Proposed Collection; 60-Day Comment Request; Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought 42 CFR Part 50 Subpart F and Responsible Prospective Contractors 45 CFR Part 94 (OD), 78452-78453 [2014-30355]
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78452
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
and pharmacodynamics of nicotine
exposure in users; (4) abuse liability and
dependence; (5) short and long-term
health effects in users; (6)
considerations for high risk or
vulnerable populations; and (7) human
factors. Additional information related
to workshop presentations and
discussion topics, including specific
questions to be addressed at the
workshop, can be found at https://
www.fda.gov/TobaccoProducts/
NewsEvents/ucm238308.htm.
Dated: December 22, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014–30450 Filed 12–29–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Responsibility of Applicants
for Promoting Objectivity in Research
for Which Public Health Service (PHS)
Funding Is Sought 42 CFR Part 50
Subpart F and Responsible
Prospective Contractors 45 CFR Part
94 (OD)
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 (OD), National
Institutes of Health (NIH), will publish
SUMMARY:
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
DATES: Comment 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.
Proposed Collection: Title:
Responsibility of Applicants for
Promoting Objectivity in Research for
which Public Health Service (PHS)
Funding is Sought 42 CFR part 50
Subpart F and Responsible Prospective
Contractors 45 CFR part 94 OMB# 0925–
0417, Expiration Date: 02/2015,
EXTENSION, National Institutes of
Health (NIH), Office of the Director
(OD).
Need and Use of Information
Collection: This is a request for OMB
Approval for an extension of the
information collection and
recordkeeping requirements contained
in the final rule 42 CFR part 50, subpart
F and 45 CFR part 94. The purpose of
these regulations is to promote
objectivity in research by requiring
institutions to establish standards that
provide a reasonable expectation that
the design, conduct, and reporting of
research funded under PHS grants,
cooperative agreements and contracts
will be free from bias resulting from
Investigator financial conflicts of
interest.
OMB approval is requested for an
extension of 3 years. There are operating
costs and/or maintenance costs per
response. The total estimated
annualized burden hours are 676,130.
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
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.
To submit comments and for further
information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Ms. Kathy Hancock,
Assistant Grants Compliance Officer,
Division of Grants Compliance and
Oversight, Office of Policy for
Extramural Research Administration
(OPERA), 6705 Rockledge Drive, Room
3523, Bethesda, MD 20892, or call nontoll-free number (301) 435–1962, or
Email your request, including your
address to: FCOICompliance@
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Type of respondent based on applicable section of regulation
Average
burden per
response
(in hours)
Total annual
burden hour
Reporting
mstockstill on DSK4VPTVN1PROD with NOTICES
Initial Reports under 42 CFR 50.605(b)(1) and (b)(3) or 45 CFR 94.5(b)(1)
and (b)(3) from Awardee Institutions ...........................................................
Subsequent Reports under 42 CFR 50.605(a)(3)(iii) and (b)(2) or 45 CFR
94.5(a)(iii) and (b)(2) from Awardee Institutions ..........................................
Mitigation Reports under 45 CFR 94.5(a)(3)(iii) and (b)(2) from Awardee Institutions .......................................................................................................
Annual Report under 42 CFR 50.605(b)(4) or 45 CFR 94.5(b)(4) from
Awardee Institution .......................................................................................
Subsequent Reports under 42 CFR 60.606(a) or 45 CFR 94.6(a) from
Awardee Institution .......................................................................................
950
1
2
1,900
50
1
2
100
5
1
2
10
950
1
1
950
20
1
10
200
2,000
1
4
8,000
3,000
38,000
2,000
1
1
1
81
30/60
6
243,000
19,000
12,000
Record Keeping
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from Awardee Institutions ..........
Disclosure
Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for Investigators .......................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Investigators .......................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for Institutions ..........................
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30DEN1
78453
Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondent based on applicable section of regulation
Under
Under
Under
Under
Under
Under
Under
Under
Under
Under
Under
Under
Under
Under
42
42
42
42
42
42
42
42
42
42
42
42
42
42
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
50.604(c)(1) or 45 CFR 94(c)(1) from Sub-recipients ............
50.604(d) or 45 CFR 94.4(d) Institutions ................................
50.604(e)(1) or 45 CFR 94.4(e)(1) for Investigators ..............
50.604(e)(2) or 45 CFR 94.4(e)(2) for Investigators ..............
50.604(e)(3) or 45 CFR 94.4(e)(3) for Investigators ..............
50.604(f) or 45 CFR 94.4(f) for Institutions ............................
50.605(a)(1) or 45 CFR 94.5(a)(1) for Institutions ..................
50.605(a)(3) or 45 CFR 94.5(a)(3) for Institutions ..................
50.605(a)(3)(i) or 45 CFR 94.5(a)(3)(i) for Institutions ...........
50.605(a)(3)(ii) or 45 CFR 94.5(a)(3)(ii) for Institutions ..........
50.605(a)(3)(iii) or 45 CFR 94.5(a)(3)(iii) for Institutions ........
50.605(a)(4) or 45 CFR 94.5(a)(4) for Institutions ..................
50.605(a)(5) or 45 CFR 94.5(a)(5) for Institutions ..................
50.606(c) or 45 CFR 94.6(c) for Institutions ...........................
Dated: December 17, 2014.
Lawrence Tabak,
Deputy Director, Office of the Director, NIH.
[FR Doc. 2014–30355 Filed 12–29–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery (NINR)
As part of a Federal
Government-wide effort to streamline
the process to seek feedback from the
public on service delivery, the National
Institute of Nursing Research has
submitted a Generic Information
Collection Request (Generic ICR):
‘‘Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery’’ to OMB for approval under
the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.). This notice
announces our intent to submit this
collection to OMB for approval and
solicits comments on specific aspects
for the proposed information collection.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. Rebecca Hawes,
Division of Science Policy and Public
Liaison, NINR, NIH, Democracy One,
6701 Democracy Blvd., Suite 710,
Bethesda, MD 20892, by phone at (301)
594–0791 or email your request,
including your address to: hawesr@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:42 Dec 29, 2014
Jkt 235001
500
3,000
38,000
38,000
950
2,000
2,000
500
50
50
50
950
2,000
50
Comment 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.
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery, 0925–0653, Expiration Date
3/31/2015, EXTENSION, National
Institutes of Health (NIH), National
Institute of Nursing Research (NINR).
Need and Use of Information
Collection: There are no changes being
requested for this submission. The
information collection activity will
continue to garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Improving agency programs requires
ongoing assessment of service delivery,
by which we mean systematic review of
the operation of a program compared to
a set of explicit or implicit standards, as
a means of contributing to the
PO 00000
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Average
burden per
response
(in hours)
1
1
4
1
30/60
1
82
3
80
80
1
12
5
30/60
Total annual
burden hour
500
3,000
152,000
38,000
475
2,000
164,000
1,500
4,000
4,000
50
11,400
10,000
45
continuous improvement of the
program. The Agency will collect,
analyze, and interpret information
gathered through this generic clearance
to identify strengths and weaknesses of
current services and make
improvements in service delivery based
on feedback. The solicitation of
feedback will target areas such as:
Timeliness, appropriateness, accuracy
of information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the Agency’s services
will be unavailable.
NINR will only submit a collection for
approval under this generic clearance if
it meets the following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are noncontroversial and do not raise issues of
concern to other Federal agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered will be used
only internally for general service
improvement and program management
purposes and is not intended for release
outside of the agency;
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78452-78453]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Responsibility of
Applicants for Promoting Objectivity in Research for Which Public
Health Service (PHS) Funding Is Sought 42 CFR Part 50 Subpart F and
Responsible Prospective Contractors 45 CFR Part 94 (OD)
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 (OD),
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.
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.
To submit comments and for further information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Ms. Kathy
Hancock, Assistant Grants Compliance Officer, Division of Grants
Compliance and Oversight, Office of Policy for Extramural Research
Administration (OPERA), 6705 Rockledge Drive, Room 3523, Bethesda, MD
20892, or call non-toll-free number (301) 435-1962, or Email your
request, including your address to: FCOICompliance@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
DATES: Comment 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.
Proposed Collection: Title: Responsibility of Applicants for
Promoting Objectivity in Research for which Public Health Service (PHS)
Funding is Sought 42 CFR part 50 Subpart F and Responsible Prospective
Contractors 45 CFR part 94 OMB# 0925-0417, Expiration Date: 02/2015,
EXTENSION, National Institutes of Health (NIH), Office of the Director
(OD).
Need and Use of Information Collection: This is a request for OMB
Approval for an extension of the information collection and
recordkeeping requirements contained in the final rule 42 CFR part 50,
subpart F and 45 CFR part 94. The purpose of these regulations is to
promote objectivity in research by requiring institutions to establish
standards that provide a reasonable expectation that the design,
conduct, and reporting of research funded under PHS grants, cooperative
agreements and contracts will be free from bias resulting from
Investigator financial conflicts of interest.
OMB approval is requested for an extension of 3 years. There are
operating costs and/or maintenance costs per response. The total
estimated annualized burden hours are 676,130.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent based on applicable section Number of responses per per response Total annual
of regulation respondents respondent (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
Reporting
----------------------------------------------------------------------------------------------------------------
Initial Reports under 42 CFR 50.605(b)(1) and 950 1 2 1,900
(b)(3) or 45 CFR 94.5(b)(1) and (b)(3) from
Awardee Institutions...........................
Subsequent Reports under 42 CFR 50 1 2 100
50.605(a)(3)(iii) and (b)(2) or 45 CFR
94.5(a)(iii) and (b)(2) from Awardee
Institutions...................................
Mitigation Reports under 45 CFR 94.5(a)(3)(iii) 5 1 2 10
and (b)(2) from Awardee Institutions...........
Annual Report under 42 CFR 50.605(b)(4) or 45 950 1 1 950
CFR 94.5(b)(4) from Awardee Institution........
Subsequent Reports under 42 CFR 60.606(a) or 45 20 1 10 200
CFR 94.6(a) from Awardee Institution...........
----------------------------------------------------------------------------------------------------------------
Record Keeping
----------------------------------------------------------------------------------------------------------------
Under 42 CFR 50.604(i) or 45 CFR 94.4(i) from 2,000 1 4 8,000
Awardee Institutions...........................
----------------------------------------------------------------------------------------------------------------
Disclosure
----------------------------------------------------------------------------------------------------------------
Under 42 CFR 50.604(a) or 45 CFR 94.4(a) for 3,000 1 81 243,000
Investigators..................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for 38,000 1 30/60 19,000
Investigators..................................
Under 42 CFR 50.604(b) or 45 CFR 94.4(b) for 2,000 1 6 12,000
Institutions...................................
[[Page 78453]]
Under 42 CFR 50.604(c)(1) or 45 CFR 94(c)(1) 500 1 1 500
from Sub-recipients............................
Under 42 CFR 50.604(d) or 45 CFR 94.4(d) 3,000 1 1 3,000
Institutions...................................
Under 42 CFR 50.604(e)(1) or 45 CFR 94.4(e)(1) 38,000 1 4 152,000
for Investigators..............................
Under 42 CFR 50.604(e)(2) or 45 CFR 94.4(e)(2) 38,000 1 1 38,000
for Investigators..............................
Under 42 CFR 50.604(e)(3) or 45 CFR 94.4(e)(3) 950 1 30/60 475
for Investigators..............................
Under 42 CFR 50.604(f) or 45 CFR 94.4(f) for 2,000 1 1 2,000
Institutions...................................
Under 42 CFR 50.605(a)(1) or 45 CFR 94.5(a)(1) 2,000 1 82 164,000
for Institutions...............................
Under 42 CFR 50.605(a)(3) or 45 CFR 94.5(a)(3) 500 1 3 1,500
for Institutions...............................
Under 42 CFR 50.605(a)(3)(i) or 45 CFR 50 1 80 4,000
94.5(a)(3)(i) for Institutions.................
Under 42 CFR 50.605(a)(3)(ii) or 45 CFR 50 1 80 4,000
94.5(a)(3)(ii) for Institutions................
Under 42 CFR 50.605(a)(3)(iii) or 45 CFR 50 1 1 50
94.5(a)(3)(iii) for Institutions...............
Under 42 CFR 50.605(a)(4) or 45 CFR 94.5(a)(4) 950 1 12 11,400
for Institutions...............................
Under 42 CFR 50.605(a)(5) or 45 CFR 94.5(a)(5) 2,000 1 5 10,000
for Institutions...............................
Under 42 CFR 50.606(c) or 45 CFR 94.6(c) for 50 1 30/60 45
Institutions...................................
----------------------------------------------------------------------------------------------------------------
Dated: December 17, 2014.
Lawrence Tabak,
Deputy Director, Office of the Director, NIH.
[FR Doc. 2014-30355 Filed 12-29-14; 8:45 am]
BILLING CODE 4140-01-P
