Agency Information Collection Activities: Proposed Collection: Comment Request, 77648-77649 [2010-31238]
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77648
Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
holding a public meeting where
stakeholders and other members of the
public were given an opportunity to
present their views on reauthorization
(75 FR 49502, August 13, 2010). This
meeting and written comments
submitted to the docket have provided
critical input as FDA prepares for
reauthorization discussions. Section
738A(b)(3) of the FD&C Act further
requires that FDA meet with patient and
consumer advocacy groups at least once
every month during negotiations with
the regulated industry to continue
discussions of their views on the
reauthorization, and their suggestions
for changes to the MDUFA program.
FDA is issuing this Federal Register
notice to request that patient and
consumer advocacy groups notify FDA
of their intent to participate in periodic
consultation meetings on
reauthorization of MDUFA. FDA
believes that consistent representation
at these meetings will be important to
ensuring progress in these discussions.
If you wish to participate in this part of
the reauthorization process, please
designate one or more representatives
from your organization who will
commit to attending these meetings
regularly and preparing for the
discussions as needed. Patient and
consumer advocacy groups who identify
themselves through this notice will be
included in all future patient and
consumer advocacy group meetings
while FDA negotiates with the regulated
industry. If a representative of a patient
and consumer advocacy group decides
to participate in these monthly meetings
at a later time, they may still participate
in remaining monthly meetings by
notifying FDA (see ADDRESSES). These
meetings will satisfy the requirement in
section 738A(b)(3) of the FD&C Act.
II. Additional Information on MDUFA
There are several sources of
information on FDA’s Web site that may
serve as useful resources for patient and
consumer advocacy groups participating
in the periodic consultation meetings:
• Information on the September 2010
public meeting on MDUFA
Reauthorization, the Federal Register
notice announcing the meeting, and the
transcript of the meeting are available at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm218250.htm.
• FDA created a Webinar on the
Medical Device User Fee program,
medical device development, and FDA’s
medical device review in MDUFA.
These presentations are available at
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https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm218250.htm.
• Key Federal Register documents,
MDUFA-related guidances, legislation,
performance reports, and financial
reports and plans are posted at https://
www.fda.gov/MDUFA.
• FDAAA-specific information is
available at: https://www.fda.gov/
RegulatoryInformation/Legislation/
FederalFoodDrugandCosmeticAct
FDCAct/SignificantAmendmentstothe
FDCAct/FoodandDrugAdministration
AmendmentsActof2007/default.htm.
III. Notification of Intent To Participate
in Periodic Patient and Consumer
Advocacy Group Consultation Meetings
If you intend to participate in
continued periodic patient and
consumer advocacy group consultation
meetings regarding MDUFA
Reauthorization, please provide
notification by e-mail to
MDUFAReauthorization@fda.hhs.gov by
January 6, 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.
Representatives of patient and
consumer advocacy groups will receive
confirmation and additional information
about the first meeting once FDA
receives their notification.
Dated: December 8, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2010–31160 Filed 12–10–10; 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
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
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submission to the Office of Management
and Budget 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, call the
HRSA Reports Clearance Officer on
(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,
including whether the information shall
have practical utility; (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: Retention Survey of
NHSC Clinicians and Alumni/NHSC
Site Administrators—
[NEW] The National Health Service
Corps (NHSC) Loan Repayment and
Scholarship Programs were established
to assure an adequate supply of trained
primary care health care professionals to
provide services in the neediest Health
Professional Shortage Areas (HPSAs) of
the United States. Under these
programs, the Department of Health and
Human Services agrees to repay the
educational loans of, or provide
scholarships to, primary care health
professionals. In return, the
professionals agree to serve for a
specified period of time in a Federally
designated HPSA approved by the
Secretary. The last survey conducted to
analyze retention of NHSC clinicians is
more than ten years old. There is a need
to distribute a survey to reevaluate the
personal/professional development of
NHSC clinicians in an effort to retain
the clinicians in service providing care
for individuals residing in underserved
areas. The survey will ask current and
former NHSC clinicians questions
regarding professional satisfaction,
expectations of service in the NHSC,
and their experiences at NHSC sites.
The survey will also ask questions of
NHSC site administrators about their
locations and the attributes of current
and former NHSC clinicians at these
sites.
The estimated response burden for the
survey is as follows:
E:\FR\FM\13DEN1.SGM
13DEN1
77649
Federal Register / Vol. 75, No. 238 / Monday, December 13, 2010 / Notices
SURVEY
Number of
respondents
Instrument
Responses
per
respondent
Total
responses
Hours per
response
Total burden
hours
Survey of Site Administrator ................................................
Survey of NHSC Clinicians in Service .................................
Survey of NHSC ..................................................................
Alumni (Recent) ...................................................................
Survey of NHSC ..................................................................
Alumni (Remote) ..................................................................
2,000
6,500
1
1
2,000
6,500
.15
.13
300
845
3,000
1
3,000
.20
600
1,143
1
1,143
.15
171
Total ..............................................................................
12,643
4
12,643
.63
1,916
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: December 8, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–31238 Filed 12–10–10; 8:45 am]
BILLING CODE 4165–15–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) 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: The Division of
Independent Review Grant Reviewer
Recruitment Form (OMB No. 0915–
0295)—[Extension]
HRSA’s Division of Independent
Review (DIR) is responsible for carrying
Number of
respondents
Grant recruitment form
Responses
per
respondent
out the independent and objective
review of all eligible applications
submitted to HRSA. DIR ensures that
the independent review process is
efficient, effective, economical, and
complies with statutes, regulations, and
policies. The review of applications is
performed by people knowledgeable in
the field of endeavor for which support
is requested and is advisory to
individuals in HRSA responsible for
making award decisions.
To streamline the selection and
assignment of grant reviewers to
objective review committees, HRSA
utilizes a Web-based data collection
form to gather critical reviewer
information. The Grant Reviewer Form
standardizes pertinent categories of
reviewer information, such as: areas of
expertise; occupations; work settings;
reviewer experience; and allows
maximum use of drop-down menus to
simplify the data collection process. The
Web-based system also permits
reviewers to update their information as
needed. HRSA maintains a pool of
approximately 5,000 individuals that
have previously served on HRSA
objective review committees.
The estimated annual burden is as
follows:
Total
responses
Hours per
Response
Total burden
hours
1,380
4,255
1
1
1,380
4,255
45 min.
30 min.
1,035
1,850
Total ..............................................................................
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
New reviewer .......................................................................
Updating reviewer information .............................................
4,900
........................
4,900
........................
2,750
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: December 8, 2010.
Robert Hendricks,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2010–31236 Filed 12–10–10; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Notices]
[Pages 77648-77649]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31238]
-----------------------------------------------------------------------
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
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, call the HRSA Reports Clearance Officer on
(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, including whether the information shall have practical
utility; (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: Retention Survey of NHSC Clinicians and Alumni/NHSC
Site Administrators--
[NEW] The National Health Service Corps (NHSC) Loan Repayment and
Scholarship Programs were established to assure an adequate supply of
trained primary care health care professionals to provide services in
the neediest Health Professional Shortage Areas (HPSAs) of the United
States. Under these programs, the Department of Health and Human
Services agrees to repay the educational loans of, or provide
scholarships to, primary care health professionals. In return, the
professionals agree to serve for a specified period of time in a
Federally designated HPSA approved by the Secretary. The last survey
conducted to analyze retention of NHSC clinicians is more than ten
years old. There is a need to distribute a survey to reevaluate the
personal/professional development of NHSC clinicians in an effort to
retain the clinicians in service providing care for individuals
residing in underserved areas. The survey will ask current and former
NHSC clinicians questions regarding professional satisfaction,
expectations of service in the NHSC, and their experiences at NHSC
sites. The survey will also ask questions of NHSC site administrators
about their locations and the attributes of current and former NHSC
clinicians at these sites.
The estimated response burden for the survey is as follows:
[[Page 77649]]
Survey
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Survey of Site Administrator.... 2,000 1 2,000 .15 300
Survey of NHSC Clinicians in 6,500 1 6,500 .13 845
Service........................
Survey of NHSC.................. 3,000 1 3,000 .20 600
Alumni (Recent).................
Survey of NHSC.................. 1,143 1 1,143 .15 171
Alumni (Remote).................
-------------------------------------------------------------------------------
Total....................... 12,643 4 12,643 .63 1,916
----------------------------------------------------------------------------------------------------------------
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: December 8, 2010.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2010-31238 Filed 12-10-10; 8:45 am]
BILLING CODE 4165-15-P
