Agency Forms Undergoing Paperwork Reduction Act Review, 44774-44775 [2014-18057]
Download as PDF
<![CDATA[
44774
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
which will in turn decide whether to
proceed with formal advice to GSA
based upon these recommendations.
Dated: July 28, 2014.
Kevin Kampschroer,
Federal Director, Office of Federal HighPerformance Green Buildings, General
Services Administration.
[FR Doc. 2014–18280 Filed 7–31–14; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Jun Fu, Ph.D., University of Texas MD
Anderson Cancer Center: Based on the
Respondent’s admission, the report of
an inquiry conducted by the University
of Texas MD Anderson Cancer Center
(MDACC), and analysis conducted by
ORI in its oversight review, ORI found
that Dr. Jun Fu, former Postdoctoral
Fellow, Department of Neuro-Oncology,
MDACC, engaged in research
misconduct in research supported by
National Cancer Institute (NCI),
National Institutes of Health (NIH),
grants CA56041 and CA127001.
The Respondent has admitted to
knowingly and intentionally falsifying
Figure 8a in the following publication:
• ‘‘Novel HSP90 inhibitor NVP–
HSP990 targets cell-cycle regulators to
ablate Olig2-positive glioma tumorinitiating cells.’’ Cancer Res.
73(10):3062–74, 2013 May 15.
Specifically, the Respondent falsified
survival times of mice to show that
NVP–HSP990 prolonged survival rates
in glioblastoma tumor bearing mice
when experimental data were
incomplete and unusable.
As a result of its inquiry, MDACC has
recommended that the senior author of
this paper take any appropriate steps
with the journal to correct the scientific
literature.
Dr. Fu has entered into a Voluntary
Settlement Agreement (Agreement) and
has voluntarily agreed for a period of
two (2) years, beginning on July 15,
2014:
(1) To have his research supervised;
Respondent agrees that prior to the
submission of an application for U.S.
Public Health Service (PHS) support for
a research project on which the
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity on PHS-supported
research, Respondent shall ensure that a
plan for supervision of Respondent’s
duties is submitted to ORI for approval;
the supervision plan must be designed
to ensure the scientific integrity of
Respondent’s research; Respondent
agrees that he shall not participate in
any PHS-supported research until such
a supervision plan is submitted to and
approved by ORI; Respondent agrees to
maintain responsibility for compliance
with the agreed upon supervision plan;
(2) that any institution employing him
shall submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which
Respondent is involved, a certification
to ORI that the data provided by
Respondent are based on actual
experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract; and
(3) to exclude himself voluntarily
from serving in any advisory capacity to
PHS including, but not limited to,
service on any PHS advisory committee,
board, and/or peer review committee, or
as a consultant.
FOR FURTHER INFORMATION CONTACT:
Acting Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453–
8800.
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Donald Wright,
Acting Director, Office of Research Integrity.
Respiratory Protective Devices—42
CFR part 84—Regulation—(0920–
0109)—Revision—National Institute for
Occupational Safety and Health
(NIOSH), of the Centers for Disease
Control and Prevention (CDC).
[FR Doc. 2014–18173 Filed 7–31–14; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–14–0109]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Proposed Project
Background and Brief Description
This data collection was formerly
named Respiratory Protective Devices
30 CFR part 11 but in 1995, the
respirator standard was moved to 42
CFR Part 84. The regulatory authority
for the National Institute for
Occupational Safety and Health
(NIOSH) certification program for
respiratory protective devices is found
in the Mine Safety and Health
Amendments Act of 1977 (30 U.S.C.
577a, 651 et seq., and 657(g)) and the
Occupational Safety and Health Act of
1970 (30 U.S.C. 3, 5, 7, 811, 842(h),
844). These regulations have, as their
basis, the performance tests and criteria
for approval of respirators used by
millions of American construction
workers, miners, painters, asbestos
removal workers, fabric mill workers,
and fire fighters.
E:\FR\FM\01AUN1.SGM
01AUN1
44775
Federal Register / Vol. 79, No. 148 / Friday, August 1, 2014 / Notices
Regulations of the Environmental
Protection Agency (EPA) and the
Nuclear Regulatory Commission (NRC)
also require the use of NIOSH-approved
respirators. These regulations also
establish methods for respirator
manufacturers to submit respirators for
testing under the regulation and have
them certified as NIOSH-approved if
they meet the criteria given in the above
regulation.
NIOSH, in accordance with 42 CFR
Part 84: (1) Issues certificates of
approval for respirators which have met
specified construction, performance,
and protection requirements; (2)
establishes procedures and
requirements to be met in filing
applications for approval; (3) specifies
minimum requirements and methods to
be employed by NIOSH and by
applicants in conducting inspections,
examinations, and tests to determine
effectiveness of respirators; (4)
establishes a schedule of fees to be
charged applicants for testing and
certification, and (5) establishes
approval labeling requirements.
Information is collected from those who
request services under 42 CFR Part 84
in order to properly establish the scope
and intent of request.
Information collected from requests
for respirator approval functions
includes contact information and
information about factors likely to affect
respirator performance and use. Such
information includes, but is not
necessarily limited to, respirator design,
manufacturing methods and materials,
quality assurance plans and procedures,
and user instruction and draft labels, as
specified in the regulation.
The main instrument for data
collection for respirator approval
functions is the Standard Application
for the Approval of Respirators (SAF),
currently Version 7. A replacement
instrument which will collect the same
information is in development.
Respirator manufacturers are the
respondents (estimated to average 63
each year over the years 2014–2016) and
upon completion of the SAF their
requests for approval are evaluated. The
applications are submitted at will and
the most reasonable prediction of
respondents is the number from the
most recent year, 63 in 2013. The
decrease is likely due to random
fluctuations and changes in business
conditions. No survey was conducted to
more thoroughly analyze the reasons for
the change in number of respondents.
Although there is no cost to respondents
to submit other than their time to
participate, respondents requesting
respirator approval are required to
submit fees for necessary testing as
specified in 42 CFR Parts 84.20–22,
84.66, 84.258 and 84.1102. In calendar
year 2013 $449,610 was accepted.
Applicants are required to provide
test data that shows that the
manufacturer is capable of ensuring that
the respirator is capable of meeting the
specified requirements in 42 CFR Part
84. The requirement for submitted test
data is likely to be satisfied by standard
testing performed by the manufacturer,
and is not required to follow the
relevant NIOSH Standard Test
Procedures. As additional testing is not
required, providing proof that an
adequate test has been performed is
limited to providing existing paperwork.
42 CFR Part 84 approvals offer
corroboration that approved respirators
are produced to certain quality
standards. Although 42 CFR Part 84
Subpart E prescribes certain quality
standards, it is not expected that
requiring approved quality standards
will impose an additional cost burden
over similarly effective quality
standards that are not approved under
42 CFR Part 84.
Manufacturers with current approvals
are subject to site audits by the Institute
or its agents under 42 CFR 84.43. There
is no fee or form associated with audits.
Audits may occur periodically or as a
result of a reported issue. Sixty site
audits were scheduled for the 2013
calendar year. The total request burden
hours are 102,429.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Business or other for-profit .............................
Standard Application for the Approval of
Respirators Version 7 and Version 8.
Audit ...............................................................
(42 CFR 84.43) ..............................................
Business or other for-profit .............................
Leroy Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2014–18057 Filed 7–31–14; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–222–92]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
BILLING CODE 4163–18–P
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
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
(PRA), federal agencies are required to
SUMMARY:
VerDate Mar<15>2010
22:09 Jul 31, 2014
Jkt 232001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
63
7
229
60
1
24
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
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate 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 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
E:\FR\FM\01AUN1.SGM
01AUN1
]]>Agencies
[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44774-44775]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18057]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-0109]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
Respiratory Protective Devices--42 CFR part 84--Regulation--(0920-
0109)--Revision--National Institute for Occupational Safety and Health
(NIOSH), of the Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This data collection was formerly named Respiratory Protective
Devices 30 CFR part 11 but in 1995, the respirator standard was moved
to 42 CFR Part 84. The regulatory authority for the National Institute
for Occupational Safety and Health (NIOSH) certification program for
respiratory protective devices is found in the Mine Safety and Health
Amendments Act of 1977 (30 U.S.C. 577a, 651 et seq., and 657(g)) and
the Occupational Safety and Health Act of 1970 (30 U.S.C. 3, 5, 7, 811,
842(h), 844). These regulations have, as their basis, the performance
tests and criteria for approval of respirators used by millions of
American construction workers, miners, painters, asbestos removal
workers, fabric mill workers, and fire fighters.
[[Page 44775]]
Regulations of the Environmental Protection Agency (EPA) and the
Nuclear Regulatory Commission (NRC) also require the use of NIOSH-
approved respirators. These regulations also establish methods for
respirator manufacturers to submit respirators for testing under the
regulation and have them certified as NIOSH-approved if they meet the
criteria given in the above regulation.
NIOSH, in accordance with 42 CFR Part 84: (1) Issues certificates
of approval for respirators which have met specified construction,
performance, and protection requirements; (2) establishes procedures
and requirements to be met in filing applications for approval; (3)
specifies minimum requirements and methods to be employed by NIOSH and
by applicants in conducting inspections, examinations, and tests to
determine effectiveness of respirators; (4) establishes a schedule of
fees to be charged applicants for testing and certification, and (5)
establishes approval labeling requirements. Information is collected
from those who request services under 42 CFR Part 84 in order to
properly establish the scope and intent of request.
Information collected from requests for respirator approval
functions includes contact information and information about factors
likely to affect respirator performance and use. Such information
includes, but is not necessarily limited to, respirator design,
manufacturing methods and materials, quality assurance plans and
procedures, and user instruction and draft labels, as specified in the
regulation.
The main instrument for data collection for respirator approval
functions is the Standard Application for the Approval of Respirators
(SAF), currently Version 7. A replacement instrument which will collect
the same information is in development.
Respirator manufacturers are the respondents (estimated to average
63 each year over the years 2014-2016) and upon completion of the SAF
their requests for approval are evaluated. The applications are
submitted at will and the most reasonable prediction of respondents is
the number from the most recent year, 63 in 2013. The decrease is
likely due to random fluctuations and changes in business conditions.
No survey was conducted to more thoroughly analyze the reasons for the
change in number of respondents. Although there is no cost to
respondents to submit other than their time to participate, respondents
requesting respirator approval are required to submit fees for
necessary testing as specified in 42 CFR Parts 84.20-22, 84.66, 84.258
and 84.1102. In calendar year 2013 $449,610 was accepted.
Applicants are required to provide test data that shows that the
manufacturer is capable of ensuring that the respirator is capable of
meeting the specified requirements in 42 CFR Part 84. The requirement
for submitted test data is likely to be satisfied by standard testing
performed by the manufacturer, and is not required to follow the
relevant NIOSH Standard Test Procedures. As additional testing is not
required, providing proof that an adequate test has been performed is
limited to providing existing paperwork.
42 CFR Part 84 approvals offer corroboration that approved
respirators are produced to certain quality standards. Although 42 CFR
Part 84 Subpart E prescribes certain quality standards, it is not
expected that requiring approved quality standards will impose an
additional cost burden over similarly effective quality standards that
are not approved under 42 CFR Part 84.
Manufacturers with current approvals are subject to site audits by
the Institute or its agents under 42 CFR 84.43. There is no fee or form
associated with audits. Audits may occur periodically or as a result of
a reported issue. Sixty site audits were scheduled for the 2013
calendar year. The total request burden hours are 102,429.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Business or other for-profit.......... Standard Application for 63 7 229
the Approval of
Respirators Version 7
and Version 8.
Business or other for-profit.......... Audit................... 60 1 24
(42 CFR 84.43)..........
----------------------------------------------------------------------------------------------------------------
Leroy Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2014-18057 Filed 7-31-14; 8:45 am]
BILLING CODE 4163-18-P
