Proposed Collection; Comment Request; A Process Evaluation of the NIH Director's New Innovator Award (NIA) Program, 7908-7909 [E9-3584]
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7908
Federal Register / Vol. 74, No. 33 / Friday, February 20, 2009 / Notices
Dated: February 17, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–3647 Filed 2–19–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0044]
Draft Guidance for Industry on
Influenza: Developing Drugs for
Treatment and/or Prophylaxis;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Influenza: Developing
Drugs for Treatment and/or
Prophylaxis.’’ Recent concerns about the
possibility of pandemic spread of novel
influenza strains have increased interest
in influenza drug development for both
seasonal and pandemic settings. The
purpose of this guidance is to assist
sponsors in all phases of influenza drug
development and to address questions
FDA often receives regarding the
potential for emergency use of influenza
drugs for the treatment and/or
prophylaxis of influenza.
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considers your comment on this draft
guidance before it begins work on the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
written or electronic comments on the
draft guidance by May 21, 2009.
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single copies of the draft guidance to the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. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
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FOR FURTHER INFORMATION CONTACT:
Debra Birnkrant, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6332,
Silver Spring, MD 20993–0002, 301–
796–0770.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Influenza: Developing Drugs for
Treatment and/or Prophylaxis.’’ Because
of the public health implications of both
seasonal and pandemic influenza, the
variable nature of the disease, and the
limited therapeutic options and
challenges in studying new options,
FDA is developing guidance to assist
sponsors in all phases of influenza drug
development. This draft guidance
addresses preclinical development,
early phases of clinical development,
phase 3 protocol designs and endpoints
for the treatment of both uncomplicated
and serious influenza, and protocol
designs for the prophylaxis of
symptomatic influenza. This guidance
also addresses the role of animal data in
an influenza drug development program
and considerations relating to the
potential for emergency use of influenza
drugs including advance development
of protocols for further exploration and
verification of drug effects.
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
and/or prophylaxis of influenza. 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 (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
Control Numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
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comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified 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
eitherhttps://www.fda.gov/cder/
guidance/index.htm or https://
www.regulations.gov.
Dated: February 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–3554 Filed 2–19–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; A Process Evaluation of the
NIH Director’s New Innovator Award
(NIA) Program
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
Office of the Director, the 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: A Process
Evaluation of the NIH Director’s New
Innovator Award (NIA) Program. Type
of Information Collection Request: New
collection. Need and Use of Information
Collection: This study will assess the
NIA Program operations and the outputs
of the identification, evaluation and
selection process. The primary
objectives of the study are to: (1) Assess
the NIA award selection process; (2)
determine if the program was
implemented as planned; and (3)
determine if the process was conducted
in accordance with the overall mission
of the NIA program. The findings will
provide valuable information
concerning: (1) The characteristics of
applicants and reviewers; (2) the criteria
used to evaluate and select awardees;
and (3) aspects of the process that could
be revised or improved.
Frequency of Response: Once.
Affected Public: none. Type of
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7909
Federal Register / Vol. 74, No. 33 / Friday, February 20, 2009 / Notices
Respondents: Applicants, Reviewers.
There are no Capital Costs to report.
There are no Operating or Maintenance
Costs to report. Estimated Number of
Respondents: 662; Estimated Number of
Responses per Respondent: 1: Average
Burden Hours Per Response: .28 (15
minutes for applicants and 30 minutes
for Extramural Reviewers), and
Estimated Total Annual Burden Hours
Requested: 188.5 and the annualized
cost to respondents is estimated at
$12,199.72. Table l 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*
Applicants ........................................................................................................
Extramural Reviewers ......................................................................................
570
92
1
1
.25
.50
142.5
46
Total ..........................................................................................................
662
1
.28
188.5
Response frequency
Approx. hourly
wage rate
Total Burden = N Respondents*Response Frequency*(minutes to complete/60).
TABLE 2—ANNUALIZED COST TO RESPONDENTS
Number of
respondents
Type of respondents
Total
respondent
cost**
Applicants ........................................................................................................
Extramural Reviewers ......................................................................................
570
92
1
1
$64.72
64.72
$9,226.60
2977.12
Total ..........................................................................................................
662
1
64.72
12,199.72
**Total Respondent Cost = Total Hour Burden * Hourly Wage 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) 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 G. Stephane
Philogene, Ph.D., Assistant Director for
Policy and Planning, Office of
Behavioral and Social Sciences
Research, National Institutes of Health,
31 Center Drive. Building 31, Room B2–
B37, Bethesda, MD 20892, or call nontoll-free number (301) 402–3902 or email your request, including your
address to: philoges@od.nih.gov.
Comments Due Date: Comments
regarding this information collection are
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17:55 Feb 19, 2009
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best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: February 10, 2009.
G. Stephane Philogene,
Assistant Director for Policy and Planning,
Office of Behavioral and Social Sciences
Research, National Institutes of Health.
[FR Doc. E9–3584 Filed 2–19–09; 8:45 am]
BILLING CODE 4140–10–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
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.
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 Institute of
General Medical Sciences Initial Review
Group, Minority Programs Review
Subcommittee B.
Date: March 13, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Rebecca H. Johnson, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18C, Bethesda,
MD 20892, 301–594–2771,
johnsonrh@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: February 12, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–3581 Filed 2–19–09; 8:45 am]
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]]>Agencies
[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Pages 7908-7909]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3584]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; A Process Evaluation of the
NIH Director's New Innovator Award (NIA) Program
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 Office of the Director, the
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: A Process Evaluation of the NIH
Director's New Innovator Award (NIA) Program. Type of Information
Collection Request: New collection. Need and Use of Information
Collection: This study will assess the NIA Program operations and the
outputs of the identification, evaluation and selection process. The
primary objectives of the study are to: (1) Assess the NIA award
selection process; (2) determine if the program was implemented as
planned; and (3) determine if the process was conducted in accordance
with the overall mission of the NIA program. The findings will provide
valuable information concerning: (1) The characteristics of applicants
and reviewers; (2) the criteria used to evaluate and select awardees;
and (3) aspects of the process that could be revised or improved.
Frequency of Response: Once. Affected Public: none. Type of
[[Page 7909]]
Respondents: Applicants, Reviewers. There are no Capital Costs to
report. There are no Operating or Maintenance Costs to report.
Estimated Number of Respondents: 662; Estimated Number of Responses per
Respondent: 1: Average Burden Hours Per Response: .28 (15 minutes for
applicants and 30 minutes for Extramural Reviewers), and Estimated
Total Annual Burden Hours Requested: 188.5 and the annualized cost to
respondents is estimated at $12,199.72. Table l 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*
----------------------------------------------------------------------------------------------------------------
Applicants...................................... 570 1 .25 142.5
Extramural Reviewers............................ 92 1 .50 46
---------------------------------------------------------------
Total....................................... 662 1 .28 188.5
----------------------------------------------------------------------------------------------------------------
Total Burden = N Respondents*Response Frequency*(minutes to complete/60).
Table 2--Annualized Cost to Respondents
----------------------------------------------------------------------------------------------------------------
Total
Type of respondents Number of Response Approx. hourly respondent
respondents frequency wage rate cost**
----------------------------------------------------------------------------------------------------------------
Applicants...................................... 570 1 $64.72 $9,226.60
Extramural Reviewers............................ 92 1 64.72 2977.12
---------------------------------------------------------------
Total....................................... 662 1 64.72 12,199.72
----------------------------------------------------------------------------------------------------------------
**Total Respondent Cost = Total Hour Burden * Hourly Wage 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) 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 G. Stephane Philogene, Ph.D., Assistant Director
for Policy and Planning, Office of Behavioral and Social Sciences
Research, National Institutes of Health, 31 Center Drive. Building 31,
Room B2-B37, Bethesda, MD 20892, or call non-toll-free number (301)
402-3902 or e-mail your request, including your address to:
philoges@od.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: February 10, 2009.
G. Stephane Philogene,
Assistant Director for Policy and Planning, Office of Behavioral and
Social Sciences Research, National Institutes of Health.
[FR Doc. E9-3584 Filed 2-19-09; 8:45 am]
BILLING CODE 4140-10-P
