Agency Information Collection Activities: Proposed Collection: Public Comment Request, 73200-73201 [2013-29038]
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Federal Register / Vol. 78, No. 234 / Thursday, December 5, 2013 / Notices
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single copies of the draft guidance to the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, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. 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access to the draft guidance document.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draft guidance to https://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 (HFD–600), Food and Drug
Administration,7519 Standish Pl.,
Rockville, MD 20855,240–276–9326.
SUPPLEMENTARY INFORMATION:
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/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that
guidance, FDA adopted this process as
a means to develop and disseminate
product-specific BE recommendations
and 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
paliperidone palmitate extended-release
injectable suspension.
New drug application 022264 for
INVEGA SUSTENNA (paliperidone
palmitate) extended-release injectable
suspension was initially approved by
FDA in July 2009. In August 2011, FDA
issued a draft guidance for industry on
BE recommendations for generic
paliperidone palmitate (Draft BE
Recommendations for Paliperidone
Palmitate). FDA is now issuing a revised
version of the Draft BE
Recommendations for Paliperidone
Palmitate Extended-Release Injectable
Suspension (Revised Draft BE
Recommendations).
In May 2013, Janssen Research &
Development, LLC, submitted a citizen
petition requesting that FDA require
that any ANDA referencing INVEGA
SUSTENNA (paliperidone palmitate)
extended-release injectable suspension
meet certain conditions, including
conditions related to demonstrating BE
(Docket No. FDA–2013–P–0608). FDA is
reviewing the issues raised in the
petition. FDA will consider any
comments on the Revised Draft BE
Recommendations in responding to the
citizen petition.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on the design of BE studies to support
ANDAs for paliperidone palmitate
extended-release injectable suspension.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
I. Background
In the Federal Register of June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369 (Formerly
Docket No. 2007D–0168)]
Draft Guidance for Industry on
Bioequivalence Recommendations for
Paliperidone Palmitate ExtendedRelease Injectable Suspension;
Availability
AGENCY:
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 ‘‘Bioequivalence
Recommendations for Paliperidone
Palmitate.’’ The guidance provides
specific recommendations on the design
of bioequivalence (BE) studies to
support abbreviated new drug
applications (ANDAs) for paliperidone
palmitate extended-release injectable
suspension.
SUMMARY:
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 February 3,
2014.
DATES:
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ADDRESSES:
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Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–29080 Filed 12–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
SUMMARY:
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Federal Register / Vol. 78, No. 234 / Thursday, December 5, 2013 / Notices
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Rural Health Network Development
Planning Performance Improvement
and Measurement System Database
OMB No. 0915–xxxx—[NEW]
Abstract: The purpose of the Rural
Health Network Development Planning
(Network Planning) program, authorized
by Section 330A(f) of the Public Health
Service Act, 42 U.S.C. 254c(f), as
amended by section 201, Public Law
107–251 of the Health Care Safety Net
Amendments of 2002, is to assist in the
development of an integrated healthcare
network, if the network participants do
not have a history of collaborative
efforts.
The Network Planning program helps
to promote the planning and
development of healthcare networks in
order to: (i) Achieve efficiencies; (ii)
expand access to, coordinate, and
improve the quality of essential health
care services; and (iii) strengthen the
rural health care system as a whole.
This program brings together key parts
of a rural health care delivery system,
particularly those entities that may not
have collaborated in the past under a
formal relationship, to work together to
establish and improve local capacity
and coordination of care. This grant
program supports one year of planning
with the primary goal of helping
networks create a foundation for their
infrastructure and focusing member
efforts to address important regional or
local community health needs.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data to the program and to
enable HRSA to provide aggregate
program data. These measures cover the
principal topic areas of interest to the
Office of Rural Health Policy, including
(a) network infrastructure; (b) network
collaboration; (c) sustainability; and (d)
network assessment. Several measures
will be used for this program.
Likely Respondents: The respondents
would be Network Planning grant
recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Performance Improvement and Measurement System
(PIMS) Database ..............................................................
21
1
21
1
21
Total ..............................................................................
21
1
21
1
21
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Dated: November 22, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–29038 Filed 12–4–13; 8:45 am]
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BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a conference call of the
Interagency Autism Coordinating
Committee (IACC).
The IACC Full Committee will have a
conference call meeting on Friday,
December 13, 2013. The committee will
discuss and finalize the 2013 IACC
Strategic Plan Update. The conference
call will be publicly accessible in listenonly mode.
Name of Committee: Interagency Autism
Coordinating Committee (IACC).
Type of meeting: Open—Conference Call.
Date: December 13, 2013.
Time: 12:00 p.m. to 1:30 p.m. *Eastern
Time*—Approximate end time.
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Agenda: To discuss and finalize the 2013
IACC Strategic Plan Update.
Written Public Comments: Due by 5:00
p.m. ET on Tuesday, December 10, 2013.
Place: Conference call only; No in-person
meeting.
Conference Call: Dial: 888–390–8568,
Access code: 8162989.
Cost: The conference call is free.
Contact Person: Ms. Lina Perez, Office of
Autism Research Coordination, National
Institute of Mental Health, NIH, 6001
Executive Boulevard, NSC, Room 6182A,
Rockville, MD 20852, Phone: (301) 443–6040,
Email: IACCPublicInquiries@mail.nih.gov.
Please Note:
The meeting will be open to the public
through a conference call phone number.
Members of the public who participate using
the conference call phone number will be
able to listen to the meeting but will not be
heard. If you experience any technical
problems with the conference call, please
send an email to helpdeskiacc@gmail.com or
by phone at 415–652–8023.
Written Public Comments:
Written public comments may be
submitted to: Office of Autism Research
Coordination, National Institute of Mental
Health, NIH, 6001 Executive Boulevard, NSC,
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]]>Agencies
[Federal Register Volume 78, Number 234 (Thursday, December 5, 2013)]
[Notices]
[Pages 73200-73201]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-29038]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects (Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995), the Health Resources and Services
Administration (HRSA) announces plans to submit an Information
Collection Request (ICR), described below, to the Office of Management
and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks
comments from the public regarding the burden estimate, below, or any
other aspect of the ICR.
DATES: Comments on this Information Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance Officer, Room 10-29, Parklawn
Building, 5600 Fishers Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of
[[Page 73201]]
the data collection plans and draft instruments, email
paperwork@hrsa.gov or call the HRSA Information Collection Clearance
Officer at (301) 443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Rural Health Network Development
Planning Performance Improvement and Measurement System Database
OMB No. 0915-xxxx--[NEW]
Abstract: The purpose of the Rural Health Network Development
Planning (Network Planning) program, authorized by Section 330A(f) of
the Public Health Service Act, 42 U.S.C. 254c(f), as amended by section
201, Public Law 107-251 of the Health Care Safety Net Amendments of
2002, is to assist in the development of an integrated healthcare
network, if the network participants do not have a history of
collaborative efforts.
The Network Planning program helps to promote the planning and
development of healthcare networks in order to: (i) Achieve
efficiencies; (ii) expand access to, coordinate, and improve the
quality of essential health care services; and (iii) strengthen the
rural health care system as a whole. This program brings together key
parts of a rural health care delivery system, particularly those
entities that may not have collaborated in the past under a formal
relationship, to work together to establish and improve local capacity
and coordination of care. This grant program supports one year of
planning with the primary goal of helping networks create a foundation
for their infrastructure and focusing member efforts to address
important regional or local community health needs.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data to the program and to
enable HRSA to provide aggregate program data. These measures cover the
principal topic areas of interest to the Office of Rural Health Policy,
including (a) network infrastructure; (b) network collaboration; (c)
sustainability; and (d) network assessment. Several measures will be
used for this program.
Likely Respondents: The respondents would be Network Planning grant
recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this Information Collection Request are summarized in the table below.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Performance Improvement and 21 1 21 1 21
Measurement System (PIMS)
Database.......................
-------------------------------------------------------------------------------
Total....................... 21 1 21 1 21
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: November 22, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-29038 Filed 12-4-13; 8:45 am]
BILLING CODE 4165-15-P
