Submission for OMB Review; 30-Day Comment Request Surveys and Interviews To Support an Evaluation of the Innovative Molecular Analysis Technologies (IMAT) Program (NCI), 12487-12488 [2015-05298]
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12487
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
One-time (initial) burden ......................................................
Burden from future review ...................................................
1 There
1
1
Average
burden per
respondent
Total annual
responses
1
1
1
1
Total hours
80
26
80
26
are no capital costs or operating costs associated with the collection of information.
Description of Respondents for
Reporting: The final regulation on BSE
(73 FR 22720) included a provision that
exempts cattle materials prohibited in
animal feed (CMPAF) from designated
countries from the prohibition on its use
in animal feed. A foreign country
seeking this designation will submit a
written request to FDA that includes a
variety of information about the
country’s BSE status (§ 589.2001(f)).
During the past 6 years, FDA received
2 requests from countries to be
exempted from CMPAF restrictions.
One-Time (Initial) Reporting Burden
There is a one-time burden to
countries that apply to FDA seeking to
be designated as not subject to
restrictions applicable to CMPAF. We
estimate that each country that applies
for an exclusion will spend 80 hours
putting information together to submit
to FDA. Table 2 row 1 presents the onetime burden for the exclusion. (See final
BSE regulation at 73 FR 22754).
Recurring Burden
Countries that successfully petition
FDA to be designated as exempt from
certain BSE-related restrictions
applicable to animal feed will be subject
to future review by FDA to ensure that
their designation remains appropriate.
As part of this process, FDA may ask
designated countries from time-to-time
to confirm that their BSE situation and
the information submitted by them in
support of their original application
remains unchanged. We assume it will
take FDA and the designated country
undergoing a review in the future about
one third the time and effort it did when
the information was submitted. Table 2
row 2 presents the expected recurring
burden.
mstockstill on DSK4VPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
21 CFR section 589.2001(f)
Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05356 Filed 3–6–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 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.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel Small Business Innovation
Research (SBIR).
Date: March 31, 2015.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Rahat Khan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, 6701 Democracy
Blvd., Rm 1078, Bethesda, MD 20892, 301–
894–7319, khanr2@csr.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel CTSA Meeting 1.
Date: April 8–9, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Carol Lambert, Ph.D.,
Acting Deputy Director, Office of Grants
Management & Scientific Review, National
Center for Advancing Translational Sciences
(NCATS) National Institutes of Health, 6701
Democracy Boulevard, Democracy 1, Room
1076, Bethesda, MD 20892, 301–435–0814,
lambert@mail.nih.gov.
Name of Committee: National Center for
Advancing Translational Sciences Special
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Emphasis Panel 2015 CTSA Application
Review.
Date: April 15–16, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Guo He Zhang, Ph.D.,
MPH, Scientific Review Office, Office of
Grants Management & Scientific Review,
National Center for Advancing Translational
Sciences (NCATS) National Institutes of
Health, 6701 Democracy Boulevard,
Democracy 1, Room 1064, Bethesda, MD
20892, 301–435–0812, zhanggu@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.350, B–Cooperative Agreements;
93.859, Biomedical Research and Research
Training, National Institutes of Health, HHS).
Dated: March 3, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05304 Filed 3–6–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Surveys and
Interviews To Support an Evaluation of
the Innovative Molecular Analysis
Technologies (IMAT) Program (NCI)
Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on December 4,
2014, Vol. 79, Page 72004 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
SUMMARY:
E:\FR\FM\09MRN1.SGM
09MRN1
12488
Federal Register / Vol. 80, No. 45 / Monday, March 9, 2015 / Notices
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
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, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Anthony Dickherber, NCI
Center for Strategic Scientific Initiatives,
31 Center Drive, Rm10A33, Bethesda,
MD 20892 or call non-toll-free number
301–547–9980 or Email your request,
including your address to:
dickherberaj@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Surveys and
Interviews to Support an Evaluation of
the Innovative Molecular Analysis
Technologies (IMAT) Program (NCI),
0925–NEW, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The purpose of the proposed
evaluation is to pursue a comprehensive
process and outcome assessment of the
15-year old Innovative Molecular
Analysis Technologies (IMAT) program.
While the program consistently offers
promising indicators of success, the full
program has not been evaluated since
2008, and never in as comprehensive a
manner as has been formulated in the
current evaluation plan. An outcome
evaluation of the long-standing National
Cancer Institute’s (NCI) IMAT program
presents a rich and unique opportunity
likely to serve institutes across the
National Institutes of Health (NIH), and
perhaps other federal agencies,
considering the costs and benefits of
directing resources towards supporting
technology development. An award
through the NIH Evaluation Set-Aside
program to support this evaluation, for
which NIH-wide relevance is a principle
element of determining merit for
support, is testament to this. The
evaluation serves as an opportunity to
gauge the impact of investments in
technology development and also to
assess the strengths and weaknesses of
phased innovation award mechanisms.
Like all institutes and centers (ICs) of
the NIH, NCI seeks opportunities for
improving their programs’ utility for the
broad continuum of researchers,
clinicians and ultimately patients. NCI
Director Harold Varmus and other
leadership across NCI, as well as the
NCI Board of Scientific Advisors, will
be the primary users of the evaluation
results. Findings are primarily intended
for considering the long-term strategy to
support innovative technology
development and how to more
efficiently translate emerging
capabilities through such technologies
into the promised benefits for cancer
research and clinical care. Interviews
with grantees, program officers, review
officers, and other NIH awardees make
up a crucial component of the
evaluation plan and will largely follow
set survey protocols. Specific near-term
aims include the use of this information
to consider the utility of continued
investment through existing
solicitations and in strategic planning
generally for institute support for
innovative technology development.
OMB approval is requested for 1 year.
There are no costs to respondents other
than their time. The total estimated
annualized burden hours are 575.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Type of
respondents
IMAT Awardee Interview ...............
Evaluation Web-based Survey ......
Tech End Users Interview .............
IMAT Awardees ...............................................
IMAT Applicants and Other NIH Awardees .....
Technology End-Users ....................................
Dated: February 23, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–05298 Filed 3–6–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on DSK4VPTVN1PROD with NOTICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10555]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
AGENCY:
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ACTION:
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden
(in hours)
100
900
50
1
1
1
1
30/60
30/60
100
450
25
Notice.
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
any of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
SUMMARY:
PO 00000
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performance of the agency’s functions;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Comments must be received by
May 8, 2015.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
DATES:
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Agencies
[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12487-12488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05298]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Surveys and
Interviews To Support an Evaluation of the Innovative Molecular
Analysis Technologies (IMAT) Program (NCI)
SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on December 4, 2014, Vol. 79, Page 72004 and allowed 60-days
for public comment. No public comments were received. The purpose of
this notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an
[[Page 12488]]
information collection that has been extended, revised, or implemented
on or after October 1, 1995, unless it displays a currently valid OMB
control number.
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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Anthony Dickherber, NCI Center for Strategic
Scientific Initiatives, 31 Center Drive, Rm10A33, Bethesda, MD 20892 or
call non-toll-free number 301-547-9980 or Email your request, including
your address to: dickherberaj@mail.nih.gov. Formal requests for
additional plans and instruments must be requested in writing.
Proposed Collection: Surveys and Interviews to Support an
Evaluation of the Innovative Molecular Analysis Technologies (IMAT)
Program (NCI), 0925-NEW, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of the proposed
evaluation is to pursue a comprehensive process and outcome assessment
of the 15-year old Innovative Molecular Analysis Technologies (IMAT)
program. While the program consistently offers promising indicators of
success, the full program has not been evaluated since 2008, and never
in as comprehensive a manner as has been formulated in the current
evaluation plan. An outcome evaluation of the long-standing National
Cancer Institute's (NCI) IMAT program presents a rich and unique
opportunity likely to serve institutes across the National Institutes
of Health (NIH), and perhaps other federal agencies, considering the
costs and benefits of directing resources towards supporting technology
development. An award through the NIH Evaluation Set-Aside program to
support this evaluation, for which NIH-wide relevance is a principle
element of determining merit for support, is testament to this. The
evaluation serves as an opportunity to gauge the impact of investments
in technology development and also to assess the strengths and
weaknesses of phased innovation award mechanisms.
Like all institutes and centers (ICs) of the NIH, NCI seeks
opportunities for improving their programs' utility for the broad
continuum of researchers, clinicians and ultimately patients. NCI
Director Harold Varmus and other leadership across NCI, as well as the
NCI Board of Scientific Advisors, will be the primary users of the
evaluation results. Findings are primarily intended for considering the
long-term strategy to support innovative technology development and how
to more efficiently translate emerging capabilities through such
technologies into the promised benefits for cancer research and
clinical care. Interviews with grantees, program officers, review
officers, and other NIH awardees make up a crucial component of the
evaluation plan and will largely follow set survey protocols. Specific
near-term aims include the use of this information to consider the
utility of continued investment through existing solicitations and in
strategic planning generally for institute support for innovative
technology development.
OMB approval is requested for 1 year. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 575.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average Total
Number of Number of burden per annual
Form name Type of respondents respondents responses per response burden (in
respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
IMAT Awardee Interview............ IMAT Awardees........ 100 1 1 100
Evaluation Web-based Survey....... IMAT Applicants and 900 1 30/60 450
Other NIH Awardees.
Tech End Users Interview.......... Technology End-Users. 50 1 30/60 25
----------------------------------------------------------------------------------------------------------------
Dated: February 23, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-05298 Filed 3-6-15; 8:45 am]
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