Office of Loan Repayment; Submission for OMB Review; Comment Request; National Institutes of Health Loan Repayment Programs, 20760-20761 [05-8003]
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Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
the DailyMed, a new way to distribute
up-to-date and comprehensive
medication information in a
computerized format for use in health
care information systems.
Because FDA’s current procedures
using PDF are not adequate to support
these initiatives, the agency is changing
the way it processes, reviews, and
archives the content of labeling. We are
adopting a new technology for
exchanging information between
computer systems developed by Health
Level Seven (HL7), a standards
development organization accredited by
the American National Standards
Institute. The new technology, based on
Clinical Document Architecture (CDA),
allows information to be exchanged in
extensible markup language (XML) and
is the standard being investigated for the
EHR. FDA, working with other parties
in HL7 (experts from HL7, industry, and
technology solution providers), has
adapted CDA for labeling in an HL7
standard called Structured Product
Labeling (SPL).
FDA is developing an automated
system using SPL for processing and
managing labeling and labeling changes.
FDA’s Center for Drug Evaluation and
Research has identified SPL in public
docket number 1992S–0251 as a format
that FDA can use to process, review,
and archive the content of labeling.
During our transition to the automated
system, the agency is able to accept the
content of labeling in either PDF or SPL
file format. After the automated system
is implemented, PDF will no longer be
a format that we can use to process,
review, and archive the content of
labeling. At this time, it is our goal to
complete the transition to SPL format
for content of labeling submissions by
fall 2005.
In the Federal Register of February 5,
2004 (69 FR 5552), FDA published a
document announcing the availability of
a draft guidance for industry and gave
interested persons an opportunity to
submit comments by April 5, 2004.
Based on comments received on the
draft guidance, the agency has taken the
following actions:
• Lengthened the timeframe for the
agency’s implementation of the
automated system using SPL;
• Developed a Web site (on the
Internet at https://www.fda.gov/oc/
datacouncil/spl.html) to provide
technical support for the transition to
SPL, including links to SPL-related
documents and resources, stylesheet
files for viewing SPL files, and example
labels; and
• Revised the guidance to clarify the
procedures for submitting content of
labeling in electronic format.
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14:55 Apr 20, 2005
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This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on providing the
content of labeling in electronic format
as required in 21 CFR parts 314 and 601.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the guidance at any time.
Two copies of mailed comments are to
be submitted, except that individuals
may submit one copy. Comments are to
be identified with the docket number
found in brackets in the heading of this
document. The guidance and received
comments are available for public
examination in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Paperwork Reduction Act of 1995
This guidance contains information
collection provisions that are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
this guidance have been approved under
OMB control number 0910–0530,
expiring November 30, 2006.
V. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/guidance/index.htm,
https://www.fda.gov/cber/
guidelines.htm, or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: April 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–7946 Filed 4–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Loan Repayment; Submission
for OMB Review; Comment Request;
National Institutes of Health Loan
Repayment Programs
Summary: In compliance with the
requirement of Section 3507(a)(1)(D) of
the Paperwork Reduction Act of 1995,
PO 00000
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the Office of Loan Repayment, the
National Institutes of Health (NIH), has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on December 10,
2004, and allowed 60 days for public
comment. No responses to the notice
were received. The purpose of this
notice is to allow an additional 30 days
for public comment. The National
Institutes of Health may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
The programs have existing data
collections with an OMB control
number (OMB No. 0925–0361,
expiration date 12/31/2004). An
extension has been granted until March
2005 due to an administrative delay
caused by a change in office responsible
for the LRPs.
Proposed Collection
Title: National Institutes of Health
Loan Repayment Programs.
Type of Information Collection
Request: Revision of a currently
approved collection (OMB No. 0925–
0361, expiration date 12/31/04,
extension granted until 03/05).
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 biobehavioral research in
NIH intramural laboratories or who
perform research that is supported by a
domestic non-profit institution or a U.S.
Government (Federal, state, local) entity
for a minimum of 2 years (3 years for
the General Research 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.
E:\FR\FM\21APN1.SGM
21APN1
20761
Federal Register / Vol. 70, No. 76 / Thursday, April 21, 2005 / Notices
288–5); the General Research Loan
Repayment Program (GR–LRP) is
authorized by Section 487C of the
Public Health Service Act (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 can
repay up to $35,000 per year toward a
participant’s extant eligible educational
loans, directly to lenders, in addition to
salary and benefits. The information
proposed for collection will be used by
Number of
respondents
Type of respondents
the Office of Loan Repayment to
determine an applicant’s eligibility for
participation in the program.
Frequency of Response: Initial
application and annual renewal
application.
Affected Public: Applicants, financial
institutions, recommenders, and
advisors.
Type of Respondents: Physicians,
other scientific or medical personnel,
and institutional representatives. The
annual reporting burden is as follows:
Estimated
number of
responses
per respondent
Average
burden hours
per response
Annual burden
hours requested
Intramural LRPs:
Initial Applicants ................................................................................
Recommenders ................................................................................
Financial Institutions .........................................................................
75
225
8
1
1
1
8.98
0.38
0.33
673.50
85.50
2.64
Subtotal .....................................................................................
308
..........................
..........................
761.64
Extramural LRPs:
Initial Applicants ................................................................................
Recommenders ................................................................................
Advisors/Supervisors ........................................................................
Financial Institutions .........................................................................
1,600
4,800
1,600
160
1
1
1
1
10.30
0.38
1.15
0.33
16,480.00
1,824.00
1,840.00
52.80
Subtotal .....................................................................................
8,160
..........................
..........................
20,196.880
Extramural LRPs:
Renewal Applicants ..........................................................................
Recommenders ................................................................................
Advisors/Supervisors ........................................................................
800
2,400
800
1
1
1
7.81
0.38
1.15
6,248.00
912.00
920.00
Subtotal .....................................................................................
4,000
..........................
..........................
8,080.00
Total ...........................................................................................
12,468
..........................
..........................
29,038.44
The annualized cost to respondents is
estimated at $996,420.66. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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
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Jkt 205001
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Alfred
C. Johnson, Ph.D., Deputy Director,
Office of Loan Repayment and
Scholarship, National Institutes of
Health, 6011 Executive Blvd, Room 206
(MSC 7650), Bethesda, Maryland
20892–7650. Dr. Johnson can be
contacted via e-mail at
JohnsoA1@od.nih.gov or by calling 301–
402–6425.
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Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: April 12, 2005.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. 05–8003 Filed 4–20–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
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
meeting.
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 70, Number 76 (Thursday, April 21, 2005)]
[Notices]
[Pages 20760-20761]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Office of Loan Repayment; Submission for OMB Review; Comment
Request; National Institutes of Health Loan Repayment Programs
Summary: In compliance with the requirement of Section
3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of
Loan Repayment, the National Institutes of Health (NIH), has submitted
to the Office of Management and Budget (OMB) a request to review and
approve the information collection listed below. This proposed
information collection was previously published in the Federal Register
on December 10, 2004, and allowed 60 days for public comment. No
responses to the notice were received. The purpose of this notice is to
allow an additional 30 days for public comment. The National Institutes
of Health may not conduct or sponsor, and the respondent is not
required to respond to, an information collection that has been
extended, revised, or implemented on or after October 1, 1995, unless
it displays a currently valid OMB control number. The programs have
existing data collections with an OMB control number (OMB No. 0925-
0361, expiration date 12/31/2004). An extension has been granted until
March 2005 due to an administrative delay caused by a change in office
responsible for the LRPs.
Proposed Collection
Title: National Institutes of Health Loan Repayment Programs.
Type of Information Collection Request: Revision of a currently
approved collection (OMB No. 0925-0361, expiration date 12/31/04,
extension granted until 03/05).
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 biobehavioral
research in NIH intramural laboratories or who perform research that is
supported by a domestic non-profit institution or a U.S. Government
(Federal, state, local) entity for a minimum of 2 years (3 years for
the General Research 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.
[[Page 20761]]
288-5); the General Research Loan Repayment Program (GR-LRP) is
authorized by Section 487C of the Public Health Service Act (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 can repay up to $35,000 per year toward
a participant's extant eligible educational loans, directly to lenders,
in addition to salary and benefits. The information proposed for
collection will be used by the Office of Loan Repayment to determine an
applicant's eligibility for participation in the program.
Frequency of Response: Initial application and annual renewal
application.
Affected Public: Applicants, financial institutions, recommenders,
and advisors.
Type of Respondents: Physicians, other scientific or medical
personnel, and institutional representatives. The annual reporting
burden is as follows:
----------------------------------------------------------------------------------------------------------------
Estimated
Number of number of Average burden Annual burden
Type of respondents respondents responses per hours per hours requested
respondent response
----------------------------------------------------------------------------------------------------------------
Intramural LRPs:
Initial Applicants...................... 75 1 8.98 673.50
Recommenders............................ 225 1 0.38 85.50
Financial Institutions.................. 8 1 0.33 2.64
------------------
Subtotal............................ 308 ............... ............... 761.64
==================
Extramural LRPs:
Initial Applicants...................... 1,600 1 10.30 16,480.00
Recommenders............................ 4,800 1 0.38 1,824.00
Advisors/Supervisors.................... 1,600 1 1.15 1,840.00
Financial Institutions.................. 160 1 0.33 52.80
------------------
Subtotal............................ 8,160 ............... ............... 20,196.880
==================
Extramural LRPs:
Renewal Applicants...................... 800 1 7.81 6,248.00
Recommenders............................ 2,400 1 0.38 912.00
Advisors/Supervisors.................... 800 1 1.15 920.00
------------------
Subtotal............................ 4,000 ............... ............... 8,080.00
==================
Total............................... 12,468 ............... ............... 29,038.44
----------------------------------------------------------------------------------------------------------------
The annualized cost to respondents is estimated at $996,420.66.
There are no Capital Costs, Operating Costs, and/or Maintenance Costs
to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Alfred C. Johnson, Ph.D., Deputy Director,
Office of Loan Repayment and Scholarship, National Institutes of
Health, 6011 Executive Blvd, Room 206 (MSC 7650), Bethesda, Maryland
20892-7650. Dr. Johnson can be contacted via e-mail at
JohnsoA1@od.nih.gov or by calling 301-402-6425.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30 days
of the date of this publication.
Dated: April 12, 2005.
Raynard S. Kington,
Deputy Director, National Institutes of Health.
[FR Doc. 05-8003 Filed 4-20-05; 8:45 am]
BILLING CODE 4140-01-M
