Submission for OMB Review; Comment Request; Assessing the Long-Term Impacts of the John E. Fogarty International Center's Research and Training Programs, 52754-52755 [2010-21350]
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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices
comments that yielded improvements to
our data collection instrument, and we
are therefore submitting a revised data
collection form for emergency clearance.
The definition of subsidized
employment used for this collection is
the same as the definition for the TANF
program in general, given in 45 CFR
261.2(c) and (d). This information will
help the agency as well as the public
better understand how jurisdictions are
using the money they are awarded
through the Emergency Fund.
A voluntary information collection
relating to the number of individuals in
subsidized employment will serve
several purposes.
This information will demonstrate the
impact of the program, help ACF to
evaluate the effectiveness of this
initiative, and provide information to
aide in the transparency and
accountability of jurisdictions receiving
Recovery Act funds. This information
will also allow the Administration to
publicly communicate the impact and
achievements of the program, and make
future policy decisions on the basis of
such knowledge.
Respondents: State, territory, and
tribal agencies administering the
Temporary Assistance for Needy
Families (TANF) Program that have
received TANF Emergency Funds.
Number of
respondents
(jurisdictions)
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Subsidized Employment Report OFA–200 ......................................................
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Instrument
74
1
24
1,776
Estimated Total Annual Burden
Hours: We estimate the annualized cost
of the hour burden to be $159,840. This
figure is based on an estimated average
hourly cost of $90 (including fringe
benefits, overhead, and general and
administrative costs) for the jurisdiction
staff performing the work multiplied by
the estimated 1,776 burden hours,
calculated based on 74 jurisdictions
applying for and receiving TANF
Emergency Funds (all States and
Territories, plus an estimated 20 tribes)
If the TANF Emergency Fund is
extended and jurisdictions report in FY
2011, the jurisdiction would submit four
additional responses and the total
burden hours for FY 2011 would be
7,104.
Additional Information: ACF is
requesting that OMB grant a 180-day
approval for this information collection
under procedures for emergency
processing by September 13, 2010. A
copy of this information collection, with
applicable supporting documentation,
may be obtained by calling the
Administration for Children and
Families, Reports Clearance Officer,
Robert Saris at (202) 690–7275.
Comments about the information
collection described above should be
directed to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for ACF, Office of Management
and Budget, Paperwork Reduction
Project, 725 17th Street, NW.,
Washington, DC 20503; FAX: (202) 395–
7285; e-mail: oirasubmission@ornb.eop.
gov.
Dated: August 18, 2010.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2010–21203 Filed 8–26–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Assessing the
Long-Term Impacts of the John E.
Fogarty International Center’s
Research and Training Programs
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the John E.
Fogarty International Center, the
National Institutes of Health 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 May 27, 2010
(volume 75, number 102, page 29763)
and allowed 60 days for public
comment. One comment was received
from a member of the public. The
purpose of this notice is to allow an
additional 30 days for public comment.
Proposed Collection: Title: Assessing
the Long-Term Impacts of the John E.
Fogarty International Center’s Research
and Training Programs. Type of
Information Collection Request: New
collection. Need and Use of Information
Collection: This study will inform
investment decisions and strategies
employed by the Fogarty International
Center for the purpose of strengthening
biomedical research capacity in low and
middle income countries. The primary
objective of the study is to develop
detailed case studies of the long-term
impacts of Fogarty’s research and
training programs on educational
institutions located in low and middle
income countries. The findings will
provide valuable information
concerning return on the Center’s
investments over the past twenty years
and effective strategies for promoting
SUMMARY:
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research capacity development in the
future. Frequency of Response: Once.
Affected Public: Individuals. Type of
Respondents: Current and former NIH
grantees; Current and former NIH
trainees in countries of interest; Leaders
and administrators at institutions of
interest; Policy-makers and scientific
leaders in countries of interest. The
annual reporting burden is as follows:
Estimated Number of Respondents:
210 per year. Estimated Number of
Responses per Respondent: 1. Average
Burden Hours per Response: 1.
Estimated Total Annual Burden Hours
Requested: 290. The annualized cost to
respondents is estimated at: $4,841.
There are no Capital Costs to report.
There are no Operating 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.
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
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Federal Register / Vol. 75, No. 166 / Friday, August 27, 2010 / Notices
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
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 Dr. Linda Kupfer,
Fogarty International Center, National
Institutes of Health, 16 Center Drive,
Bethesda, MD 20892, or call non-tollfree number 301–496–3288, or e-mail
your request, including your address to:
Linda.Kupfer@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: August 23, 2010.
Timothy J. Tosten,
Executive Officer, John E. Fogarty
International Center, National Institutes of
Health.
[FR Doc. 2010–21350 Filed 8–26–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0433]
Draft Guidance for Industry on Acute
Bacterial Skin and Skin Structure
Infections: Developing Drugs for
Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Acute Bacterial Skin
and Skin Structure Infections:
Developing Drugs for Treatment.’’ The
purpose of this draft guidance is to
assist clinical trial sponsors and
investigators in the development of
antimicrobial drugs for the treatment of
acute bacterial skin and skin structure
infections (ABSSSI), impetigo, and
minor cutaneous abscesses. FDA’s
thinking in this area has evolved in
recent years, and this draft guidance,
when finalized, will inform sponsors of
the changes in the definitions of ABSSSI
and the recommendations for clinical
drug development.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
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SUMMARY:
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on the draft guidance by November 26,
2010.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Acute Bacterial Skin and Skin
Structure Infections: Developing Drugs
for Treatment.’’ The purpose of this draft
guidance is to assist clinical trial
sponsors and investigators in the
development of antimicrobial drugs for
the treatment of ABSSSI, impetigo, and
minor cutaneous abscesses. This
guidance revises the draft guidance
regarding uncomplicated and
complicated skin and skin structure
infections published in 1998. The
guidance also addresses the clinical
development of new drugs to treat drugresistant bacterial pathogens implicated
in ABSSSI, such as methicillin-resistant
Staphylococcus aureus.
The definitions of ABSSSI and the
designs of ABSSSI clinical trials were
discussed at a meeting of the AntiInfective Drugs Advisory Committee on
November 18, 2008. In addition, other
advisory committee meetings have
focused on the development of specific
drugs for this indication. As a result of
these public discussions, as well as
review of applications at FDA, the
agency’s thinking in this area has
evolved in recent years and this draft
guidance informs sponsors of the
changes in our recommendations.
Specifically, the guidance defines the
clinical disease entities and provides a
justification for a noninferiority margin
for the design of active-controlled
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52755
clinical trials that can be used to
provide evidence of efficacy for the
treatment of ABSSSI. The guidance
describes a new responder efficacy
endpoint for noninferiority trials that is
based on the historical studies used to
justify the noninferiority margin.
Currently, there are ongoing efforts in
the scientific community to develop and
evaluate new efficacy endpoints for
ABSSSI. The guidance also defines the
clinical disease entities of skin
infections for which a superiority trial is
recommended.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on developing drugs for the treatment of
ABSSSI. 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.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget under the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3520). The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014 and the collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
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]]>Agencies
[Federal Register Volume 75, Number 166 (Friday, August 27, 2010)]
[Notices]
[Pages 52754-52755]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Assessing the Long-
Term Impacts of the John E. Fogarty International Center's Research and
Training Programs
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the John E. Fogarty International Center, the
National Institutes of Health 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 May 27, 2010 (volume
75, number 102, page 29763) and allowed 60 days for public comment. One
comment was received from a member of the public. The purpose of this
notice is to allow an additional 30 days for public comment.
Proposed Collection: Title: Assessing the Long-Term Impacts of the
John E. Fogarty International Center's Research and Training Programs.
Type of Information Collection Request: New collection. Need and Use of
Information Collection: This study will inform investment decisions and
strategies employed by the Fogarty International Center for the purpose
of strengthening biomedical research capacity in low and middle income
countries. The primary objective of the study is to develop detailed
case studies of the long-term impacts of Fogarty's research and
training programs on educational institutions located in low and middle
income countries. The findings will provide valuable information
concerning return on the Center's investments over the past twenty
years and effective strategies for promoting research capacity
development in the future. Frequency of Response: Once. Affected
Public: Individuals. Type of Respondents: Current and former NIH
grantees; Current and former NIH trainees in countries of interest;
Leaders and administrators at institutions of interest; Policy-makers
and scientific leaders in countries of interest. The annual reporting
burden is as follows:
Estimated Number of Respondents: 210 per year. Estimated Number of
Responses per Respondent: 1. Average Burden Hours per Response: 1.
Estimated Total Annual Burden Hours Requested: 290. The annualized cost
to respondents is estimated at: $4,841. There are no Capital Costs to
report. There are no Operating 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.
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
[[Page 52755]]
Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-
6974, 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 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 e-mail your
request, including your address to: Linda.Kupfer@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: August 23, 2010.
Timothy J. Tosten,
Executive Officer, John E. Fogarty International Center, National
Institutes of Health.
[FR Doc. 2010-21350 Filed 8-26-10; 8:45 am]
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