Agency Forms Undergoing Paperwork Reduction Act Review, 76690-76692 [2015-31104]

Download as PDF 76690 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices technically feasible. We therefore cannot find that the New 2010 Requirements that we analyzed under the full authorization criteria are inconsistent with section 209 of the Act. Having found that the New 2010 Requirements satisfy each of the criteria for full authorization, and having received no contrary evidence to contradict this finding, we cannot deny authorization of the amendments. mstockstill on DSK4VPTVN1PROD with NOTICES III. Decision The Administrator has delegated the authority to grant California section 209(e) authorizations to the Assistant Administrator for Air and Radiation. After evaluating CARB’s amendments to its Portable Engine ATCM regulations described above and CARB’s submissions for EPA review, EPA is granting a within-the-scope authorization for the Portable Engine ATCM 2007, 2009, and 2010 Amendments, other than the New 2010 Requirements (as specified above). In addition, EPA is granting a full authorization for the New 2010 Requirements. This decision will affect persons in California and those manufacturers and/ or owners/operators nationwide who must comply with California’s requirements. In addition, because other states may adopt California’s standards for which a section 209(e)(2)(A) authorization has been granted if certain criteria are met, this decision would also affect those states and those persons in such states. See CAA section 209(e)(2)(B). For these reasons, EPA determines and finds that this is a final action of national applicability, and also a final action of nationwide scope or effect for purposes of section 307(b)(1) of the Act. Pursuant to section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeals for the District of Columbia Circuit. Petitions for review must be filed by February 8, 2016. Judicial review of this final action may not be obtained in subsequent enforcement proceedings, pursuant to section 307(b)(2) of the Act. IV. Statutory and Executive Order Reviews As with past authorization and waiver decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866. In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 flexibility analysis addressing the impact of this action on small business entities. Further, the Congressional Review Act, 5 U.S.C. 801, et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3). Dated: December 1, 2015. Janet G. McCabe, Acting Assistant Administrator, Office of Air and Radiation. [FR Doc. 2015–31043 Filed 12–9–15; 8:45 am] insurance plans, including designing plans, assisting in the implementation of plans, providing administrative services to plans, and developing employee communication programs for plans, pursuant to sections 225.28(b)(5), (b)(6)(ii), (b)(9)(ii) and (b)(14)(i), respectively. Board of Governors of the Federal Reserve System, December 7, 2015. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2015–31109 Filed 12–9–15; 8:45 am] BILLING CODE 6210–01–P BILLING CODE 6560–50–P FEDERAL RESERVE SYSTEM Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y, (12 CFR part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or other company, in a nonbanking activity that is listed in § 225.28 of Regulation Y (12 CFR 225.28) or that the Board has determined by Order to be closely related to banking and permissible for bank holding companies. Unless otherwise noted, these activities will be conducted throughout the United States. Each notice is available for inspection at the Federal Reserve Bank indicated. The notice also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the question whether the proposal complies with the standards of section 4 of the BHC Act. Unless otherwise noted, comments regarding the notices must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 28, 2015. A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480–0291: 1. State Bankshares, Inc., Fargo, North Dakota to acquire an additional 51 percent of the voting shares of Discovery Benefits, Inc., Fargo, North Dakota, and indirectly acquire additional voting shares of Discovery Benefits, Inc., Fargo, North Dakota, and thereby engage in providing consulting services to employee benefit, compensation and PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Sunshine Act; Notice of Meeting/ Correction—Addition of #6 10:00 a.m. (Eastern Time) December 14, 2015 (Telephonic) PLACE: 10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002. STATUS: Parts will be open to the public and parts will be closed to the public. MATTERS TO BE CONSIDERED: TIME AND DATE: Open to the Public 1. Approval of the Minutes for the November 25, 2015 Board Member Meeting 2. Monthly Reports (a) Monthly Participant Activity Report (b) Monthly Investment Performance Report (c) Legislative Report 3. Quarterly Metrics Report 4. OGC Report and Annual Presentation Closed to the Public 5. Security 6. Personnel CONTACT PERSON FOR MORE INFORMATION: Kimberly Weaver, Director, Office of External Affairs, (202) 942–1640. Dated: December 8, 2015. James Petrick, General Counsel, Federal Retirement Thrift Investment Board. [FR Doc. 2015–31268 Filed 12–8–15; 4:15 pm] BILLING CODE 6760–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–16–0307] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices 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. mstockstill on DSK4VPTVN1PROD with NOTICES Proposed Project The Gonococcal Isolate Surveillance Project (GISP, OMB No. 0920–0307 exp. 08/31/2016) – Extension – National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description The objectives of GISP are: (1) To monitor trends in antibiotic resistance VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 of Neisseria gonorrhoeae strains in the United States and (2) to characterize resistant specimens. Surveillance of N. gonorrhoeae antibiotic resistance is important because: (1) Nearly all gonococcal infections are treated empirically (meaning that healthcare providers have to decide how to treat their patients without having resistance testing results for individual patients upon which to base clinical decisionmaking) and susceptibility/resistance testing data are not routinely available in clinical practice; (2) N. gonorrhoeae has consistently demonstrated the ability to develop resistance to the antibiotics used for treatment; (3) effective treatment of gonorrhea is a critical component of gonorrhea control and prevention, and (4) untreated or inadequately treated gonorrhea can cause serious reproductive health complications. GISP is the only source in the United States of national, regional, and sitespecific gonococcal antibiotic resistance information. GISP provides information to support informed and scientificallybased treatment recommendations. GISP was established in 1986 as a voluntary surveillance project and now involves 5 regional laboratories and 30 publicly funded sexually transmitted disease (STD) clinics around the country. The STD clinics submit up to 25 gonococcal specimens (or isolates) per month to the regional laboratories, which measure the ability of the specimens to resist the effects of multiple antibiotics. Limited demographic and clinical information corresponding to the isolates (and that do not allow identification of the patient) are submitted directly by the clinics to CDC. During 1986–2015, GISP has demonstrated the ability to effectively achieve its objectives. GISP has tracked penicillin and tetracycline resistance and identified the emergence of fluoroquinolone resistance. Increased prevalence of fluoroquinolone-resistant N. gonorrhoeae (QRNG), as documented by GISP data, prompted CDC to update treatment recommendations for gonorrhea in CDC’s Sexually Transmitted Diseases Treatment Guidelines, 2006 and to release an MMWR article stating that CDC no longer recommended fluoroquinolones for treatment of gonococcal infections. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 76691 Information from GISP thus allowed public health officials to change treatment recommendations before resistance became widespread, ensuring that patients were able to be successfully treated. Recently, GISP isolates demonstrated increasing minimum inhibitory concentrations of cefixime, which can be an early warning of impending resistance. This worrisome trend prompted CDC to again update treatment recommendations and no longer recommend the use of cefixime as first-line treatment for gonococcal infections. Under the GISP protocol, each of the 30 clinics submit an average of 20 isolates per clinic per month (i.e. 240 times per year) recorded on Form 1: Demographic/Clinical Data. The estimated time for clinical personnel to abstract data for Form 1: Demographic/ Clinical Data is 11 minutes per response. Each of the 5 Regional laboratories receives and processes approximately 20 isolates from each referring clinic per month (i.e. 121 isolates per regional laboratory per month [based on 2011 specimen volume]) using Form 2: Antimicrobial Susceptibility Testing. For Form 2: Antimicrobial Susceptibility Testing, the annual frequency of responses per respondent is 1452 (121 isolates x 12 months). Based on previous laboratory experience, the estimated burden of completing Form 2 for each participating laboratory is 1 hour per response, which includes the time required for laboratory processing of the patient’s isolate, gathering and maintaining the data needed, and completing and reviewing the collection of information. For Form 3: Control Strain Susceptibility Testing, a ‘‘response’’ is defined as the processing and recording of Regional laboratory data for a set of 7 control strains. It takes approximately 12 minutes to process and record the Regional laboratory data on Form 3 for one set of 7 control strains, of which there are 4 sets. The number of responses per respondent is 48 (4 sets x 12 months). The total estimated annual burden hours are 8,628. Respondents receive federal funds to participate in this project. There are no additional costs to respondents other than their time. E:\FR\FM\10DEN1.SGM 10DEN1 76692 Federal Register / Vol. 80, No. 237 / Thursday, December 10, 2015 / Notices ESTIMATE OF ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Clinic ............................................................... Laboratory ....................................................... Demographic Clinical Data Form 1 ................ Antimicrobial Susceptibility Testing Form 2 ... Control Strain Susceptibility Testing Form 3 Leroy A. 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. 2015–31104 Filed 12–9–15; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–16–0488] mstockstill on DSK4VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 19:33 Dec 09, 2015 Jkt 238001 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 Restrictions on Interstate Travel of Persons (42 CFR part 70) (OMB Control No. 0920–0488, expiration, 3/31/ 2016)— Revision—Division of Global Migration and Quarantine, National Center for Emerging Zoonotic and Infectious Diseases, Centers for Disease Control and Prevention (CDC). Background and Brief Description This revision to an existing information collection request is intended to ensure that CDC can continue collect pertinent information related to communicable disease or deaths that occur aboard conveyances during interstate travel within the United States, as authorized under 42 Code of Federal Regulations (CFR) part 70. Additionally, CDC is requesting approval to use the Passenger Locator Form in the event that travelers on domestic flights within the United States need to be contacted for public health follow-up. The intended use of the information is to ensure that CDC can assess and respond to reports of communicable disease or death that occur on conveyances engaged in interstate travel, and assist state and local health authorities if an illness or death occurs that poses a risk to public health. Generally, the primary source of this information is aircraft and travelers moving within the United States. This revision makes several modification to this information collection. They are as follows: In current practice, CDC does not process applications for travel permits using the Restriction On Travel Of Persons Multipurpose Application Form Under PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 30 5 5 Number of responses per respondent 240 1,452 48 Average burden per response (in hours) 11/60 1 12/60 the Provisions of 42 CFR part 70 (aka Ill Person Travel Permit); therefore the information collections under 42 CFR 70.3, Application to the State of destination for a permit, Copy of material submitted by applicant and permit issued by State health authority (Attending physician), and Copy of material submitted by applicant and permit issued by State health authority (State health authority) are being removed. Similarly, information collections under 42 CFR 70.5, Application for a permit to move from State to State while in the communicable period (Attending physician) and Application for a permit to move from State to State while in the communicable period (Traveler) are also being removed. The issuance of travel restrictions is a collaborative process between public health partners, e.g. state health departments, the Department of Homeland Security, and CDC. There is no standardized collection of information involved. This change results in the removal of the information collections under 42 CFR 70.3 and 70.5 from the list of information collections as well as the removal of the associated burden. Reports of communicable disease or death from domestic conveyances are almost always submitted electronically to meet requirements of 42 CFF 70.4, so the current hard copy Master of Vessel or Conveyance Illness Report, which was constructed to be used by masters of vessels to comply with 42 CFR 70.4, has been rendered obsolete. In addition, CDC has issued guidance stating that reports to CDC, instead of local health authorities, regarding domestic reports of communicable disease or death on board conveyances meet the requirements of the regulation; therefore, information collections related to copies of the report sent by masters of vessels to state health departments are no longer necessary. The only remaining information collection under 42 CFR 70.4 is Report by the master of a vessel or person in charge of conveyance of the incidence of a communicable disease occurring while in interstate travel. E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 80, Number 237 (Thursday, December 10, 2015)]
[Notices]
[Pages 76690-76692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31104]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0307]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the

[[Page 76691]]

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

    The Gonococcal Isolate Surveillance Project (GISP, OMB No. 0920-
0307 exp. 08/31/2016) - Extension - National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    The objectives of GISP are: (1) To monitor trends in antibiotic 
resistance of Neisseria gonorrhoeae strains in the United States and 
(2) to characterize resistant specimens. Surveillance of N. gonorrhoeae 
antibiotic resistance is important because: (1) Nearly all gonococcal 
infections are treated empirically (meaning that healthcare providers 
have to decide how to treat their patients without having resistance 
testing results for individual patients upon which to base clinical 
decision-making) and susceptibility/resistance testing data are not 
routinely available in clinical practice; (2) N. gonorrhoeae has 
consistently demonstrated the ability to develop resistance to the 
antibiotics used for treatment; (3) effective treatment of gonorrhea is 
a critical component of gonorrhea control and prevention, and (4) 
untreated or inadequately treated gonorrhea can cause serious 
reproductive health complications.
    GISP is the only source in the United States of national, regional, 
and site-specific gonococcal antibiotic resistance information. GISP 
provides information to support informed and scientifically-based 
treatment recommendations.
    GISP was established in 1986 as a voluntary surveillance project 
and now involves 5 regional laboratories and 30 publicly funded 
sexually transmitted disease (STD) clinics around the country. The STD 
clinics submit up to 25 gonococcal specimens (or isolates) per month to 
the regional laboratories, which measure the ability of the specimens 
to resist the effects of multiple antibiotics. Limited demographic and 
clinical information corresponding to the isolates (and that do not 
allow identification of the patient) are submitted directly by the 
clinics to CDC.
    During 1986-2015, GISP has demonstrated the ability to effectively 
achieve its objectives. GISP has tracked penicillin and tetracycline 
resistance and identified the emergence of fluoroquinolone resistance. 
Increased prevalence of fluoroquinolone-resistant N. gonorrhoeae 
(QRNG), as documented by GISP data, prompted CDC to update treatment 
recommendations for gonorrhea in CDC's Sexually Transmitted Diseases 
Treatment Guidelines, 2006 and to release an MMWR article stating that 
CDC no longer recommended fluoroquinolones for treatment of gonococcal 
infections. Information from GISP thus allowed public health officials 
to change treatment recommendations before resistance became 
widespread, ensuring that patients were able to be successfully 
treated. Recently, GISP isolates demonstrated increasing minimum 
inhibitory concentrations of cefixime, which can be an early warning of 
impending resistance. This worrisome trend prompted CDC to again update 
treatment recommendations and no longer recommend the use of cefixime 
as first-line treatment for gonococcal infections.
    Under the GISP protocol, each of the 30 clinics submit an average 
of 20 isolates per clinic per month (i.e. 240 times per year) recorded 
on Form 1: Demographic/Clinical Data. The estimated time for clinical 
personnel to abstract data for Form 1: Demographic/Clinical Data is 11 
minutes per response.
    Each of the 5 Regional laboratories receives and processes 
approximately 20 isolates from each referring clinic per month (i.e. 
121 isolates per regional laboratory per month [based on 2011 specimen 
volume]) using Form 2: Antimicrobial Susceptibility Testing. For Form 
2: Antimicrobial Susceptibility Testing, the annual frequency of 
responses per respondent is 1452 (121 isolates x 12 months). Based on 
previous laboratory experience, the estimated burden of completing Form 
2 for each participating laboratory is 1 hour per response, which 
includes the time required for laboratory processing of the patient's 
isolate, gathering and maintaining the data needed, and completing and 
reviewing the collection of information. For Form 3: Control Strain 
Susceptibility Testing, a ``response'' is defined as the processing and 
recording of Regional laboratory data for a set of 7 control strains. 
It takes approximately 12 minutes to process and record the Regional 
laboratory data on Form 3 for one set of 7 control strains, of which 
there are 4 sets. The number of responses per respondent is 48 (4 sets 
x 12 months).
    The total estimated annual burden hours are 8,628. Respondents 
receive federal funds to participate in this project. There are no 
additional costs to respondents other than their time.

[[Page 76692]]



                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Clinic................................  Demographic Clinical                  30             240           11/60
                                         Data Form 1.
Laboratory............................  Antimicrobial                          5           1,452               1
                                         Susceptibility Testing
                                         Form 2.
                                        Control Strain                         5              48           12/60
                                         Susceptibility Testing
                                         Form 3.
----------------------------------------------------------------------------------------------------------------


Leroy A. 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. 2015-31104 Filed 12-9-15; 8:45 am]
 BILLING CODE 4163-18-P
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