Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request, 24755-24756 [2013-09946]
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Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
polymorphs, which generally speaking
contain only the API within the crystal
lattice, co-crystals are composed of an
API with a neutral guest compound in
the crystal lattice. Similarly, unlike
salts, where the components in the
crystal lattice are in an ionized state, a
co-crystal’s components are in a neutral
state and interact via nonionic
interactions.
At present, no formal regulatory
policy exists governing the classification
of pharmaceutical co-crystals. In
response to this need for regulatory
guidance, the guidance provides the
Agency’s current thinking on the
appropriate classification of co-crystal
solid-state forms.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on regulatory
classification of pharmaceutical cocrystals. 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.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
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.
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III. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information
found in FDA regulations. This
guidance refers to information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 314.50(d)(1) and 314.94(a)(5)
and 314.94(a)(9) have been approved
under OMB control number 0910–0001.
The collections of information in the
current good manufacturing practice
(CGMP) regulations (21 CFR part 211)
have been approved under OMB control
number 0910–0139.
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IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–09872 Filed 4–25–13; 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
ACTION:
Notice.
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
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.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
SUMMARY:
Information Collection Request Title:
Medicare Rural Hospital Flexibility
Grant Program Performance Measure
Determination (OMB No. 0915–xxxx)—
New
Abstract: The purpose of the Medicare
Rural Hospital Flexibility Program
(Flex), authorized by Section 4201 of the
Balanced Budget Act of 1997 (BBA),
Public Law 105–33 and reauthorized by
Section 121 of the Medicare
Improvements for Patients and
Providers Act of 2008, Public Law 110–
275, is to support improvements in the
quality of health care provided in
communities served by Critical Access
Hospitals (CAHs); to support efforts to
improve the financial and operational
performance of the CAHs; and to
support communities in developing
collaborative regional and local delivery
systems. Additionally, the Flex program
assists in the conversion of qualified
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24755
small rural hospitals to CAH status. The
provision and delivery of quality health
care to rural America is a priority of the
Department of Health and Human
Services (HHS). The Flex program
provides funding for states to support
technical assistance activities in
hospitals related to: improving health
care quality, patient safety, hospital
financial and operational efficiency, and
care coordination; and ensuring
adequate training and support within
rural Emergency Medical Services
systems. Measures and goals identified
in the Flex program take into
consideration existing measures and
priorities HHS has set for hospitals, to
avoid both conflict and duplication of
efforts.
For this program, performance
measures were drafted to provide data
useful to the Flex program and to enable
HRSA to provide aggregate program data
required by Congress under the
Government Performance and Results
Act (GPRA) of 1993 (Pub. L. 103–62).
These measures cover principal topic
areas of interest to the Office of Rural
Health Policy, including: (a) Quality
reporting; (b) quality improvement
interventions; (c) financial and
operational improvement initiatives;
and (d) multi-hospital patient safety
initiatives. Several measures will be
used for this program and will inform
the Office’s progress toward meeting the
goals set in GPRA.
This notice is the second of two
Federal Register Notices issued
regarding the intent to collect program
performance measures, and the Office of
Rural Health Policy received one set of
comments for the original 60-day notice
published on December 31, 2012 (Vol.
77, No. 250, pp. 77079–77080). The
Office of Rural Policy responded to the
comments and adjusted the burden
estimate based on new calculations.
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.
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24756
Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Notices
The annual estimate of burden is as
follows:
Number of
respondents
Form name
Responses
per
respondent
Total
responses
Hours per
response
Total
burden
hours
Medicare Rural Hospital Flexibility Grant Program .............
45
1
45
216
9,720
Total ..............................................................................
45
1
45
216
9,720
Submit your comments to
the desk officer for HRSA, either by
email to OIRA_submission@
omb.eop.gov or by fax to 202–395–5806.
Please direct all correspondence to the
‘‘attention of the desk officer for HRSA.’’
Deadline: Comments on this ICR
should be received within 30 days of
this notice.
ADDRESSES:
Dated: April 22, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–09946 Filed 4–25–13; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Center Program
Health Resources and Services
Administration, HHS.
ACTION: Notice of Noncompetitive
Replacement Award to Genesee Health
System.
AGENCY:
The Health Resources and
Services Administration (HRSA) will be
transferring Health Center Program
(section 330 of the Public Health Service
Act) funds originally awarded to the
County of Genesee to ensure the
provision of critical primary health care
services to underserved populations in
Genesee County, Michigan.
SUPPLEMENTARY INFORMATION:
Former Grantee of Record: County of
Genesee.
Original Period of Grant Support:
June 1, 2012, to April 30, 2014.
Replacement Awardee: Genesee
Health System.
Amount of Replacement Award: The
original award to the County of Genesee
was issued as a result of a New Access
Point application. The County of
Genesee and Genesee Health System
have agreed that the funds to be
transferred will be the remaining
amount in the account as of the date of
this transfer.
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SUMMARY:
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14:46 Apr 25, 2013
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Period of Replacement Award: The
period of support for the replacement
award is May 1, 2013, to April 30, 2014.
Dated: April 19, 2013.
Mary K. Wakefield,
Administrator.
Authority: Sections 330 of the Public
Health Service Act, 42 U.S.C. 245b.
CFDA Number: 93.224.
[FR Doc. 2013–09942 Filed 4–25–13; 8:45 am]
Justification for the Exception to
Competition: The former grantee, the
County of Genesee, has requested that
HRSA transfer a Health Center Program
section 330 grant to Genesee Health
System to implement and carry out
grant activities originally proposed
under the County of Genesee’s funded
section 330 grant application. Genesee
County Community Mental Health
(GCCMH)—now Genesee Health
System—was formerly a department of
the County of Genesee and has
continued to carry out the operations of
the grant program since its award in
June 2012. On January 1, 2013, the State
of Michigan approved GCCMH’s
independence as a separate public
governmental entity, and GCCMH was
legally renamed the Genesee Health
System. The Genesee Health System is
directly engaged in the delivery of
primary health care services on the
County of Genesee’s behalf and has
indicated an ability to continue
operations without a disruption of
services.
Genesee Health System is currently
providing primary health care services
on behalf of the County of Genesee to
the original target population and is
located in the same geographical area.
This underserved target population has
an immediate need for vital primary
health care services and would be
negatively impacted by any delay or
disruption of services caused by a
competition. As a result, in order to
ensure that critical primary health care
services remain available to the original
target population without disruption,
this replacement award will not be
competed.
FOR FURTHER INFORMATION CONTACT:
Kirsten Argueta, Senior Advisor, North
Central Division, Bureau of Primary
Health Care, Health Resources and
Services Administration, 5600 Fishers
Lane, Rockville, MD 20857, via email at
KArgueta@hrsa.gov or (301) 594–1055.
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BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
SUMMARY:
Zirconium-89 PET Imaging Agent for
Cancer
Description of Technology: This
technology is a new generation of
rationally designed chelating agents
which improve the complexation of
Zirconium-89 for PET imaging of
cancers. The technology uses cyclic or
acyclic chelators made of 4
hydroxamate donors groups for
improved stability compared to the
currently used natural product
siderophore desferrioxamine B (DFB), a
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]]>Agencies
[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Notices]
[Pages 24755-24756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09946]
-----------------------------------------------------------------------
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
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and
Services Administration (HRSA) will submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). 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. To request a copy of the clearance requests
submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA
Reports Clearance Office at (301) 443-1984.
Information Collection Request Title: Medicare Rural Hospital
Flexibility Grant Program Performance Measure Determination (OMB No.
0915-xxxx)--New
Abstract: The purpose of the Medicare Rural Hospital Flexibility
Program (Flex), authorized by Section 4201 of the Balanced Budget Act
of 1997 (BBA), Public Law 105-33 and reauthorized by Section 121 of the
Medicare Improvements for Patients and Providers Act of 2008, Public
Law 110-275, is to support improvements in the quality of health care
provided in communities served by Critical Access Hospitals (CAHs); to
support efforts to improve the financial and operational performance of
the CAHs; and to support communities in developing collaborative
regional and local delivery systems. Additionally, the Flex program
assists in the conversion of qualified small rural hospitals to CAH
status. The provision and delivery of quality health care to rural
America is a priority of the Department of Health and Human Services
(HHS). The Flex program provides funding for states to support
technical assistance activities in hospitals related to: improving
health care quality, patient safety, hospital financial and operational
efficiency, and care coordination; and ensuring adequate training and
support within rural Emergency Medical Services systems. Measures and
goals identified in the Flex program take into consideration existing
measures and priorities HHS has set for hospitals, to avoid both
conflict and duplication of efforts.
For this program, performance measures were drafted to provide data
useful to the Flex program and to enable HRSA to provide aggregate
program data required by Congress under the Government Performance and
Results Act (GPRA) of 1993 (Pub. L. 103-62). These measures cover
principal topic areas of interest to the Office of Rural Health Policy,
including: (a) Quality reporting; (b) quality improvement
interventions; (c) financial and operational improvement initiatives;
and (d) multi-hospital patient safety initiatives. Several measures
will be used for this program and will inform the Office's progress
toward meeting the goals set in GPRA.
This notice is the second of two Federal Register Notices issued
regarding the intent to collect program performance measures, and the
Office of Rural Health Policy received one set of comments for the
original 60-day notice published on December 31, 2012 (Vol. 77, No.
250, pp. 77079-77080). The Office of Rural Policy responded to the
comments and adjusted the burden estimate based on new calculations.
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.
[[Page 24756]]
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Form name respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Medicare Rural Hospital 45 1 45 216 9,720
Flexibility Grant Program......
-------------------------------------------------------------------------------
Total....................... 45 1 45 216 9,720
----------------------------------------------------------------------------------------------------------------
ADDRESSES: Submit your comments to the desk officer for HRSA, either by
email to OIRA_submission@omb.eop.gov or by fax to 202-395-5806. Please
direct all correspondence to the ``attention of the desk officer for
HRSA.''
Deadline: Comments on this ICR should be received within 30 days of
this notice.
Dated: April 22, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-09946 Filed 4-25-13; 8:45 am]
BILLING CODE 4165-15-P
