Agency Information Collection Activities: Proposed Collection: Comment Request, 48171-48172 [2011-20077]
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48171
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
proposed by FDA, and information on
reference databases; an open public
comment session; and an open
discussion on selected topics raised by
the presentations (see section III of this
document.) During the discussions, the
participants will not be asked to
develop consensus opinions but rather
to provide their individual perspectives.
Additional information, including a
meeting agenda, will be available on the
Internet, immediately after publication
of this document in the Federal
Register. The evaluation approach
proposed by FDA is expected to be
available at a later date. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at
https://www.regulations.gov. This
information will also be available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
III. Topics for Input
FDA will seek input on its proposed
performance evaluation approach,
which will include the following topics:
1. Clinical Application of Highly
Multiplexed Microbiology Devices: Their
clinical application and public health/
clinical needs; inclusion of MCMrelated pathogens that are expected to
be rarely present in the tested
specimens; the composition of clinically
relevant panels of pathogens; the
interpretation of the test results taking
into consideration the possible
detection of microorganisms that are not
clinically relevant, and what is known
and unknown about co-infections.
2. Device Evaluation: How to evaluate
the analytical and clinical performance
of highly multiplexed microbiology
devices; approaches to device validation
when positive specimens are not easily
available, which is the case for many
MCM pathogens; sufficiency, feasibility,
and practicality of the proposed FDA
evaluation approach to establish device
performance.
3. Reference Databases: Quality
criteria for establishing the accuracy of
reference databases; methods for
curating, maintaining, and updating
these databases; what is the current
practice for creating and maintaining
reference databases.
IV. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information (ELEM–1029),
Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., rm. 1050,
Rockville, MD 20857.
Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–19996 Filed 8–5–11; 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:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency; (b) the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: National Health
Service Corps Site Application (OMB
No. 0915–0230)—Revision
The National Health Service Corps
(NHSC) of the Bureau of Clinician
Recruitment and Service (BCRS), Health
Resources and Services Administration,
is committed to improving the health of
the Nation’s underserved by uniting
communities in need with caring health
professionals, and by supporting their
efforts to build better systems of care.
The NHSC Site Application, which
renames and revises the previous
Recruitment and Retention Assistance
Application, requests information on
the clinical service site, sponsoring
agency, recruitment contact, staffing
levels, service users, charges for
services, employment policies, and
fiscal management capabilities.
Assistance in completing the
application may be obtained through the
appropriate State Primary Care Offices,
State Primary Care Associations and the
NHSC. The information on the
application is used for determining the
eligibility of sites for assignment of
NHSC-obligated health professionals
and to verify the need for NHSC
clinicians. Approval as an NHSC service
site is good for 3 years; sites wishing to
remain eligible for assignment of NHSC
providers must submit a new Site
Application every 3 years.
The annual estimate of burden is as
follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
Number of
respondents
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
NHSC Site Application .........................................................
3000
1
3000
0.5
1500
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48172
Federal Register / Vol. 76, No. 152 / Monday, August 8, 2011 / Notices
E-mail comments to
paperwork@hrsa.gov or mail to the
HRSA Reports Clearance Officer, Room
10–33, Parklawn Building, 5600 Fishers
Lane, Rockville, MD 20857. Written
comments should be received within 30
days of this notice.
Dated: August 2, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–20077 Filed 8–5–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Reports Clearance Officer at (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the Agency; (b) the accuracy of the
Agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
Proposed Project: National Sample
Survey of Nurse Practitioners (OMB No.
0915–xxxx)–[NEW]
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
The number of Nurse Practitioners
(NP) in the United States has been
growing rapidly over the past decade
and continued growth is expected as the
annual number of graduates of NP
programs is at an all time high.
Furthermore, over the past 20 years,
many regulatory and financial barriers
to using NPs have been removed. The
expansion of health insurance under the
Patient Protection and Affordable Care
Act of 2010 (Pub. L. 111–148) will also
increase the demand for services. With
increasing numbers, NPs are poised to
play a critical role in the nation’s efforts
to expand access to health care services.
Despite the increasing number and
role of NPs, unfortunately, there is
currently only limited, inconsistent data
available to policy makers and the
health care community. Accordingly, it
is difficult for these leaders to quantify
Number of
respondents
Instrument
Responses
per
respondent
or fully understand the role of NPs in
the current or future health care system.
In fact, it is difficult to project with
confidence the number of NPs
practicing in the United States today.
The primary purpose of the Bureau of
Health Professions’ National Sample
Survey of Nurse Practitioners data
collection is to: (1) Improve estimates of
NPs providing services; (2) describe the
settings where NPs are working; (3)
identify the positions/roles in which
NPs are working; (4) describe the
activities and services NPs are providing
in the healthcare workforce; (5)
determine the specialties in which NPs
are working; (6) explore NPs’
satisfaction with and perception of the
extent to which they are working to
their full scope of practice; and (7)
assess variations in practice settings,
positions, and practice patterns by
demographic and educational
characteristics.
The statutory provision that
authorizes this data collection is section
761 of the Public Health Service Act,
‘‘Health Professions Workforce
Information and Analysis,’’ which is
codified at 42 U.S.C. 294n. The
information obtained from this survey
will ultimately lead to more accurate
and complete national estimates of the
current NP supply, as well as assist in
the development of more accurate
supply and demand projections for NPs.
This, in turn, is likely to influence
decisions regarding both the educational
capacity and the number of NP
programs at the national level.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
National Sample Survey of Nurse Practitioners ..................
10,000
1
10,000
.33
3,300
Total ..............................................................................
10,000
........................
10,000
........................
3,300
mstockstill on DSK4VPTVN1PROD with NOTICES
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Dated: August 2, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–20000 Filed 8–5–11; 8:45 am]
BILLING CODE 4165–15–P
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18:57 Aug 05, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Use of PKM2 Activators for
the Treatment of Cancer
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
SUMMARY:
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
contemplating the grant of an exclusive
patent license to practice the inventions
embodied in U.S. Provisional Patent
Application No. 61/104,091, entitled
‘‘Activators of Human Pyruvate Kinase,’’
filed October 9, 2008, now abandoned
[HHS Ref. No. E–326–2008/0–US–01];
PCT/US2009/60237 Application
entitled ‘‘Small Molecule Activators of
Pyruvate Kinase,’’ filed October 9, 2009,
now abandoned [HHS Ref. No. E–326–
2008/0–PCT–02]; EP Application No.
09740795.1, entitled ‘‘Small Molecule
Activators of Pyruvate Kinase,’’ filed
October 9, 2009 [HHS Ref. No. E–326–
2008/0–EP–05]; U.S. Non-Provisional
Application No. 13/123,297, entitled
E:\FR\FM\08AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Notices]
[Pages 48171-48172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20077]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Comment Request
In compliance with the requirement for opportunity for public
comment on proposed data collection projects (section 3506(c)(2)(A) of
Title 44, United States Code, as amended by the Paperwork Reduction Act
of 1995, Pub. L. 104-13), the Health Resources and Services
Administration (HRSA) publishes periodic summaries of proposed projects
being developed for submission to the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995. To request more
information on the proposed project or to obtain a copy of the data
collection plans and draft instruments, e-mail paperwork@hrsa.gov or
call the HRSA Reports Clearance Officer at (301) 443-1129.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency; (b) the accuracy of the agency's estimate of the burden of
the proposed collection of information; (c) ways to enhance the
quality, utility, and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology.
Proposed Project: National Health Service Corps Site Application (OMB
No. 0915-0230)--Revision
The National Health Service Corps (NHSC) of the Bureau of Clinician
Recruitment and Service (BCRS), Health Resources and Services
Administration, is committed to improving the health of the Nation's
underserved by uniting communities in need with caring health
professionals, and by supporting their efforts to build better systems
of care. The NHSC Site Application, which renames and revises the
previous Recruitment and Retention Assistance Application, requests
information on the clinical service site, sponsoring agency,
recruitment contact, staffing levels, service users, charges for
services, employment policies, and fiscal management capabilities.
Assistance in completing the application may be obtained through the
appropriate State Primary Care Offices, State Primary Care Associations
and the NHSC. The information on the application is used for
determining the eligibility of sites for assignment of NHSC-obligated
health professionals and to verify the need for NHSC clinicians.
Approval as an NHSC service site is good for 3 years; sites wishing to
remain eligible for assignment of NHSC providers must submit a new Site
Application every 3 years.
The annual estimate of burden is as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses per Hours per Total burden
Instrument respondents respondent Total responses response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
NHSC Site Application.............................................. 3000 1 3000 0.5 1500
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 48172]]
E-mail comments to paperwork@hrsa.gov or mail to the HRSA Reports
Clearance Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments should be received within 30 days
of this notice.
Dated: August 2, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-20077 Filed 8-5-11; 8:45 am]
BILLING CODE 4165-15-P
