        DEPARTMENT OF TRANSPORTATION
        Pipeline and Hazardous Materials Safety Administration
        49 CFR Parts 172 and 177
        [Docket Number PHMSA-2007-28119 (HM-247)]
        RIN 2137-AE37
        Hazardous Materials: Cargo Tank Motor Vehicle Loading and Unloading Operations

          AGENCY:
          Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.

          ACTION:
          Notice of proposed rulemaking; extension of comment period.

          SUMMARY:
          On March 11, 2011, PHMSA published a notice of proposed rulemaking (NPRM) seeking public comment on a proposal to amend the HMR requirements for cargo tank loading or unloading operations. PHMSA is notifying the public of our intent to extend the comment period by 30 days for a notice of proposed rulemaking published on March 11, 2011.

          DATES:
          The comment period for the NPRM closing on May 10, 2011, is extended until June 9, 2011. To the extent possible, PHMSA will consider late-filed comments during the next stage of the rulemaking process.

          ADDRESSES:
          You may submit comments identified by the docket number (PHMSA-2007-28119) by any of the following methods:
          • Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting comments.
          • Fax: 1-202-493-2251.
          • Mail: Docket Operations, U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, Routing Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590.
          • Hand Delivery: To Docket Operations, Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays.

            Instructions: All submissions must include the agency name and docket number for this notice at the beginning of the comment. Note that all comments received will be posted without change to the docket management system, including any personal information provided.

            Docket: For access to the dockets to read background documents or comments received, go to http://www.regulations.gov, or DOT's Docket Operations Office (see ADDRESSES).

          FOR FURTHER INFORMATION CONTACT:
          Kurt Eichenlaub or Dirk Der Kinderen, Standards and Rulemaking Division, Pipeline and Hazardous Materials Safety Administration, telephone (202) 366-8553.

        SUPPLEMENTARY INFORMATION:

          Privacy Act: Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477) or you may visit http://www.regulations.gov.

        I. Background
        On March 11, 2011, PHMSA published an NPRM (HM-247; 76 FR 13313) seeking public comment on a proposal to amend the HMR requirements for cargo tank loading or unloading operations. Specifically, the NPRM amendments included requirements to:
        • Assess the risks of loading and unloading operations and develop written operating procedures based on the risk assessment;
        • Train hazmat employees in the relevant aspects of the operational procedures;
        • Qualify annually hazmat employees who perform loading and unloading operations;
        • Develop and implement a periodic maintenance schedule for equipment and conduct periodic operational tests of equipment; and
        • Ensure that the equipment meets the performance standards.
        In the NPRM, we invited comment on a number of provisions as well as comment on the methodology used to develop the regulatory evaluation supporting the NPRM. See the March 11, 2011 NPRM for a complete discussion of the proposals and requests for comment and information.
        II. Comment Period Extension
        Given the abundance of requests for comment and data contained in this NPRM as well as our consideration of a number of other proposed rulemakings concurrently impacting interested parties affected by the cargo tank motor vehicle proposals in this notice, we are providing affected entities as well as the general public an additional 30 days to allow for thorough review, analysis, and response to the NPRM. Thus, the comment period for the HM-247 NPRM is extended from May 10, 2011 until June 9, 2011.

          Issued in Washington, DC, on May 5, 2011 under authority delegated in 49 CFR part 106.
          Magdy El-Sibaie,
          Associate Administrator for Hazardous Materials Safety.

      [FR Doc. 2011-11494 Filed 5-10-11; 8:45 am]
      BILLING CODE 4910-60-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 52
        [EPA-R08-OAR-2013-0006; FRL-9915-74-Region 8]
        Approval and Promulgation of Air Quality Implementation Plans; Wyoming; Revisions to the Wyoming Air Quality Standards and Regulations; Ambient Standards for Particulate Matter and for Lead

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Wyoming. The revision affects Wyoming's Air Quality Standards and Regulations (WAQSR) regarding ambient standards for particulate matter and for lead (Pb). This action is being taken under section 110 of the Clean Air Act (CAA).

          DATES:
          Written comments must be received on or before September 25, 2014.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. EPA-R08-OAR-2013-0006, by one of the following methods:
          • http://www.regulations.gov. Follow the on-line instructions for submitting comments.
          • Email: pratt.steven@epa.gov.

          • Fax: (303) 312-6064 (please alert the individual listed in the FOR FURTHER INFORMATION CONTACT if you are faxing comments).
          • Mail: Director, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129.
          • Hand Delivery: Director, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129. Such deliveries are only accepted Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding Federal holidays. Special arrangements should be made for deliveries of boxed information.

          Please see the direct final rule which is located in the Rules Section of this Federal Register for detailed instruction on how to submit comments.

          FOR FURTHER INFORMATION CONTACT:

          Steven Pratt, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop, Denver, Colorado 80202-1129, (303) 312-6575, pratt.steven@epa.gov.

        SUPPLEMENTARY INFORMATION:
        In the “Rules and Regulations” section of this Federal Register, EPA is approving Wyoming's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial SIP revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the preamble to the direct final rule. If EPA receives no adverse comments, EPA will not take further action on this proposed rule. If EPA receives adverse comments, EPA will withdraw the direct final rule and it will not take effect. EPA will address all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. See the information provided in the Direct Final action of the same title which is located in the Rules and Regulations Section of this Federal Register.

          Authority:
           42 U.S.C. 7401 et seq.

          Dated: August 5, 2014.
          Shaun L. McGrath,
          Regional Administrator, Region 8.

      [FR Doc. 2014-20224 Filed 8-25-14; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF VETERANS AFFAIRS
        38 CFR Part 17
        RIN 2900-AN23
        Expansion of Enrollment in the VA Health Care System

          AGENCY:
          Department of Veterans Affairs.

          ACTION:
          Proposed rule.

          SUMMARY:
          The Department of Veterans Affairs (VA) proposes to amend its regulations regarding enrollment in the VA health care system. In particular, it proposes to establish additional subpriorities within enrollment priority category 8 and provide that beginning on the effective date of the rule, VA would enroll priority category 8 veterans whose income exceeds the current means test and geographic means test income thresholds by 10 percent or less.

          DATES:
          Written comments must be received on or before February 20, 2009.

          ADDRESSES:
          Written comments may be submitted through http://www.Regulations.gov; by mail or hand-delivery to the Director, Regulations Management (02REG), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; or by fax to (202) 273-9026. Comments should indicate that they are submitted in response to “RIN 2900-AN23—Expansion of Enrollment.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.Regulations.gov.

          FOR FURTHER INFORMATION CONTACT:
          Tony Guagliardo, Director, Business Policy, Chief Business Office (163), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461-1591. (This is not a toll free number.)

        SUPPLEMENTARY INFORMATION:
        Public Law 104-262, the Veterans' Health Care Eligibility Reform Act of 1996, required VA to establish a national enrollment system to manage the delivery of inpatient hospital care and outpatient medical care, within available appropriated resources. It directed that the enrollment system be managed in such a way as “to ensure that the provision of care to enrollees is timely and acceptable in quality,” and authorized such subprioritization of the statutory enrollment categories “as the Secretary determines necessary.” The law also provided that starting October 1, 1998, most veterans had to enroll in the VA health care system as a condition for receiving VA hospital and outpatient care.
        In a document published in the Federal Register on January 17, 2003 (68 FR 2670), VA published an interim final rule that amended 38 CFR 17.36 to add two new subpriorities to both enrollment priority categories 7 and 8, for a total of four subpriorities in each category. It also announced that beginning January 17, 2003, VA would enroll all priority categories of veterans except that those veterans in priority category 8 who were not in an enrolled status on January 17, 2003, or who requested disenrollment after that date, would not be eligible to be enrolled. The veterans in this priority category are those whose incomes exceed certain income limits and who do not qualify for enrollment in another priority category. Since then, VA has not enrolled veterans in priority category 8 unless they had been enrolled in another priority category and no longer qualified for enrollment in that category.
        This proposed rule would establish additional subpriorities within enrollment priority category 8 and would provide that beginning on the effective date of the rule, VA would enroll priority category 8 veterans whose income exceeds the current means test and geographic means test income thresholds by 10 percent or less. These veterans would continue enrollment in these subpriority groups (even if their income exceeds the current tests by more than 10 percent) unless they become eligible for enrollment in a higher category or subpriority; a request for disenrollment is made; or a decision is made to disenroll their particular subpriority or category. This proposed rule would also amend the medical regulations by making a nonsubstantive change to reflect an alternative method to submit VA's Application for Health Care Benefits (VA Form 10-10EZ).
        Projections for Increasing Enrollment of Priority Category 8 Veterans Whose Income Exceeds the Current VA Means Test and Geographic Means Test Income Thresholds by 10 Percent or Less

        An existing regulation (38 CFR 17.36(c)) requires that the Secretary determine which categories of veterans are eligible to be enrolled and that the Secretary notify eligible enrollees of the determination by announcing it in the Federal Register. In making that determination, the Secretary must consider an array of factors including economic information such as available resources, projections of demand for enrollment, and the length of waiting times for appointments for care.
        The actual number of total enrollees who were enrolled at any time in 2003 was 7,120,347. The corresponding number in 2008 was 7,802,382. The increase in the veterans enrolled in the VA health care system between 2003 and 2008 is, therefore, 682,035.
        The 2009 Appropriations Act provided funding in VA's health care appropriation to increase priority category 8 enrollment. The Veterans Health Administration's (VHA) total FY 2009 medical care appropriation is $40.434 billion. This is supplemented by an additional $3.717 billion from collections for copayments, third-party reimbursements for services, other revenue, and carry-over funds. The sum of these resources is $44.151 billion. The following table shows the projected enrollment for FY 2009 together with the projected expenditures that would be needed to provide the medical benefits package to enrollees under VA's current enrollment policy:

          FY 2009 Projections Under VA's Current Enrollment Policy 1

            Priority category
            Enrollment
            Expenditures
            Cumulative expenditures

            1
            1,079,852
            $10,552,245,777
            $10,552,245,777

            2
            595,548
            2,352,417,015
            12,874,662,792

            3
            1,090,376
            3,517,387,015
            16,392,050,361

            4
            233,153
            3,461,043,477
            19,853,093,838

            5
            2,361,166
            11,513,021,012
            31,366,114,850

            6
            354,785
            606,349,476
            31,972,464,326

            7
            1,056,733
            2,041,244,267
            34,013,708,592

            8
            1,286,626
            2,692,952,224
            36,706,660,817

            Total
            8,058,238
            36,706,660,817

            1 This table does not include projections regarding the impact of the proposed regulatory change.

        The following table shows the projected enrollment and expenditures for FY 2009 if the expanded enrollment as proposed in this document is implemented. The projections are based on reopening enrollment for Priority 8 veterans whose income exceeds the current VA means test (VMT) and geographic means test (GMT) income thresholds by 10 percent or less. The means tests are currently based on Calendar Year (CY) 2007 income.
        Priority 8 veterans eligible to enroll under VMT/GMT+10 percent are assumed to enroll at higher rates than the average historical rates evidenced in the current Priority 8 enrollee population. Experience shows that veterans in the lower income ranges for Priority 8 veterans are more likely to enroll. The FY 2009 enrollment projections also reflect an expected surge in enrollment when the suspension is lifted and veterans who have not been able to enroll take advantage of this opportunity. The higher enrollment rates for VMT/GMT+10 percent veterans were increased by 17.5 percent for FY 2009 to reflect the expected surge. In absence of any data to support a different assumption, the projections for VMT/GMT+10 percent assume the new Priority 8 enrollees will have the same reliance and morbidity as current Priority 8 enrollees.

          FY 2009 Projections Under VA's Current Enrollment Policy Plus GMT/VMT 10 Percent Scenario 1

            Priority category
            Enrollment
            Expenditures
            Cumulative expenditures

            1
            1,079,852
            $10,552,245,777
            $10,522,245,777

            2
            595,548
            2,352,417,015
            12,874,662,792

            3
            1,090,376
            3,517,387,568
            16,392,050,361

            4
            233,153
            3,461,043,477
            19,853,093,838

            5
            2,361,166
            11,513,021,012
            31,366,114,850

            6
            354,785
            606,349,476
            31,972,464,326

            7
            1,056,733
            2,041,244,267
            34,013,708,592

            8
            1,545,331
            3,178,199,353
            37,191,907,945

            Total
            8,316,943
            37,191,907,945

            1 FY 2009 Projections in this table include projections under Current Enrollment Policy plus the impact of the proposed regulatory change.

        The previous tables display 2009 projections based on the 2008 Enrollee Health Care Projection Model, VA's health care actuarial model. The VA Enrollee Health Care Projection Model (the “Model”) supports the VHA health care budget, projects the number of veterans who will be enrolled, the health care services they will choose to get from VHA, and the expenditures associated with that utilization for 20 years. The utilization and expenditure projections are developed based on where enrollees live to support population-based long-term planning. Base year unit costs are based on FY 2007 unit cost data from VA's financial accounting system—Decision Support System (DSS). The base year unit costs are trended forward using health care cost trends and adjusted for the impact of enrollee aging and changes in VA's level of health care management over the 20-year projection period. The expenditures projected by this model reflected in these tables exclude services such as Long Term Care, Readjustment Counseling, Spina Bifida, Foreign Medical Programs, Non-Veteran Medical Care, and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA). Total expenditures for medical care not included in the model are projected to be $6.959 billion in FY 2009. The following tables show VA's projections for enrollment through 2019 under the current enrollment policy and how the proposed expansion of enrollment in priority category 8 would affect that.

          Projected Priority Category 8 Enrollment: FY 2009-2019 1

            Fiscal year
            Current enrollment policy 2

            GMT/VMT 10% scenario 3

            Total enrollment

            2009
            1,286,626
            258,705
            1,545,331

            2010
            1,291,964
            265,571
            1,557,535

            2011
            1,294,969
            271,755
            1,566,724

            2012
            1,295,921
            281,598
            1,577,518

            2013
            1,293,672
            295,772
            1,589,444

            2014
            1,288,124
            290,583
            1,578,707

            2015
            1,280,054
            294,617
            1,574,671

            2016
            1,269,050
            297,001
            1,566,051

            2017
            1,258,489
            299,393
            1,557,882

            2018
            1,244,623
            300,847
            1,545,470

            2019
            1,228,603
            300,798
            1,529,401

            1 The enrollment projections begin with VetPop data, 20-year projections of the veteran population that are produced by the VA Office of the Actuary. At this time, VetPop does not provide veteran projections by Priority Levels so VetPop data is combined with other data sources to create VetPop Proxy data, which provides veteran projections by Priority Level.
          Historical enrollment data are analyzed to develop enrollment rates by Priority Level, Age Band, Geographic Area, and Special Conflict Status. The enrollment rates are then applied to the enrollment pool, which is VetPop minus the enrolled veteran population, to determine projected enrollees for any given year.
          Mortality rates specific to age, gender, and Priority Level are then applied to the enrollee population, and the enrollment and potential enrollee pool are aged one year at the end of each fiscal year to arrive at the projections for the beginning of the next fiscal year. The process of applying enrollment and mortality rates then repeats for the duration of the enrollment projections.
          The VA Enrollee Health Care [Projection Model (EHCPM) also accounts for geographic migration and enrollees who transition between enrollment Priority Levels.

            2 FY 2009-2019 Projections under Current Enrollment Policy do not include the impact of the proposed regulatory change.

            3 FY 2009-2019 Projections under GMT/VMT 10 percent represent the impact of the proposed regulatory change.

          Projected Total Priority Category 1-8 Enrollment: FY 2009-2019

            Fiscal year
            Current enrollment policy 1

            Current enrollment plus GMT/VMT 10% scenario 2

            Change from current policy

            2009
            8,058,238
            8,316,943
            258,705

            2010
            8,173,270
            8,438,842
            265,578

            2011
            8,274,706
            8,546,461
            271,755

            2012
            8,341,713
            8,623,310
            281,598

            2013
            8,378,061
            8,673,833
            295,772

            2014
            8,384,127
            8,674,710
            290,583

            2015
            8,364,224
            8,658,841
            294,617

            2016
            8,318,496
            8,615,497
            297,001

            2017
            8,277,135
            8,576,528
            299,393

            2018
            8,231,823
            8,532,671
            300,847

            2019
            8,181,196
            8,481,994
            300,798

            1 FY 2009-2019 Projections under Current Enrollment Policy do not include the impact of the proposed regulatory change.

            2 FY 2009-2019 Projections in this column include projections under Current Enrollment Policy plus the impact of the proposed regulatory change.

        As can be seen from the FY 2009 medical care appropriation and the tables above, VA projects that available resources to expand enrollment will be adequate to support the proposed expansion of enrollment of Priority 8 veterans.
        Previous Interim Final Rules and Responses to Comments

        This document includes proposed changes in the provisions adopted in the interim final rule published in the Federal Register on January 17, 2003 (68 FR 2669, RIN 2900-AL51). We received five comments on that interim final rule. All of the commenters expressed disagreement with VA's decision to suspend enrollment of additional veterans in priority category 8. Each of the commenters generally expressed the view that VA should provide care to all veterans seeking care because they had served their country. Thoughtful consideration was given to the comments received. However, as discussed in the preamble accompanying publication of the interim final rule, VA is required to assess available resources and determine the number of veterans it is able to enroll to ensure that medical services provided are both timely and acceptable in quality. An enrollment system is necessary because the provision of VA health care is discretionary and can be provided only to the extent that appropriated resources are available for that purpose. The enrollment decision made in January 2003 was based on available resources, and the comments do not suggest that VA's assessment of available resources was incorrect.
        Unfunded Mandates
        The Unfunded Mandates Reform Act requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector of $100 million or more in any given year. This rule would have no such effect on State, local, or tribal governments.
        Paperwork Reduction Act
        This proposed rule contains no provisions constituting a new collection of information, but would change, merely by adding an option of a new method of submission, a collection of information that has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). OMB assigns a control number for each collection of information it approves. VA may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The information collection provisions affected by this proposed rule have been approved under control number 2900-0091.
        Executive Order 12866 and Congressional Review Act
        This is an economically significant regulatory action under Executive Order 12866 and constitutes a major rule under the Congressional Review Act.
        Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 12866 classifies a “significant regulatory action” requiring review by OMB as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of entitlement recipients; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
        VA has examined the economic, interagency, budgetary, legal, and policy implications of this proposed rule and has concluded that it is an economically significant regulatory action under Executive Order 12866 because it is likely to result in a rule that may have an annual effect on the economy of $100 million or more and may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This proposed rule is also a major rule under the Congressional Review Act because it is likely to result in an annual effect on the economy of $100 million or more.
        VA has attempted to follow OMB circular A-4 to the extent feasible in this analysis. The circular first calls for a discussion of the need for the regulation. The Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Pub. L. 110-329) was enacted on September 30, 2008. The accompanying report language stated that funding was included to reopen priority category 8 enrollment. The preamble above discusses the need for the regulation in more detail. There are not any alternatives to publishing this proposed rule that will accomplish the stated provisions in the report language of the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Pub. L. 110-329).

        VA uses the Enrollee Health Care Projection Model (Model), a health care actuarial model, to project veteran demand for VA health care. To project enrollment and expenditures under this proposed regulatory change, VA first identified the number of non-enrolled veterans whose income exceeds the current VA means test and geographic means test income thresholds by 10 percent or less. VA then projected the number of those veterans who would enroll based on historical priority category 8 enrollment rates. The projected health care service utilization for these new enrollees was based on the historical morbidity and reliance rates of the current priority category 8 enrollee population. The projected expenditures represent the cost to provide the projected health care services to these new enrollees.
        Using the 2008 Model, VA projects that this proposed regulatory change would result in an additional 258,705 priority category 8 enrollees in FY 2009. The projected increase in total health care service expenditures associated with this new enrollment is $485 million in FY 2009. The revenues generated by the first- and third-party collections are projected to be $121 million,1 resulting in a $364 million growth in net health service expenditures for FY 2009, and $375 million was provided in the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 (Pub. L. 110-329). VA's expenditures related to this proposed regulatory change are projected to be approximately $2.931 billion for five years.2 These expenditures exclude services such as Long Term Care, Readjustment Counseling, Spina Bifida, Foreign Medical Programs, Non-Veteran Medical Care and CHAMPVA.

            1 The first party collections are based on the projected health care service utilization of the new Priority 8 enrollees. In the base year (2007), we applied the appropriate co-payment to the projected services. We then balanced the resulting co-payment revenue projections to the actual collections for 2007 for four categories (inpatient, outpatient, residential rehabilitation, and pharmacy) and by Veterans Integrated Service Network (VISN) to account for the amount actually collected. The resulting first-party revenue per service developed for 2007 is applied to the projected services in future years to project the first-party revenue associated with health care utilization of the new Priority 8 enrollees. Further, the pharmacy co-payment is increased over time based on the legislated Consumer Price Index (CPI) schedule.

            To develop the third-party collections, we calculated the percentage of third-party revenue collected in 2007 as a percent of 2007 expenditures by VISN, priority level, and two age bands (under and over age 65). We then applied these percentages to the projected expenditures for the new Priority 8 enrollees in future years. For 2010, the percentages were increased to reflect VHA's initiatives to increase third-party revenue collections.

              2 Five Year Projection Table
            [Present value: (future value)/((1+i−^n)]

              ($ in billions)
              FY 2009
              FY 2010
              FY 2011
              FY 2012
              FY 2013
              5 year

              Future Value (FV)
              $0.485
              $0.533
              $0.580
              $0.631
              $0.702
              $2.931

              3% discount rate (i)
              3.00%
              3.00%
              3.00%
              3.00%
              3.00%

              7% discount rate (i)
              7.00%
              7.00%
              7.00%
              7.00%
              7.00%

              Number of Years (n)
              0
              1
              2
              3
              4

              Present Value (PV) at 3%
              $0.485
              $0.517
              $0.546
              $0.578
              $0.624
              $2.751

              Present Value (PV) at 7%
              $0.485
              $0.498
              $0.506
              $0.515
              $0.536
              $2.540

          VA requests comments on all of these projections.

        Regulatory Flexibility Act
        The Secretary hereby certifies that the adoption of this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This rule would not directly affect any small entities. Only individuals could be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.
        Catalog of Federal Domestic Assistance
        The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.005, Grants to States for the Construction of State Homes; 64.007, Blind Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; 64.011, Veterans Dental Care; 64.012, Veterans Prescription Service; 64.013, Veterans Prosthetic Appliances; 64.014, Veterans State Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016, Veterans State Hospital Care; 64.018, Sharing Specialized Medical Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence; and 64.022, Veterans Home Based Primary Care.

          List of Subjects in 38 CFR Part 17
          Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and record-keeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans.

          Approved: January 13, 2009.
          James B. Peake,
          Secretary of Veterans Affairs.

        For the reasons set out in the preamble, VA proposes to amend 38 CFR part 17 as set forth below:

          PART 17—MEDICAL
          1. The authority citation for part 17 continues to read as follows:

            Authority:
            38 U.S.C. 501, 1721, and as stated in specific sections.

          2. Amend § 17.36 by revising paragraphs (b)(8), (c)(1), (c)(2), and (d)(1) and the authority citation to read as follows:

            § 17.36
            Enrollment—provision of hospital and outpatient care to veterans.

            (b) * * *
            (8) Veterans not included in priority category 4 or 7, who are eligible for care only if they agree to pay to the United States the applicable copayment determined under 38 U.S.C. 1710(f) and 1710(g). This category is further prioritized into the following subcategories:
            (i) Noncompensable zero percent service-connected veterans who were in an enrolled status on January 17, 2003, or who are moved from a higher priority category or subcategory due to no longer being eligible for inclusion in such priority category or subcategory and who subsequently do not request disenrollment;

            (ii) Noncompensable zero percent service-connected veterans not included in paragraph (b)(8)(i) of this section and whose income is not greater than ten percent more than the income that would permit their enrollment in priority category 5 or priority category 7, whichever is higher;
            (iii) Nonservice-connected veterans who were in an enrolled status on January 17, 2003, or who are moved from a higher priority category or subcategory due to no longer being eligible for inclusion in such priority category or subcategory and who subsequently do not request disenrollment;
            (iv) Nonservice-connected veterans not included in paragraph (b)(8)(iii) of this section and whose income is not greater than ten percent more than the income that would permit their enrollment in priority category 5 or priority category 7, whichever is higher;
            (v) Noncompensable zero percent service-connected veterans not included in paragraph (b)(8)(i) or paragraph (b)(8)(ii) of this section; and
            (vi) Nonservice-connected veterans not included in paragraph (b)(8)(iii) or paragraph (b)(8)(iv) of this section.
            (c) * * *

            (1) It is anticipated that each year the Secretary will consider whether to change the categories and subcategories of veterans eligible to be enrolled. The Secretary at any time may revise the categories or subcategories of veterans eligible to be enrolled by amending paragraph (c)(2) of this section. The preamble to a Federal Register document announcing which priority categories and subcategories are eligible to be enrolled must specify the projected number of fiscal year applicants for enrollment in each priority category, projected healthcare utilization and expenditures for veterans in each priority category, appropriated funds and other revenue projected to be available for fiscal year enrollees, and projected total expenditures for enrollees by priority category. The determination should include consideration of relevant internal and external factors, e.g., economic changes, changes in medical practices, and waiting times to obtain an appointment for care. Consistent with these criteria, the Secretary will determine which categories of veterans are eligible to be enrolled based on the order of priority specified in paragraph (b) of this section.
            (2) Unless changed by a rulemaking document in accordance with paragraph (c)(1) of this section, VA will enroll the priority categories of veterans set forth in § 17.36(b) beginning [effective date of regulation], except that those veterans in subcategories (v) and (vi) of priority category 8 are not eligible to be enrolled.
            (d) * * *
            (1) Application for enrollment. A veteran may apply to be enrolled in the VA healthcare system at any time. A veteran who wishes to be enrolled must apply by submitting a VA Form 10-10EZ to a VA medical facility or via an online submission at https://www.1010ez.med.va.gov/sec/vha/1010ez/.

              (Authority: 38 U.S.C. 101, 501, 1521, 1701, 1705, 1710, 1722)

       [FR Doc. E9-1024 Filed 1-16-09; 8:45 am]
      BILLING CODE 8320-01-P


        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        42 CFR Part 51c
        RIN 0906-AB25
        Implementation of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications”

          AGENCY:
          Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          The Department of Health and Human Services (HHS) proposes to implement the Executive Order 13937 (Executive Order) of July 24, 2020. The Executive Order requires that entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and who also participate in the 340B Drug Pricing Program, must establish practices to provide access to insulin and injectable epinephrine to low-income patients at the price the health center purchased these two drugs through the 340B Drug Pricing Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements. HHS is seeking public comment on this notice of proposed rulemaking (NPRM).

          DATES:

          Written comments and related material to this proposed rule must be received to the online docket via https://www.regulations.gov on or before October 28, 2020.

          ADDRESSES:

          Comments must be identified by HHS Docket No. HRSA-2020-0004 and submitted electronically to the Federal eRulemaking Portal at https://www.regulations.gov. Follow the instructions for submitting comments. Comments and attachments will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information. Additionally, if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted as well.

          FOR FURTHER INFORMATION CONTACT:

          Jennifer Joseph, Director, Office of Policy and Program Development, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857; email: jjoseph@hrsa.gov; telephone: 301-594-4300; fax: 301-594-4997.

        SUPPLEMENTARY INFORMATION:
        I. Background
        On March 13, 2020, President Trump declared the ongoing Coronavirus Disease COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration for all states, territories, and the District of Columbia. With the COVID-19 emergency, many low-income individuals are experiencing significant economic hardship. These low-income individuals who are dependent upon the life-saving medications of insulin and/or injectable epinephrine are now less able to access these drugs at an affordable price. On July 24, 2020, President Trump issued Executive Order 13937 (Executive Order), “Executive Order on Access to Affordable Life-saving Medications,” was issued to direct health centers that receive grants under section 330(e) of the PHS Act to support the improved access to certain life-saving medications by low income individuals. As provided in the Executive Order, it is the policy of the United States to enable Americans without access to affordable insulin and injectable epinephrine through commercial insurance or Federal programs, such as Medicare and Medicaid, to purchase these pharmaceuticals from a health center at the same price at which the health center acquired the medication through the 340B Drug Pricing Program.
        Through the Executive Order, the President directed the Secretary of Health and Human Services (the Secretary) to take action, to the extent permitted by law, to ensure all future grants available under section 330(e) of the PHS Act, as amended, 42 U.S.C. 254b(e), are conditioned upon health centers having established practices to make insulin and injectable epinephrine available at the discounted price paid by the health center grantee or sub-grantee under the 340B Prescription Drug Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who:
        (a) Have a high cost sharing requirement for either insulin or injectable epinephrine;
        (b) have a high unmet deductible; or
        (c) have no health care insurance.
        Under section 330(k)(3) of the Act, the Secretary may not approve an application for a grant under subparagraph (A) or (B) of subsection (e)(1) unless the Secretary determines that the entity for which the application is submitted meets the requirements enumerated in section 330(k)(3)(A)-(N). Section 330(k)(3)(N) requires that “the center has written policies and procedures in place to ensure the appropriate use of Federal funds in compliance with applicable Federal statutes, regulations, and the terms and conditions of the Federal award.” Consistent with the Act, the HRSA would include in the Terms section of applicable Notices of Award (NOAs) issued under section 330(e) grant awards, the requirement that health center awardees comply with the discounted price provisions described herein.
        This proposed regulation would apply to new grants and new project periods for service area, new access point, supplemental, and expanded services awards issued under section 330(e) of the PHS Act.
        II. Statutory Authority
        The statement of authority for 42 CFR part 51c continues to read section 330 of the PHS Act (42 U.S.C. 254b) and section 215 of the PHS Act, (42 U.S.C. 216).
        III. Discussion of Proposed Rule
        Overview

        The Executive Order was issued to support the improved access to certain life-saving medications for low-income individuals. HRSA is proposing to establish a requirement for awarding new grants under section 330(e) of the PHS Act (42 U.S.C. 254b) that the awardee have established written practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee under the 340B Drug Pricing Program (plus a minimal administration fee) to individuals with low incomes who: (a) Have a high cost sharing requirement for either insulin or injectable epinephrine, (b) have a high unmet deductible, or (c) have no health insurance. This NPRM also provides definitions relevant to this requirement.
        1. What is the proposed requirement?
        The proposed requirement for all awards under section 330(e) is as follows:
        Under Executive Order 13937, issued July 24, 2020, if your health center, or a subrecipient, receives section 330(e) funding, is enrolled in the 340B Drug Pricing Program and purchases, is reimbursed, or provides reimbursement to other entities for insulin and injectable epinephrine, whether obtained using federal or non-federal funds, your health center must have established practices to make insulin and injectable epinephrine available to low-income health center patients (defined herein as those individuals or families with annual incomes at or below 350% of the Federal Poverty Guidelines)—who either have insurance with a high cost sharing requirement for either insulin or injectable epinephrine, as applicable, a high unmet deductible, or who have no health insurance—at or below the price the health center paid through the 340B Drug Pricing Program, plus a minimal administration fee. You are not required to charge third party payors this discounted price.
        Consistent with the Executive Order, this Term would only apply to health centers receiving section 330(e) grant funds that participate in the 340B Drug Pricing Program (42 U.S.C. 254b). This requirement is limited to increasing affordable access to insulin and injectable epinephrine. The requirement to make these two drug categories available at or below the same price paid through the 340B Drug Pricing Program does not apply to other 340B drugs. Health centers subject to this requirement would be expected to provide drugs in these two categories at or below the price paid through the 340B Drug Pricing Program to health center patients only, and further only to those health center patients identified as low income, as described below. An individual would not be considered a “patient” of the health center for this purpose if the only health care service received by the individual from the health center is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting. Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Patient and Entity Eligibility, 61 FR 55,156 (Oct. 24, 1996). Nothing in this Program Term or the actions described in this NPRM prohibits or otherwise restricts a health center from setting the price for insulin or injectable epinephrine lower than the price the health center paid through the 340B Drug Pricing Program.
        This Program Term would be included on all Notices of Award issued to health centers receiving grants under section 330(e) of the Act.
        2. How would HRSA ensure that a health center has established practices in order to receive an award under section 330(e) under this proposed rule?
        The Executive Order states that future grants under section 330(e) should be conditioned upon health centers or subrecipients participating in the 340B Drug Pricing Program, including through contract pharmacy arrangements, having established practices to make insulin and injectable epinephrine accessible at an affordable price to low income health center patients. To implement this requirement, all future awards made available under section 330(e) would include the requirement that health centers participating in the 340B Drug Pricing Program comply with the proposed regulation as described in the Program Term in order to receive a grant award. Specifically, these competitions would require health centers that receive section 330(e) funding and that participate in the 340B Drug Pricing Program to have established practices that implement the Executive Order by offering insulin and injectable epinephrine to patients at no more than the same price the health center paid through the 340B Program plus a minimal administration fee. Health centers that have one or more subgrantees that participate in the 340B Program must demonstrate such subgrantees have established practices to offer patients these 340B discounted drugs as described in this proposed rule. In particular, these practices would provide information to patients in an easily understandable format regarding their administration fees, and the low-income, high cost sharing, and high unmet deductibles standard as described in this proposed regulation.
        How will the HRSA define the terms and phrases, such as “minimal administration fee,” in the Executive Order?
        HRSA proposes to define the following terms and to assist health centers in complying with, and implementing the Executive Order.
        1. “Established practices”: The health center demonstrates through its written policies, procedures, and/or other relevant documents that it has established practices to offer insulin and injectable epinephrine at no more than the discounted price paid by the health center under the 340B Drug Pricing Program plus a minimal administration fee.
        2. “Health center grantee or sub-grantee”: The Executive Order cites section 1905(l)(2)(B)(i) and (ii) of the Social Security Act, as amended (42 U.S.C. 1396d(l)(2)(B)(i) and (ii)). These two subparagraphs refer to organizations receiving an award under section 330 of the PHS Act (health centers) directly or as a subrecipient of grant funding. For purposes of this NPRM, this definition of health center grantee or subgrantee would be defined as organizations receiving funding under section 330(e) of the PHS Act.
        3. “Minimal administration fee”: This NPRM proposes that health centers would be expected to offer insulin and injectable epinephrine at or below the price the health center paid through the 340B Program, plus a minimal administration fee. As the Executive Order does not allow any other charge for these two categories of drugs, the minimal administration fee would be expected to include any dispensing fee, counseling costs, and any other charges associated with the patient receiving the medication. As the fee must be “minimal,” consistent with the stated policy of the Executive Order, the administration fee should not create a barrier to low income patients accessing these drugs, and health centers should make every reasonable effort to keep the fee as low as possible. Health centers may consider referring to the Medicaid dispensing fee in their state 1

           as a comparison for what may be considered a minimal administration fee. Please note that when there is a separate fee associated with provision of the pharmaceutical service, such as a dispensing fee, health centers must apply a sliding fee discount to that fee. The Health Center Program Compliance Manual's Sliding Fee Discount Program Chapter specifies the requirements of a health center's sliding fee discount program for in-scope services including pharmaceutical services.2

            1 Please see https://www.medicaid.gov/medicaid/prescription-drugs/state-prescription-drug-resources/medicaid-covered-outpatient-prescription-drug-reimbursement-information-state/index.html for further information.

            2 Please see https://bphc.hrsa.gov/programrequirements/compliancemanual/chapter-9.html#titletop for further information.

        4. “Individuals with low incomes”: The NPRM proposes that low income would be defined as individuals and families with annual incomes of no greater than 350 percent of the Federal Poverty Guidelines.
        5. “High cost sharing requirement”: For purposes of this NPRM, cost sharing refers to a patient's out-of-pocket costs, including, but not limited to, deductibles, coinsurance, and copayments, or similar charges. More specifically, a cost sharing requirement that exceeds twenty percent of the amount the health center is charging patients for the drug would be considered a high cost sharing requirement.
        6. “High deductible”: High deductible refers to a deductible amount that is not less than the amount required for a high deductible health plan as defined in section 223(c)(2)(A) of the Internal Revenue Code, which, for 2020, is any plan with a deductible of at least $1,400 for an individual or $2,800 for a family, with out-of-pocket costs not to exceed $6,900 for an individual and $13,800 for a family for in-network services. For 2021, the deductible limits would remain the same, while the limits for out-of-pocket costs would increase to $7,000 for self-only coverage and $14,000 for family coverage. When the Internal Revenue Service (IRS) updates these figures, HRSA will post the updated high deductible amounts on the Health Center Program website.
        7. “High unmet deductible”: High unmet deductible refers to the amount a patient owes toward his/her high deductible at any time during a plan year in which the portion of the patient's high deductible for the plan year that has not yet been met exceeds 20% of the deductible, regardless of the total annual deductible of the health insurance plan.
        8. “Health insurance Health insurance refers to private insurance, State and exchange plans, employer-funded plans, and coverage under titles XVIII, XIX, and XXI of the Social Security Act.
        IV. Regulatory Impact Analysis
        HHS has examined the effects of this proposed rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 8, 2011), the Regulatory Flexibility Act (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), and Executive Order 13132 on Federalism (August 4, 1999). HHS has also considered E.O. 13771 and has determined that the associated designation will be informed by public comments received.
        Executive Orders 12866 and 13563
        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866, emphasizing the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year), and a “significant” regulatory action is subject to review by the Office of Management and Budget (OMB).
        HHS does not believe that this rule, if finalized, will have an economic impact of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities. Because this proposed rule is limited in scope to two classes of drugs that are of particular need and it aligns with the mission and related Health Center Program requirements of health centers to provide access to care for vulnerable individuals and families, HHS believes it will have minimal economic impacts on health centers. The economic impact is also expected to be minimal given the proposed rule is limited to only two drug products which are available under the 340B Program at significantly reduced prices. Therefore, OMB has not designated this proposed rule as “economically significant” under section 3(f)(1) of the Executive Order 12866. HHS welcomes comments concerning the economic impact of this proposed rule.
        The Regulatory Flexibility Act (RFA)
        The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) and the Small Business Regulatory Enforcement and Fairness Act of 1996, which amended the RFA, require HHS to analyze options for regulatory relief of small businesses. If a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of the rule on small entities and analyze regulatory options that could lessen the impact of the rule. HHS will use an RFA threshold of at least a 3 percent impact on at least 5 percent of small entities.
        For purposes of the RFA, HHS considers all health care providers to be small entities either by meeting the Small Business Administration (SBA) size standard for a small business, or for being a nonprofit organization that is not dominant in its market. The current SBA size standard for health care providers ranges from annual receipts of $8 million to $41.5 million. As of August 8, 2020, the Health Center Program provides grant funding under section 330(e) of the PHS Act to 1,310 organizations to provide health care to medically underserved communities. HHS has determined, and the Secretary certifies, that this proposed rule will not have a significant impact on the operations of a substantial number of small health centers; therefore, we are not preparing an analysis of impact for this RFA. HHS estimates that the economic impact on small entities would be minimal; therefore, we are not preparing an analysis of impact for the purposes of the RFA. HHS welcomes comments concerning the impact of this proposed rule on health centers.
        Unfunded Mandates Reform Act

        Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.” In 2019, that threshold level was approximately $164 million. HHS does not expect this rule to exceed the threshold.
        Executive Order 13132—Federalism
        HHS has reviewed this proposed rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This proposed rule would not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule would not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture, and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.
        Paperwork Reduction Act of 1995
        The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that OMB approve all collections of information by a federal agency from the public before they can be implemented. This proposed rule is projected to have no impact on current reporting and recordkeeping burden for health centers. This proposed rule would result in no new reporting burdens. Comments are welcome on the accuracy of this statement.

          List of Subjects in 42 CFR Part 51c
          Grant programs—Health, Health care, Health facilities, Reporting and recordkeeping requirements.

          Dated: September 21, 2020.
          Thomas J. Engels,
          Administrator, Health Resources and Services Administration.
          Dated: September 22, 2020.
          Alex M. Azar II,
          Secretary, Department of Health and Human Services.

        Accordingly, 42 CFR part 51c is proposed to be amended as follows:

          PART 51c—GRANTS FOR COMMUNITY HEALTH CENTERS

        1. The authority statement for part 51c is revised to read as follows:

          Authority:
          Sec. 330, Public Health Service Act, (42 U.S.C. 254b); sec. 215, Public Health Service Act, (42 U.S.C. 216).

        2. Section 51c.303 is amended by adding paragraph (w) to read as follows:

          § 51c.303
           Project elements.

          (w)(1) Provision. To the extent that an applicant has indicated that it plans to distribute, either directly, or through a written agreement, drugs purchased through the 340B Drug Discount Program (42 U.S.C. 256b), and to the extent that such applicant plans to make insulin and/or injectable epinephrine available to its patients, the applicant shall provide an assurance that it has established practices provide insulin and injectable epinephrine at or below the discounted price paid by the health center grantee or sub-grantee under the 340B Drug Pricing Program (plus a minimal administration fee) to individuals with low incomes, as determined by the Secretary, who have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or have no health insurance.
          (2) Definitions. For purposes of this paragraph (w) exclusively:
          (i) Established practices. The health center has written policies, procedures, and/or other relevant documents that it has established practices to offer insulin and injectable epinephrine at no more than the discounted price paid by the health center under the 340B Drug Pricing Program plus a minimal administration fee.
          (ii) Health center grantee or sub-grantee. Organizations receiving an award under section 330(e) of the PHS Act (i.e., health centers) directly or as subgrantees of section 330(e) grant funding.
          (iii) Minimal administration fee. The minimal administration fee includes any dispensing fee, counseling costs, and any other charges associated with the patient receiving the medication. The administration fee may not create a barrier to low-income patients accessing these drugs, and health centers should make every reasonable effort to keep the fee as low as possible. Health centers may refer to the Medicaid dispensing fee in their state as a reference for minimal administration fees. When there is a separate fee associated with provision of the pharmaceutical service, such as a dispensing fee, health centers must apply a sliding fee discount to that fee.
          (iv) Individuals with low incomes. Individuals and families with annual incomes no greater than 350 percent of the Federal Poverty Guidelines.
          (v) High cost sharing requirement. A cost sharing requirement that exceeds twenty percent of the amount the health center charges its patients for the drug is a high cost sharing requirement. Cost sharing refers to a patient's out-of-pocket costs, including, but not limited to, deductibles, coinsurance, and copayments, or similar charges.
          (vi) High deductible. High deductible refers to a deductible amount that is not less than the amount required for a high deductible health plan as defined in section 223(c)(2)(A) of the Internal Revenue Code, as implemented by the Internal Revenue Service.
          (vii) High unmet deductible. High unmet deductible refers to the amount a patient owes toward his/her high deductible at any time during a plan year in which the outstanding deductible portion exceeds 20% of the total deductible, regardless of the total annual deductible of the health insurance plan.
          (viii) Health insurance. Health insurance refers private insurance, State and exchange plans, employer-funded plans, and coverage under titles XVIII, XIX, and XXI of the Social Security Act.
          (ix) “Patient.” For purposes of this subsection, an individual would not be considered a “patient” of the health center for this purpose if the only health care service received by the individual from the health center is the dispensing of a drug or drugs for subsequent self-administration or administration in the home setting.

      [FR Doc. 2020-21358 Filed 9-24-20; 4:15 pm]
      BILLING CODE 4165-15-P


        DEPARTMENT OF HOMELAND SECURITY
        Coast Guard
        33 CFR Part 147
        [Docket Number USCG-2017-0446]
        RIN 1625-AA00
        Safety Zone; Appomattox FPS, Mississippi Canyon 437, Outer Continental Shelf on the Gulf of Mexico

          AGENCY:
          Coast Guard, DHS.

          ACTION:
          Notice of proposed rulemaking.

          SUMMARY:
          The Coast Guard proposes to establish a safety zone around the Appomattox Floating Production System (FPS) facility located in Mississippi Canyon Block 437 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. The purpose of the safety zone is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. Placing a safety zone around the facility will significantly reduce the threat of allisions, collisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the environment. We invite your comments on this proposed rulemaking.

          DATES:
          Comments and related material must be received by the Coast Guard on or before April 19, 2018.

          ADDRESSES:

          You may submit comments identified by docket number USCG-2017-0446 using the Federal eRulemaking Portal at http://www.regulations.gov. See the “Public Participation and Request for Comments” portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments.

          FOR FURTHER INFORMATION CONTACT:

          If you have questions about this proposed rulemaking, call or email Ms. Laura Knoll, U.S. Coast Guard, District Eight Waterways Management Branch; telephone 504-671-2139, laura.b.knoll@uscg.mil.

        SUPPLEMENTARY INFORMATION:

        I. Table of Abbreviations

          CFR Code of Federal Regulations
          DHS Department of Homeland Security
          FPS Floating production system
          FR Federal Register
          NPRM Notice of proposed rulemaking
          OCS Outer Continental Shelf
          §  Section
          U.S.C. United States Code

        II. Background, Purpose, and Legal Basis
        Under the authority provided in 14 U.S.C. 85, 43 U.S.C. 1333, and Department of Homeland Security Delegation No. 0170.1(90), Title 33, CFR 147.1, 147.5, and 147.10 permit the establishment of safety zones for facilities located on the Outer Continental Shelf (OCS) for the purpose of protecting life and property on the facilities, their appurtenances and attending vessels, and on the adjacent waters within the safety zones.
        The safety zone proposed by this rulemaking is on the OCS in the deepwater area of the Gulf of Mexico at Mississippi Canyon Block 437. The area for the safety zone would be 500 meters (1640.4 feet) from each point on the facility, which is located at 28°34′25.47″ N, 87°56′03.11″ W. The deepwater area would be considered to be waters of 304.8 meters (1,000 feet) or greater depth extending to the limits of the Exclusive Economic Zone (EEZ) contiguous to the territorial sea of the United States and extending to a distance up to 200 nautical miles from the baseline from which the breadth of the sea is measured. The deepwater area would also include an extensive system of fairways. Navigation in the vicinity of the safety zone consists of large commercial shipping vessels, fishing vessels, cruise ships, tugs with tows and the occasional recreational vessels. The establishment of this safety zone will not interfere with these vessels' navigation in the area.
        III. Discussion of Proposed Rule
        Shell Exploration and Production Co. requested that an OCS safety zone extending 500 meters from each point on the Appomattox Floating Production System (FPS) facility structure's outermost edge be established. There are safety concerns for both the personnel aboard the facility and the environment. The District Commander has determined that it was highly likely that any allision with the facility would result in a catastrophic event. Placing a safety zone around the facility will significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the living marine resources.

        In evaluating this request, the Coast Guard explored relevant safety factors and considered several criteria, including but not limited to (1) the level of the existing and foreseeable shipping activity, the presence of unusually harmful or hazardous substances and obstructions within 500 meters of the facility, (2) safety concerns for personnel aboard the facility, (3) concerns for the environment, (4) the likelihood that an allision would result in a catastrophic event based on the proximity to shipping fairways, offloading operations, production levels, and size of the crew, (5) the volume of traffic in the vicinity of the proposed safety zone, (6) the types of vessels navigating in the vicinity of the proposed area, and (7) the structural configuration of the facility.
        Results from a thorough and comprehensive examination of the criteria, International Maritime Organization (IMO)'s guidelines, and existing regulations, warrant the establishment of a safety zone of 500 meters around the facility. The proposed safety zone would significantly reduce the threat of allisions, oil spills, and releases of natural gas, and increase the safety of life, property, and the environment in the Gulf of Mexico by prohibiting entry into the zone. Only vessels measuring less than 100 feet in length overall and not engaged in towing, attending vessels as defined in 33 CFR 147.20, or those vessels specifically authorized by the Eighth Coast Guard District Commander or a designated representative would be permitted to enter the proposed safety zone.
        IV. Regulatory Analyses
        We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking, and we considered the First Amendment rights of protestors. Below we summarize our analyses based on a number of these statutes or Executive Orders.
        A. Regulatory Planning and Review
        Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
        This regulatory action determination is based on the safety zone's location and its distance from both land and safety fairways. This proposed rule is not a significant regulatory action due to the location of the Appomattox FPS, on the Outer Continental Shelf, and its distance from both land and safety fairways. Vessels traversing waters near the proposed safety zone would be able to safely travel around the zone using alternate routes. Exceptions to this proposed rule would include vessels measuring less than 100 feet in length overall and not engaged in towing. The Eighth Coast Guard District Commander, or a designated representative, would consider requests to transit through the proposed safety zone on a case-by-case basis.
        B. Impact on Small Entities
        The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
        While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator. This proposed safety zone would not have a significant economic impact or a substantial number of small entities for the following reasons. Vessel traffic can pass safely around the safety zone using alternate routes. Based on the limited scope of the safety zone, any delay resulting from using an alternate route is expected to be minimal depending on vessel traffic and speed in the area. Additionally, exceptions to this proposed rule would include vessels measuring less than 100 feet in length overall and not engaged in towing, as well as any attending vessel, as defined in 33 CFR 147.20. Entry into and transit through the proposed safety zone could be requested. Such requests would be considered on a case-by-case basis and may be authorized by the Eighth Coast Guard District Commander or a designated representative.

        If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

        Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.
        C. Collection of Information
        This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
        D. Federalism and Indian Tribal Governments
        A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

        Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.
        E. Unfunded Mandates Reform Act

        The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
        F. Environment

        We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves establishing a safety zone around an offshore deepwater facility. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
        G. Protest Activities

        The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.
        V. Public Participation and Request for Comments
        We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

        We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

        We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

        Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

          List of Subjects in 33 CFR Part 147
          Continental shelf, Marine safety, Navigation (water).

        For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 147 as follows:

          PART 147—SAFETY ZONES

        1. The authority citation for part 147 continues to read as follows:

          Authority:
          14 U.S.C. 85; 43 U.S.C. 1333; and Department of Homeland Security Delegation No. 0170.1.

        2. Add § 147.869 to read as follows:

          § 147.869
           Safety Zone; Appomattox FPS Facility, Outer Continental Shelf on the Gulf of Mexico
          (a) Description. The Appomattox Floating Production System (FPS) system is in the deepwater area of the Gulf of Mexico at Mississippi Canyon Block 437. The facility is located at 28°34′25.47″ N, 87°56′03.11″ W (NAD 83), and the area within 500 meters (1640.4 feet) from each point on the facility structure's outer edge is a safety zone.
          (b) Regulation. No vessel may enter or remain in this safety zone except the following:
          (1) An attending vessel, as defined by 33 CFR 147.20;
          (2) A vessel under 100 feet in length overall not engaged in towing; or
          (3) A vessel authorized by the Eighth Coast Guard District Commander.

          Dated: March 9, 2018.
          Paul F. Thomas,
          Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.

      [FR Doc. 2018-05605 Filed 3-19-18; 8:45 am]
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