Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 49841-49842 [2017-23443]
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Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
withdraws or suspends approval of the
drug’s NDA or ANDA for reasons of
safety or effectiveness or if FDA
determines that the listed drug was
withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, and 60 mg, are the subject of NDA
020005, initially approved on February
21, 1992. CARDENE SR is indicated for
the treatment of hypertension.
In a letter dated September 15, 2014,
EKR Therapeutics, Inc., requested
withdrawal of NDA 020005 for
CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, and 60 mg. In the Federal Register
of October 4, 2016 (81 FR 68427), FDA
announced that it was withdrawing
approval of NDA 020005, effective
November 3, 2016.
Jubilant Generics submitted a citizen
petition dated April 27, 2017 (Docket
No. FDA–2017–P–2660), under 21 CFR
10.30, requesting that the Agency
determine whether CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were not withdrawn for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that CARDENE
SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg,
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of CARDENE
SR (nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg from
sale. We have also independently
evaluated relevant literature and data
for possible postmarketing adverse
events. We have found no information
that would indicate that this drug
product was withdrawn from sale for
reasons of safety or effectiveness.
VerDate Sep<11>2014
17:54 Oct 26, 2017
Jkt 244001
Accordingly, the Agency will
continue to list CARDENE SR
(nicardipine HCl) extended-release
capsules, 30 mg, 45 mg, and 60 mg, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to CARDENE SR (nicardipine HCl)
extended-release capsules, 30 mg, 45
mg, or 60 mg, may be approved by the
Agency as long as they meet all other
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23438 Filed 10–26–17; 8:45 am]
BILLING CODE 4164–01–P
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 Agency 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.
DATES: Fax written comments on the
collection of information by November
27, 2017.
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
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
49841
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Generic Clearance for the Collection of
Qualitative Feedback on Agency
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 we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This voluntary feedback will provide
insights 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. These collections will allow
for ongoing, collaborative, and
actionable communications between the
Agency 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 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,
E:\FR\FM\27OCN1.SGM
27OCN1
49842
Federal Register / Vol. 82, No. 207 / Friday, October 27, 2017 / Notices
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 June 15,
2017 (82 FR 27508), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Focus groups ...........................................................
Customer comment cards/forms .............................
Small discussion groups ..........................................
Customer satisfaction surveys ................................
Usability studies .......................................................
800
1,325
800
12,000
800
1
1
1
1
1
800
1,325
800
12,000
800
Total ..................................................................
........................
........................
........................
1 There
1.75
0.25
1.75
0.33
1.75
Total hours
............................
(15 minutes) .......
............................
(20 minutes) .......
............................
1,400
331.25
1,400
3,960
1,400
....................................
8,491.25
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–23443 Filed 10–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Teleconference
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Average
burden per
response
Total annual
responses
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following Subcommittee
meetings of the National Committee on
Vital and Health Statistics to be held
virtually.
Name: National Committee on Vital
and Health Statistics (NCVHS), Virtual
Meetings of the Subcommittee.
Dates and Times:
NCVHS Population Health
Subcommittee; Tuesday, November
28, 2017: 9:00 a.m.—1:00 p.m. ET
NCVHS Privacy, Confidentiality, and
Security Subcommittee; Tuesday,
November 28, 2017: 1:30 p.m.—5:30
p.m. ET
NCVHS Standards Subcommittee;
Wednesday, November 29, 2017: 1:00
p.m.—5:00 p.m. ET
Place: WebEx/teleconference—To
participate in the virtual meeting, please
use the following URL https://
www.ncvhs.hhs.gov/ that points to the
NCVHS homepage. Further information
and meeting agendas will be available
on the NCVHS Web site including
instructions for accessing the live
meeting broadcast.
Status: Open by WebEx/
teleconference. There will be an open
comment period during the final 10
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17:54 Oct 26, 2017
Jkt 244001
minutes of each of the three virtual
meetings where the public can provide
comments via the WebEx on-line
meeting interface. Written comments
may also be provided to the Executive
Secretary at the contact information
provided below.
Purpose: The NCVHS virtual meeting
of the Population Health Subcommittee
will convene to discuss: (1) Follow up
work on the NCVHS September 11–12,
2017 Next Generation Vital Statistics
Hearing, including the draft hearing
report and follow up analyses being
conducted on the Committee’s behalf,
and; (2) topics and projects to be
considered for the 2018 workplan.
The NCVHS virtual meeting of the
Privacy, Confidentiality and Security
Subcommittee will convene to discuss a
draft environmental scan report of the
health information privacy and security
landscape in the U.S. that extends
beyond HIPAA. This will include
formal presentations from invited
experts to further inform the draft
environmental scan research being
conducted on the Committee’s behalf.
The agenda also will include discussion
of privacy-related topics under
consideration for the 2018 workplan.
The NCVHS virtual meeting of the
Standards Subcommittee will convene
to consider the Subcommittee’s
workplan and high level milestones for
three possible projects in 2018: (1) A
Chief Information Officer (CIO) Forum;
(2) the challenge of patient
identification and matching for
healthcare providers and patients; and
(3) potential guidance pertaining to the
prior authorization transaction. In
addition, CMS will provide a briefing to
the Subcommittee on the New Medicare
Card Project.
For more Information Contact:
Substantive program information may
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Sfmt 4703
be obtained from Rebecca Hines, MHS,
Executive Secretary, NCVHS, National
Center for Health Statistics, Centers for
Disease Control and Prevention, 3311
Toledo Road, Hyattsville, Maryland
20782, telephone (301) 458–4715.
Summaries of meetings and a roster of
Committee members are available on the
NCVHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda and
instructions to access the broadcast of
the meeting will be posted.
Dated: October 23, 2017.
Laina Bush,
Deputy Assistant Secretary for Planning and
Evaluation, Office of the Assistant Secretary
for Planning and Evaluation.
[FR Doc. 2017–23358 Filed 10–26–17; 8:45 am]
BILLING CODE 4151–05–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2016–1059]
Towing Safety Advisory Committee;
December 2017 Meeting
U.S. Coast Guard, Department
of Homeland Security.
ACTION: Notice of Federal Advisory
Committee meeting.
AGENCY:
The Towing Safety Advisory
Committee and its Subcommittees will
meet in New Orleans, Louisiana to
review and discuss recommendations
from its Subcommittees and to receive
briefs on items listed in the agenda
under SUPPLEMENTARY INFORMATION. All
meetings will be open to the public.
DATES:
Meetings. The Subcommittees of the
Towing Safety Advisory Committee will
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 82, Number 207 (Friday, October 27, 2017)]
[Notices]
[Pages 49841-49842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23443]
-----------------------------------------------------------------------
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 Agency 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.
DATES: Fax written comments on the collection of information by
November 27, 2017.
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 [email protected]. 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
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 Agency
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 we mean information that provides
useful insights on perceptions and opinions, but are not statistical
surveys that yield quantitative results that can be generalized to the
population of study. This voluntary feedback will provide insights 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. These collections will allow
for ongoing, collaborative, and actionable communications between the
Agency 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 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,
[[Page 49842]]
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 June 15, 2017 (82 FR 27508), 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:
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................................ 800 1 800 1.75...................................... 1,400
Customer comment cards/forms................ 1,325 1 1,325 0.25 (15 minutes)......................... 331.25
Small discussion groups..................... 800 1 800 1.75...................................... 1,400
Customer satisfaction surveys............... 12,000 1 12,000 0.33 (20 minutes)......................... 3,960
Usability studies........................... 800 1 800 1.75...................................... 1,400
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 8,491.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23443 Filed 10-26-17; 8:45 am]
BILLING CODE 4164-01-P
