Agency Forms Undergoing Paperwork Reduction Act Review, 44774-44775 [2014-18057]

Download as PDF 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]


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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