Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery, 56587-56588 [2014-22461]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices
Matters to be discussed: Diabetes,
cardiovascular disease, and promoting
health equity. Topics are subject to
change.
Roybal Campus Security Guidelines:
The Edward R. Roybal Campus is the
headquarters of the U.S. Centers for
Disease Control and Prevention and is
located at 1600 Clifton Road NE.,
Atlanta, Georgia. The meeting is being
held in a Federal government building;
therefore, Federal security measures are
applicable.
All meeting attendees must RSVP by
the dates outlined under Meeting
Accessability. In planning your arrival
time, please take into account the need
to park and clear security. All visitors
must enter the Roybal Campus through
the entrance on Clifton Road. Your car
may be searched, and the guard force
will then direct visitors to the
designated parking area. Upon arrival at
the facility, visitors must present
government issued photo identification
(e.g., a valid federal identification
badge, state driver’s license, state nondriver’s identification card, or passport).
Non-United States citizens must
complete the required security
paperwork prior to the meeting date and
must present a valid passport, visa,
Permanent Resident Card, or other type
of work authorization document upon
arrival at the facility. All persons
entering the building must pass through
a metal detector. Visitors will be issued
a visitor’s ID badge at the entrance to
Building 19 and may be escorted to the
meeting room. All items brought to
HHS/CDC are subject to inspection.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0487]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Food and Drug
Administration Service Delivery
AGENCY:
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by October 22,
2014.
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 emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0697. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
[FR Doc. 2014–22502 Filed 9–19–14; 8:45 am]
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
BILLING CODE 4163–18–P
SUPPLEMENTARY INFORMATION:
Dated: September 17, 2014.
Ron A. Otten,
Acting Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Generic Clearance for the Collection of
Qualitative Feedback on FDA Service
Delivery—(OMB Control Number 0910–
0697)—Extension
The information collection activity
will garner qualitative customer and
stakeholder feedback in an efficient,
VerDate Sep<11>2014
17:07 Sep 19, 2014
Jkt 232001
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
56587
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback, FDA means
information that provides useful insight
on perceptions and opinions, not
statistical surveys that yield quantitative
results that can be generalized to the
population of study. This feedback will
provide insight into customer or
stakeholder perceptions; experiences
and expectations; provide an early
warning of issues with service; or focus
attention on areas where
communication, training, or changes in
operations might improve delivery of
products or services. This information
collection will allow for ongoing
collaborative and actionable
communications among the FDA and its
customers and stakeholders. It will also
allow feedback to contribute directly to
the improvement of program
management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address the
following: The target population to
which the generalizations will be made,
the sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
the methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
In the Federal Register of April 29,
2014 (79 FR 23980), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\22SEN1.SGM
22SEN1
56588
Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Focus groups ....................................................
Customer comment cards/forms ......................
Small discussion groups ...................................
Customer satisfaction surveys ..........................
725
1,200
725
6,450
1
1
1
1
725
1,200
725
6,450
Total ...........................................................
........................
........................
........................
1 There
approval expires on August 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.
[FR Doc. 2014–22461 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–22452 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–1164]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Exceptions or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Exceptions Or Alternatives to Labeling
Requirements for Products Held by the
Strategic National Stockpile’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
On July
22, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Exceptions Or Alternatives to
Labeling Requirements for Products
Held by the Strategic National
Stockpile’’ 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 0910–0614. The
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:07 Sep 19, 2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Estradiol Vaginal Cream; Draft
Guidance for Industry; Availability
AGENCY:
SUMMARY:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
...................................
(15 minutes) .............
...................................
(20 minutes) .............
1,269
300
1,269
2,129
...........................................
4,967
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
1.75
0.25
1.75
0.33
Total hours
Jkt 232001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry entitled ‘‘Draft Guidance on
Estradiol.’’ The guidance provides
specific recommendations on the design
of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for estradiol
vaginal cream. This draft guidance is a
revised version of a previously issued
draft guidance of the same subject.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comments on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 21,
2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kris
´
Andre, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 1615, Silver Spring,
MD 20993, 240–402–7800.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. As described in
that guidance, FDA adopted this process
as a means to develop and disseminate
product-specific BE recommendations
and to provide a meaningful
opportunity for the public to consider
and comment on those
recommendations. This notice
announces the availability of revised
draft BE recommendations for estradiol
vaginal cream.
ANDA 086069 for Estrace Cream
(estradiol vaginal cream, USP, 0.01%)
was initially approved by FDA in
January 1984. In August 2009, FDA
issued a draft guidance for industry on
BE recommendations for generic
estradiol vaginal cream. FDA is now
issuing a revised version of the draft BE
recommendations for estradiol vaginal
cream. This revised draft guidance
changes the recommendation for an in
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56587-56588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0487]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Qualitative Feedback on Food and Drug Administration
Service Delivery
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 (PRA).
DATES: Fax written comments on the collection of information by October
22, 2014.
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 emailed to oirasubmission@omb.eop.gov.
All comments should be identified with the OMB control number 0910-
0697. Also include the FDA 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, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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.
Generic Clearance for the Collection of Qualitative Feedback on FDA
Service Delivery--(OMB Control Number 0910-0697)--Extension
The information collection activity will garner qualitative
customer and stakeholder feedback in an efficient, timely manner, in
accordance with the Administration's commitment to improving service
delivery. By qualitative feedback, FDA means information that provides
useful insight on perceptions and opinions, not statistical surveys
that yield quantitative results that can be generalized to the
population of study. This feedback will provide insight into customer
or stakeholder perceptions; experiences and expectations; provide an
early warning of issues with service; or focus attention on areas where
communication, training, or changes in operations might improve
delivery of products or services. This information collection will
allow for ongoing collaborative and actionable communications among the
FDA and its customers and stakeholders. It will also allow feedback to
contribute directly to the improvement of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address the following: The
target population to which the generalizations will be made, the
sampling frame, the sample design (including stratification and
clustering), the precision requirements or power calculations that
justify the proposed sample size, the expected response rate, the
methods for assessing potential non-response bias, the protocols for
data collection, and any testing procedures that were or will be
undertaken prior to fielding the study. Depending on the degree of
influence the results are likely to have, such collections may still be
eligible for submission for other generic mechanisms that are designed
to yield quantitative results.
In the Federal Register of April 29, 2014 (79 FR 23980), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 56588]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Focus groups............................. 725 1 725 1.75......................................... 1,269
Customer comment cards/forms............. 1,200 1 1,200 0.25 (15 minutes)............................ 300
Small discussion groups.................. 725 1 725 1.75......................................... 1,269
Customer satisfaction surveys............ 6,450 1 6,450 0.33 (20 minutes)............................ 2,129
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 4,967
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22461 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P
