Agency Information Collection Activities: Proposed Collection: Comment Request, 58021-58023 [2011-23892]
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
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Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
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of the SUPPLEMENTARY INFORMATION
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SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
an updated IT plan entitled ‘‘PDUFA IV
Information Technology Plan.’’ This
plan will meet one of the performance
goals agreed to under the 2007
reauthorization of PDUFA IV (Title I of
the Food and Drug Administration
Amendments Act of 2007 (Pub. L. 110–
85)). Under section XIV of the PDUFA
Performance Goals, FDA agreed to
develop, periodically update, and
publish for comment an IT plan for
achieving the objectives defined in
section XIV, Information Technology
Goals, of the PDUFA Performance Goals
(see https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm119243.htm). This plan is intended
to provide regulated industry and other
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automation of business processes and
maintaining information systems that
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objectives defined in section XIV of the
PDUFA Performance Goals. The
objectives of the PDUFA IV IT Goals are
to move FDA towards the long-term goal
of an automated standards-based
information technology environment for
the exchange, review, and management
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of information supporting the process
for the review of human drug
applications throughout the product life
cycle.
In the Federal Register of June 30,
2008 (73 FR 36880), FDA issued a notice
announcing the availability of an earlier
version of the IT plan entitled
‘‘Prescription Drug User Fee Act
(PDUFA) IV Information Technology
Plan’’ (June 2008 plan). This updated
plan revises the June 2008 plan; it
communicates the progress and strategic
changes for key initiatives that illustrate
the accomplishment of near-term
objectives and describes FDA’s strategy
for meeting the long-term goal of a fully
electronic submission and review
environment. The sections that have
been revised are identified in the
Revision Index (after the Table of
Contents) in the updated plan.
FDA conducts an annual IT
assessment to measure performance
against the IT plan. The 2010 Annual IT
Assessment is available at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm183308.htm.
II. Electronic Access
Persons with access to the Internet
may obtain the updated plan at https://
www.regulations.gov.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed 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.
Dated: September 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23923 Filed 9–16–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
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–
0165.
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: Health Professions
Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program
Administrative Requirements
(Regulations and Policy) (OMB No.
0915–0047)—[Extension]
The regulations for the Health
Professions Student Loan (HPSL)
Program and Nursing Student Loan
(NSL) Program contain a number of
reporting and recordkeeping
requirements for schools and loan
applicants. The requirements are
essential for assuring that borrowers are
aware of rights and responsibilities,
know the history and status of each loan
account in order to pursue aggressive
collection efforts to reduce default rates,
and that they maintain adequate records
for audit and assessment purposes.
Schools are free to use improved
information technology to manage the
information required by the regulations.
The estimated total burden is 49,489
hours. The annualized burden estimates
are as follows:
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / Notices
RECORDKEEPING REQUIREMENTS
Number of
recordkeepers
Regulatory/section requirements
HPSL Program:
57.206(b)(2), Documentation of Cost of Attendance ...................................
57.208(a), Promissory Note .........................................................................
57.210(b)(1)(i), Documentation of Entrance Interview .................................
57.210(b)(1)(ii), Documentation of Exit Interview .........................................
57.215(a) & (d), Program Records ...............................................................
57.215(b), Student Records .........................................................................
57.215(c), Repayment Records ...................................................................
Hours per year
Total burden hours
435
435
435
* 477
* 477
*477
* 477
1.17
1.25
1.25
0.33
10
10
18.75
509
544
544
157
4,770
4,770
8,944
HPSL Subtotal .......................................................................................
NSL Program:
57.306(b)(2)(ii), Documentation of Cost of Attendance ...............................
57.308(a), Promissory Note .........................................................................
57.310(b)(1)(i), Documentation of Entrance Interview .................................
57.310(b)(1)(ii), Documentation of Exit Interview .........................................
57.315(a)(1) & (a)(4), Program Records ......................................................
57.315(a)(2), Student Records .....................................................................
57.215(b)(3), Repayment Records ...............................................................
................................
................................
20,238
304
304
304
* 486
* 486
* 486
* 486
0.3
0.5
0.5
0.17
5
1
2.51
91
152
152
83
2,430
486
1,220
NSL Subtotal .........................................................................................
................................
................................
4,614
* Includes active and closing schools.
HPSL data include active and closing Loans for Disadvantaged Students (LDS) program schools.
REPORTING REQUIREMENTS
Number of
respondents
Regulatory/section requirements
HPSL Program:
57.206(a)(2), Student Financial Aid Transcript ............
57.208(c), Loan Information Disclosure .......................
57.210(b)(1)(i), Entrance Interview ...............................
57.210(b)(1)(ii), Exit Interview ......................................
57.210(b)(1)(iii), Notification of Repayment ..................
57.210(b)(1)(iv), Notification During Deferment ...........
57.210(b)(1)(vi), Notification of Delinquent Accounts ...
57.210(b)(1)(x), Credit Bureau Notification ..................
57.210(b)(4)(i), Write-off of Uncollectable Loans .........
57.211(a), Disability Cancellation .................................
57.215(a)(2), Administrative Hearings ..........................
57.215(a)(d), Administrative Hearings ..........................
Responses
per
respondent
Total annual
responses
Hours per
response
Total burden
hours
4,600
435
435
* 477
* 477
* 477
* 477
* 477
20
10
0
0
1
68.73
68.73
12
30.83
24.32
10.28
8.03
1
1
0
0
4,600
29,898
29,898
5,724
14,706
11,601
4,904
3,830
20
10
0
0
0.25
0.0833
0.167
0.5
0.167
0.0833
0.167
0.6
3
0.75
0
0
1,150
2,490
4,993
2,862
2,456
966
819
2,298
60
8
0
0
HPSL Subtotal .......................................................
NSL Program:
57.306(a)(2), Student Financial Aid Transcript ............
57.310(b)(1)(i), Entrance Interview ...............................
57.310(b)(1)(ii), Exit Interview ......................................
57.310(b)(1)(iii), Notification of Repayment ..................
57.310(b)(1)(iv), Notification During Deferment ...........
57.310(b)(1)(vi), Notification of Delinquent Accounts ...
57.310(b)(1)(x), Credit Bureau Notification ..................
57.310(b)(4)(i), Write-off of Uncollectable Loans .........
57.311(a), Disability Cancellation .................................
57.315(a)(1)(ii), Administrative Hearings ......................
57.316(a)(d), Administrative Hearings ..........................
........................
........................
........................
........................
18,102
4,100
304
* 486
* 486
* 486
* 486
* 486
20
10
0
0
1
23.51
3.77
6.18
0.65
4.61
8.3
1
1
0
0
4,100
7,147
1,832
3,003
316
2,240
4,033
20
10
0
0
0.25
0.167
0.5
0.167
0.083
0.167
0.6
3.5
0.8
0
0
1,025
1,193
916
501
26
374
2,420
70
8
0
0
NSL Subtotal .........................................................
........................
........................
........................
........................
6,535
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* Includes active and closing schools.
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Federal Register / Vol. 76, No. 181 / Monday, September 19, 2011 / 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: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–23892 Filed 9–16–11; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
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 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
Biomedical Imaging and Bioengineering
Special Emphasis Panel; P41 Site Visit (2012/
01).
Date: October 24–26, 2011.
Time: 8 p.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: Springhill Suites by Marriott,
Pittsburgh Southside Works, 2950 South
Water Street, Pittsburgh, PA 15203.
Contact Person: John K. Hayes, PhD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Room 959, Bethesda,
MD 20892, 301–451–3398,
hayesj@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Health Disparities
SBIR 2012/01.
Date: November 7, 2011.
Time: 11 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health/NIBIB,
DEM II, 6707 Democracy Blvd, 900,
Bethesda, MD 20892. (Telephone Conference
Call.)
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Contact Person: Ruixia Zhou, PhD,
Scientific Review Officer, 6707 Democracy
Boulevard, Democracy Two Building, Suite
957, Bethesda, MD 20892, 301–496–4773,
zhour@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; 2012–01 K-Award
Review Meeting.
Date: November 16, 2011.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call.)
Contact Person: John K. Hayes, PhD,
Scientific Review Officer, 6707 Democracy
Boulevard, Room 959, Bethesda, MD 20892,
301–451–3398, hayesj@mail.nih.gov.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; Development of
Multiscale Models (U01).
Date: November 17, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington, DC
Dupont Circle Hotel, 1143 New Hampshire
Avenue, NW., Washington, DC 20037.
Contact Person: Manana Sukhareva, PhD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 959, Bethesda,
MD 20892, 301–451–3397,
sukharem@mail.nih.gov.
Dated: September 13, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–24031 Filed 9–16–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Human Genome Research
Institute; 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.
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Name of Committee: National Human
Genome Research Institute Initial Review
Group; Genome Research Review Committee;
Centers of Excellence in Genomic Science
(CEGS).
Date: November 3–4, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Ken D. Nakamura, PhD,
Scientific Review Officer, Office of Scientific
Review, National Human Genome Research
Institute, National Institutes of Health,
Bethesda, MD 20892, 301 402–0838.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: September 13, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–24026 Filed 9–16–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the Board
of Scientific Counselors, NIDCD.
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 as indicated below in accordance
with the provisions set forth in section
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for the review, discussion, and
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including consideration of personnel
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invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIDCD.
Date: October 27–28, 2011.
Closed: October 27, 2011, 10 a.m. to 10:30
a.m.
E:\FR\FM\19SEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Notices]
[Pages 58021-58023]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23892]
-----------------------------------------------------------------------
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) 443-0165.
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: Health Professions Student Loan (HPSL) Program and
Nursing Student Loan (NSL) Program Administrative Requirements
(Regulations and Policy) (OMB No. 0915-0047)--[Extension]
The regulations for the Health Professions Student Loan (HPSL)
Program and Nursing Student Loan (NSL) Program contain a number of
reporting and recordkeeping requirements for schools and loan
applicants. The requirements are essential for assuring that borrowers
are aware of rights and responsibilities, know the history and status
of each loan account in order to pursue aggressive collection efforts
to reduce default rates, and that they maintain adequate records for
audit and assessment purposes. Schools are free to use improved
information technology to manage the information required by the
regulations.
The estimated total burden is 49,489 hours. The annualized burden
estimates are as follows:
[[Page 58022]]
Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
Number of
Regulatory/section requirements recordkeepers Hours per year Total burden hours
----------------------------------------------------------------------------------------------------------------
HPSL Program:
57.206(b)(2), Documentation of Cost of 435 1.17 509
Attendance.....................................
57.208(a), Promissory Note...................... 435 1.25 544
57.210(b)(1)(i), Documentation of Entrance 435 1.25 544
Interview......................................
57.210(b)(1)(ii), Documentation of Exit * 477 0.33 157
Interview......................................
57.215(a) & (d), Program Records................ * 477 10 4,770
57.215(b), Student Records...................... *477 10 4,770
57.215(c), Repayment Records.................... * 477 18.75 8,944
-----------------------------------------------------------
HPSL Subtotal............................... .................. .................. 20,238
NSL Program:
57.306(b)(2)(ii), Documentation of Cost of 304 0.3 91
Attendance.....................................
57.308(a), Promissory Note...................... 304 0.5 152
57.310(b)(1)(i), Documentation of Entrance 304 0.5 152
Interview......................................
57.310(b)(1)(ii), Documentation of Exit * 486 0.17 83
Interview......................................
57.315(a)(1) & (a)(4), Program Records.......... * 486 5 2,430
57.315(a)(2), Student Records................... * 486 1 486
57.215(b)(3), Repayment Records................. * 486 2.51 1,220
-----------------------------------------------------------
NSL Subtotal................................ .................. .................. 4,614
----------------------------------------------------------------------------------------------------------------
* Includes active and closing schools.
HPSL data include active and closing Loans for Disadvantaged Students (LDS) program schools.
Reporting Requirements
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total annual Hours per Total burden
Regulatory/section requirements respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
HPSL Program:
57.206(a)(2), Student 4,600 1 4,600 0.25 1,150
Financial Aid Transcript...
57.208(c), Loan Information 435 68.73 29,898 0.0833 2,490
Disclosure.................
57.210(b)(1)(i), Entrance 435 68.73 29,898 0.167 4,993
Interview..................
57.210(b)(1)(ii), Exit * 477 12 5,724 0.5 2,862
Interview..................
57.210(b)(1)(iii), * 477 30.83 14,706 0.167 2,456
Notification of Repayment..
57.210(b)(1)(iv), * 477 24.32 11,601 0.0833 966
Notification During
Deferment..................
57.210(b)(1)(vi), * 477 10.28 4,904 0.167 819
Notification of Delinquent
Accounts...................
57.210(b)(1)(x), Credit * 477 8.03 3,830 0.6 2,298
Bureau Notification........
57.210(b)(4)(i), Write-off 20 1 20 3 60
of Uncollectable Loans.....
57.211(a), Disability 10 1 10 0.75 8
Cancellation...............
57.215(a)(2), Administrative 0 0 0 0 0
Hearings...................
57.215(a)(d), Administrative 0 0 0 0 0
Hearings...................
-------------------------------------------------------------------------------
HPSL Subtotal........... .............. .............. .............. .............. 18,102
NSL Program:
57.306(a)(2), Student 4,100 1 4,100 0.25 1,025
Financial Aid Transcript...
57.310(b)(1)(i), Entrance 304 23.51 7,147 0.167 1,193
Interview..................
57.310(b)(1)(ii), Exit * 486 3.77 1,832 0.5 916
Interview..................
57.310(b)(1)(iii), * 486 6.18 3,003 0.167 501
Notification of Repayment..
57.310(b)(1)(iv), * 486 0.65 316 0.083 26
Notification During
Deferment..................
57.310(b)(1)(vi), * 486 4.61 2,240 0.167 374
Notification of Delinquent
Accounts...................
57.310(b)(1)(x), Credit * 486 8.3 4,033 0.6 2,420
Bureau Notification........
57.310(b)(4)(i), Write-off 20 1 20 3.5 70
of Uncollectable Loans.....
57.311(a), Disability 10 1 10 0.8 8
Cancellation...............
57.315(a)(1)(ii), 0 0 0 0 0
Administrative Hearings....
57.316(a)(d), Administrative 0 0 0 0 0
Hearings...................
-------------------------------------------------------------------------------
NSL Subtotal............ .............. .............. .............. .............. 6,535
----------------------------------------------------------------------------------------------------------------
* Includes active and closing schools.
[[Page 58023]]
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: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-23892 Filed 9-16-11; 8:45 am]
BILLING CODE 4165-15-P
