Submission for OMB Review; Comment Request; Process Evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP), 9577-9578 [E8-3166]
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Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
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SUPPLEMENTARY INFORMATION section for
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document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Robert H.
King, Sr., Center for Drug
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003), Food and Drug
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4480.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important
initiatives have been undertaken by
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associations to promote international
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requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically based harmonized
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harmonization of technical
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and Welfare; the Japanese
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In the Federal Register of August 8,
2006 (71 FR 45058), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q4B Regulatory
Acceptance of Analytical Procedures
and/or Acceptance Criteria; Annex 1:
Residue on Ignition/Sulphated Ash
General Chapter.’’ The notice gave
interested persons an opportunity to
submit comments by October 10, 2006.
After consideration of the comments
received and revisions to the guidance,
a final draft guidance entitled ‘‘Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
ICH Regions; Annex 1: Residue on
Ignition/Sulphated Ash General
Chapter’’ was submitted to the ICH
Steering Committee and endorsed by the
three participating regulatory agencies
in November 2007.
The guidance provides the specific
evaluation outcome from the ICH Q4B
process for the Residue on Ignition/
Sulphated Ash General Chapter
harmonization proposal originating
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is in the form of an annex to the core
ICH Q4B guidance. When implemented,
the annex will provide guidance for
industry and regulators on the use of the
specific pharmacopeial texts evaluated
by the ICH Q4B process. Following
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substantive changes were made to the
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guidance was changed to more closely
reflect the actual workings and process
of the Q4B EWG.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
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The guidance represents the agency’s
current thinking on this topic. It does
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approach may be used if such approach
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II. Comments
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Please note that on January 15, 2008,
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Electronic submissions will be accepted
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III. Electronic Access
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default.htm, https://www.fda.gov/cder/
guidance/index.htm, or https://
www.fda.gov/cber/publications.htm.
Dated: February 12, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8–3187 Filed 2–20–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Process Evaluation
of the Global Health Research Initiative
Program for New Foreign Investigators
(GRIP)
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty
International Center (FIC), 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 November 30, 2007, and
allowed 60 days for public comment. No
public comments were received. The
E:\FR\FM\21FEN1.SGM
21FEN1
9578
Federal Register / Vol. 73, No. 35 / Thursday, February 21, 2008 / Notices
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.
Proposed Collection: Title: Process
evaluation of the Global Health
Research Initiative Program for New
Foreign Investigators (GRIP). Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
This study will assess the outputs of the
Global Health Research Initiative
Program for New Foreign Investigators
(GRIP) to date, assess the program’s
alignment with new strategic goals of
the FIC, and identify potential
directions for program enhancement.
The primary objectives of the study are
to determine if GRIP awards (1) promote
productive re-entry of NIH-trained
foreign investigators into their home
countries, (2) increase the research
capacity of the international scientists
and institutions, and (3) stimulate
research on a wide variety of high
priority health-related issues. The
findings will provide valuable
information concerning: (1) Specific
research advances attributable to GRIP
support; (2) specific capacity and career
enhancing advances that are attributable
to GRIP; (3) policy implications for GRIP
at the program level based on survey
responses, such as successes and
challenges of the program’s
implementation, the GRIP support
mechanism, etc. Frequency of Response:
Once. Affected Public: None. Type of
Respondents: Foreign researchers. The
annual reporting burden is as follows:
Estimated Number of Respondents: 101;
Estimated Number of Responses Per
Respondent: 1; Average Burden Hours
Per Response: 0.50; and Estimated Total
Annual Burden Hours Requested: 50.5.
The annualized cost to respondents is
estimated at: $656.50. There are no
Capital Costs to report. There are no
Operating or Maintenance Costs to
report. Table 1 and Table 2 respectively
present data concerning the burden
hours and cost burdens for this data
collection.
TABLE 1.—ANNUALIZED ESTIMATE OF HOUR BURDEN
Number of respondents
Type of respondents
Frequency of
response
Average time
for response
(hr)
Total hour
burden*
GRIP Awardees ...............................................................................................
101
1
0.50
50.5
Total ..........................................................................................................
101
1
0.50
50.5
Approx. hourly
wage rate
Total respondent cost*
Total Burden = N Respondents x Response Frequency x minutes to complete/60.
TABLE 2.—ANNUALIZED COST TO RESPONDENTS
Number of respondents
Type of respondents
Frequency of
response
GRIP Awardees ...............................................................................................
101
1
$13/hr
$656.50
Total ..........................................................................................................
101
1
13/hr
656.50
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Total Respondent Cost = N Respondents x Response Frequency x minutes to complete/60 x hourly rate.
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) Evaluate 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) Evaluate 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) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) 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
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16:34 Feb 20, 2008
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public burden and associated response
time, should be directed to the Office of
Management and Budget at
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Dr.
Linda Kupfer, Fogarty International
Center, National Institutes of Health, 16
Center Drive, Bethesda, MD 20892, or
call non-toll-free number 301–496–
3288, or email your request, including
your address to: kupferl@mail.nih.gov.
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: February 12, 2008.
Timothy Tosten,
Executive Officer, FIC, National Institutes of
Health.
[FR Doc. E8–3166 Filed 2–20–08; 8:45 am]
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National Institutes of Health
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for licensing.
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]]>Agencies
[Federal Register Volume 73, Number 35 (Thursday, February 21, 2008)]
[Notices]
[Pages 9577-9578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-3166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Process Evaluation of
the Global Health Research Initiative Program for New Foreign
Investigators (GRIP)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Fogarty International Center (FIC), 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 November
30, 2007, and allowed 60 days for public comment. No public comments
were received. The
[[Page 9578]]
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.
Proposed Collection: Title: Process evaluation of the Global Health
Research Initiative Program for New Foreign Investigators (GRIP). Type
of Information Collection Request: NEW. Need and Use of Information
Collection: This study will assess the outputs of the Global Health
Research Initiative Program for New Foreign Investigators (GRIP) to
date, assess the program's alignment with new strategic goals of the
FIC, and identify potential directions for program enhancement. The
primary objectives of the study are to determine if GRIP awards (1)
promote productive re-entry of NIH-trained foreign investigators into
their home countries, (2) increase the research capacity of the
international scientists and institutions, and (3) stimulate research
on a wide variety of high priority health-related issues. The findings
will provide valuable information concerning: (1) Specific research
advances attributable to GRIP support; (2) specific capacity and career
enhancing advances that are attributable to GRIP; (3) policy
implications for GRIP at the program level based on survey responses,
such as successes and challenges of the program's implementation, the
GRIP support mechanism, etc. Frequency of Response: Once. Affected
Public: None. Type of Respondents: Foreign researchers. The annual
reporting burden is as follows: Estimated Number of Respondents: 101;
Estimated Number of Responses Per Respondent: 1; Average Burden Hours
Per Response: 0.50; and Estimated Total Annual Burden Hours Requested:
50.5. The annualized cost to respondents is estimated at: $656.50.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report. Table 1 and Table 2 respectively present
data concerning the burden hours and cost burdens for this data
collection.
Table 1.--Annualized Estimate of Hour Burden
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondents Number of Frequency of for response Total hour
respondents response (hr) burden*
----------------------------------------------------------------------------------------------------------------
GRIP Awardees................................... 101 1 0.50 50.5
---------------------------------------------------------------
Total....................................... 101 1 0.50 50.5
----------------------------------------------------------------------------------------------------------------
Total Burden = N Respondents x Response Frequency x minutes to complete/60.
Table 2.--Annualized Cost to Respondents
----------------------------------------------------------------------------------------------------------------
Total
Type of respondents Number of Frequency of Approx. hourly respondent
respondents response wage rate cost*
----------------------------------------------------------------------------------------------------------------
GRIP Awardees................................... 101 1 $13/hr $656.50
---------------------------------------------------------------
Total....................................... 101 1 13/hr 656.50
----------------------------------------------------------------------------------------------------------------
Total Respondent Cost = N Respondents x Response Frequency x minutes to complete/60 x hourly rate.
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) Evaluate 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) Evaluate 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) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) 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 at OIRA_
submission@omb.eop.gov, or by fax to 202-395-6974. To request more
information on the proposed project or to obtain a copy of the data
collection plans and instruments, contact Dr. Linda Kupfer, Fogarty
International Center, National Institutes of Health, 16 Center Drive,
Bethesda, MD 20892, or call non-toll-free number 301-496-3288, or email
your request, including your address to: kupferl@mail.nih.gov.
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: February 12, 2008.
Timothy Tosten,
Executive Officer, FIC, National Institutes of Health.
[FR Doc. E8-3166 Filed 2-20-08; 8:45 am]
BILLING CODE 4140-01-P
