Agency Information Collection Activities: Proposed Collection: Comment Request, 76473-76474 [2010-30894]
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Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices
• Comments submitted in response to
the November 2010 public hearing
notice can be found at https://
www.regulations.gov using Docket No.
FDA–2010–N–0477.
• Additional information regarding
implementation of the BPCI Act is
available at: https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/UCM215031.
IV. Notification of Intent To Participate
in Consultation Meetings
If you intend to participate in
stakeholder consultation meetings
regarding the development of
recommendations for a user fee program
for biosimilar and interchangeable
biological product applications for FYs
2013 through 2017, please provide
notification by e-mail to BiosimilarsUser
FeeProgram@fda.hhs.gov by January 10,
2011. Your e-mail should contain
complete contact information, including
name, title, affiliation, address, e-mail
address, telephone number, and notice
of any special accommodations required
because of disability. Stakeholders will
receive confirmation and additional
information about the first meeting once
FDA receives their notification.
Dated: December 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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: Data Collection Tool
for Rural Health Community-Based
Grant Programs (OMB No. 0915–
0319)—[Revision]
[FR Doc. 2010–30713 Filed 12–7–10; 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
On May 20, 2008, OMB approved the
Agency’s request for the collection of
data related to program and clinical
measures (OMB No. 0915–0319) and set
an expiration date of May 31, 2011. The
Agency is now proceeding to submit a
revised package which will include
program specific measures that are
further aligned with the agency’s
updated clinical measures. These
measures were modified based on the
feedback received from grantees and to
reflect ORHP and HRSA’s current
Number of
respondents
Instrument
Responses
per
respondent
priorities and clarify certain measures
across all 330A programs. In addition,
these revisions will enhance data
collection and analysis in an effort to
strengthen the value of the data
collection tool.
There are currently six rural health
grant programs that operate under the
authority of Section 301 of the Public
Health Service (PHS) Act. These
programs include: (1) Rural Health Care
Services Outreach Grant Program
(Outreach); (2) Rural Health Network
Development Grant Program (Network
Development); (3) Small Healthcare
Provider Quality Grant Program
(Quality); (4) Delta States Rural
Development Network Grant Program
(Delta); (5) Network Planning Grant
Program and (6) Rural Health Workforce
Development Grant Program. These
grants are to provide for the expanded
delivery of health care services, the
planning and implementation of
integrated health care networks, and the
planning and implementation of quality
improvement and workforce activities—
all in rural areas.
For these programs, performance
measures were drafted to provide data
useful to the programs and to enable
HRSA to provide aggregate program data
required by Congress under the
Government Performance and Results
Act (GPRA) of 1993. These measures
cover the principal topic areas of
interest to ORHP, 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 all six
programs. All measures will speak to
the Office’s progress toward meeting the
goals set.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
jlentini on DSKJ8SOYB1PROD with NOTICES
Rural Health Care Services Outreach Grant Program ....
Rural Health Network Development ................................
Delta States Rural Development Network Grant Program .............................................................................
Small Health Care Provider Quality Improvement Grant
Program ........................................................................
Network Development Planning Grant Program .............
Rural Health Workforce Development Program ..............
111
49
1
1
111
49
12
1
12
3
59
30
20
1
1
1
59
30
20
6
1
1.75
Total ..........................................................................
281
........................
281
..........................
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
VerDate Mar<15>2010
18:23 Dec 07, 2010
Jkt 223001
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
PO 00000
Frm 00081
Fmt 4703
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2.75
2
Total burden
hours
305.25
98
36
354
30
35
858.25
should be received within 60 days of
this notice.
E:\FR\FM\08DEN1.SGM
08DEN1
76474
Federal Register / Vol. 75, No. 235 / Wednesday, December 8, 2010 / Notices
Dated: December 1, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
National Institutes of Health
[FR Doc. 2010–30894 Filed 12–7–10; 8:45 am]
National Eye Institute; Notice of Closed
Meeting
Dated: December 2, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel. A Tolerance Approach to
Xenotransplantation.
Date: January 20, 2011.
Time: 12 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
Contact Person: Quirijn Vos, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIH/NIAID/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892. 301–451–
2666. qvos@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
jlentini on DSKJ8SOYB1PROD with NOTICES
Dated: December 2, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–30811 Filed 12–7–10; 8:45 am]
BILLING CODE 4140–01–P
VerDate Mar<15>2010
18:23 Dec 07, 2010
Jkt 223001
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the National Advisory
Eye Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Eye Council.
Date: January 20, 2011.
Open: 8:30 a.m. to 12 p.m.
Agenda: Following opening remarks by the
Director, NEI, there will be presentations by
the staff of the Institute and discussions
concerning Institute programs.
Place: National Institutes of Health, 5635
Fishers Lane, Terrace Level Conference
Center, Bethesda, MD 20892.
Closed: 1:15 p.m. to Adjournment.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Terrace Level Conference
Center, Bethesda, MD 20892.
Contact Person: Andrew P. Mariani, PhD,
Executive Secretary, National Advisory Eye
Council, National Eye Institute, National
Institutes of Health. 301–451–2020.
amp@nei.nih.gov.
Any person interested may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nei.nih.gov, where an agenda and any
additional information will be posted when
available.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
[FR Doc. 2010–30812 Filed 12–7–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel
Developing Implementation Packages for
Evidenced-based HIV Prevention
Intervention Materials for Drug Users (5563).
Date: December 14, 2010.
Time: 9:30 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Telephone Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 220, MSC 8401, 6101 Executive
Boulevard, Bethesda, MD 20892–8401. (301)
435–1439. lf33c.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel Rapid
Portable Devices to Measure Drug Use (1206).
Date: December 20, 2010.
Time: 9:30 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6101
Executive Boulevard, Rockville, MD 20852.
(Telephone Conference Call).
Contact Person: Lyle Furr, Contract Review
Specialist, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, Room 220, MSC 8401, 6101 Executive
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Notices]
[Pages 76473-76474]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30894]
-----------------------------------------------------------------------
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: Data Collection Tool for Rural Health Community-Based
Grant Programs (OMB No. 0915-0319)--[Revision]
On May 20, 2008, OMB approved the Agency's request for the
collection of data related to program and clinical measures (OMB No.
0915-0319) and set an expiration date of May 31, 2011. The Agency is
now proceeding to submit a revised package which will include program
specific measures that are further aligned with the agency's updated
clinical measures. These measures were modified based on the feedback
received from grantees and to reflect ORHP and HRSA's current
priorities and clarify certain measures across all 330A programs. In
addition, these revisions will enhance data collection and analysis in
an effort to strengthen the value of the data collection tool.
There are currently six rural health grant programs that operate
under the authority of Section 301 of the Public Health Service (PHS)
Act. These programs include: (1) Rural Health Care Services Outreach
Grant Program (Outreach); (2) Rural Health Network Development Grant
Program (Network Development); (3) Small Healthcare Provider Quality
Grant Program (Quality); (4) Delta States Rural Development Network
Grant Program (Delta); (5) Network Planning Grant Program and (6) Rural
Health Workforce Development Grant Program. These grants are to provide
for the expanded delivery of health care services, the planning and
implementation of integrated health care networks, and the planning and
implementation of quality improvement and workforce activities--all in
rural areas.
For these programs, performance measures were drafted to provide
data useful to the programs and to enable HRSA to provide aggregate
program data required by Congress under the Government Performance and
Results Act (GPRA) of 1993. These measures cover the principal topic
areas of interest to ORHP, 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 all six programs. All measures will speak to the
Office's progress toward meeting the goals set.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Rural Health Care Services 111 1 111 2.75 305.25
Outreach Grant Program.........
Rural Health Network Development 49 1 49 2 98
Delta States Rural Development 12 1 12 3 36
Network Grant Program..........
Small Health Care Provider 59 1 59 6 354
Quality Improvement Grant
Program........................
Network Development Planning 30 1 30 1 30
Grant Program..................
Rural Health Workforce 20 1 20 1.75 35
Development Program............
-------------------------------------------------------------------------------
Total....................... 281 .............. 281 .............. 858.25
----------------------------------------------------------------------------------------------------------------
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.
[[Page 76474]]
Dated: December 1, 2010.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-30894 Filed 12-7-10; 8:45 am]
BILLING CODE 4165-15-P
