Agency Information Collection Activities: Submission to OMB for Review and Approval: Public Comment Request, 29784-29785 [2014-12042]
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29784
Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
3. The date the application was
approved: January 27, 2012. FDA has
verified the applicant’s claim that NDA
202324 was approved on January 27,
2012.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the U.S. Patent and
Trademark Office applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,763 days of patent
term extension.
Anyone with knowledge that any of
the dates as published are incorrect may
submit to the Division of Dockets
Management (see ADDRESSES) either
electronic or written comments and ask
for a redetermination by July 22, 2014.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
November 19, 2014. To meet its burden,
the petition must contain sufficient facts
to merit an FDA investigation. (See H.
Rept. 857, part 1, 98th Cong., 2d sess.,
pp. 41–42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written or electronic
petitions. 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. If you submit a written
petition, two copies are required. A
petition submitted electronically must
be submitted to https://
www.regulations.gov, Docket No. FDA–
2013–S–0610. Comments and petitions
that have not been made publicly
available on https://www.regulations.gov
may be viewed in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: May 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11925 Filed 5–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval: Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 23, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Delta States Rural Development
Network Grant Program Performance
Improvement Measurement System
Measures OMB No. 0915-xxxx—New
Abstract: The Delta States Rural
Development Network Grant Program
supports projects that demonstrate
evidence based and/or promising
approaches around cardiovascular
SUMMARY:
disease, diabetes, or obesity in order to
improve health status in rural
communities throughout the Delta
Region. Key features of programs are
collaboration, adoption of an evidencebased approach, demonstration of
health outcomes, program replicability,
and sustainability.
Need and Proposed Use of the
Information: For this program,
performance measures were drafted to
provide data useful to the program and
to enable HRSA to provide aggregate
program data required by Congress
under the Government Performance and
Results Act (GPRA) of 1993 (Public Law
103–62). These measures cover the
principal topic areas of interest to the
Office of Rural Health Policy, including:
(a) access to care; (b) the underinsured
and uninsured; (c) workforce
recruitment and retention; (d)
sustainability; (e) health information
technology; (f) network development;
and (g) health related clinical measures.
Several measures will be used for this
program. These measures will speak to
the Office’s progress toward meeting set
goals. Summary of Prior Comments and
Agency Response: A 60-day Federal
Register Notice was published in the
Federal Register on February 11, 2014
(79 FR 8196). There were no comments.
Likely Respondents: Delta States Rural
Development Network Grant Program
award 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 ICR are
summarized in the table below.
mstockstill on DSK4VPTVN1PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total responses
Total burden
hours
Delta States Rural Development Network Program Performance Measures ..........................................................
12
1
12
6
72
Total ..............................................................................
12
1
12
6
72
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29785
Federal Register / Vol. 79, No. 100 / Friday, May 23, 2014 / Notices
Dated: May 19, 2014.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2014–12042 Filed 5–22–14; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health
Resources and Services Administration
(HRSA) has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than June 23, 2014.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUMMARY:
When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Small Health Care Provider Quality
Improvement Program. OMB No. 0915xxxx—NEW.
Abstract: This program is authorized
by Title III, Public Health Service Act,
Section 330A(g) (42 U.S.C. 254c(g)), as
amended by Section 201, Public Law
107–251, and Section 4, Public Law
110–355. This authority directs the
Office of Rural Health Policy (ORHP) to
support grants that expand access to,
coordinate, contain the cost of, and
improve the quality of essential health
care services, including preventive and
emergency services, through the
development of health care networks in
rural and frontier areas and regions.
Across these various programs, the
authority allows HRSA to provide funds
to rural and frontier communities to
support the direct delivery of health
care and related services, to expand
existing services, or to enhance health
service delivery through education,
promotion, and prevention programs.
The purpose of the Small Health Care
Provider Quality Improvement Grant
(Rural Quality) Program is to provide
support to rural primary care providers
for implementation of quality
improvement activities. The goal of the
program is to promote the development
of an evidence-based culture and
delivery of coordinated care in the
primary care setting. Additional
objectives of the program include:
Improved health outcomes for patients;
enhanced chronic disease management;
and better engagement of patients and
their caregivers. Organizations
participating in the program are
required to utilize an evidence-based
quality improvement model, perform
tests of change focused on
SUPPLEMENTARY INFORMATION:
improvement, and use health
information technology (HIT) to collect
and report data. HIT may include an
electronic patient registry (EPR) or an
electronic health record (EHR), and is a
critical component for improving
quality and patient outcomes. With HIT
it is possible to generate timely and
meaningful data, which helps providers
track and plan care.
Need and Proposed Use of the
Information: ORHP collects this
information to quantify the impact of
grant funding on access to health care,
quality of services, and improvement of
health outcomes. ORHP uses the data
for program improvement and grantees
use the data for performance tracking
and improvement.
Summary of Prior Comments and
Agency Response: A 60-day Federal
Register Notice was published in the
Federal Register on February 11, 2014.
See, 79 FR 8201. There were no
comments.
Likely Respondents: The respondents
will be grantees of the Small Health
Care Provider Quality Improvement
Program.
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 ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondents
Average
burden per
response
(in hours)
Total responses
Total burden
hours
30
2
60
8
480
Total ..............................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Performance Improvement and Measurement System
(PIMS) Database ..............................................................
30
2
60
8
480
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]]>Agencies
[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29784-29785]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12042]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval: Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Health Resources and Services Administration
(HRSA) has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period.
DATES: Comments on this ICR should be received no later than June 23,
2014.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
Information Collection Request Title: Delta States Rural
Development Network Grant Program Performance Improvement Measurement
System Measures OMB No. 0915-xxxx--New
Abstract: The Delta States Rural Development Network Grant Program
supports projects that demonstrate evidence based and/or promising
approaches around cardiovascular disease, diabetes, or obesity in order
to improve health status in rural communities throughout the Delta
Region. Key features of programs are collaboration, adoption of an
evidence-based approach, demonstration of health outcomes, program
replicability, and sustainability.
Need and Proposed Use of the Information: For this program,
performance measures were drafted to provide data useful to the program
and to enable HRSA to provide aggregate program data required by
Congress under the Government Performance and Results Act (GPRA) of
1993 (Public Law 103-62). These measures cover the principal topic
areas of interest to the Office of Rural Health Policy, including: (a)
access to care; (b) the underinsured and uninsured; (c) workforce
recruitment and retention; (d) sustainability; (e) health information
technology; (f) network development; and (g) health related clinical
measures. Several measures will be used for this program. These
measures will speak to the Office's progress toward meeting set goals.
Summary of Prior Comments and Agency Response: A 60-day Federal
Register Notice was published in the Federal Register on February 11,
2014 (79 FR 8196). There were no comments.
Likely Respondents: Delta States Rural Development Network Grant
Program award 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 ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Delta States Rural Development 12 1 12 6 72
Network Program Performance
Measures.......................
-------------------------------------------------------------------------------
Total....................... 12 1 12 6 72
----------------------------------------------------------------------------------------------------------------
[[Page 29785]]
Dated: May 19, 2014.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2014-12042 Filed 5-22-14; 8:45 am]
BILLING CODE 4165-15-P
