Division of Loan Repayment; Proposed Collection; Comment Request; National Institutes of Health Loan Repayment Programs, 73030-73031 [E7-24899]
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73030
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
these report types change over the
product’s marketed life cycle?
(4) What are the roles of reports by
health care professionals and consumers
in safety signal detection?
(5) Are there any types of AE reports
that are not helpful to safety signal
detection?
(6) What do we know about nonreported AEs or characteristics
associated with non-reporting?
FDA is working to refine the
workshop agenda and to invite panel
members. We are seeking broad
participation by safety researchers,
health system officials, the
pharmaceutical industry, and others.
We anticipate issuing a summary of the
workshop findings, including a
discussion of implications and next
steps for further development.
II. Comments
The agency is interested in hearing
comments at the public workshop or
receiving written comments (see
ADDRESSES) on the issues described
previously. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
III. Attendance and Registration
The Conference Facility (terrace level)
located at 5635 Fishers Lane is a Federal
facility with limited seating and security
procedures for entrance. Workshop
attendees will be required to show
proper identification and are asked to
allow time for security procedures.
Seating will be made available on a firstcome basis. Individuals who wish to
speak during the public workshop must
register on or before January 15, 2008.
You should identify the subject matter
you wish to address during the public
workshop. Please specify either panel
one or panel two (see section I of this
document). To register to speak, please
contact Lana Pauls (see FOR FORTHER
INFORMATION CONTACT).
Ample time will be allowed during
the scheduled agenda for attendees to
ask questions of panelists. In addition,
we strongly encourage written
comments to the docket.
If you need special accommodations
because of disability, please contact
Lana Pauls (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the workshop.
IV. Workshop Transcripts
The workshop will be transcribed.
The transcript will be available for
review at the Division of Dockets
Management (see ADDRESSES) and on
the Internet at https://www.fda.gov/
ohrms/dockets, approximately 30 days
after the workshop.
Dated: December 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–24960 Filed 12–21–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Division of Loan Repayment; Proposed
Collection; Comment Request;
National Institutes of Health Loan
Repayment Programs
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for opportunity for public comment on
proposed data collection projects, the
Division of Loan Repayment, National
Institutes of Health (NIH), will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: National
Institutes of Health Loan Repayment
Programs. Type of Information
Collection Request: Revision of
currently approved collection (OMB No.
0925–0361, expiration date 6/30/08).
Form Numbers: NIH 2674–1, NIH 2674–
2, NIH 2674–3, NIH 2674–4, NIH 2674–
5, NIH 2674–6, NIH 2674–7, NIH 2674–
8, NIH 2674–9, NIH 2674–10, NIH
2674–11, NIH 2674–12, NIH 2674–13,
NIH 2674–14, NIH 2674–15, NIH 2674–
16, NIH 2674–17, NIH 2674–18, and
NIH 2674–19. Need and Use of
Information Collection: The NIH makes
available financial assistance, in the
form of educational loan repayment, to
M.D., Ph.D., Pharm.D., D.D.S., D.M.D.,
pwalker on PROD1PC71 with NOTICES
Type of
respondents
Number of
respondents
Intramural LRPs
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
VerDate Aug<31>2005
17:33 Dec 21, 2007
Jkt 214001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
D.P.M., D.C., and N.D. degree holders,
or the equivalent, who perform
biomedical or behavioral research in
NIH intramural laboratories or as
extramural grantees for a minimum of 2
years (3 years for the General Research
Loan Repayment Program (LRP)) in
research areas supporting the mission
and priorities of the NIH.
The AIDS Research Loan Repayment
Program (AIDS–LRP) is authorized by
Section 487A of the Public Health
Service Act (42 U.S.C. 288–1); the
Clinical Research Loan Repayment
Program for Individuals from
Disadvantaged Backgrounds (CR–LRP)
is authorized by Section 487E (42 U.S.C.
288–5); the General Research Loan
Repayment Program (GR–LRP) is
authorized by Section 487C (42 U.S.C.
288–3); the Loan Repayment Program
Regarding Clinical Researchers (LRP–
CR) is authorized by Section 487F (42
U.S.C. 288–5a); the Pediatric Research
Loan Repayment Program (PR–LRP) is
authorized by Section 487F (42 U.S.C.
288–6); the Extramural Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds (ECR-LRP)
is authorized by an amendment to
Section 487E (42 U.S.C. 288–5); the
Contraception and Infertility Research
LRP (CIR–LRP) is authorized by Section
487B (42 U.S.C. 288–2); and the Health
Disparities Research Loan Repayment
Program (HD–LRP) is authorized by
Section 485G (42 U.S.C. 287c-33).
The Loan Repayment Programs
provide for the repayment of up to
$35,000 a year of the principal and
interest of the educational loan debt of
qualified health professionals who agree
to conduct qualifying research for each
year of obligated service. The
information proposed for collection will
be used to determine an applicant’s
eligibility for participation in the
program. Frequency of Response: Initial
application and annual or biennial
renewal application. Affected Public:
Applicants, financial institutions,
research institutions, recommenders.
Type of Respondents: Physicians, other
scientific or medical personnel, and
organizational officials. The annual
reporting burden is as follows:
Estimated
number of
responses per
respondent
30
30
90
10
E:\FR\FM\26DEN1.SGM
1
1
1
1
26DEN1
Average
burden hours
per response
10.11
.5
.33
1.25
Annual burden
hours
requested
303.30
15.00
29.70
12.50
73031
Federal Register / Vol. 72, No. 246 / Wednesday, December 26, 2007 / Notices
Estimated
number of
responses per
respondent
Average
burden hours
per response
160
........................
........................
360.50
1,900
1,750
5,700
300
1
1
1
1
10.35
.5
.33
1.25
19,665.00
875.00
1881.00
375.00
Subtotal .............................................................................................
Intramural LRPs
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
9,650
........................
........................
22,796.00
60
60
1
1
7.42
1.33
445.20
79.80
Subtotal .............................................................................................
Extramural LRPs
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
120
........................
........................
525.00
1,225
925
3,675
1
1
1
8.58
1.00
.33
10,510.50
925.00
1,212.75
Subtotal .............................................................................................
5,825
........................
........................
12,648.25
Total ...........................................................................................
15,755
........................
........................
36,329.75
Type of
respondents
Number of
respondents
Subtotal .............................................................................................
Extramural LRPs
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
The annualized cost to respondents is
estimated at $1,298,341. There are no
capital costs, operating costs, or
maintenance costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Sherry Mills,
M.D., M.P.H., Acting Director, Division
of Loan Repayment, National Institutes
of Health, 6011 Executive Blvd, Room
206 (MSC 7650), Bethesda, Maryland
20892–7650. Dr. Mills may be contacted
via e-mail at Millsshe@od.nih.gov or by
calling 301–402–2642 (not a toll-free
number).
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
pwalker on PROD1PC71 with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Aug<31>2005
17:33 Dec 21, 2007
Jkt 214001
received within 60 days from the date
of this publication.
Dated: December 17, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7–24899 Filed 12–21–07; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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 material,
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 Heart, Lung,
and Blood Institute Special Emphasis Panel,
Blood Substitute Study.
Date: January 15, 2008.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Annual burden
hours
requested
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Youngsuk Oh, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7182, Bethesda, MD 20892–7924, 301–435–
0277, yoh@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Vaccine Study.
Date: January 22, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Youngsuk Oh, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7182, Bethesda, MD 20892–7924, 301–435–
0277, yoh@mail.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
Cardiovascular and Lung Imaging.
Date: January 23, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Youngsuk Oh, PhD,
Scientific Review Administrator, Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7182, Bethesda, MD 20892–7924, 301–435–
0277, yoh@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
E:\FR\FM\26DEN1.SGM
26DEN1
Agencies
[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73030-73031]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-24899]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Division of Loan Repayment; Proposed Collection; Comment Request;
National Institutes of Health Loan Repayment Programs
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 for opportunity for public comment
on proposed data collection projects, the Division of Loan Repayment,
National Institutes of Health (NIH), will publish periodic summaries of
proposed projects to be submitted to the Office of Management and
Budget (OMB) for review and approval.
Proposed Collection: Title: National Institutes of Health Loan
Repayment Programs. Type of Information Collection Request: Revision of
currently approved collection (OMB No. 0925-0361, expiration date 6/30/
08). Form Numbers: NIH 2674-1, NIH 2674-2, NIH 2674-3, NIH 2674-4, NIH
2674-5, NIH 2674-6, NIH 2674-7, NIH 2674-8, NIH 2674-9, NIH 2674-10,
NIH 2674-11, NIH 2674-12, NIH 2674-13, NIH 2674-14, NIH 2674-15, NIH
2674-16, NIH 2674-17, NIH 2674-18, and NIH 2674-19. Need and Use of
Information Collection: The NIH makes available financial assistance,
in the form of educational loan repayment, to M.D., Ph.D., Pharm.D.,
D.D.S., D.M.D., D.P.M., D.C., and N.D. degree holders, or the
equivalent, who perform biomedical or behavioral research in NIH
intramural laboratories or as extramural grantees for a minimum of 2
years (3 years for the General Research Loan Repayment Program (LRP))
in research areas supporting the mission and priorities of the NIH.
The AIDS Research Loan Repayment Program (AIDS-LRP) is authorized
by Section 487A of the Public Health Service Act (42 U.S.C. 288-1); the
Clinical Research Loan Repayment Program for Individuals from
Disadvantaged Backgrounds (CR-LRP) is authorized by Section 487E (42
U.S.C. 288-5); the General Research Loan Repayment Program (GR-LRP) is
authorized by Section 487C (42 U.S.C. 288-3); the Loan Repayment
Program Regarding Clinical Researchers (LRP-CR) is authorized by
Section 487F (42 U.S.C. 288-5a); the Pediatric Research Loan Repayment
Program (PR-LRP) is authorized by Section 487F (42 U.S.C. 288-6); the
Extramural Clinical Research LRP for Individuals from Disadvantaged
Backgrounds (ECR-LRP) is authorized by an amendment to Section 487E (42
U.S.C. 288-5); the Contraception and Infertility Research LRP (CIR-LRP)
is authorized by Section 487B (42 U.S.C. 288-2); and the Health
Disparities Research Loan Repayment Program (HD-LRP) is authorized by
Section 485G (42 U.S.C. 287c-33).
The Loan Repayment Programs provide for the repayment of up to
$35,000 a year of the principal and interest of the educational loan
debt of qualified health professionals who agree to conduct qualifying
research for each year of obligated service. The information proposed
for collection will be used to determine an applicant's eligibility for
participation in the program. Frequency of Response: Initial
application and annual or biennial renewal application. Affected
Public: Applicants, financial institutions, research institutions,
recommenders. Type of Respondents: Physicians, other scientific or
medical personnel, and organizational officials. The annual reporting
burden is as follows:
----------------------------------------------------------------------------------------------------------------
Estimated
Number of number of Average Annual burden
Type of respondents respondents responses per burden hours hours
respondent per response requested
----------------------------------------------------------------------------------------------------------------
Intramural LRPs
Initial Applicants.......................... 30 1 10.11 303.30
Advisors/Supervisors........................ 30 1 .5 15.00
Recommenders................................ 90 1 .33 29.70
Financial Institutions...................... 10 1 1.25 12.50
---------------------------------------------------------------
[[Page 73031]]
Subtotal................................ 160 .............. .............. 360.50
Extramural LRPs
Initial Applicants.......................... 1,900 1 10.35 19,665.00
Advisors/Supervisors........................ 1,750 1 .5 875.00
Recommenders................................ 5,700 1 .33 1881.00
Financial Institutions...................... 300 1 1.25 375.00
---------------------------------------------------------------
Subtotal................................ 9,650 .............. .............. 22,796.00
Intramural LRPs
Renewal Applicants.......................... 60 1 7.42 445.20
Advisors/Supervisors........................ 60 1 1.33 79.80
---------------------------------------------------------------
Subtotal................................ 120 .............. .............. 525.00
Extramural LRPs
Renewal Applicants.......................... 1,225 1 8.58 10,510.50
Advisors/Supervisors........................ 925 1 1.00 925.00
Recommenders................................ 3,675 1 .33 1,212.75
---------------------------------------------------------------
Subtotal................................ 5,825 .............. .............. 12,648.25
===============================================================
Total............................... 15,755 .............. .............. 36,329.75
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at $1,298,341.
There are no capital costs, operating costs, or maintenance costs to
report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) the
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Sherry Mills, M.D., M.P.H., Acting Director,
Division of Loan Repayment, National Institutes of Health, 6011
Executive Blvd, Room 206 (MSC 7650), Bethesda, Maryland 20892-7650. Dr.
Mills may be contacted via e-mail at Millsshe@od.nih.gov or by calling
301-402-2642 (not a toll-free number).
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
from the date of this publication.
Dated: December 17, 2007.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. E7-24899 Filed 12-21-07; 8:45 am]
BILLING CODE 4140-01-P