specified lots, batches, or other units of
medical products in the request. The
appropriate FDA Center Director may
also grant an exception or alternative to
the labeling provisions specified in the
regulations on his or her own initiative.
Under § 201.26(b)(1)(i) (human drug
products), § 610.68(b)(1)(i) (biological
products), § 801.128(b)(1)(i) (medical
devices), and § 809.11(b)(1)(i) (in vitro
diagnostic products for human use) an
SNS official or any entity that
manufactures (including labeling,
packing, relabeling, or repackaging),
distributes, or stores such products that
are or will be included in the SNS may
submit, with written concurrence from
a SNS official, a written request for an
exception or alternative to certain
labeling requirements to the appropriate
E:\FR\FM\30NON1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 229 (Tuesday, November 30, 2010)]
[Notices]
[Pages 74061-74062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30037]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0594]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration (All Food and Drug Administration Regulated Products)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on focus groups as used by FDA to
gauge public opinion on all FDA-regulated products.
DATES: Submit either electronic or written comments on the collection
of information by January 31, 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: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-3794, e-mail:
Jonnalynn.capezzuto@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, 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.
Focus Groups as Used by the Food and Drug Administration (All FDA-
Regulated Products)--(OMB Control Number 0910-0497)--Extension
FDA conducts focus group interviews on a variety of topics
involving FDA-regulated products, including drugs, biologics, devices,
food, tobacco, and veterinary medicine.
Focus groups provide an important role in gathering information
because they allow for a more indepth understanding of consumers'
attitudes, beliefs, motivations, and feelings than do quantitative
studies. Focus groups serve the narrowly defined need for direct and
informal opinion on a specific topic and as a qualitative research tool
have three major purposes:
To obtain consumer information that is useful for
developing variables and measures for quantitative studies,
To better understand consumers' attitudes and emotions in
response to topics and concepts, and
To further explore findings obtained from quantitative
studies.
FDA will use focus group findings to test and refine their ideas
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 estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews............................................. 1,440 1 1,440 1.75 2,520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital or operating and maintenance costs associated with this collection of information.
[[Page 74062]]
Annually, FDA projects about 20 focus group studies using 160 focus
groups with an average of 9 persons per group, and lasting an average
of 1.75 hours each. FDA is requesting this burden for unplanned focus
groups so as not to restrict the Agency's ability to gather information
on public sentiment of its proposals in its regulatory and
communications programs.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30037 Filed 11-29-10; 8:45 am]
BILLING CODE 4160-01-P
