Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration (All FDA-Regulated Products), 9222-9223 [2014-03351]
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
The guidance documents explain
what information firms should submit
to us in order to be considered for
inclusion on the lists and what criteria
we intend to use to determine eligibility
for placement on the lists. The guidance
documents also explain how we intend
to update the list and how we intend to
communicate any new information to
the government that requested the list.
Finally, the guidance documents note
that the information is provided
voluntarily by firms with the
understanding that it will be posted on
our Web site and communicated to, and
possibly further disseminated by, the
government that requested the list; thus,
we consider the information on the lists
to be information that is not protected
from disclosure under 5 U.S.C.
552(b)(4).
Application for inclusion on each list
is voluntary. In the guidance
documents, we recommend that U.S.
firms that want to be placed on either
list send the following information to
us: Name and address of the firm and
the manufacturing plant; name,
telephone number, and email address (if
available) of the contact person; a list of
products presently shipped and
expected to be shipped in the next 3
years; identities of agencies that inspect
the plant and the date of last inspection;
plant number and copy of last
inspection notice; and, if other than an
FDA inspection, copy of last inspection
report. We request that this information
be updated every 2 years.
We use the information submitted by
firms to determine their eligibility for
placement on the list, which is
published on our Web site. The purpose
of the list is to help the governments of
Chile and China in their determination
of which U.S. milk product
manufacturers are eligible to export to
their respective countries.
Description of Respondents:
Respondents to this information
collection include U.S. food product
manufacturers/processors subject to our
jurisdiction that wish to export products
requested by foreign governments to be
included in this list process.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
New written requests to be placed on the list .....................
Biennial updates ..................................................................
Occasional updates .............................................................
125
125
50
1
1
1
125
125
50
1.5
1.0
0.5
188
125
25
Total ..............................................................................
........................
........................
........................
........................
338
tkelley on DSK3SPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimate of the number of firms
that will submit new written requests to
be placed on the list, biennial updates,
and occasional updates is based on the
FDA’s experience maintaining the list
over the past 8 years. The estimate of
the number of hours that it will take a
firm to gather the information needed to
be placed on the list or update its
information is based on FDA’s
experience with firms submitting
similar requests. FDA believes that the
information to be submitted will be
readily available to the firms.
Based on submissions received for the
Chile list over the past 3 years and the
China list over the past 3 months, we
estimate that, annually, an average of
100 new firms will submit written
requests to be placed on the China list
and 25 new firms will seek to be placed
on the Chile list, reported as 125 total
respondents on line 1 of table 1. We
estimate that a firm will require 1.5
hours to read the guidance, to gather the
information needed, and to prepare a
communication to FDA that contains
the information and requests that the
firm be placed on the list, for a total of
187.5 burden hours, rounded to 188, as
reported on line 1 of table 1. Under the
guidance, every 2 years each firm on the
list must provide updated information
in order to remain on the list.
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There are approximately 250 firms on
the 2 lists combined. We estimate that,
each year, approximately half of the
firms on the list, 125 firms, will
resubmit the information to remain on
the list. We estimate that a firm already
on the list will require 1 hour to
biennially update and resubmit the
information to us, including time
reviewing the information and
corresponding with us, for a total of 125
hours. In addition, we expect that, each
year, approximately 50 firms will need
to submit an occasional update and each
firm will require 0.5 hours to prepare a
communication to us reporting the
change, for a total of 125 hours.
Dated: February 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03389 Filed 2–14–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0444]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All FDA-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:
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Federal Register / Vol. 79, No. 32 / Tuesday, February 18, 2014 / Notices
Submit either electronic or
written comments on the collection of
information by April 21, 2014.
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: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@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
DATES:
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 FDARegulated Products)—(OMB Control
Number 0910–0497)—Extension
FDA conducts focus group interviews
on a variety of topics involving FDA-
9223
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 in-depth
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:
Activity
Number of
respondents
Annual
frequency
per response
Total annual
responses
Hours per
response
Total hours
Focus Group Interviews .......................................................
1440
1
1440
1.75
2520
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03351 Filed 2–14–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0764]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Animal Feed Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Animal Feed Regulatory Program
Standards’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
SUMMARY:
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FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
December 6, 2013; the Agency
submitted a proposed collection of
information entitled ‘‘Animal Feed
Regulatory Program Standards’’ to OMB
for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0760. The
approval expires on January 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9222-9223]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03351]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0444]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Focus Groups as Used by the Food and Drug
Administration (All FDA-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.
[[Page 9223]]
DATES: Submit either electronic or written comments on the collection
of information by April 21, 2014.
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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, PRAStaff@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 in-depth 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:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual
Activity Number of frequency per Total annual Hours per Total hours
respondents response responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus Group Interviews............................................. 1440 1 1440 1.75 2520
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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: February 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03351 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-01-P
