| Page Range | 39669-39939 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 39810 - In the Matter of International Hi-Tech Industries Inc., Mark One Global Industries, Inc., Nortel Networks Corporation, and Silverado Gold Mines Ltd.; Order of Suspension of Trading | |
| 80 FR 39820 - In the Matter of Arrin Corporation, Gundaker/Jordan American Holdings (a/k/a Jordan American Holdings, Inc.), Liberty Petroleum Corporation, Mikojo Incorporated, Royal Invest International Corp., and San Joaquin Bancorp; Order of Suspension of Trading | |
| 80 FR 39688 - Safety Zones; Recurring Marine Events in Captain of the Port Long Island Sound Zone | |
| 80 FR 39683 - Drawbridge Operation Regulation; Victoria Barge Canal, Bloomington, TX | |
| 80 FR 39810 - Sunshine Act Meeting | |
| 80 FR 39686 - Safety Zones; Annual Fireworks Displays Within the Sector Columbia River Captain of the Port Zone | |
| 80 FR 39783 - Determining Mental Health Professional Shortage Areas of Greatest Need; Correction | |
| 80 FR 39831 - Sixth Meeting: Special Committee 231 (SC 231) | |
| 80 FR 39830 - Twenty-Third Meeting: Special Committee 214 (SC 214) | |
| 80 FR 39829 - Determination Regarding Waiver of Discriminatory Purchasing Requirements With Respect to Goods and Services of Montenegro | |
| 80 FR 39790 - Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test | |
| 80 FR 39720 - World Trade Center Health Program; Petition 008-Autoimmune Diseases; Finding of Insufficient Evidence | |
| 80 FR 39761 - The Release of the Supplemental Environmental Impact Statement for the Figure Eight Island Shoreline Management Project, on Figure Eight Island, New Hanover County, NC | |
| 80 FR 39771 - Environmental Impact Statements; Notice of Availability | |
| 80 FR 39787 - National Institute of Allergy and Infectious Diseases: Notice of Closed Meeting | |
| 80 FR 39832 - RECARO Child Safety, LLC, Denial of Petition for Decision of Inconsequential Noncompliance | |
| 80 FR 39734 - Fisheries of the Exclusive Economic Zone Off Alaska; Revise Maximum Retainable Amounts for Skates in the Gulf of Alaska | |
| 80 FR 39759 - Procurement List; Additions | |
| 80 FR 39759 - Procurement List; Proposed Additions and Deletion | |
| 80 FR 39748 - Hand Trucks and Certain Parts Thereof From the People's Republic of China: Final Results of the Expedited Second Sunset Review of the Antidumping Duty Order | |
| 80 FR 39836 - Sanctions Actions Pursuant to Executive Order 13664 | |
| 80 FR 39748 - Civil Nuclear Trade Advisory Committee (CINTAC) Meeting | |
| 80 FR 39806 - Proposed Submission of Information Collection for OMB Review; Comment Request; Qualified Domestic Relations Orders Submitted to PBGC | |
| 80 FR 39747 - Approval of Subzone Status, Syngenta Crop Protection LLC, St. Gabriel and Baton Rouge, Louisiana | |
| 80 FR 39809 - New Postal Product | |
| 80 FR 39771 - Meetings of the Local Government Advisory Committee and the Small Communities Advisory Subcommittee | |
| 80 FR 39771 - Clean Air Act Operating Permit Program; Petitions for Objection to State Operating Permit for the U.S. Department of Energy-Hanford Operations, Benton County, Washington | |
| 80 FR 39804 - NASA Advisory Council; Science Committee; Meeting | |
| 80 FR 39752 - Marine Mammals; File No. 14186 | |
| 80 FR 39750 - Marine Mammals; File No. 19108 | |
| 80 FR 39750 - Marine Mammals; File No. 19526 | |
| 80 FR 39751 - Marine Mammals; File No. 17967 | |
| 80 FR 39749 - Marine Mammals; File No. 17670 | |
| 80 FR 39777 - Agency Information Collection Activities: Proposed Collection Renewals; Comment Request (3064-0090, 3064-0111, 3064-0136, 3064-0138 & 3064-0171) | |
| 80 FR 39836 - Indexing the Annual Operating Revenues of Railroads | |
| 80 FR 39837 - Proposed Information Collection (Former Prisoner of War Medical History) Activity: Comment Request | |
| 80 FR 39797 - Notice of Availability of the Bay Delta Conservation Plan/California WaterFix Partially Recirculated Draft Environmental Impact Report/Supplemental Draft Environmental Impact Statement and Announcement of Public Meetings | |
| 80 FR 39719 - Federal Management Regulation; Art-in-Architecture | |
| 80 FR 39745 - Plant Variety Protection Board; Open Teleconference Meeting | |
| 80 FR 39745 - Peanut Standards Board | |
| 80 FR 39669 - Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products | |
| 80 FR 39781 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 80 FR 39779 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 80 FR 39780 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 80 FR 39835 - School Bus Occupant Protection: Taking Safety to a New Level Meeting | |
| 80 FR 39731 - Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Northeast Groundfish Fishery; Denial of Petition for Rulemaking for Gulf of Maine Cod | |
| 80 FR 39764 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Study on Sustaining the Positive Effects of Preschool | |
| 80 FR 39764 - Joint Consumer Representatives v. PJM Interconnection, L.L.C.; Notice of Complaint | |
| 80 FR 39766 - Combined Notice of Filings | |
| 80 FR 39770 - Combined Notice of Filings | |
| 80 FR 39765 - Combined Notice of Filings | |
| 80 FR 39769 - Rice Energy Marketing LLC; Notice of Petition for Declaratory Order | |
| 80 FR 39767 - Notice of Commission Staff Attendance | |
| 80 FR 39766 - 2015 ESA Project Company, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 39765 - Combined Notice of Filings #2 | |
| 80 FR 39768 - Combined Notice of Filings #1 | |
| 80 FR 39719 - Petition for a Rulemaking of the Liquids Shippers Group, Airlines for America, and the National Propane Gas Association | |
| 80 FR 39767 - Combined Notice of Filings #1 | |
| 80 FR 39800 - Certain Steel Nails From Korea, Malaysia, Oman, Taiwan, and Vietnam | |
| 80 FR 39800 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With Change, of a Previously Approved Collection Applications for Special Deputation | |
| 80 FR 39799 - Marine Sonar Imaging Devices, Including Downscan and Sidescan Devices, Products Containing the Same, and Components Thereof; Notice of Request for Statements on the Public Interest | |
| 80 FR 39801 - Comment Request for Information Collections in the H-2B Temporary Non-Agricultural Employment-Based Visa Program (OMB Control Number 1205-0509), Extension | |
| 80 FR 39751 - Submission for OMB Review; Comment Request | |
| 80 FR 39784 - Agency Information Collection Request; 60-Day Public Comment Request | |
| 80 FR 39783 - Agency Information Collection Activities; Proposed Collection; Public Comment Request | |
| 80 FR 39760 - Proposed Collection; Comment Request | |
| 80 FR 39830 - Petition for Exemption; Summary of Petition Received | |
| 80 FR 39675 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date | |
| 80 FR 39747 - Notice of Public Meeting of the Arizona Advisory Committee To Discuss Findings Regarding Equity in School Funding and Plan Police Community Relations Public Meeting | |
| 80 FR 39715 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2015 Commercial Accountability Measure and Closure for Gulf of Mexico Greater Amberjack | |
| 80 FR 39815 - Self-Regulatory Organizations; C2 Options Exchange, Incorporated; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Correct an Inaccurate Rule Reference | |
| 80 FR 39827 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Fees Assessed Under Rules 7015(b) and (g) | |
| 80 FR 39811 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Rule 4553 and Fees for Access to Alternative Trading System Volume Information Published on FINRA's Web Site | |
| 80 FR 39818 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend FINRA Rule 7650A Relating to Submission of Billing Disputes by FINRA/Nasdaq Trade Reporting Facility Participants | |
| 80 FR 39824 - Self-Regulatory Organizations: Notice of Filing and Immediate Effectiveness of a Proposed Rule Change by Miami International Securities Exchange LLC To Amend Exchange Rule 612 Regarding Enhanced Aggregate Risk Manager Protections for Exchange Market Makers | |
| 80 FR 39816 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change to Rule 21.1(d)(9), (h) and (i) To Modify the Operation of BATS Post Only Orders on the Exchange's Options Platform | |
| 80 FR 39821 - Self-Regulatory Organizations; Chicago Board Options Exchange, Incorporated; Notice of Designation of Longer Period for Commission Action on Proposed Rule Change Relating to Rule 6.53C and Complex Orders on the Hybrid System | |
| 80 FR 39772 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 80 FR 39773 - Information Collections Being Reviewed by the Federal Communications Commission | |
| 80 FR 39796 - Notice of Intent To Prepare an Environmental Impact Statement and Management Plan for Moose, Wolves, and Vegetation, Isle Royale National Park, Michigan | |
| 80 FR 39810 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 39810 - Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement | |
| 80 FR 39752 - United States Patent and Trademark Office and Japan Patent Office Collaborative Search Pilot Program | |
| 80 FR 39805 - Notice of Proposed Information Collection Requests; Museum Assessment Program Evaluation | |
| 80 FR 39808 - New Postal Product | |
| 80 FR 39789 - Center for Scientific Review; Notice of Closed Meetings | |
| 80 FR 39786 - Center for Scientific Review; Notice of Closed Meeting | |
| 80 FR 39787 - National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting | |
| 80 FR 39787 - Office of the Director; Notice of Charter Renewal | |
| 80 FR 39787 - Government-Owned Inventions; Availability for Licensing | |
| 80 FR 39821 - Consolidated Tape Association; Notice of Filing of the Twenty Third Substantive Amendment to the Second Restatement of the CTA Plan | |
| 80 FR 39749 - Guidance on MBDA Applications for Federal Funding; Correction | |
| 80 FR 39795 - Endangered Species; Receipt of Applications for Permit | |
| 80 FR 39807 - New Postal Product | |
| 80 FR 39716 - Fisheries Off West Coast States; Modifications of the West Coast Commercial Salmon Fisheries; Inseason Actions #7 Through #13 | |
| 80 FR 39802 - NASA Advisory Council; Technology, Innovation, and Engineering Committee; Meeting | |
| 80 FR 39805 - NASA Advisory Council; Human Exploration and Operations Committee; Meeting | |
| 80 FR 39804 - NASA Advisory Council; Institutional Committee; Meeting | |
| 80 FR 39803 - NASA Advisory Council; Aeronautics Committee Meeting | |
| 80 FR 39785 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-March Through June 2015 | |
| 80 FR 39696 - Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Determination of Attainment of the 2006 24-Hour Fine Particulate Standard for the Liberty-Clairton Nonattainment Area | |
| 80 FR 39694 - Safety Zone; Oswego Harborfest Jet Ski Show; Oswego Harbor, Oswego, NY | |
| 80 FR 39840 - Medicare and Medicaid Programs; CY 2016 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements | |
| 80 FR 39676 - Venezuela Sanctions Regulations | |
| 80 FR 39752 - Evaluation of National Estuarine Research Reserve | |
| 80 FR 39746 - National Stakeholder Forum-Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program | |
| 80 FR 39689 - Safety Zone-Oil Exploration Staging Area in Goodhope Bay; Kotzebue Sound, AK | |
| 80 FR 39793 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 80 FR 39778 - Agency Information Collection Activities: Notice; Amendment | |
| 80 FR 39691 - Safety Zone-Oil Exploration Staging Area in Dutch Harbor, AK | |
| 80 FR 39763 - Availability of a Draft Regional Environmental Impact Statement to Analyze Potential Impacts within Defined Geographic Regions in Texas that may be Affected by Future U.S. Army Corps of Engineers, Fort Worth District, Permit Decisions for Future Surface Coal and Lignite Mine Expansions or Satellite Mines within the District's area of Responsibility (USACE Project No. SWF-2010-00244) | |
| 80 FR 39698 - Accessible Emergency Information, and Apparatus Requirements for Emergency Information and Video Description | |
| 80 FR 39722 - Accessible Emergency Information, and Apparatus Requirements for Emergency Information and Video Description | |
| 80 FR 39916 - Pipeline Safety: Operator Qualification, Cost Recovery, Accident and Incident Notification, and Other Pipeline Safety Proposed Changes | |
| 80 FR 39831 - Notice of Final Federal Agency Actions on US 69/Loop 49 North Lindale Reliever Route, Smith County, Texas |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Rural Business-Cooperative Service
Foreign-Trade Zones Board
International Trade Administration
Minority Business Development Agency
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Army Department
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
National Park Service
Reclamation Bureau
Employment and Training Administration
Institute of Museum and Library Services
Federal Aviation Administration
Federal Highway Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Surface Transportation Board
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Animal and Plant Health Inspection Service, USDA.
Final rule.
We are amending the Virus-Serum-Toxin Act regulations to provide for the use of a simpler labeling format that would better communicate product performance to the user. Under this rulemaking, the previous label format, which reflected any of four different levels of effectiveness, is replaced with a single, uniform label format. We are also requiring biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A simpler label format, along with publicly available safety and efficacy data, will help biologics producers to more clearly communicate product performance to their customers.
Effective September 8, 2015.
Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851-3426.
The Animal and Plant Health Inspection Service (APHIS) administers and enforces the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151-159). The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions. The regulations in 9 CFR part 112, “Packaging and Labeling,” (referred to below as the regulations) prescribe requirements for the packaging and labeling of veterinary biologics. The regulations ensure that labeling provides adequate information concerning the proper use and safety of the product, including vaccination schedules, warnings, and cautions.
APHIS guidelines provide examples of label claims that may be used to reflect the expected performance of the product, provided that appropriate efficacy data has been submitted and approved by APHIS. Prior to this rulemaking, the guidelines, contained in APHIS Veterinary Services Memorandum No. 800.202 (
On April 21, 2014, we published in the
We solicited comments concerning our proposal for 60 days ending June 20, 2014. We received seven comments by that date. They were from veterinary biologics laboratories, trade associations, a veterinarians' association, and individuals. They are discussed below by topic.
One commenter noted that in both the preamble to the April 2014 proposed rule and the accompanying economic analysis, we stated that the removal of the four-tiered efficacy labeling structure will simplify our evaluation of efficacy studies by focusing on a basic claim of effectiveness, resulting in a reduction of the time required for evaluation and a likely reduction in the number of studies being found unacceptable. The commenter requested further explanation of how those benefits will result from this rulemaking.
As a result of this rulemaking, APHIS will be able to evaluate these studies for product efficacy rather than whether or not the data demonstrate a higher efficacy tier or “stronger” label claim. For example, under the four-tiered efficacy system, if efficacy data is submitted to support the claim of “Prevention of infection,” the data must be analyzed with a very high degree of confidence to determine if it meets the criteria of preventing all colonization or replication of the challenge organism in vaccinated and challenged animals. This is considered an extremely strong claim and would entail a more extensive statistical analysis, as compared to a claim of “Aids in disease control,” for which the data needs to demonstrate that the product alleviates disease severity or reduces disease duration. Conducting data reviews with the aim of determining whether a product is effective rather than how “strong” its label claim is will simplify and streamline our review process. Fewer studies will be found unacceptable because the data will only have to show that the product is efficacious rather than having to support a label claim of a particular level of strength.
One commenter stated that the title of the April 2014 proposed rule, specifically its reference to single label claims, was misleading. The commenter stated that the proposed rule related to
Throughout this rulemaking, as well as in the Veterinary Services Memorandum referred to above, APHIS has used the term “label claim” to represent the level of efficacy of the product, as demonstrated by the manufacturer, based on approved data. Taken in context, the meaning of the term should be clear to readers.
A commenter stated that APHIS should provide for the continued use of distinct label statements for various diseases/syndromes, primary parameters in the case definition, or other situations in which such label statements would be appropriate. According to the commenter, the indications statement contained in the April 2014 proposed rule would not fit certain cases, such as those where the indication for a biological product is to reduce the shedding of an organism or reduce viremia.
We are not making any changes to the rule text based on this comment. The proposed text in § 112.2(a)(5) was sufficiently flexible to allow the indications statement to be modified to include a specific parameter associated with the case definition of a disease syndrome. For example, with acceptable data, the indications statement could read, “This product has been shown to be effective for the vaccination of healthy swine__ weeks of age or older against the respiratory form of porcine reproductive and respiratory syndrome.”
A commenter stated that the April 2014 proposed rule offered no foundation for our conclusion that the change in labels will provide clarity for vaccine users. According to the commenter, there is no evidence that a significant percentage of the vaccine users will read the labels and choose to look up the required data summary of the studies on the Web site. The commenter stated that, contrary to what we claimed in the preamble to the April 2014 proposed rule, the proposed labeling requirements would make labeling more complex rather than simpler.
We disagree with this comment. In our view, providing safety and efficacy data, combined with a simpler labeling format, will allow the end user to better assess product performance. We developed the proposed requirements in cooperation with stakeholders and the public. In 2009, APHIS met with representatives of veterinary biologics manufacturers and the American Veterinary Medical Association, which represents the largest group of consumers of veterinary biologics. We were informed that the current labeling indications were confusing and did not provide sufficient insight into the actual performance of the product. Further, in 2011, APHIS held a public meeting to discuss effectiveness indications statements and received additional feedback from the public on draft guidelines concerning effectiveness indications statements on labels. The proposed labeling requirements, therefore, reflect the views of both APHIS and entities and individuals potentially affected by this rulemaking.
In the preamble to the April 2014 proposed rule, we stated that products for which efficacy data are no longer available should indicate on the label that the data are not available because the product was licensed “x” years ago. A commenter suggested that the required statement should be modified to remove the reference to a year or specific date in order to preclude the need to update the label on an annual basis.
We agree with this comment. APHIS guidelines regarding label claims will be revised as this final rule is implemented. The new guideline regarding products for which efficacy data is no longer available will read as follows: “Original efficacy data is not available because the product was licensed in (date).” This change will preclude the need to update the label each year.
A commenter stated that a common adverse event warning should appear on all biologics. The same commenter also recommended that we institute an active adverse event reporting structure.
While those issues are beyond the scope of the current rulemaking, APHIS does recognize the need for adverse event warnings and reporting. We intend to address the issues in a future rulemaking.
A commenter stated that in the proposed rule, we did not adequately consider the potential impact of the required label changes upon the export of currently licensed veterinary biological products. In the commenter's view, APHIS must allow the continued use of currently approved export labels (containing the tiered claims and establishment number) for all products licensed at the time this rule becomes effective.
Requirements for export labels are beyond the scope of the present rulemaking. APHIS is open to working with industry and the public regarding transition of international labels, as we have done in the past.
A commenter stated that as a logical next step in our effort to standardize labeling requirements for biological products, we should require standardized pregnant animal language for product labels. The commenter offered examples of pregnant animal language that could be used on labels.
This comment is beyond the scope of the present rulemaking.
A commenter requested more guidance as to the basic efficacy threshold for licensure of new products, stating that neither the current efficacy thresholds nor the manner in which they are determined for novel products was mentioned in the April 2014 proposed rule.
Our methodology for statistical and scientific review of efficacy data will not change under this rulemaking. We will continue to evaluate data based on the primary outcome and clinically relevant outcomes of the study. Guidance for efficacy studies can be found on the Center for Veterinary Biologics home page under “Biologics Regulation and Guidance” (
In the preamble to the April 2014 proposed rule, we indicated that for currently licensed products, manufacturers would have to submit a standardized summary of efficacy and safety data and the revised labels to APHIS within 4 years of the effective date of this final rule. Licensees would have the option of requesting an extension for up to 2 years.
Some commenters questioned whether we could realistically implement the proposed requirements in 4 years without tremendous disruption to APHIS operations, the biologics industry, and the consumer. It was also suggested that we could be diverted from ongoing review and approval activities because instituting the proposed new requirements would necessitate that APHIS management and staff perform a number of new tasks. Such an additional workload, it was further suggested, may be especially problematic at a time when we already may not have adequate resources due to budget pressure. One commenter recommended that we phase in the requirements over a period of 8 years. In addition, commenters requested clarification on how the phase-in of the requirements will be approached and communicated to the public, such that
We do not agree that the 8-year implementation period recommended by one commenter is needed. In our view, a 4-year phase-in of the labeling and data summary requirements, with additional extensions of up to 2 years allowed under certain conditions, will provide manufacturers and consumers with adequate time to adapt to the requirements. We further intend to implement the requirements by species (
Some commenters noted that on January 13, 2011, APHIS had published an earlier proposed rule in the
APHIS agrees with commenters that implementing the rules concurrently would be advantageous for end users and industry. We intend to finalize the rules in as close proximity to one another as possible and to coordinate their implementation with industry.
Some commenters addressed issues related to the scope of the proposed data summary requirement. It was suggested that the April 2014 proposed rule was not clear as to the studies that will need to be summarized and appear on the APHIS Web site. A commenter stated that only “pivotal” efficacy and safety studies should be included and that reference requalification or other studies that do not lead to a change in a label claim should not be among those summarized. It was also recommended that, for safety summaries, only field safety studies should be included, as they are the most clinically relevant.
We do not agree with these comments. The purpose of the summaries is to present efficacy and safety data in a non-confusing manner. Efficacy data summaries will include information regarding study design and associated raw data used to license the product, and the results of each study will be evaluated in terms of statistical and clinical relevance to the disease in question. Because each study is unique in terms of health status of the animals, environmental conditions, challenge model/strain, and other factors, limiting the range of the studies in the manner recommended by the commenters could mean that relevant efficacy data would not be made available to the public.
Some commenters raised concerns related to the parameters we listed in the preamble to the April 2014 proposed rule for the data summaries. These included, among others, the minimum and maximum age of the target species; the diversity of target species; the number of animals in the study; whether animals are client-owned; the serologic status of animals (including presence or absence of maternal antibody when appropriate); and dosage, timing, and route of administration. It was noted that we do not currently require information on some of these items. The issues raised by these commenters are discussed individually in the paragraphs that follow.
Commenters stated that the maximum age of the target species should be removed from the list of parameters. It was stated that because older animals have better developed immune systems and are more resistant to infection, the minimum age utilized in the study is more important to the field use of the vaccine than the maximum.
It was also recommended by one commenter that the term “diversity of target species” be removed from the list of parameters. The commenter stated that the term is vague and, if meant to distinguish among categories (
Another commenter stated that the serological status of the animals in the study should not be included unless it is relevant to the label claim. If that is not the case, according to the commenter, the information is not useful.
We have already noted that efficacy data summaries will need to include information regarding study design and associated raw data used to license the product. The study parameters listed in the preamble to the April 2014 proposed rule, however, were examples rather than requirements. Further guidance documents, including but not limited to, a users' guide, will be developed by APHIS to provide, among other things, additional clarification of the parameters associated with the data summaries. These guidance documents, which are discussed in greater detail later in this document, will be released by APHIS and made available for public review and comment.
Some commenters expressed concerns that our parameters for the data summaries could potentially lead to exposure of confidential business information. One commenter stated that clarification was needed that the reference to “dose” related to the volume and not to the potency of the vaccine. The potency of the vaccine reflects antigen content and is confidential business information that has been historically protected by APHIS, according to the commenter. The same commenter also asserted that the case definition and data regarding the concentration of the challenge organism should be removed from the list of parameters for the same reason. The commenter suggested that the “strength” of challenge can be assessed by the morbidity/mortality observed in the controls versus the vaccinates. Another commenter stated that the primary outcome and clinically relevant outcomes of the study used for analysis were confidential business information that should not be required in the summaries.
As noted above, the parameters listed in the preamble of the April 2014 proposed rule were provided as examples only, not as requirements. The studies that will be summarized and included on the APHIS Web site are those studies that demonstrate product efficacy and safety sufficient for product licensure. We will not require the data summaries to include case definitions or statistical results of an inferential nature (
A commenter stated that the proposed rule was unclear about the type of explanatory statistical information that will need to be included in the data summaries, given that we indicated that the summaries will not include statistical information of an inferential nature.
The purpose of the summaries is to present efficacy and safety data in a non-confusing manner. Because these data summaries may be read by persons with little to no medical/scientific background, some statistical data may be confusing to such readers. Additionally, including some statistical
Some commenters noted that the April 2014 proposed rule did not include a format for the summaries. It was suggested that there is a lack of consistency in how the firms present information and what APHIS reviewers consider acceptable and that if customers are reading the product summaries on the Web site, this variability could have a large effect on the public perception of different companies' products. Given that possibility, it was suggested that APHIS should provide information on its Web site to educate users on the complex nature of efficacy studies, as well as explanatory statistical information, where appropriate, related to individual data summaries. Commenters requested more information regarding the nature of such materials and stated that APHIS should allow input from the regulated industry in the development of both the format and content of the summaries and the educational materials.
As indicated in the preamble to the April 2014 proposed rule, given the large number of diseases, vaccine types, and efficacy models, it is not possible to standardize the study design for all efficacy studies. We will, however, seek industry input regarding the development of a data summary template and educational guide. These documents will then be made available on our Web site in draft form for public comment.
Some commenters emphasized the need for a general users' guide or other guidance documents to supplement this final rule. It was suggested that, among other things, our guidance documents should address advertising and promotion of products under the new system. Commenters stated that such documents should indicate that the data in the summaries is intended to provide information relative to the licensure of a product, that comparisons among the products with differing experimental models is not scientifically valid, and that we preclude manufacturers from making such comparisons in advertising and promotion outside of head-to-head studies.
We agree with these comments and, as noted above, we will release a users' guide and other guidance documents as this final rule is being implemented, and we will make the documents available on our Web site in draft form for public comment. For the purposes of marketing, promotion, or advertising, the manufacturers will be allowed to include a statement on promotional and advertising material referring the user to the APHIS Web site, where additional efficacy and safety data may be found. Promotional studies would not be disclosed on the Web site. This policy is consistent with previous guidelines and regulations and would not confer an advantage to any particular manufacturer.
A commenter suggested that our Web site should contain a “click through” requiring a person wanting to access the data summaries to “click” to indicate he or she has read the statements on the limitation of data comparisons before accessing the material.
We will consider this comment as we craft the Web site that will house the educational material and efficacy and safety summaries.
Commenters stated that the Web address allowing users to access the data summaries is too long and not user friendly. The commenters suggested that the URL should fit on a label and that, in addition, we should allow the Web address to be excluded from very small labels.
We agree with these comments. The new Web address reads as follows:
A commenter stated that clarification was needed regarding how the requirements contained in this final rule would apply to in-vitro diagnostics, which are subject to the same restrictions as vaccines and other in-vivo products.
As indicated in the preamble to the April 2014 proposed rule, diagnostic products are not covered under this rulemaking. Further, the rulemaking is not applicable to allergenic extracts or autogenous products.
Several commenters expressed concern that the economic analysis provided with the April 2014 proposed rule underestimated the costs associated with the implementation of this rule. The issues raised by the commenters are discussed individually in the paragraphs that follow.
One commenter stated that in that economic analysis, we significantly underestimated the costs of preparing safety and efficacy summaries, which we estimated to be $55 per summary, and product labels, which we estimated to be $99 to $500 per label. According to the commenter, current preparation of labels involves input and review by scientific, commercial, and regulatory staff, preparation of label artwork, generation of printing specifications, generation of controlled documentation for the label, formal review and approval processes, submission to APHIS for approval, and then formal implementation into the production process. Another commenter stated that the cost estimates provided in the economic analysis to demonstrate lack of significant economic impact seem very optimistic, particularly the costs of preparing the summaries, as well as the costs of development of new labels and product outlines for the entire vaccine line.
We used cost range information for label changes from a model developed by The Food and Drug Administration. The model estimates the cost of labeling changes in consumer labeling regulations. While not directly applicable to veterinary biologics labeling changes, the model does include cost range information on various areas pertinent to a veterinary biologics label change.
We agree that label changes go through multiple approval steps. However, because the rule does not require any new scientific content, changing the text on the label to fit with the rule requirements should be much simpler than the comment would imply. The estimates of costs we included in the analysis of the proposed rule do include ranges for administrative and recordkeeping costs associated with labeling changes. Those costs to manufacturers include understanding the regulation, determining their responses, tracking the required change throughout the labeling change process, and reviewing and updating their records of product labels.
These labeling cost ranges were used in reference to the cost for products for which label changes could be coordinated with planned label changes that occur in the normal course of business, and only included administrative and recordkeeping costs. For label changes that cannot be coordinated with planned label changes, we also included other types of costs, such as prepress, graphic design, and
After considering these comments, we did revise our estimate of the cost of preparing a summary. We continue to believe that it will take approximately 1 hour to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The rule does not require any new scientific content, and the new summary format requirement is simply a repackaging of existing information on a product that has already been collected and assembled as part of the initial licensing process. This activity will most likely be done by a mid-level manager, who will most likely already be very familiar with the product in question, and this labor will cost a manufacturer about $55. We do acknowledge, however, that there will be some further management review involved. Therefore, we are including another one-half hour of management time to our estimate of the cost of preparing a summary. The revised estimate is $83 per summary.
A commenter noted that in the preamble to the July 2014 proposed rule, we stated that most labels would be replaced in the normal course of business regardless of this rule, given the 4- to 6-year implementation timeframe. The commenter disagreed, estimating that approximately 20 percent of the labels for existing products would be replaced as normal practice. The commenter suggested that the number of entities that would incur the expenses associated with replacing labels as a result of this rulemaking will be far larger than we projected.
We respectfully disagree. Of the approximately 11,700 active, approved labels, 53 percent, or about 6,200, are no more than 4 years old, suggesting that a similar number will be replaced in the ordinary course of business during the implementation period. We therefore considered 53 percent to be an appropriate percentage to use to estimate the number of products for which regulatory labeling changes can be coordinated with otherwise planned labeling changes.
One commenter, representing a manufacturer, stated that we did not factor in the cost of replacing printing plates for existing labels, thereby significantly underestimating the economic burden placed on that entity by this rulemaking.
In the proposed rule, we did not include the cost of conventional printing plates. Based on our review of all labels for licensed biologics, we concluded that the general practice among manufacturers is to use computer-generated labels. However, to be conservative in our cost estimates for this final rule, we assume that 5 percent of labels are printed using conventional printing plates. Therefore, we added cost estimates for conventional printing plates for 5 percent of the labeling changes that cannot be coordinated with otherwise planned label changes.
A commenter stated that the posting of quantitative results accompanying the studies would be valuable for veterinarians.
Basic statistical data may be applicable to certain disease situations, such as when lesion consolidation is a primary outcome. Such data will be presented in terms of the number of animals exhibiting (controls) and not exhibiting (vaccinates) clinical signs of disease out of the total numbers of animals vaccinated or not vaccinated. For safety studies, the number of animals presenting with adverse reactions to vaccination out of the total number of animals will be included in the data.
In addition to the changes described above that we are making in response to the comments we received, we are making an editorial change for the sake of clarity. In § 112.2(a)(5) of the April 2014 proposed rule, we proposed to require an indications statement to read, “This product has been shown to be effective for the vaccination of healthy animals __ weeks of age or older against __.” In order to clarify that the specific animal species must be included on the label, we are amending that sentence to read as follows: “An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) __ weeks of age or older against __.”
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.
This final rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this rule. The economic analysis provides a cost-benefit analysis, as required by Executive Orders 12866 and 13563, which 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, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The economic analysis also provides a final regulatory flexibility analysis that examines the potential economic effects of this rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under
We are amending the Virus-Serum-Toxin Act regulations to require the use of a simpler labeling format. Biologics licensees and permittees will also be required to provide a standardized summary of the efficacy and safety data.
This rule will simplify the evaluation of efficacy studies, thereby reducing the amount of time required by APHIS to evaluate study data. A novel veterinary biological product can generate revenue in the neighborhood of $5 to $10 million per year. Increased efficiencies in the generation and evaluation of efficacy data should result in fewer delays in bringing a product to market. In addition, a simpler label may benefit those manufacturers, both large and small, who export their products, as foreign manufacturers do not use a tiered approach to label claims.
This rule will affect all veterinary biologics licensees and permittees. Currently, there are approximately 100 veterinary biological establishments, including permittees. These companies produce about 1,900 different products, and there are about 11,700 active approved labels for veterinary biologics. There were about 3,100 labels submitted for approval from June 2012 through May 2013, by about two-thirds of the companies.
Costs of the rule for licensees and permittees are not expected to be significant, whether the affected entity is small or large. APHIS anticipates that the only costs associated with the new labeling format will be one-time costs incurred by licensees and permittees in having labels for existing licensed
Products that are not yet licensed but are within 6 months of licensure at the time these regulations become effective will be expected to be fully compliant no later than 1 year after licensure. Products that are more than 6 months away from licensure at the time these regulations become effective will be expected to be fully compliant at the time of licensure. For products that are currently licensed, the standardized summary of efficacy and safety data and the revised labels will have to be submitted to APHIS within 4 years of the time these regulations become effective. APHIS will consider written requests to extend the time period for submitting the summaries by an additional 2 years if necessary.
We estimate that, in total, this rule will cost veterinary biological establishments between $1.1 million and $4.1 million, with a median estimate of about $2.4 million. Costs associated with the rule for an individual manufacturer will depend on the extent of the changes required, type of printing method used, and whether the label changes can be coordinated with planned label changes. All affected manufacturers will incur administrative and recordkeeping costs, that is, costs associated with understanding the regulation, determining responses, tracking the required changes throughout the labeling change process, and reviewing and updating their records of product labels. For label changes not coordinated with planned label changes, costs will also include labor and materials associated with generating the new labels, such as prepress, graphic design, and label printing. Those costs are not attributable to the regulation if the labeling revisions are coordinated with planned changes.
In many instances manufacturers will not have to produce new labeling materials before they would otherwise do so in the normal course of business and will only incur additional administrative and recordkeeping costs to track the changes. Costs incurred for minor label changes that are coordinated with planned label changes are estimated to range between $99 and $500 per label. We estimate that there are about 6,200 labels associated with about 1,000 products for which there will be this type of coordinated change, and the total cost is estimated to range between $99,000 and $500,000.
Costs incurred for minor label changes that cannot be coordinated with planned label changes include costs for prepress, graphic design, and printing the labels, in addition to administrative and recordkeeping activities. We expect that about 5,500 of the active labels, associated with about 900 products, will be changed other than in conjunction with a planned change. Administrative and recordkeeping costs for these label changes are estimated to range between $198 and $1,000 per product, or between about $178,000 and $900,000 in total. We estimate that at least 95 percent of the products with labels that will need to be changed other than in conjunction with a planned change are computer generated with no outside design assistance. The internal prepress and graphic design labor costs associated with these changes are estimated to be between $135 and $743 for each product. The material costs for computer generated labels are estimated to be between $100 and $275 for each new label. For these label changes, production labor and material costs are estimated to range between about $638,000 and $2 million.
To be conservative in our cost estimates, we assume that 5 percent of the products with labels that will need to be changed other than in conjunction with a planned change are printed using more costly conventional printing plates, and the manufacturers of these products use external prepress and graphic design consultants. Prepress and graphic design labor costs, internal and external, are estimated to be between $810 and $5,043 for each product, totaling between about $36,000 and $227,000. There is significant variation in the cost of conventionally printed labels depending on the printing method. Printing material costs for these label changes are estimated to range between about $47,000 and $306,000.
Minor costs may be incurred in producing the standardized summaries of efficacy and safety data for currently licensed products within the 4-year implementation period. We estimate that about 1,700 revised summaries will need to be produced as a result of this rule because efficacy and safety studies are frequently provided for multiple products. The estimated cost will be about $83 per summary, or about $141,000 in total.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency's intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule.
This final rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Animal biologics, Exports, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR part 112 as follows:
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
The additions read as follows:
(a) * * *
(5) An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) __ weeks of age or older against __.” * * *
(9) * * *
(v) A statement similar to “For more information regarding efficacy and
The addition reads as follows:
(b) A data summary, available on the Internet at
Food and Drug Administration, HHS.
Final rule; extension of compliance date.
The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the
Ashley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email:
In the
• Defines terms, including terms that describe criteria for determining whether an establishment is subject to the rule;
• establishes which foods are subject to the nutrition labeling requirements and which foods are not subject to these requirements;
• requires that calories for standard menu items be declared on menus and menu boards that list such foods for sale;
• requires that calories for standard menu items that are self-service or on display be declared on signs adjacent to such foods;
• requires that written nutrition information for standard menu items be available to consumers who ask to see it;
• requires, on menus and menu boards, a succinct statement concerning suggested daily caloric intake (succinct statement), designed to help the public understand the significance of the calorie declarations;
• requires, on menus and menu boards, a statement regarding the availability of the written nutrition information (statement of availability);
• establishes requirements for determination of nutrient content of standard menu items;
• establishes requirements for substantiation of nutrient content determined for standard menu items, including requirements for records that a covered establishment must make available to FDA within a reasonable period of time upon request; and
• establishes terms and conditions under which restaurants and similar retail food establishments not otherwise subject to the rule could elect to be subject to the requirements by registering with FDA.
In the preamble to the final rule (79 FR 71156 at 71239 through 71241), we stated that the rule would be effective on December 1, 2015, and also provided a compliance date of December 1, 2015, for covered establishments. The final rule (at 21 CFR 101.11(a)) defines “covered establishment” as a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership,
Since we published the final rule in the
Since February 2015, we have received four requests asking us to extend the compliance date of the final rule based on concerns that covered establishments do not have adequate time to fully implement the requirements of the rule by the compliance date. These requests were submitted by a large retailer and trade and other associations, and they provide information regarding steps involved in implementation of the requirements. More specifically, the requests describe steps involved in developing software, information systems, and other technologies for providing nutrition information in ways that better correspond to how foods are offered for sale in covered establishments and allow for more efficient and product-specific nutrition labeling. In addition, the requests describe steps involved in training staff, implementing standard operating procedures, and developing and installing updated and consistent menu boards across all locations within a chain. Most requests sought to extend the compliance date by 1 year.
In light of these requests, we have decided to extend the compliance date for the final rule to December 1, 2016. The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices. Therefore, allowing adequate time for covered establishments to fully implement the final rule's requirements, as described in the requests, helps accomplish the primary objective of the final rule and is in the public interest.
FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct 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). FDA has developed a regulatory impact analysis that presents the benefits and costs of this final rule (Ref. 1). The Agency believes that this final rule is not a significant regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule changes the compliance date from December 1, 2015, to December 1, 2016, the Agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.
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 $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have determined under 21 CFR 25.30(k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
The following reference has been placed on display in the Division of Dockets Management (see
1. FDA, “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date,” 2015. Available at:
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is issuing regulations to implement the Venezuela Defense of Human Rights and Civil Society Act of 2014 (Pub. L. 113-278) and Executive Order 13692 of March 8, 2015 (“Blocking Property and Suspending Entry of Certain Persons Contributing to the Situation in Venezuela”). OFAC intends to supplement this part 591 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance and additional general licenses and statements of licensing policy.
Assistant Director for Licensing, tel.: 202/622-2480, Assistant Director for Policy, tel.: 202/622-6746, Assistant Director for Regulatory Affairs, tel.: 202/622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, OFAC, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
This document and additional information concerning OFAC are available from OFAC's Web site (
On December 18, 2014, President Obama signed the Venezuela Defense of Human Rights and Civil Society Act of 2014 (Pub. L. 113-278) (the “Act”) into law. The Act required the President to impose targeted sanctions on certain persons that he determines to be responsible for significant acts of violence or serious human rights abuses against antigovernment protesters in Venezuela and to have ordered or otherwise directed the arrest or prosecution of persons in Venezuela primarily because of the person's legitimate exercise of freedom of expression or assembly.
On March 8, 2015, the President issued Executive Order 13692 (80 FR 12747, March 11, 2015) (E.O. 13692), invoking the authority of,
OFAC is issuing the Venezuela Sanctions Regulations, 31 CFR part 591 (the “Regulations”), to implement the Act and E.O. 13692, pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13692. A copy of E.O. 13692 appears in Appendix A to this part.
The Regulations are being published in abbreviated form at this time for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part 591 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance and additional general licenses and statements of licensing policy. The appendix to the Regulations will be removed when OFAC supplements this part with a more comprehensive set of regulations.
Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banking, Banks, Blocking of assets, Brokers, Credit, Foreign trade, Investments, Loans, Securities, Services, Venezuela.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control adds part 591 to 31 CFR chapter V to read as follows:
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); Pub. L. 113-278, 128 Stat. 3011 (50 U.S.C. 1701 note); E.O. 13692, 80 FR 12747, March 11, 2015.
This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.
This part has been published in abbreviated form for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance and
All transactions prohibited pursuant to Executive Order 13692 of March 8, 2015, are also prohibited pursuant to this part.
The names of persons designated pursuant to Executive Order 13692, whose property and interests in property therefore are blocked pursuant to this section, are published in the
The International Emergency Economic Powers Act (50 U.S.C. 1701-1706), in Section 203 (50 U.S.C. 1702), authorizes the blocking of property and interests in property of a person during the pendency of an investigation. The names of persons whose property and interests in property are blocked pending investigation pursuant to this section also are published in the
Sections 501.806 and 501.807 of this chapter describe the procedures to be followed by persons seeking, respectively, the unblocking of funds that they believe were blocked due to mistaken identity, or administrative reconsideration of their status as persons whose property and interests in property are blocked pursuant to this section.
(a) Any transfer after the effective date that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 591.201, is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or property interest.
(b) No transfer before the effective date shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interest in property blocked pursuant to § 591.201, unless the person who holds or maintains such property, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, a license or other authorization issued by OFAC before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of this part and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property is or was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of OFAC each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property is or was held or maintained (and as to such person only);
(2) The person with whom such property is or was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property is or was held or maintained filed with OFAC a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other directive or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by OFAC; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained.
The filing of a report in accordance with the provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms of paragraphs (d)(1) and (2) of this section have been satisfied.
(e) Unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property and interests in property blocked pursuant to § 591.201.
(a) Except as provided in paragraphs (e) or (f) of this section, or as otherwise directed by OFAC, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 591.201 shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For purposes of this section, the term
(i) In a federally-insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) Funds held or placed in a blocked account pursuant to paragraph (a) of this section may not be invested in instruments the maturity of which exceeds 180 days.
(c) For purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(d) For purposes of this section, if interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(e) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 591.201 may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraphs (a) or (f) of this section.
(f) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 591.201 may continue to be held in the same type of accounts or instruments, provided the funds earn interest at rates that are commercially reasonable.
(g) This section does not create an affirmative obligation for the holder of blocked tangible property, such as chattels or real estate, or of other blocked property, such as debt or equity
(h) Funds subject to this section may not be held, invested, or reinvested in a manner that provides immediate financial or economic benefit or access to any person whose property and interests in property are blocked pursuant to § 591.201, nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted prior to the effective date, all expenses incident to the maintenance of physical property blocked pursuant to § 591.201 shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 591.201 may, in the discretion of OFAC, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
The definitions in this subpart apply throughout the entire part.
The terms
See § 591.406 concerning the blocked status of property and interests in property of an entity that is 50 percent or more owned by persons whose property and interests in property are blocked pursuant to § 591.201.
The term
(a) With respect to a person listed in the Annex to E.O. 13692 of March 8, 2015, 12:01 a.m. eastern daylight time, March 9, 2015; and
(b) With respect to a person whose property and interests in property are otherwise blocked pursuant to § 591.201, the earlier of the date of actual or constructive notice that such person's property and interests in property are blocked.
The term
The term
Except as otherwise provided in this part, the term
(a) Except as otherwise provided in this part, the term
(b) The term
(c) The term
The term
The term
The terms
The term
The term
The term
The term
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person whose property and interests in property are blocked pursuant to § 591.201, such property shall no longer be deemed to be property blocked pursuant to § 591.201, unless there exists in the property another interest that is blocked pursuant to § 591.201, the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or other authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property and interests in property are blocked pursuant to § 591.201, such property shall be deemed to be property in which such a person has an interest and therefore blocked.
Any transaction ordinarily incident to a licensed transaction and necessary to give effect thereto is also authorized, except:
(a) An ordinarily incident transaction, not explicitly authorized within the terms of the license, by or with a person whose property and interests in property are blocked pursuant to § 591.201; or
(b) An ordinarily incident transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property.
A setoff against blocked property (including a blocked account), whether by a U.S. bank or other U.S. person, is a prohibited transfer under § 591.201 if effected after the effective date.
Persons whose property and interests in property are blocked pursuant to § 591.201 have an interest in all property and interests in property of an entity in which such blocked persons own, whether individually or in the aggregate, directly or indirectly, a 50 percent or greater interest. The property and interests in property of such an entity, therefore, are blocked, and such an entity is a person whose property and interests in property are blocked pursuant to § 591.201, regardless of whether the name of the entity is incorporated into OFAC's Specially Designated Nationals and Blocked Persons List (SDN List).
For provisions relating to licensing procedures, see part 501, subpart E of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Venezuela sanctions page on OFAC's Web site:
OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.
Any payment of funds or transfer of credit in which a person whose property and interests in property are blocked pursuant to § 591.201 has any interest that comes within the possession or control of a U.S. financial institution
(a) A U.S. financial institution is authorized to debit any blocked account held at that financial institution in payment or reimbursement for normal service charges owed it by the owner of that blocked account.
(b) As used in this section, the term
(a) The provision of the following legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, is authorized, provided that receipt of payment of professional fees and reimbursement of incurred expenses must be specifically licensed or otherwise authorized pursuant to § 591.507:
(1) Provision of legal advice and counseling on the requirements of and compliance with the laws of the United States or any jurisdiction within the United States, provided that such advice and counseling are not provided to facilitate transactions in violation of this part;
(2) Representation of persons named as defendants in or otherwise made parties to legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(3) Initiation and conduct of legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(4) Representation of persons before any U.S. federal, state, or local court or agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to persons whose property and interests in property are blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, not otherwise authorized in this part, requires the issuance of a specific license.
(c) Entry into a settlement agreement or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, is prohibited unless licensed pursuant to this part.
U.S. persons seeking administrative reconsideration or judicial review of their designation or the blocking of their property and interests in property may apply for a specific license from OFAC to authorize the release of a limited amount of blocked funds for the payment of legal fees where alternative funding sources are not available. For more information, see OFAC's
(a) Receipts of payment of professional fees and reimbursement of incurred expenses for the provision of legal services authorized pursuant to § 591.506(a) to or on behalf of any person whose property and interests in property are blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, are authorized from funds originating outside the United States, provided that the funds received by U.S. persons as payment of professional fees and reimbursement of incurred expenses for the provision of legal services authorized pursuant to § 591.506(a) do not originate from:
(1) A source within the United States;
(2) Any source, wherever located, within the possession or control of a U.S. person; or
(3) Any individual or entity, other than the person on whose behalf the legal services authorized pursuant to § 591.506(a) are to be provided, whose property and interests in property are blocked pursuant to any part of this chapter or any Executive order.
This paragraph authorizes the blocked person on whose behalf the legal services authorized pursuant to § 591.506(a) are to be provided to make payments for authorized legal services using funds originating outside the United States that were not previously blocked. Nothing in this paragraph authorizes payments for legal services using funds in which any other person whose property and interests in property are blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, any other part of this chapter, or any Executive order has an interest.
(b)
(i) The individual or entity from whom the funds originated and the amount of funds received; and
(ii) If applicable:
(A) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(B) A general description of the services provided; and
(C) The amount of funds paid in connection with such services.
(2) The reports, which must reference this section, are to be mailed to: Licensing Division, Office of Foreign Assets Control, U.S. Department of the Treasury, 1500 Pennsylvania Avenue NW., Annex, Washington, DC 20220.
U.S. persons who receive payments in connection with legal services authorized pursuant to § 591.506(a) do not need to obtain specific authorization to contract for related services that are ordinarily incident to the provision of those legal services, such as those provided by private investigators or expert witnesses, or to pay for such services. Additionally, U.S. persons do not need to obtain specific
The provision of nonscheduled emergency medical services in the United States to persons whose property and interests in property are blocked pursuant to § 591.201 or any further Executive orders relating to the national emergency declared in Executive Order 13692 of March 8, 2015, is authorized, provided that all receipt of payment for such services must be specifically licensed.
Any action that the Secretary of the Treasury is authorized to take pursuant to Executive Order 13692 of March 8, 2015, and any further Executive orders relating to the national emergency declared therein, may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
For approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to recordkeeping and reporting requirements, licensing procedures (including those pursuant to statements of licensing policy), and other procedures,
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the International Emergency Economic Powers Act (50 U.S.C. 1701
I, BARACK OBAMA, President of the United States of America, find that the situation in Venezuela, including the Government of Venezuela's erosion of human rights guarantees, persecution of political opponents, curtailment of press freedoms, use of violence and human rights violations and abuses in response to antigovernment protests, and arbitrary arrest and detention of antigovernment protestors, as well as the exacerbating presence of significant public corruption, constitutes an unusual and extraordinary threat to the national security and foreign policy of the United States, and I hereby declare a national emergency to deal with that threat. I hereby order:
Section 1. (a) All property and interests in property that are in the United States, that hereafter come within the United States, or that are or hereafter come within the possession or control of any United States person of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in:
(i) the persons listed in the Annex to this order; and
(ii) any person determined by the Secretary of the Treasury, in consultation with the Secretary of State:
(A) to be responsible for or complicit in, or responsible for ordering, controlling, or otherwise directing, or to have participated in, directly or indirectly, any of the following in or in relation to Venezuela:
(1) actions or policies that undermine democratic processes or institutions;
(2) significant acts of violence or conduct that constitutes a serious abuse or violation of human rights, including against persons involved in antigovernment protests in Venezuela in or since February 2014;
(3) actions that prohibit, limit, or penalize the exercise of freedom of expression or peaceful assembly; or
(4) public corruption by senior officials within the Government of Venezuela;
(B) to be a current or former leader of an entity that has, or whose members have, engaged in any activity described in subsection (a)(ii)(A) of this section or of an entity whose property and interests in property are blocked pursuant to this order;
(C) to be a current or former official of the Government of Venezuela;
(D) to have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of:
(1) a person whose property and interests in property are blocked pursuant to this order; or
(2) an activity described in subsection (a)(ii)(A) of this section; or
(E) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to this order.
(b) The prohibitions in subsection (a) of this section apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to this order, and notwithstanding any contract entered into or any license or permit granted prior to the effective date of this order.
Sec. 2. I hereby find that the unrestricted immigrant and nonimmigrant entry into the United States of aliens determined to meet one or more of the criteria in subsection 1(a) of this order would be detrimental to the interests of the United States, and I hereby suspend entry into the United States, as immigrants or nonimmigrants, of such persons, except where the Secretary of State determines that the person's entry is in the national interest of the United States. This section shall not apply to an alien if admitting the alien into the United States is necessary to permit the United States to comply with the Agreement Regarding the Headquarters of the United Nations, signed at Lake Success June 26, 1947, and entered into force November 21, 1947, or other applicable international obligations.
Sec. 3. I hereby determine that the making of donations of the type of articles specified in section 203(b)(2) of IEEPA (50 U.S.C. 1702(b)(2)) by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to section 1 of this order would seriously impair my ability to deal with the national emergency declared in this order, and I hereby prohibit such donations as provided by section 1 of this order.
Sec. 4. The prohibitions in section 1 of this order include but are not limited to:
(a) the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to this order; and
(b) the receipt of any contribution or provision of funds, goods, or services from any such person.
Sec. 5. (a) Any transaction that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this order is prohibited.
(b) Any conspiracy formed to violate any of the prohibitions set forth in this order is prohibited.
Sec. 6. For the purposes of this order:
(a) the term “person” means an individual or entity;
(b) the term “entity” means a partnership, association, trust, joint venture, corporation, group, subgroup, or other organization;
(c) the term “United States person” means any United States citizen, permanent resident alien, entity organized under the laws of the United States or any jurisdiction within the United States (including foreign branches), or any person in the United States;
(d) the term “Government of Venezuela” means the Government of Venezuela, any political subdivision, agency, or instrumentality thereof, including the Central Bank of Venezuela, and any person owned or controlled by, or acting for or on behalf of, the Government of Venezuela.
Sec. 7. For those persons whose property and interests in property are blocked pursuant to this order who might have a constitutional presence in the United States, I find that because of the ability to transfer funds or other assets instantaneously, prior
Sec. 8. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA and section 5 of the Venezuela Defense of Human Rights Act, other than the authorities contained in sections 5(b)(1)(B) and 5(c) of that Act, as may be necessary to carry out the purposes of this order, with the exception of section 2 of this order, and the relevant provisions of section 5 of that Act. The Secretary of the Treasury may redelegate any of these functions to other officers and agencies of the United States Government consistent with applicable law. All agencies of the United States Government are hereby directed to take all appropriate measures within their authority to carry out the provisions of this order.
Sec. 9. The Secretary of State is hereby authorized to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA, the INA, and section 5 of the Venezuela Defense of Human Rights Act, including the authorities set forth in sections 5(b)(1)(B), 5(c), and 5(d) of that Act, as may be necessary to carry out section 2 of this order and the relevant provisions of section 5 of that Act. The Secretary of State may redelegate any of these functions to other officers and agencies of the United States Government consistent with applicable law.
Sec. 10. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to determine that circumstances no longer warrant the blocking of the property and interests in property of a person listed in the Annex to this order, and to take necessary action to give effect to that determination.
Sec. 11. The Secretary of the Treasury, in consultation with the Secretary of State, is hereby authorized to submit the recurring and final reports to the Congress on the national emergency declared in this order, consistent with section 401(c) of the NEA (50 U.S.C. 1641(c)) and section 204(c) of IEEPA (50 U.S.C. 1703(c)).
Sec. 12. This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Sec. 13. This order is effective at 12:01 a.m. eastern daylight time on March 9, 2015.
Approved:
Coast Guard, DHS.
Interim rule with request for comments.
The Coast Guard is modifying the method of operation for the Victoria Barge Canal Railroad Bridge across the Victoria Barge Canal, mile 29.4, at Bloomington, Victoria County, Texas. The bridge owner, the Victoria County Navigation District, in conjunction with the Union Pacific Railroad (UPRR), the operator of the bridge, is operating the bridge remotely under a temporary deviation. This interim rule codifies the change in method of operation while allowing for comments regarding the remote operations. This interim rule increases the efficiency of operations allowing for the safe navigation of vessels through the bridge while recognizing the bridge's importance to the Port of Victoria that it serves.
This interim rule is effective July 10, 2015.
Comments and related material must reach the Coast Guard on or before September 8, 2015.
You may submit comments, identified by docket number, using any one of the following methods:
(1)
(2)
(3)
See the “Public Participation and Request for Comments” portion of the
If you have questions on this rule, call or email Ms. Geri Robinson; Bridge Administration Branch, Eighth Coast Guard District; telephone 504-671-2128, email
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change to
If you submit a comment, please include the docket number for this rulemaking (USCG-2014-0952), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, or by fax, mail or hand delivery, but please use only one of these means. If you submit a comment online via
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
We do not now plan to hold a public meeting. But you may submit a request for one to the docket using one of the four methods specified under
On December 30, 2014, we published a temporary deviation from regulations; request for comments (TD) entitled, “Drawbridge Operation Regulation; Victoria Barge Canal, Bloomington, Texas” in the
The Coast Guard is issuing this interim final rule without prior notice pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C.) 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because doing so would be impracticable and contrary to the public interest. This bridge has been operating on a modified schedule under a temporary deviation, and given that we have received no comments, we believe that the schedule has been working. Reverting to the old schedule in order to accept comment would present logistical difficulties for the operator and users.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the
The Coast Guard received a request from the bridge owner, the Victoria County Navigation District, in conjunction with the bridge operator, the Union Pacific Railroad (UPRR) to remotely operate the vertical lift span bridge across the Victoria Barge Canal, at Mile 29.4 near Bloomington, Texas. The bridge owner and operator requested to operate the bridge remotely from its dispatching center in Spring, Texas and remove the requirement that a bridge tender be present on site at all times. A temporary deviation was issued permitting these practices. Under the procedures now in use, the bridge will continue to open on signal for the passage of vessels.
This final rule will allow the bridge operator to increase efficiency of bridge operations and vessel transit by remotely operating the bridge. This method provides for the opening signal to be received by the railroad dispatcher and allows the dispatcher to open the bridge from a remote location. Vessel traffic on the waterway will be monitored by the railroad dispatcher by use of an Automatic Identification System (AIS). The AIS System allows the Port of Victoria and the UPRR dispatcher to determine where vessels are located along the waterway in the vicinity of the bridge. We also note that the Victoria County Navigation District has a carriage requirement that all vessels desiring to transit the Victoria Barge Canal to the Port of Victoria be equipped with an operating AIS transponder.
The Victoria Barge Canal Railroad Bridge is a vertical lift span bridge across the Victoria Barge Canal, at Mile 29.4 near Bloomington, Texas. The vertical lift bridge has a vertical clearance of 22 feet above high water in the closed-to-navigation position and 50 feet above high water in the open-to-navigation position. Traffic on this waterway is primarily commercial and consists of vessels and tows that provide services to the Port of Victoria.
No comments were received during the comment period of the temporary deviation. However, a contractor raised an issue regarding the requirements of dispatchers to contact the vessels when a vessel entered the two-mile bridge zone. In response to this concern, the Coast Guard decided that further comments would be accepted under an Interim Rule.
The bridge owner, the Victoria County Navigation District, in conjunction with
Prior to the granting of the temporary deviation, the bridge opened on signal for the passage of vessels in accordance with 33 CFR 117.5. When a request signal to open the bridge is received and before opening the bridge for vessel traffic, the tender was required by his company to contact the railroad dispatcher so that railroad traffic could be stopped. Under the existing deviation, the bridge continues to open on signal for the passage of vessels, but the method of opening the bridge is accomplished through remote operation by the railroad dispatcher.
The bridge operator, UPRR, determined that by remotely operating the bridge, vessel transit through the bridge is more efficient. This remote method of operation provides for the signal to open to be received directly by the railroad dispatcher and will allow the railroad dispatcher to then open the bridge from the remote location.
The Interim Rule allows for mariners to continue their transit while the bridge is remotely operated and to comment as to whether the proposed method of operation is sufficient to insure the safety of vessels transiting the area.
This interim rule allows the bridge to be unmanned and operated remotely at all times. To facilitate the continued smooth operation of the bridge, mariners should exchange opening requests using the following method:
1. When a vessel with AIS equipment onboard approaches the two-mile post, the dispatcher will receive a prompt to open the bridge, if required, because a vessel is approaching. The vessel may continue to transit the waterway, but must tune their radiotelephone to VHF-FM channel 13 and receive passing instructions from the railroad dispatcher. The dispatcher must contact the vessel promptly to provide passing instructions to ensure the continued safe transit of the vessel. Operators of vessels without AIS equipment or operators of vessels with AIS who prefer to contact the railroad dispatcher via telephone may call the railroad dispatcher at 800-262-4691 to receive instructions and arrange passing.
2. When any vessel approaches the one mile post, the railroad dispatcher should have either cleared the vessel through the bridge or given an indication that a train is in the block and the vessel will be cleared as soon as practicable. If the vessel operator has not yet communicated with the railroad dispatcher, the vessel operator should immediately call the railroad dispatcher via telephone at 800-262-4691.
3. If any vessel reaches the one-half mile post and has not communicated with the railroad dispatcher nor been cleared to proceed, the vessel should stop and contact either the railroad dispatcher at 800-262-4691 or the Port of Victoria emergency contact at 361-570-8855.
Traffic on this waterway is primarily commercial and consists of vessels and tows that provide services to the Port of Victoria.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
This rule allows all vessels utilizing this stretch of the waterway to continue to transit the waterway unencumbered while provide for the bridge owner to operate the bridge from a remote location. Vessel operators should not see any changes in the efficiency of vessel movements as the bridge will still be required to open on signal for the passage of vessels.
The Regulatory Flexibility Act of 1980 (RFA), 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 rule would not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which may be small entities: the property owners, vessel operators and waterway users who wish to transit on Victoria Barge Canal daily. This rule will not have a significant impact on a substantial number of small entities for the following reasons: a test deviation was conducted and no opposition in response to the test was received by the Coast Guard Office of Bridge Administration. Further, through pre-coordination and consultation with property owners, vessel operators and waterway users, this operating schedule will accommodate all waterway users with minimal impact to their transits on the waterway.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this 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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
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 rule under that Order and have determined that it does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and Department of Homeland Security Delegation No. 0170.1.
The draw of the Victoria Barge Canal Railroad Bridge across Victoria Barge Canal, mile 29.4, at the Bloomington, Victoria County, Texas, shall operate as follows:
(a) The draw shall be unmanned and when a vessel with AIS equipment onboard approaches the two-mile post, the dispatcher will receive a prompt to open the bridge, if required, because a vessel is approaching. The vessel may continue to transit the waterway, but must tune their radiotelephone to VHF-FM channel 13 and receive passing instructions from the railroad dispatcher. The dispatcher must contact the vessel promptly to provide passing instruction to insure the continued safe transit of the vessel. Vessels without AIS equipment or vessels with AIS who would prefer to call via telephone, may call the railroad dispatcher at 800-262-4691 to arrange passing instructions.
(b) When any vessel approaches the one-mile post, the railroad dispatcher should have either cleared the vessel through the bridge or given an indication that a train is in the block and the vessel will be cleared as soon as practicable. If the vessel has not yet spoken with the railroad dispatcher, the vessel should immediately call the railroad dispatcher via telephone at 800-262-4691.
(c) If any vessel reaches the one-half mile post and has not communicated with the railroad dispatcher nor been cleared to proceed, the vessel should stop and contact either the railroad dispatcher at 800-262-4691 or the Port of Victoria emergency contact at 361-570-8855.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Annual Fireworks Display Safety Zones in the Captain of the Port Columbia River Zone. Each safety zone will be enforced 1 hour before and 1 hour after each scheduled fireworks display described in that rule. The Coast Guard will not enforce zones which are intended for fireworks displays that are not planned to occur this year. This action is necessary to protect watercraft and their occupants from the inherent safety hazards associated with fireworks displays. During the enforcement period, no person or vessel may enter or remain in the safety zone without permission from the Sector Columbia River Captain of the Port.
The regulations in 33 CFR 165.1315 will be enforced 1 hour before
If you have questions on this notice of enforcement, call or email Mr. Ken Lawrenson, Waterways Management Division, MSU Portland, Coast Guard; telephone 503-240-9319, email
The Coast Guard will enforce the safety zone regulations for the Annual Fireworks displays within the Captain of the Port Columbia River Zone in the locations and during the dates and times listed in the table below, reproduced from 33 CFR 165.1315(a):
Under the provisions of 33 CFR 165.1315 and 33 CFR part 165, subpart C, no person or vessel may enter or remain in the safety zones without permission of the Captain of the Port Columbia River or his designated representative. See 33 CFR 165.1315 and 33 CFR part 165, subpart C for additional information and prohibitions. Persons or vessels wishing to enter the safety zones may request permission to do so from the Captain of the Port Columbia River or his designated representative via VHF Channel 16 or 13. The Coast Guard may be assisted by other Federal, State, or local enforcement agencies in enforcing this regulation.
This notice of enforcement is issued under authority of 33 CFR 165.1315 and 5 U.S.C. 552 (a). In addition to this notice in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce two safety zones for fireworks displays in the Sector Long Island Sound area of responsibility on the dates and times listed in the table below. This action is necessary to provide for the safety of life on navigable waterways during the events. During the enforcement periods, no person or vessel may enter the safety zones without permission of the Captain of the Port (COTP) Sector Long Island Sound or designated representative.
The regulations in 33 CFR 165.151 will be enforced during the dates and times as listed in the
If you have questions on this notice of enforcement, call or email Petty Officer Ian Fallon, Waterways Management Division, U.S. Coast Guard Sector Long Island Sound; telephone 203-468-4565, email
The Coast Guard will enforce the safety zones listed in 33 CFR 165.151 on the specified dates and times as indicated in the following Table.
Under the provisions of 33 CFR 165.151, the fireworks displays listed above are established as safety zones. During the enforcement periods, persons and vessels are prohibited from entering into, transiting through, mooring, or anchoring within the safety zones unless they receive permission from the COTP or designated representative.
This notice of enforcement is issued under authority of 33 CFR part 165 and 5 U.S.C. 552 (a). In addition to this notice in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary safety zones in the Port of Goodhope Bay, Alaska, and adjacent U.S. territorial sea on July 1 and October 15, 2015. The temporary safety zones will encompass the navigable waters within a 25-yard radius of moored or anchored offshore exploration or support vessels, and the navigable waters within a 100-yard radius of underway offshore exploration or support vessels. The purpose of the safety zones are to protect persons and vessels during an unusually high volume of vessel traffic in the Port of Goodhope Bay and the adjacent territorial sea due to additional vessel traffic associated with exploratory drilling operations in the Chukchi and Beaufort seas during the summer of 2015.
This rule is effective without actual notice from July 10, 2015 until October 15, 2015. For the purposes of enforcement, actual notice will be used from July 1, 2015, until July 10, 2015.
Documents mentioned in this preamble are part of docket [USCG-2015-0267]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this temporary rule, call or email LT Eugene Chung, Sector Anchorage Prevention, Coast Guard; telephone 907-428-4189, Email
On May 1, 2015, we published a notice of proposed rulemaking (NPRM) entitled Safety Zones: Oil Exploration Staging Area in Goodhope Bay, Kotzebue Sound, AK in the
Based on information provided by private entities affiliated with oil exploration activities, the Coast Guard anticipates approximately eleven vessels associated with exploratory drilling operations will call upon the Port of Goodhope Bay, Alaska, en route to proposed drilling sites in the Chukchi and Beaufort. The addition of these vessels in conjunction with the high volume of traffic operating within the Port of Goodhope Bay creates a safety risk for all vessels operating therein. Such risks include reduced ability to navigate safely within the congested waterways of the port during the subject time period.
The vessels and equipment anticipated to be staged within these areas, due to their size and technical complexity, pose a safety risk to vessels that attempt to navigate too closely to them. Limited rescue capabilities are available in the area. In evaluating whether a safety zone would be appropriate, the Coast Guard explored relevant safety factors and considered several criteria, including, but not limited to: (1) The amount of commercial activity in and around the Port of Goodhope Bay; (2) safety concerns for personnel aboard the vessels; (3) sensitivity of the environment in the region and potential adverse affects caused by a grounding, allision, or collision; (4) the types and volume of vessels navigating in the vicinity of the Port of Goodhope Bay; and (5) the need to allow for lawful demonstrations without endangering the safe operations of support vessels. Vessels transiting in the vicinity of the proposed safety zones could consist of large commercial shipping vessels, fishing vessels, tugs and tows, and recreational vessels. Any group or individual intending to conduct lawful demonstrations in the vicinity of offshore exploration support vessels must do so outside of the temporary safety zones. Results from a thorough and comprehensive examination of the five criteria identified above, in conjunction with International Maritime Organization guidelines and existing regulations, warrant establishment of safety zones to ensure safe and efficient vessel transits within the Port of Goodhope Bay and the adjacent territorial sea. These safety zones will facilitate safe navigation and protect vessels from hazards caused by increased volume of vessel traffic, including hazards that may be intentionally created, in the Port of Goodhope Bay.
For the reasons described above, the Coast Guard is finalizing a temporary safety zone due to safety concerns for personnel aboard the support vessels, mariners operating other vessels in the vicinity of Goodhope Bay, and to protect the environment. The regulation will significantly reduce the threat of collisions, allisions, or other incidents which could endanger the safety of all vessels operating on the navigable waters of the Port of Goodhope Bay and the adjacent territorial sea. The Coast Guard is establishing temporary safety zones that will prohibit entry into the zones unless specifically authorized by the Captain of the Port, Western Alaska, or his designated on-scene representative.
The temporary safety zones will encompass the waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit. They are in effect from July 1 through October 15, in order to encompass the expected period of operations.
We developed this temporary final rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order
This rule is not a significant regulatory action due to the minimal impact this will have on standard vessel operations within the Port of Goodhope Bay because of the limited area affected and the limited duration of the rule. The safety zones are also designed to allow vessels transiting through the area to safely travel around the safety zones without incurring additional costs.
The Regulatory Flexibility Act of 1980 (RFA), (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 rule will not have a significant economic impact on a substantial number of small entities.
This rule could affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit through or anchor in within a portion of the Port of Dutch Harbor or adjacent waters, from June 15, 2015 to July 15, 2015.
This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons: These safety zone restrictions are only effective from July 1, 2015 to October 15, 2015, and are limited only to waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit. The Coast Guard will publish a local notice to mariners (LNM) and will issue broadcast notice to mariners (BNM) alerts via marine channel 16 VHF before the safety zone is enforced.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
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 rule under that Order and determined that this rule does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
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 rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This 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.
This rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this 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 (NEPA) (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. Specifically, the rule involves establishing a safety zone, which is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this temporary final rule. An environmental analysis checklist and a categorical exclusion determination are available in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1
(a)
(1) All navigable waters within a 25-yard radius of a moored or anchored offshore exploration or support vessel, or within a 100-yard radius of any underway offshore exploration or support vessel, located within the Port of Goodhope Bay, to the limits of the U.S. territorial sea.
(2) [Reserved]
(b)
(c)
(1) If a non-exploration or support vessel is moored or anchored and an offshore exploration or support vessel transits near them such that it places the moored or anchored vessel within the 100-yard safety zone described in paragraph (a) of this section, the moored or anchored vessel must remain stationary until the offshore exploration or support vessel maneuvers to a distance exceeding the 100-yard safety zone.
(2) All persons and vessels shall comply with the instructions of the Captain of the Port (COTP) or designated on-scene representative, consisting of commissioned, warrant, and petty officers of the Coast Guard. Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of a vessel shall proceed as directed by the COTP's designated on-scene representative.
(3) Entry into the safety zone is prohibited unless authorized by the COTP or his designated on-scene representative. Any persons desiring to enter the safety zone must contact the designated on-scene representative on VHF channel 16 (156.800 MHz) and receive permission prior to entering.
(4) If permission is granted to transit within the safety zone, all persons and vessels must comply with the instructions of the designated on-scene representative.
(5) The COTP, Western Alaska, will notify the maritime and general public by marine information broadcast during the period of time that the safety zones are in force by providing notice in accordance with 33 CFR 165.7.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary safety zones in the Port of Dutch Harbor, Broad Bay or adjacent navigable waters in the Dutch Harbor area on June 15, 2015. The temporary safety zones will encompass the navigable waters within a 25-yard radius of moored or anchored offshore exploration or support vessels, and the navigable waters within a 100-yard radius of underway offshore exploration or support vessels. The purpose of the safety zones is to protect persons and vessels during an unusually high volume of vessel traffic in the Port of Dutch Harbor, and the adjacent territorial sea due to additional vessel traffic associated with exploratory drilling operations in the Chukchi and Beaufort seas during the summer of 2015.
This rule is effective without actual notice from July 10, 2015 until July 15, 2015. For the purposes of enforcement, actual notice will be used from June 15, 2015, until July 10, 2015.
Documents mentioned in this preamble are part of docket [USCG-2015-0246]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this temporary rule, call or email LT Eugene Chung, Sector Anchorage Prevention, Coast Guard; telephone 907-428-4189, Email
On May 1, 2015, we published a notice of proposed rulemaking (NPRM) entitled Safety Zones: Oil Exploration Staging Area in Dutch Harbor, AK in the
Based on the expectation of increased maritime traffic primarily due to the anticipated arrival of approximately twenty eight (28) vessels affiliated with planned offshore drilling operations in the Chukchi and Beaufort Seas, temporary safety zones needed to ensure the safe transit of vessels within the navigable waters of the Port of Dutch Harbor and adjacent waters extending seaward to the limits of the territorial sea. The Coast Guard believes temporary safety zones are needed due to safety concerns for personnel aboard the support vessels, mariners operating
In evaluating this request, the Coast Guard explored relevant safety factors and considered several criteria, including, but not limited to: (1) The amount of commercial activity in and around the Port of Dutch Harbor; (2) safety concerns for personnel aboard the vessels; (3) sensitivity of the environment in the region and potential adverse affects caused by a grounding, allision, or collision; (4) the types and volume of vessels navigating in the vicinity of the Port of Dutch Harbor; and (5) the need to allow for lawful demonstrations without endangering the safe operations of support vessels. Vessels transiting in the vicinity of the safety zones could consist of large commercial shipping vessels, fishing vessels, tugs and tows, and recreational vessels. Any group or individual intending to conduct lawful demonstrations in the vicinity of offshore exploration support vessels must do so outside of the temporary safety zones.
Results from a thorough and comprehensive examination of the five criteria identified above, in conjunction with International Maritime Organization guidelines and existing regulations, warrant establishment of the temporary safety zones. A safety zone would significantly reduce the threat of collisions, allisions, or other incidents which could endanger the safety of all vessels operating on the navigable waters of the Port of Dutch Harbor and the adjacent territorial sea.
For the reasons described above, the Coast Guard is establishing temporary safety zones that would surround the designated vessels while at anchor, moored or underway on the navigable waters of the Port of Dutch Harbor and the adjacent territorial sea in order to mitigate the potential safety risks associated with the increased vessel traffic. The temporary safety zones will encompass the waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit.
The Coast Guard received one comment on the NPRM. The commenter suggested that the end date, originally proposed as July 1, 2015, be extended to July 15, 2015. The commenter noted that several of the assets that will be staged in Dutch Harbor are not scheduled to depart until early July, 2015. Based on this suggestion, the Coast Guard is adjusting the end date until July 15, 2015.
Enforcing temporary safety zones for each offshore exploration or support vessel while they are on the navigable waters in the Port of Dutch Harbor or the adjacent territorial sea will help ensure the safety of all vessels, including the diverse commercial fleets of Dutch Harbor.
We developed this temporary final rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. The safety zone will have negligible economic impact, as there will be ample room for navigation around it.
This rule is not a significant regulatory action due to the minimal impact this will have on standard vessel operations within the port of Dutch Harbor because of the limited area affected and the limited duration of the rule. The safety zones are also designed to allow vessels transiting through the area to safely travel around the safety zones without incurring additional costs.
The Regulatory Flexibility Act of 1980 (RFA), (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 rule will not have a significant economic impact on a substantial number of small entities.
This rule could affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit through or anchor in within a portion of the Port of Dutch Harbor or adjacent waters, from June 15, 2015 to July 15, 2015.
This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons: These safety zone restrictions are only effective from June 15, 2015 to July 15, 2015, and are limited only to waters within 25 yards of the support vessel if the support vessel is moored or at anchor, and 100 yards if the support vessel is in transit. The Coast Guard will publish a local notice to mariners (LNM) and will issue broadcast notice to mariners (BNM) alerts via marine channel 16 VHF before the safety zone is enforced.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
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 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.
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 rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This 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.
This rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this 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 (NEPA) (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. Specifically, the rule involves establishing a safety zone, which is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this temporary final rule. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under Supporting Documents.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1
(a)
(1) All navigable waters within a 25-yard radius of a moored or anchored offshore exploration or support vessel, or within a 100-yard radius of any underway offshore exploration or support vessel, located within the Port of Dutch Harbor, Broad Bay or adjacent navigable waters encompassed within the area from Cape Cheerful at 54-12.000 N 166-38.000 W north to the limits of the U.S. territorial sea, and from Princess Head at 53-59.000 N 166-25.900 W to the limits of the U.S. territorial sea.
(2) [Reserved]
(b)
(c)
(1) If a non-exploration or support vessel is moored or anchored and an offshore exploration or support vessel transits near them such that it places the moored or anchored vessel within the 100-yard safety zone described in paragraph (a) of this section, the moored or anchored vessel must remain stationary until the offshore exploration or support vessel maneuvers to a distance exceeding the 100-yard safety zone.
(2) All persons and vessels shall comply with the instructions of the Captain of the Port (COTP) or designated on-scene representative, consisting of commissioned, warrant, and petty officers of the Coast Guard. Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of a vessel shall proceed as directed by the COTP's designated on-scene representative.
(3) Entry into the safety zone is prohibited unless authorized by the COTP or his designated on-scene representative. Any persons desiring to enter the safety zone must contact the designated on-scene representative on VHF channel 16 (156.800 MHz) and receive permission prior to entering.
(4) If permission is granted to transit within the safety zone, all persons and vessels must comply with the instructions of the designated on-scene representative.
(5) The COTP, Western Alaska, will notify the maritime and general public by marine information broadcast during the period of time that the safety zones are in force by providing notice in accordance with 33 CFR § 165.7.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on Oswego Harbor, Oswego, NY. This safety zone is intended to restrict vessels from a portion of Oswego Harbor during the Oswego Harborfest Jet Ski Show. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a jet ski show.
This rule will be effective from 12:45 p.m. on July 25, 2015 until 7:15 p.m. on July 26, 2015.
Documents mentioned in this preamble are part of docket [USCG-2015-0507]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LTJG Amanda Garcia, Chief of Waterways Management, U.S. Coast Guard Sector Buffalo; telephone 716-843-9343, email
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect spectators and vessels from the hazards associated with a maritime fireworks display. Therefore, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this temporary rule effective less than 30 days after publication in the
The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.
Between 12:45 p.m. and 7:15 p.m. on July 25, 2015 and between 12:45 p.m. and 7:15 p.m. on July 26, 2015, a jet ski show will be taking place on Oswego Harbor in Oswego, NY. Based on recent accidents that have occurred in other Captain of the Port zones, the Captain of the Port Buffalo has determined a jet ski show presents significant risks to public safety and property. The likely combination of large numbers of recreational vessels, congested waterways, and alcohol use by some spectators, present a significant risk of serious injuries or fatalities.
With the aforementioned hazards in mind, the Captain of the Port Buffalo has determined that this temporary safety zone is necessary to ensure the safety of spectators and vessels during the Oswego Harborfest Jet Ski Show. This zone will be effective and enforced intermittently from 12:45 p.m. until 7:15 p.m. on July 25, 2015 and from 12:45 p.m. until 7:15 p.m. on July 26, 2015. This zone will encompass all waters of Oswego Harbor; Oswego, NY starting at position 43°27′49.88″ N. and 076°31′15.41″ W. then Northwest to 43°27′51.72″ N. and 076°31′18.13 then Southwest to 43°27′44.26″ N. and 076°31′39.18″ W. then South to 43°27′42.68″ N. and 076°31′36.91″ W. then returning the point of origin.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone is designed to minimize its impact on navigable waters. Furthermore, the
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Oswego Harbor on July 25 and 26, 2015.
This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this safety zone would be subject to enforcement for a few hours a day over the course of two days and the safety zone will allow vessels to move freely around the safety zone in Oswego Harbor. Traffic may be allowed to pass through the zone with the permission of the Captain of the Port. The Captain of the Port can be reached via VHF channel 16. Before the enforcement of the zone, we would issue local Broadcast Notice to Mariners.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this 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
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
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 rule under that Order and determined that this rule does not have implications for federalism.
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.
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 rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this 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 (NEPA) (42 U.S.C. 4321-4370f), and have determined 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 rule involves the establishment of a safety zone and, therefore it is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port Buffalo is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Buffalo to act on his behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Buffalo or his on-scene representative to obtain permission to do so. The Captain of the Port Buffalo or his on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Buffalo, or his on-scene representative.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing a determination of attainment regarding the Liberty-Clairton, Pennsylvania 2006 24-hour fine particulate matter (PM
This final rule is effective on August 10, 2015.
EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2015-0175. All documents in the docket are listed in the
Emlyn Vélez-Rosa, (215) 814-2038, or by email at
On November 13, 2009, EPA published designations for the 2006 24-hour PM
A nonattainment designation under the CAA triggers additional planning requirements for states to show attainment of the NAAQS in the nonattainment areas by a statutory attainment date, as specified in the CAA. Since 2005, EPA had implemented the 1997 and 2006 PM
On April 25, 2014, EPA finalized a rule identifying the classification of all PM
Under EPA's longstanding Clean Data Policy interpretation, a determination that a nonattainment area has attained the NAAQS suspends the state's obligation to submit an attainment demonstration, RFP, RACM, and contingency measures as required by the CAA for so long as the area continues to attain the standard. Since the purpose of these provisions is to help reach attainment, a goal which has already been achieved, EPA interprets that these requirements should no longer be applicable. Although the D.C. Circuit remanded the 1997 PM
On April 23, 2015 (78 FR 22666), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania proposing to determine that the Liberty-Clairton Area has attained the 2006 24-hour PM
This final “clean data determination” for the Liberty-Clairton Area is based on the quality-controlled, quality assured, certified PM
EPA determines that the Liberty-Clairton Area is currently attaining the 2006 24-hour PM
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 8, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action, determining that the Liberty-Clairton Area has attained the 2006 24-hour PM
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
Federal Communications Commission.
Final rule.
In this document, the Commission adopts additional rules under the authority of the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA) to make emergency information in video programming accessible to individuals who are blind or visually impaired. First, the document requires multichannel video programming distributors to pass through a secondary audio stream containing audible emergency information when they permit consumers to access linear programming on second screen devices, such as tablets, smartphones, laptops, and similar devices. Second, the document requires manufacturers of apparatus that receive or play back video programming to provide a mechanism that is simple and easy to use for activating the secondary audio stream to access audible emergency information.
Effective August 10, 2015.
Evan Baranoff,
This is a summary of the Commission's
1. In this
2. First, this
3. Second, this
4. In the
5. The CVAA was enacted on October 8, 2010 with the purpose of ensuring that individuals with disabilities are able to fully utilize modern communications services and equipment and to better access video programming.
6. The Commission adopted the
7. In the
8. To further implement sections 202 and 203 of the CVAA, we adopt the rules discussed below. Consistent with the intent of the CVAA, we must ensure that individuals with disabilities are not left behind as new technologies and platforms for viewing video programming are developed, and we are mindful of this as we revise our rules promoting the accessibility of emergency information.
9. Given the increasing number of ways in which consumers are accessing linear video programming from MVPDs, we believe that it is important to further define MVPD responsibilities with regard to the secondary audio stream for emergency information on mobile and other devices. Specifically, we conclude that MVPDs must pass through a secondary audio stream containing audible emergency information when they permit consumers to access linear programming on tablets, smartphones, laptops, and similar devices
10. In the
11. We conclude that the accessible emergency information requirements adopted in the
12. NCTA, AT&T Services, Inc. (“AT&T”), and the Wireless RERC argue that MVPDs should be covered by the emergency information rules in section 79.2 when they provide linear programming that contains emergency information for viewing on mobile and other devices within the home. NCTA contends that “a cable operator delivering linear broadcast stations containing emergency information (or any other linear video programming service that might provide an aural version of emergency information covered by the rules) within a subscriber's home would be a `video programming distributor' for . . . purposes [of the rules], even if the linear service is received through use of an operator-supplied app on a device owned by a consumer.”
13. We believe that requiring MVPDs to pass through a secondary audio stream with audible emergency information in these circumstances will further the goals of the CVAA by helping to ensure that emergency information is made accessible to individuals who are blind or visually impaired when they watch linear video programming provided by their MVPD over the MVPD's network, regardless of the device on which they are viewing the programming. The number of ways in which consumers are able to access linear programming from their MVPDs is growing. As NCTA points out, “[c]able operators, as part of their existing services, increasingly are providing applications (`apps') or other technologies that enable their subscribers to view linear programming within the home over the cable operator's network.”
14. Although we inquired in the
15. As mentioned above, we do not apply these rules to over-the-top services provided by MVPDs at this time. In December 2014, we adopted a
16. We conclude that MVPDs must ensure that any application or plug-in that they provide to consumers to access linear programming over the MVPD's network on mobile and other devices is capable of passing through the aural representation of emergency information (including the accompanying aural tone) on a secondary audio stream. In so concluding, we do not change the underlying obligations applicable to video programming distributors and video programming providers as set forth in the
17. We also sought comment in the
18. Based on the record, we do not impose compliance obligations on the manufacturers of apparatus covered by section 203 of the CVAA with regard to ensuring that any application or plug-in that MVPDs provide to consumers to access linear programming on mobile and other devices is capable of passing through audible emergency information on a secondary audio stream. The record demonstrates that such entities typically do not control either the applications or technologies in question or the ability of consumers to select and receive the secondary audio stream for MVPD-provided linear programming on mobile and other devices. We believe that the responsibility for passing through the aural representation of emergency information in the secondary audio stream properly lies with MVPDs. However, to the extent MVPD applications or other technologies have been designed and developed to work on a specific type of device or platform, we expect that users will be able to hear the secondary audio stream in an MVPD application through the native audio functionality of the device, as professed by industry commenters. We may impose obligations on manufacturers in the future if we find that the apparatus itself does not make a secondary audio stream with audible emergency information from an MVPD application available to the apparatus user or otherwise impedes the ability of a user to hear the secondary audio stream.
19. We adopt a compliance deadline of two years after publication of the
20. Although we acknowledge that today MVPDs typically pass through a single audio stream in the IP context,
21. Based on our review of the record, we conclude that a compliance deadline of two years after publication of the
22. We require manufacturers of apparatus subject to section 79.105 of the Commission's rules
23. In the
24. As noted above, in the
25. Although the requirements related to the provision of accessible emergency information on a secondary audio stream have not yet gone into effect,
26. Requiring a simple and easy to use mechanism for activating the secondary audio stream for emergency information will provide a substantial benefit for consumers who are blind or visually impaired by providing an easy and quick method to switch to the secondary audio stream to hear critical emergency information. According to AFB and ACB, “the importance of a streamlined and obvious means for accessing emergency information is indispensable,” given that the information being accessed “may very well save lives.”
27. We find that requiring the provision of a simple and easy to use activation mechanism for audible emergency information on the secondary audio stream is necessary to fulfill the statute's mandate that emergency information be made accessible to individuals who are blind or visually impaired. This is particularly true given the time-sensitive nature of emergency information. At the same time, however, we believe it is important that the industry has flexibility in choosing the precise means for activating the secondary audio stream.
28. Industry commenters raise a number of legal arguments as to why they believe the Commission should not require an activation mechanism for audible emergency information on section 203 apparatus, but we find each of them to be unpersuasive. As we explain below, we require covered entities to provide a simple and easy to use activation mechanism and find that a mechanism reasonably comparable to a button, key, or icon would satisfy this standard. We disagree with commenters who contend that the Commission should not require covered entities to provide a simple means for accessing the secondary audio stream for emergency information because section 203 does not contain such a mandate.
29. For similar reasons, we reject industry commenters' argument that the Commission has no authority to require an activation mechanism for audible emergency information because Congress specifically required an activation mechanism reasonably comparable to a button, key, or icon in sections 204 and 205 of the CVAA, but not in section 203 of the CVAA.
30. NCTA and CEA point out that the Commission adopted rules pursuant to sections 204 and 205 of the CVAA requiring the accessibility of appropriate built-in apparatus functions on digital apparatus and the audible accessibility of on-screen text menus and guides used for the display or selection of multichannel video programming on navigation devices for individuals who are blind or visually impaired.
31. Manufacturers of apparatus covered by section 79.105 of the Commission's rules must provide a simple and easy to use mechanism for activating the secondary audio stream for audible emergency information.
32. We find that manufacturers are not responsible for providing a simple and easy to use mechanism to activate the secondary audio stream for emergency information on third-party MVPD applications and plug-ins that are downloaded by consumers to view linear programming on mobile and other devices. As noted above, manufacturers typically do not control such applications and, in particular, they do not control the ability of consumers to select and receive the secondary audio stream for linear programming provided through an MVPD application on mobile and other devices. In the
33. We note that the provisions for achievability determinations, purpose-based waivers, and exemptions that apply to devices covered by Section 79.105 of the Commission's rules will apply equally to the requirement that covered apparatus provide an activation mechanism that is simple and easy to use for accessing the secondary audio stream.
34. In the
35. The Wireless RERC, the only party to comment on this issue, argues that the deadline for a requirement to provide a simple and easy to use mechanism for accessing the secondary audio stream for audible emergency information should be consistent with the deadlines for apparatus that the Commission adopted in the
36. We conclude that it is reasonable to apply the same compliance deadline that we adopted in the
37. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”),
38. In the
39. First, the
40. Second, the
41. No public comments were filed in response to the IRFA.
42. Pursuant to the Small Business Jobs Act of 2010, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rules as a result of those
43. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of
44.
45.
46.
47.
48.
49.
50.
51.
52. In addition, the SBA's placement of Cable Television Distribution Services in the category of Wired
53.
54.
55.
56.
57.
58. The
59. With respect to the first issue, the
60. With respect to the second issue, the
61. No commenter provided specific information about the costs and administrative burdens associated with the rules adopted in the
62. The RFA requires an agency to describe the steps the agency has taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.
63. The rules adopted in the
64. In crafting its new requirements, the Commission provided reasonable timeframes within which covered entities may come into compliance, as requested in the record.
65. In addition, with regard to the accessibility requirements adopted pursuant to Section 203 of the CVAA, in certain instances, the Commission may grant exemptions to the rules where a petitioner has shown that compliance is not achievable (
66. Overall, we believe we have appropriately considered both the interests of individuals with disabilities and the
67. The Commission will send a copy of the
68. The
69. The Commission will send a copy of the
70. For
71. Accordingly,
72.
73.
74.
Cable television operators, Communications equipment, Multichannel video programming distributors (MVPDs), Satellite television service providers.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 79 as follows:
47 U.S.C. 151, 152(a), 154(i), 303, 307, 309, 310, 330, 544a, 613, 617.
(b) * * *
(2) * * *
(ii) Emergency information that is provided visually during programming that is neither a regularly scheduled newscast, nor a newscast that interrupts regular programming, must be accompanied with an aural tone, and beginning May 26, 2015 except as provided in paragraph (b)(6) of this section, must be made accessible to individuals who are blind or visually impaired through the use of a secondary audio stream to provide the emergency information aurally. Emergency information provided aurally on the secondary audio stream must be preceded by an aural tone and must be conveyed in full at least twice. Emergency information provided through use of text-to-speech (“TTS”) technologies must be intelligible and must use the correct pronunciation of relevant information to allow consumers to learn about and respond to the emergency, including, but not limited to, the names of shelters, school districts, streets, districts, and proper names noted in the visual information. The video programming distributor or video programming provider that creates the visual emergency information content and adds it to the programming stream is responsible for providing an aural representation of the information on a secondary audio stream, accompanied by an aural tone. Video programming distributors are responsible for ensuring that the aural representation of the emergency information (including the
(6) Beginning July 10, 2017, multichannel video programming distributors must ensure that any application or plug-in that they provide to consumers to access linear programming on tablets, smartphones, laptops, and similar devices over the MVPD's network as part of their multichannel video programming distributor services is capable of passing through to consumers an aural representation of the emergency information (including the accompanying aural tone) on a secondary audio stream.
(d) Beginning December 20, 2016, all apparatus subject to this section must provide a simple and easy to use mechanism for activating the secondary audio stream for audible emergency information.
This paragraph places no restrictions on the importing, shipping, or sale of navigation devices that were manufactured before December 20, 2016.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements accountability measures (AMs) for commercial greater amberjack in the Gulf of Mexico (Gulf) reef fish fishery for the 2015 fishing year through this temporary rule. NMFS projects commercial landings for greater amberjack, will reach the commercial ACT (commercial quota) by July 19, 2015. Therefore, NMFS closes the commercial sector for greater amberjack in the Gulf on July 19, 2015, and it will remain closed until the start of the next fishing season on January 1, 2016. This closure is necessary to protect the Gulf greater amberjack resource.
This rule is effective 12:01 a.m., local time, July 19, 2015, until 12:01 a.m., local time, January 1, 2016.
Rich Malinowski, NMFS Southeast Regional Office, telephone: 727-824-5305, or email:
NMFS manages the reef fish fishery of the Gulf, which includes greater amberjack, under the Fishery Management Plan for the Reef Fish Resources of the Gulf (FMP). The Gulf of Mexico Fishery Management Council (Council) prepared the FMP and NMFS implements the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All greater amberjack weights discussed in this temporary rule are in round weight.
The commercial annual catch limit (ACL) for Gulf greater amberjack is 481,000 lb (218,178 kg), as specified in 50 CFR 622.41(a)(1), and the commercial ACT (equivalent to the commercial quota) is 409,000 lb (185,519 kg), as specified in 50 CFR 622.39(a)(1)(v).
Under 50 CFR 622.41(a)(1)(i), NMFS is required to close the commercial sector for greater amberjack when the commercial ACT (commercial quota) is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined the commercial ACT (commercial quota) will be reached by July 19, 2015. Accordingly, the commercial sector for Gulf greater amberjack is closed effective 12:01 a.m., local time, July 19, 2015, until 12:01 a.m., local time, January 1, 2016.
The operator of a vessel with a valid commercial vessel permit for Gulf reef fish with greater amberjack on board must have landed, bartered, traded, or sold such greater amberjack prior to 12:01 a.m., local time, July 19, 2015. During the commercial closure, the bag and possession limits specified in 50 CFR 622.38(b)(1), apply to all harvest or possession of greater amberjack in or from the Gulf exclusive economic zone (EEZ). However, from June 1 through July 31 each year, the recreational sector for greater amberjack is also closed, as specified in 50 CFR 622.34(c), and during this recreational closure, the bag and possession limits for greater amberjack in or from the Gulf EEZ are zero. During the commercial closure, the sale or purchase of greater amberjack taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of greater amberjack that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, July 19, 2015, and were held in cold storage by a dealer or processor. The commercial sector for greater amberjack will reopen on January 1, 2016, the beginning of the 2016 commercial fishing season.
The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the Gulf greater amberjack component of the Gulf reef fish fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.
This action is taken under 50 CFR 622.41(a)(1) and is exempt from review under Executive Order 12866.
These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and comment.
This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this action to close the commercial sector for greater amberjack constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule establishing the closure provisions was subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect greater amberjack. The capacity of the commercial sector allows for rapid harvest of the commercial ACT (commercial quota), and prior notice and opportunity for public comment would require time and would potentially result in harvest exceeding the commercial ACT (commercial quota) and commercial ACL.
For the aforementioned reasons, the AA also finds good cause to waive the
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Modification of fishing seasons; request for comments.
NMFS announces seven inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial salmon fisheries in the area from the U.S./Canada border to the U.S./Mexico border.
The effective dates for the inseason actions are set out in this document under the heading Inseason Actions. Comments will be accepted through July 27, 2015.
You may submit comments, identified by NOAA-NMFS-2015-0001, by any one of the following methods:
•
•
Peggy Mundy at 206-526-4323.
In the 2015 annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), NMFS announced the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, beginning May 1, 2015, and 2016 salmon seasons opening earlier than May 1, 2016. NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions). The state management agencies that participated in the consultations described in this document were: Oregon Department of Fish and Wildlife (ODFW) and Washington Department of Fish and Wildlife (WDFW).
Management of the salmon fisheries is generally divided into two geographic areas: North of Cape Falcon (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). The inseason actions reported in this document affect fisheries north and south of Cape Falcon. Within the south of Cape Falcon area, the Klamath Management Zone (KMZ) extends from Humbug Mountain, OR, to Humboldt South Jetty, CA, and is divided at the Oregon/California border into the Oregon KMZ to the north and California KMZ to the south. All times mentioned refer to Pacific daylight time.
All other restrictions and regulations remain in effect as announced for the 2015 ocean salmon fisheries and 2016 fisheries opening prior to May 1, 2016 (80 FR 25611, May 5, 2015).
The RA determined that the best available information indicated that Chinook salmon and Pacific halibut catch to date and fishery effort supported the above inseason actions recommended by the states of Washington and Oregon. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice of the described regulatory actions was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.
The Assistant Administrator for Fisheries, NOAA (AA), finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory actions was provided to fishers through telephone hotline and radio notification. These actions comply with the requirements of the annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), the West Coast Salmon Fishery Management Plan (Salmon FMP), and regulations implementing the Salmon FMP, 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies had insufficient time to provide for prior notice and the opportunity for public comment between the time Chinook salmon catch and effort assessments and projections were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best available scientific information, ensuring that conservation objectives and ESA consultation standards are not exceeded. The AA also finds good cause to waive the 30-day delay in effectiveness required under 5 U.S.C. 553(d)(3), as a delay in effectiveness of these actions would allow fishing at levels inconsistent with the goals of the Salmon FMP and the current management measures.
These actions are authorized by 50 CFR 660.409 and 660.411 and are exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Energy Regulatory Commission, Energy.
Notice of technical conference.
In this notice, the Federal Energy Regulatory Commission (Commission) plans to hold a technical conference on July 30, 2015, to discuss issues raised by the petition for rulemaking. The petition for rulemaking is requesting that the Commission issue a Notice of Proposed Rulemaking (NOPR) requiring changes to the FERC Form No. 6 (Annual Report of Oil Pipeline Companies), Page 700.
The technical conference will be held on July 30, 2015.
Adrianne Cook, Office of Energy Market Regulation, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426,
On April 20, 2015, the Liquids Shippers Group, Airlines for America and the National Propane Gas Association (Joint Petitioners) filed a petition for rulemaking requesting that the Commission issue a Notice of Proposed Rulemaking (NOPR) requiring changes to the FERC Form No. 6 (Annual Report of Oil Pipeline Companies), Page 700.
The Joint Petitioners request that the Commission issue a NOPR in which it proposes to revise Form No. 6, Page 700 by (1) requiring a pipeline that (i) files a single Form No. 6 report for both crude oil and petroleum product systems, and/or (ii) has multiple established and recognized segments which correspond to how the pipeline's rates are established or designed, to file a separate Page 700 for each individual system or segment rather than reporting aggregated cost and revenue data on a single Page 700; and (2) revising the Page 700 instructions to require crude oil and petroleum product pipelines to make their workpapers available to shippers and interested persons upon request, not just to the Commission and its Staff.
Take notice that the Commission plans to hold a technical conference on July 30, 2015, to discuss issues raised by the petition for rulemaking.
The Commission will issue a subsequent notice organizing the conference. The Commission contemplates utilizing panels to work through the issues presented. Those interested in serving on panels are asked to submit a short notice of intent in the instant docket, along with the specific issues they plan to address on or before July 10, 2015. Due to time constraints, we may not be able to accommodate all those interested in speaking.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Proposed rule.
GSA is proposing to amend the Federal Management Regulation (FMR) by revising its coverage of Art-in-Architecture. This proposed rule provides clarification to the policies that support the efforts to collect, manage, fund and commission fine art in Federal buildings.
Interested parties should submit written comments to the Regulatory Secretariat at one of the addresses shown below on or before September 8, 2015 to be considered in the formation of the final rule.
Submit comments in response to FMR Case 2015-102-3 by any of the following methods:
•
•
Ms. Aluanda Drain, Office of Government-wide Policy, Office of Asset and Transportation Management (MA), at
As part of its regular cycle to review and update its real property policies, GSA is proposing to revise its policy on Art-in-Architecture that is located in FMR part 102-77 (41 CFR part 102-77). This part was last revised on November 8, 2005 at 70 FR 67847.
The proposed changes to FMR part 102-77 reflect an internal as well as an interagency collaborative effort. Major proposed changes include the following:
Executive Orders (E.O.S.) 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action, and therefore was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
While these revisions are substantive, this proposed rule would not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
The Paperwork Reduction Act does not apply because the proposed changes to the FMR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget under 44 U.S.C. 3501,
This proposed rule is exempt from Congressional review prescribed by 5 U.S.C. 801 since it relates to agency management and personnel.
Arts and Crafts.
For the reasons set forth in the preamble, GSA proposes to amend 41 CFR part 102-77 as follows:
40 U.S.C. 121 and 3306.
Federal agencies must incorporate fine arts as an integral part of the total building concept when designing new Federal buildings, and when making substantial repairs and alterations to existing Federal buildings, as appropriate. The commissioned artworks—including painting, sculpture and various other media—must reflect the national cultural heritage and be the work of living American artists (citizens or permanent residents of the United States).
To the maximum extent practicable, Federal agencies should collaborate with representatives of the client agency and the local community, the designer, and arts professionals to commission the nation's most talented artists to create significant civic-scaled artwork of outstanding quality and value. Federal agencies should work collaboratively with the artist, community, and art and design professionals to produce works of art that reflect the cultural, intellectual, and historic interests of the nation and the community. Federal agencies should commission artwork that is diverse in style and media.
Yes, Federal agencies should implement these Art-in-Architecture policies in a manner that receives appropriate national and local visibility to facilitate participation by a large and diverse group of American artists representing a wide variety of types of artwork.
Centers for Disease Control and Prevention, HHS.
Denial of petition for addition of a health condition.
On May 11, 2015, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 008) to add autoimmune diseases to the List of WTC-Related Health Conditions (List). Upon reviewing the information provided by the petitioner, the Administrator has determined that Petition 008 is not substantially different from Petition 007, which also requested the addition of autoimmune diseases. The Administrator recently published a response to Petition 007 in the
The Administrator of the WTC Health Program is denying this petition for the addition of a health condition as of July 10, 2015.
Rachel Weiss, Program Analyst, 1090 Tusculum Avenue, MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629 (this is a toll-free number); email
Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act) to add Title XXXIII
All references to the Administrator of the WTC Health Program (Administrator) in this notice mean the Director of the National Institute for Occupational Safety and Health (NIOSH) or his or her designee.
Pursuant to section 3312(a)(6)(B) of the PHS Act, interested parties may petition the Administrator to add a health condition to the List in 42 CFR 88.1. Within 60 calendar days after receipt of a petition to add a condition to the List, the Administrator must take one of the following four actions described in section 3312(a)(6)(B) and 42 CFR 88.17: (i) Request a recommendation of the STAC; (ii) publish a proposed rule in the
On May 11, 2015, the Administrator received a petition to add “autoimmune disease—encephalitis of the brain” to the List (Petition 008).
Although Petition 008 specifically requested the addition of “autoimmune disease—encephalitis of the brain,” the Administrator determined that the scope of the petition properly includes only the autoimmune diseases identified in Webber
The Administrator has established a methodology for evaluating whether to add non-cancer health conditions to the List of WTC-Related Health Conditions, published online in the Policies and Procedures section of the WTC Health Program Web site.
Accordingly, with regard to Petition 008, the Administrator has determined that insufficient evidence exists to take further action, including either proposing the addition of autoimmune
For the reasons discussed above, the request made in Petition 008 to add autoimmune diseases to the List of WTC-Related Health Conditions is denied.
The Administrator is aware that another study of autoimmune diseases among WTC Health Program members is being conducted by the WTC Health Registry; however, results from this study are not yet available in the scientific literature. The Administrator will monitor the scientific literature for publication of the results of this study and any other studies that address autoimmune diseases among 9/11-exposed populations.
Federal Communications Commission.
Proposed rule.
In this document, the Commission seeks comments on issues related to making emergency information audibly accessible to individuals who are blind or visually impaired. Specifically, this document seeks comment on: How to prioritize aural emergency information on the secondary audio stream; whether to continue to require school closing information to be included aurally on the secondary audio stream; and whether to require MVPDs to ensure that the devices and applications they provide to subscribers include a simple and easy to use activation mechanism for accessing audible emergency information on the secondary audio stream.
Comments are due on or before August 10, 2015; reply comments are due on or before September 8, 2015.
You may submit comments, identified by MB Docket No. 12-107, by any of the following methods:
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For detailed instructions for submitting comments and additional information on the rulemaking process, see the section IV. “Procedural Matters” heading of the
Evan Baranoff,
This is a summary of the Commission's
1. In this
2. We seek comment on how video programming providers and video programming distributors should prioritize emergency information conveyed aurally on the secondary audio stream when more than one source of visual emergency information is presented on-screen at the same time.
3. Section 79.2(b)(2)(ii) of the Commission's rules requires that emergency information provided visually during programming that is neither a regularly scheduled newscast, nor a newscast that interrupts regular programming, must be made accessible to individuals who are blind or visually impaired through the use of a secondary audio stream to provide such information aurally.
4. In its recently-filed petition for temporary waiver of the emergency information rules, the National Association of Broadcasters (“NAB”) indicated that “maps and other graphics almost always share the screen with other crawls” and, thus, broadcasters may encounter an issue with how to prioritize these sources of emergency information on the secondary audio stream to “ensur[e] that the most critical audible crawl reaches the public.”
5. Currently, our rule requires that the critical details about an emergency and how to respond to it must be conveyed aurally on the secondary stream to the same extent that this information is conveyed visually. If more than one crawl or a crawl and a graphic are shown on-screen at the same time, how can covered entities ensure that all of the critical details about the emergency and how to respond are conveyed aurally? Should we adopt rules that provide guidance to covered entities on how to prioritize emergency information conveyed aurally on the secondary audio stream when graphics or multiple crawls are used? For example, should we indicate that certain categories of emergency information should be prioritized based on the severity and proximity of the emergency and the potential impact on life, health, safety, and property? If multiple critical details about an emergency are broadcast simultaneously, should we prioritize them with respect to the requirement to provide audio information about their content (
6. Given the time-sensitive nature of emergency information, as well as quick-changing developments that may occur during the course of an emergency situation, should we require that
7. We also seek comment on whether the Commission should reconsider its requirement for “school closings and changes in school bus schedules” resulting from emergency situations to be conveyed aurally on the secondary audio stream, considering the length of such information and the limits of the secondary audio stream.
8. “Emergency information” is currently defined in the Commission's rules as “[i]nformation, about a current emergency, that is intended to further the protection of life, health, safety, and property,
9. In its waiver petition, NAB requests a limited waiver of the requirement to include school closings in the audible crawl pending identification of an alternative solution by all interested stakeholders.
10. We seek comment on NAB's assertions. Given NAB's arguments, should the Commission revise its rule to provide that “school closings and changes in school bus schedules” resulting from emergency situations are not required to be conveyed aurally on the secondary audio stream? Or should we revise the rule to indicate that such information must be provided on the secondary audio stream only if no other emergency information is being conveyed audibly on the secondary audio stream at the same time? Should we revise the rule to provide that such information need only be conveyed once in full, rather than twice as currently required, given the potential lengthiness of the crawl? In addition, we seek comment on the benefits of providing information about school closings and changes in school bus schedules on the secondary audio stream for individuals who are blind or visually impaired, and whether the availability of other sources of this information is adequate. Although we seek comment on this issue, we encourage broadcasters and the disability community to work toward a mutually agreeable resolution in the interim through the DAC.
11. We seek comment on whether we should require MVPDs to provide their customers with navigation devices that contain a simple and easy to use activation mechanism for accessing emergency information on the secondary audio stream. In the
12. In addition, we seek comment on whether we should require MVPDs to provide a simple and easy to use mechanism to activate the secondary audio stream for emergency information when they permit subscribers to view linear programming on mobile and other devices as part of their MVPD services. In the
13. As required by the Regulatory Flexibility Act of 1980, as amended (“RFA”),
14. In the
15. The proposed action is authorized pursuant to the Twenty-First Century Communications and Video Accessibility Act of 2010, Public Law 111-260, 124 Stat. 2751, and Sections 4(i), 4(j), 303, 330(b), 713, and 716 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303, 330(b), 613, and 617.
16. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the rules adopted in the
17.
18.
19.
20.
21.
22.
23.
24.
25. In addition, the SBA's placement of Cable Television Distribution Services in the category of Wired Telecommunications Carriers is applicable to cable-based Educational Broadcasting Services. Since 2007, these services have been defined within the broad economic census category of Wired Telecommunications Carriers, which was developed for small wireline businesses. This category is defined as follows: “This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services; wired (cable) audio and video programming distribution; and wired broadband Internet services.”
26.
27.
28.
29. In this section, we describe the reporting, recordkeeping, and other compliance requirements proposed in the
30. In the
31. With respect to the first issue, the
32. With respect to the second issue, the
33. With respect to the third issue, the
34. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities; (3) the
35. Two of the rule changes contemplated by the
36. The Commission is also seeking comment on whether to require MVPDs to ensure that the navigation devices that they provide to subscribers include a simple and easy to use activation mechanism for accessing audible emergency information on the secondary audio stream, and to provide a simple and easy to use mechanism to activate the secondary audio stream for emergency information when they permit subscribers to view linear programming on mobile and other devices as part of their MVPD services. This proposed rule may have an economic impact in some cases, and that impact may affect small entities. Although the Commission has considered alternatives where possible, as directed by the RFA, to minimize economic impact on small entities, we emphasize that our action is governed by the congressional mandate contained in section 202 of the CVAA.
37. Based on these considerations, we believe that, in proposing additional rules in the
38. None.
39. This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA).
40. We remind interested parties that this proceeding is treated as a “permit-but-disclose” proceeding in accordance with the Commission's
41. Pursuant to sections 1.415 and 1.419 of the Commission's rules,
Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS:
Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
U.S. Postal Service first-class, Express, and Priority mail must be
42. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to
43.
44. For additional information on this proceeding, contact Maria Mullarkey,
45. Accordingly,
46.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of agency decision.
In response to the most recent stock assessment for Gulf of Maine cod, which indicated that the stock is at historically low abundance levels, a group of environmental organizations have requested that NMFS initiate rulemaking to make the following changes: prohibit commercial and recreational fishing for Gulf of Maine cod until the incidental fishing mortality does not exceed the acceptable biological catch limit; and limit catch, including discards, to the level that achieves the fishing mortality that meets rebuilding requirements, in accordance with Amendment 16 to the Northeast Multispecies Fishery Management Plan. After reviewing the petition and considering recent management measures we have implemented to prevent overfishing of Gulf of Maine cod and promote Gulf of Maine cod rebuilding efforts, we are denying the Petition for Rulemaking request.
The petition for rulemaking was denied on June 4, 2015.
William Whitmore, Fishery Policy Analyst, phone: 978-281-9182; email:
A group of environmental organizations, including The Center for Biological Diversity, Greenpeace, SandyHook Life Foundation, and The Turtle Island Restoration Network, have requested that NMFS initiate rulemaking under the Administrative Procedure Act. The petitioners request that, because the most recent stock assessment for Gulf of Maine (GOM) cod indicates that the stock is at historically low abundance levels, NMFS initiate rulemaking to make the following changes: (1) Prohibit commercial and recreational fishing for GOM cod until the incidental fishing mortality does not exceed the acceptable biological catch (ABC) limit; and (2) limit catch, including discards, to the level that achieves the fishing mortality that meets rebuilding requirements (F
We are denying the Petition for Rulemaking. The measures in Framework Adjustment 53 to the FMP (80 FR 25110; May 1, 2015), combined with other conservation and management measures we implemented for the recreational fishery (80 FR 25160; May 1, 2015), are expected to prevent catch from exceeding the ABC, prevent overfishing, and rebuild the GOM cod stock within the rebuilding period. Further, we intend to carefully monitor updated stock assessment information, which will be available later this year, and will adjust measures, if necessary, to address any changes to stock condition. We carefully considered the available information and determined that all of the management measures implemented in the Framework 53 final rule, along with corresponding recreational measures, and our continued close monitoring of the stock's condition, will provide sufficient protection for GOM cod to prevent overfishing and contribute to rebuilding consistent with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act. These measures balance Magnuson-Stevens Act objectives, including achieving optimum yield and taking into account the needs of fishing communities, without compromising conservation objectives to prevent overfishing and rebuild the stock. In effect, therefore, Framework 53, combined with the other recreational measures, achieves exactly what the petition for rulemaking seeks. Moreover, Framework 53 was developed and implemented through the preferred Regional Fishery Management Council process as intended by the Magnuson-Stevens Act. Accordingly, as described in more detail below, neither a Secretarial amendment nor an emergency action is necessary or warranted to further limit GOM cod mortality at this time.
In August 2014, the Northeast Fisheries Science Center updated the 2012 benchmark GOM cod stock assessment. The assessment found that the GOM cod stock is overfished, subject to overfishing, and that the condition of the stock had declined
We received a petition for rulemaking on March 3, 2015, largely in response to the results of the most recent GOM cod stock assessment, the interim measures to reduce GOM cod mortality, and the Council's recommended measures for long-term GOM cod protection in Framework 53. The petitioners requested that NMFS initiate rulemaking to limit GOM fishing mortality consistent with the specifications of the default ABC control rule implemented in Amendment 16. In support of their request, the petitioners contend that historic overfishing and mismanagement of the GOM cod stock have led to declines in landings and stock abundance, and resulted in changes to the stock's age structure (
The petitioners claim that the ongoing management regime for GOM cod has not successfully ended overfishing or promoted rebuilding of the GOM cod stock, and that the management measures proposed in Framework 53 will not support rebuilding by the end of the revised rebuilding plan deadline in 2024. Specifically, they claimed:
• The 2004 GOM cod rebuilding plan failed because the Council set catch limits to maximize fishing opportunity rather than promote stock conservation, and because the Council prolonged overfishing by choosing the maximum rebuilding timeline possible.
• The 2014 GOM cod interim measures did not temporarily address overfishing or allow for stock rebuilding, and were only projected to result in a 33-percent reduction in fishing mortality in spite of advice from the Council's Scientific and Statistical Committee (SSC) that a 75-percent reduction in fishing limits was necessary.
• The 386-mt GOM cod ABC recommended by the Council in Framework 53 is above the legal limit (
To remedy the situation, the petitioners request that we prohibit commercial and recreational fishing for GOM cod until incidental fishing mortality does not exceed the ABC, and limit catch, including discards, to the level that achieves a fishing mortality rate that meets rebuilding requirements (F
While we were developing the GOM cod interim measures, the New England Fishery Management Council developed measures to end overfishing in the 2015 fishing year (beginning May 1, 2015) and for long-term measures to rebuild the GOM cod stock, consistent with the revised rebuilding program, as part of Framework 53. Framework 53, which was implemented May 1, 2015, includes a 75-percent reduction to the GOM cod catch limit compared to 2014, a prohibition on recreational possession of GOM cod, and seasonal area closures intended to protect spawning and reduce fishing mortality on GOM cod.
Framework 53 also includes measures consistent with the goals of a revised 10-year rebuilding plan for GOM cod that was established in Framework 51 (79 FR 22421; April 22, 2014). The 10-year rebuilding program is intended to account for past performance of groundfish rebuilding programs and uncertainties in long-term catch projections by setting conservative catch levels in the early years of the program. This timeframe also provides flexibility to better address the needs of fishing communities compared to rebuilding programs that target an earlier end date.
Section 304 of the Magnuson-Stevens Act provides the Secretary of Commerce with the authority to prepare and implement a fishery management plan if the Council fails to develop and submit a plan or amendment after a reasonable period of time that meets necessary conservation and management objectives. Or, the agency may put in place emergency regulations or interim measures to address an emergency or overfishing. An emergency rulemaking allows actions to prevent overfishing or economic loss or to preserve economic opportunity when the emergency results from recent, unforeseen events or recently discovered circumstances. An interim rule allows for measures that reduce overfishing for a limited time. The benefits of using the abbreviated rulemaking procedures associated with emergency rulemaking and interim measures must outweigh the value of advance notice, public comment, and deliberative consideration of the impacts on participants to the same extent as expected under the normal Council and full notice-and-comment rulemaking process.
Rulemaking is not appropriate in this instance because it would unnecessarily replace the measures established in Framework 53 and the recreational measures put in place through the Council process. These measures achieve what the petition for rulemaking seeks. These measures balance Magnuson-Stevens Act objectives, including achieving optimum yield and taking into account the needs of fishing communities, without compromising conservation objectives to prevent overfishing and rebuild the stock. Therefore, neither a Secretarial amendment nor an emergency action is necessary or warranted at this time to further limit GOM cod mortality.
We do not agree with the petitioner's statements that the Council-recommended catch levels for GOM cod during the 2004 rebuilding program were intended to maximize economic gain at the expense of the health of the stock. A 2008 stock assessment reviewed progress under the plan and concluded that the stock was not overfished but overfishing was occurring, and, based in part on a strong 2005 year class, the stock was expected to rebuild by 2014.
We notified the Council about the lack of progress under the 2004 rebuilding plan following the 2012 GOM cod benchmark assessment. We determined that inadequate progress under the 2004 rebuilding plan was due to a revised understanding of the condition of the stock since the 2008 GOM cod assessment. In response to the new understanding of the status of the GOM cod stock, we worked with the Council to implement measures to reduce overfishing and revise the rebuilding plan as swiftly as possible though a 2012 interim action, and Frameworks 50 and 51. These actions incorporated new information and lessons from past management approaches. Our review of the Council's
We reject the petitioners claim that the 2014 interim action insufficiently addressed the information provided in the updated assessment. One of our primary objectives of the interim action was to reduce overfishing by reducing GOM cod commercial and recreational catch. Given the mixed nature of the groundfish fishery and its interaction with other fisheries, this objective was analyzed in the context of not closing down the entire GOM, but to allow some harvesting of other groundfish stocks. We wanted to reduce GOM cod mortality while the Council developed more permanent measures in Framework 53. We determined it was unnecessary to try to prevent all fishing mortality for the remainder of the 2014 fishing year as the stock can rebuild even if subject to overfishing in 2014 as long as measures would be in place to prevent overfishing beginning in 2015. Achieving zero fishing mortality would have required closing all GOM fisheries, including those that do not target groundfish. The impacts of such measures would be substantial and impracticable. Such a closure was unwarranted to ensure effective cod conservation.
Most recently, we considered public comment on and supporting analysis for Framework 53 and the 2015 recreational measures, and the best scientific information available in making the determination that an ABC of 386 mt was appropriate and consistent with the requirements of the Magnuson-Stevens Act and its National Standards. In light of current stock conditions, the 386 mt ABC is a 75-percent catch limit reduction compared to 2014, which is in addition to the 80-percent reduction implemented for the 2013-2014 fishing years. In total, the GOM cod catch limit has been reduced by 95 percent over the last 5 years. Further, new recreational measures prohibit recreational fishermen from retaining any GOM cod. This is the first zero-retention prohibition on GOM cod for recreational fishermen. Detailed information that addresses the petitioners concerns about the GOM cod ABC and further justifies our decision to approve an ABC of 386 mt can be found in the Framework 53 final rule (see pages 25125-25127).
We will continue to carefully consider management measures to promote timely rebuilding of the GOM cod stock. In an effort to closely monitor stock indicators, we reviewed the recent fall 2014 NEFSC bottom trawl survey indices. The fall survey indicated a small increase compared to 2012 and 2013; however, the general trend of survey indices, as well as recruitment, remains very low. While the updated survey information may provide an initial, and potentially positive, indication of improvement, it is difficult to anticipate the results of the full 2015 assessment. In any event, we plan to make necessary adjustments for the 2016 fishing year based on the upcoming 2015 stock assessment.
The petitioners request prohibiting fishing mortality until incidental mortality does not exceed the ABC. An ABC of 386 mt is expected to have substantial adverse economic impacts on groundfish vessels, and is below the estimate of incidental catch of GOM cod that occurred in the 2013 fishing year. In the 2013 fishing year, when the ACL was reduced by 80 percent, incidental catch was estimated to be approximately 500-600 mt. Beginning in the 2013 fishing year, sectors primarily used their GOM cod allocation to access other groundfish stocks. Multiple sources of information indicate a marked decline in directed fishing for GOM cod. With an additional 75-percent reduction beginning in the 2015 fishing year, the incentive to target GOM cod is virtually eliminated, and the fishery will be, in effect, a “bycatch-only” fishery. Incidental catch is largely a function of the overall ACLs on other stocks. At such a low GOM cod catch limit, fishery operations will be greatly restricted, and in some cases eliminated. In addition, the recreational fishery will be prohibited from possessing any GOM cod. Under this incidental catch scenario, the GOM cod ABC is expected to severely restrict catch of other groundfish stocks, particularly GOM haddock, pollock, redfish, and some flatfish. Based on this information, the 386-mt ABC balances Magnuson-Stevens Act requirements of conservation and achieving optimum yield.
The petitioners raised a concern that inaccurate accounting for catch could undermine conservation objectives for GOM cod. We share their concern, and available analyses suggest that an extremely low catch limit for GOM cod may create an economic incentive to misreport catch. If misreporting occurs, it could reduce the accuracy of catch apportionment. Information indicates that this incentive increases as the GOM cod catch limit is further reduced. To help ensure correct catch apportionment and compliance with the GOM cod ACL adopted in Framework 53, we also implemented an additional daily reporting requirement for common pool and sector vessels fishing in multiple broad stock areas on the same trip. This requirement is intended to help ensure accurate catch attribution and reduce the incentive for vessels to misreport.
We do not share the petitioners' view that 100-percent observer coverage is necessary to monitor GOM cod fishing mortality. Rather, we apply at-sea monitoring coverage levels that we determine are necessary to monitor and enforce catch levels, or increase buffers to account for uncertainty in catch as part of the biennial quota-setting process. We have received similar comments on prior groundfish rulemakings requesting high levels of observer coverage for the commercial fishery since the implementation of Amendment 16. For the most part, commenters have generally asserted that the levels of monitoring we have implemented are inadequate without providing any specific justification or information to support their assertion.
For sector trips, we have determined that 24-percent observer coverage is sufficient this fishing year, to the extent practicable in light of Magnuson-Stevens Act requirements, to reliably estimate catch for purposes of monitoring ACLs for groundfish stocks. This level of coverage is achieved through a combination of groundfish at-sea monitoring coverage and observer coverage furnished by the Northeast Fisheries Observer Program. Amendment 16 specified that at-sea monitoring coverage levels should be less than 100 percent, which requires estimations of the discard portion of catch and thus total catch. Amendment 16 also specified that the at-sea monitoring coverage levels should achieve a 30-percent coefficient of variation (CV). The level of observer coverage, ultimately, should provide confidence that the overall catch estimate is sufficiently accurate to ensure that sector fishing activities are consistent with National Standard 1 requirements to prevent overfishing while achieving optimum yield. To that end, significant additional uncertainty buffers are established when setting ACLs that mitigate any lack of absolute precision and accuracy in estimating overall catch by sector vessels. Collectively, the current level of sector
On February 18, 2014, in
We remain concerned about the status of GOM cod, but have determined that the current FMP, as adjusted by Framework 53, along with recreational measures and planned future Council and agency actions, provide the appropriate regulatory mechanisms for addressing the concerns regarding this stock that were raised in the petition for rulemaking. We will continue to carefully monitor stock indicators leading into the 2015 assessment to fully inform our re-evaluation of the GOM cod catch limit, and the need to balance conservation and management objectives. Therefore, we are denying this petition; no other rulemaking is necessary in response to the petition for rulemaking.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations to reduce the maximum retainable amount (MRA) of skates using groundfish and halibut as basis species in the Gulf of Alaska (GOA) from 20 percent to 5 percent. Reducing skate MRAs is necessary to decrease the incentive for fishermen to target skates and slow the catch rate of skates in these fisheries. This proposed rule would enhance conservation and management of skates and minimize skate discards in GOA groundfish and halibut fisheries. This proposed rule is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act, the Northern Pacific Halibut Act of 1982, the Fishery Management Plan for Groundfish of the Gulf of Alaska, and other applicable laws.
Comments must be received no later than August 10, 2015.
You may submit comments on this document, identified by NOAA-NMFS-2015-0015, by any of the following methods:
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Electronic copies of the draft Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (collectively the “Analysis”), Alaska Groundfish Harvest Specifications Final Environmental Impact Statement (Final EIS), Supplementary Information Report (SIR) to the Final EIS, and the Initial Regulatory Flexibility Analysis (IRFA) for the Gulf of Alaska Groundfish Harvest Specifications for 2015 and 2016 (Harvest Specifications IRFA) prepared for this action are available from
Peggy Murphy, 907-586-7228.
NMFS manages the groundfish fisheries in the exclusive economic zone of the GOA under the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). The North Pacific Fishery Management Council (Council) prepared the FMP under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
NMFS proposes to modify regulations that specify the MRA for skates in the GOA. An MRA is the maximum amount of a species closed to directed fishing (
The Council recommended and NMFS proposes to reduce the skate MRA to decrease the incentive for fishermen to target skates while directed fishing for groundfish and halibut, and to slow the harvest rate of skates in GOA groundfish and halibut fisheries. Information from recent years of skate catch in directed groundfish and halibut fisheries indicates that some fishermen have maximized their retention of skates early in the year by deliberately targeting them while directed fishing for other species. Over a period of years, the TAC of big skate and longnose skate has been exceeded in the Central GOA and Western GOA, respectively. In response, NMFS has prohibited retention of skates earlier in the year to reduce incentives to target skates and maintain catch at or below the TACs established for skate species in specific GOA regulatory areas. A prohibition on retention results in mandatory discard of all skate catch for the remainder of the year.
This proposed rule would limit the amount of skates that could be retained while directed fishing for other groundfish and halibut. The proposed rule would slow the harvest rate of skates and would enhance NMFS' ability to limit the catch of skates to the skate TACs. In addition, the proposed rule is expected to minimize discards of skates by reducing the likelihood that NMFS would need to prohibit retention of a skate species in a GOA management area during the year to maintain skate catch at or below its TAC.
This proposed rule would make four amendments to regulations. First, this proposed rule would amend regulations to reduce the skate MRA for all vessels fishing for groundfish and halibut in the GOA. This proposed rule would amend regulations that establish a skate MRA for all groundfish and halibut basis species in Table 10 to 50 CFR part 679 and for the fisheries under the Central GOA Rockfish Program in Table 30 to 50 CFR part 679. Second, this proposed rule would make minor clarifications in MRA regulations applicable to the Central GOA Rockfish Program. Third, this proposed rule would make minor corrections to incorrect cross references in regulations in §§ 679.7 and 679.28. Finally, this proposed rule would revise Table 2a to 50 CFR part 679 by adding whiteblotched, Alaska, and Aleutian skates as well as the scientific names for individual skate species that were inadvertently removed by a previous rule making.
The following sections describe (1) management of skates in the GOA and the fisheries that would be affected by the rule; (2) the need for the proposed rule; and (3) the proposed rule.
In the GOA, the Council and NMFS manage skates as a groundfish species under the FMP. Management of skates in the GOA is described in Section 3.1.2 of the Analysis. Big skate and longnose skate are managed as single species, and all other skate species are managed in the “other skates” species group.
GOA skate catches are managed subject to annual limits on the amounts of each species of skate, or group of skate species, that may be taken. The annual limits are defined in the FMP and referred to as “harvest specifications.” The overfishing limits (OFLs), acceptable biological catch (ABCs), and TACs for skates are specified through the annual “harvest specification process.” The FMP requires that the Council recommend and NMFS specify these annual limits for each species or species group of groundfish on an annual basis. A detailed description of the annual harvest specification process is provided in the Final EIS, the SIR, and the final 2015 and 2016 harvest specifications for groundfish of the GOA (80 FR 10250, February 25, 2015) and is briefly summarized here.
Section 3.2.1 of the FMP defines the OFL as the annual amount of catch that results whenever a stock or stock complex is subjected to a level of fishing mortality or annual total catch that jeopardizes the capacity of a stock or stock complex to produce maximum sustainable yield on a continuing basis. The OFL is the catch level above which overfishing is occurring. NMFS manages fisheries to ensure that no OFLs are exceeded in any year.
Section 3.2.1 of the FMP defines the ABC as the level of a stock or stock complex's annual catch that accounts for the scientific uncertainty in the estimate of OFL and any other scientific uncertainty. The ABC is set below the OFL.
Section 3.2.1 of the FMP defines the TAC as the annual catch target for a stock or stock complex, derived from the ABC by considering social and economic factors and management uncertainty (
Big skate and longnose skate have OFLs and ABCs defined for the GOA management area. The ABCs for big skate and longnose skate are apportioned to each of the regulatory areas in the GOA management area according to the proportion of the biomass estimated in each regulatory area. NMFS specifies TACs for big skate and longnose skate for the Western GOA, Central GOA, and Eastern GOA equal to the ABC for each of these regulatory areas. All other species of skates are assigned to the “other skates” species group. The other skates species group has an OFL and ABC, and TAC specified for the GOA management area (
NMFS ensures that OFLs, ABCs, and TACs are not exceeded by requiring vessel operators participating in groundfish fisheries in the GOA to comply with a range of restrictions, such as area, time, gear, and operation-specific fishery closures. Regulations at § 679.20(d)(1), (d)(2), and (d)(3) describe the range of management measures that NMFS uses to maintain total catch at or below the TAC.
Regulations at § 679.20(d)(1)(i) specify that NMFS may establish a directed fishing allowance (DFA) for a species or species group when any allocation or apportionment of a target species or species group allocated or apportioned to a fishery will be reached. Regulations at § 679.20(d)(1)(ii)(B) specify that NMFS must also consider the amount of a species or species group closed to directed fishing that will be taken in directed fishing for other species when establishing a DFA. NMFS implements this provision through the annual
Directed fishing for groundfish in the GOA is defined at § 679.2 as any fishing activity that results in the retention of an amount of a species or species group onboard a vessel that is greater than the MRA for that species or species group. Therefore, when directed fishing for a species or species group is prohibited, retention of the species or species group is limited to an MRA. These species are referred to as incidental catch species. NMFS established MRAs to allow vessel operators fishing for species or species groups open to directed fishing to retain a specified amount of incidental catch species.
NMFS has determined that the TACs specified for all skate species in the GOA are needed to support incidental catch of skates in other groundfish and halibut fisheries. As a result, there are insufficient TACs for these species to support directed fisheries, the DFA for skates is set to zero mt, and directed fishing for skates is prohibited at the beginning of the fishing year. When directed fishing for skates is prohibited, the catch of skates is limited by an MRA.
The skate MRA is specified by basis species in Table 10 and Table 30 to 50 CFR part 679. The skate MRA is not specified by skate species. Instead, the skate MRA is based on the combined round weight of all skate species retained onboard a vessel. A single MRA for all skates was established because fishermen and processors may have difficulty identifying skate species and may not be able to easily determine if they have reached an MRA for a specific skate species. Therefore, a separate MRA for each species would be difficult to manage and enforce. Additional detail on the designation of a single skate MRA is provided in Section 4.1 of the Analysis.
Currently, the skate MRA for all basis species in the GOA is 20 percent of the basis species round weight retained onboard a vessel. This means the maximum amount of big, longnose, and other skate species that may be retained onboard a vessel must not exceed 20 percent of the round weight of other groundfish species and halibut (basis species) retained onboard a vessel. For example, a vessel operator fishing Pacific cod, a basis species open to directed fishing, may retain big, longnose, and other skates in an amount up to 20 percent of the round weight equivalent of Pacific cod that is onboard the vessel at any point in time during a fishing trip.
Amounts of skates onboard the vessel that are below or equal to the MRA may be retained. Amounts of skates in excess of the MRA must be discarded. An MRA applies at all times and to all areas for the duration of a fishing trip (see § 679.20(e)(3)). Vessel operators may retain incidental catch species while directed fishing for other groundfish species or halibut up to the MRA percentage of the basis species retained catch until the TAC for the incidental catch species is met.
Regulations at § 679.20(d)(2) specify that if the TAC for the incidental catch species is met, NMFS will prohibit retention of the incidental catch species for the remainder of the year. Regulations at § 679.21(b) specify that if retention of a species is prohibited, the operator of each vessel engaged in directed fishing for groundfish in the GOA must return the prohibited species to the sea immediately, with a minimum of injury, regardless of its condition. Therefore, when NMFS prohibits retention of an incidental catch species, such as skates, vessel operators must discard all catch of that species. The primary purpose of requiring discards is to remove any incentive for vessel operators to increase incidental catch of the species as a portion of other fisheries and to minimize the catch of that species.
Although MRAs limit the incentive to target on an incidental catch species, fishermen can “top off” their retained groundfish and halibut catch with incidental catch species up to the maximum permitted under the MRA. Fishermen are top-off fishing when they deliberately target and retain incidental catch species up to the MRA instead of harvesting the species incidentally. Thus, MRAs reflect a balance between NMFS' need to limit the harvest rate of incidental catch species and minimize regulatory discards of the incidental catch species while providing fishermen an opportunity to harvest available incidental species TAC through limited retention.
Skates are caught in the GOA primarily by vessels directed fishing for groundfish with non-pelagic trawl gear and by vessels directed fishing for groundfish and halibut with hook-and-line gear. Very limited amounts of skates are also caught by vessels using pelagic trawl, pot, and jig gear in directed groundfish fisheries in the GOA. Section 3.1.1 of the Analysis presents detailed information on GOA skate catch by species, management area, gear, and target fishery for two time periods: From 2008 through 2012, and in 2013 and 2014. This information is briefly summarized below.
Catch data are divided into these two periods, because the individual fishing quota (IFQ) halibut and small catcher vessel hook-and-line Pacific cod fisheries were largely unobserved before 2013. Data on the incidental catch of skate species from these fisheries prior to 2013 is limited or not available. In 2013, the North Pacific Groundfish Observer Program was restructured (Restructured Observer Program) and observers were deployed in the IFQ halibut fishery and on smaller vessels (77 FR 70062, November 21, 2012). As a result, new observer data on skate catch were included in NMFS' catch accounting system. The improved observer data since 2013, and information on the amount of at-sea discards of skates from the IFQ halibut fishery and smaller hook-and-line vessels, show that an increased proportion of skate catch occurs on vessels using hook-and-line gear.
Based upon NMFS' catch accounting system, big skate catch occurs primarily in the Central GOA. Less than one tenth of the catch comes from the Western GOA or the Eastern GOA. NMFS data show that from 2008 through 2012, an average of 67 percent of the big skate catch was caught by vessels using non-pelagic trawl gear and 32 percent was caught by vessels using hook-and-line gear. During 2013 and 2104, the proportion of big skate catch by vessels using non-pelagic trawl gear decreased to 54 percent, and the proportion caught by vessels using hook-and-line gear increased to 46 percent. Big skate catch by vessels using non-pelagic trawl gear occurs predominantly in the arrowtooth flounder directed fishery. Big skate catch by vessels using hook-and-line gear occurs predominantly in the Pacific cod and halibut directed fisheries. Less than 1 percent of the big skate catch was caught by vessels using other types of gear.
The analysis indicates that congregations of big skate in the spring enable catcher vessel operators using non-pelagic trawl gear and hook-and-line gear to engage in top-off fishing. NMFS groundfish landings data on big skate confirm that specific areas have higher retention of big skate when
Longnose skate are caught predominantly in the Central GOA, with more limited catch in the Eastern GOA, and the least amount of catch in the Western GOA. NMFS data show that from 2008 through 2012, an average of 53 percent of the longnose skate catch was caught by vessels using hook-and-line gear and 44 percent was caught by vessels using non-pelagic trawl gear. During 2013 and 2014, the proportion of longnose skate catch by vessels using hook-and-line gear increased to 67 percent, and the proportion of catch by vessels using non-pelagic trawl gear decreased to 31 percent. Longnose skate catch by vessels using hook-and-line gear occurs predominantly in Pacific cod, halibut, and sablefish directed fisheries. Longnose skate catch by vessels using non-pelagic trawl gear occurs predominantly in the arrowtooth flounder and flatfish directed fisheries. Approximately 2 percent of the longnose skate catch was caught by vessels using other types of gear.
Other skates are caught primarily in the Central GOA. From 2008 through 2012, an average of 78 percent of the other skate catch was caught by vessels using hook-and-line gear, and 20 percent was caught by vessels using non-pelagic trawl gear. During 2013 and 2014, the proportion of catch of other skate catch by vessels using hook-and-line gear increased to 90 percent and the proportion of catch by vessels using non-pelagic trawl gear decreased to 10 percent. Other skate catch by vessels using hook-and-line gear occurs predominantly in the Pacific cod, halibut, and sablefish directed fisheries. Other skate catch by vessels using non-pelagic trawl gear occurs predominantly in the arrowtooth and deep-water flatfish target fisheries. Less than 1 percent of the other skate catch was caught by vessels using other types of gear.
In December 2013, the Council received public testimony that the current MRA for skates in the GOA allows fishermen to deliberately target skates while ostensibly directed fishing for other groundfish or halibut. This “topping-off” pattern of maximizing skate catch up to the MRA limit of 20 percent of the basis species onboard a vessel has increased the harvest rate of skates. In recent years, skate catch has exceeded the TAC in some areas. The estimated catch of big skate exceeded the TAC in the Central GOA in 2010, 2011, 2012, and 2013, and the estimated catch of longnose skates exceeded the TAC in the Western GOA in 2009, 2010, and 2013. The catch of other skates has not exceeded the TACs established for the GOA management area; however, in 2013 and 2014, the catch of other skates was estimated at 93 percent and 98 percent of the 2013 and 2014 TACs, respectively.
When fishery managers estimated the big or longnose skate TACs would be exceeded, NMFS prohibited retention of big or longnose skates in the directed fisheries for groundfish and halibut and required discard of all big or longnose skate catch for the remainder of the calendar year. The earlier in the year that big or longnose skate retention is prohibited, the more regulatory discards of big or longnose skate can occur since groundfish and halibut fisheries will continue to catch these skates incidentally.
The Council determined and NMFS agrees that reducing the skate MRA would decrease the incentive for fishermen to engage in top-off fishing for skates and slow the harvest rate of skates to levels that more accurately reflect the rate of incidental catch of skates in the directed groundfish and halibut fisheries in the GOA. Reducing the skate MRA would slow the skate harvest rate and accrual of skate catch against the TAC. A slower harvest rate may reduce the potential that NMFS will have to prohibit skate retention to avoid exceeding a skate species' TAC. In addition, a slower harvest rate could extend skate retention throughout the year and result in lower regulatory discards of skates.
This proposed rule would help ensure that skate catch in the future does not exceed a TAC, ABC, or OFL. The Council and NMFS analyzed four alternative MRAs to reduce the incentive for fishermen to pursue top-off fishing for skates and slow the rate of skate harvest. In addition to the status quo of an MRA of 20 percent, the Council and NMFS evaluated alternatives to reduce skate MRAs to 15, 10, and 5 percent. To estimate impacts of the alternative MRAs, the Analysis considered two metrics.
First, the Analysis examined the rate of big skate catch relative to groundfish catch by directed fishery before and after big skate retention was prohibited in 2013 and 2014 (see Section 4.5.1.1 of the Analysis). The Analysis assumed that once big skate retention was prohibited by regulation, a vessel operator would not be engaging in top-off fishing for big skates if they were encountered while directed fishing for groundfish or halibut. Thus, the Analysis assumed that the relative catch rates of big skate after retention was prohibited were a reasonable estimate of the likely incidental catch rate of big skate.
The Analysis examined big skate catch rates because they are the most abundant skates in the GOA and significant proportions of big skate catches are retained compared to the catch of longnose and other skates. The 2013 and 2014 period was selected for analysis because NMFS prohibited retention of big skates in the Central GOA during these years, allowing a clear comparison of changes in catch rates after retention was prohibited. NMFS also has more complete data on big skate catch rates after 2013 due to the Restructured Observer Program.
Results from the analysis of big skate harvest rates indicate that after big skate retention was prohibited the harvest rate for big skate dropped from as much as 8.6 percent of the total groundfish and halibut catch to a harvest rate that ranged from 6.3 percent to 0.1 percent of the total groundfish and halibut catch depending on the year, gear type, and target fishery. These data indicate that participants in various target fisheries could avoid the incidental catch of big skate when there was not an incentive to retain big skates.
Second, the Analysis used a model of retained skate catch of all skate species, in all areas and by vessels using all gear types under a range of hypothetical MRAs ranging from one percent to 20 percent of the basis species. The model allowed the Council and NMFS to compare the amount of retained skate catch that would be likely under these alternative MRAs (see Section 4.5.1.4 of the Analysis).
Results from the model indicate that as the MRA becomes more restrictive, the incentive for vessel operators to engage in top-off fishing is reduced and overall skate catch may be reduced as fishermen avoid areas where skates are encountered. The model estimated that a reduction in the skate MRA ranging from 20 percent to 10 percent would have relatively limited impacts on the amount of GOA skates that are retained relative to the current 20 percent MRA. Therefore, NMFS expects reducing the MRA to 15 or 10 percent would not result in a significantly lower catch rate of GOA skates. The model indicates that reducing the skate MRA below 10 percent would be expected to result in more limited top-off fishing and lower overall catch of skates. The model indicates that a 5 percent MRA would best ensure that NMFS did not have to prohibit the retention of skates and that skate TACs would not be exceeded.
In December 2014, following public comment and input from its advisory
This proposed rule would affect all catcher vessels and catcher/processors directed fishing for groundfish and halibut in the GOA that may harvest any species of skate. Section 4.6.1.1 of the Analysis estimates the annual revenue at risk for all catcher vessels and catcher/processors that could be affected by this proposed rule at $2.4 million. However, the impact relative to each vessel that retains skates in the GOA is quite small. Analysis of the gross revenue data for vessels that retained GOA skates indicates that from 2008 through 2013 the average percentage of annual gross revenue derived from skate catch by catcher vessels ranged between 0.7 percent and 1.28 percent of their total annual gross revenue; the average percentage of annual gross revenue derived from skate catch by catcher/processors ranged between 0.26 percent and 0.77 percent of their total annual gross revenue (see Section 4.6.1.1 of the Analysis). In general, vessels that catch and retain skates show relatively little dependence on GOA skates for their gross revenues. The actual impact on gross revenue for a specific vessel may vary from year to year depending on the total abundance of skates, total catch of skates, market conditions, and ex-vessel price. Section 4.5.1.4 of the Analysis describes the effect of the 5 percent MRA on specific vessel operations in greater detail.
The impact of this proposed rule on communities is discussed in Section 4.6.2 of the Analysis. Impacts would be most pronounced on Kodiak, AK, where, from 2008 through 2014, 87 percent to 93 percent of skates retained by catcher vessels were delivered. Kodiak accounted for between 84 percent and 91 percent of the first wholesale value of shoreside skate processing in Alaska, which ranged between $3.2 and $5.1 million annually. Skates accounted for between 0.98 percent and 1.38 percent of the first wholesale value of production at Kodiak.
Although this proposed rule could limit the total amount of skates delivered, it is also possible that skate deliveries would continue under the 5 percent MRA, but would be distributed throughout the year provided a TAC limit is not reached. Therefore, the impact on total landings on any community may be limited. Communities in the State of Alaska where skates and processed skate products are landed may realize lower tax revenues from the State of Alaska Fisheries Business Tax and Fishery Resource Landing Tax, but only if total skate landings decline.
This proposed rule would make four changes to the regulations. First, this proposed rule would revise skate MRAs in Table 10 to 50 CFR part 679, Gulf of Alaska Retainable Percentages, and in Table 30 to 50 CFR part 679, Rockfish Program Retainable Percentages. NMFS would reduce the incidental catch species MRAs for skates for each basis species listed in Tables 10 and 30 from 20 percent to 5 percent. NMFS notes the basis species termed “Aggregated amount of non-groundfish species” includes all legally retained IFQ halibut as explained in footnote 12 to Table 10. If the proposed reductions in skate MRAs are approved, then skate MRAs would be set equal to 5 percent in Tables 10 and 30 on the effective date of the final rule.
Second, this proposed rule would correct two regulatory cross-reference errors. These errors resulted from reorganizing and renumbering the Federal Fisheries Permit requirements in § 679.4(b) and were implemented in a final rule published on October 21, 2014 (79 FR 62885). Current regulations at § 679.7(a)(18) and § 679.28(f)(6)(i) incorrectly refer to the FFP requirements at § 679.4(b)(5)(vi), a paragraph that no longer exists. This proposed rule would correct those cross references to § 679.4(b).
Third, this proposed rule would modify regulatory text to clarify that a vessel fishing under a Rockfish Program cooperative quota (CQ) permit may harvest groundfish species not allocated as CQ up to the MRA for that species as established in Table 30 to 50 CFR part 679. This proposed rule would remove the last sentence in regulations at § 679.20(f)(2), because the sentence makes an incorrect statement. The heading in the last column in Table 30 correctly states that the MRA for vessels fishing under the Rockfish Program is calculated as “a percentage of total retained rockfish primary species and rockfish secondary species”. This proposed rule would correct this discrepancy by removing the last sentence of § 679.20(f)(2). The current regulations at § 679.81(h)(4)(i) and (h)(5) use the term “incidental catch species” in the calculation of an MRA to refer to “groundfish species not allocated as cooperative quota (CQ).” This proposed rule would add the referenced text to § 679.81(h)(4)(i) and (h)(5) to ensure consistent use of terminology in the regulations.
Fourth, this proposed rule would revise Table 2a to 50 CFR part 679 to add whiteblotched, Alaska, and Aleutian skates, as well as the scientific names for individual skate species. Adding these individual skate species and the scientific names would facilitate the reporting of individual skate species taken during groundfish harvest and provides more detailed information regarding skate harvests for stock assessments and fisheries management. This revision would support managing skates as a target species group or as individual target species. These skate species and scientific names were added to Table 2a in final regulations implementing changes to groundfish management in the BSAI and GOA on October 6, 2010 (75 FR 61639). Subsequent regulations published on July 11, 2011 (76 FR 40628), amended Table 2a to 50 CFR part 679 and that revision inadvertently removed the skate species codes implemented on October 6, 2010. The proposed addition of these skate species and scientific names would correct this error that was noticed during the preparation of this proposed rule. The proposed addition of species codes does not change the management of skates or the other provisions of this proposed rule.
Pursuant to sections 304 (b)(1)(A) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
NMFS prepared an Initial Regulatory Flexibility Analysis (IRFA) as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A copy of the Analysis is available from NMFS (see
This proposed rule, a reduction in GOA skate MRAs, directly regulates all entities fishing for groundfish and halibut in the GOA that have the potential to catch any species of skate. These entities operate vessels that are directly regulated by the GOA groundfish harvest specifications.
On June 12, 2014, the Small Business Administration issued an interim final rule revising the small business size standards for several industries effective July 14, 2014 (79 FR 33647, June 12, 2014). The rule increased the size standard for Finfish Fishing from $19.0 million to $20.5 million. The new size standards were used to prepare the IRFA for this proposed rule.
The IRFA estimates that this proposed rule would directly regulate 1,153 small entities. Of these small entities, the IRFA estimates that this proposed rule would directly regulate 1,073 small catcher vessels fishing with hook-and-line gear (including jig gear), 116 small catcher vessels fishing with pot gear, and 32 small catcher vessels fishing with trawl gear. In addition, this proposed rule would directly regulate 2 small catcher/processors fishing with hook-and-line gear, and one small catcher/processor fishing with trawl gear. Specific revenue data for these small catcher/processors are confidential but are less than $20.5 million annually. The IRFA estimates that the average gross revenues for 2013 (the most recent year of complete revenue data) are $380,000 for small hook-and-line catcher vessels, $960,000 for small pot catcher vessels, and $2.8 million for small trawl catcher vessels.
This proposed rule does not create new recordkeeping and reporting requirements, or alter existing requirements.
The IRFA prepared for this proposed rule has not identified Federal rules that duplicate, overlap, or conflict with the preferred alternative (a 5 percent MRA).
An IRFA should include a description of any significant alternatives to the proposed rule that accomplish the stated objectives, are consistent with applicable statutes, and that would minimize the significant economic impact of the proposed rule on small entities.
The Council and NMFS considered four alternatives in the development of this proposed rule. This proposed rule would implement Alternative 4, a 5 percent skate MRA. The significant alternatives to this proposed rule are Alternatives 1, 2, and 3, a 20 percent, 15 percent, and 10 percent skate MRA, respectively. As discussed in Section 4.7 and 4.8 of the Analysis, these proposed alternatives are not expected to reduce the incentive for fishermen to target and retain skates and thus, would not accomplish the objectives of this proposed rule—to slow the harvest rate of skates that may be incidentally retained to ensure that the TACs for skate species are not exceeded. The Analysis did not identify any other alternatives that would more effectively meet the RFA criteria to minimize adverse economic impacts on directly regulated small entities.
Alaska, Fisheries.
For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 679 as follows:
16 U.S.C. 773
(a) * * *
(18)
(f) * * *
(2)
(f) * * *
(6) * * *
(i) You operate a vessel in any reporting area (see definitions at § 679.2) off Alaska while any fishery requiring VMS, for which the vessel has a species and gear endorsement on its Federal Fisheries Permit under § 679.4(b), is open.
(h) * * *
(4) * * *
(i) The MRA for groundfish species not allocated as CQ (incidental catch species) for vessels fishing under the authority of a CQ permit is calculated as a proportion of the total allocated rockfish primary species and rockfish secondary species on board the vessel in round weight equivalents using the retainable percentage in Table 30 to this part; except that—
(5)
Agricultural Marketing Service, USDA.
Notice; request for nominations.
The Farm Security and Rural Investment Act of 2002 (2002 Farm Bill) requires the Secretary of Agriculture to establish a Peanut Standards Board (Board) for the purpose of advising the Secretary on quality and handling standards for domestically produced and imported peanuts. The initial Board was appointed by the Secretary and announced on December 5, 2002. USDA seeks nominations for individuals to be considered for selection as Board members for a term of office ending June 30, 2018. Selected nominees would replace three producers and three industry representatives who currently serve on the Board and have terms of office that end on June 30, 2015. The Board consists of 18 members representing producers and the industry. In an effort to obtain diversity among candidates, USDA encourages the nomination of men and women of all racial and ethnic groups and persons with a disability.
Written nominations must be received on or before August 24, 2015.
Nominations should be sent to Jennie M. Varela of the Southeast Marketing Field Office, Marketing Order and Agreement Division, Fruit and Vegetable Program, AMS, USDA, 1124 1st Street South, Winter Haven, FL 33880; Telephone: (863) 324-3375; Fax: (863) 291-8614; Email:
Section 1308 of the 2002 Farm Bill requires the Secretary of Agriculture to establish and consult with the Board for the purpose of advising the Secretary regarding the establishment of quality and handling standards for all domestic and imported peanuts marketed in the United States.
The 2002 Farm Bill provides that the Board's makeup will include three producers and three peanut industry representatives from states specified in each of the following producing regions: Southeast (Alabama, Georgia, and Florida); Southwest (Texas, Oklahoma, and New Mexico); and Virginia/Carolina (Virginia and North Carolina).
The term “peanut industry representatives” includes, but is not limited to, representatives of shellers, manufacturers, buying points, and marketing associations and marketing cooperatives. The 2002 Farm Bill exempted the appointment of the Board from the requirements of the Federal Advisory Committee Act.
USDA invites individuals, organizations, and groups affiliated with the categories listed above to nominate individuals for membership on the Board. Nominees sought by this action would fill two positions in the Southeast region, two positions in the Southwest region, and two positions in the Virginia/North Carolina region.
Nominees should complete a Peanut Standards Board Background Information form and submit it to Jennie Varela at the address provided in the “Addresses” section above. Copies of this form may be obtained at the internet site
Equal opportunity practices will be followed in all appointments to the Board in accordance with USDA policies. To ensure that the recommendations of the Board have taken into account the needs of the diverse groups within the peanut industry, membership shall include, to the extent practicable, individuals with demonstrated abilities to represent minorities, women, persons with disabilities, and limited resource agriculture producers.
7 U.S.C. 7958.
Agricultural Marketing Service, USDA.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act (FACA), the Agricultural Marketing Service (AMS) is announcing a meeting of the Plant Variety Protection Board (Board). The meeting is being held to discuss a variety of topics including, but not limited to, work and outreach plans, subcommittee activities, and proposals for procedure changes. The meeting is open to the public. This notice sets forth the schedule and location for the meeting.
Thursday, August 6, 2015, from 10:00 a.m. to 12:00 p.m.
The Board meeting will be held at the United States Department of Agriculture, Room 3543, South Building, 1400 Independence Avenue SW., Washington, DC 20250.
Maria Pratt, Program Analyst, U.S. Department of Agriculture (USDA), AMS, Science and Technology Programs, 1400 Independence Avenue SW., Washington, DC 20250. Telephone: (202) 720-1104; Fax: (202) 260-8976, or Email:
Pursuant to the provisions of section 10(a) of the FACA (5 U.S.C., Appendix 2), this notice informs the public that the Plant Variety Protection Office (PVPO) is having a Board meeting earlier than the 15 day requirement of the FACA. The Plant Variety Protection Act (PVPA) (7 U.S.C. 2321
The purpose of the meeting will be to discuss the PVPO's 2015 achievements, the electronic application system, the reports of the subcommittees to change PVP forms and to evaluate molecular techniques for PVP distinctness characterization, and PVP cooperation with other countries.
Agenda Items: The agenda will include, welcome and introductions, discussions on program activities that encourage the development of new plant varieties and also address appeals to the Secretary. There will be presentations on 2015 accomplishments, the electronic PVP application system, proposed changes to PVP forms, the use of molecular markers for PVP applications, and PVP cooperation with other countries. The meeting will be open to the public. Those wishing to participate are encouraged to pre-register by July 30, 2015 by contacting Maria Pratt, Program Analyst; Telephone: (202) 720-1104; Email:
Meeting Accommodation: If you need a reasonable accommodation to participate in this public meeting, please notify Maria Pratt at: Email:
Rural Business-Cooperative Service, USDA.
Notice of a public meeting.
The Rural Business-Cooperative Service (RBS), an Agency within USDA Rural Development, is holding a forum to introduce the new “Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program” (Section 9003 Program), formerly the Biorefinery Assistance Program (BAP), as found in the new regulation and the Notice of Solicitation of Applications (NOSA). Major changes to the Section 9003 Program include the addition of renewable chemicals and biobased product manufacturing to the program area and a two-phase application process to streamline the application process and limit the expense to applicants.
Speakers from the Agency will discuss the changes to the 9003 Program in order to educate applicants on changes to program eligibility and the new application process. The National Stakeholder Forum can be attended via webinar or in person.
The National Stakeholder Forum will take place in Room 107-A of the Whitten Building on 1400 Jefferson Drive SW., located between 12th and 14th streets SW., in Washington DC 20250.
Todd Hubbell, Rural Business-Cooperative Service, Room 6865, 1400 Independence Avenue SW., Washington, DC 20250, Telephone: (202) 690-2516. Email:
Section 9003 of the 2008 Farm Bill authorized the Agency to provide loan guarantees for the construction of advanced biofuel biorefineries under the Biorefinery Assistance Program (often referred to as the Section 9003 Program). The 2014 Farm Bill modified the provisions associated with the Section 9003 Program. In response to the 2014 Farm Bill, the Agency published a new interim rule for the program, now entitled the Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance Program. This interim final rule was published in the
In order to familiarize the public with the new Section 9003 Program rule, representatives from the U.S. Department of Agriculture (USDA) are conducting this National Stakeholder Forum. Discussion points will include the expansion of the program to include renewable chemicals and biobased product manufacturing and the new two-phase application process. Participants will be afforded the opportunity to ask questions on the material in the presentation through the webinar software or in person.
Space for attendance at the meeting is limited. Due to USDA headquarters security and space requirements, all persons wishing to attend the forum in person must send an email to
To register, provide the following information:
Upon arrival at the USDA Whitten Building, registered persons must
The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, age, disability, and where applicable, sex, marital status, familial status, parental status, religion, sexual orientation, genetic information, political beliefs, reprisal, or because of all or part of an individual's income is derived from any public assistance program. (Not all prohibited bases apply to all programs.)
If you wish to file a Civil Rights program complaint of discrimination, complete the USDA Program Discrimination Complaint Form, found online at
Individuals who are deaf, hard of hearing, or have speech disabilities and you wish to file a program complaint please contact USDA through the Federal Relay Service at (800) 877-8339 or (800) 845-6136 (in Spanish).
Persons with disabilities who wish to file a program complaint, please see information above on how to contact us by mail directly or by email. If you require alternative means of communication for program information (
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Arizona Advisory Committee (Committee) to the Commission will be held on Wednesday, July 29, 2015. The meeting has two purposes: (1) To receive and discuss a recommendation from the education sub-committee regarding Committee findings on equity in school spending, and (2) discuss and plan the Committee's public meeting on police and community relations. The meeting will be held at Chicanos por la Causa, 1242 E. Washington Street, Suite 200, Phoenix, AZ 85034. It is scheduled to begin at 3:00 p.m. and adjourn at approximately 4:30 p.m.
Members of the public are entitled to make comments in the open period at the end of the meeting. Members of the public may also submit written comments. The comments must be received in the Western Regional Office of the Commission by July 30, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angelica Trevino, Civil Rights Analyst, Western Regional Office, at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Wednesday, July 29, 2015 from 3 p.m. to 4:30 p.m. PST
Chicanos por la Causa, 1242 E. Washington Street, Suite 200, Phoenix, AZ 85034
Peter Minarik, DFO, at (213) 894-3437 or
On April 27, 2015, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Greater Baton Rouge Port Commission, grantee of FTZ 154, requesting subzone status subject to the existing activation limit of FTZ 154 on behalf of Syngenta Crop Protection LLC in St. Gabriel and Baton Rouge, Louisiana.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 154B is approved, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 154's 2,000-acre activation limit.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
As a result of this sunset review, the Department of Commerce (Department) finds that revocation of the antidumping duty order on hand trucks and certain parts thereof (hand trucks) from the People's Republic of China (PRC) would be likely to lead to continuation or recurrence of dumping. The magnitude of the dumping margins likely to prevail is indicated in the “Final Results of Sunset Review” section of this notice.
Jacqueline Arrowsmith, AD/CVD Operations, Office VII, Enforcement and Compliance, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-5255.
The antidumping duty order on hand trucks from the PRC was published on December 2, 2004.
In accordance with 19 CFR 351.218(d)(1)(i) and (ii), the Department received a notice of intent to participate in this sunset review from Gleason Industrial Products, Inc. and Precision Products, Inc. (collectively, Petitioners), within 15 days after the date of publication of the
On March 26, 2015, the Department received a complete substantive response to the notice of initiation from Petitioners within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i). The Department received no substantive response from any respondent interested parties. As a result, the Department conducted an expedited,
The merchandise subject to the order consists of hand trucks manufactured from any material, whether assembled or unassembled, complete or incomplete, suitable for any use, and certain parts thereof, namely the vertical frame, the handling area and the projecting edges or toe plate, and any combination thereof. They are typically imported under heading 8716.80.50.10 of the Harmonized Tariff Schedule of the United States (HTSUS), although they may also be imported under heading 8716.80.50.90 and 8716.90.50.60. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive. A full description of the scope of the order is contained in the “Issues and Decision Memorandum for the Final Results of the Expedited Second Sunset Review of the Antidumping Duty Order on Hand Trucks and Certain Parts Thereof from the People's Republic of China,” dated concurrently with and hereby adopted by this notice (Decision Memorandum).
All issues raised in this review are addressed in the Decision Memorandum, including the likelihood of continuation or recurrence of dumping in the event of revocation, and the magnitude of dumping margins likely to prevail if the order was revoked. Parties can find a complete discussion of all issues raised in this review and the corresponding recommendations in the Decision Memorandum, which is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Pursuant to sections 752(c)(1) and (3) of the Act, we determine that revocation of the antidumping duty order on hand trucks from the PRC would be likely to lead to continuation or recurrence of dumping at weighted-average margins up to 383.60 percent.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a). Timely written notification of the destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
The Department is issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act and 19 CFR 351.218.
ITA, DOC.
Notice of Federal Advisory Committee Meeting.
This notice sets forth the schedule and proposed agenda for a meeting of the CINTAC.
The meeting is scheduled for Thursday, July 23, 2015, from 9:00 a.m. to 4:00 p.m. Eastern Standard Time (EST). The public session is from 3:00 p.m.-4:00p.m.
The meeting will be held in Room 4830, U.S. Department of Commerce, Herbert Clark Hoover Building, 1401 Constitution Ave. NW., Washington, DC 20230.
Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, ITA, Room 4053, 1401 Constitution Ave. NW., Washington, DC 20230. (Phone: 202-482-1297; Fax: 202-482-5665; email:
1. Discussion of matters determined to be exempt from the provisions of the Federal Advisory Committee Act relating to public meetings found in 5 U.S.C. App. (10)(a)(1) and 10(a)(3).
1. International Trade Administration's Civil Nuclear Trade Initiative Update.
2. Civil Nuclear Trade Promotion Activities Discussion.
3. Public comment period.
The meeting will be disabled-accessible. Public seating is limited and available on a first-come, first-served basis. Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information below by 5:00 p.m. EDT on Friday, July 17, 2015 in order to pre-register for clearance into the building. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting. Last minute requests will be accepted, but may be impossible to fill.
A limited amount of time will be available for pertinent brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5:00 p.m. EDT on Friday, July 17, 2015. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers. Speakers are requested to bring at least 20 copies of their oral comments for distribution to the participants and public at the meeting.
Any member of the public may submit pertinent written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to the Civil Nuclear Trade Advisory Committee, Office of Energy & Environmental Industries, Room 4053, 1401 Constitution Ave. NW., Washington, DC 20230. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EDT on Friday, July 17, 2015. Comments received after that date will be distributed to the members but may not be considered at the meeting.
Copies of CINTAC meeting minutes will be available within 90 days of the meeting.
Minority Business Development Agency, Department of Commerce.
Notice of public meeting; correction.
The Minority Business Development Agency (MBDA) published a notice in the
For additional information please contact: Ms. Nakita Y. Chambers, Program Manager, Telephone (202) 482-0065, email
In the
The public meeting will be held on Thursday, July 23, 2015; 1:00 p.m.-3:30 p.m. CDT. The meeting will be available via webinar. Please submit your written questions to Nakita Y. Chambers (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for permit amendment.
Notice is hereby given that the NMFS Northeast Fisheries Science Center, 166 Water Street, Woods Hole, MA 02543 (Responsible Party: William Karp, Ph.D.), has applied for an amendment to Scientific Research Permit No. 17670-02.
Written, telefaxed, or email comments must be received on or before August 10, 2015.
The application and related documents are available for review by written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Amy Sloan or Courtney Smith, (301) 427-8401.
The subject amendment to Permit No. 17670-02 is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
Permit No. 17670-00 issued on April 11, 2013 (77 FR 64959), authorized the permit holder to take gray (
The permit holder is requesting the permit be amended to include authorization to (1) increase the number of gray and harbor seals harassed annually during research; (2) add use of unmanned aircraft systems to survey seals; (3) increase the number of gray and harbor seals captured and handled for sampling and instrumentation, and increase the frequency of sampling; (4) increase the number of biopsy samples (from one to two) taken during sampling; (5) add harassment from photo-identification of gray seals to study pup molting; (6) increase the number of gray and harbor seal samples imported/exported annually; (7) increase unintentional mortality including via euthanasia in the event sick or injured seals are inadvertently captured. Take numbers are enumerated in the amendment request take tables.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit.
Notice is hereby given that a permit has been issued to Daniel P. Costa, Ph.D., University of California at Santa Cruz, Long Marine Laboratory, 100 Shaffer Road, Santa Cruz, CA 95064, to conduct research on northern elephant seals (
The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Amy Sloan, (301) 427-8401.
On May 27, 2015, notice was published in the
Permit No. 19108 authorizes continued research on northern elephant seal population status, reproduction, diving and fasting, physiology, and metabolism. Research methods include behavioral observations, marking, capture and sampling, instrumentation, translocation, short-term captive holding, physiology studies, and acoustic studies. Research is permitted from California to Washington, but occurs primarily at Año Nuevo. Incidental harassment and mortalities of northern elephant seals, and incidental harassment of California sea lions (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit.
Notice is hereby given that a permit has been issued to Adam White, BBC Natural History Unit, The Limes, Lea, Malmesbury Wiltshire, SN16 9PG United Kingdom, to conduct commercial or educational photography on four species of cetaceans and five species of pinnipeds.
The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Carrie Hubard or Jennifer Skidmore, (301) 427-8401.
On May 15, 2015, notice was published in the
The permit authorizes filming of marine mammals along the California coast from Point Año Nuevo south to the Channel Islands. Cetaceans may be filmed from boats and pole cameras. Pinnipeds may be filmed from boats, pole cameras, underwater divers, and while hauled out on land. Footage will be used for a
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
On March 28, 2003, the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (Services) announced a final policy on the criteria the Services will use to evaluate conservation efforts by states and other non-Federal entities (68 FR 15100). The Services take these efforts into account when making decisions on whether to list a species as threatened or endangered under the Endangered Species Act. The efforts usually involve the development of a conservation plan or agreement, procedures for monitoring the effectiveness of the plan or agreement, and an annual report.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that a permit has been issued to Minnesota Zoological Gardens (MZG), 13000 Zoo Blvd., Apple Valley, MN 55124, to conduct research on and enhancement of Hawaiian monk seals (
The permit and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Amy Sloan or Jennifer Skidmore, (301) 427-8401.
On March 23, 2015, notice was published in the
The permit authorizes MZG to maintain up to eight nonreleasable Hawaiian monk seals in captivity at the MZG. Permitted research includes: (1) Annual blood samples and nasal swabs to be analyzed for presence of West Nile virus, canine distemper virus, and phocine distemper virus in seals previously vaccinated; and (2) testing various sedatives to inform use in the wild population. Seals may be used in research projects authorized under separate permits. MZG will continue public awareness on the status of the species through education and public observation of the seals. The permit expires May 1, 2020.
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management, National Ocean Service, Commerce.
Notice of intent to evaluate and notice of availability of final findings.
The NOAA Office for Coastal Management (OCM) announces its intent to evaluate the performance of the Guana Tolomato Matanzas (GTM) National Estuarine Research Reserve.
The National Estuarine Research Reserve evaluation will be conducted pursuant to sections 312 and 315 of the Coastal Zone Management Act (CZMA) and regulations at 15 CFR part 921, subpart E and part 923, subpart L. Evaluation of a National Estuarine Research Reserve requires findings concerning the extent to which a state has met the national objectives, adhered to its Reserve final management plan approved by the Secretary of Commerce, and adhered to the terms of financial assistance awards funded under the CZMA.
The evaluation will include a public meeting, consideration of written and oral public comments and consultations with interested Federal, state, and local agencies and members of the public. When the evaluation is completed, OCM will place a notice in the
The GTM National Estuarine Research Reserve public meeting will be held Wednesday, August 26, 2015, at 6:00 p.m. at the GTM NERR Environmental Education Center Auditorium, 505 Guana River Road, Ponte Vedra Beach, Florida.
Copies of the reserve's most recent performance report, as well as OCM's evaluation notification letter to the state, are available upon request from OCM. Written comments from interested parties regarding these programs are encouraged and will be accepted until September 4, 2015. Please direct written comments to Carrie Hall, Evaluator, Planning and Performance Measurement Program, Office for Coastal Management, NOS/NOAA, 1305 East-West Highway, 11th Floor, N/OCM1, Silver Spring, Maryland 20910, or
Carrie Hall, Evaluator, Planning and Performance Measurement Program, Office for Coastal Management, NOS/NOAA, 1305 East-West Highway, 11th Floor, N/OCM1, Silver Spring, Maryland 20910, or
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit amendment.
Notice is hereby given that Sea World LLC, 9205 South Park Center Loop, Suite 400, Orlando, FL 32819 [Brad Andrews, Responsible Party] has been issued a minor amendment to Enhancement Permit No. 14186.
The amendment and related documents are available for review upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Jennifer Skidmore or Amy Sloan, (301) 427-8401.
The requested permit has been issued under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
The original permit (No. 14186), issued on June 17, 2010 (75 FR 36064) authorized Sea World LLC to maintain up to six (6) non-releasable stranded Guadalupe fur seals (
United States Patent and Trademark Office, Commerce.
Notice.
The United States Patent and Trademark Office (USPTO) is initiating a joint Work Sharing Pilot Program with the Japan Patent Office (JPO) to study whether the exchange of search results between offices for corresponding counterpart applications improves patent quality and facilitates the examination of patent applications in both offices. In the pilot program, each office will conduct a prior art search for its corresponding counterpart application and exchange the search results with the other office before
Effective date: August 1, 2015.
Daniel Hunter, Director of International Work Sharing, Planning, and Implementation, Office of International Patent Cooperation, by telephone at 571-272-8050 regarding the handling of any specific application participating in the pilot. Any questions concerning this notice may be directed to Joseph Weiss, Senior Legal Advisor, Office of Patent Legal Administration, by phone 571-272-7759. Any inquiries regarding this pilot program can be emailed to
The USPTO is continually looking for ways to improve the quality of issued patents and to promote work sharing between other Intellectual Property (IP) Offices throughout the world. The USPTO has launched several work sharing pilot programs in recent years (
Currently, an application filed in the USPTO with a claim of foreign priority may have a search report and art cited by the foreign office in the priority application provided to the applicant during the U.S. application's pendency. After review of the search report and cited art, the applicant may submit an Information Disclosure Statement (IDS) in the U.S. application to provide the information to the USPTO. Often, this submission occurs after examination on the merits is already underway in the U.S. application. Upon evaluation of the search report and cited art, the U.S. examiner may determine that the art cited by the foreign office is relevant to patentability and merits further examination before making a final determination on patentability. The delay caused by further examination results in additional costs to an applicant and the USPTO that could have been avoided if the U.S. examiner was in possession of the foreign office's search results before commencing examination of the application. Furthermore, in light of the various expedited examination programs currently in place, the potential exists that a U.S. application may reach final disposition before an applicant is in receipt of a foreign office's search report. Work sharing between intellectual Property (IP) offices in the form of an exchange of search results may increase efficiency and promote patent examination quality by providing the examiner with both offices' search results when examination commences. In order to study the benefits of the exchange of search results between offices, current USPTO examination practice would need to be modified to conduct a search and generate a search report, without issuance of an Office action. The U.S. application also would need to be “made special” pursuant to USPTO procedures to ensure that it could be contemporaneously searched with its corresponding counterpart application.
The USPTO is using the First Action Interview Pilot Program (FAI) in this search results work sharing pilot program, because its procedure bifurcates the determination and evaluation of a prior art search from the notice of rejection.
The USPTO also is initiating a joint Work Sharing Pilot Program with the Korean Intellectual Property Office (KIPO). The JPO and KIPO pilot programs are different in the way that they operate. Thus, while there may be applications that are eligible for both pilot programs, such applications will not be permitted to participate in both pilot programs due to the differences in work sharing procedures of these two different programs. More information about the US-JP CSP program can be found on the USPTO's Internet Web site at:
An application must meet all of the requirements set forth in section III of this notice, to be accepted into this pilot program. An applicant must file via EFS-Web a Petition to Make Special using form PTO/SB/437JP in a published U.S. application. Use of the form will assist an applicant in complying with the pilot program's requirements. Form PTO/SB/437JP is available at:
No fee is required for submission of petitions using Form PTO/SB/437JP. The fee (currently $140.00) for a petition under 37 CFR 1.102 (other than those enumerated in 37 CFR 1.102(c)) is hereby
The offices will search the corresponding counterpart applications participating in the pilot program sequentially. The office of first search will be set based upon which participating counterpart application, the JPO or the U.S. application, has the earlier filing date. In the event that corresponding counterpart applications were filed on the same day, then the office of first search will be determined as agreed to by the offices. Each office may reevaluate the workload and resources needed to administer the pilot program at any time. The USPTO will provide notice of any substantive changes to the program (including early termination of the program) at least thirty (30) days prior to implementation of any changes.
New patent applications are normally taken up for examination in the order of their U.S. filing date. Applications accepted into this pilot program will receive expedited processing by being granted special status and taken out of turn until issuance of a Pre-Interview Communication, or first-action Notice of Allowability but will not maintain special status thereafter. While JPO and USPTO will be sharing search results, the possibility exists that there may be differences in the listing of references made of record by the USPTO versus those made of record in the corresponding JPO counterpart application. Participants in the US-JP CSP program should review the references cited in each office's communication. If any JPO communication to an applicant cites references that are not already of record in the USPTO application and the applicant wants the examiner to consider the references, the applicant should promptly file an Information Disclosure Statement (IDS) that includes a copy of the JPO communication along with copies of the newly cited references in accordance with 37 CFR 1.98 and MPEP § 609.04(a)-(b). See also MPEP §§ 609 and 2001.06(a).
The following requirements must be satisfied for a petition under the US-JP CSP program to be granted:
(1) The application must be a published, non-reissue, non-provisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage in compliance with 35 U.S.C. 371(c) with an effective filing date no earlier than March 16, 2013. The U.S. application and the corresponding JPO counterpart application must have a common earliest priority date that is no earlier than March 16, 2013.
(2) A completed petition form PTO/SB/437JP must be filed in the application via EFS-Web after the U.S. application has published. Form PTO/SB/437JP is available at:
(3) The petition submission must include an express written consent under 35 U.S.C. 122(c) for the USPTO to receive prior art references and comments from the JPO that will be considered during the examination of the U.S. application participating in the US-JP CSP Program. Form PTO/SB/437JP includes language compliant with the consent requirements for this pilot program.
(4) The petition must be filed at least one day before a first Office action on the merits of the application appears in the Patent Application Information Retrieval (PAIR) system (
(5) The petition for participation filed in the corresponding JPO counterpart application for the US-JPO CSP program must be granted or have been granted by JPO. The USPTO and JPO petitions should be filed within fifteen days of each other. Both the JPO and the USPTO petitions must be granted before either application can be treated under the US-JP CSP program. As the requirements of each office's pilot programs may differ, applicants should review the requirements for both pilot programs when considering participation, ensuring that the respective corresponding counterpart applications can comply with each office's requirements.
(6) The petition submission must include a claims correspondence table that notes which independent claims between the pending U.S. and JPO applications have a substantially corresponding scope to each other. Claims are considered to have “substantially corresponding scope” where, after accounting for differences due to claim format requirements, the scope of the corresponding independent claims in the corresponding counterpart applications would either anticipate or render obvious the subject matter recited under U.S. law. Additionally, claims in the corresponding U.S. counterpart application that introduce a new/different category of claims than those presented in the corresponding JPO counterpart application(s) are not considered to substantially correspond. For example, where a corresponding JPO counterpart application contains only claims relating to a process of manufacturing a product, then any product claims in the corresponding U.S. counterpart application are not considered to substantially correspond, even if the product claims are dependent on process claims, which substantially correspond to claims in each corresponding counterpart application. Applicants may file a preliminary amendment in compliance with 37 CFR 1.121 to amend the claims of the corresponding U.S. counterpart application to satisfy this requirement when attempting to make the U.S. application eligible for the program.
(7) The application must contain three or fewer independent claims and twenty or fewer total claims. The application must not contain any multiple dependent claims. For an application that contains more than three independent claims or twenty total claims, or any multiple dependent claims, applicants must file a preliminary amendment in compliance with 37 CFR 1.121 to cancel the excess claims and/or the multiple dependent claims to make the application eligible for the program.
(8) The claims must be directed to a single invention. If the Office determines that the claims are directed to multiple inventions (
(9) All submissions for the participating application while being treated under the US-JP CSP program's examination procedure must be filed via EFS-Web.
(10) The petition must include a statement that the applicant agrees not to file a request for a refund of the search fee and any excess claim fees paid in the application after the mailing or notification date of the Pre-Interview Communication. See Form PTO/SB/413C. Any petition for express abandonment under 37 CFR 1.138(d) to obtain a refund of the search fee, and excess claims fee filed after the mailing or notification date of a Pre-Interview Communication will not be granted.
An applicant must file a Petition to Make Special using Form PTO/SB/437JP in an eligible U.S. application for entry into the US-JP CSP program after the application has published. An applicant may request early publication in accordance with 37 CFR 1.219 to expedite the filing of the petition. An applicant also must file the appropriate petition paper in the corresponding JPO counterpart application for participation in the US-JP CSP program. Once both petitions are granted, the corresponding U.S. counterpart application will receive expedited processing by being placed on the examiner's special docket for examination in accordance with sections V-IX of this notice.
A.
B.
C.
If the examiner determines that not all the claims presented are directed to a single invention, the telephone restriction practice set forth in MPEP § 812.01 will be followed. An applicant must make an election without traverse during the telephonic interview in accordance with the procedures outlined in sections V.A. or V.B. of this notice. When a telephonic election is made, the examiner will provide a complete record of the telephone interview, including the restriction or lack of unity requirement and the applicant's election, as an attachment to the Pre-Interview Communication. Applicants are strongly encouraged to ensure that applications submitted for the pilot are written such that they claim a single, independent, and distinct invention. An applicant is responsible to ensure the same invention is elected in both the U.S. and JPO corresponding counterpart applications for concurrent treatment in the US-JP CSP program.
A.
B.
The offices will search the corresponding counterpart applications participating in the pilot program sequentially. The office of first search will be set based upon which participating counterpart application (JPO or U.S.) has the earlier filing date. In the event that both corresponding counterpart applications were filed on the same day, then the office of first search will be determined as agreed to by the offices.
A.
B.
C.
Once all search results are received by the examiner and considered, then either a Notice of Allowability or a Pre-Interview Communication may issue.
A.
B.
The Pre-Interview Communication issued to an applicant will set forth a time period of one month or thirty days, whichever is longer, for the applicant to request or decline an interview. An applicant is responsible for responding to the Pre-Interview Communication in accordance with the First Action Interview Program procedures discussed in Section VIII of this notice. The USPTO will permit an applicant to extend this time period for reply pursuant to 37 CFR 1.136(a) for one additional month in accordance with the First Action Interview Program, as set forth in section VIII, subsection B (Applicant's Options and Reply to Pre-Interview Communication) and subsection C (Failure to Respond to Pre-Interview Communication) of this notice. The examiner's typical working schedule also will be provided with the Pre-Interview Communication to indicate the examiner's availability for scheduling the interview.
A.
B.
(1) File a “Request to Not Have a First Action Interview”;
(2) File a reply under 37 CFR 1.111 waiving the first action interview and First Action Interview Office Action—an applicant is accepting that the Pre-Interview Communication is the first Office action on the merits; or
(3) Schedule the first action interview—an applicant must file an Applicant Initiated Interview Request Form (PTOL-413A) electronically via EFS-Web, accompanied by a proposed amendment or arguments, and schedule the interview to be conducted within two months or sixty days, whichever is longer, from the filing of the Applicant Initiated Interview Request.
1.
Once the petition for entry into the pilot has been granted (one day before it appears in PAIR), withdrawal from the program is not permitted. Therefore, the USPTO will treat a request for withdrawal from the pilot program filed after the mailing or notification of granting an applicant's petition to participate in the pilot as a request to not conduct an interview, issue a Pre-Interview Communication, and subsequently enter a First Action Interview-Office Action, in due course.
2.
In this situation, a first action interview will not be conducted, and a First Action Interview Office Action will not be provided to the applicant. The Pre-Interview Communication will be deemed the first Office action on the merits. The examiner will consider the reply under 37 CFR 1.111 and provide an Office action in response to the reply, in due course. The Office action will be the second Office action on the merits, and thus it could be a final Office action, a notice of allowability, or other appropriate action.
3.
An applicant must designate a proposed date to conduct the interview to facilitate scheduling of the first action interview. The applicant's proposed date to conduct the interview must be within two months or sixty days, whichever is longer, from the filing of the Applicant Initiated Interview Request Form. An applicant should consult the examiner's work schedule provided in the Pre-Interview Communication and discuss with the examiner the best date for conducting the interview.
After filing the Applicant Initiated Interview Request Form, an applicant must contact the examiner to confirm the interview date. The applicant's
The proposed amendment or arguments must be clearly labeled as “
Multiple proposed amendments or sets of arguments are
C.
The interview will be conducted in accordance with the procedure provided in MPEP § 713 except as otherwise provided in this notice. The interview should focus on and include:
1. A discussion to assist the examiner in developing a better understanding of the invention;
2. A discussion to establish the state of the art as of the effective filing date of the claimed invention, including the prior art references cited by both applicant and examiner (as only applications subject to the First Inventor to File provisions of the Leahy-Smith America invents act (AIA) are eligible for this pilot program); and
3. A discussion of the features of the claimed subject matter which make the invention patentable, including any proposed amendments to the claims.
1.
2.
For this situation, the First Action Interview Office Action is deemed the first Office action on the merits. Because the requirements, objections, and grounds of rejection are provided in the Pre-Interview Communication and the First Action Interview Office Action, an applicant has sufficient notice of the requirements, objections, and grounds of rejection. To avoid abandonment of the application, the applicant must, within two months or sixty days, whichever is longer, from the mailing or notification date of the First Action Interview Office Action, file a reply in compliance with 37 CFR 1.111(b)-(c). This time period for reply is extendable under 37 CFR 1.136(a) for only two additional months. The First Action Interview Office Action, interview summary, and a completed Notice of References Cited form PTO-892 listing any newly cited references also will be forwarded to JPO for consideration by the JPO examiner of record for the corresponding JPO counterpart application.
3.
In this situation, a First Action Interview Office Action will not be provided to the applicant. The Pre-Interview Communication and the interview will be deemed the first Office action on the merits. The examiner will enter the proposed amendment and/or arguments, consider it as the reply under 37 CFR 1.111, and provide an Office action in response to the reply. The Office action will be the second Office action on the merits, and thus it could be a final Office action, a notice of allowability, or other appropriate action.
A complete written statement as to the substance of the interview with regard to the merits of the application must be made of record in the application, whether or not an agreement with the examiner was reached at the interview. It is applicant's responsibility to make of record the substance of an interview, and it is the examiner's responsibility to see that such a record is made and to correct inaccuracies, including those which bear directly on the question of patentability. See MPEP § 713.04.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 6/5/2015 (80 FR 32096-32097), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products to the Government.
2. The action will result in authorizing small entities to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
Committee for Purchase from People Who are Blind or Severely Disabled.
Proposed additions to and deletion from the Procurement List.
The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a service previously provided by such agency.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
For further information or to submit comments contact Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the services listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following services are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following service is proposed for deletion from the Procurement List:
Department of Defense/Department of the Army/U.S. Army Training and Doctrine Command (TRADOC), DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by September 8, 2015.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Headquarters, U.S. Army Training and Doctrine Command, Learning Integration, Institute for NCO Professional Development (ATCG-NCI), ATTN: Jeffery J. Colimon, 950 Jefferson Avenue, Fort Eustis, Virginia 23604-5702.
Respondents are DA Civilian employees and Soldiers. Departing Soldiers or DA Civilian employees complete the DA Form 5434 during initial reassignment interview or are interviewed by a DA Civilian employee following selection notification and acceptance of a position. The automation of the collection action into the Army Career Tracker (ACT) will help commanders with their basic responsibility to assist Soldiers, civilian employees, and families successfully relocate in and out of their commands. The form will be hosted into the ACT system to facilitate the execution of the Total Army Sponsorship Program (TASP).
Office of the Under Secretary of Defense for Personnel & Readiness, DoD.
Notice.
In compliance with the
Consideration will be given to all comments received by September 8, 2015.
You may submit comments, identified by docket number and title, by any of the following methods:
•
•
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of Family Readiness Policy, ATTN: Program Manager, Spouse Education & Career Opportunities Program, 4800 Mark Center Drive, Suite 03G15, Alexandria, VA 22350-2300.
Military Spouses = 16,500.
MSEP Partners = 125.
Companies = 38.
TOTAL = 900,163.
Military Spouses = 22,000 military spouses.
MSEP Partners = 300 partners.
Companies = 150 companies.
TOTAL = 1,200,450 respondents.
Military Spouses = 45 minutes.
MSEP Partners = 25 minutes.
Companies = 15 minutes.
TOTAL = 85 minutes.
Military Spouses = On occasion.
MSEP Partners = On occasion.
Companies = Once.
The Military Spouse Employment Partnership (MSEP) Career Portal is the sole web platform utilized to connect military spouses with companies seeking to hire military spouse employees. Participating companies, called MSEP Partners, are vetted and approved participants in the MSEP Program and have pledged to recruit, hire, promote and retain military spouses in portable careers. MSEP is a targeted recruitment and employment partnership that connects American businesses with military spouses who possess essential 21st-century workforce skills and attributes and are seeking portable, fulfilling careers. The MSEP program is part of the overall Spouse Education and Career Opportunities (SECO) program which falls under the auspices of the office of the Deputy Assistant Secretary of Defense for Military Community & Family Policy.
This program was developed in compliance with 10 U.S. Code 1784 Employment Opportunities for Military Spouses which states:
(f) Private-Sector Employment.—The Secretary of Defense—
(1) Shall seek to develop partnerships with firms in the private sector to enhance employment opportunities for spouses of members of the armed forces and to provide for improved job portability for such spouses, especially in the case of the spouse of a member of the armed forces accompanying the member to a new geographical area because of a change of permanent duty station of the member; and
(2) shall work with the United States Chamber of Commerce and other appropriate private-sector entities to facilitate the formation of such partnerships.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of Availability.
The U.S. Army Corps of Engineers (COE), Wilmington District, Wilmington Regulatory Field Office has received a request for Department of the Army authorization, pursuant to Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbors Act, from Figure Eight Beach Homeowners' Association Inc. (HOA) to install a terminal groin structure along Rich Inlet and to conduct a supplemental beach nourishment on approximately 4,500 linear feet of oceanfront beach and 1,400 linear feet of back barrier shoreline to protect residential homes and infrastructures along the central and northern sections of Figure Eight Island. The terminal groin structure will be placed perpendicular on the northern tip of the island along the shoulder of Rich Inlet; and the proposed source of the material for the nourishment will be dredged from an area within Nixon Channel, a back barrier channel, that has been previously used for past beach nourishment projects. In case the quantity of material from Nixon Channel is not sufficient, material pumped from (3) nearby upland disposal islands will be used to supplement the nourishment needs. The majority of the material will be disposed within the fillet area, or down shore, of the groin. Pending storm events and shoreline changes, maintenance, or periodic nourishment, of the beach is proposed a maximum of once every five years, or potential 6 separate events over the 30-year study period. Nixon Channel and the upland disposal islands are the proposed material sources for the periodic maintenance, or renourishment, events.
Written comments on the Supplemental EIS must be received at (see
Copies of comments and questions regarding the Supplemental EIS may be addressed to: U.S. Army Corps of Engineers, Wilmington District, Regulatory Division. ATTN: File Number 2006-41158, 69 Darlington Avenue, Wilmington, NC 28403. Copies of the Supplemental EIS can be reviewed on the Corps homepage at,
Questions about the proposed action and SEIS and/or to receive CD or written copies of the Supplemental EIS can be directed to Mr. Mickey Sugg,
1.
2.
Construction of the terminal groin will be kept within a corridor varying in width from 50 feet to 200 feet. Within this corridor, a 40-70 foot wide trench will be excavated to a depth of −2.5 feet NAVD in order to construct the foundation of the landward section. The approximate 6,000 cubic yards of excavated material will be replaced on and around the structure once it's in place. Material used to build the groin will be barged down the Atlantic Intracoastal Waterway (AIWW), through Nixon Channel, and either offloaded onto a temporary loading dock or directly onto shore. It will then be transported, via dump trucks, within the designated corridor to the construction site.
Material used for nourishment will be dredged, using a hydraulic cutterhead plant, from a designated borrow site within Nixon Channel, which has been previously used for beach fill needs. Approximately 294,500 cubic yards will be required for both the oceanfront (237,500 cubic yards) and the Nixon Channel shoreline (57,000 cubic yards) fill areas under the 2006 and 2012 shoreline study conditions. Beach compatible material from (3) upland disposal islands would serve as a contingency sediment source.
Engineer modeling results have shown that periodic nourishment will be required approximately once every five years to maintain the beach and Nixon Channel shorelines. The combined 5-year estimated maintenance needs for both areas are 320,000 cubic yards of material under the 2006 condition and 255,000 cubic yards of material under 2012 condition, equivalent to approximately 58,000 and 45,000 cubic yards per year respectively. This material will come from the designated Nixon Channel borrow site and the (3) upland disposal areas.
3.
4.
The COE is consulting with the U.S. Fish and Wildlife Service under the Endangered Species Act and the Fish and Wildlife Coordination Act, and with the National Marine Fisheries Service under the Magnuson-Stevens Act and Endangered Species Act. Additionally, the SEIS assesses the potential water quality impacts pursuant to Section 401 of the Clean Water Act, and is coordinated with the North Carolina Division of Coastal Management (DCM) to insure the projects consistency with the Coastal Zone Management Act. The COE is coordinating closely with DCM in the development of the SEIS to ensure the process complies with State Environmental Policy Act (SEPA) requirements, as well as the NEPA requirements. The Supplemental EIS has been designed to consolidate both NEPA and SEPA processes to eliminate duplications.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of availability.
The U.S. Army Corps of Engineers (USACE), Fort Worth District, as lead federal agency, is preparing this Regional Environmental Impact Statement (REIS) to analyze potential impacts within defined geographic regions in Texas that may be affected by future USACE, Fort Worth District, permit decisions for future surface coal and lignite mine expansions or satellite mines within the District's area of responsibility. The REIS is being prepared in compliance with the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality (CEQ) Regulations for Implementing the Procedural Provisions of NEPA (40 Code of Federal Regulations [CFR] 1500-1508), and the USACE Procedures for Implementing NEPA (33 CFR 230).
Submit comments no later than 60 days from the date of publication of this notice in the
Send written comments and suggestions concerning this proposal to Mr. Darvin Messer, Regulatory Project Manager, Regulatory Branch, CESWF-DE-R, U.S. Army Corps of Engineers, Fort Worth District, P.O. Box 17300, Fort Worth, TX 76102-0300 or via email:
Requests to be placed on the mailing list should also be sent to this address. Please reference USACE Project No. SWF-2010-00244 in all communications.
Mr. Darvin Messer, Regulatory Project Manager at (817) 886-1744 or via email:
The USACE, Fort Worth District, is proposing changes to its regulatory framework for surface coal and lignite mines in Texas. The proposed regulatory framework includes the establishment of a Regional General Permit (RGP) and a revised Letter of Permission (LOP) procedure with modifications to aquatic resource impact thresholds and a change from agency concurrence to agency coordination as compared to the current process. No changes to the criteria for Nationwide Permit (NWP) 21 or NWP 49 are proposed.
The REIS considers the potential environmental impacts of future mine expansions or satellite mines in six study areas along the coal-bearing formations in Texas that run from southwest Texas to northeast Texas. The study areas encompass locations within the coal/lignite belt in Texas that were determined to be within reasonable proximity to existing surface coal and lignite mines with potential for future expansion.
As part of the public involvement process, notice is hereby given by the USACE Fort Worth District of informal public information meetings (open house format) and formal Public Hearings regarding this Draft REIS will be held August 10-13, 2015, at the following locations:
August 10, 2015; International Center for Trade; 3295 Bob Rogers Drive, Eagle Pass, TX 78852.
August 11, 2015; Pleasanton Country Club; 1801 McGuffin Drive, Pleasanton, TX 78064.
August 12, 2015; Bell County Expo Center; 301 West Loop 121, Belton, TX 76513.
August 13, 2015; Holiday Inn South Broadway; 5701 South Broadway, Tyler, TX 75703.
Open House meetings will be held from 4:30 p.m. to 6:30 p.m. with the Formal Public Hearings beginning at 6:30 p.m. at each location. Written comments should be sent to Mr. Darvin Messer (see ADDRESSES). The comments are due no later than 60 days from the date of publication of this notice. Copies of the Draft REIS may be obtained by contacting USACE Fort Worth District Regulatory Branch at (817) 886-1731 or downloaded/printed from the Fort Worth District USACE internet Web site at:
Copies of the Draft REIS are also available for inspection at the locations identified below:
After the public comment period ends, the USACE will consider all comments received by the due date, revise the Draft REIS as appropriate, and issue a Final Regional Environmental Impact Statement.
OPEPD, Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before August 10, 2015.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
For specific questions related to collection activities, please contact Erica Lee, (202) 260-1463.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that on June 30, 2015, pursuant to sections 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824(e) and 825(e), the Joint Consumer Representatives (Complainant) filed a formal complaint against PJM Interconnection, L.L.C, (Respondent) alleging that PJM Interconnection, L.L.C. has violated Federal Power Act Section 206 by failing to update its 2015 PJM Region Peak Load Forecast values, for purposes of the upcoming Capacity Performance Transition Incremental Auctions and 2015 Base Residual Auction, to reflect the impact of recent enhancements to PJM's load forecasting model that results in an enhanced load forecast.
The Complainant certify that copies of the complaint were served on the contacts for PJM Interconnection, L.L.C. as listed on the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of 2015 ESA Project Company, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is July 21, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified date(s). Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the PJM Interconnection, L.L.C. (PJM):
The above-referenced meetings will be held at: PJM Conference and Training Center, PJM Interconnection, 2750 Monroe Boulevard, Audubon, PA 19403.
The above-referenced meetings are open to stakeholders.
Further information may be found at
The discussions at the meetings described above may address matters at issue in the following proceedings:
For more information, contact the following:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following qualifying facility filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric reliability filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on June 29, 2015, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2014), Rice Energy Marketing LLC filed a petition for a declaratory order seeking
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Environmental Protection Agency.
Notice.
The Small Communities Advisory Subcommittee (SCAS) will meet in Washington, DC, on Friday, July 31, 2015, 8:00 a.m.-9:00 a.m. (EDT). The Subcommittee will discuss rural strategy; E-Enterprise; and other issues and recommendations to the Administrator regarding environmental issues affecting small communities. The Local Government Advisory Committee (LGAC) will meet in Washington, DC, on Thursday, July 30, 2015, 8:15 a.m.-5:30 p.m. (EDT), and Friday, July 31, 2015, 9:15 a.m.-12:40 p.m. (EDT). The focus of the Committee meeting will be on issues pertaining to protecting America's waters; hydrofracturing; cleaning up our communities; air, climate and energy; and climate change resiliency and sustainability.
These are open meetings, and all interested persons are invited to participate. The SCAS will hear comments from the public between 8:35 a.m. and 8:45 a.m. on Friday, July 31, 2015, and the LGAC will hear comments from the public between 9:30 a.m. and 9:45 a.m. on Friday, July 31, 2015. Individuals or organizations wishing to address the Subcommittee or the Committee will be allowed a maximum of five minutes to present their point of view. Also, written comments should be submitted electronically to
The Small Communities Advisory Subcommittee meetings will be held at the U.S. Environmental Protection Agency, Conference Room William Jefferson Clinton Building North, Room 6045, 1200 Pennsylvania Ave. NW., Washington, DC 20460. The Local Government Advisory Committee meetings will be held at the U.S. Environmental Protection Agency, William Jefferson Clinton Building North, Room 6045, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Meeting summaries will be available after the meeting online at
Local Government Advisory Committee (LGAC) and Small Communities Advisory Subcommittee (SCAS), contact Frances Eargle, Designated Federal Officer, at (202) 564-3115 or email at
Environmental Protection Agency (EPA).
Notice of final action.
Pursuant to Clean Air Act (CAA) Section 505(b)(2) and 40 CFR 70.8(d), the Environmental Protection Agency (EPA) Administrator signed an Order, dated May 29, 2015, partially granting and partially denying two petitions filed by Bill Green of Richland, Washington (dated April 23, 2013, and April 21, 2014) asking the EPA to object to the title V operating permit (Permit No. 00-05-006, Renewal 2 and Permit No. 00-05-006, Renewal 2, Revision A) issued by the Washington State Department of Ecology (Ecology) to the U.S. Department of Energy-Hanford Operations (DOE) relating to the Hanford site located in south central Washington. Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may ask for judicial review by the United States Court of Appeals for the appropriate circuit of those portions of the Order that denies objections raised in the petitions.
Petitions for review of this Order must be filed by September 8, 2015, pursuant to section 307(b) of the CAA.
You may review copies of the final Order, the petitions, and other supporting information during normal business hours at EPA Region 10, 1200 Sixth Avenue, Seattle, Washington. If you wish to examine these documents, you should make an appointment at least 24 hours before the visiting day. Additionally, the final Order is available electronically at:
Don Dossett at telephone number: (206) 553-1783, email address:
The CAA affords the EPA a 45-day period to review, and object to, as appropriate, a title V operating permit proposed by a state permitting authority. Section 505(b)(2) of the CAA authorizes any person to petition the EPA Administrator, within 60 days after the expiration of this review period, to object to a title V operating permit if the EPA has not done so. Petitions must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the state, unless the petitioner demonstrates that it was impracticable to raise these issues during the comment period or that the grounds for the objection or other issues arose after this period.
The claims are described in detail in Section IV of the Order. In summary, the issues raised are that: (1) The structure of the Hanford Title V Permit does not provide Ecology the authority to issue a permit that assures compliance with all applicable requirements, in particular, 40 CFR part 61, subpart H (Subpart H) relating to radionuclide air emissions (radionuclides); (2) the structure of the Hanford Title V Permit does not provide Ecology with authority to enforce the portions of the Hanford Title V Permit relating to Subpart H; (3) Ecology did not comply with the requirements for public participation in issuing the Hanford Title V Permit; (4) the permit issuance procedures for the Hanford Title V Permit prevent access to judicial review; (5) the statement of basis for the Hanford Title V Permit related to radionuclides is inadequate; and (6) the Hanford Title V Permit does not include all applicable CAA Section 112 requirements for radionuclides.
The EPA's rationale for partially granting and partially denying the claims raised in the petitions is described in the Order.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before August 10, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991.
To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
This information collection addresses requirements to carry out the rural broadband experiments the Commission adopted in the
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before September 8, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In 1997, the Commission determined that SDARS licensees must comply with the Commission's EEO requirements. See Establishment of Rules and Policies for the Digital Audio Radio Satellite Service in the 2310-2360 MHz Frequency Band, 12 FCC Rcd 5754, 5791, ¶ 91 (1997) (“1997 SDARS Order”), FCC 97-70. In 2008, the Commission clarified that SDARS licensees must comply with the Commission's EEO broadcast rules and policies, including the same recruitment, outreach, public file, Web site posting, record-keeping, reporting, and self-assessment obligations required of broadcast licensees, consistent with 47 CFR 73.2080, as well as any other Commission EEO policies. See Applications for Consent to the Transfer of Control of Licenses, SM Satellite Radio Holdings Inc., Transferor, to Sirius Satellite Radio Inc., Transferee, 23 FCC Rcd 12348, 12426, ¶ 174, and note 551 (2008) (“XM-Sirius Merger Order”).
The Commission is making this submission to the Office of Management and Budget for approval to add SDARS licensees to this information collection.
The recordkeeping requirements for FCC Form 396 are covered under OMB control number 3060-0214.
In 1997, the Commission determined that SDARS licensees must comply with the Commission's EEO requirements. See Establishment of Rules and Policies for the Digital Audio Radio Satellite Service in the 2310-2360 MHz Frequency Band, 12 FCC Rcd 5754, 5791, ¶ 91 (1997) (“1997 SDARS Order”), FCC 97-70. In 2008, the Commission clarified that SDARS licensees must comply with the Commission's EEO broadcast rules and policies, including the same recruitment, outreach, public file, Web site posting, record-keeping, reporting, and self-assessment obligations required of broadcast licensees, consistent with 47 CFR 73.2080, as well as any other Commission EEO policies. See Applications for Consent to the Transfer of Control of Licenses, SM Satellite Radio Holdings Inc., Transferor, to Sirius Satellite Radio Inc., Transferee, 23 FCC Rcd 12348, 12426, ¶ 174, and note 551 (2008) (“XM-Sirius Merger Order”).
The Commission is making this submission to the Office of Management and Budget for approval to add SDARS licensees to this information collection.
Revised Information Collection Requirements Which Require Approval and Review by the Office of Management and Budget (OMB):
Satellite Radio (also referred to as “Satellite Digital Audio Radio Services” or “SDARS”) licensees are required to comply with the Commission's EEO broadcast rules and policies. They must engage in the same recruitment, outreach, public file, Web site posting, record-keeping, reporting, and self-assessment obligations required of broadcast licensees, consistent with 47 CFR 73.2080, and are subject to the same EEO policies. See Applications for Consent to the Transfer of Control of Licenses, XM Satellite Radio Holdings Inc., Transferor, to Sirius Satellite Radio Inc., Transferee, 23 FCC Rcd 12348, 12426, ¶ 174, and note 551 (2008) (“XM-Sirius Merger Order”). See also Establishment of Rules and Policies for the Digital Audio Radio Satellite Service in the 2310-2360 MHz Frequency Band, 12 FCC Rcd 5754, 5791-92, ¶¶ 91-92 (1997) (“SDARS Order”), FCC 97-70. This collection is being revised to reflect the burden associated with filing FCC Form 397 by SDARS licensees. Therefore, these respondents are being
47 CFR 25.701(c)(1)(i)(C) states DBS providers may establish and define their own reasonable classes of immediately preemptible time so long as the differences between such classes are based on one or more demonstrable benefits associated with each class and are not based solely upon price or identity of the advertiser. Such demonstrable benefits include, but are not limited to, varying levels of preemption protection, scheduling flexibility, or associated privileges, such as guaranteed time sensitive make goods. DBS providers may not use class distinctions to defeat the purpose of the lowest unit charge requirement. All classes must be fully disclosed and made available to candidates.
47 CFR 25.701(c)(1)(i)(D) states DBS providers may establish reasonable classes of preemptible with notice time so long as they clearly define all such classes, fully disclose them and make them available to candidates.
47 CFR 25.701(c)(1)(i)(E) states DBS providers may treat non preemptible and fixed position as distinct classes of time provided that they articulate clearly the differences between such classes, fully disclose them, and make them available to candidates.
47 CFR 25.701(c)(1)(i)(I) states DBS providers shall review their advertising records periodically throughout the election period to determine whether compliance with this section requires that candidates receive rebates or credits. Where necessary, DBS providers shall issue such rebates or credits promptly.
47 CFR 25.701(c)(1)(i)(M) states DBS providers must disclose and make available to candidates any make good policies provided to commercial advertisers. If a DBS provider places a make good for any commercial advertiser or other candidate in a more valuable program or daypart, the value of such make good must be included in the calculation of the lowest unit charge for that program or daypart.
47 CFR 25.701(c)(1)(ii) states at any time other than the respective periods set forth in paragraph (c)(1)(i) of this section, DBS providers may charge legally qualified candidates for public office no more than the charges made for comparable use of the facility by commercial advertisers. The rates, if any, charged all such candidates for the same office shall be uniform and shall not be rebated by any means, direct or indirect. A candidate shall be charged no more than the rate the DBS provider would charge for comparable commercial advertising. All discount privileges otherwise offered by a DBS provider to commercial advertisers must be disclosed and made available upon equal terms to all candidates for public office.
47 CFR 25.701(d) states each DBS provider shall keep and permit public inspection of a complete and orderly political file and shall prominently disclose the physical location of the file, and the telephonic and electronic means to access the file.
(1) The political file shall contain, at a minimum:
(i) A record of all requests for DBS origination time, the disposition of those requests, and the charges made, if any, if the request is granted. The “disposition” includes the schedule of time purchased, when spots actually aired, the rates charged, and the classes of time purchased; and
(ii) A record of the free time provided if free time is provided for use by or on behalf of candidates.
(2) DBS providers shall place all records required by this section in a file available to the public as soon as possible and shall be retained for a period of four years until December 31, 2006, and thereafter for a period of two years.
47 CFR 25.701(e)(3) requires DBS providers airing children's programming must maintain records sufficient to verify compliance with this rule and make such records available to the public. Such records must be maintained for a period sufficient to cover the limitations period specified in 47 U.S.C. 503(b)(6)(B).
47 CFR 25.701(f)(6) states that each DBS provider shall keep and permit public inspection of a complete and orderly record of:
(A) Quarterly measurements of channel capacity and yearly average calculations on which it bases its four percent reservation, as well as its response to any capacity changes;
(B) A record of entities to whom noncommercial capacity is being provided, the amount of capacity being provided to each entity, the conditions under which it is being provided and the rates, if any, being paid by the entity;
(C) A record of entities that have requested capacity, disposition of those requests and reasons for the disposition.
(ii) All records required by this paragraph shall be placed in a file available to the public as soon as possible and shall be retained for a period of two years.
The statutory authority which covers this information collection is contained in 47 U.S.C. 335 of the Communications Act of 1934, as amended.
The Commission is reinstating this collection into the Office of Management and Budget's (OMB's) inventory because after further evaluation the Commission has determined that this collection is still
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of existing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the FDIC is soliciting comment on the renewal of the information collections described below.
Comments must be submitted on or before September 8, 2015.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
•
•
•
•
All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Gary A. Kuiper or John W. Popeo, at the FDIC address above.
Proposal to renew the following currently-approved collections of information:
1.
2.
3.
4.
Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the collections of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.
Board of Governors of the Federal Reserve System.
On June 29, 2015, the Board published a notice of final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority. The Board did not include in the June 2015 notice information related to the public comment period. Accordingly, this notice supplements the June 2015 notice providing information related to the public comment period for transparency.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
The following information was not included in the June 2015 notice.
On April 14, 2015, the Federal Reserve published a notice in the
Board of Governors of the Federal Reserve System, July 1, 2015.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed field survey to assess safety and health hazards to workers in oil and gas (O&G) extraction.
Written comments must be received on or before September 8, 2015.
You may submit comments, identified by Docket No. CDC-2015-0051 by any of the following methods:
All public comment should be submitted through the Federal eRulemaking portal (
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Assessing Safety and Health Hazards to Workers in Oil and Gas Extraction: A Survey—New—Information Collection Request—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. The Occupational Safety and Health Act, 91 (section 20[a] [1]), authorizes NIOSH to conduct research to advance the health and safety of workers. NIOSH is proposing a three year study to conduct a survey questionnaire of 500 land-based oil and gas (O&G) extraction workers in 3 U.S. states (Texas, North Dakota, and a state in the Appalachian Basin) to examine safety and health issues and concerns of this workforce. Workers who drive as a part of their work duties will be asked to complete an additional set of questions about their driving environment and behaviors. We expect a response rate of 80%, so it is estimated that we will approach 625 workers in order to have 500 workers complete the survey.
The goals of this study are (1) To determine on-duty and off-duty factors that contribute to motor vehicle crashes, injuries and illness among U.S. land-based O&G extraction workers and (2) To identify other safety and health needs and concerns of U.S. land-based O&G extraction workers, a largely non-unionized workforce. The results of this study will guide the development of evidence-based and priority interventions and future research in the O&G extraction industry that will improve the safety and health of O&G workers.
Administration of the survey questionnaire will occur at temporary modular lodging facilities (‘man camps’), training centers, equipment/trucking yards, well sites, and community centers in oilfield towns. A screening questionnaire, “Module 1: Screening” will be administered to 313 workers per year (for 2 years) to determine that the worker is eligible for the survey. This questionnaire will take about 5 minutes. NIOSH anticipates that up to 63 workers per year (20% of screened workers) will be eligible but not interested in participating in this study. These workers will be asked to complete a brief, 6-question “Non-Respondent Questionnaire”, which will take about 5 minutes. Approximately 250 workers per year (for 2 years) will be eligible and agree to participate in the study (80% response rate). These workers will complete “Module 2: General,” “Module 3: Well-site work,” and “Module 5: Closing Questions” (approximately 225 workers will use the tablet version and 25 will opt to use the hardcopy version). “Module 5: Closing
The total estimated burden hours are 236. There is no cost to respondents other than their time.
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,
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
Emerging Infections Program—Revision—(OMB Control No. 0920-0978, Expires 8/31/2016), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions; local health departments; public health and clinical laboratories; infection control professionals; and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases. Various parts of the EIP have received separate Office of Management and Budget (OMB) clearances (Active Bacterial Core Surveillance [ABCs]—OMB Control Number 0920-0802 and All Age Influenza Hospitalization Surveillance—OMB Control Number 0920-0852).
In this revision package we wish to seek OMB clearance to add Healthcare Associated Infections—Community Interface (HAIC): active population-based surveillance for healthcare associated pathogens and infections (including
Activities of the EIPs fall into the following general categories: (1) Active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies.
Activities of the EIPs are designed to: (1) Address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease. Proposed respondents will include state health departments who may collaborate with one or more of the following: academic institutions, local health departments, public health and clinical laboratories, infection control professionals, and healthcare providers. Frequency of reporting will be determined as cases arise.
The addition of HAIC to the EIP increases the total estimated burden by 10,300 hours to 22, 755 hours. There is no cost to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the proposed extension of the information collection entitled
Written comments must be received on or before September 8, 2015.
You may submit comments, identified by Docket No. CDC-2015-0053 by any of the following methods:
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Evaluating the Effectiveness of Occupational Safety and Health Program Elements in the Wholesale Retail Trade Sector OMB No. 0920-0949, expires 10/31/2015)—Extension—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. Under Public Law 91-596, sections 20 and 22 (Section 20-22, Occupational Safety and Health Act of 1970), NIOSH has the responsibility to conduct research to advance the health and safety of workers. In this capacity, NIOSH proposes to conduct a study to assess the effectiveness of occupational safety and health (OSH) program elements in the wholesale/retail trade (WRT) sector. An extension is being requested in order to allow for additional time to complete the study. Data has already been collected for the first year of the study. Additional time is being requested in order to collect the remaining data for the second and third year.
Liberty Mutual has estimated direct workers compensation costs to industry in the United States in 2009 to be $50 billion. The WRT industry sector employs over 21 million workers or 19% of the workforce in private industry. In 2007, the majority of non-fatal injuries and illnesses involving days away from work in the WRT sector involved musculoskeletal disorders (MSDs, 29%) or slip/trip/falls (STFs, 22%). For this reason, major strategic NIOSH goals in the WRT sector are to reduce MSDs, STFs and other injuries/illnesses in part by assessing the effectiveness of occupational safety and health (OSH) programs designed to prevent these outcomes. There is some evidence that OSH prevention programs built on key elements (management leadership, employee participation, hazard identification and control, medical management, training, and program evaluation) reduce losses. However, little evidence exists on the relative effectiveness of program elements compared to each other. There is a need for research to develop reliable OSH program metrics and determine which elements have the greatest impact on injuries, illnesses and work disability. A renewed partnership between NIOSH and the Ohio Bureau of Workers Compensation (OBWC) a timely opportunity to conduct such research in a relevant and efficient manner.
A collaborative study involving NIOSH and the OBWC will examine the association between survey-assessed OSH program elements (organizational policies, procedures, practices) and workers compensation (WC) injury/illness outcomes in a stratified sample of OBWC-insured wholesale/retail trade (WRT) firms. Crucial OSH program elements with particularly high impact on WC losses will be identified in this study and disseminated to the WRT sector. This study will provide important information that is not currently available elsewhere on the effectiveness of OSH programs for the WRT sector. This project fits the mission of CDC-NIOSH to conduct scientific intervention effectiveness research to support the evidenced based prevention of occupational injuries and illnesses.
For this study, the target population includes United States WRT firms (North American Industry Classification System codes 42, 44, 45, 45). The sampling frame includes OBWC-insured WRT firms in Ohio. The study sample includes OBWC-insured WRT firms who volunteer to participate in the OBWC-NIOSH research project.
The proposed research involves a firm-level survey of a series of organizational metrics considered to be
An individual responsible for the OSH program at each firm will be asked to complete survey that include a background section related to respondent and company demographics and a main section where individuals will be asked to evaluate organizational metrics related to their firm's OSH program. The firm-level survey data will be linked to five years of retrospective injury and illness WC claims data and two years of prospective injury and illness WC claims data from OBWC to determine which organizational metrics are related to firm-level injury and illness WC claim rates. A nested study will ask multiple respondents at a subset of 60 firms to participate by completing surveys. A five-minute interview will be conducted with a 10% sample of non-responders (up to 792 individuals).
In order to maximize efficiency and reduce burden, a web-based survey is proposed for the majority (95%) of survey data collection. Collected information will be used to determine whether a significant relationship exists between self-reported firm OSH elements and firm WC outcomes while controlling for covariates. Once the study is completed, benchmarking reports about OSH elements that have the highest impact on WC losses in the WRT sector will be made available through the NIOSH-OBWC internet sites and peer-reviewed publications.
In summary, this study will determine the effectiveness of OSH program elements in the WRT sector and enable evidence-based prevention practices to be shared with the greatest audience possible. NIOSH expects to complete data collection in 2015. There is no cost to respondents other than their time.
Health Resources and Services Administration, HHS.
Notice; correction.
In accordance with the requirements of section 333A(b)(1) of the Public Health Service (PHS) Act, as amended by the Health Care Safety Net Amendments of 2002, 42 U.S.C. 254f-1(b)(1), the Secretary of HHS shall establish the criteria which she will use to make determinations under section 333A(a)(1)(A) of the Health Professional Shortage Areas (HPSAs) with the greatest shortages. The Health Resources and Services Administration published a notice in the
Kae Brickerd, Chief, Shortage Designation Branch, Bureau of Health Workforce, Division of Policy and Shortage Designation, Health Resources and Services Administration, 11W14 Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, 301 945-0828,
In the
In the section For Geographic High Need and Population HPSAs, the table for Core Mental Health (Geographic High Need and Population), should read as follows below.
Office of the Secretary, HHS.
Notice.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection
Comments on the ICR must be received on or before September 8, 2015.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the document identifier HHS-OS-0990-0281-60D or reference.
The information collected will be used by ODPHP to improve its communication, products, and services that support key office activities including: Healthy People, Dietary Guidelines for Americans, Physical Activity Guidelines for Americans, healthfinder.gov, and increasing health care quality and patient safety. ODPHP communicates through its Web sites (
The primary methods of data collection will be qualitative and may include in-depth interviews, focus groups, web-based surveys, card sorting, and various forms of usability testing of materials and interactive tools to assess the public's understanding of disease prevention and health promotion content, responses to prototype materials, and barriers to effective use.
The research methods outlined in this supporting statement have five major purposes:
The program is requesting a 3-year clearance.
Likely Respondents: Respondents are likely to be either consumers or health professionals.
Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed information collection request for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, email your request, including your address, phone number, OMB number, and OS document identifier, to
Previous research demonstrates that consumers respond both to information about their options and the way those options are presented. Accordingly, restaurants can utilize presentation effects on menus and menu boards to influence consumer perceptions and choices. By analyzing the consumer response to menu options and design, this study will offer a wide-ranging view of the consumer and producer response to menu labeling requirements.
ASPE is requesting comment on the burden for this study aimed at understanding the impact that the new FDA rule on calorie labeling will have on consumer choice when ordering from a restaurant. The goal of developing this activity is to examine consumer and producer responses to restaurant menu labeling requirements recently enacted by the FDA. The participants will include members of the RAND American Life Panel (ALP) which includes participants from several sources, including the University of Michigan Monthly Survey, the National Survey Project cohort, and several specific recruitment methods to add specific populations (
Office of Medicare Hearings and Appeals (OMHA), HHS.
Notice.
This notice announces the implementation of the OMHA Case Processing Manual (OCPM). This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Jason Green, by telephone at (703) 235-0124, or by email at
The Office of Medicare Hearings and Appeals (OMHA), a staff division within the Office of the Secretary of the U.S. Department of Health and Human Services (HHS), administers the nationwide Administrative Law Judge hearing program for Medicare claim, organization and coverage determination, and entitlement appeals under sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of the Social Security Act (the Act). OMHA ensures that Medicare beneficiaries and the providers and suppliers that furnish items or services to Medicare beneficiaries, as well as Medicare Advantage Organizations (MAOs) and Medicaid State Agencies, have a fair and impartial forum to address disagreements with Medicare coverage and payment determinations made by Medicare contractors, MAOs, or Part D Plan Sponsors (PDPSs), and determinations related to Medicare eligibility and entitlement, Part B late enrollment penalty, and income-related monthly adjustment amounts (IRMAA) made by the Social Security Administration (SSA).
The Medicare claim, organization and coverage determination appeals processes consist of four levels of administrative review, and a fifth level of review with the Federal district courts after administrative remedies under HHS regulations have been exhausted. The first two levels of review are administered by the Centers for Medicare & Medicaid Services (CMS) and conducted by Medicare contractors for claim appeals, by MAOs and an independent review entity for Part C organization determination appeals, or by PDPSs and an independent review entity for Part D coverage determination appeals. The third level of review is administered by OMHA and conducted by Administrative Law Judges. The fourth level of review is administered by the HHS Departmental Appeals Board (DAB) and conducted by the Medicare Appeals Council. In addition, OMHA and the DAB administer the second and third levels of appeal, respectively, for Medicare eligibility, entitlement, Part B late enrollment penalty, and IRMAA reconsiderations made by SSA; a fourth level of review with the Federal district courts is available after administrative
Sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of the Act are implemented through the regulations at 42 CFR part 405 subparts I and J; part 417, subpart Q; part 422, subpart M; part 423, subparts M and U; and part 478, subpart B. As noted above, OMHA administers the nationwide Administrative Law Judge hearing program in accordance with these statutes and applicable regulations. As part of that effort, OMHA is establishing a manual, the OMHA Case Processing Manual (OCPM). Through the OCPM, the OMHA Chief Administrative Law Judge establishes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations and OMHA directives. The OCPM provides direction for processing appeals at the OMHA level of adjudication for Medicare Part A and B claims; Part C organization determinations; Part D coverage determinations; and SSA eligibility and entitlement, Part B late enrollment penalty, and IRMAA determinations.
Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the
This quarterly notice announces the publication of the initial OCPM chapters. A hyperlink to the available chapters on the OMHA Web site is provided below. The OMHA Web site contains the most current, up-to-date chapters and revisions to chapters, and will be available earlier than we publish our quarterly notice. We believe the OMHA Web site list provides more timely access to the current OCPM chapters for those involved in the Medicare claim, organization and coverage determination and entitlement appeals processes. We also believe the Web site offers the public a more convenient tool for real time access to current OCPM provisions. In addition, OMHA has a listserv to which the public can subscribe to receive immediate notification of any updates to the OMHA Web site. This listserv avoids the need to check the OMHA Web site, as update notifications are sent to subscribers as they occur. If accessing the OMHA Web site proves to be difficult, the contact person listed above can provide the information.
This notice lists the OCPM chapters and subjects published during the quarter covered by the notice so the reader may determine whether any are of particular interest. We expect this notice to be used in concert with future published notices. The OCPM can be accessed at
The OCPM is used by OMHA adjudicators and staff to administer the OMHA program. It offers day-to-day operating instructions, policies, and procedures based on statutes and regulations, and OMHA directives.
The following is a list and description of new OCPM provisions and the subject matter. For future quarterly notices, we will list only the specific updates to the list of manual provisions that have occurred in the covered 3-month period. This information is available on our Web site at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In accordance with Title 41 of the U.S. Code of Federal Regulations, section 102-3.65(a), notice is hereby given that the Charter for the Recombinant DNA Advisory Committee, National Institutes of Health, was renewed for an additional two-year period on June 30, 2015.
It is determined that the Recombinant DNA Advisory Committee, National Institutes of Health, is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group.
Inquiries may be directed to Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail code 4875). Telephone (301) 496-2123, or
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office
Technology descriptions follow.
• Specificity of mode of action may reduce potential side-effects.
• Novel mode of action may increase market competition.
• No effective therapy is currently available for patients with advanced FH-deficient kidney cancer.
• In vitro data available.
• In vivo data available (animal).
• US Patent Application No. 62/003,319 filed May 27, 2014.
• PCT/US2015/03267 filed May 27, 2015.
The subject technology may offer an alternative to therapeutic NA inhibitors currently available. CD6 is a potent monoclonal antibody against N1 subtypes of NA that inhibits the enzymatic activity of the NA protein, including NA variants resistant to NA inhibitors. In a murine model of infection, a single dose of antibody was protective against lethal challenge with H1N1 influenza virus. The CD6 antibody can potentially be used in combination with other antibodies in an antibody “cocktail” or in conjunction with other therapeutic agents. Additionally, this unique anti-NA antibody may be useful in combination with known neutralizing anti-hemagglutinin (HA) antibodies.
• Prophylactic and therapeutic against influenza virus infections.
• Diagnostic tests for influenza virus infections.
• Reagent to measure the potency of H1N1 NA in influenza virus vaccines.
• Monoclonal antibody demonstrated to be effective against circulating H1N1 influenza viruses.
• Monoclonal antibody binds a novel, conserved epitope spanning NA dimers.
• Monoclonal antibody is well-suited for an antibody cocktail that includes anti-HA antibodies.
• Early-stage.
• In vitro data available.
• In vivo data available (animal).
This technology includes the confocal laser device and methodology for assessing spherical IOLs with an integrated component for assessing toric IOLs. The IOL market is growing steadily and IOL technology is continually improving to correct complex vision errors. It is estimated that 3 million IOLs are implanted annually in the U.S. and 19.7 million worldwide. This device can be used to precisely assess IOL key properties such as dioptric power, cylinder power, optical plane orthogonality and IOL markings used for IOL positioning in the eye during surgery. Thus, this new technology provides a simple, noninvasive, accurate and objective methodology to evaluate IOL characteristics with higher accuracy and repeatability in wider power ranges compared to the conventional test
• Development and implementation of novel test devices and independent methodologies for precise evaluation and validation of critical IOL characteristics.
• Development and evaluation of novel IOL designs.
• Higher accuracy.
• Higher repeatability.
• Larger range of positive and negative IOL dioptric power measurement.
• In vitro data available.
• In situ data available (on-site).
• Prototype.
1. Walker BN, et al. Assessing the effect of laser beam width on quantitative evaluation of optical properties of intraocular lens implants. J Biomed Opt. 2014 May;19(5):055004. [PMID 24817618]
2. Walker BN, et al. Impact of environmental temperature on optical power properties of intraocular lenses. Appl Opt. 2014 Jan 20;53(3):453-7. [PMID 24514132]
3. Hoffer KJ, et al. Testing the dioptric power accuracy of exact-power-labeled intraocular lenses. J Cataract Refract Surg. 2009 Nov;35(11):1995-9. [PMID 19878834]
4. Ilev IK. A simple confocal fibre-optic laser method for intraocular lens power measurement. Eye (Lond). 2007 Jun;21(6):819-23. [PMID 16710435]
• HHS Reference No. E-047-2015/0—US Provisional Application No. 62/108,795 filed January 28, 2015.
• HHS Reference No. E-038-2005/0—US Patent No. 8,456,738 issued June 4, 2013; EP Application 06750250.0.
• HHS Reference No. E-039-2005/0—US Patent No. 7,719,668 issued May 18, 2010; EP Application 06736741.7.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Customs and Border Protection, DHS.
General notice.
This document announces that U.S. Customs and Border Protection (CBP) plans to conduct the Automated Commercial Environment (ACE) Export Manifest for Air Cargo Test, a National Customs Automation Program (NCAP) test concerning ACE export manifest capability. The ACE Export Manifest for Air Cargo Test is a voluntary test in which participants agree to submit export manifest data electronically, at least 4 hours prior to loading of the cargo onto the aircraft in preparation for departure from the United States. CBP regulations require carriers to submit a paper manifest for export air shipments generally within 4 days after departure. This notice provides a description of the test, sets forth eligibility requirements for participation, and invites public comment on any aspect of the test.
The test will begin no earlier than August 10, 2015 and will run for approximately two years. CBP is accepting applications for participation in this planned test until CBP has received applications from nine parties that meet all test participant requirements. Comments concerning this notice and all aspects of the announced test may be submitted at any time during the test period.
Applications to participate in the ACE Export Manifest for Air Cargo Test must be submitted via email to CBP Export Manifest at
Robert Rawls, Cargo and Conveyance Security, Office of Field Operations, U.S. Customs & Border Protection, via email at
The National Customs Automation Program (NCAP) was established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, Dec. 8, 1993) (Customs Modernization Act) (19 U.S.C. 1411-14). Through NCAP, the initial thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS). ACE is an automated and electronic system for commercial trade processing which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for CBP and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions. CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace a specific legacy ACS or paper function. Each release begins with a test and ends with mandatory use of the new ACE feature, thus retiring the legacy ACS or paper function. Each release builds on previous releases and sets the foundation for subsequent releases.
The Customs Modernization Act provides the Commissioner of CBP with the authority to conduct limited test programs or procedures designed to evaluate planned components of the NCAP. The test described in this notice is authorized pursuant to the Customs Modernization Act and section 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)) which provides for the testing of NCAP programs or procedures. As provided in 19 CFR 101.9(b), for purposes of conducting an NCAP test, the Commissioner of CBP may impose requirements different from those specified in the CBP regulations.
This test is also in furtherance of the International Trade Data System (ITDS) key initiatives, set forth in section 405 of the Security and Accountability for Every Port Act of 2006 (Pub. L. 109-347, 120 Stat. 1884, Oct. 13, 2006) (SAFE Port Act) (19 U.S.C. 1411(d)) and Executive Order 13659 of February 19, 2014,
Executive Order 13659 requires that by December 2016, ACE, as the ITDS single window, have the operational capabilities to serve as the primary means of receiving from users the standard set of data and other relevant documentation (exclusive of applications for permits, licenses, or certifications) required for the release of imported cargo and clearance of cargo for export, and to transition from paper-based requirements and procedures to faster and more cost-effective electronic submissions to, and communications with, U.S. government agencies.
Under 19 CFR 122.72, 19 CFR 122.73, 19 CFR 122.74, 19 CFR 122.75, and 19 CFR 192.14, certain information must be submitted to CBP for aircraft with export cargo leaving the United States for any foreign area.
As indicated in the previous section, the aircraft commander or agent must file copies of the air cargo manifest on CBP Form 7509. CBP Form 7509 consists of the following data elements:
The air cargo manifest may be filed in complete form or incomplete form (pro forma). Under 19 CFR 122.74, the complete manifest must be filed with CBP before the aircraft will be cleared to depart during any time covered by a proclamation of the President that a state of war exists between foreign nations, or if the aircraft is departing on a flight from the United States directly or indirectly to a foreign country listed in 19 CFR 4.75. Otherwise, for shipments to a foreign country, an incomplete manifest may be filed with CBP at the departure airport when accompanied by the proper bond. For shipments on direct flights to Puerto Rico, an incomplete manifest may be filed with CBP upon arrival in Puerto Rico. If the complete manifest will not be filed within one business day of arrival in Puerto Rico, the proper bond must be filed at that time.
Under the bond accompanying the incomplete manifest, the complete manifest must be filed with CBP by the airline within the appropriate time period. For shipments to foreign countries, the complete manifest must generally be filed no later than 4 business days post-departure. For shipments between the United States and Puerto Rico, the complete manifest must be filed no later than 7 business days after arrival into or departure from Puerto Rico. For shipments between the United States or Puerto Rico and U.S. possessions, the complete manifest must be filed no later than 7 business days after departure.
Section 343(a) of the Trade Act of 2002, as amended (Trade Act) (19 U.S.C. 2071 note), requires CBP to promulgate regulations providing for the mandatory transmission of electronic cargo information by way of a CBP-approved electronic data interchange (EDI) system before the cargo is brought into or departs the United States by any mode of commercial transportation (sea, air, rail, or truck). The required cargo information is that which is reasonably necessary to enable high-risk shipments to be identified for purposes of ensuring cargo safety and security and preventing smuggling pursuant to the laws enforced and administered by CBP. Section 192.14 of title 19 of the Code of Federal Regulations (19 CFR 192.14) implements the requirements of the Trade Act with regard to cargo departing the United States.
While the air cargo manifest described above must be submitted by the aircraft commander or agent, that is, by the air carrier, any required EEI must be filed by the USPPI under 19 CFR 192.14. Using a CBP-approved EDI system, the USPPI or its authorized agent must transmit and verify system acceptance of this EEI, generally no later than 2 hours prior to the scheduled departure time of the aircraft from the last U.S. port. The air carrier may not load cargo without first receiving from the USPPI or its authorized agent either the related EEI filing citation, covering all cargo for which the EEI is required, or exemption legends, covering cargo for which EEI need not be filed. The outbound air carrier then must annotate the air cargo manifest, waybill, or other export documentation with the applicable AES proof of filing, post departure, downtime, exclusion or exemption citations, conforming to the approved data formats found in the Bureau of the Census Foreign Trade Regulations (FTR) (15 CFR part 30).
The ACE Export Manifest for Air Cargo Test will test the functionality regarding the filing of export manifest data for air cargo electronically to ACE in furtherance of the ITDS initiatives described above. CBP has re-engineered AES to move it to an ACE system platform. The re-engineering and incorporation of AES into ACE will result in the creation of a single automated export processing platform for certain export manifest, commodity, licensing, export control, and export targeting transactions. This will reduce costs for CBP, partner government agencies, and the trade community and improve facilitation of export shipments through the supply chain.
The ACE Export Manifest for Air Cargo Test will also test the feasibility of requiring the manifest information to be filed electronically in ACE within a specified time before the cargo is loaded on the aircraft. (Under the current regulatory requirements, the complete manifest is required to be submitted by the airline on paper CBP Form 7509 generally after the departure of the aircraft). As described in the paragraph below, in the test, participants will submit export manifest data electronically to ACE at least 4 hours prior to loading of the cargo. This will enable CBP to easily link the EEI submitted by the USPPI with the export manifest information earlier in the process. This capability will better enable CBP to assess risk and effectively target and inspect shipments prior to the loading of cargo to ensure compliance with all U.S. export laws.
Participants in the ACE Export Manifest for Air Cargo Test agree to provide export manifest data electronically at least 4 hours prior to loading of the cargo onto the aircraft in preparation for departure from the United States. If the air carrier files this ACE Export Manifest data, the electronic filing is in lieu of the paper
The ACE Export Manifest data submission will be used to target high-risk air cargo. The data should be available to test participants early in the planning stages of an export air cargo transaction. It is anticipated that data provided 4 hours prior to loading will permit adequate time for proper risk assessment and identification of shipments to be inspected early enough in the supply chain to enhance security while minimizing disruption to the flow of goods.
Any air cargo identified as potentially high-risk will receive a hold until required additional information related to the shipment is submitted to clarify non-descriptive, inaccurate, or insufficient information, a physical inspection is performed, or some other appropriate action is taken, as specified by CBP. Once the cargo is cleared for loading, a release message will be generated and transmitted to the filer.
The ACE Export Manifest for Air Cargo Test data elements are similar, but not identical to the data elements required on CBP Form 7509. The data elements are mandatory unless otherwise indicated. Data elements that are indicated as “conditional” must be transmitted to CBP only if the particular information pertains to the cargo. The ACE Export Manifest for Air Cargo data elements are to be submitted at the lowest bill level. The data elements consist of:
There are currently no additional data elements identified for other participating U.S. Government Agencies (PGAs) for the ACE Export Manifest for Air Cargo Test. However, CBP may enhance the test in the future with additional data or processing capabilities to assist with facilitation of air shipment movements and to be consistent with Executive Order 13659. Any such enhancement will be announced in the
CBP is limiting this test to nine stakeholders in the air cargo environment. Specifically, CBP is seeking participation from:
• At least three, but no more than six, air carriers currently required to file paper export air cargo manifest CBP Form 7509 under 19 CFR 122.72 and 122.73; and
• At least three, but no more than six, freight forwarders.
There are no restrictions with regard to organization size, location, or commodity type. However, participation is limited to those parties able to electronically transmit export manifest data in the identified acceptable format. Prospective ACE Export Manifest for Air Cargo Test participants must have the technical capability to electronically submit data to CBP and receive response message sets via Cargo-IMP, AIR CAMIR, XML, or Unified XML, and must successfully complete certification testing with their client representative. (Unified XML may not be immediately available at the start of the test. However, parties wishing to utilize Unified XML may be accepted, pending its development and implementation). Once parties have applied to participate, they must complete a test phase to determine if the data transmission is in the required readable format. Applicants will be notified once they have successfully completed testing and are permitted to participate fully in the test. In selecting participants, CBP will take into consideration the order in which the applications are received.
Test participants agree to submit export manifest data electronically to CBP via an approved EDI at least 4 hours prior to the loading of the cargo onto the aircraft in preparation for departure from the United States. In addition, test participants agree to establish operational security protocols that correspond to CBP hold messages that mandate the participant to take responsive action and respond to CBP confirming that the requested action was taken to mitigate any threat identified, respond promptly with complete and accurate information when contacted by CBP with questions regarding the data submitted, and comply with any “Do Not Load” instructions.
Finally, test participants agree to participate in any teleconferences or meetings established by CBP, when necessary, to ensure any challenges, or operational or technical issues regarding the test are properly communicated and addressed.
Participation in the ACE Export Manifest for Air Cargo Test does not impose any legally binding obligations on either CBP or the participant, and CBP generally does not intend to enforce or levy punitive measures if test participants are non-compliant with these conditions of participation during the test.
Those interested in participating in the ACE Export Manifest for Air Cargo Test should submit an email to CBP Export Manifest at
Test participants will receive technical, operational, and policy guidance through all stages of test participation, from planning to implementation, on the necessary steps
ACE Export Manifest for Air Cargo Test participants are responsible for all costs incurred as a result of their participation in the test and such costs will vary, depending on their pre-existing infrastructures. Costs may be offset by a significant reduction in expenses associated with copying, storing, and courier services for presenting the paper manifest to CBP.
While the benefits to ACE Export Manifest for Air Cargo Test participants will vary, several advantages of joining may include:
• Reduction in costs associated with generating copies, transportation, and storage of paper manifest documentation;
• Increases in security by leveraging CBP threat model and other data to employ a risk-based approach to improve air cargo security and to ensure compliance with U.S. export laws, rules and regulations through targeted screening;
• Gains in efficiencies by automating the identification of high-risk cargo for enhanced screening;
• The ability to provide input into CBP efforts to establish, test, and refine the interface between government and industry communication systems for the implementation of the electronic export manifest; and
• Facilitation of corporate preparedness for future mandatory implementation of electronic export manifest submission requirements.
For purposes of this test, the requirement to file a paper CBP Form 7509, as provided in 19 CFR 122.72-122.75 will be waived for air carrier test participants that submit the ACE Export Manifest for Air Cargo data elements electronically as described above. If a freight forwarder submits the electronic ACE Export Manifest data, the air carrier is still required to file the paper CBP Form 7509 (or the electronic ACE Export Manifest data, if the air carrier is a test participant). The air carrier maintains responsibility for submitting the manifest data to CBP to cover all cargo on the aircraft, even if the freight forwarder has also submitted manifest data. Participation in the test does not alter the participant's obligations to comply with any other applicable statutory and regulatory requirements, including 19 CFR 122.72-122.75, and participants will still be subject to applicable penalties for non-compliance. In addition, submission of data under the pilot does not exempt the participant from any CBP or other U.S. Government agency program requirements or any statutory sanctions in the event that a violation of U.S. export laws or prohibited articles are discovered within a shipment/container presented for export destined from the United States on an aircraft owned and/or operated by the participant.
The test will be activated on a case-by-case basis with each participant and may be limited to a single or small number of ports until any operational, training, or technical issues on either the trade or government side are established and/or resolved. The test will run for approximately two years from August 10, 2015. While the test is ongoing, CBP will evaluate the results and determine whether the test will be extended, expanded to include additional participants, or otherwise modified. CBP will announce any such modifications by notice in the
All data submitted and entered into ACE is subject to the Trade Secrets Act (18 U.S.C. 1905) and is considered confidential, except to the extent as otherwise provided by law. However, participation in this or any ACE test is not confidential and upon a written Freedom of Information Act (FOIA) request, the name(s) of an approved participant(s) will be disclosed by CBP in accordance with 5 U.S.C. 552.
If a test participant fails to abide by the rules, procedures, or terms and conditions of this and all other applicable
If CBP determines that a suspension is warranted, CBP will notify the participant of this decision, the facts or conduct warranting suspension, and the date when the suspension will be effective. In the case of willful misconduct, or where public health interests or safety are concerned, the suspension may be effective immediately. This decision may be appealed in writing to the Assistant Commissioner, Office of Field Operations, within 15 days of notification. The appeal should address the facts or conduct charges contained in the notice and state how the participant has or will achieve compliance. CBP will notify the participant within 30 days of receipt of an appeal whether the appeal is granted. If the participant has already been suspended, CBP will notify the participant when their participation in the test will be reinstated.
As noted above, CBP will be accepting no more than nine participants in the ACE Export Manifest for Air Cargo Test. This means that fewer than ten persons will be subject to any information collections under this test. Accordingly, collections of information within this notice are exempted from the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3502 and 3507).
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301)-443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before August 10, 2015.
Brenda Tapia, U.S. Fish and Wildlife Service, Division of Management Authority, Branch of Permits, MS: IA, 5275 Leesburg Pike, Falls Church, VA 22041; fax (703) 358-2281; or email
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to import one female and one male cheetah (
The applicant requests a permit to biological samples from any endangered or threatened species for the purpose of scientific research, including but not limited to, phylogenetic, reproductive physiology, disease transmission, and applied animal ecology. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a renewal and amendment to their captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival:
The applicant requests a renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival: radiated tortoise (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species to enhance species propagation or survival:
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for Golden parakeet (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
National Park Service, Interior.
Notice of intent.
The National Park Service (NPS) announces that we are preparing an Environmental Impact Statement (EIS) for a plan to determine how to manage the Isle Royale moose population in light of the dynamic changes occurring on the island, in particular the declining wolf population.
The public comment period will begin on the date this Notice of Intent is published in the
Information, including a copy of the public scoping brochure, will be available for public review online at
Superintendent Phyllis Green, or Chief of Natural Resources Paul Brown, Isle Royale National Park, Wolf-Moose-Vegetation Management Plan, 800 East Lakeshore Drive, Houghton, Michigan 49931-1896, or by telephone at (906) 482-0984.
Isle Royale is an island archipelago in the northwestern portion of Lake Superior. Organisms that live on islands have dynamic populations and are subject to immigration and extinction events. Local extirpation is natural and expected, as is establishment and re-establishment of new populations.
Wolves were first documented on Isle Royale through identification of tracks in 1949-50 and by 1957 the island supported an estimated 25 wolves. The first systematic research on Isle Royale wolves was conducted in the 1950s and has continued largely unabated. The research on the “Wolves of Isle Royale” is now world-renowned. Like many mainland wolf populations, the island population has fluctuated widely over this time, though on Isle Royale they have always been protected and never hunted or subjected to control efforts. Population variation on the island is related to inherent dynamic wolf ecology, island biogeography, and presence of disease in the wolf population. Wolves on Isle Royale have recently declined and the primary cause is thought to be genetic inbreeding leading to low productivity. With currently less than 10 individual wolves on the island, scientists differ on what will happen to the population in the short-term (25 years). Many believe that their persistence is doubtful unless new wolves emigrate or are introduced to the island.
The moose population on Isle Royale (which arrived on the island in the early 1900s) has fluctuated dramatically (500 to several thousand) over the past century. Moose have important effects on island vegetation including forest cover and wolves are the only moose predator on the island.
The park lies within a temperate-boreal forest transition zone where temperate tree species are at or near their northern range limits and boreal trees are near their southern range limits. Recent trends suggest the beginning of a shift from boreal to temperate vegetation. The relatively short-lived boreal paper birch and aspen, which established widely on lands disturbed by European settlement activities, are reaching the end of their natural lifespans and rapid successional changes in favor of more shade-tolerant tree species are underway. Successional trends on the island indicate that recent conditions favored temperate hardwood species, which expanded and replaced boreal trees. Since moose favor some boreal tree species such as balsam fir for food, this succession may alter the available moose forage in the future.
The wolf-moose-vegetation food web is tightly coupled. Since the wolf population at Isle Royale is very low and local extirpation of wolves is possible in the near future (
A plan is needed to address environmental impacts that could occur to the moose population and vegetation from the potential extirpation of wolves. The purpose of the plan is to provide direction for managing the Isle Royale moose and wolf populations for at least the next 20 years in light of the dynamic changes occurring on the island.
In this context, we must determine allowable types of change. Specifically, we need to decide whether to intervene with a declined or extirpated wolf population in order to perpetuate the role wolves play with regard to the moose population through predation and spatial distribution (wolf management actions); whether to directly intervene with an increased moose population (moose management actions); and whether to intervene to manage vegetation to mitigate impacts from moose herbivory as temperate species replace the historical boreal forest (vegetation management actions). For each of these decisions, we must determine the type and extent of intervention appropriate in a designated wilderness given a changing climate. While specific alternatives have not yet been developed, options available include: (1) not actively managing moose, wolves, or vegetation; (2) managing moose abundance and distribution; (3) managing wolf abundance by supplementing the current wolf population or introducing wolves following extirpation; and (4) managing vegetation through the use of fire, direct restoration, or other tools.
Interested individuals, organizations, and agencies are encouraged to provide written comments regarding the scope of issues to be addressed in the EIS, alternative approaches to managing wolves, moose, or vegetation on Isle Royale, and other concerns regarding this conservation planning and environmental impact analysis process. Within the comment period, we intend to hold public scoping meetings on the EIS in the vicinity of the park, including Houghton, Michigan. Specific dates, times and locations of the public scoping meetings will be made available via a press release to local media, a public scoping brochure to be mailed or emailed to interested parties and on the NPS's Planning, Environment and Public Comment (PEPC) Web site at
If you wish to comment during the public comment period, you may use any one of several methods. The preferred method for submitting comments is at the PEPC Web site address given above. You may also mail or hand-deliver your comments to the Superintendent or the Chief of Natural Resources at the address given above. Written comments will also be accepted during scheduled public meetings. Comments will not be accepted by fax, email, or any other way than those specified above. Bulk comments in any format (hard copy or electronic) submitted on behalf of others will not be accepted. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
This document was received at the Office of the Federal Register on Monday, July 06, 2015.
Bureau of Reclamation, Interior.
Notice.
This notice announces the availability of the Bay Delta Conservation Plan/California WaterFix Partially Recirculated Draft
Based on project revisions and in consideration of comments received on the Draft Bay Delta Conservation Plan, Draft EIR/EIS, and Draft Implementing Agreement, the State and Federal lead agencies recognize that additional information is appropriate to address comments and to enhance the environmental analysis.
Comments on the RDEIR/SDEIS must be received or postmarked by 5 p.m. Pacific Time on August 31, 2015.
Two public meetings will be held to provide an overview of the project and allow public comment and discussion on the RDEIR/SDEIS:
• Tuesday, July 28, 2015, 3:00 p.m.-7:00 p.m., Sacramento, CA.
• Wednesday, July 29, 2015, 3:00 p.m.—7:00 p.m., Walnut Grove, CA.
You may submit written comments by one of the following methods:
1.
2.
The two public meetings will be held at the following locations:
• Sacramento—Sheraton Grand Sacramento Hotel, Magnolia Room, 1230 J Street, Sacramento, CA 95814.
• Walnut Grove—Jean Harvie Community Center, 14273 River Road, Walnut Grove, CA 95690.
To view or download the RDEIR/SDEIS, or for a list of locations to view hard-bound copies, go to
Ms. Michelle Banonis, Bureau of Reclamation, (916) 930-5676.
On January 24, 2008, the U.S. Fish and Wildlife Service (USFWS) and National Marine Fisheries Service (NMFS) issued a Notice of Intent (NOI) to prepare an EIS on the Bay Delta Conservation Plan (BDCP or Plan) (73 FR 4178). The NOI was re-issued on April 15, 2008, to include the Bureau of Reclamation (Reclamation) as a co-lead Federal agency, update the status of the planning process, and provide updated information related to scoping meetings (73 FR 20326). The April 15, 2008, NOI identified scoping meeting locations and stated that written comments would be accepted until May 30, 2008. Additional information was later developed to describe the proposed BDCP, and subsequent scoping activities were initiated on February 13, 2009, with the publication of a revised NOI (74 FR 7257). The NOI identified scoping meeting locations and stated that written comments would be accepted until May 14, 2009.
In 2008, ten public scoping meetings were held throughout California. In spring 2009, a summary update was produced and distributed about the development of the Plan to interested members of the public, including details of individual elements of the Plan (referred to in the Plan as “conservation measures”) that were being considered as part of the conservation strategy. Twelve additional public scoping meetings were then held throughout California, seeking input about the scope of covered activities and potential alternatives to the proposed action.
In December 2010, the California Natural Resources Agency disseminated to the public a summary of the BDCP, its status, and a list of outstanding issues. In 2011 and 2012, public meetings continued in Sacramento, California, to update stakeholders and the public on elements of the draft BDCP and EIR/EIS that were being developed.
On December 13, 2013, the Draft BDCP and associated Draft EIR/EIS were released to the public and a 120-day public comment period was opened through notification in the
As a result of considering comments on the Draft BDCP, Draft EIR/EIS, and Draft Implementing Agreement, Reclamation and the California Department of Water Resources have proposed three additional conveyance alternatives for analysis in the RDEIR/SDEIS. These new alternatives 2D, 4A, and 5A, each contain fewer Conservation Measures than the conveyance alternatives circulated in the Draft EIR/EIS. Specifically, the new alternatives no longer contain the following Conservation Measures: CM-2 Yolo Bypass Fisheries Enhancement; CM-5 Seasonally Inundated Floodplain Restoration; CM-13 Invasive Aquatic Vegetation Control; CM-14 Stockton Deep Water Ship Channel Dissolved Oxygen Levels; CM-17 Illegal Harvest Reduction; CM-18 Conservation Hatcheries; CM-19 Urban Stormwater Treatment; CM-20 Recreational Users Invasive Species Program; and CM-21 Non-project Diversions. The new alternatives contain modified versions of the following Conservation Measures (referred to as Environmental Commitments in the RDEIR/SDEIS): CM-3 Natural Communities Protection and Restoration; CM-4 Tidal Natural Communities Restoration; CM-6 Channel Margin Enhancement; CM-7 Riparian Natural Community Restoration; CM-8 Grassland Natural Community Restoration; CM-9 Vernal Pool and Alkali Seasonal Wetland Complex Restoration; CM-10 Nontidal Marsh Restoration; CM-11 Natural Communities Enhancement and Management; CM-12 Methylmercury Management; CM-15 Localized Reduction of Predatory Fishes; and CM-16 Non-Physical Fish Barriers. The new alternatives are not structured as a Habitat Conservation Plan/Natural Communities Conservation Plan but are structured to achieve compliance with the Federal Endangered Species Act through consultation under Section 7 and the California Endangered Species Act through the incidental take permit process under Section 2081(b) of the California Fish & Game Code.
The California Department of Water Resources has identified Alternative 4A (known as the California WaterFix) as their proposed project and Reclamation has selected Alternative 4A as the National Environmental Policy Act (NEPA) preferred alternative. This alternative will consist of a water conveyance facility with three intakes, habitat restoration measures necessary to minimize or avoid project effects, and the previously described Conservation Measures. Alternative 4A is proposed to make physical and operational improvements to the State Water Project system in the Delta necessary to restore
The RDEIR/SDEIS will also analyze the impacts for two additional new alternatives: Alternative 2D, which will consist of a water conveyance facility with five intakes, and Alternative 5A, which will consist of a water conveyance facility with one intake. Both of these alternatives will contain the habitat protection and restoration measures necessary to minimize or avoid project effects, and the previously described Conservation Measures listed above. In addition, the RDEIR/SDEIS will describe and analyze project modifications and refinement of the resource area analyses, alternatives, and actions. Reclamation will be the Federal lead agency and NMFS, USFWS, and the U.S. Army Corps of Engineers, by virtue of their regulatory review requirements, will be cooperating agencies for the RDEIR/SDEIS. All other entities identified as Cooperating Agencies through prior agreements will retain their status for the RDEIR/SDEIS.
Council on Environmental Quality regulations for implementing NEPA (40 CFR 1502.9(c)) do not require any additional scoping for a supplement to a Draft EIS, and the lead agencies are not proposing any scoping process for this RDEIR/SDEIS in addition to the scoping that has already been done for the EIR/EIS as described above.
For further background information, see the December 13, 2013,
This notice is provided pursuant to NEPA. Reclamation is furnishing this notice to allow other agencies and the public an opportunity to review and comment on this RDEIR/SDEIS. All comments received will become part of the public record for this action. Comments on the RDEIR/SDEIS should be submitted to the address listed in the
Reclamation will compile and review all public comments on the RDEIR/SDEIS submitted to them prior to preparation of a final EIR/EIS. A decision by Reclamation on Central Valley Project operations consistent with the RDEIR/SDEIS will be made no sooner than 30 days after the publication of the final EIR/EIS. The decision will be documented with the completion of the Record of Decision.
The public meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Ms. Michelle Banonis, Bureau of Reclamation, (916) 930-5676 at least 5 working days prior to the meeting date.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge has issued a final initial determination and recommended determination on remedy and bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, specifically a limited exclusion order against certain marine sonar imaging devices, including downscan and sidescan devices, products containing the same, and components thereof, imported by respondents Garmin International, Inc., Garmin USA, Inc., each of Olathe, Kansas, and Garmin (Asia) Corporation of New Taipei City, Taiwan, and a cease and desist order against the domestic respondents. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
Lucy Grace D. Noyola, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3438. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, members of the public are invited to file submissions of no more than five pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's recommended determination on remedy and bonding issued in this investigation on July 2, 2015. Comments should address whether issuance of a limited exclusion order and cease and desist order in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the limited exclusion order and cease and desist order would impact consumers in the United States.
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.50 of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50).
By order of the Commission.
On the basis of the record
The Commission, pursuant to sections 705(b) and 735(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)) and (19 U.S.C. 1673d(b)), instituted these investigations effective May 29, 2014, following receipt of a petition filed with the Commission and Commerce by Mid Continent Nail Corporation (Poplar Bluff, MO). The Commission scheduled the final phase of the investigations after Commerce published preliminary determinations that imports of certain steel nails from Korea, Malaysia, Oman, Taiwan, and Vietnam were dumped within the meaning of 733(b) of the Act (19 U.S.C. 1673b(b)) and that imports of certain steel nails from Vietnam were subsidized within the meaning of section 703(b) of the Act (19 U.S.C. 1671b(b)). Notice of the scheduling of the final phase of the Commission's investigations and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to sections 705(b) and 735(b) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)) and (19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations on July 6, 2015. The views of the Commission will be contained in USITC Publication 4541 (July 2015), entitled
By order of the Commission.
U.S. Marshals Service, Department of Justice.
60-day notice.
The Department of Justice (DOJ), U.S. Marshals Service, will be submitting 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.
Comments are encouraged and will be accepted for 60 days until September 8, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Nicole Feuerstein, Publications Specialist, U.S. Marshals Service, CS-3, 10th Floor, Washington, DC 20530-0001 (phone: 202-307-5168).
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
The following factors were considered when created the burden estimate: The estimated total number of active task force officers, the number of federal agencies requesting Special Deputation and their activity, the number of applications processed by the U.S. Marshals Service during the last five fiscal years by agency, upcoming regularly scheduled National Security Special Events that require large numbers of Special Deputy U.S. Marshals, Presidential Inaugurations, Special Operations, and unforeseen emergencies and natural disasters.
6.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Employment and Training Administration (ETA), Labor.
Notice.
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
Currently, the Employment and Training Administration (ETA) is soliciting comments concerning the information collections in the H-2B temporary non-agricultural employment-based visa program, which includes Form ETA-9142B,
Written comments must be submitted to the office listed in the addresses section below on or before September 8, 2015.
Submit written comments to Brian Pasternak, National Director of Temporary Programs, Office of Foreign Labor Certification, Room C-4312, Employment & Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: 202-693-3010 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD). Fax: 202-693-2768. Email:
The information collection is required by sections 101(a)(15)(H)(ii)(b) and 214(c) of the Immigration and Nationality Act (INA) (8 U.S.C. 1011(a)(15)(H)(ii)(b) and 1184(c)) and 8 CFR 214.2(h)(6). Before an employer may petition for any temporary skilled or unskilled foreign workers, it must submit a request for certification to the Secretary of Labor containing the elements prescribed by the INA and the Department of Labor's (Department) implementing regulations, which differ depending on the visa program under which the foreign workers are sought.
The H-2B visa program enables employers to bring nonimmigrant foreign workers to the U.S. to perform nonagricultural work of a temporary or seasonal nature as defined in 8 U.S.C. 1101(a)(15)(H)(ii)(b). For purposes of the H-2B program, the INA and governing federal regulations require the Secretary of Labor to certify, among other things, that any foreign worker seeking to enter the United States on a temporary basis for the purpose of performing non-agricultural services or labor will not, by doing so, adversely affect wages and working conditions of U.S. workers who are similarly employed. In addition, the Secretary must certify that qualified U.S. workers are not available to perform such temporary labor or services. (8 CFR 214.2(h)(6)(i)(A), (iii)(A).)
The Form ETA-9142B
The Form ETA-9155
The
DOL is particularly interested in comments that:
• 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;
• evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• enhance the quality, utility, and clarity of the information to be collected; and
• 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,
Comments submitted in response to this comment request will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record. Commenters are encouraged not to submit sensitive information (
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Technology, Innovation and Engineering (TI&E) Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. This meeting will include a joint session with the NAC Human Exploration and Operations (HEO) Committee.
Monday, July 27, 2015, 12:00 p.m.-5:30 p.m., Local Time; and Tuesday, July 28, 2015, 8:00 a.m.-2:00 p.m., Local Time.
Jet Propulsion Laboratory, Building 180, Room 101, 4800 Oak Grove Drive, Pasadena, CA 91019.
Mr. Mike Green, Executive Secretary for the
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch tone phone to participate in this meeting. Any interested person may call the USA toll-free conference call number 1-844-467-6272, passcode 102421, to participate in this meeting by telephone. The WebEx link is
The agenda for the NAC TI&E Committee meeting includes the following topics:
The joint session with the NAC HEO Committee includes the following topics:
Attendees will be required sign a register and to comply with Jet Propulsion Laboratory (JPL) security requirements including presentation of a valid picture ID (such as a driver's license for U.S. Citizens; Permanent Resident green card; or passport/visa for non-U.S. Citizens) before receiving admittance to JPL. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Arizona, Idaho, Louisiana, Maine, Minnesota, New Hampshire, and New York. Individuals without proper identification will not be admitted to the JPL. Members of the public interested in attending this meeting must contact Ms. Helen N. Paley of JPL at phone number 818-354-6427 or
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.
Tuesday, July 28, 2015, 9:00 a.m.-5:00 p.m., Local Time.
Jet Propulsion Laboratory, Building 180, Room 703C, 4800 Oak Grove Drive, Pasadena, CA 91109.
Ms. Brenda L. Mulac, Executive Secretary for the NAC Aeronautics Committee, NASA Headquarters, Washington, DC 20546, phone number 202-358-1578, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any person interested in participating in the meeting by telephone and WebEx should contact Ms. Brenda L. Mulac at 202-358-1578 for the web link, toll-free number and passcode. The agenda for the meeting includes the following topics:
Attendees will be required sign a register and to comply with Jet Propulsion Laboratory (JPL) security requirements including presentation of a valid picture ID (such as a driver's license for U.S. Citizens; Permanent Resident green card; or passport/visa for non-U.S. Citizens) before receiving admittance to JPL. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Arizona, Idaho, Louisiana, Maine, Minnesota, New Hampshire, and New York. Individuals without proper identification will not be admitted to the JPL. Members of the public interested in attending this meeting must contact Ms. Helen N. Paley of JPL at phone number 818-354-6427 or
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Pub. L. 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Science Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Monday, July 27, 2015, 9:30 a.m. to 5:00 p.m., Local Time; Tuesday, July 28, 2015, 8:00 a.m. to 1:00 p.m.; Local Time; and Wednesday, July 29, 2015, 8:00 a.m. to 9:45 a.m., Local Time.
Jet Propulsion Laboratory, Building 167, Special Events Room (SER), 4800 Oak Grove Drive, Pasadena, CA 91011.
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0750, fax (202) 358-2779, or
The meeting will be open to the public up to the capacity of the room. The meeting will also be available telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll free conference call number 1-800-988-9663, passcode 8015, to participate in this meeting by telephone on all three days. A toll number also is available, 1-517-308-9483, passcode 8015, for all three days. The WebEx link is
Attendees will be required sign a register and to comply with Jet Propulsion Laboratory (JPL) security requirements including presentation of a valid picture ID (such as a driver's license for U.S. Citizens; Permanent Resident green card; or passport/visa for non-U.S. Citizens) before receiving admittance to JPL. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Arizona, Idaho, Louisiana, Maine, Minnesota, New Hampshire, and New York. Individuals without proper identification will not be admitted to the JPL. Members of the public interested in attending this meeting must contact Ms. Helen N. Paley of JPL at phone number 818-354-6427 or
National Aeronautics and Space Administration.
Notice of Meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration announces a meeting of the Institutional Committee of the NASA Advisory Council (NAC). This committee reports to the NAC.
Tuesday, July 28, 2015, 8:30 a.m.-5:45 p.m., Local Time; and Wednesday, July 29, 2015, 8:00 a.m.-10:00 a.m., Local Time.
Jet Propulsion Laboratory, Building 183, Room 328, 4800 Oak Grove Drive, Pasadena, CA 91109.
Mr. Todd Mullins, Executive Secretary for the NAC Institutional Committee, NASA Headquarters, Washington, DC 20546, phone number 202-358-3831, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch tone phone to participate in this meeting Any interested person may dial the toll free access number 844-467-6272 or toll access number 720-259-6462, and then the numeric participant passcode: 180093 followed by the # sign. To join via WebEx on July 28, the link is
Attendees will be required sign a register and to comply with Jet Propulsion Laboratory (JPL) security requirements including presentation of a valid picture ID (such as a driver's license for U.S. Citizens; Permanent Resident green card; or passport/visa for non-U.S. Citizens) before receiving admittance to JPL. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Human Exploration and Operations (HEO) Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Monday, July 27, 2015, 10:00 a.m.-5:30 p.m., Local Time; and ; Tuesday, July 28, 2015, 8:00 a.m.-5:30 p.m., Local Time.
Jet Propulsion Laboratory, Building 186, Von Kármán Auditorium, 4800 Oak Grove Drive, Pasadena, CA 91109.
Dr. Bette Siegel, Executive Secretary for the NAC HEO Committee, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, phone number 202-358-2245, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch tone phone to participate in this meeting. Any interested person may dial the USA toll-free conference call number 1-888-455-6733 or toll number 1-210-839-8935, and then the numeric participant passcode 3453695, to participate in this meeting by telephone. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be required sign a register and to comply with Jet Propulsion Laboratory (JPL) security requirements including presentation of a valid picture ID (such as a driver's license for U.S. Citizens; Permanent Resident green card; or passport/visa for non-U.S. Citizens) before receiving admittance to JPL. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Arizona, Idaho, Louisiana, Maine, Minnesota, New Hampshire, and New York. Individuals without proper identification will not be admitted to the JPL. Members of the public interested in attending this meeting must contact Ms. Helen N. Paley of JPL at phone number 818-354-6427 or
Institute of Museum and Library Services, National Foundation on the Arts and the Humanities.
Notice, request for comments, collection of information.
The Institute of Museum and Library Services (IMLS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act (44 U.S.C. 35). This pre-clearance consultation program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. By this notice, IMLS is soliciting comments concerning a proposed survey to collect information to monitor the use, expectations, of and satisfaction with cultural programs and services, particularly library and museum services.
A copy of the proposed information collection request can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the addressee section below on or before September 8, 2015.
IMLS is particularly interested in comments that help the agency to:
• 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;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• 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,
Send comments to: Christopher J. Reich, Senior Advisor, Institute of Museum and Library Services, 1800 M St. NW., 9th Floor, Washington, DC 20036. Mr. Reich can be reached by Telephone: 202-653-4685, Fax: 202-653-4608, or by email at
The Institute of Museum and Library Services is the primary source of federal support for the Nation's 123,000 libraries and 35,000 museums. The Institute's mission is to inspire libraries and museums to advance innovation, learning, and civic engagement. The Institute works at the national level and in coordination with state and local organizations to sustain heritage, culture, and knowledge; enhance learning and innovation; and support professional development. IMLS is responsible for identifying national needs for and trends in museum, library, and information services; measuring and reporting on the impact and effectiveness of museum, library and information services throughout the United States, including programs conducted with funds made available by IMLS; identifying, and disseminating information on, the best practices of such programs; and developing plans to improve museum, library, and information services of the United States and strengthen national, State, local, regional, and international communications and cooperative networks (20 U.S.C. 72, 20 U.S.C. 9108).
The purpose of this survey is to gauge the effect of the Museum Assessment Program (MAP) on participating museums and the museum field at large. The survey will be used to measure the degree to which the program is meeting the needs and building the institutional capacity of individual museums, and its overall impact on the museum field nationwide. Methods will include web surveys, telephone interviews, and focus group meetings.
The web survey will consist of approximately 40 questions that will examine the participating museums' experience with the MAP program and the subsequent changes in its operations that can be attributed to the program, as well as basic institutional profile information. The web survey will require an average of 60 minutes to complete. The telephone interview guide will be organized into approximately four sections (
Christopher J. Reich, Senior Advisor, Institute of Museum and Library Services, 1800 M St. NW., 9th Floor, Washington, DC 20036. Mr. Reich can be reached by Telephone: 202-653-4685, Fax: 202-653-4608, or by email at
Pension Benefit Guaranty Corporation.
Notice of intent to request extension of OMB approval.
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend its approval, under the Paperwork Reduction Act, of the information collection related to PBGC's booklet, Qualified Domestic Relations Orders & PBGC. The booklet provides guidance on how to submit a qualified domestic relations order to PBGC. This notice informs the public of PBGC's intent and solicits public comment on the collection of information.
Comments must be submitted by September 8, 2015.
Comments may be submitted by any of the following methods:
•
•
•
•
PBGC will make all comments available on its Web site at
Copies of the collection of information may be obtained without charge by writing to the Disclosure Division of the Office of the General Counsel of PBGC at the above address or by visiting that office or calling 202-326-4040 during normal business hours. (TTY and TDD users may call the Federal relay service toll-free at 1-800-
Jo Amato Burns, Attorney, or Catherine B. Klion, Assistant General Counsel, Office of the General Counsel, Pension Benefit Guaranty Corporation, 1200 K Street NW., Washington, DC 20005-4026, 202-326-4223. (For TTY and TDD, call 800-877-8339 and ask to be connected to 202-326-4223.)
A defined benefit pension plan that does not have enough money to pay benefits may be terminated if the employer responsible for the plan faces severe financial difficulty, such as bankruptcy, and is unable to maintain the plan. In such an event, PBGC becomes trustee of the plan and pays benefits, subject to legal limits, to plan participants and beneficiaries.
The benefits of a pension plan participant generally may not be assigned or alienated. Title I of ERISA provides an exception for domestic relations orders that relate to child support, alimony payments, or marital property rights of an alternate payee (a spouse, former spouse, child, or other dependent of a plan participant). The exception applies only if the domestic relations order meets specific legal requirements that make it a qualified domestic relations order (QDRO).
When PBGC is trustee of a plan, it reviews submitted domestic relations orders to determine whether the order is qualified before paying benefits to an alternate payee. The requirements for submitting a domestic relations order and the contents of such orders are established by statute. The models and the guidance provided by PBGC assist parties by making it easier for them to comply with ERISA's QDRO requirements in plans trusteed by PBGC; they do not create any additional requirements and result in a reduction of the statutory burden.
OMB has approved the collection of information in PBGC's booklet,
PBGC is not proposing any substantive changes to the booklet.
PBGC estimates that over the next three years it will receive approximately 1,200 domestic relations orders each year from prospective alternate payees and participants. PBGC further estimates that the total average annual burden of this collection of information will be approximately 2,100 hours and $350,000.
PBGC is soliciting public comments to—
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collections of information, including the validity of the methodologies and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collections 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,
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 129 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-62 and CP2015-93 to consider the Request pertaining to the proposed Priority Mail Contract 129 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than July 13, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Cassie D'Souza to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-62 and CP2015-93 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Cassie D'Souza is appointed to serve as an officer of the Commission to represent
3. Comments are due no later than July 13, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an amendment to the existing Priority Mail Contract 62 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On June 23, 2015, the Postal Service filed notice that it has agreed to an Amendment to the existing Priority Mail Contract 62 negotiated service agreement approved in this docket.
The Postal Service also filed the unredacted Amendment and supporting financial information under seal. The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal.
The Amendment replaces the rate table in section I.F. of the contract.
The Postal Service intends for the Amendment to become effective one business day after the date that the Commission completes its review of the Notice.
The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than July 13, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to represent the interests of the general public (Public Representative) in this docket.
1. The Commission reopens Docket No. CP2013-74 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, the Commission appoints Curtis E. Kidd to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments are due no later than July 13, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning an amendment to the existing Priority Mail Contract 88 negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
On July 2, 2015, the Postal Service filed notice that it has agreed to an Amendment to the existing Priority Mail Contract 88 negotiated service agreement approved in this docket.
The Postal Service also filed the unredacted Amendment under seal. The Postal Service seeks to incorporate by reference the Application for Non-Public Treatment originally filed in this docket for the protection of information that it has filed under seal.
The Amendment changes terms of applicability for Priority Mail shipments under the contract.
The Postal Service intends for the Amendment to become effective one business day after the date that the Commission completes its review of the Notice.
The Commission invites comments on whether the changes presented in the Postal Service's Notice are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR 3015.5, and 39 CFR part 3020, subpart B. Comments are due no later than July 13, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to represent the interests of the
1. The Commission reopens Docket No. CP2014-63 for consideration of matters raised by the Postal Service's Notice.
2. Pursuant to 39 U.S.C. 505, the Commission appoints Curtis E. Kidd to serve as an officer of the Commission (Public Representative) to represent the interests of the general public in this proceeding.
3. Comments are due no later than July 13, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail & First-Class Package Service Contract 6 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-63 and CP2015-94 to consider the Request pertaining to the proposed Priority Mail & First-Class Package Service Contract 6 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than July 14, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Lyudmila Y. Bzhilyanskaya to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-63 and CP2015-94 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Lyudmila Y. Bzhilyanskaya is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than July 14, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 128 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of
The Commission establishes Docket Nos. MC2015-61 and CP2015-92 to consider the Request pertaining to the proposed Priority Mail Contract 128 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than July 13, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-61 and CP2015-92 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than July 13, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 2, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 2, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on July 2, 2015, it filed with the Postal Regulatory Commission a
Closed Meeting.
100 F Street NE., Washington, DC.
Thursday, July 9, 2015 at 2 p.m.
Time Change.
The Closed Meeting scheduled for Thursday, July 9, 2015 at 2 p.m. has been changed to Thursday, July 9, 2015 at 1 p.m.
At times, changes in Commission priorities require alterations in the scheduling of meeting items. For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
It appears to the Securities and Exchange Commission that there is a
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Mark One Global Industries, Inc. (CIK No. 1000791) (“MKGLF”), a British Columbia corporation with its principal place of business in Olathe, Kansas, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended December 31, 2009. On April 29, 2013, Corporation Finance sent a delinquency letter to MKGLF requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission, but MKGLF did not receive the delinquency letter due to its failure to maintain a valid address on file with the Commission as required by Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer Manual).
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Nortel Networks Corporation (CIK No. 72911) (“NRTLQ”), a Canadian corporation with its principal place of business in Mississauga, Ontario, Canada, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended June 30, 2012. On October 17, 2014, Corporation Finance sent a delinquency letter to NRTLQ requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission which was delivered.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Silverado Gold Mines Ltd. (CIK No. 731727) (“SLGLF”), a defaulted British Columbia corporation with its principal place of business in Surrey, British Columbia, Canada, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended August 31, 2011. On September 13, 2013, Corporation Finance sent a delinquency letter to SLGLF requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission which was delivered.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EDT on July 8, 2015, through 11:59 p.m. EDT on July 21, 2015.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to remove Rule 4553 (Fees for ATS Data) from the FINRA rulebook.
Below is the text of the proposed rule change. Proposed new language is in italics; proposed deletions are in brackets.
[Fees are charged for ATS Data as set forth in this Rule. Professionals and Vendors must pay the subscription fee to receive ATS Data in accordance with this Rule and execute appropriate agreements with FINRA.]
[(1) Professionals may subscribe for the most currently published ATS Data and up to five years of historical ATS Data in a downloadable, pipe delimited format for a twelve-month subscription fee of $12,000. Such fee is not refundable or transferable.]
[(2) Payment of the Professional subscription fee described in this paragraph (b) provides the Professional with use of such ATS Data to generate Derived Data.]
[(3) Professionals may distribute ATS Data or Derived Data to their employees, affiliates, or employees of affiliates but are prohibited from providing ATS Data or Derived Data to any third party.]
[(1) Vendors may subscribe for access to the most currently published ATS Data and up to five years of historical ATS Data in a downloadable, pipe delimited format for a twelve-month subscription fee of $18,000. Such fee is not refundable or transferable.]
[(2) Payment of the Vendor subscription fee described in this paragraph (c) provides the Vendor with use of such ATS Data to generate Derived Data.]
[(3) Vendors are prohibited from providing ATS Data to any third party unless a Professional subscription has been purchased
[(1) There shall be no charge paid by a Non-Professional for access to the most recently published four weeks of ATS Data; however, such ATS Data will not be available in a downloadable format.]
[(2) A Non-Professional must agree to terms of use before accessing the ATS Data, including that he or she receives and uses the ATS Data solely for his or her personal, non-commercial use and will not otherwise distribute the ATS Data or Derived Data to other parties. The terms of use for Non-Professionals will be clearly posted on the FINRA.org Web site, and access to the non-fee liable ATS Data content will require a user to acknowledge the terms of use.]
[For purposes of this rule, the following terms have the meaning set forth:]
[(1) “ATS Data” means Trading Information published by FINRA on its Web site.]
[(2) “Derived Data” means data that is derived from ATS Data and that is not able to be (A) reverse engineered by a reasonably skilled user into ATS Data or (B) used as a surrogate for ATS Data.]
[(3) “Non-Professional” means a natural person who uses the ATS Data solely for his or her personal, non-commercial use. A “Non-Professional” is not:]
[(A) registered nor qualified in any capacity with the SEC, the Commodity Futures Trading Commission, any state securities agency, any securities exchange or association, or any commodities or futures contract market or association, nor an employee of the above and, with respect to any person identified in this subparagraph (A), uses ATS Data for other than personal, non-commercial use;]
[(B) engaged as an “investment adviser” as that term is defined in Section 202(a)(11) of the Investment Advisers Act (whether or not registered or qualified under that Act), nor an employee of the above and, with respect to any person identified in this subparagraph (B), uses ATS Data for other than personal, non-commercial use;]
[(C) employed by a bank, insurance company or other organization exempt from registration under federal or state securities laws to perform functions that would require registration or qualification if such functions were performed for an organization not so exempt, nor any other employee of a bank, insurance company or such other organization referenced above and, with respect to any person identified in this subparagraph (C), uses ATS Data for other than personal, non-commercial use; nor]
[(D) engaged in, nor has the intention to engage in, any commercial redistribution of all or any portion of the ATS Data or Derived Data.]
[(4) “Professional” means any non-natural person or any natural person that does not meet the definition of “Non-Professional” in subparagraph (3).]
[(5) “Trading Information” has the same meaning as set forth in Rule 4552.]
[(6) “Vendor” means a Professional who distributes ATS Data or Derived Data to any third party.]
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On January 17, 2014, the SEC approved a proposed rule change to (i) adopt Rule 4552 (Alternative Trading Systems—Trading Information for Securities Executed Within the Alternative Trading System) to require alternative trading systems (“ATSs”)
Under Rule 4552, individual ATSs are required to submit weekly reports to FINRA regarding equity security volume information within the ATS, including share volume and number of trades for both NMS stocks and OTC equity securities.
Rule 4553 establishes three categories of users of the ATS Data, each of which is entitled to different levels and use of data and is subject to a different fee structure: (i) Non-Professionals; (ii) Professionals; and (iii) Vendors.
Under Rule 4553, Professionals are required to pay an annual, enterprise-wide subscription fee of $12,000 that is non-transferable and renewable annually to access the ATS Data.
Rule 4553 also includes a Vendor subscription fee of $18,000 per year.
FINRA established the fee rates for access to ATS Data by Professionals and Vendors to recover the costs associated with collecting, formatting, and disseminating the data.
After approximately one year of receiving and disseminating the ATS Data on FINRA's Web site, FINRA has reviewed the usage of the ATS Data and the costs incurred and is proposing to eliminate the fee for all potential users and disseminate the ATS Data on its Web site at no charge. FINRA has found that there are significantly fewer firms and data vendors accessing the ATS Data than anticipated, which limits the opportunities for broader dissemination and analysis of the data FINRA makes available. By making the ATS Data available at no cost, FINRA believes more data vendors and firms will access the ATS Data and provide useful statistics and analysis to the industry and to individual investors and the public. FINRA currently anticipates making publicly available on its Web site 27 weeks of online reports and up to five years of historical reports available in a downloadable format.
As FINRA noted when it proposed collecting and disseminating the ATS Data, Rule 4552 was intended in part to increase transparency in the over-the-counter market. Although Rule 4552 has no doubt achieved this goal, particularly by providing individual investors with access to the ATS Data at no cost, FINRA believes that transparency may be even further enhanced by eliminating the fee for Professionals and Vendors so that individual investors and the public can benefit from more detailed and widely-available analysis of the ATS Data. Consequently, FINRA is proposing to eliminate the fee for Professionals and Vendors and make the ATS Data publicly available at no cost.
FINRA has filed the proposed rule change for immediate effectiveness. The implementation date will be July 13, 2015. FINRA staff is currently working on changes to FINRA's Web site to enable all users to access the ATS Data and to remove functionality that currently limits access to the ATS Data to either Non-Professionals or those with paid subscriptions. FINRA anticipates that these changes will be made so that the ATS Data will be publicly available beginning July 13, 2015. Until that time, the ATS Data will continue to be available only to paid subscribers or, in more limited formats, to Non-Professionals consistent with Rule 4553.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA believes that, by eliminating the fees imposed by Rule 4553 and making the ATS Data available to the public at no cost, more data vendors and firms will use the ATS Data to provide useful statistics and analysis to the industry, individual investors, and the public. This, in turn, will further improve transparency in the over-the-counter market by making the ATS Data, and analysis of the data, more widely available not only for Professionals and Vendors, but also for individual investors who can benefit from more detailed analysis of the ATS Data.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. FINRA believes that eliminating the fee may, in fact, remove potential burdens by widening access to the ATS Data, particularly for smaller firms that may not have been able to pay the existing Professional or Vendor fees.
As described above, FINRA is proposing to remove Rule 4553 to eliminate the fee for all potential users of ATS Data and disseminate the ATS Data on its Web site at no charge. Currently, FINRA makes this data available on its Web site and charges according to the three tiers described above. In the presence of this proposed rule change, the ATS Data will continue to be made available, and FINRA will seek no fees for its usage. FINRA anticipates that the demand for the ATS Data will increase in the absence of professional and vendor fees.
FINRA believes that eliminating the fee for Professionals and Vendors to access ATS Data will extend the impact of transparency in the over-the-counter market and will not result in any burden on FINRA members or the public. Yet, investors may benefit from an externality if the wider availability of the ATS Data leads to an increased production of relevant analysis by professionals.
FINRA would incur no additional costs as a result of the proposed rule change, as FINRA already aggregates and publishes the ATS Data on a weekly basis; however, FINRA will forego the revenue that partially covers the cost of maintaining the ATS Data, although both the cost and revenue have been non-material since the data dissemination started in June 2014. FINRA's experience in the past year suggests that the marginal costs to provide this information to the public is de minimis, with no material impact to its budget or members.
Although written comments were not solicited regarding the elimination of Rule 4553, FINRA has received one comment letter since the adoption of Rule 4553 that addresses the current fee structure for access to ATS Data.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to correct an inaccurate rule reference in its Fees Schedule. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to make an administrative change to correct an incorrect rule reference in its Fees Schedule. Specifically, the Exchange notes it recently streamlined part of its Fees Schedule by consolidating certain sections in order to make the Fees Schedule easier to read.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes correcting an inaccurate rule reference will help to avoid confusion, thereby removing impediments to and perfecting the mechanism of a free and open market and a national market system. Additionally, the Exchange notes that no substantive changes are being made by the proposed rule change.
C2 does not believe that the proposed rule change will impose any burden on intramarket or intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed change to correct an inaccurate rule reference and alleviate confusion is not intended for competitive reasons and only applies to C2. The Exchange also notes that no rights or obligations of Permit Holders are affected by the change.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend Rules 21.1(d)(9), (h) and (i) to modify the operation of BATS Post Only Orders subject to the Price Adjust process on the Exchange's options platform (“BATS Options”). The proposed rule change is based on the operation of similar order types currently offered by the Nasdaq Stock Market LLC (“Nasdaq”) and Nasdaq OMX BX, Inc. (“BX”).
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to amend Rules 21.1(d)(9), (h) and (i) to modify the operation of BATS Post Only Orders that are subject to the Price Adjust process on BATS Options. The proposed rule change is based on the operation of similar order types currently offered by Nasdaq and BX.
BATS Post Only Orders are orders that are to be ranked and executed on the Exchange pursuant to Rule 21.8 (Order Display and Book Processing) or cancelled, as appropriate, without routing away to another trading center. Currently, a BATS Post Only Order will not remove liquidity from the BATS Options Book
The Exchange proposes to amend the operation of BATS Post Only Orders such that they will not remove liquidity from the BATS Options Book where the User elects that the order be subject to the Price Adjust process set forth under Exchange Rule 21.1(i). Specifically, a BATS Post Only Order subject to the Price Adjust process will no longer remove liquidity from the BATS Options Book pursuant to Rule 21.1(d)(9) where the value of price improvement associated with such execution equals or exceeds the sum of fees charged for such execution and the value of any rebate that would be provided if the order posted to the BATS Options Book and subsequently provided liquidity. Under the Price Adjust process, a BATS Post Only order that locks or crosses a Protected Quotation displayed by the Exchange upon entry will continue to be ranked and displayed by the System at one minimum price variation below the current NBO (for bids) or to one minimum price variation above the current NBB (for offers). As a result, the Exchange proposes to amend: (i) The description of BATS Post Only Orders under Rule 21.1(d)(9) to specify that the price improvement formula described above would only be applied to BATS Post Only Orders subject to the Display-Price Sliding process; (ii) the description of the Price Adjust process under Rule 21.1(i)(4) to no longer state that a BATS Post Only Order subject to the Price Adjust process would be executed as set forth in Rule 21.1(d)(9); and (iii) Rule 21.1(h) to clarify it is limited to BATS Post Only Orders subject to the Display-Price Sliding process.
The Exchange does not propose to amend the operation of BATS Post Only Orders subject to the Display-Price Sliding process. A BATS Post Only Order subject to the Display-Price Sliding process that locks or crosses a Protected Quotation displayed by the Exchange upon entry will either remove liquidity from the BATS Options Book pursuant to Rule 21.1(d)(9) or be cancelled. Should the order lock or cross a Protected Quotation displayed by an external market upon entry, it will be subject to the Display-Price Sliding process described in Rule 21.1(h). A BATS Post Only Order subject to the Display-Price Sliding process would continue to be cancelled where the NBBO changes such that the order would be ranked at a price at which it could remove displayed liquidity from the BATS Options Book.
The Exchange does, however, propose to amend the description of the Display-Price Sliding process under Rule 21.1(h)(4) to specify that a Partial Post Only at Limit Order that locks or crosses a Protected Quotation displayed by the Exchange upon entry will be executed subject to the price improvement formula set forth in Rule 21.1(d)(10) or cancelled when the order is subject to display-price sliding process. The Exchange does not propose to modify the operation of Partial Post Only at Limit Orders that are subject to the Display-Price Sliding Process.
The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of section 6(b) of the Act.
Lastly, the Exchange believes the proposed amendment to Rule 21.1(h)(4) specifying that it applies to Partial Post Only at Limit Orders that are subject to the Display-Price Sliding process also promotes just and equitable principles of trade, and perfects the mechanism of a free and open market and a national market system because it provides additional specificity to the rule and does not modify the operation of Partial Post Only at Limit Orders that are subject to the Display-Price Sliding Process.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the proposed rule change is a competitive change that is based on the operation of similar order types currently offered by Nasdaq and BX.
The Exchange has neither solicited nor received written comments on the proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The Exchange has designated this rule filing as non-controversial under section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily temporarily suspend such rule change if it appears to the Commission that such action is: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to amend FINRA Rule 7650A (Collection of Fees) to require FINRA members that are FINRA/Nasdaq Trade Reporting Facility (“FINRA/Nasdaq TRF”) participants to submit billing disputes within sixty days of receipt of the invoice to the FINRA/Nasdaq TRF. The proposed rule change also would rename Rule 7650A as “Collection of Fees and Billing Policy.”
The text of the proposed rule change is available on FINRA's Web site at
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The FINRA/Nasdaq TRF is a facility of FINRA that is operated by The NASDAQ OMX Group, Inc. (“NASDAQ OMX”). In connection with the establishment of the FINRA/Nasdaq TRF, FINRA and NASDAQ OMX entered into a limited liability company agreement (the “LLC Agreement”). Under the LLC Agreement, FINRA, the “SRO Member,” has sole regulatory responsibility for the FINRA/Nasdaq TRF. NASDAQ OMX, the “Business Member,” is primarily responsible for the management of the FINRA/Nasdaq TRF's business affairs to the extent those affairs are not inconsistent with the regulatory and oversight functions of FINRA. As such, the Business Member establishes pricing for use of the FINRA/
Pursuant to the FINRA Rule 7600A Series, FINRA members that are FINRA/Nasdaq TRF participants are charged fees (Rule 7620A) and also may qualify for credits for trade reporting to the FINRA/Nasdaq TRF (Rule 7610A). These rules are administered by NASDAQ OMX, in its capacity as the “Business Member” and operator of the FINRA/Nasdaq TRF on behalf of FINRA,
On June 23, 2015, FINRA filed a proposed rule change to adopt Rule 7650A to require FINRA members that are FINRA/Nasdaq TRF participants to provide a clearing account number for an account at National Securities Clearing Corporation (“NSCC”) to the FINRA/Nasdaq TRF for purposes of permitting NASDAQ OMX, on behalf of the FINRA/Nasdaq TRF, to debit any undisputed or final fees due and owing under the FINRA Rule 7600A Series relating to the FINRA/Nasdaq TRF.
FINRA is proposing to amend Rule 7650A to add a new paragraph (b) to require all billing disputes to be submitted to the FINRA/Nasdaq TRF in writing
FINRA has filed the proposed rule change for immediate effectiveness and requested waiver of the 30-day operative delay. FINRA proposes that the proposed rule change will become operative on July 1, 2015. The proposed billing policy would apply to invoices for trade reporting activity occurring in July 2015 and thereafter.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. As described above, and consistent with the LLC Agreement, the proposed billing policy is identical to the billing policy NASDAQ OMX currently has in place for NOM participants and is also identical to the billing policy proposed by Nasdaq for Nasdaq equity participants under Nasdaq Stock Market rules. As the Business Member, NASDAQ OMX has the obligation of assessing the potential impacts of the proposed billing policy in its own rulemaking. FINRA notes that Nasdaq's billing policy was subject to proposed rule changes filed by Nasdaq with the Commission.
Consistent with SR-NASDAQ-2015-050, the proposed billing policy would apply uniformly to all members that are FINRA/Nasdaq TRF participants, as it does today with NOM participants and as proposed for Nasdaq equity participants. In addition, consistent with SR-NASDAQ-2015-050, the proposed billing policy would conserve FINRA/Nasdaq TRF resources, which are expended when untimely billing disputes require staff to research applicable fees and other information beyond two months after the invoice is issued.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative before 30 days from the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
FINRA has asked the Commission to waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. The proposed rule change proposes a billing policy that is identical to the billing policy proposed by Nasdaq relating to fees under Nasdaq Stock Market rules pursuant to SR-NASDAQ-2015-050. The operative date
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Arrin Corporation (CIK No. 1427433) (“ARRI”
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Gundaker/Jordan American Holdings, Inc. (a/k/a Jordan American Holdings, Inc.) (CIK No. 855663) (“JAHI”), a Florida corporation with its principal place of business in Excello, Missouri, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended September 30, 2005. On March 19, 2015, Corporation Finance sent a delinquency letter to JAHI requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission, but JAHI did not receive the delinquency letter due to its failure to maintain a valid address on file with the Commission as required by Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer Manual).
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Liberty Petroleum Corporation (CIK No. 59270) (“LBPE”), a Delaware corporation with its principal place of business in New York, New York, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended June 30, 1987. On August 24, 2012, Corporation Finance sent a delinquency letter to LBPE requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission, but LBPE did not receive the delinquency letter due to its failure to maintain a valid address on file with the Commission as required by Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer Manual).
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Mikojo Incorporated (CIK No. 1411085) (“MKJI”), a void Delaware corporation with its principal place of business in Foster City, California, with stock quoted on OTC Link, because it has not filed any periodic reports since the period ended March 31, 2011. On April 29, 2013, Corporation Finance sent a delinquency letter to MKJI requesting compliance with its periodic reporting
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Royal Invest International Corp. (CIK No. 1079574) (“RIIC”), a void Delaware corporation with its principal place of business in Westport, Connecticut, with stock quoted on OTC Link because it has not filed any periodic reports since the period ended September 30, 2010. On June 26, 2013, Corporation Finance sent a delinquency letter to RIIC requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission, but RIIC did not receive the delinquency letter due to its failure to maintain a valid address on file with the Commission as required by Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer Manual).
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of San Joaquin Bancorp (CIK No. 1368883) (“SJQU”), a suspended California corporation with its principal place of business in Bakersfield, California, with stock quoted on OTC Link because it has not filed any periodic reports since the period ended June 30, 2009. On June 26, 2013, Corporation Finance sent a delinquency letter to SJQU requesting compliance with its periodic reporting obligations at the address shown in its then-most recent filing with the Commission, but SJQU did not receive the delinquency letter due to its failure to maintain a valid address on file with the Commission as required by Commission rules (Rule 301 of Regulation S-T, 17 CFR 232.301 and Section 5.4 of the EDGAR Filer Manual).
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EDT on July 8, 2015, through 11:59 p.m. EDT on July 21, 2015.
By the Commission.
On May 12, 2015, Chicago Board Options Exchange, Incorporated (the “Exchange” or “CBOE”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the 45-day time period for Commission action on the proposed rule change. The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change, as modified by Amendment No. 1.
Accordingly, pursuant to Section 19(b)(2) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”),
The Commission is publishing this notice to solicit comments from interested persons on the proposed Amendment.
Historically, the Plan participants have not applied device fees to devices that receive consolidated volume (
However, some data redistributors include consolidated volume in displays of unconsolidated last sale prices and/or unconsolidated bid-asked quotes, such as displays of one exchange's trade prices and quotes.
Such displays, whether displayed internally or externally, could mislead investors in respect of the nature of the information they are viewing. A significant number of data users receive proprietary trade prices and quotes. Unless the data users understand the content being displayed, they could mistakenly think that they are seeing consolidated trades and quotes because they see consolidated volume without any explanation.
To make the displays transparent and less likely to mislead, the Approving Participants have determined to require data redistributors that include consolidated volume in displays of unconsolidated prices and quotes to incorporate into those displays the following statement (or a close iteration of the statement that the network administrator(s) have approved): “Realtime quote and/or trade prices are not sourced from all markets.”
A data redistributor must also assure that any person included in the redistribution chain starting with the data redistributor places the statement in any such display that it provides. The statement must be clearly visible to the end users so that they understand the differences in the data sources.
In addition, data redistributors need to assure that they, and any person or entity included in the redistribution chain starting with them, clearly incorporate the display statement into any advertisement, sales literature or other material displaying CTA Consolidated Volume alongside unconsolidated prices or quotes.
These requirements apply to both real-time and delayed displays of consolidated volume.
In order to ensure compliance with these requirements, the participants will require all recipients of the CTA last sale price datafeed (whether directly or indirectly) to submit a declaration. The participants will require those firms that include consolidated volume in displays of unconsolidated prices and quotes to submit to NYSE a screen print of the displays, showing the display statement. As this is a new requirement, the CTA Administrator will work with firms to facilitate their compliance.
A firm with access to CTA consolidated volume data must submit the declaration and, if applicable, the screen print within 120 days from the effective date of the amendment or within 30 days of the effective date of the firm's market data agreement with the participants that governs its receipt of the CTA datafeed (its “Vendor Agreement”). Thereafter, each firm must submit its declaration and, if applicable, its screen print annually by the 31st day of each January. The declaration and screen print (if applicable) must be submitted to
The Approving Participants' representatives met with SIFMA and the CTA Plan's Advisory Committee to discuss the consolidated volume requirements and responded to their questions. The Approving Participants shortened the display statement in response to comments and made clear that a datafeed recipient is free to provide an exchange's trading volume with displays of the exchanges trade prices and quotes, without the need to include a display requirement.
In order to motivate data recipients to comply with the display statement requirements, including the requisite declarations and screen submissions, the Approving Participants have determined to establish a non-compliance fee for each month of non-compliance. For each of Network A and Network B, the monthly fee is $3,000.
A datafeed recipient must submit the required screen prints by July 9, 2015
The non-compliance charges will be assessed against a data redistributor for each month in which it fails to provide the declaration or a copy of a Consolidated Volume screen print with the required display statement in a timely manner. The charge will also be assessed against a data redistributor each month for non-compliance by persons in the redistribution chain starting with the data redistributor where such persons have not entered into an applicable agreement with CTA.
The non-compliance charges seek to provide incentives for data redistributors to comply with the consolidated volume requirements. The Approving Participants do not view the non-compliance fee as establishing a new revenue source. Rather, they hope it encourages all data redistributors to submit their declarations and screen prints (where applicable) in a timely fashion. They hope that the fee will motivate non-compliant redistributors to adopt the same practices that the majority of redistributors follow.
The inclusion of delayed displays of consolidated volume in the consolidated volume requirements seeks to add clarity where a data redistributor accompanies displays of real-time unconsolidated prices and quotes with delayed consolidated volume. The Approving Participants seek to prevent that data redistributor from misleading investors while escaping the consolidated display requirements.
Not applicable.
Approving Participants have manifested their approval of the
The Approving Participants anticipate commencing to apply the compliance fee on data redistributors that fail to submit declarations or required screen prints by [DATE] [sic]. The Approving Participants will give notice of the compliance fee to all data redistributors no less than 120 days prior to its implementation.
The amendment will impose no burden on competition.
The participants have no written understandings or agreements between or among them relating to interpretation of the CTA Plan as a result of the amendment.
Section XII (b)(iii) of the CTA Plan provides that “[a]ny addition of any charge to . . . the charges set forth in Exhibit E . . . shall be effected by an amendment to this CTA Plan . . . that is approved by affirmative vote of not less than two-thirds of all of the then voting members of CTA. Any such amendment shall be executed on behalf of each Participant that appointed a voting member of CTA who approves such amendment and shall be filed with the SEC.”
The Approving Participants have executed this Amendment and represent not less than two-thirds of all of the parties to the Plan. That satisfies the Plan's participant-approval requirements.
Not applicable.
Not applicable.
The Approving Participants believe that the proposed compliance fee is fair and reasonable and provides for an equitable allocation of dues, fees, and other charges among vendors, data recipients and other persons using CTA Network A facilities. They intend that it will provide incentives for compliance with consolidated volume requirements. The charge will be applied uniformly to vendors, data recipients and other persons that fail to comply.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
Not applicable.
The Commission seeks general comments on the Amendment. Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed Amendment are consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Exchange Rule 612 to provide Enhanced Aggregate Risk Manager Protections for Exchange Market Makers.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 612, Aggregate Risk Manager (“ARM”) to provide optional enhanced risk protections for Exchange Market Makers.
The Exchange proposes to add new, optional enhanced functionality to the ARM by adopting new Interpretations and Policies .02 to Rule 612, entitled Enhanced Aggregate Risk Manager Protections. The proposed rule would address circumstances where a Market Maker experiences multiple, successive triggers of the Aggregate Risk Manager. The Enhanced ARM Protections would be triggered when the Allowable Engagement Percentage has been equaled or exceeded a specified number of times (not less than three times and not greater than 99 times) within a specified time period (not less than one second and not greater than 24,300 seconds) (each as determined by the Market Maker). For purposes of the Enhanced ARM Protections, the specified time period will be called the “ARM trigger counting period” in the rule.
The Enhanced ARM Protections may be engaged simultaneously and will operate independently of one another. The ARM trigger counting period may be set differently for each Enhanced ARM Protection when they are engaged simultaneously. The determination not to engage the Enhanced ARM Protections does not require any action on the part of Market Makers.
Current Interpretations and Policies .01 to Rule 612 states that eQuotes
All other eQuotes (Auction or Cancel,
Proposed Interpretations and Policies .02(a) would provide that a Market Maker may determine to engage the Class Protection feature for a particular option class in which the Market Maker is appointed (an “appointed option class”). When the Allowable Engagement Percentage in such appointed option class has been equaled or exceeded a specified number of times within the ARM trigger counting period, the Class Protection feature will remove the Market Maker's quotations from the Exchange's disseminated quotation in such appointed option class until the Market Maker instructs the Exchange (in a manner required by the Exchange and communicated to Members by Regulatory Circular) to reset the Class Protection feature. Additional quotations from the Market Maker in the affected class are not accepted until the Class Protection feature is reset.
The Class Protection feature is distinguished from the regular function of ARM because the ARM trigger counting period, during which the System counts the number of times ARM is triggered for the affected option class, usually would be longer than the “specified time period” described in Rule 612(a), during which the ARM counts executed contracts. The Class Protection feature is intended to alert Market Makers that there may be ongoing volatile or otherwise unusual market conditions that necessitate specific evaluation of their ARM settings, and of the conditions that result in the number of ARM triggers that occurred during the ARM trigger counting period.
The Class Protection feature removes quotes from the Exchange's disseminated quotation until the Market Maker instructs the Exchange (in a manner required by the Exchange and communicated to Members by Regulatory Circular) to reset the Class Protection feature.
The System will aggregate the specified number of times that the Allowable Engagement percentage has been equaled or exceeded in the Market Maker's specified number of unique appointed option classes within the ARM trigger counting period for an entire Market Maker organization. The Market Maker Protection feature will remove the Market Maker organization's quotations in all of the Market Maker organization's appointed option classes when the Allowable Engagement Percentage has been equaled or exceeded in the Market Maker organization's specified number of appointed option classes within the ARM trigger counting period, regardless of how many individual Market Makers in the same Market Maker organization are submitting quotations on MIAX. As with the Class Protection feature, and for the reasons described above, such quotes will be removed until the Market Maker instructs the Exchange (in a manner required by the Exchange and communicated to Members by Regulatory Circular) to reset the Market Maker Protection feature. Additional quotations from the Market Maker are not accepted until the Market Maker Protection feature is reset. One representative from a Market Maker organization may instruct the Exchange to reset the Market Maker Protection feature on behalf of his or her Market Maker organization.
Market Maker organization “Red, Inc.” has three individual Market Makers (“MMs”) properly registered on MIAX. Red, Inc. MM 1 is appointed in option classes A, B and C. Red, Inc. MM2 is appointed in option classes D, E, F, and G. Red, Inc. MM3 is appointed in option classes H and I. Assume Red, Inc. determines that the Market Maker Protection feature will be engaged when the Allowable Engagement Percentage is equaled or exceeded three times (as described below) within their designated ARM trigger counting period.
If within the ARM trigger counting period the Allowable Engagement Percentage is equaled or exceeded in option classes A, B, and C, the Market Maker Protection feature will remove Red Inc.'s quotations in all of its appointed option classes, (classes A through I), even though the only individual Market Maker affected is MM1, who is appointed in the three affected option classes.
If within the ARM trigger counting period the Allowable Engagement
In the event that the Allowable Engagement Percentage in one appointed option class is equaled or exceeded multiple times during the ARM trigger counting period, the System will consider such multiple events to be one single trigger for purposes of the activation of the Market Maker Protection feature. For example, if during the ARM trigger counting period there is one trigger in option class A, and there are five triggers in option class D, the System will calculate one trigger for option class A and just one trigger for option class D. Accordingly, the System will consider only two triggers to have occurred in Red, Inc.'s appointed option classes (one trigger in option class A, and one in option class D) during the ARM trigger counting period. In this example, the Market Maker Protection feature will not be engaged because Red, Inc. has determined that there must be three triggers during the ARM trigger counting period before the Market Maker Protection feature is to be activated. The purpose of this provision is to ensure that unusual activity or volatility in one particular appointed option class does not unnecessarily prompt the Market Maker Protection feature to remove a Market Maker or Market Maker organization's quotations from the Exchange's disseminated quotation in all of their other unaffected appointed option classes. In such a situation, the normal ARM functionality described in Exchange Rule 612 (or the Class Protection feature
The Exchange believes that the instant proposal should further assist Exchange Market Makers in managing their risk by establishing and making available additional risk management tools in the System. The Enhanced ARM Protection features will enable Exchange Market Makers to target a specific appointed option class, or all of its appointed option classes, for enhanced risk management and protection. This should assist Exchange Market Makers in targeting appointed option classes that could become extremely volatile under certain market conditions or when market events, news or other factors affect a Market Maker's ability to manage risk. The Enhanced ARM Protections are intended to address both foreseeable and unforeseeable market conditions in general, and can be tailored to meet the risk management needs of Exchange Market Makers and Market Maker organizations.
The Exchange will announce the implementation date of the proposed rule change by Regulatory Circular to be published no later than 60 days following the operative date of the proposed rule. The implementation date will be no later than 60 days following the issuance of the Regulatory Circular.
MIAX believes that its proposed rule change is consistent with section 6(b) of the Act
The Exchange believes that Members will benefit from the proposed Enhanced Aggregate Risk Manager Protections. Market Makers, who are obligated to submit continuous two-sided quotations in a certain number of series in their appointed option classes for a certain percentage of each trading session,
Without adequate risk management tools in place on the Exchange, such as the existing ARM and the proposed Enhanced ARM Protections, the incentive for Exchange Market Makers to quote aggressively respecting both price and size could be diminished, and could result in a concomitant reduction in the depth and liquidity they provide to the market. Such a result may undermine the quality of the markets that would otherwise be available to customers and other market participants. Accordingly, the Exchange proposes the Enhanced ARM Protections to help Market Makers better manage their risk exposure and thus encourage Market Makers to provide additional depth and liquidity to the Exchange's markets, thereby removing impediments to and perfecting the mechanisms of a free and open market and a national market system and, in general, protecting investors and the public interest.
In addition, the Enhanced ARM Protections promote just and equitable principles of trade by providing Exchange Market Makers with more risk management mechanisms available on the Exchange to give them confidence that protections are in place to reduce the risks associated with their Market Making obligations. The Exchange notes that the implementation and use of the Enhanced ARM Protections will not relieve Exchange Market Makers of their continuous quoting obligations under Exchange Rule 604 and under Reg NMS Rule 602.
Finally, the proposed Enhanced ARM Protections are designed to protect investors and the public interest by helping Market Makers prevent executions resulting from activity that exceeds their risk tolerance level under these rules as established by the Exchange.
With regard to the impact of this proposal on system capacity, the Exchange notes that it has analyzed its capacity and represents that it and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle any potential additional traffic associated with the proposed rule change. The Exchange believes that its members will not have a capacity issue as a result of this proposal.
The Exchange does not believe that the proposed rule change will impose
On the contrary, the Exchange believes that the proposed Enhanced ARM Protections will foster competition by providing Exchange Market Makers with an additional set of tools to use in submitting quotations with the best possible price and size in order to compete for executions and order flow. The Exchange believes the proposed Enhanced ARM Protections will not impose any burden on intra-market competition because its use is voluntary and is available to all Exchange Market Makers and Market Maker organizations.
The Exchange notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues who offer similar functionality. As to inter-market competition, the Exchange believes that the proposed Enhanced ARM Protections should promote competition because they are designed to protect Exchange Market Makers from unusual market conditions or events that may cause them to receive multiple, automatic executions before they can adjust their quotation exposure in the market.
For all the reasons stated, the Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, and believes the proposed change will in fact enhance competition.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to revert recently-increased fees assessed under Rules 7015(b) and (g) to their levels prior to the fee increase and to retroactively apply the lower fees in light of delays in implementing hardware upgrades.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On April 22, 2015, NASDAQ filed a rule change that increased the port fees assessed members and non-members for ports used to enter orders into NASDAQ systems, in connection with the use of FIX and OUCH trading telecommunication protocols.
The Exchange had anticipated purchasing and installing FPGA hardware by May 2015, however, NASDAQ encountered an unanticipated delay in implementation. As a consequence, the Exchange was unable to implement the upgraded hardware in May; however, the increased fees assessed to recoup costs arising from the upgrade remain in place. NASDAQ does not believe that it is appropriate to assess the increased fees under Rules 7015(b) and (g) in the absence of the FPGA hardware upgrade, which, as noted, was the basis for increasing the fees.
NASDAQ believes that the proposed rule changes are consistent with the provisions of Section 6 of the Act,
The Exchange believes that reverting the fees assessed for FIX and OUCH ports under Rules 7015(b) and (g), respectively, back to their prior levels and retroactively applying those lower fees is reasonable because NASDAQ has not provided the upgraded hardware to date, the cost of which was the basis for increasing the fees under Rules 7015(b) and (g). In addition, applying the lower fees will allow NASDAQ to keep the fee increase in line with its realized capital and operating expenditures, which have not increased as a result of the delayed implementation of the upgrade. The Exchange believes that the proposed reduction of the fees to their prior levels and retroactive application thereof is both equitably allocated and not unfairly discriminatory because it will apply uniformly to all market participants that subscribe to FIX and OUCH ports based on the number of such ports subscribed. Accordingly, such market participants will be assessed the fees in place prior to the increase and will continue to have the same hardware supported by those fees.
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The Exchange believes that the proposal is irrelevant to competition because it is not driven by, and will have no impact on, competition. Specifically, the Exchange is reverting fees to their prior, lower levels and applying them retroactively in light of delays in implementing upgrades to NASDAQ systems, the cost of which was the basis for fee increase. Reverting the fees to their lower levels will keep the fees assessed in line with the Exchange's expenditures at this juncture associated with upgrading to FPGA hardware. As such, the Exchange does not believe the proposed change will have any impact on competition, as market participants will be assessed the same fee for their FIX and OUCH ports with the same hardware that was in place prior to the fee increase.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative before 30 days from the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
The Exchange has asked the Commission to waive the 30-day operative delay. The Commission believes that waiving the 30-day operative delay is consistent with the
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Office of the United States Trade Representative.
Determination Regarding Waiver of Discriminatory Purchasing Requirements under the Trade Agreements Act of 1979.
Scott Pietan, Director of International Procurement Policy, Office of the United States Trade Representative, (202) 395-9646.
On October 29, 2014, the WTO Committee on Government Procurement approved the accession of Montenegro to the World Trade Organization (“WTO”) Agreement on Government Procurement (“GPA”). Montenegro submitted its instrument of accession to the Secretary-General of the WTO on June 15, 2015. The GPA will enter into force for Montenegro on July 15, 2015. The United States, which is also a party to the GPA, has agreed to waive discriminatory purchasing requirements for eligible products and suppliers of Montenegro beginning on July 15, 2015.
Section 1-201 of Executive Order 12260 of December 31, 1980 delegated the functions of the President under sections 301 and 302 of the Trade Agreements Act of 1979 (“the Trade Agreements Act”) (19 U.S.C. 2511, 2512) to the United States Trade Representative.
1. Montenegro has become a party to the GPA and will provide appropriate reciprocal competitive government procurement opportunities to United States products and services and suppliers of such products and services. In accordance with section 301(b)(1) of the Trade Agreements Act, Montenegro is so designated for purposes of section 301(a) of the Trade Agreements Act.
2. Accordingly, beginning on July 15, 2015, with respect to eligible products (namely, those goods and services covered under the GPA for procurement by the United States) of Montenegro and suppliers of such products, the application of any law, regulation, procedure, or practice regarding government procurement that would, if applied to such products and suppliers, result in treatment less favorable than that accorded—
(A) To United States products and suppliers of such products, or
(B) To eligible products of another foreign country or instrumentality which is a party to the GPA and suppliers of such products, shall be waived. This waiver shall be applied by all entities listed in United States Annexes 1 and 3 of GPA Appendix 1.
3. The Trade Representative may modify or withdraw the designation in paragraph 1 and the waiver in paragraph 2.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Twenty-Third Meeting Notice of Special Committee 214.
The FAA is issuing this notice to advise the public of the twenty-third meeting of the Special Committee 214.
The meeting will be held August 31st-September 4th from 9:00 a.m.-5:00 p.m.
The meeting will be held at RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036, Tel: (202) 330-0663.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Special Committee 214. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14, Code of Federal Regulations (14 CFR). The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number involved and must be received on or before July 30, 2015.
You may send comments identified by docket number FAA-2015-0469 using any of the following methods:
•
•
•
•
Deana Stedman, ANM-113, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356, email
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Sixth Meeting Notice of Special Committee 231.
The FAA is issuing this notice to advise the public of the sixth meeting of the Special Committee 231.
The meeting will be held September 22nd-September 24th from 9:00 a.m.-5:00 p.m.
The meeting will be held at RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036, Tel: (202) 330-0663.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Special Committee 231. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Highway Administration (FHWA), U.S. DOT.
Notice of Limitation on Claims for Judicial Review of Actions by TxDOT and Federal Agencies.
This notice announces actions taken by Texas Department of Transportation (TxDOT) and Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, US 69/Loop 49 North Lindale Reliever Route, Smith County, Texas. Those actions grant licenses, permits, and approvals for the project.
By this notice, TxDOT is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before December 7, 2015. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mr. Carlos Swonke, P.G., Environmental Affairs Division, Texas Department of Transportation, 125 East 11th Street, Austin, Texas 78701; telephone: (512) 416-2734; email:
Notice is hereby given that TxDOT and Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following highway project in the State of Texas: US 69/Loop 49 North Lindale Reliever Route, Smith County, Texas. The project will construct a new location, full control of access reliever route around the city of Lindale in Smith County, Texas, referred to as U.S. Highway (US) 69/Loop 49 North Lindale Reliever Route (Lindale Reliever Route). The proposed action is intended to provide relief to the existing US 69 through the city of Lindale and extend a proposed toll facility (Loop 49 West) from Interstate Highway (IH) 20 southwest of Lindale to US 69 north of Lindale, a distance of approximately seven miles.
The actions by TxDOT and the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Impact Statement (FEIS) for the project, approved on February 10, 2015, in the Record of Decision (ROD) issued on April 24, 2015, and in other documents in the TxDOT administrative record. The FEIS, ROD, and other documents in the administrative record file are available by contacting TxDOT at the address provided above. The FEIS and ROD can be viewed on the project Web site at
1. General: National Environmental Policy Act (NEPA) [42 U.S.C. 4321-4351]; Federal-Aid Highway Act [23 U.S.C. 109].
2. Air: Clean Air Act [42 U.S.C. 7401-7671(q)].
3. Land: Section 4(f) of the Department of Transportation Act of 1966 [49 U.S.C. 303]; Landscaping and Scenic Enhancement (Wildflowers), 23 U.S.C. 319.
4. Wildlife: Endangered Species Act [16 U.S.C. 1531-1544 and Section 1536]; Fish and Wildlife Coordination Act [16 U.S.C. 661-667(d)]; Migratory Bird Treaty Act [16 U.S.C. 703-712].
5. Historic and Cultural Resources: Section 106 of the National Historic Preservation Act of 1966, as amended [16 U.S.C. 470(f)
6. Social and Economic: Civil Rights Act of 1964 [42 U.S.C. 2000(d)-2000(d)(1)]; American Indian Religious Freedom Act [42 U.S.C. 1996]; Farmland
7. Wetlands and Water Resources: Land and Water Conservation Fund (LWCF) [16 U.S.C. 4601-4604]; Safe Drinking Water Act (SDWA) [42 U.S.C. 300(f)-300(j)(6)]; Rivers and Harbors Act of 1899 [33 U.S.C. 401-406]; Wild and Scenic Rivers Act [16 U.S.C. 1271-1287]; Emergency Wetlands Resources Act [16 U.S.C. 3921, 3931]; TEA-21 Wetlands Mitigation [23 U.S.C. 103(b)(6)(m), 133(b)(11)]; Flood Disaster Protection Act [42 U.S.C. 4001-4128].
8. Executive Orders: E.O. 11990, Protection of Wetlands; E.O. 11988, Floodplain Management; E.O. 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations; E.O. 11593, Protection and Enhancement of Cultural Resources; E.O. 13007, Indian Sacred Sites; E.O. 13287, Preserve America; E.O. 13175, Consultation and Coordination with Indian Tribal Governments; E.O. 11514, Protection and Enhancement of Environmental Quality; E.O. 13112, Invasive Species; E.O. 12372, Intergovernmental Review of Federal Programs.
The environmental review, consultation, and other actions required by applicable Federal environmental laws for this project are being, or have been, carried-out by TxDOT pursuant to 23 U.S.C. 327 and a Memorandum of Understanding dated December 16, 2014, and executed by FHWA and TxDOT.
23 U.S.C. 139(l)(1).
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Denial of petition.
RECARO Child Safety, LLC (Recaro) determined that certain Recaro child restraints do not fully comply with the system integrity requirements of paragraph S5.1.1(a) of Federal Motor Vehicle Safety Standard (FMVSS) No. 213,
For further information on this decision contact Zachary Fraser, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5754, facsimile (202) 366-5930.
I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see implementing rule at 49 CFR part 556), Recaro submitted a petition for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis of the petitioner's belief that this noncompliance is inconsequential to motor vehicle safety.
Notice of receipt of the petition was published, with a 30-day public comment period, on November 21, 2014 in the
II. Child Restraints Involved: Affected are approximately 78,339 Recaro ProRIDE child restraints manufactured between April 9, 2010 and July 8, 2014, and approximately 42,303 Recaro Performance RIDE child restraints manufactured between January 15, 2013 and July 8, 2014.
III. Noncompliance: Recaro explains that the subject child restraints do not comply with the system integrity requirements of FMVSS No. 213, paragraph S5.1.1(a), when subjected to the dynamic test requirements of FMVSS No. 213 S6.1. During NHTSA's compliance tests with the Hybrid II six-year-old child dummy and the Hybrid III weighted six-year-old child dummy connected to the child restraints with the internal harness and the child restraints attached to the test bench with a lap belt and top tether, the tether belt separated at the attachment point to the child restraints. The top tether belt separation exhibited a complete separation of a load bearing structural element. Therefore, the child restraints do not comply with the requirements set forth in FMVSS No. 213 S5.1.1(a).
IV. Rule Text: Paragraph S5.1.1 of FMVSS No. 213 requires, in pertinent part:
S5.1.1 Child restraint system integrity. When tested in accordance with S6.1, each child restraint system shall meet the requirements of paragraphs (a) through (c) of this section.
(a) Exhibit no complete separation of any load bearing structural element and no partial separation exposing either surfaces with a radius of less than 1/4 inch or surfaces with protrusions greater than 3/8 inch above the immediate adjacent surrounding contactable surface of any structural element of the system.
Under S6.1 of FMVSS No. 213, NHTSA tests child restraints with a child test dummy selected for use in accordance with the provisions of S7 of the standard. Under S7, the selection is based on the heights and weights of the children for whom the child restraint is sold. Under S7.1.2(d), NHTSA uses the Hybrid II (HII) or Hybrid III (HIII) six-year-old child test dummy to test CRSs recommended for children with masses greater than 18 kg (40 lb). Under S7.1.2(e), NHTSA uses the HIII weighted six-year-old child test dummy to test CRSs for children with masses above 22.7 kg (50 lb). The children for whom Recaro sold the subject CRSs included children with masses from 18 kilograms (kg) (40 pounds (lb)) to 30 kg (65 lb). Thus, under FMVSS No. 213, Recaro's child restraints were required to meet the child restraint system integrity requirements of FMVSS No. 213 when tested with the six-year-old
V. Summary of Recaro's Position: Recaro believes that the subject noncompliance is inconsequential to motor vehicle safety for the following reasons.
(A) Recaro believes that the FMVSS No. 213 test procedure “is a direct violation of the instructions and warnings included with each ProRIDE and Performance RIDE child restraint and would constitute a misuse of the child restraint by the consumer.” Petitioner refers to page 36 of the ProRIDE/Performance RIDE instruction manuals and states that Recaro designed and tested the ProRIDE/Performance RIDE child restraints “to meet FMVSS requirements when tested according to the instruction manual.” Recaro highlights a statement on page 36 that states: “Additionally, LATCH and top tether anchors are designed to a maximum limit which can vary by vehicle. Due to this variation, RECARO requires use of the vehicle seat belt for any child weighing more than 52 lbs (23.6 kg).”
(B) Recaro states that “post-crash structural integrity of the occupant compartment is more insignificant to safety when compared to the injury values and excursion data gathered from testing.” Petitioner also states that “technology has shown repeatedly that collapse, breakage, and crumpling of material minimizes energy and increases the rate of survival for the occupant in the event of a collision.” Recaro believes that child restraint technology has fallen in-line with vehicle technology in recent years and that other child restraints have been designated “compliant” even though their convertible shell-to-base connection has been designed to crack and break during the peak loading in a crash. Recaro further states that the top tether webbing has been designed to rip and break apart under extreme loads to allow the deceleration time to increase for the occupant in the crash event. Petitioner states that, “As long as the injury criterion meets industry standards, controlled breakage has proven multiple times to be a positive outcome in the event of a vehicle crash, as seen in the RIDE platform.”
(C) Recaro states that the “2013 LATCH Manual” published by Safe Ride News Publication “confirms that top tether anchors in vehicles are becoming limited more frequently in the weight to which they can be subjected.” Recaro argues that “a majority of vehicles on the road instruct consumers to use top tether with load limit restrictions that align with RECARO's top tether load limit of 65 pounds minus the 20 pound weight of the child restraint equaling a 45 pound load limit.” Recaro also refers to documents NHTSA placed in Docket No. NHTSA-2011-0176 regarding a 2012 final rule amending FMVSS No. 213 (77 FR 11626, February 27, 2012). Petitioner believes that the documents “give validation to the reasoning by RECARO to limit the use of the top tether.”
(D) Recaro states that it is aware that NHTSA has a clear precedent of denying child restraint manufacturers' petitions for inconsequential noncompliance concerning top tether separation. However, Recaro believes that “the environment in which those decisions were made has changed.” Recaro claims that the methodology it uses to limit top tether loads actually increases safe installations of child restraints by limiting the pounds of force applied and decreasing the chance tether anchor load failures. Recaro also believes that in the event of tether separation, the increase to risk of safety is non-existent because the head excursion limits were not exceeded in NHTSA's compliance tests. Petitioner indicates that the risk of the subject child restraints impacting objects in the vehicle is identical to, or better than, other compliant child restraints because both restraints meet the same head excursion requirements.
Recaro states that in a previous denial of a petition for inconsequential noncompliance, NHTSA noted that if it granted the petition it would be contradictory to NHTSA's mission to promote greater use of LATCH and tether. Recaro believes that this reasoning is no longer relevant because in the aftermath of the February 2012 final rule, “consumers are now more aware of the variation of tether load limits by vehicle manufacturers and consumers are also now becoming accustomed to reviewing limits to the LATCH system. This falls in line with the information and limits in the owner's manual provided with the ProRIDE and Performance RIDE.”
(E) Recaro states that its accident reports for the four years that the subject restraints have been on the market indicate no incidents of separation in the tether anchorage area. Petitioner surmises the reason that tether separation occurs in testing is due to an outdated test bench seat and testing apparatus.
In summation, Recaro believes that the described noncompliance of the subject child restraints is inconsequential to motor vehicle safety, and that its petition to exempt Recaro from providing recall notification of noncompliance, as required by 49 U.S.C. 30118, and remedying the recall noncompliance, as required by 49 U.S.C. 30120, should be granted.
VI. NHTSA Decision:
We will now specifically address each of Recaro's arguments in the order presented in its petition.
(A) Recaro first characterizes NHTSA's installation of the ProRIDE and Performance RIDE with a top tether as “a direct violation of the instructions and warnings . . . and would constitute a misuse” condition. The petitioner's reasoning is unpersuasive. Recaro apparently argues (the petitioner's arguments are unclear) that NHTSA should not have tested the child restraints attached to the test seat assembly with a lap belt and tether because the manufacturer instructs consumers to use the “vehicle seat belt for any child weighing more than 52 lbs (23.6 kg).” The petitioner is unclear but we surmise that Recaro is saying that because it instructs users not to use the top tether with children weighing more than 52 lb, NHTSA's tethering the CRS was in error.
This view constitutes an incorrect reading of FMVSS No. 213. FMVSS No. 213 requires that the ProRIDE/Performance RIDE meet FMVSS No. 213's dynamic test requirements when installed as specified by the standard. Recaro recommended (marketed) the ProRIDE/Performance RIDE child restraints for children with masses from 18 kg (40 lb) to 30 kg (65 lb). Under FMVSS No. 213, child restraints sold for children in this mass range are required to meet the standard's performance requirements, including the system integrity requirements, when tested with the six-year-old and weighted six-year-old test dummies. These test dummies represent the children for whom the child restraint is sold, and are used by NHTSA to assess the performance of the child restraint in protecting children intended for the restraint. If a top tether is necessary to meet FMVSS No. 213's 720 millimeter (mm) (28 inch) head excursion requirement,
If Recaro did not wish to have its child restraints tested with the six-year-old and weighted six-year-old test dummies in the tethered condition, the manufacturer could have recommended its CRSs for children weighing up to 18 kg (40 lb), not 30 kg (65 lb). Since Recaro marketed the CRS as suitable for children over 18 kg (40 lb), the manufacturer is responsible for ensuring that its CRSs meet all the requirements of FMVSS No. 213 when tested as specified by FMVSS No. 213, and cannot absolve itself of those responsibilities by using its instruction manual to limit NHTSA's assessment of the CRS in a compliance test.
Mr. Stewart states in his comment opposing the petition that, “If a manufacturer is allowed to bypass FMVSS 213 standards simply by mandating or prohibiting certain actions in the instruction manual, what is the point of having standards?” NHTSA concurs with the commenter that FMVSS No. 213's effectiveness would be substantially diminished if manufacturers were generally permitted to bypass the standard's requirements simply by mandating or prohibiting certain actions in the instruction manual.
The ProRIDE/Performance RIDE demonstrated structural integrity failure when the top tether belt separated at the attachment point to the child restraints. The top tether belt separation exhibited a complete separation of a load bearing structural element and therefore does not comply with the requirements set forth in paragraph S5.1.1(a) of FMVSS No. 213. Failure of a child restraint system in this manner increases the likelihood of head injury to the occupant, which is not insignificant or inconsequential to safety.
(B) NHTSA does not agree with Recaro's line of reasoning that its petition should be granted because “technology has shown repeatedly that collapse, breakage, and crumpling of material minimizes energy and increases the rate of survival for the occupant in the event of a collision.” The agency has consistently viewed tether strap separation in FMVSS No. 213 sled tests as a load bearing structural failure. A portion of the load of the child restraint and dummy is transferred to the vehicle by the top tether. A tether attachment failure in a compliance sled test indicates that the minimum level of occupant protection established by FMVSS No. 213 has not been provided.
In requiring the upper tether anchorage on vehicles and the tether strap on CRSs, NHTSA noted that, “Test data show that an attached tether substantially improves the ability of a child restraint to protect against head impacts in a crash.”
In its comment, Advocates states that—
The damage to the child restraints in this case is unrelated to controlled breakage, of the RECARO restraint. For one thing, RECARO does not assert that the complete separation of the upper tether was a planned design feature of the child restraint. In addition, many other manufacturers have made use of controlled breakage techniques while still meeting all federal regulations. In this case, the failure of the top tether was not planned and its failure mode is not compliant with federal regulation. The consequences of unplanned, uncontrolled complete separation of a load bearing structural element are unknown and can be significantly dangerous if the failure leads to components becoming projectiles in the vehicle or if the failure induces a shock load to other load bearing structural elements.
NHTSA concurs with Advocates' observation that the ripping out of the top tether on the Recaro CRSs was likely an unplanned, uncontrolled event, far from a sought-after engineering feat of child restraint technology.
Moreover, FMVSS No. 213 does recognize the role that purposeful breakage in child restraint design can have in improving energy absorption performance. However, such breakage is and must be limited by the standard. S5.1.1 permits partial separations that do not result in sharp edges that may contact an occupant. Breakage of the CRS such as that demonstrated by the Recaro child restraints demonstrates a lack of system integrity and is prohibited by S5.1.1, FMVSS No. 213.
We disagree with Recaro's statement that “post-crash structural integrity of the occupant compartment is more insignificant to safety when compared to the injury values and excursion data gathered from testing.” Each of the requirements in FMVSS No. 213 addresses a safety need. The commenters address this issue well. Advocates states: “NHTSA specifically included the prohibition against complete separation of any load bearing structural element specifically because the dangers associated with this occurrence were not addressed by the injury criteria alone.” Mr. Stewart observes: “If a seat breaks in half during testing but the dummy records lower injury measurement does the manufacturer get away with claiming that they designed it to break in half on purpose—as a way to manage energy?” Child restraints must be able to hold together in a crash and safely manage the crash forces on the child occupant. To accomplish this, all requirements of the standard must be met.
We further note that the weighted six-year-old child test dummy is not instrumented and is not used to measure injury values and excursion limits when testing CRSs under FMVSS No. 213.
NHTSA has taken enforcement action for similar failures. In 2001, the agency notified Britax Child Safety, Inc., (Britax) of a potential noncompliance due to the detachment of a tether strap during dynamic testing of one of its child restraint models. Britax initiated a recall campaign to provide owners of the affected model with repair kits. In 2007, the agency notified Britax of a potential noncompliance due to the tether hook opening during dynamic testing of one of its child restraint models. Britax initiated a recall campaign to provide owners of the affected model with new tether hooks.
(C) The materials cited by the petitioner have no bearing on the merits of Recaro's petition. As explained above in NHTSA's response to Recaro's first argument, FMVSS No. 213 requires that the ProRIDE and Performance RIDE child restraints meet the structural integrity requirements when installed with the top tether. NHTSA does not know of any current material published on use of child restraint top tethers that supports not using the child restraint's top tether.
(D) Recaro's statement that “the environment in which [previous denials of inconsequentiality petitions on tether failures] were made has changed” is incorrect. NHTSA does not know of any current material published on use of child restraint top tethers that supports not using the child restraint's top tether. Moreover, granting the petition would be contradictory to NHTSA's mission to promote greater use of the top tether.
(E) The shortcoming in Recaro's design to meet the applicable FMVSS No. 213 dynamic test requirements poses an unacceptable safety risk. The risk exists and is unacceptable even if there has been no incident of separation in the tether anchorage area thus far.
(49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8)
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of public meeting.
The National Highway Traffic Safety Administration (NHTSA) is announcing a meeting that will be held in Washington, DC on July 23, 2015 to address the challenges and barriers that have prevented schools from taking action to install three-point seat belt systems in school buses. The workshop will include presentations and discussions on the topic. Information on the date, time, location, and framework for this public event is included in this notice. Attendance requires prior registration; there will be no registration at the door. There are no fees to register or to attend this event; however space is limited on a first-come basis. The meeting will also be webcast live at
The workshop will be held on July 23, 2015, at the location indicated in the
The July 23, 2015 meeting will be held in the Media Center of the U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590.
If you would like to attend the workshop, please contact Pei Lee by the date specified under
NHTSA is hosting a meeting to address the challenges and barriers that have prevented schools from taking action to install three-point seat belt systems in school buses.
This meeting will update the current state of knowledge regarding occupant protection technology on school buses, identify operational challenges, and explore new approaches for funding mechanisms. The meeting will explore topics such as seating capacity loss, which in the past has prevented many States and school districts from considering three-point belt systems as an option, communication strategies to reach parents and children, and new training programs that may be needed for bus drivers and students. Additionally, the National Transportation Safety Board has been invited to present on their findings and recommendations from investigations of school bus crashes.
To attend this workshop, please register with NHTSA by the date specified under the
For security purposes, photo identification is required to enter the Department of Transportation building. To allow sufficient time to clear security and enter the building, NHTSA recommends that workshop participants arrive 30 to 60 minutes prior to the start of the event.
49 U.S.C. 30182.
The Surface Transportation Board (STB) is publishing the annual inflation-adjusted index factors for 2014. These factors are used by the railroads to adjust their gross annual operating revenues for classification purposes. This indexing methodology ensures that railroads are classified based on real business expansion and not from the effects of inflation. Classification is important because it determines the extent to which individual railroads must comply with STB reporting requirements.
The STB's annual inflation-adjusted factors are based on the annual average Railroad's Freight Price Index which is developed by the Bureau of Labor Statistics (BLS). The STB's deflator factor is used to deflate revenues for comparison with established revenue thresholds.
The base year for railroads is 1991. The inflation index factors are presented as follows:
Pedro Ramirez 202-245-0333. [Federal Information Relay Service (FIRS) for the hearing impaired: 1-800-877-8339]
By the Board, William F. Huneke, Director, Office of Economics.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (OFAC) is publishing the names of two individuals and supplemental information for one individual whose property and interests in property are blocked pursuant to Executive Order (E.O.) 13664 and whose names have been added to OFAC's list of Specially Designated Nationals and Blocked Persons (SDN List).
OFAC's actions described in this notice were effective July 2, 2015.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On July 2, 2014, OFAC blocked the property and interests in property of the following two persons pursuant to E.O. 13664, “Blocking Property of Certain Persons With Respect to South Sudan”:
1. DUAL, Simon Gatwech (a.k.a. DUAL, Simon Gatwec; a.k.a. DUAL, Simon Gatwich; a.k.a. DUAL, Simon Getwech; a.k.a. GARWICH, Simon; a.k.a. GATWEACH, Simon; a.k.a. GATWECH, Simon; a.k.a. GATWICK, Simon; a.k.a. “Dhual”; a.k.a. “General Gaduel”), Jonglei State, South Sudan; DOB 1953; POB Akobo, Jonglei State, South Sudan; alt. POB Akobo, Jonglei State, Sudan; alt. POB Uror County, Jonglei State, South Sudan; alt. POB Uror County, Jonglei State, Sudan; SPLA in Opposition Chief of General Staff; Major General (individual) [SOUTH SUDAN].
2. JOK RIAK, Gabriel (a.k.a. JOK, Gabriel; a.k.a. RIAK, Jock; a.k.a. RIAK, Jok), Wau, Western Bahr El Ghazal State, South Sudan; Unity State, South Sudan; DOB 1966; POB Bor, South Sudan; alt. POB Bor, Sudan; nationality South Sudan; Lieutenant General; Sector One Commander (individual) [SOUTH SUDAN].
WOL, Santino Deng (a.k.a. KUOL, Santino Deng; a.k.a. WUOL, Santino Deng); DOB 09 Nov 1962; POB Aweil, South Sudan; alt. POB Aweil, Sudan; Major General; Sudan People's Liberation Army Third Division Commander (individual) [SOUTH SUDAN].
Veterans Health Administration, Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before September 8, 2015.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Audrey Revere at (202) 461-5694.
Under the PRA of 1995 (Pub. L. 104-13; 44 U.S.C. 3501-3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
VA physician will obtain the information on the VA Form 10-0048 during a medical examination. If these questions were not asked, the physician would be unable to assess the health care, disability compensation or rehabilitation needs of the Former Prisoner Of War (FPOW). The importance of collecting this very detailed information when the veteran is first seen is critical, not only with the physician evaluating the veteran but also by the rating specialist who will rate this claim. The rater also reviews the statements given by the veteran on this form not only at the first claim submission but in future years when other disabilities are claimed. Feedback from POW physicians in the field indicates their appreciation of the well thought out content and structure of the form. It is useful not only for Compensation and Pension examinations but also as a guide and reference for treatment planning for the FPOW patient. The questions in the form make it relevant for FPOWS of current as well as prior conflicts.
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would update Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60-day episode payment rates, the national per-visit rates, and the non-routine medical supply (NRS) conversion factor under the Medicare prospective payment system for home health agencies (HHAs), effective for episodes ending on or after January 1, 2016. As required by the Affordable Care Act, this proposed rule implements the third year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates. This proposed rule provides information on our efforts to monitor the potential impacts of the rebasing adjustments. This proposed rule also proposes: reductions to the national, standardized 60-day episode payment rate in CY 2016 and CY 2017 of 1.72 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014; a HH value-based purchasing (HHVBP) model to be implemented beginning January 1, 2016 in which all Medicare-certified HHAs in selected states will be required to participate; changes to the home health quality reporting program requirements; and minor technical regulations text changes. Finally, this proposed rule would update the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking and provide an update on the Report to Congress regarding the home health (HH) study.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 4, 2015.
In commenting, please refer to file code CMS-1625-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
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Please allow sufficient time for mailed comments to be received before the close of the comment period.
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a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address, please call (410) 786-7195 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Hillary Loeffler, (410) 786-0456, for general information about the HH PPS.
Michelle Brazil, (410) 786-1648 for information about the HH quality reporting program.
Lori Teichman, (410) 786-6684, for information about HHCAHPS.
Robert Flemming, (844) 280-5628, for information about the HHVBP model.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. EST.
To schedule an appointment to view public comments, phone 1-800-743-3951.
In addition, because of the many terms to which we refer by abbreviation in this proposed rule, we are listing these abbreviations and their corresponding terms in alphabetical order below:
This proposed rule would update the payment rates for HHAs for calendar year (CY) 2016, as required under section 1895(b) of the Social Security Act (the Act). This would reflect the third year of the four-year phase-in of the rebasing adjustments to the national, standardized 60-day episode payment rate, the national per-visit rates, and the NRS conversion factor finalized in the CY 2014 HH PPS final rule (78 FR 72256), as required under section 3131(a) of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the “Affordable Care Act”).
This proposed rule also discusses our efforts to monitor the potential impacts of the rebasing adjustments mandated by section 3131(a) of the Affordable Care Act. This rule proposes: Reductions to the national, standardized 60-day episode payment rate in CY 2016 and CY 2017 of 1.72 percent in each year to account for case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014 under the authority of section 1895(b)(3)(B)(iv) of the Act; a HH Value-Based Purchasing (VBP) model, in which certain Medicare-certified HHAs would be required to participate beginning January 1, 2016, under the authority of section 1115(A) of the Act; changes to the home health quality reporting program requirements under section 1895(b)(3)(B)(v)(II) of the Act; and minor technical regulations text changes in 42 CFR parts 409, 424, and 484 to better align the payment requirements with recent statutory and regulatory changes for home health
As required by section 3131(a) of the Affordable Care Act, and finalized in the CY 2014 HH final rule, “Medicare and Medicaid Programs; Home Health Prospective Payment System Rate Update for 2014, Home Health Quality Reporting Requirements, and Cost Allocation of Home Health Survey Expenses” (78 FR 77256, December 2, 2013), we are implementing the third year of the four-year phase-in of the rebasing adjustments to the national, standardized 60-day episode payment amount, the national per-visit rates and the NRS conversion factor in section III.C.3. The rebasing adjustments for CY 2016 would reduce the national, standardized 60-day episode payment amount by $80.95, increase the national per-visit payment amounts by 3.5 percent of the national per-visit payment amounts in CY 2010 with the increases ranging from $1.79 for home health aide services to $6.34 for medical social services, and reduce the NRS conversion factor by 2.82 percent.
This proposed rule also discusses our efforts to monitor the potential impacts of the rebasing adjustments in section III.A. In the CY 2015 HH PPS final rule (79 FR 66072), we finalized our proposal to recalibrate the case-mix weights every year with more current data. In section III.B.1 of this rule, we are recalibrating the HH PPS case-mix weights, using the most current cost and utilization data available, in a budget neutral manner. In addition, in section III.B.2 of this rule, we propose to reduce to the national, standardized 60-day episode payment rate in CY 2016 and CY 2017 by 1.72 percent in each year to account for estimated case-mix growth unrelated to increases in patient acuity (nominal case-mix growth) between CY 2012 and CY 2014. In section III.C.1 of this rule, we propose to update the payment rates under the HH PPS by the home health payment update percentage of 2.3 percent (using the 2010-based Home Health Agency (HHA) market basket update of 2.9 percent, minus 0.6 percentage point for productivity as required by section 1895(b)(3)(B)(vi)(I) of the Act. In the CY 2015 final rule (79 FR 66083 through 66087), we incorporated new geographic area designations, set out in a February 28, 2013 office of Management and Budget (OMB) bulletin, into the home health wage index. For CY 2015, we implemented a wage index transition policy consisting of a 50/50 blend of the old geographic area delineations and the new geographic area delineations. In section III.C.2 of this proposed rule, we propose to update the CY 2016 home health wage index using solely the new geographic area designations. In section III.D of this proposed rule, we discuss payments for high cost outliers. In section III.E, we propose to make several technical corrections in § 409, 424, and § 484 to better align the payment requirements with recent statutory and regulatory changes for home health services. The sections include § 409.43(e), § 424.22(a), § 484.205(d), § 484.205(e), § 484.220, § 484.225, § 484.230, § 484.240(b), § 484.240(e), § 484.240(f), § 484.245. In section III.F, we discuss the Report to Congress on the home health study required by section 3131(d) of the Affordable Care Act and provide an update on subsequent research and analysis.
In section IV of this proposed rule, we propose a HHVBP model to be implemented beginning January 1, 2016. Medicare-certified HHAs selected for inclusion in the HHVBP model would be required to compete for payment adjustments to their current PPS reimbursements based on quality performance. A competing Medicare-certified HHA is defined as an agency having a current Medicare certification and which is being reimbursed by CMS for home health care delivered within any of the nine states randomly selected under CMS' proposed selection methodology.
This proposed rule also includes changes to the home health quality reporting program in section III.V, including the proposal of one new quality measure, the establishment of a minimum threshold for submission of Outcome and Assessment Information Set (OASIS) assessments for purposes of quality reporting compliance, and submission dates for Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey (HHCAHPS) Survey through CY 2018.
The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33, enacted August 5, 1997), significantly changed the way Medicare pays for Medicare HH services. Section 4603 of the BBA mandated the development of the HH PPS. Until the implementation of the HH PPS on October 1, 2000, HHAs received payment under a retrospective reimbursement system.
Section 4603(a) of the BBA mandated the development of a HH PPS for all Medicare-covered HH services provided under a plan of care (POC) that were paid on a reasonable cost basis by adding section 1895 of the Social Security Act (the Act), entitled “Prospective Payment For Home Health Services.” Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of HH services paid under Medicare.
Section 1895(b)(3)(A) of the Act requires the following: (1) The computation of a standard prospective payment amount include all costs for HH services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary; and (2) the standardized prospective payment amount be adjusted to account for the
Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the HH applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of an appropriate case-mix change adjustment factor for significant variation in costs among different units of services.
Similarly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to HH services furnished in a geographic area compared to the applicable national average level. Under section 1895(b)(4)(C) of the Act, the wage-adjustment factors used by the Secretary may be the factors used under section 1886(d)(3)(E) of the Act.
Section 1895(b)(5) of the Act gives the Secretary the option to make additions or adjustments to the payment amount otherwise paid in the case of outliers due to unusual variations in the type or amount of medically necessary care. Section 3131(b)(2) of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) (Pub. L. 111-148, enacted March 23, 2010) revised section 1895(b)(5) of the Act so that total outlier payments in a given year would not exceed 2.5 percent of total payments projected or estimated. The provision also made permanent a 10 percent agency-level outlier payment cap.
In accordance with the statute, as amended by the BBA, we published a final rule in the July 3, 2000
Section 5201(c) of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171, enacted February 8, 2006) added new section 1895(b)(3)(B)(v) to the Act, requiring HHAs to submit data for purposes of measuring health care quality, and links the quality data submission to the annual applicable percentage increase. This data submission requirement is applicable for CY 2007 and each subsequent year. If an HHA does not submit quality data, the HH market basket percentage increase is reduced by 2 percentage points. In the November 9, 2006
The Affordable Care Act made additional changes to the HH PPS. One of the changes in section 3131 of the Affordable Care Act is the amendment to section 421(a) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003) as amended by section 5201(b) of the DRA. Section 421(a) of the MMA, as amended by section 3131 of the Affordable Care Act, requires that the Secretary increase, by 3 percent, the payment amount otherwise made under section 1895 of the Act, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act) with respect to episodes and visits ending on or after April 1, 2010, and before January 1, 2016. Section 210 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) amended section 421(a) of the MMA to extend the rural add-on for two more years. Section 421(a) of the MMA, as amended by section 210 of the MACRA, requires that the Secretary increase, by 3 percent, the payment amount otherwise made under section 1895 of the Act, for HH services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act) with respect to episodes and visits ending on or after April 1, 2010, and before January 1, 2018.
Generally, Medicare makes payment under the HH PPS on the basis of a national standardized 60-day episode payment rate that is adjusted for the applicable case-mix and wage index. The national standardized 60-day episode rate includes the six HH disciplines (skilled nursing, HH aide, physical therapy, speech-language pathology, occupational therapy, and medical social services). Payment for non-routine supplies (NRS) is no longer part of the national standardized 60-day episode rate and is computed by multiplying the relative weight for a particular NRS severity level by the NRS conversion factor (See section II.D.4.e). Payment for durable medical equipment covered under the HH benefit is made outside the HH PPS payment system. To adjust for case-mix, the HH PPS uses a 153-category case-mix classification system to assign patients to a home health resource group (HHRG). The clinical severity level, functional severity level, and service utilization are computed from responses to selected data elements in the OASIS assessment instrument and are used to place the patient in a particular HHRG. Each HHRG has an associated case-mix weight which is used in calculating the payment for an episode.
For episodes with four or fewer visits, Medicare pays national per-visit rates based on the discipline(s) providing the services. An episode consisting of four or fewer visits within a 60-day period receives what is referred to as a low-utilization payment adjustment (LUPA). Medicare also adjusts the national standardized 60-day episode payment rate for certain intervening events that are subject to a partial episode payment adjustment (PEP adjustment). For certain cases that exceed a specific cost threshold, an outlier adjustment may also be available.
As required by section 1895(b)(3)(B) of the Act, we have historically updated the HH PPS rates annually in the
To account for the changes in case-mix that were not related to an underlying change in patient health status, we implemented a reduction, over 4 years, to the national, standardized 60-day episode payment rates. That reduction was to be 2.75 percent per year for 3 years beginning in CY 2008 and 2.71 percent for the fourth year in CY 2011. In the CY 2011 HH PPS final rule (76 FR 68532), we updated our analyses of case-mix change and finalized a reduction of 3.79 percent, instead of 2.71 percent, for CY 2011 and deferred finalizing a payment reduction for CY 2012 until further study of the case-mix change data and methodology was completed.
In the CY 2012 HH PPS final rule (76 FR 68526), we updated the 60-day national episode rates and the national per-visit rates. In addition, as discussed in the CY 2012 HH PPS final rule (76 FR 68528), our analysis indicated that there was a 22.59 percent increase in overall case-mix from 2000 to 2009 and that only 15.76 percent of that overall observed case-mix percentage increase was due to real case-mix change. As a result of our analysis, we identified a 19.03 percent nominal increase in case-mix. At that time, to fully account for the 19.03 percent nominal case-mix growth identified from 2000 to 2009, we finalized a 3.79 percent payment reduction in CY 2012 and a 1.32 percent payment reduction for CY 2013.
In the CY 2013 HH PPS final rule (77 FR 67078), we implemented a 1.32 percent reduction to the payment rates for CY 2013 to account for nominal case-mix growth from 2000 through 2010. When taking into account the total measure of case-mix change (23.90 percent) and the 15.97 percent of total case-mix change estimated as real from 2000 to 2010, we obtained a final nominal case-mix change measure of 20.08 percent from 2000 to 2010 (0.2390 * (1−0.1597) = 0.2008). To fully account for the remainder of the 20.08 percent increase in nominal case-mix beyond that which was accounted for in previous payment reductions, we estimated that the percentage reduction to the national, standardized 60-day episode rates for nominal case-mix change would be 2.18 percent. Although we considered proposing a 2.18 percent reduction to account for the remaining increase in measured nominal case-mix, we finalized the 1.32 percent payment reduction to the national, standardized 60-day episode rates in the CY 2012 HH PPS final rule (76 FR 68532).
Section 3131(a) of the Affordable Care Act requires that, beginning in CY 2014, we apply an adjustment to the national, standardized 60-day episode rate and other amounts that reflect factors such as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other relevant factors. Additionally, we must phase in any adjustment over a four-year period in equal increments, not to exceed 3.5 percent of the amount (or amounts) as of the date of enactment of the Affordable Care Act, and fully implement the rebasing adjustments by CY 2017. The statute specifies that the maximum rebasing adjustment is to be no more than 3.5 percent per year of the CY 2010 rates. Therefore, in the CY 2014 HH PPS final rule (78 FR 72256) for each year, CY 2014 through CY 2017, we finalized a fixed-dollar reduction to the national, standardized 60-day episode payment rate of $80.95 per year, increases to the national per-visit payment rates per year as reflected in Table 2, and a decrease to the NRS conversion factor of 2.82 percent per year. We also finalized three separate LUPA add-on factors for skilled nursing, physical therapy, and speech-language pathology and removed 170 diagnosis codes from assignment to diagnosis groups in the HH PPS Grouper. In the CY 2015 HH PPS final rule (79 FR 66032), we implemented the second year of the four-year phase-in of the rebasing adjustments to the HH PPS payment rates and made changes to the HH PPS case-mix weights. In addition, we simplified the face-to-face encounter regulatory requirements and the therapy reassessment timeframes.
HHS has a number of initiatives designed to encourage and support the adoption of health information technology and to promote nationwide health information exchange to improve health care. As discussed in the August 2013 Statement “Principles and Strategies for Accelerating Health Information Exchange” (available at
The Office of the National Coordinator for Health Information Technology (ONC) has released a document entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Draft Version 1.0 (draft Roadmap) (available at
In addition, ONC has released the draft version of the 2015 Interoperability Standards Advisory (available at
We encourage stakeholders to utilize health information exchange and certified health IT to effectively and efficiently help providers improve internal care delivery practices, engage patients in their care, support management of care across the continuum, enable the reporting of electronically specified clinical quality measures (eCQMs), and improve efficiencies and reduce unnecessary costs. As adoption of certified health IT increases and interoperability standards continue to mature, HHS will seek to reinforce standards through relevant policies and programs.
As part of our efforts in monitoring the potential impacts of the rebasing adjustments finalized in the CY 2014 HH PPS final rule (78 FR 72293), we continue to update our analysis of home health cost report and claims data. In the CY 2014 HH PPS final rule, using 2011 cost report and 2012 claims data, we estimated the 2013 60-day episode cost to be $2,565.51 (78 FR 72277). In that final rule, we stated that our analysis of 2011 cost report data and 2012 claims data indicated a need for a −3.45 percent rebasing adjustment to the national, standardized 60-day episode payment rate each year for four years. However, as specified by statute, the rebasing adjustment is limited to 3.5 percent of the CY 2010 national, standardized 60-day episode payment rate of $2,312.94 (74 FR 58106), or $80.95. We stated that given that a −3.45 percent adjustment for CY 2014 through CY 2017 would result in larger dollar amount reductions than the maximum dollar amount allowed under section 3131(a) of the Affordable Care Act of $80.95, we were limited to implementing a reduction of $80.95 (approximately 2.8 percent for CY 2014) to the national, standardized 60-day episode payment amount each year for CY 2014 through CY 2017.
In the CY 2015 HH PPS final rule, (79 FR 66032-66118) using 2012 cost report and 2013 claims data, we estimated the 2013 60-day episode cost to be $2,485.24 (79 FR 66037). Similar to our discussion in the CY 2014 HH PPS final rule, we stated that absent the Affordable Care Act's limit to rebasing, in order to align payments with costs, a −4.21 percent adjustment would have been applied to the national, standardized 60-day episode payment amount each year for CY 2014 through CY 2017.
For this proposed rule, we analyzed 2013 HHA cost report data and 2013 HHA claims data to determine whether the average cost per episode was higher using 2013 cost report data compared to the 2011 cost report and 2012 claims data used in calculating the rebasing adjustments. To determine the 2013 average cost per visit per discipline, we applied the same trimming methodology outlined in the CY 2014 HH PPS proposed rule (78 FR 40284) and weighted the costs per visit from the 2013 cost reports by size, facility type, and urban/rural location so the costs per visit were nationally representative according to 2013 claims data. The 2013 average number of visits was taken from 2013 claims data. We estimate the cost of a 60-day episode in CY 2013 to be $2,402.11 using 2013 cost report data (Table 3). Our latest analysis of 2013 cost report and 2013 claims data suggests that an even larger reduction (−5.02 percent) than the reduction described in the CY 2014 HH PPS final rule (−3.45 percent) or the reduction described in the CY 2015 HH PPS final rule (−4.21) would have been needed in order to align payments with costs.
Section 3131(a) of the Affordable Care Act required the Medicare Payment Advisory Commission (MedPAC) to assess, by January 1, 2015, the impact of the mandated rebasing adjustments on quality of and beneficiary access to home health care. As part of this assessment, the statute required MedPAC to consider the impact on care delivered by rural, urban, nonprofit, and for-profit home health agencies. MedPAC's Report to Congress noted that the rebasing adjustments are partially offset by the payment update each year and across all four years of the phase-in of the rebasing adjustments the cumulative net reduction would equal about 2 percent. MedPAC concluded that, as a result of the payment update offsets to the rebasing adjustments, HHA margins are likely to remain high under the current rebasing policy and quality of care and beneficiary access to care are unlikely to be negatively affected.
As we noted in the CY 2014 HH PPS final rule (78 FR 72291), MedPAC's past reviews of access to home health care found that access generally remained adequate during periods of substantial decline in the number of agencies. MedPAC stated that this is due in part to the low capital requirements for home health care services that allow the industry to react rapidly when the supply of agencies changes or contracts. As described in section III.A.3, the number of HHAs billing Medicare for home health services in CY 2013 is 80 percent higher than the number of HHAs billing Medicare for home health services in 2001. Even if some HHAs were to exit the program due to possible reimbursement concerns, the home health market would be expected to remain robust.
In the CY 2014 HH PPS final rule (78 FR 72256), some commenters expressed concern that the rebasing of the HH PPS payment rates would result in HHA closures and would therefore diminish access to home health services. In addition to examining more recent cost report data, for this proposed rule we examined home health claims data from the first year of the four-year phase-in of the rebasing adjustments (CY 2014), the first calendar year of the HH PPS (CY 2001), and claims data for the three years before implementation of the rebasing adjustments (CY 2011-2013). Preliminary analysis of CY 2014 home health claims data indicates that the number of episodes decreased by 3.8 percent between 2013 and 2014. In addition, the number of home health users decreased by approximately 3 percent between 2013 and 2014, while the number of FFS beneficiaries has remained the same. Between 2013 and 2014 there appears to be a net decrease in the number of HHAs billing Medicare for home health services of 1.6 percent, driven mostly by decreases TX and FL, two of the six states with the highest utilization of Medicare home health (
We would note that preliminary data on hospital and skilled nursing facility discharges and days indicates that there was a decrease in hospital discharges of approximately 3 percent and a decrease in SNF days of approximately 2 percent in CY 2014. Any decreases in hospital discharges and skilled nursing facility days could, in turn, impact home health utilization as those settings serve as important sources of home health referrals.
For the six states (TX, LA, OK, MS, FL, and IL) with the highest utilization of Medicare home health (as measured by the number of episodes per Part A and/or Part B FFS beneficiaries), the number of episodes decreased by 5.7 percent, the number of home health users decreased by 4.3 percent, and the number of HHAs billing Medicare decreased by 3.7 percent (5,280-5,085) between 2013 and 2014 (
In addition to examining home health claims data from the first year of the implementation of rebasing adjustments required by the Affordable Care Act and comparing utilization in that year (CY 2014) to the three years prior and to the first calendar year following the implementation of the HH PPS (CY 2001), we subsequently examined trends in home health utilization for all years starting in CY 2001 and up through CY 2014. Figure 1, displays the average number of visits per 60-day episode of care and the average payment per visit. While the average payment per visit has steadily increased from approximately $116 in CY 2001 to $162 for CY 2014, the average total number of visits per 60-day episode of care has declined, most notably between CY 2009 (21.7 visits per episode) and CY 2014 (18.0 visit per episode). As noted in section II.C, we implemented a series of reductions to the national, standardized 60-day episode payment rate to account for increases in nominal case-mix, starting in CY 2008. The reductions to the 60-day episode rate were: 2.75 percent each year for CY 2008, CY 2009, and CY 2010; 3.79 percent for CY 2011and CY 2012; and a 1.32 percent payment reduction for CY 2013. Figure 2 displays the average number of visits by discipline type for a 60-day episode of care and shows that while the number of therapy visits per 60-day episode of care has increased slightly, the number of skilled nursing and home health aide visits have decreased, between CY 2009 and CY 2014. Section III.F describes the results of the home health study required by section 3131(d) of the Affordable Care Act, which suggests that the current home health payment system may discourage HHAs from serving patients with clinically complex and/or poorly controlled chronic conditions who do not qualify for therapy but require a large number of skilled nursing visits. The home health study results seems to be consistent with the recent trend in the decreased number of visits per episode of care driven by decreases in skilled nursing and home health aide services evident in Figures 1 and 2.
We will continue to monitor for potential impacts due to rebasing adjustments required by section 3131(a) of the Affordable Care Act and other policy changes in the future. Independent effects of any one policy may be difficult to discern in years where multiple policy changes occur in any given year.
For CY 2014, as part of the rebasing effort mandated by the Affordable Care Act, we reset the HH PPS case-mix weights, lowering the average case-mix weight to 1.0000. To lower the HH PPS case-mix weights to 1.0000, each HH PPS case-mix weight was decreased by the same factor (1.3464), thereby maintaining the same relative values between the weights. This “resetting” of the HH PPS case-mix weights was done in a budget neutral manner by inflating the national, standardized 60-day episode rate by the same factor (1.3464) that was used to decrease the weights. For CY 2015, we finalized a policy to annually recalibrate the HH PPS case-mix weights—adjusting the weights relative to one another—using the most current, complete data available. To recalibrate the HH PPS case-mix weights for CY 2016, we propose to use the same methodology finalized in the CY 2008 HH PPS final rule (72 FR 49762), the CY 2012 HH PPS final rule (76 FR 68526), and the CY 2015 HH PPS final rule (79 FR 66032). Annual recalibration of the HH PPS case-mix weights ensures that the case-mix weights reflect, as accurately as possible, current home health resource use and changes in utilization patterns.
To generate the proposed CY 2016 HH PPS case-mix weights, we used CY 2014 home health claims data (as of December 31, 2014) with linked OASIS data. These data are the most current and complete data available at this time. We will use CY 2014 home health claims data (as of June 30, 2015) with linked OASIS data to generate the CY 2016 HH PPS case-mix weights in the CY 2016 HH PPS final rule. The process
In updating the four-equation model for CY 2016, using 2014 data (the last update to the four-equation model for CY 2015 used 2013 data), there were few changes to the point values for the variables in the four-equation model. These relatively minor changes reflect the change in the relationship between the grouper variables and resource use between 2013 and 2014. The CY 2016 four-equation model resulted in 130 point-giving variables being used in the model (as compared to the 124 variables for the 2015 recalibration). There were nine variables that were added to the model and three variables that were dropped from the model due to the absence of additional resources associated with the variable. The points for 18 variables increased in the CY 2016 four-equation model and the points for 43 variables decreased in the CY 2016 4-equation model. There were 58 variables with the same point values.
• Step 1: First and second episodes, 0-13 therapy visits.
• Step 2.1: First and second episodes, 14-19 therapy visits.
• Step 2.2: Third episodes and beyond, 14-19 therapy visits.
• Step 3: Third episodes and beyond, 0-13 therapy visits.
• Step 4: Episodes with 20+ therapy visits
We then divide the distribution of the clinical score for episodes within a step such that a third of episodes are classified as low clinical score, a third of episodes are classified as medium clinical score, and a third of episodes are classified as high clinical score. The same approach is then done looking at the functional score. It was not always possible to evenly divide the episodes within each step into thirds due to many episodes being clustered around one particular score.
For Step 2.1, 77.2% of episodes were in the low functional level (Most with score 2 and 4).
For Step 2.2, 67.1% of episodes were in the low functional level (All with score 0).
For Step 3, 60.9% of episodes were in the medium functional level (Most with score 10).
For Step 4, 49.8% of episodes were in the low functional level (Most with score 2).
To ensure the changes to the HH PPS case-mix weights are implemented in a budget neutral manner, we would apply a case-mix budget neutrality factor to the CY 2016 national, standardized 60-day episode payment rate (
Section 1895(b)(3)(B)(iv) of the Act gives the Secretary the authority to implement payment reductions for nominal case-mix growth (that is, case-mix growth unrelated to changes in patient acuity). Previously, we accounted for nominal case-mix growth through case-mix reductions implemented from 2008 through 2013 (76 FR 68528-68543). As stated in the 2013 final rule, the goal of the reductions for nominal case-mix growth is to better align payment with real changes in patient severity (77 FR 67077). Our analysis of data from CY 2000 through CY 2010 found that only 15.97 percent of the total case-mix change was real and 84.03 percent of total case-mix change was nominal (77 FR 41553). In the CY 2015 HH PPS final rule (79 FR 66032), we estimated that total case-mix increased by 2.76 percent between CY 2012 and CY 2013 and of that amount, we estimated that 2.32 percent was a result of nominal case-mix growth (2.76 − (2.76 × 0.1597)). However, for 2015, we did not implement a reduction to the 2015 national, standardized 60-day episode payment amount to account for nominal case-mix growth, but stated that we would continue to monitor case-mix growth and may consider proposing nominal case-mix reductions in the future. Since the publication of the CY 2015 HH PPS final rule (79 FR 66032),
We are proposing to implement this 3.41 percent reduction in equal increments over 2 years. Specifically, in addition to continuing our third year of implementation of the rebasing adjustments required under section 3131(a) of the Affordable Care Act, we are proposing to apply a 1.72 percent (1 − 1/(1.0232 × 1.0118)
We invite comments on the proposed reduction to the national, standardized 60-day episode payment amount of 1.72 percent in CY 2016 and 1.72 percent in CY 2017 to account for nominal case-mix growth from CY 2012 through CY 2014 and the associated changes in the regulations text at § 484.220.
Section 1895(b)(3)(B) of the Act requires that the standard prospective payment amounts for CY 2015 be increased by a factor equal to the applicable HH market basket update for those HHAs that submit quality data as required by the Secretary. The home health market basket was rebased and revised in CY 2013. A detailed description of how we derive the HHA market basket is available in the CY 2013 HH PPS final rule (77 FR 67080- 67090).
Section 3401(e) of the Affordable Care Act, adding new section 1895(b)(3)(B)(vi) to the Act, requires that, in CY 2015 (and in subsequent calendar years), the market basket percentage under the HHA prospective payment system as described in section 1895(b)(3)(B) of the Act be annually adjusted by changes in economy-wide productivity. The statute defines the productivity adjustment, described in section 1886(b)(3)(B)(xi)(II) of the Act, to be equal to the 10-year moving average of change in annual economy-wide private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, calendar year, cost reporting period, or other annual period) (the “MFP adjustment”). The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private nonfarm business MFP. Please see
Multifactor productivity is derived by subtracting the contribution of labor and capital input growth from output growth. The projections of the components of MFP are currently produced by IGI, a nationally recognized economic forecasting firm with which CMS contracts to forecast the components of the market basket and MFP. As described in the CY 2015 HH PPS proposed rule (79 FR 38384 through 38386), in order to generate a forecast of MFP, IGI replicated the MFP measure calculated by the BLS using a series of proxy variables derived from IGI's U.S. macroeconomic models. In the CY 2015 HH PPS proposed rule, we identified each of the major MFP component series employed by the BLS to measure MFP as well as provided the corresponding concepts determined to be the best available proxies for the BLS series.
Beginning with the CY 2016 rulemaking cycle, the MFP adjustment is calculated using a revised series developed by IGI to proxy the aggregate capital inputs. Specifically, IGI has replaced the Real Effective Capital Stock used for Full Employment GDP with a forecast of BLS aggregate capital inputs recently developed by IGI using a regression model. This series provides a better fit to the BLS capital inputs as measured by the differences between the actual BLS capital input growth rates and the estimated model growth rates over the historical time period. Therefore, we are using IGI's most recent forecast of the BLS capital inputs series in the MFP calculations beginning with the CY 2016 rulemaking cycle. A complete description of the MFP projection methodology is available on our Web site at
Using IGI's first quarter 2015 forecast, the MFP adjustment for CY 2016 (the 10-year moving average of MFP for the period ending CY 2016) is projected to be 0.6 percent. Thus, in accordance with section 1895(b)(3)(B)(iii) of the Act, we propose to base the CY 2016 market basket update, which is used to determine the applicable percentage increase for the HH payments, on the most recent estimate of the proposed 2010-based HH market basket (currently estimated to be 2.9 percent based on IGI's first quarter 2015 forecast). We propose to then reduce this percentage increase by the current estimate of the MFP adjustment for CY 2016 of 0.6 percentage point (the 10-year moving average of MFP for the period ending CY 2016 based on IGI's first quarter 2015 forecast), in accordance with 1895(b)(3)(B)(vi). Therefore, the current estimate of the CY 2016 HH update is 2.3 percent (2.9 percent market basket update, less 0.6 percentage point MFP adjustment). Furthermore, we note that if more recent data are subsequently
Section 1895(b)(3)(B) of the Act requires that the home health update be decreased by 2 percentage points for those HHAs that do not submit quality data as required by the Secretary. For HHAs that do not submit the required quality data for CY 2016, the home health update would be 0.3 percent (2.3 percent minus 2 percentage points).
Sections 1895(b)(4)(A)(ii) and (b)(4)(C) of the Act require the Secretary to provide appropriate adjustments to the proportion of the payment amount under the HH PPS that account for area wage differences, using adjustment factors that reflect the relative level of wages and wage-related costs applicable to the furnishing of HH services. Since the inception of the HH PPS, we have used inpatient hospital wage data in developing a wage index to be applied to HH payments. We propose to continue this practice for CY 2016, as we continue to believe that, in the absence of HH-specific wage data, using inpatient hospital wage data is appropriate and reasonable for the HH PPS. Specifically, we propose to continue to use the pre-floor, pre-reclassified hospital wage index as the wage adjustment to the labor portion of the HH PPS rates. For CY 2016, the updated wage data are for hospital cost reporting periods beginning on or after October 1, 2011 and before October 1, 2012 (FY 2012 cost report data).
We would apply the appropriate wage index value to the labor portion of the HH PPS rates based on the site of service for the beneficiary (defined by section 1861(m) of the Act as the beneficiary's place of residence). Previously, we determined each HHA's labor market area based on definitions of metropolitan statistical areas (MSAs) issued by the Office of Management and Budget (OMB). In the CY 2006 HH PPS final rule (70 FR 68132), we adopted revised labor market area definitions as discussed in the OMB Bulletin No. 03-04 (June 6, 2003). This bulletin announced revised definitions for MSAs and the creation of micropolitan statistical areas and core-based statistical areas (CBSAs). The bulletin is available online at
In this proposed rule, we propose to continue to use the same methodology discussed in the CY 2007 HH PPS final rule (71 FR 65884) to address those geographic areas in which there are no inpatient hospitals, and thus, no hospital wage data on which to base the calculation of the CY 2015 HH PPS wage index. For rural areas that do not have inpatient hospitals, we would use the average wage index from all contiguous CBSAs as a reasonable proxy. For FY 2016, there are no rural geographic areas without hospitals for which we would apply this policy. For rural Puerto Rico, we would not apply this methodology due to the distinct economic circumstances that exist there (for example, due to the close proximity to one another of almost all of Puerto Rico's various urban and non-urban areas, this methodology would produce a wage index for rural Puerto Rico that is higher than that in half of its urban areas). Instead, we would continue to use the most recent wage index previously available for that area. For urban areas without inpatient hospitals, we would use the average wage index of all urban areas within the state as a reasonable proxy for the wage index for that CBSA. For CY 2016, the only urban area without inpatient hospital wage data is Hinesville, GA (CBSA 25980).
On February 28, 2013, OMB issued Bulletin No. 13-01, announcing revisions to the delineations of MSAs, Micropolitan Statistical Areas, and CBSAs, and guidance on uses of the delineation of these areas. This bulletin is available online at
While the revisions OMB published on February 28, 2013 are not as sweeping as the changes made when we adopted the CBSA geographic designations for CY 2006, the February 28, 2013 bulletin does contain a number of significant changes. For example, there are new CBSAs, urban counties that have become rural, rural counties that have become urban, and existing CBSAs that have been split apart.
In the CY 2015 HH PPS final rule (79 FR 66085 through 66087), we finalized changes to the HH PPS wage index based on the newest OMB delineations, as described in OMB Bulletin No. 13-01, beginning in CY 2015, including a one-year transition with a blended wage index for CY 2015. Because the one-year transition period expires at the end of CY 2015, the proposed HH PPS wage index for CY 2016 is fully based on the revised OMB delineations adopted in CY 2015. The proposed CY 2016 wage index is available on the CMS Web site at
The Medicare HH PPS has been in effect since October 1, 2000. As set forth in the July 3, 2000 final rule (65 FR 41128), the base unit of payment under the Medicare HH PPS is a national, standardized 60-day episode payment rate. As set forth in 42 CFR 484.220, we adjust the national, standardized 60-day episode payment rate by a case-mix relative weight and a wage index value based on the site of service for the beneficiary.
To provide appropriate adjustments to the proportion of the payment amount under the HH PPS to account for area wage differences, we apply the appropriate wage index value to the labor portion of the HH PPS rates. The labor-related share of the case-mix adjusted 60-day episode rate would continue to be 78.535 percent and the non-labor-related share would continue to be 21.465 percent as set out in the CY 2013 HH PPS final rule (77 FR 67068). The CY 2016 HH PPS rates would use the same case-mix methodology as set forth in the CY 2008 HH PPS final rule with comment period (72 FR 49762) and would be adjusted as described in section III.C. of this rule. The following are the steps we take to compute the case-mix and wage-adjusted 60-day episode rate:
1. Multiply the national 60-day episode rate by the patient's applicable case-mix weight.
2. Divide the case-mix adjusted amount into a labor (78.535 percent) and a non-labor portion (21.465 percent).
3. Multiply the labor portion by the applicable wage index based on the site of service of the beneficiary.
4. Add the wage-adjusted portion to the non-labor portion, yielding the case-mix and wage adjusted 60-day episode rate, subject to any additional applicable adjustments.
In accordance with section 1895(b)(3)(B) of the Act, this document constitutes the annual update of the HH PPS rates. Section 484.225 sets forth the specific annual percentage update methodology. In accordance with § 484.225(i), for a HHA that does not submit HH quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable HH market basket index amount minus two percentage points. Any reduction of the percentage change would apply only to the calendar year involved and would not be considered in computing the prospective payment amount for a subsequent calendar year.
Medicare pays the national, standardized 60-day case-mix and wage-adjusted episode payment on a split percentage payment approach. The split percentage payment approach includes an initial percentage payment and a final percentage payment as set forth in § 484.205(b)(1) and (b)(2). We may base the initial percentage payment on the submission of a request for anticipated payment (RAP) and the final percentage payment on the submission of the claim for the episode, as discussed in § 409.43. The claim for the episode that the HHA submits for the final percentage payment determines the total payment amount for the episode and whether we make an applicable adjustment to the 60-day case-mix and wage-adjusted episode payment. The end date of the 60-day episode as reported on the claim determines which calendar year rates Medicare would use to pay the claim.
We may also adjust the 60-day case-mix and wage-adjusted episode payment based on the information submitted on the claim to reflect the following:
• A low-utilization payment adjustment (LUPA) is provided on a per-visit basis as set forth in § 484.205(c) and § 484.230.
• A partial episode payment (PEP) adjustment as set forth in § 484.205(d) and § 484.235.
• An outlier payment as set forth in § 484.205(e) and § 484.240.
Section 1895(3)(A)(i) of the Act required that the 60-day episode base rate and other applicable amounts be standardized in a manner that eliminates the effects of variations in relative case mix and area wage adjustments among different home health agencies in a budget neutral manner. To determine the CY 2016 national, standardized 60-day episode payment rate, we would apply a wage index standardization factor, a case-mix budget neutrality factor described in section III.B.1, a nominal case-mix growth adjustment described in section III.B.2, the rebasing adjustment described in section II.C, and the MFP-adjusted home health market basket update discussed in section III.C.1 of this proposed rule.
To calculate the wage index standardization factor, henceforth referred to as the wage index budget neutrality factor, we simulated total payments for non-LUPA episodes using the 2016 wage index and compared it to our simulation of total payments for non-LUPA episodes using the 2015 wage index. By dividing the total payments for non-LUPA episodes using the 2016 wage index by the total payments for non-LUPA episodes using the 2015 wage index, we obtain a wage index budget neutrality factor of 1.0006. We would apply the wage index budget neutrality factor of 1.0006 to the CY 2016 national, standardized 60-day episode rate.
As discussed in section III.B.1 of this proposed rule, to ensure the changes to the case-mix weights are implemented in a budget neutral manner, we would apply a case-mix weight budget neutrality factor to the CY 2016 national, standardized 60-day episode payment rate. The case-mix weight budget neutrality factor is calculated as the ratio of total payments when CY 2016 case-mix weights are applied to CY 2014 utilization (claims) data to total payments when CY 2015 case-mix weights are applied to CY 2014 utilization data. The case-mix budget neutrality factor for CY 2016 would be 1.0141 as described in section III.B.1 of this proposed rule.
Next, as discussed in section III.B.2 of this proposed rule, we would apply a reduction of 1.72 percent to the national, standardized 60-day episode payment rate in CY 2016 to account for nominal case-mix growth between CY 2012 and CY 2014. Then, we would apply the −$80.95 rebasing adjustment finalized in the CY 2014 HH PPS final rule (78 FR 72256) and discussed in section II.C. Lastly, we would update the payment rates by the CY 2016 HH payment update percentage of 2.3 percent (MFP-adjusted home health market basket update) as described in section III.C.1 of this proposed rule. The CY 2016 national, standardized 60-day episode payment rate is calculated in Table 10.
The CY 2016 national, standardized 60-day episode payment rate for an HHA that does not submit the required quality data is updated by the CY 2016 HH payment update (2.3 percent) minus 2 percentage points and is shown in Table 11.
The national per-visit rates are used to pay LUPAs (episodes with four or fewer visits) and are also used to compute imputed costs in outlier calculations. The per-visit rates are paid by type of visit or HH discipline. The six HH disciplines are as follows:
• Home health aide (HH aide);
• Medical Social Services (MSS);
• Occupational therapy (OT);
• Physical therapy (PT);
• Skilled nursing (SN); and
• Speech-language pathology (SLP).
To calculate the CY 2016 national per-visit rates, we start with the CY 2015 national per-visit rates. We then apply a wage index budget neutrality factor to ensure budget neutrality for LUPA per-visit payments and increase each of the six per-visit rates by the maximum rebasing adjustments described in section II.C. of this rule. We calculate the wage index budget neutrality factor by simulating total payments for LUPA episodes using the 2016 wage index and comparing it to simulated total payments for LUPA episodes using the 2015 wage index. By dividing the total payments for LUPA episodes using the 2016 wage index by the total payments for LUPA episodes using the 2015 wage index, we obtain a wage index budget neutrality factor of 1.0006. We would apply the wage index budget neutrality factor of 1.0006 to the CY 2016 national per-visit rates.
The LUPA per-visit rates are not calculated using case-mix weights. Therefore, there is no case-mix weights budget neutrality factor needed to ensure budget neutrality for LUPA payments. Finally, the per-visit rates for each discipline are updated by the CY 2016 HH payment update percentage of 2.3 percent. The national per-visit rates are adjusted by the wage index based on the site of service of the beneficiary. The per-visit payments for LUPAs are separate from the LUPA add-on payment amount, which is paid for episodes that occur as the only episode or initial episode in a sequence of adjacent episodes. The CY 2016 national per-visit rates are shown in Tables 12 and 13.
The CY 2016 per-visit payment rates for an HHA that does not submit the required quality data are updated by the CY 2016 HH payment update (2.3 percent) minus 2 percentage points and is shown in Table 13.
LUPA episodes that occur as the only episode or as an initial episode in a sequence of adjacent episodes are adjusted by applying an additional amount to the LUPA payment before adjusting for area wage differences. In the CY 2014 HH PPS final rule, we changed the methodology for calculating the LUPA add-on amount by finalizing the use of three LUPA add-on factors: 1.8451 for SN; 1.6700 for PT; and 1.6266 for SLP (78 FR 72306). We multiply the per-visit payment amount for the first SN, PT, or SLP visit in LUPA episodes that occur as the only episode or an initial episode in a sequence of adjacent episodes by the appropriate factor to determine the LUPA add-on payment amount. For example, for LUPA episodes that occur as the only episode or an initial episode in a sequence of adjacent episodes, if the first skilled visit is SN, the payment for that visit would be $248.90 (1.8451 multiplied by $134.90), subject to area wage adjustment.
Payments for NRS are computed by multiplying the relative weight for a particular severity level by the NRS conversion factor. To determine the CY 2016 NRS conversion factor, we start with the 2015 NRS conversion factor ($53.23) and apply the −2.82 percent rebasing adjustment described in section II.C. of this rule (1−0.0282 = 0.9718). We then update the conversion factor by the CY 2016 HH payment update percentage (2.3 percent). We do not apply a standardization factor as the NRS payment amount calculated from the conversion factor is not wage or case-mix adjusted when the final claim payment amount is computed. The NRS conversion factor for CY 2016 is shown in Table 14.
Using the CY 2015 NRS conversion factor, the payment amounts for the six severity levels are shown in Table 15.
For HHAs that do not submit the required quality data, we again begin with the CY 2015 NRS conversion factor ($53.23) and apply the −2.82 percent rebasing adjustment discussed in section II.C of this proposed rule (1−0.0282= 0.9718). We then update the NRS conversion factor by the CY 2016 HH payment update percentage (2.3 percent) minus 2 percentage points. The CY 2016 NRS conversion factor for HHAs that do not submit quality data is shown in Table 16.
The payment amounts for the various severity levels based on the updated conversion factor for HHAs that do not submit quality data are calculated in Table 17.
Section 421(a) of the MMA required, for HH services furnished in a rural areas (as defined in section 1886(d)(2)(D) of the Act), for episodes or visits ending on or after April 1, 2004, and before April 1, 2005, that the Secretary increase the payment amount that otherwise would have been made under section 1895 of the Act for the services by 5 percent.
Section 5201 of the DRA amended section 421(a) of the MMA. The amended section 421(a) of the MMA required, for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), on or after January 1, 2006 and before January 1, 2007, that the Secretary increase the payment amount otherwise made under section 1895 of the Act for those services by 5 percent.
Section 3131(c) of the Affordable Care Act amended section 421(a) of the MMA to provide an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act for HH services furnished in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes and visits ending on or after April 1, 2010, and before January 1, 2016.
Section 210 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) amended section 421(a) of the MMA to extend the rural add-on by providing an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act for HH services provided in a rural area (as defined in section 1886(d)(2)(D) of the Act), for episodes and visits ending before January 1, 2018.
Section 421 of the MMA, as amended, waives budget neutrality related to this provision, as the statute specifically states that the Secretary shall not reduce the standard prospective payment amount (or amounts) under section 1895 of the Act applicable to HH services furnished during a period to offset the increase in payments resulting in the application of this section of the statute.
For CY 2016, home health payment rates for services provided to beneficiaries in areas that are defined as rural under the OMB delineations would be increased by 3 percent as mandated by section 210 of the MACRA. The 3 percent rural add-on is applied to the national, standardized 60-day episode payment rate, national per visit rates, and NRS conversion factor when HH services are provided in rural (non-CBSA) areas. Refer to Tables 18 through 21 for these payment rates.
Section 1895(b)(5) of the Act allows for the provision of an addition or adjustment to the national, standardized 60-day case-mix and wage-adjusted episode payment amounts in the case of episodes that incur unusually high costs due to patient care needs. Prior to the enactment of the Affordable Care Act, section 1895(b)(5) of the Act stipulated that projected total outlier payments could not exceed 5 percent of total projected or estimated HH payments in a given year. In the July 3, 2000 Medicare Program; Prospective Payment System for Home Health Agencies final rule (65 FR 41188 through 41190), we described the method for determining outlier payments. Under this system, outlier payments are made for episodes whose estimated costs exceed a threshold amount for each HH Resource Group (HHRG). The episode's estimated cost is the sum of the national wage-adjusted per-visit payment amounts for all visits delivered during the episode. The outlier threshold for each case-mix group or Partial Episode Payment (PEP) adjustment is defined as the 60-day episode payment or PEP adjustment for that group plus a fixed-dollar loss (FDL) amount. The outlier payment is defined to be a proportion of the wage-adjusted estimated cost beyond the wage-adjusted threshold. The threshold amount is the sum of the wage and case-mix adjusted PPS episode amount and wage-adjusted FDL amount. The proportion of additional costs over the outlier threshold amount paid as outlier payments is referred to as the loss-sharing ratio.
In the CY 2010 HH PPS final rule (74 FR 58080 through 58087), we discussed excessive growth in outlier payments, primarily the result of unusually high outlier payments in a few areas of the country. Despite program integrity efforts associated with excessive outlier payments in targeted areas of the country, we discovered that outlier expenditures still exceeded the 5 percent target and, in the absence of corrective measures, would continue do to so. Consequently, we assessed the appropriateness of taking action to curb outlier abuse. To mitigate possible billing vulnerabilities associated with excessive outlier payments and adhere to our statutory limit on outlier payments, we adopted an outlier policy that included a 10 percent agency-level cap on outlier payments. This cap was implemented in concert with a reduced FDL ratio of 0.67. These policies resulted in a projected target outlier pool of approximately 2.5 percent. (The previous outlier pool was 5 percent of total HH expenditure). For CY 2010, we first returned the 5 percent held for the previous target outlier pool to the national, standardized 60-day episode rates, the national per-visit rates, the LUPA add-on payment amount, and the NRS conversion factor. Then, we reduced the CY 2010 rates by 2.5 percent to account for the new outlier pool of 2.5 percent. This outlier policy was adopted for CY 2010 only.
As we noted in the CY 2011 HH PPS final rule (75 FR 70397 through 70399), section 3131(b)(1) of the Affordable Care Act amended section 1895(b)(3)(C) of the Act, and requires the Secretary to reduce the HH PPS payment rates such that aggregate HH PPS payments are reduced by 5 percent. In addition, section 3131(b)(2) of the Affordable Care Act amended section 1895(b)(5) of the Act by re-designating the existing language as section 1895(b)(5)(A) of the Act, and revising it to state that the Secretary may provide for an addition or adjustment to the payment amount for outlier episodes because of their unusual variation in the type or amount of medically necessary care. The total amount of the additional payments or payment adjustments for outlier episodes may not exceed 2.5 percent of the estimated total HH PPS payments for that year and outlier payments as a percent of total payments are capped for each HHA at 10 percent.
As such, beginning in CY 2011, our HH PPS outlier policy is that we reduce payment rates by 5 percent and target up to 2.5 percent of total estimated HH PPS payments to be paid as outliers. To do so, we first returned the 2.5 percent held for the target CY 2010 outlier pool to the national, standardized 60-day episode rates, the national per visit rates, the LUPA add-on payment amount, and the NRS conversion factor for CY 2010. We then reduced the rates by 5 percent as required by section 1895(b)(3)(C) of the Act, as amended by section 3131(b)(1) of the Affordable Care Act. For CY 2011 and subsequent calendar years we target up to 2.5 percent of estimated total payments to
For a given level of outlier payments, there is a trade-off between the values selected for the FDL ratio and the loss-sharing ratio. A high FDL ratio reduces the number of episodes that can receive outlier payments, but makes it possible to select a higher loss-sharing ratio, and therefore, increase outlier payments for qualifying outlier episodes. Alternatively, a lower FDL ratio means that more episodes can qualify for outlier payments, but outlier payments per episode must then be lower.
The FDL ratio and the loss-sharing ratio must be selected so that the estimated total outlier payments do not exceed the 2.5 percent aggregate level (as required by section 1895(b)(5)(A) of the Act). Historically, we have used a value of 0.80 for the loss-sharing ratio which, we believe, preserves incentives for agencies to attempt to provide care efficiently for outlier cases. With a loss-sharing ratio of 0.80, Medicare pays 80 percent of the additional estimated costs above the outlier threshold amount.
In the CY 2011 HH PPS final rule (75 FR 70398), in targeting total outlier payments as 2.5 percent of total HH PPS payments, we implemented an FDL ratio of 0.67, and we maintained that ratio in CY 2012. Simulations based on CY 2010 claims data completed for the CY 2013 HH PPS final rule showed that outlier payments were estimated to comprise approximately 2.18 percent of total HH PPS payments in CY 2013, and as such, we lowered the FDL ratio from 0.67 to 0.45. We stated that lowering the FDL ratio to 0.45, while maintaining a loss-sharing ratio of 0.80, struck an effective balance of compensating for high-cost episodes while allowing more episodes to qualify as outlier payments (77 FR 67080). The national, standardized 60-day episode payment amount is multiplied by the FDL ratio. That amount is wage-adjusted to derive the wage-adjusted FDL amount, which is added to the case-mix and wage-adjusted 60-day episode payment amount to determine the outlier threshold amount that costs have to exceed before Medicare would pay 80 percent of the additional estimated costs.
For this proposed rule, simulating payments using preliminary CY 2014 claims data (as of December 31, 2014) and the CY 2015 payment rates (79 FR 66088 through 66092), we estimate that outlier payments in CY 2015 would comprise 2.02 percent of total payments. Based on simulations using CY 2014 claims data and the CY 2016 payments rates in section III.C.3 of this proposed rule, we estimate that outlier payments would comprise approximately 2.34 percent of total HH PPS payments in CY 2016, a percent change of almost 16 percent. This increase is attributable to the increase in the national per-visit amounts through the rebasing adjustments and the decrease in the national, standardized 60-day episode payment amount as a result of the rebasing adjustment and the nominal case-mix growth reduction. Given similar rebasing adjustments and case-mix growth reduction would also occur for 2017, and hence a similar anticipated increase in the outlier payments, we estimate that for CY 2017 outlier payments as a percent of total HH PPS payments would exceed 2.5 percent.
At this time, we are not proposing a change to the FDL ratio or loss-sharing ratio for CY 2016 as we believe that maintaining an FDL of 0.45 and a loss-sharing ratio of 0.80 are appropriate given the percentage of outlier payments is estimated to increase as a result of the increase in the national per-visit amounts through the rebasing adjustments and the decrease in the national, standardized 60-day episode payment amount as a result of the rebasing adjustment and nominal case-mix growth reduction. In the final rule, we will update our estimate of outlier payments as a percent of total HH PPS payments using the most current and complete year of HH PPS data (CY 2014 claims data as of June 30, 2015). We would continue to monitor the percent of total HH PPS payments paid as outlier payments to determine if future adjustments to either the FDL ratio or loss-sharing ratio are warranted.
The current home health prospective payment system (HH PPS) pays a determined amount for a 60-day episode of care adjusted for case mix using 153 home health resource groups (HHRGs). The 153 HHRGs are determined based on the amount of therapy provided, the episode's timing in a sequence of episodes, and the patient's clinical and functional status determined from data reported on the Outcome and Assessment Information Set (OASIS). There has been criticism that home health providers have responded to Medicare's payment policy by altering the level of service provided to patients.
This raises the question whether there is a disparity in payment for those patients with clinically complex and/or poorly controlled chronic conditions who do not qualify for therapy but require a large number of skilled nursing visits.
Section 3131(d) of the Affordable Care Act directed the Secretary to conduct a study on HHA costs involved with providing ongoing access to care to low-income Medicare beneficiaries or beneficiaries in medically underserved areas, and in treating beneficiaries with high levels of severity of illness.
The results of the survey revealed that over 80 percent of HHAs and over 90 percent of physicians reported that access to home health care for Medicare fee-for-service beneficiaries in their local area was excellent or good. When survey respondents reported access issues, specifically their inability to place or admit Medicare fee-for-service patients into home health, the most common reason reported was that the patients did not qualify for the Medicare home health benefit. HHAs and physicians also cited family or caregiver issues as an important contributing factor in the inability to admit or place patients. About 17.2 percent of HHAs and 16.7 percent of physicians reported insufficient payment as an important contributing factor in the inability to admit or place patients. The survey results suggest that much of the variation in access to Medicare home health services is associated with social and personal conditions and therefore CMS' ability to improve access for certain vulnerable patient populations through payment policy may be limited.
Analysis of CY 2010 HHA payment and cost data suggests that margins may differ substantially across the HH PPS case-mix groups. In addition, particular beneficiary characteristics appear to be strongly associated with margin, and thus may create financial incentives to select certain patients over others. Margins were estimated to be lower in CY 2010 for patients who required parenteral nutrition, who had traumatic wounds or ulcers, or required substantial assistance in bathing. Given that these variables are already included in the HH PPS case-mix system, the results indicate that modifications to the case-mix system may be needed. Furthermore, in CY 2010, beneficiaries admitted after acute or post-acute stays or who had high Hierarchical Condition Category scores or certain poorly-controlled clinical conditions, such as poorly-controlled pulmonary disorders, were also associated with substantially lower home health margins. In addition, other characteristics, such as those describing assistance by informal caregivers for ADL needs and those describing socio- economic status, such as dual eligibility for Medicare and Medicaid, were strongly associated with lower margins. Exploration of potential payment methodology changes indicated that accounting for additional variables in HH PPS payment may decrease the difference in estimated margin between individuals in specific vulnerable subgroups and those not in the subgroups, thereby potentially decreasing financial incentives to select certain types of patients over others.
CMS awarded a follow-on contract to Abt Associates to further explore margin differences across patient characteristics and possible payment methodology changes suggested by the results of the home health study. Additionally, we have heard from various stakeholders that the current payment system methodology is overly complex and does not fully reflect the range of services provided under the home health benefit, and thus this follow-on study would look at these aspects of the current payment system as well.
Under the follow-on contract, Abt Associates convened a Clinical Workgroup meeting on June 25, 2014 to gain clinical insight from industry regarding the current HH PPS. Based upon the feedback provided during the Clinical Workgroup meeting, as well as CMS concerns about the current model given the findings from the Home Health Study, Abt Associates was tasked with developing model options for consideration and discussion. In September 2014, Abt Associates presented several payment model options for CMS consideration, which were also presented to a Technical Expert Panel meeting held on January 8, 2015.
• Diagnosis on Top Model:
The first model option, referred to as the “Diagnosis on Top” (DOT) model, combines diagnosis groups with a regression model to create separate weights for patients with different diagnoses. For its “Studies in Home Health Case Mix” project design report (January 7, 2002), Abt had explored the possibility of a DOT model for the home health payment system. At that time, there was a decision that the potential gains in payment accuracy which would result from implementing a DOT model were offset by the added complexity and burden to providers that a DOT model could introduce by requiring providers to classify their patients with a single diagnosis that would be used to determine payment. For present reform efforts, Abt revisited the DOT model with more current data and in the context of other potential changes to the payment system which a DOT model might be able to complement. In this analysis, we are removing the therapy variable, allowing us to explore new ideas and re-explore previously rejected ideas to see how we can increase the statistical power of the model without the therapy variable. In this most recent analysis, each episode is grouped into the following diagnosis groups based on the primary ICD-9-CM diagnosis code reported on the OASIS: (1) Orthopedic; (2) neurological; (3) diabetes; (4) cancer; (5) skin wounds & lesions; (6) cardiovascular; (7) pulmonary; (8) gastrointestinal; (9) genito-urinary; (10) mental/emotional disorders; (11) other diagnoses; (12) case-mix V-codes; and (13) non-case-mix V-codes. Unlike the current HH PPS case-mix system, the diagnosis on top model does not include any therapy thresholds. Under the diagnosis on top model, episodes are first divided into different diagnosis groups, prior to the determination of the clinical and functional levels, and payment model regressions would be run separately for each diagnosis group. This is intended to maximize the statistical performance of the payment system. The work conducted by Abt Associates also included OASIS and non-OASIS items (such as whether the patient was admitted from an acute or post-acute care setting and hierarchical condition categories) not used in the current payment system, but shown to correlate with resource use. In many ways, the regression component of the diagnosis on top model is very similar to the current 4-equation model except that, in later versions of Abt's work on the diagnosis on top model, the clinical and functional levels are replaced with an overall severity level. This change allows the diagnosis on top model to account for a richer set of variables than the clinical and functional levels in the current payment system.
The second model option is referred to as the “Predicted Therapy Model.” The basic structure of this model is similar to that of the current payment model. In this model option, actual therapy visits used in the current HH PPS model are replaced with predicted therapy visits to develop case mix weights and payment amounts based on
The third model is referred to as the “Home Health Groupings ” (HHG) model. The premise of this type of model is that it starts with a clinical foundation. This groupings model groups home health episodes by diagnoses and the expected types of home health interventions required. Using expert clinical judgment, each ICD-9 code is assigned to one of seven groups based on the intervention expected to be required. Those seven groups include: (1) Musculoskeletal Rehabilitation; (2) Neuro/Stroke Rehabilitation; (3) Skin/Non-Surgical Wound Care; (4) Post-Op Wound Aftercare; (5) Behavioral Health Care; (6) Complex Medical Care; and (7) Medication Management, Teaching, and Assessment. Unlike the current HH PPS case-mix system, the home health groupings model does not include any therapy thresholds. Abt Associates is currently in the process of further delineating the seven groups listed above using OASIS and non-OASIS items (such as whether the patient was admitted from an acute or post-acute care setting and hierarchical condition categories) not used in the current payment system, but shown to correlate with resource use. The HHG model groups home health episodes in a way that mirrors how clinicians would differentiate between different types of beneficiaries and would help explain why the beneficiary is receiving home health, something that the current HH PPS case-mix may be lacking. MedPAC noted that policy makers have faced challenges in defining the role of home health.
To inform the model options discussed above, Abt Associates also reviewed other Medicare prospective payment systems to identify alternative methods used in classifying patients and to better understand components of each system. In the future, we plan to issue a technical report under our contract with Abt Associates that would further describe and analyze the three model options. We also plan to reconvene the Clinical Workgroup and the Technical Experts Panel in the near future to help further inform CMS on the various model options developed and next steps.
First, we propose to make several technical corrections in part 484 to better align the payment requirements with recent statutory and regulatory changes for home health services. We propose to make changes to § 484. 205(e) to state that estimated total outlier payments for a given calendar year are limited to no more than 2.5 percent of total outlays under the HHA PPS, rather than 5 percent of total outlays, as required by section 1895(b)(5)(A) of the Act as amended by section 3131(b)(2)(B) of the Affordable Care Act. Similarly, we also propose to specify in § 484.240(e) that the fixed dollar loss and the loss sharing amounts are chosen so that the estimated total outlier payment is no more than 2.5 percent of total payments under the HH PPS, rather than 5 percent of total payments under the HH PPS as required by section 1895(b)(5)(A) of the Act as amended by section 3131(b)(2)(B) of the Affordable Care Act. We also propose to describe in § 484.240(f) that the estimated total amount of outlier payments to an HHA in a given year may not exceed 10 percent of the estimated total payments to the specific agency under the HH PPS in a given year. This update aligns the regulations text at § 484.240(f) with the statutory requirement in 1895(b)(5)(A) of the Act as amended by section 3131(b)(2)(B) of the Affordable Care Act. Finally, we propose a minor editorial change in § 484.240(b) to specify that the outlier threshold for each case-mix group is the episode payment amount for that group,
Second, in addition to the proposed changes to the regulations text pertaining to outlier payments under the HH PPS, we also propose to amend § 409.43(e)(iii) and to add language to § 484.205(d) to clarify the frequency of review of the plan of care and the provision of Partial Episode Payments (PEP) under the HH PPS as a result of a regulations text change in § 424.22(b) that was finalized in the CY 2015 HH PPS final rule (79 FR 66032). Specifically, we propose to change the definition of an intervening event to include transfers and instances where a patient is discharged and return to home health during a 60-day episode, rather than a discharge and return to the same HHA during a 60-day episode. In § 484.220, we propose to update the regulations text to reflect the downward adjustments to the 60-day episode payment rate due to changes in the coding or classification of different units of service that do not reflect real changes in case-mix (nominal case-mix growth) applied to calendar years 2012 and 2013, which were finalized in the CY 2012 HH PPS final rule (76 FR 68532). This also includes updating the CY 2011 adjustment to 3.79 percent as finalized in the CY 2011 HH PPS final rule (75 FR 70461). In § 484.225 we are proposing to eliminate references to outdated market basket index factors by removing paragraphs (b), (c), (d), (e), (f) and (g). In § 484.230 we propose to delete the last sentence as a result of a change from a separate LUPA add-on amount to a LUPA add-on factor finalized in the CY 2014 HH PPS final rule (78 FR 72256). Finally, we are deleting and reserving § 484.245 as we believe that this language is no longer applicable under the HH PPS, as it was meant to facilitate the transition to the original PPS established in CY 2000.
Lastly, we propose to make one technical correction in § 424.22 to re-designate paragraph (a)(1)(v)(B)(
We invite comments on these technical corrections and associated changes in the regulations at § 409, § 424, and § 484.
In the CY 2015 Home Health Prospective Payment System (HH PPS) final rule titled “Medicare and Medicaid Programs; CY 2015 Home Health
In the CY 2015 HH PPS final rule,
The basis for developing this proposed value-based purchasing (VBP) model, as described in the proposed regulations at § 484.300
Second, section 3006(b) of the Affordable Care Act directed the Secretary of the Department of Health and Human Services (the Secretary) to develop a plan to implement a VBP program for payments under the Medicare Program for HHAs and the Secretary issued an associated Report to Congress in March of 2012 (2012 Report).
Third, section 402(a)(1)(A) of the Social Security Amendments of 1967 (as amended) (42 U.S.C. 1395b-1(a)(1)(A)), provided authority for us to conduct the Home Health Pay-for-Performance (HHPFP) Demonstration that ran from 2008 to 2010. The results of that Demonstration found modest quality improvement in certain measures after comparing the quality of care furnished by Demonstration participants to the quality of care furnished by the control group. One important lesson learned from the HHPFP Demonstration was the need to link the HHA's quality improvement efforts and the incentives. HHAs in three of the four regions generated enough savings to have incentive payments in the first year of the Demonstration, but the size of payments were unknown until after the conclusion of the Demonstration. Also, the time lag between quality performance and payment incentives was too long to provide a sufficient motivation for HHAs to take necessary steps to improve quality. The results of the Demonstration published in a comprehensive evaluation report
Furthermore, the President's FY 2015 and 2016 Budgets proposed that VBP should be extended to additional providers including skilled nursing facilities, home health agencies, ambulatory surgical centers, and hospital outpatient departments. The FY 2015 Budget called for at least 2 percent of payments to be tied to quality and efficiency of care on a budget neutral basis. The FY 2016 Budget outlines a program which would tie at least 2 percent of Medicare payments to the quality and efficiency of care in the first 2 years of implementation beginning in 2017, and at least 5 percent beginning in 2019 without any impact to the budget. We propose in this HHVBP model to also follow a graduated payment adjustment strategy within certain selected states beginning January 1, 2016.
The Secretary has also set two overall delivery system reform goals for CMS. First, we seek to tie 30 percent of traditional, or fee-for-service, Medicare payments to quality or value-based payments through alternative payment models by the end of 2016, and to tie 50 percent of payments to these models by the end of 2018. Second, we seek to tie 85 percent of all traditional Medicare payments to quality or value by 2016 and 90 percent by 2018.
Finally, we have already successfully implemented the Hospital Value-Based Purchasing (HVBP) program, under which value-based incentive payments are made in a fiscal year to hospitals that meet performance standards established for a performance period with respect to measures for that fiscal year. The percentage of a participating hospital's base-operating DRG payment amount for FY 2015 discharges that is at risk, based on the hospital's performance under the program for that fiscal year, is 1.5 percent. That percentage will increase to 2.0 by FY 2017. We are proposing an HHVBP model that builds on the lessons learned and guidance from the HVBP program and other applicable demonstrations as discussed above, as well as from the evaluation report discussed earlier.
The proposed HHVBP model presents an opportunity to improve the quality of care furnished to Medicare beneficiaries and study what incentives are sufficiently significant to encourage HHAs to provide high quality care. The HHVBP model being proposed would offer both a greater potential reward for high performing HHAs as well as a greater potential downside risk for low performing HHAs. If implemented, the model would begin on January 1, 2016, and include an array of measures that would capture the multiple dimensions of care that HHAs furnish.
The proposed model would be tested by CMS's Center for Medicare and Medicaid Innovation (CMMI) under section 1115A of the Act. Under section 1115A(d)(1) of the Act, the Secretary may waive such requirements of Titles XI and XVIII and of sections 1902(a)(1), 1902(a)(13), and 1903(m)(2)(A)(iii) as may be necessary solely for purposes of carrying out section 1115A with respect to testing models described in section 1115A(b). The Secretary is not issuing any waivers of the fraud and abuse provisions in sections 1128A, 1128B, and 1877 of the SSA or any other Medicare or Medicaid fraud and abuse laws for this model. Thus, notwithstanding any other provisions of this proposed rule, all providers and suppliers participating in the HHVBP model must comply with all applicable fraud and abuse laws and regulations.
We are proposing to use the section 1115A(d)(1) waiver authority to apply a reduction or increase of up to 8 percent to current Medicare payments to Medicare-certified HHAs delivering care to beneficiaries within the boundaries of certain states, depending on the HHA's performance on specified quality measures relative to its peers. Specifically, the HHVBP model proposes to utilize the waiver authority to adjust Medicare payment rates under section 1895(b) of the Act.
The defined population would include all Medicare beneficiaries being provided care by any Medicare-certified HHA delivering care within the selected states. Medicare-certified HHAs that are delivering care within the boundaries of selected states are considered `Competing Medicare-certified Home Health Agencies' within the scope of this HHVBP Model. If care is delivered outside of boundaries of selected states, or inside the boundaries of a non-selected state that does not have a reciprocal agreement with a selected state, payments for those beneficiaries would not be considered within the scope of the model because we are basing participation in the model on state specific CMS Certification Numbers (CCNs). Payment adjustments for each year of the model would be calculated based on a comparison of how well each competing Medicare-certified HHA performed during the performance period for that year (proposed below to be one year in length, starting in CY 2016) with its performance on the same measures in 2015 (proposed below to be the baseline data year).
The first performance year would be CY 2016, the second would be CY 2017, the third would be CY 2018, the fourth would be 2019, and the fifth would be CY 2020. Greater details on performance periods are outlined in further detail in section D—Performance Assessment and Payment Periods. This model would test whether being subject to significant payment adjustments to the Medicare payment amounts that would otherwise be made to competing Medicare-certified HHAs would result in statistically significant improvements in the quality of care being delivered to this specific population of Medicare beneficiaries.
We propose to identify Medicare-certified HHAs for participation in this model using state borders as boundaries. We do so under the authority granted in section 1115A(a)(5) of the Act to elect to limit testing of a model to certain geographic areas. This decision is influenced by the 2012 Report to Congress mandated under section 3006(b) of the Affordable Care Act. This Report stated that HHAs which participated in previous value-based purchasing demonstrations “uniformly believed that all Medicare-certified HHAs should be required to participate in future VBP programs so all agencies experience the potential burdens and benefits of the program” and some HHAs expressed concern that absent mandatory participation, “low-performing agencies in areas with limited competition may not choose to pursue quality improvement.”
Section 1115A(b)(2)(A) of the Act requires that the Secretary select models to be tested where the Secretary determines that there is evidence that the model addresses a defined population for which there are deficits in care leading to poor clinical outcomes or potentially avoidable expenditures. The HHVBP model was developed to improve care for Medicare patients receiving care from HHAs based on evidence in the March 2014 MedPAC Report to Congress citing quality and cost concerns in the home health sector. According to MedPAC, “about 29 percent of post-hospital home health stays result in readmission, and there is tremendous variation in performance among providers within and across geographic regions.”
In § 484.305 we propose definitions for “applicable percent”, “applicable measure”, “benchmark”, “home health prospective payment system”, “larger-volume cohort”, “linear exchange function”, “Medicare-certified home health agency”, “New Measures”, “payment adjustment”, “performance period”, “smaller-volume cohort”, “selected states”, “starter set”, “Total Performance Score”, and “value-based purchasing” as they pertain to this subpart. The HHVBP model is being proposed to encompass five performance years and be implemented beginning January 1, 2016 and conclude on December 31, 2022. Payment and service delivery models are developed by CMMI in accordance with the requirements of section 1115A of the Act. During the development of new models, CMMI builds on the ideas received from internal and external stakeholders and consults with clinical and analytical experts.
In this proposed rule, we are outlining an HHVBP model for public notice and comment that has an overall purpose of improving the quality of home health care and delivering it to the Medicare population in a more efficient manner. The specific goals of the proposed model are to:
1. Incentivize HHAs to provide better quality care with greater efficiency;
2. Study new potential quality and efficiency measures for appropriateness in the home health setting; and,
3. Enhance current public reporting processes.
We are proposing that the HHVBP model would adjust Medicare HHA payments over the course of the model by up to 8 percent depending on the applicable performance year and the degree of quality performance demonstrated by each competing Medicare-certified HHA. The proposed model would reduce the HH PPS final claim payment amount to an HHA for each episode in a calendar year by an amount up to the applicable percentage defined in proposed § 484.305. The timeline of payment adjustments as they apply to each performance year is described in greater detail in the section entitled “Payment Adjustment Timeline.”
The model would apply to all Medicare-certified HHAs in each of the selected states, which means that all HHAs in the selected states would be required to compete. We propose to codify this policy at 42 CFR 484.310. Furthermore, a competing Medicare-certified HHA would only be measured on performance for care delivered to Medicare beneficiaries within selected states (with rare exceptions given for care delivered when a reciprocal agreement exists between states). The distribution of payment adjustments would be based on quality performance, as measured by both achievement and improvement, across a proposed set of quality measures rigorously constructed to minimize burden as much as possible and improve care. Competing Medicare-certified HHAs that demonstrate they can deliver higher quality of care in comparison to their peers (as defined by the volume of services delivered within the selected state), or their own past performance, could have their payment for each episode of care adjusted higher than the amount that otherwise would be paid under section 1895 of the Act. Competing Medicare-certified HHAs that do not perform as well as other competing Medicare-certified HHAs of the same size in the same state might have their payments reduced and those competing Medicare-certified HHAs that perform similarly to others of similar size in the same state might have no payment adjustment made. This operational concept is similar in practice to what is used in the HVBP program.
We expect that the risk of having payments adjusted in this manner would provide an incentive among all competing Medicare-certified HHAs delivering care within the boundaries of selected states to provide significantly better quality through improved planning, coordination, and management of care. The degree of the payment adjustment would be dependent on the level of quality achieved or improved from the baseline year, with the highest upward performance adjustments going to competing Medicare-certified HHAs with the highest overall level of performance based on either achievement or improvement in quality. The size of a Medicare-certified HHA's payment adjustment for each year under the model would be dependent upon that HHA's performance with respect to that calendar year relative to other competing Medicare-certified HHAs of similar size in the same state and relative to its own performance during the baseline year.
We are proposing that states would be selected randomly from nine regional groupings for model participation. A competing Medicare-certified HHA is only measured on performance for care delivered to Medicare beneficiaries within boundaries of selected states and only payments for HHA services provided to Medicare beneficiaries within boundaries of selected states would be subject to adjustment under the proposed model. Requiring all Medicare-certified HHAs within the boundaries of selected states to compete in the model would ensure that: (1) There is no self-selection bias, (2) competing HHAs are representative of HHAs nationally, and (3) there is sufficient participation to generate meaningful results. We believe it is necessary to require all HHAs delivering care within boundaries of selected states to be included in the model because, in our experience, Medicare-providers are generally reluctant to participate voluntarily in models in which their Medicare payments could be subject to possible reduction. This reluctance to participate in voluntary models has been shown to cause self-selection bias in statistical assessments and thus, may present challenges to our ability to evaluate the model. In addition, state boundaries represent a natural demarcation in how quality is currently being assessed through OASIS measures on Home Health Compare (HHC).
We are proposing to adopt a methodology that uses state borders as boundaries for demarcating which Medicare-certified HHAs will be required to compete in the model. We are proposing to select nine states from nine geographically-defined groupings of five or six states. Groupings were also defined in order to ensure that the successful implementation of the model would produce robust and generalizable results, as discussed later in this section.
We took into account five key factors when deciding to propose selection at the state-level for this model. First, if we required some, but not all, Medicare-certified HHAs that deliver care within the boundaries of a selected state to participate in the model, we believe the HHA market for the state could be disrupted because HHAs in the model would be competing against HHAs not in the model (herein referenced as either `non-model HHAs' or `non-competing HHAs'). Second, we wanted to ensure that the distribution of payment adjustments based on performance under the model could be extrapolated to the entire country. Statistically, the larger the sample to which payment adjustments are applied, the smaller the variance of the sampling distribution and the greater the likelihood that the distribution accurately predicts what would transpire if the methodology were applied to the full population of
We expect that when there is a risk for a downside payment adjustment based on quality performance measures, the use of a self-contained, mandatory cohort of HHA participants will create a stronger incentive to deliver greater quality among competing Medicare-certified HHAs. Specifically, it is possible the market would become distorted if non-model HHAs are delivering care within the same market as competing Medicare-certified HHAs because competition, on the whole, becomes unfair when payment is predicated on quality for one group and volume for the other group. In addition, we expect that evaluation efforts might be negatively impacted because some HHAs would be competing on quality and others on volume within the same market.
We are proposing the use of state boundaries after careful consideration of several alternative selection approaches, including randomly selecting HHAs from all HHAs across the country, and requiring participation from smaller geographic regions including the county; the Combined Statistical Area (CSA); the Core-Based Statistical Area (CBSA); rural provider level; and the Hospital Referral Region (HRR) level.
A methodology using a national sample of HHAs that are randomly selected from all HHAs across the country could be designed to include enough HHAs to ensure robust payment adjustment distribution and a sufficient sample size for the evaluation; however, this approach may present significant limitations when compared with the state boundaries selection methodology proposed in this model. Of primary concern with randomly selecting at the provider-level across the nation is the issue with market distortions created by having competing Medicare-certified HHAs operating in the same market as non-model HHAs.
Using smaller geographic areas than states, such as counties, CSAs, CBSAs, rural, and HRRs, could also present challenges for this model. These smaller geographic areas were considered as alternate selection options; however, their use could result in too small of a sample size of potential competing HHAs. As a result, we expect the distribution of payment adjustments could become highly divergent among fewer HHA competitors. In addition, the ability to evaluate the model could become more complex and may be less generalizable to the full population of Medicare-certified HHAs and the beneficiaries they serve across the nation. Further, the use of smaller geographic areas than states could increase the proportion of Medicare-certified HHAs that could fall into groupings with too few agencies to generate a stable distribution of payment adjustments. Thus, if we were to define geographic areas based on CSAs, CBSAs, counties, or HRRs, we would need to develop an approach for consolidating smaller regions into larger regions.
Home health care is a unique type of health care service when compared to other Medicare provider types. In general, the HHA's care delivery setting is in the beneficiaries' homes as opposed to other provider types that traditionally deliver care at a brick and mortar institution within beneficiaries' respective communities. As a result, the HHVBP model needs to be designed to account for the unique way that HHA care is provided in order to ensure that the results are generalizable to the population. HHAs are limited to providing care to beneficiaries in the state that they have a CCN however; HHAs are not restricted from providing service in a county, CSA, CBSA or HRR that they are not located in (as long as the other county/CBSA/HRR is in the same state in which the HHA is certified). As a result, using smaller geographic areas (than state boundaries) could result in similar market distortion and evaluation confounders as selecting providers from a randomized national sampling. The reason is that HHAs in adjacent counties/CSAs/CBSAs/HRRs may not be in the model but, would be directly competing for services in the same markets or geographic regions. Competing HHAs delivering care in the same market area as non-competing HHAs could generate a spillover effect where non-model HHAs would be vying for the same beneficiaries as competing HHAs. This spillover effect presents several issues for evaluation as the dependent variable (quality) becomes confounded by external influences created by these non-competing HHAs. These unintentional external influences on competing HHAs may be made apparent if non-competing HHAs become incentivized to generate greater volume at the expense of quality delivered to the beneficiaries they serve and at the expense of competing HHAs that are paid on quality instead of volume. Further, the ability to extrapolate these results to the full population of HHAs and the beneficiaries they serve becomes confounded by an artifact of the model and inferences would be limited from an inability to duplicate these results. While these concerns would decrease in some order of magnitude as larger regions are considered, the only way to eliminate these concerns entirely is to define participation among Medicare-certified HHAs at the state level.
In addition, home health quality data currently displayed on HHC allows users to compare HHA services furnished within a single state. Selecting HHAs using other geographic regions that are smaller and/or cross state lines could require the model to deviate from the established process for reporting quality. For these reasons, we believe a selection methodology based on the use of Medicare-certified HHAs delivering care within state boundaries would be the most appropriate for the successful implementation and evaluation of this model.
While, for the reasons described above, we are proposing that the geographic basis of selection remain at the state-level, we nevertheless seek comment on potential alternatives that might use smaller geographic areas. With consideration of alternatives, the public should reference the five aforementioned key factors used to consider selection at the state-level for this model as they relate to the evaluative framework and operational feasibility of this model. In particular, one potential alternative would be to split states into sub-state regions using a combination of CSAs and metropolitan statistical areas (MSA), a type of CBSA. For example, regions might be defined using the following process:
•
•
•
•
We seek comment on advantages and disadvantages of this approach relative to defining regions based on state boundaries. In particular, we note that because this approach would generate a larger number of regions, it could increase the statistical power of the model evaluation, and might improve our ability to determine what effects the model has on the quality of home health care, as well as other outcomes of interest. However, we note that because regions would no longer line up with full states in most cases, the regions selected to participate in the model would no longer align directly with those displayed on HHC and therefore, quality data would have to be recalculated and displayed differently from what is currently being reported on HHC. In addition, using sub-state regions could, as noted above, lead to undesirable spillover effects between participating and non-participating HHAs. These spillover concerns would be mitigated by the fact that none of the sub-state regions defined under this approach would cross state lines and the fact that the sub-state regions would be larger than under some approaches to defining sub-state regions (for example, at the county level). Nevertheless, it is unclear how severe these evaluation and operational concerns would be in practice and how the extent of these concerns would depend on the different characteristics of the selected regions. We welcome public comment on these proposed state selection methodologies.
We are requesting comments on the following proposed methodology for selecting states. The selection methodology employed will need to provide the strongest evidence of producing meaningful results representative of the national population of Medicare-certified HHAs and, in turn, meet the evaluation requirements of section 1115A(b)(4) of the Act.
The state selections listed in proposed § 484.310 are based on the described proposed randomized selection methodology and are subject to change in the CY 2016 HH PPS final rule as a result of any changes that may be made to the proposed randomized methodology in response to comments. However, if the final methodology differs from what we are proposing here, we will apply the final methodology and identify the states selected under the final methodology in the final rule. We propose to group states by each state's geographic proximity to one another and by accounting for key evaluation characteristics (that is, proportionality of service utilization, proportionality of organizations with similar tax-exempt status and HHA size, and proportionality of beneficiaries that are dually-eligible for Medicare and Medicaid).
Based on an analysis of OASIS quality data and Medicare claims data, we believe the use of nine geographic groupings is necessary to ensure that the model accounts for the diversity of beneficiary demographics, rural and urban status, cost and quality variations, among other criteria. To provide for comparable and equitable selection probabilities, these separate geographic groupings each include a comparable number of states. We are not proposing to adopt census-based geographic groupings or the CMS Medicare Administrative Contractor (MAC) jurisdictions because those groupings would not permit an equal opportunity of selection of Medicare-certified HHAs by state or an assurance that we would be able test the model among a diversity of agencies such as is found across the nation. Following this logic, under our proposed methodology, groupings are based on states' geographic proximity to one another, having a comparable number of states if randomized for an equal opportunity of selection, and similarities in key characteristics that would be considered in the evaluation study because the attributes represent different types of HHAs, regulatory oversight, and types of beneficiaries served. This is necessary to ensure that the evaluation study remains objective and unbiased and that the results of this study best represent the entire population of Medicare-certified HHAs across the nation.
Several of the key characteristics we used for grouping state boundaries into clusters for selection into the model are also used in the impact analysis of our annual HHA payment updates, a fact that reinforces their relevance for evaluation. The additional proposed standards for grouping (level of utilization and socioeconomic status of patients) are also important to consider when evaluating the program, because of their current policy relevance. Large variations in the level of utilization of the home health benefit has received attention from policymakers concerned with achieving high-value health care and curbing fraud and abuse.
Under the proposed methodology, in order to ensure that the Medicare-certified HHAs that would be required to participate in the model are not all in one region of the country, the states in each grouping are adjacent to each other whenever possible while creating logical groupings of states based on common characteristics as described above. Specifically, analysis based on quality data and claims data found that HHAs in these neighboring states tend to hold certain characteristics in common. These include having similar; patterns of utilization, proportionality of non-profit agencies, and types of beneficiaries served (for example, severity and number, type of co-
Under our proposed randomized selection methodology, each geographic region, or grouping, has a similar number of states. As a result, all states would have a 16.7 percent to 20 percent chance of being selected under our proposed methodology, and Medicare-certified HHAs would have a similar likelihood of being required to compete in the model by using this sampling design. We assert that this sampling design would ensure that no single entity is singled out for selection, since all states and Medicare-certified HHAs would have approximately the same chance of being selected. In addition, this sampling approach would mitigate the opportunity for HHAs to self-select into the model and thereby bias any results of the test.
Without sacrificing an equal opportunity for selection, the proposed state groupings are intended to ensure that important characteristics of Medicare-certified HHAs that deliver care within state boundaries can be used to evaluate the primary intervention with greater generalizability and representativeness of the entire population of Medicare-certified HHAs in the nation. Data analysis of these characteristics employed the full data set of Medicare claims and OASIS quality data. Although some characteristics, such as beneficiary age and case-mix, yield some variations from one state to another, other important characteristics do vary substantially and could influence how HHAs respond to the incentives of the model. Specifically, home health services utilization rates, tax-exemption status of the provider, the socioeconomic status of beneficiaries (as measured by the proportion of dually-eligible beneficiaries), and agency size (as measured by average number of episodes of care per HHA), are important characteristics that could influence outcomes of the model. Subsequently, we intend to study the impacts of these characteristics for purposes of designing future value-based purchasing models and programs. These characteristics and expected variations must be considered in the evaluation study to enable us to avoid erroneous inferences about how different types of HHAs will respond to HHVBP incentives.
Under this proposed state selection methodology, state groupings reflect regional variations that enhance the generalizability of the model. In line with this methodology, each grouping includes states that are similar in at least one important aforementioned characteristic while being geographically located in close proximity to one another. Using the criteria described above, the following geographic groupings were identified using Medicare claims-based data from calendar years 2013-2014. Each of the 50 states was assigned to one of the following geographic groups:
• Group #1:
States in this group tend to have larger HHAs and have average utilization relative to other states.
• Group #2:
States in this group tend to have larger HHAs, have lower utilization, and provide care to an average number of dually-eligible beneficiaries relative to other states.
• Group #3:
States in this group tend to have larger HHAs, have average utilization rates, and provide care to a high proportion of minorities relative to other states.
• Group #4:
States in this group have HHAs that tend to be for-profit, have very high utilization rates, and have a higher proportion of dually-eligible beneficiaries relative to other states.
• Group #5:
States in this group tend to have smaller HHAs, have average utilization rates, and are more rural relative to other states.
• Group #6:
States in this group tend to have smaller HHAs, have average utilization rates, and provide care to a high proportion of minorities relative to other states.
• Group #7:
States in this group tend to have smaller HHAs, have very low utilization rates, and are more rural relative to other states.
• Group #8:
States in this group tend to have HHAs that are of average size, have average utilization rates, and provide care to a higher proportion of dually-eligible beneficiaries relative to other states.
• Group #9:
States in this group tend to have HHAs with higher utilization rates relative to other states.
Upon the careful consideration of the aforementioned alternative selection methodologies, including selecting states on a non-random basis, we choose to propose the use of a selection methodology based on a randomized sampling of states within each of the nine regional groupings described above. We examined data on the evaluation elements listed in this section to determine if specific states could be identified in order to fulfill the needs of the evaluation. After careful review, we determined that each evaluation element could be measured by more than one state. As a result, we determined that it was necessary to apply a fair method of selection where each state would have a comparable opportunity of being selected and which would fulfill the need for a robust evaluation. The proposed nine groupings of states as described in this section permit the model to capture the essential elements of the evaluation including demographic, geographic, and market factors.
The randomized sampling of states is without bias to any characteristics of any single state within any specific regional grouping, where no states are excluded, and no state appears more than once across any of the groupings. The randomized selection of states was completed using a scientifically-accepted computer algorithm designed for randomized sampling. The randomized selection of states was run on each of the previously described regional groupings using exactly the same process and, therefore, reflects a commonly accepted method of randomized sampling. This computer algorithm employs the aforementioned sampling parameters necessary to define randomized sampling and omits any human interaction once it runs.
Based on this sampling methodology, SAS Enterprise Guide (SAS EG) 5.1 software was used to run a computer algorithm designed to randomly select states from each grouping. SAS EG 5.1 and the computer algorithm were employed to conduct the randomized selection of states. SAS EG 5.1 represents an industry-standard for generating advanced analytics and provided a rigorous, standardized tool by which to satisfy the requirements of randomized selection. The key SAS commands employed include a “PROC
In § 484.310, we propose to codify the names of the states selected utilizing this proposed methodology, where one state from each of the nine groupings was selected. For each of these groupings, we propose to use state borders to demarcate which Medicare certified HHAs would be required to compete in this model: Massachusetts was randomly selected from Group 1, Maryland was randomly selected from Group 2, North Carolina was randomly selected from Group 3, Florida was randomly selected from Group 4, Washington was randomly selected from Group 5, Arizona was randomly selected from Group 6, Iowa was randomly selected from Group 7, Nebraska was randomly selected from Group 8, and Tennessee was randomly selected from Group 9. Thus, if our methodology is finalized as proposed, all Medicare-certified HHAs that provide services in Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to compete in this model.
However, should the methodology we propose in this rule change as a result of comments received during the rulemaking process, it could result in different states being selected for the model. In such an event, we would apply the final methodology and announce the selected states in the final rule. We therefore seek comment from all interested parties in every state on the randomized selection methodology proposed above and codified at § 484.310.
Based on the comments received from this proposed rule, the selection methodology for participation in the model may change from state boundaries to an approach based on sub-state regions built from CSAs/MSAs, CBSAs, rural provider level or HRRs. In that case, the goals of the model will remain the same, and therefore, we would expect to take a broadly similar approach to selecting participating regions to the approach that would be taken when regions are defined based on state boundaries. Specifically, as with the selection methodology outlined above, we would anticipate grouping sub-state regions together based on geographic proximity and other characteristics into groups of approximately equal size and then selecting some number of sub-state regions to participate from each group. The number of selected participants will be dependent on the selection methodology. We welcome public comment on these proposed state selection methodologies.
We are proposing that Total Performance Scores (TPS) and payment adjustments would be calculated based on an HHA's CCN
We are proposing the use of quarterly performance reports, annual payment adjustment reports, and annual publicly-available performance reports as a means of developing greater transparency of Medicare data on quality and aligning the competitive forces within the market to deliver care based on value over volume. The publicly-reported reports would inform home health industry stakeholders (consumers, physicians, hospitals) as well as all competing HHAs delivering care to Medicare beneficiaries within selected state boundaries on their level of quality relative to both their peers and their own past performance.
Competing HHAs would be scored for the quality of care delivered under the model based on their performance on measures compared to both the performance of their peers, defined by the same size cohort (either smaller- or larger-volume cohorts as defined in § 484.305), and their own past performance on the measures. We propose in § 484.305 to define larger-volume cohort to mean the group of Medicare-certified HHAs within the boundaries of a selected state that are participating in HHCAHPs in accordance with § 484.250 and to define smaller-volume cohort to mean the group of HHAs within the boundaries of a selected state that are exempt from participation in HHCAHPs in accordance with § 484.250. Where there are too few HHAs in the smaller-volume cohort in each state to compete in a fair manner (that is, when there is only one or two HHAs competing within a specific cohort), these specific HHAs would be included in the larger-volume cohort [for purposes of calculating the total performance score and payment adjustment] without being measured on HHCAHPS. We are requesting comments on this proposed methodology.
Quality performance scores and relative peer rankings would be determined through the use of a baseline year (calendar year 2015) and subsequent performance periods for each competing HHA. Further, these reports would provide competing HHAs with an opportunity to track their quality performance relative to their peers and their own past performance. Using these reports provides a convenient and timely means for competing HHAs to assess and track their own respective performance as capacity is developed to improve or sustain quality over time.
Beginning with the data collected during the first quarter of CY 2016 (that is, data for the period January 1, 2016 to March 31, 2016), and for every quarter of the model thereafter, we are proposing to provide each Medicare certified HHA with a quarterly report that contains information on their performance during the quarter. We expect to make the first quarterly report available in July 2016, and to make performance reports for subsequent quarters available in October, January and April. The final quarterly report would be made available in April 2021. The quarterly reports would include a competing HHA's model-specific performance results with a comparison to other competing HHAs within its cohort (larger- or smaller-volume) within the state boundary. These model-specific performance results would complement all quality data sources already being provided through the QIES system and any other quality tracking system possibly being employed by HHAs. We note that all performance measures that Medicare-certified HHAs will report through the QIES system are also already made available in the CASPER Reporting application. The primary difference between the two reports (CASPER reports and the model-specific performance report) is that the model-specific performance report we are proposing here consolidates the applicable performance measures used in the HHVBP model and provides a peer-ranking to other competing Medicare-certified HHAs within the same state and size-cohort. In addition, CASPER reports would provide quality data earlier than model-specific performance reports because CASPER reports are not limited by a quarterly run-out of data and a calculation of competing peer-rankings. For more information on the accessibility and functionality of the CASPER system, please reference the CASPER Provider Reporting Guide.
The model-specific quarterly performance report would be made available to each HHA through a dedicated CMMI model-specific platform for data dissemination and include each HHA's relative ranking amongst its peers along with measurement scores and overall performance rankings.
We are proposing that a separate payment adjustment report would be provided once a year to each of the competing HHAs. This report would focus primarily on the payment adjustment percentage and include an explanation of when the adjustment would be applied and how this adjustment was determined relative to performance scores. Each competing HHA would receive its own payment adjustment report viewable only to that HHA.
We are also proposing a separate, annual, publicly available quality report that would provide home health industry stakeholders, including providers and suppliers that refer their patients to HHAs, with an opportunity to ensure that the beneficiaries they are referring for home health services are being provided the best possible quality of care available. We seek public comment on the proposed reporting framework described above.
We propose at § 484.325 that Medicare-certified HHAs will be subject to upward or downward payment adjustments based on performance on quality measures. We propose this model would consist of 5 performance years, where each performance year would link performance to the opportunity and risk for payment adjustment up to an applicable percent as defined in proposed 42 CFR 484.305. The first performance year would transpire from January 1, 2016 through December 31, 2016, and subsequently, all other performance years would be assessed on an annual basis through 2020, unless modified through rulemaking. The first payment adjustment would begin January 1, 2018 applied to that calendar year based on 2016 performance data. Subsequently, all other payment adjustments would be made on an annual basis through the conclusion of the model, unless modified through rulemaking. We are proposing that payment adjustments will be increased incrementally over the course of the model with a maximum payment adjustment of (5 percent) upward or downward in 2018 and 2019, a maximum payment adjustment of 6 percent (upward or downward) in 2020, and a maximum payment adjustment of 8 percent (upward or downward) in 2021 and 2022. We propose to implement this model over a total of 7 years beginning on January 1, 2016, and ending on December 31, 2022.
The baseline year would run from January 1, 2015 through December 31, 2015 and provide a basis from which each respective HHA's performance would be measured in each of the performance years. Data related to performance on quality measures would continue to be provided from the baseline year through the model's tenure using a dedicated HHVBP web-based platform specifically designed to disseminate data in this model (this “portal” would present and archive the previously described quarterly and annual quality reports). Further, HHAs will provide performance data on the four new quality measures through this platform as well. Any new measures employed through the model's tenure, subject to rulemaking, would use data from the previous calendar year as the baseline.
New market entries (specifically, new Medicare-certified HHAs delivering care in the boundaries of selected states) would also be measured from their first full calendar year of services in the state, which would be treated as baseline data for subsequent performance years under this model. The delivery of services would be measured by the number of episodes of care for Medicare beneficiaries and used to determine whether an HHA falls into the smaller- or larger- volume cohort. Furthermore, these new market entries would be competing under the HHVBP model in the first full calendar year following the full calendar year baseline period.
HHAs would be notified in advance of their first performance level and payment adjustment being finalized, based on the 2016 performance period (January 1, 2016 to December 31, 2016), with their first payment adjustment to be applied January 1, 2018 through December 31, 2018. Each HHA would be notified of this first pending payment adjustment on August 1, 2017 and a preview period would run for 10 days through August 11, 2017. This preview period would provide each competing HHA an opportunity to reconcile any performance assessment issues relating to the calculation of scores prior to the payment adjustment taking effect, in accordance with the process proposed in section H—Preview and Period to Request Recalculation. Once the preview period ends, any changes would be reconciled and a report finalized no later than November 1, 2017 (or 60 days prior to the payment adjustment taking affect).
Subsequent payment adjustments would be calculated based on the applicable full calendar year of performance data from the quarterly reports, with HHAs notified and payments adjusted, respectively, every year thereafter. As a sequential example, the second payment adjustment would occur January 1, 2019 based on a full 12 months of the CY 2017 performance period. Notification of the adjustment
Beginning in CY 2019, we may consider revising this payment adjustment schedule and updating the payment adjustment more frequently than once each year if it is determined that a more timely application of the adjustment as it relates to performance improvement efforts that have transpired over the course of a calendar year would generate increased improvement in quality measures. Specifically, we would expect that having payment adjustments transpire closer together through more frequent performance periods would accelerate improvement in quality measures because HHAs would be able to justify earlier investments in quality efforts and be incentivized for improvements. In effect, this concept may be operationalized to create a smoothing effect where payment adjustments are based on overlapping 12-month performance periods that occur every 6 months rather than annually. As an example, the normal 12-month performance period occurring from January 1, 2020 to December 31, 2020 might have an overlapping 12-month performance period occurring from July 1, 2020 to June 30, 2021. Following the regularly scheduled January 1, 2022 payment adjustments, the next adjustments could be applied to payments beginning on July 1, 2022 through December 31, 2022. Depending on if and when more frequent payment adjustments would be applied, performance would be calculated based on the applicable 12-months of performance data, HHAs notified, and payments adjusted, respectively, every six months thereafter, until the conclusion of the model. As a result, separate performance periods would have a 6-month overlap through the conclusion of the model. HHAs would be notified through rulemaking and be given the opportunity to comment on any proposed changes to the frequency of payment adjustments. We seek public comment on the proposed payment adjustment schedule described above.
Initially, we propose the measures for the HHVBP model would be predominantly drawn from the current Outcome and Assessment Information Set (OASIS),
1. Use a broad measure set that captures the complexity of the HHA service provided;
2. Incorporate the flexibility to include Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014 proposed measures that are cross-cutting amongst post-acute care settings;
3. Develop second-generation measures of patient outcomes, health and functional status, shared decision making, and patient activation;
4. Include a balance of process, outcome, and patient experience measures;
5. Advance the ability to measure cost and value;
6. Add measures for appropriateness or overuse; and,
7. Promote infrastructure investments.
A central driver of the proposed measure selection process was incorporating innovative thinking from the field while simultaneously drawing on the most current evidence-based literature and documented best practices. Broadly, we propose measures that have a high impact on care delivery and support the combined priorities of HHS and CMS to improve health outcomes, quality, safety, efficiency, and experience of care for patients. To frame the selection process, we utilized the domains described in the CMS Quality Strategy that maps to the six National Quality Strategy (NQS) priority areas (
We propose at § 484.315 that Medicare-certified HHAs would be evaluated using a starter set of quality measures (“starter set” refers to the proposed quality measures for the first year of this model) designed to encompass multiple NQS domains, and provide future flexibility to incorporate and study newly developed measures over time. New and evolving measures would be considered for inclusion in subsequent years of this model and proposed through future rulemaking.
To create the proposed starter set we began researching the current set of OASIS measures that are being used within the health home environment.
To ensure proposed measures for the HHVBP model take a more holistic view of the patient beyond a particular disease state or care setting, we are proposing measures, which include outcome measures as well as process measures, that have the potential to follow patients across multiple settings, reflect a multi-faceted approach, and foster the intersection of health care delivery and population health. A key consideration behind this approach is to use in performance year one (PY1) of the model proven measures that are readily available and meet a high impact need, and in subsequent model years augment this starter set with innovative measures that have the potential to be impactful and fill critical measure gap areas. All substantive changes or additions to the proposed starter set or new measures would be proposed for inclusion in future rulemaking. This approach to quality measure selection aims to balance the burden of collecting data with the inclusion of new and important measures. We carefully considered the potential burden on HHAs to report the measure data when developing the proposed starter set, and prioritized proposed measures that would draw both from claims data and data already collected in OASIS.
The majority of the proposed measures in this model would use OASIS data currently being reported to CMS and linked to state-specific CCNs for selected states in order to promote consistency and to reduce the data collection burden for providers. Utilizing primarily OASIS data would allow the model to leverage reporting structures already in place to evaluate performance and identify weaknesses in care delivery. This model would also afford the opportunity to study measures developed in other care settings and new to the home health industry (hereinafter referred to as “New Measures”). Many of the proposed New Measures have been used in other health care settings and are readily applicable to the home health environment (for example, influenza vaccination coverage for health care personnel). Proposed New Measures for PY1 are described in detail below. We
The initial set of measures proposed for PY1 of the model utilizes data collected via OASIS, Medicare claims, HHCAHPS survey data, and data reported directly from the HHAs to CMS. In total there are 10 process measures and 15 outcome measures (
We seek public comment on the methodology for constructing the proposed starter set of quality measures and on the proposed
Figure 5 provides details on the elements of the Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey (HHCAHPS) we propose to include in the PY1 starter set. The HHVBP model would not alter the HHCAHPS current scoring methodology or the participation requirements in any way. Details on participation requirements for HHCAHPS can be found at 42 CFR 484.250
As discussed in the previous section, the New Measures we propose are not currently reported by Medicare-certified HHAs to CMS, but we believe fill gaps in the NQS Domains not completely covered by existing measures in the home health setting. All Medicare-certified HHAs in selected states, regardless of cohort size or number of episodes, will be required to submit data on the New Measures for all Medicare beneficiaries to whom they provide home health services within the state (unless an exception applies). We propose at § 484.315 that HHAs will be required to report data on these New Measures. Competing Medicare-certified HHAs would submit data through a dedicated HHVBP web-based platform. This web-based platform would function as a means to collect and distribute information from and to competing Medicare-certified HHAs. Also, for those HHAs with a sufficient number of episodes of care to be subject to a payment adjustment, New Measures scores included in the final TPS for PY1 are only based on whether the HHA has submitted data to the HHVBP web-based platform or not. We are proposing the following New Measures for competing Medicare-certified HHAs:
• Advance Care Planning;
• Adverse Event for Improper Medication Administration and/or Side Effects;
• Influenza Vaccination Coverage for Home Health Care Personnel; and,
• Herpes Zoster (Shingles) Vaccination received by HHA patients.
Advance Care Planning is an NQF-endorsed process measure in the NQS domain of Person- and Caregiver-centered experience and outcomes (see Figure 3). This measure is currently endorsed at the group practice/individual clinician level of analysis. We believe its adoption under the HHVBP model represents an opportunity to study this measure in the home health setting. This is an especially pertinent measure for home health care to ensure that the wishes of the patient regarding their medical, emotional, or social needs are met across care settings. The Advance Care Planning measure would focus on Medicare beneficiaries, including dually-eligible beneficiaries.
The measure would be numerically expressed by a ratio whose numerator and denominator are as follows:
Information on this numerator and denominator would be reported by HHAs through the HHVBP web-based platform, in addition to other information related to this measure as the Secretary deems appropriate.
Advance care planning ensures that the health care plan is consistent with the patient's wishes and preferences. Therefore, studying this measure within the HHA environment allows for further analysis of planning for the “what ifs” that may occur during the patient's lifetime. In addition, the use of this measure is expected to result in an increase in the number of patients with advance care plans. Increased advance care planning among the elderly is expected to result in enhanced patient autonomy and reduced hospitalizations and in-hospital deaths.
We welcome public comments on this measure's proposed adoption under the HHVBP model.
Adverse Event for Improper Medication Administration and/or Side Effects is a measure that aligns with the NQS domain of Safety (specifically “medication safety”—
An adverse drug event (ADE) is an injury related to medication use.
The annual incidence of ADEs in health care in the United States is high; authoritative estimates indicate that each year 400,000 preventable ADEs occur in hospitals, 800,000 in long term care settings and in excess of 500,000 among Medicare patients in outpatient settings.
The measure would be numerically expressed by a ratio whose numerator and denominator are as follows:
We welcome public comments on this measure's proposed adoption under the HHVBP model.
Staff Immunizations (Influenza Vaccination Coverage among Health Care Personnel) (NQF #0431) is an NQF-endorsed measure that addresses the NQS domain of Population Health (
The measure would be numerically expressed by a ratio whose numerator and denominator are as follows:
(1) Received an influenza vaccination administered at the health care agency, or reported in writing (paper or electronic) or provided documentation that influenza vaccination was received elsewhere; or
(2) Were determined to have a medical contraindication/condition of severe allergic reaction to eggs or to other component(s) of the vaccine, or history of Guillain-Barré Syndrome within 6 weeks after a previous influenza vaccination; or
(3) Declined influenza vaccination; or
(4) Persons with unknown vaccination status or who do not otherwise meet any of the definitions of the above-mentioned numerator categories.
Each of the above groups would be divided by the number of health care personnel who are working in the HHA for at least one working day between October 1 and March 31 of the following year, regardless of clinical responsibility or patient contact.
1. Employees: All persons who receive a direct paycheck from the reporting HHA (that is, on the agency's payroll);
2. Licensed independent practitioners: Include physicians (MD, DO), advanced practice nurses, and physician assistants only who are affiliated with the reporting agency who do not receive a direct paycheck from the reporting HHA; and
3. Adult students/trainees and volunteers: Include all adult students/trainees and volunteers who do not receive a direct paycheck from the reporting HHA.
This proposed measure for the HHVBP model is expected to result in increased influenza vaccination among home health professionals. Reporting health care personnel influenza vaccination status would allow HHAs to better identify and target unvaccinated personnel. Increased influenza vaccination coverage among HHA personnel would be expected to result in reduced morbidity and mortality related to influenza virus infection among patients, especially elderly and vulnerable populations.
Information on the above numerator and denominator would be reported by HHAs through the HHVBP web-based platform, in addition to other information related to this measure as the Secretary deems appropriate. We welcome public comments on this measure's proposed adoption under the HHVBP model.
We are proposing to adopt this measure for the HHVBP model because it aligns with the NQS Quality Strategy Goal to Promote Effective Prevention & Treatment of Chronic Disease. Currently this proposed measure is not endorsed by NQF or collected in OASIS. However, due to the severe physical consequences of symptoms associated with shingles,
The Food and Drug Administration (FDA) has approved the use of herpes zoster vaccine in adults age 50 and older. In addition, the Advisory Committee on Immunization Practices (ACIP) currently recommends that herpes zoster vaccine be routinely administered to adults, age 60 years and older.
The incidence of herpes zoster outbreak increases as people age, with a significant increase after age 50. Older people are more likely to experience the severe nerve pain known as post-herpetic neuralgia (PHN),
Studying this measure in the home health setting presents an ideal opportunity to address a population at risk which would benefit greatly from this vaccination strategy. For example, receiving the vaccine will often reduce the course and severity of the disease and reduce the risk of post herpetic neuralgia.
Information on the above numerator and denominator would be reported by HHAs through the HHVBP web-based platform, in addition to other information related to this measure as the Secretary deems appropriate. We welcome public comments on this measure's proposed adoption under the HHVBP model.
As previously stated, the quality measures that we are proposing to use in the performance years are aligned with the six NQS domains: Patient and Caregiver-centered experience and outcomes; Clinical quality of care; Care coordination; Population Health; Efficiency and cost reduction; and, Safety (see Figure 6).
We propose to filter these NQS domains and the proposed HHVBP quality measures into four classifications to align directly with the measure weighting utilized in calculating payment adjustments. The four HHVBP classifications we are proposing are: Clinical Quality of Care, Outcome and Efficiency, Person- and Caregiver-Centered Experience, and New Measures reported by the HHAs.
These four classifications capture the multi-dimensional nature of health care provided by the HHA. These classifications are further defined as:
• Classification I—Clinical Quality of Care: Measures the quality of health care services provided by eligible professionals and paraprofessionals within the home health environment.
• Classification II—Outcome and Efficiency: Outcomes measure the end result of care provided to the beneficiary. Efficiencies measure maximizing quality and minimizing use of resources.
• Classification III—Person- and Caregiver-Centered Experience: Measures the beneficiary and their caregivers' experience of care.
• Classification IV—New Measures: Measures not currently reported by Medicare-certified HHAs to CMS, but that may fill gaps in the NQS Domains not completely covered by existing measures in the home health setting.
We seek public comment on our proposed measure classifications for the HHVBP model.
We propose that measures within each classification will be weighted the same for the purposes of payment adjustment. We are weighting at the individual measure level and not the classification level. Classifications are for organizational purposes only. We selected this approach since we did not want any one measure within a classification to be more important than another measure. This approach ensures that a measure's weight will remain the same even if some of the measures within a classification group have no available data. Weighting will be re-examined in subsequent years of the model and be subject to the rulemaking process.
We welcome public comments on this proposed weighting methodology under the HHVBP model.
The methodology we are proposing for assessing each HHA's total annual performance is based on a score calculated using the proposed starter set of quality measures that apply to the HHA (based on a minimum number of cases, as discussed herein). The methodology we propose would provide an assessment on a quarterly basis for each HHA and would result in an annual distribution of value-based payment adjustments among HHAs so that HHAs achieving the highest performance scores would receive the largest upward payment adjustment. The methodology we are proposing includes three primary features:
• The HHA's Total Performance Score (TPS) would be determined using the higher of an HHA's achievement or improvement score for each measure;
• All measures in the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications will have equal weight and will account for 90 percent of the TPS (see section 2 below) regardless of the number of measures in the three classifications. Points for New Measures are awarded for submission of data on the New Measures via the HHVBP web-based platform, and withheld if data is not submitted. Data reporting for each New Measure will have equal weight and will account for 10 percent of the TPS for the first performance year; and,
• The HHA performance score would reflect all of the measures that apply to the HHA based on a minimum number of cases defined below.
In § 484.320 we propose to calculate the TPS by adding together points awarded to Medicare-certified HHAs on the starter set of measures, including the New Measures. We considered several factors when developing the proposed performance scoring methodology for the HHVBP model. First, we believe it is important that the performance scoring methodology be straightforward and transparent to HHAs, patients, and other stakeholders. HHAs must be able to clearly understand performance scoring methods and performance expectations to maximize quality improvement efforts. The public must understand performance score methods to utilize publicly-reported information when choosing HHAs.
Second, we believe the proposed performance scoring methodology for the HHVBP model should be aligned appropriately with the quality measurements adopted for other Medicare value-based purchasing programs including those introduced in the hospital and skilled nursing home settings. This alignment would facilitate the public's understanding of quality measurement information disseminated in these programs and foster more informed consumer decision-making about their health care choices.
Third, we believe that differences in performance scores must reflect true differences in quality performance. To ensure that this point is addressed in the proposed performance scoring methodology for the HHVBP model, we assessed quantitative characteristics of the measures, including the current
Fourth, we believe that both quality achievement and improvement must be measured appropriately in the performance scoring methodology for the HHVBP model. The proposed methodology specifies that performance scores under the HHVBP model are calculated utilizing the higher of achievement or improvement scores for each measure. The impact of performance scores utilizing achievement and improvement on HHAs' behavior and the resulting payment implications was also considered. Using the higher of achievement or improvement scores allows the model to recognize HHAs that have made great improvements, though their measured performance score may still be relatively lower in comparison to other HHAs.
Fifth, through careful measure selection we intend to eliminate, or at least control for, unintended consequences such as undermining better outcomes to patients or rewarding inappropriate care. As discussed above, when available, NQF endorsed measures would be used. In addition we propose to adopt measures that we believe are closely associated with better outcomes in the HHA setting in order to incentivize genuine improvements and sustain positive achievement while retaining the integrity of the model.
Sixth, we intend to ensure the model utilizes the most currently available data to assess HHA performance. We recognize that these data would not be available instantaneously due to the time required to process quality measurement information accurately; however, we intend to make every effort to process data in the timeliest fashion. Using more current data would result in a more accurate performance score while recognizing that HHAs need time to report measure data.
Many of the key elements of the proposed HHVBP model performance scoring methodology would be aligned with the scoring methodology of the Hospital Value-Based Purchasing Program (HVBP) in order to leverage the rigorous analysis and review underpinning that Program's approach to value-based purchasing in the hospital sector. The HVBP Program includes as one of its core elements the scoring methodology included in the 2007 Report to Congress “Plan to Implement a Medicare Hospital Value-Based Purchasing Program” (hereinafter referred to as “The 2007 HVBP Report”).
In the HVBP Program, the Performance Assessment Model aggregates points on the individual quality measures across different quality measurement domains to calculate a hospital's TPS. Similarly, the proposed HHVBP model would aggregate points on individual measures across four measure classifications derived from the 6 CMS/NQS domains as described above (see Figure 3) to calculate the HHA's TPS. In addition, the proposed HHVBP payment methodology is also aligned with the HVBP Program with respect to evaluating an HHA's performance on each quality measure based on the higher of an achievement or improvement score in the performance period. The proposed model is not only designed to provide incentives for HHAs to provide the highest level of quality, but also to provide incentives for HHAs to improve the care they provide to Medicare beneficiaries. By rewarding HHAs that provide high quality and/or high improvement, we believe the proposed HHVBP model would ensure that all HHAs would be incentivized to commit the resources necessary to make the organizational changes that would result in better quality.
Under the proposed model an HHA would be awarded points only for “applicable measures.” An “applicable measure” is one for which the HHA has provided 20 home health episodes of care per year. Points awarded for each applicable measure would be aggregated to generate a TPS. As described in the benchmark section below, HHAs would have the opportunity to receive 0 to 10 points for each measure in the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications. Each measure would have equal weight regardless of the total number of measures in each of the first three classifications. In contrast, we propose to score the New Measures in a different way. For each New Measure, HHAs would receive 10 points if they report the New Measure or 0 points if they do not report the measure during the performance year. In total, the New Measures would account for 10 percent of the TPS regardless of the number of measures applied to an HHA in the other three classifications.
We propose to calculate the TPS for the HHVBP methodology similarly to the TPS calculation that has been finalized under the HVBP program. The performance scoring methodology for the HHVBP model would include determining performance standards (benchmarks and thresholds) using the 2015 baseline period performance year's quality measure data, scoring HHAs based on their achievement and/or improvement with respect to those performance standards, and weighting each of the classifications by the number of measures employed, as presented in further detail in Section G below.
For scoring HHAs' performance on measures in the proposed Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications, we propose that the HHVBP model would adopt an approach using several key elements from the scoring methodology set forth in the 2007 HVBP Report and the successfully implemented HVBP Program
In determining the achievement points for each measure, HHAs would receive points along an achievement range, which is a scale between the achievement threshold and a benchmark. We propose to calculate the achievement threshold as the median of all HHAs' performance on the specified quality measure during the baseline period and to calculate the benchmark as the mean of the top decile of all HHAs' performance on the specified quality measure during the baseline period. Unlike the HVBP Program that uses a national sample, this model would calculate both the achievement threshold and the benchmark separately for each selected state and for HHA cohort size. Under this proposed methodology, we would have benchmarks and achievement
We are proposing that achievement scoring under the HHVBP model would be based on the Performance Assessment Model set forth in the 2007 HVBP Report and as implemented under the HVBP Program. An HHA would earn 0-10 points for achievement for each measure in the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications based on where its performance during the performance period falls relative to the achievement threshold and the benchmark, according to the following formula:
All achievement points would be rounded up or down to the nearest point (for example, an achievement score of 4.555 would be rounded to 5). HHAs would receive an achievement score as follows:
• An HHA with performance equal to or higher than the benchmark would receive the maximum of 10 points for achievement.
• An HHA with performance equal to or greater than the achievement threshold (but below the benchmark) would receive 1-9 points for achievement, by applying the formula above.
• An HHA with performance less than the achievement threshold would receive 0 points for achievement.
We welcome public comment on this proposed methodology for scoring HHAs on achievement under the proposed HHVBP model.
In keeping with the approach used by the HVBP program, we propose that an HHA would earn 0-10 points based on how much its performance during the performance period improved from its performance on each measure in the proposed Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications during the baseline period. A unique improvement range for each measure would be established for each HHA that defines the difference between the HHA's baseline period score and the same state and size level benchmark for the measure used in the achievement scoring calculation described previously, according to the following formula:
• Equal to or higher than the benchmark score, the HHA would receive an improvement score of 10 points;
• Greater than its baseline period score but below the benchmark (within the improvement range), the HHA would receive an improvement score of 0-10, based on the formula above; or
• Equal to or lower than its baseline period score on the measure, the HHA would receive 0 points for improvement.
We welcome public comments on this proposed methodology for scoring HHAs on improvement under the proposed HHVBP model.
For illustrative purposes we present the following examples of how the proposed performance scoring methodology would be applied in the context of the proposed measures in the proposed Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications. These HHA examples were selected from an empirical database created from 2013/2014 data from the Home Health Compare archived data, claims data and enrollment data to support the development of the HHVBP permutation of the Performance Assessment Model, and all performance scores are calculated for the pneumonia measure, with respect to the number of individuals assessed and administered the pneumococcal vaccine.
Figure 7 shows the scoring for HHA `A', as an example. The benchmark calculated for the pneumonia measure in this case was 0.87 (the mean value of the top decile in 2013), and the achievement threshold was 0.47 (the performance of the median or the 50th percentile among HHAs in 2013). HHA A's 2014 performance rate of 0.91 during the performance period for this measure exceeds the benchmark, so HHA A would earn 10 (the maximum)
Figure 7 also shows the scoring for HHA `B'. As referenced below, HHA B's performance on this measure went from 0.21 (which was below the achievement threshold) in the baseline period to 0.70 (which is above the achievement threshold) in the performance period. Applying the achievement scale, HHA B would earn 6 points for achievement, calculated as follows: [9 * ((0.70 − 0.47)/(0.87 − 0.47))] + 0.5 = 5.675, and then rounded to 6 points.
Checking HHA B's improvement score yields the following result: Based on HHA B's period-to-period improvement, from 0.21 in the baseline year to 0.70 in the performance year, HHA B would earn 7 points, calculated as follows: [10 * ((0.70 − 0.21)/(0.87 − 0.21))] − 0.5 = 6.92, rounded to 7 points. Because the higher of the achievement and improvement scores is used, HHA B would receive 7 points for this measure.
In Figure 8, HHA `C' yielded a decline in performance on the pneumonia measure, falling from 0.57 to 0.46 (a decline of 0.11 points). HHA C's performance during the performance period is lower than the achievement threshold of 0.47 and, as a result, receives 0 points based on achievement. It also receives 0 points for improvement, because its performance during the performance period is lower than its performance during the baseline period.
The HHVBP model provides us with the opportunity to study new quality measures. The four New Measures that we have proposed to adopt for the model for PY1 would be reported directly by the HHA and would account for 10 percent of the TPS regardless of the number of measures in the other three classifications. We are proposing that HHAs that report on these measures would receive 10 points out of a maximum of 10 points for each of the 4 measures in the New Measure classification. Hence a HHA that reports on all four measures would receive 40 points out of a maximum of 40. An HHA would receive 0 points for each measure that it fails to report on. If an HHA reports on all four measures, it would receive 40 points for the classification and 10 points (40/40 * 10 points) would be added to its TPS because the New Measure classification has a maximum weight of 10 percent. If an HHA reports on 3 of 4 measures, it would receive 30 points of 40 points available for the classification and 7.5 points (30/40 * 10 points) added to its TPS. If an HHA reports on 2 of 4 measures, they would receive 20 points of 40 points available for the classification and 5.0 points (20/40 * 10 points) added to their TPS. If an HHA reports on 0 of 4 measures, they would receive 0 points and have no points added to their TPS. We intend to update these measures through future rulemaking to allow us to study newer, leading-edge measures as well as retire measures that no longer require such analysis. We request comment on this proposed scoring methodology for new measures.
While no HHA in a selected state would be exempt from the HHVBP model, there may be periods when an HHA does not receive a payment adjustment because there are not an adequate number of episodes of care to generate sufficient quality measure data. The minimum threshold for an HHA to receive a score on a given measure is 20 home health episodes of care per year for HHAs that have been certified for at least 6-months. If an HHA does not meet this threshold to generate scores on five or more of the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience measures, no payment adjustment will be made, and the Medicare-certified HHA would be paid for HHA services in an amount equivalent to the amount it would have been paid under section 1895 of the Act.
HHAs with very low volumes will either increase their volume in later performance years and be subject to future payment adjustment, or the HHAs' volume will remain very low and the HHAs would continue to not have their payment adjusted in future years. Based on the most recent data available at this time, a very small number of HHAs are reporting on less than five of the total number of measures included in the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications and account for less than 0.5 percent of the claims made over 1,900 HHAs delivering care within the nine proposed selected states. We expect very little impact of very low service volume HHAs on the model due to the low number of low volume HHAs and because it is unlikely that a HHA will reduce the amount of service to such a low level to avoid a payment adjustment. Although these HHAs would not be subject to payment adjustments, they would remain in the model and have access to the same technical assistance as all other HHAs in the model, and would receive quality reports on any measures for which they do have 20 episodes of care, and a future opportunity to compete for payment adjustments.
We propose the HHA's TPS would be based on all the Clinical Quality of Care, Outcome and Efficiency, Person and Caregiver-Centered Experience measures and the New Measures that apply to the HHA. As described above, each measure in the Clinical Quality of Care, Outcome and Efficiency and Person and Caregiver-Centered
As an example, HHA “A” has at least 20 episodes of care in a 12-month period for only 9 quality measures out of a possible 25 measures from three of the four classifications (except the New Measures). Under the proposed scoring methodology outlined above, HHA A would be awarded 0, 0, 3, 4, 5, 7, 7, 9, and 10 points, respectively, for these measures. HHA A's total earned points for the three classifications would be calculated by adding together all the points awarded to HHA A, resulting in a total of 45 points. HHA A's total possible points would be calculated by multiplying the total number of measures for which the HHA reported on least 20 episodes (nine) by the maximum number of points for those measures (10), yielding a total of 90 possible points. HHA A's score for the three classifications would be the total earned points (45) divided by the total possible points (90) multiplied by 90 because as mentioned in section E7, the Clinical Quality of Care, Outcome and Efficiency, and Person and Caregiver-Centered Experience classifications account for 90 percent of the TPS and the New Measures classification accounts for 10 percent of the TPS, which yields a result of 45. In this example, HHAs also reported all four numbers and would receive the full 10 points for the new measure. As a result, the TPS for HHA A would be 55 (45 plus 10). In addition, as specified in Section E:7—Weighting, all measures have equal weights regardless of their classification (except for New Measures) and the total earned points for the three classifications can be calculated by adding the points awarded for each such measure together. We seek public comment on our proposal of the minimum number of cases for outcome and clinical quality measures.
We propose to codify at 42 CFR 484.330 a methodology for applying value-based payment adjustments to home health services under the HHVBP model. Payment adjustments would be made to the HH PPS final claim payment amount as calculated in accordance with § 484.205 using a linear exchange function (LEF) similar to the methodology utilized by the HVBP Program. The LEF is used to translate an HHA's TPS into a percentage of the value-based payment adjustment earned by each HHA under the HHVBP model. The LEF was identified by the HVBP Program as the simplest and most straightforward option to provide the same marginal incentives to all hospitals, and we believe the same to be true for HHAs. We propose the function's intercept at zero percent, meaning those HHAs that have a TPS that is average in relationship to other HHAs in their cohort (a zero percent), would not receive any payment adjustment. Payment adjustments for each HHA with a score above zero percent would be determined by the slope of the LEF. In addition we propose to set the slope of the LEF for the first performance year, CY 2016, so that the estimated aggregate value-based payment adjustments for CY 2016 are equal to 5 percent of the estimated aggregate base operating episode payment amount for CY 2018. The estimated aggregate base operating episode payment amount is the total amount of episode payments made to all the HHAs by Medicare in each individual state in the larger- and smaller-volume cohorts respectively (we are proposing nine states, which would create 18 separate aggregate base operating episode payment amounts).
Figure 9 provides an example of how the LEF is calculated and how it is applied to calculate the percentage payment adjustment to a HHA's TPS. For this example, we applied the 8 percent payment adjustment level that is proposed for the final two years of the HHVBP model. The proposed rate for the payment adjustments for other years would be proportionally less.
Step #1 involves the calculation of the `Prior Year Aggregate HHA Payment Amount' (See C2 in Figure 9) that each HHA was paid in the prior year. From claims data, all payments are summed together for each HHA for CY 2015, the year prior to the HHVBP Model.
Step #2 involves the calculation of the `8 percent Payment Reduction Amount' (C3 of Figure 9) for each HHA. The `Prior Year Aggregate HHA Payment Amount' is multiplied by the `8 percent Payment Reduction Rate'. The aggregate of the `8-percent Payment Reduction Amount' is the numerator of the LEF.
Step #3 involves the calculation of the `Final TPS Adjusted Reduction Amount' (C4 of Figure 9) by multiplying the `8-percent Payment Reduction Amount' from Step #2 by the TPS (C1) divided by 100. The aggregate of the `TPS Adjusted Reduction Amount' is the denominator of the LEF.
Step #4 involves calculating the LEF (C5 of Figure 9) by dividing the aggregate `8 percent Payment Reduction Amount' by the aggregate `TPS Adjusted Reduction Amount'.
Step #5 involves the calculation of the `Final TPS Adjusted Payment Amount' (C6 of Figure 9) by multiplying the `TPS Adjusted Reduction Amount' (C4) by the LEF (C5). This is an intermediary value used to calculate `Quality Adjusted Payment Rate'.
Step #6 involves the calculation of the `Quality Adjusted Payment Rate' (C7 of Figure 9) that the HHA would receive instead of the 8 percent reduction in payment. This is an intermediary step to determining the payment adjustment rate. For CYs 2021 and 2022, the payment adjustment in this column would range from 0 percent to 16 percent depending on the quality of care provided.
Step #7 involves the calculation of the `Final Percent Payment Adjustment' (C8 of Figure 9) that would be applied to the HHA payments after the performance period. It simply involves the CY payment adjustment percent (in 2018, 5 percent; in 2019, 5 percent; in 2020, 6 percent; in 2021, 8 percent; and in 2022, 8 percent). In this example, we use the maximum eight-percent (8 percent) subtraction to the `Quality Adjusted Payment Rate'. Note that the payment adjustment percentage is capped at no more than plus or minus 8 percent for each respective performance period and the payment adjustment would occur on the final claim payment amount.
We invite public comments on this proposed payment adjustment methodology.
We are proposing to provide HHAs two separate opportunities to review scoring information under the HHVBP model. First, HHAs will have the opportunity to review their quarterly quality reports following each quarterly posting; second, Medicare-certified HHAs will have the opportunity to review their TPS and payment adjustment calculations, and request a recalculation if a discrepancy is identified due to a CMS error as described in this section. These processes would also help educate and inform each competing Medicare-certified HHA on the direct relation between the payment adjustment and performance measure scores.
The proposed model design calls for us to inform HHA quarterly of their performance on each of the individual quality measures used to calculate the TPS. We propose that HHAs will have 10 days after the quarterly reports are provided to request a recalculation of a measure scores if it believes there is evidence of a discrepancy. We would adjust the score if it is determined that the discrepancy in the calculated measure scores was the result of our failure to follow measurement calculation protocols.
In addition, the proposed model design also calls for us to inform each Medicare-certified HHA of the TPS and payment adjustment amount in an annual report. We propose that these annual reports be provided to Medicare-certified HHAs each August prior to the calendar year for which the payment adjustment would be applied. Similar to quarterly reports, HHAs will have 10 days to request a recalculation of their TPS and payment adjustment amount from the date information is made available. For both the quarterly reports and the annual report containing the TPS and payment adjustments, Medicare-certified HHAs will only be permitted to request scoring recalculations, and must include a specific basis for the requested recalculation. We will not be responsible for providing HHAs with the underlying source data utilized to generate performance measure scores. Each HHA has access to this data via the QIES system. The final TPS and payment adjustment would then be provided to competing Medicare-certified HHAs in a final report no later than 60 days in advance of the payment adjustment taking effect.
The TPS from the annual performance report would be calculated based on the calculation of performance measures contained in the quarterly reports that have already been provided and reviewed by the HHAs. As a result, we believe that quarterly reviews would provide substantial opportunity to identify and correct errors and resolve discrepancies, thereby minimizing the challenges to the annual performance scores linked to payment adjustment.
As described above, a quarterly performance report would be provided to all Medicare-certified HHAs within the selected states beginning with the first quarter of CY 2016 being reported in July 2016. We propose that HHAs would submit recalculation requests for both quarterly quality performance measure reports and for the TPS and payment adjustment reports via an email link provided on the model-specific Web page. The request form would be entered by a person who has authority to sign on behalf of the HHA and be submitted within 10 days of receiving the quarterly data report or the annual TPS and payment adjustment report.
Requests for both quarterly report measure score recalculations or TPS and payment adjustment recalculations would contain the following information:
• The provider's name, address associated with the services delivered, and CMS Certification Number (CCN);
• The basis for requesting recalculation to include the specific quality measure data that the HHA believes is inaccurate or the calculation the HHA believes is incorrect;
• Contact information for a person at the HHA with whom CMS or its agent can communicate about this request, including name, email address, telephone number, and mailing address (must include physical address, not just a post office box); and,
• A copy of any supporting documentation the HHA wishes to submit in electronic form via the model-specific Web page.
Following receipt of a request for quarterly report measure score recalculations or a request for TPS and payment adjustment recalculation, CMS or its agent would:
+ Provide an email acknowledgement, using the contact information provided in the recalculation request, to the HHA contact notifying the HHA that the request has been received;
+ Review the request to determine validity, and determine whether the requested recalculation would result in a score change altering performance measure scores or the HHA's TPS;
+ If recalculation would result in a performance measure score or TPS change, conduct a review of quality data and if an error is found, recalculate the TPS using the corrected performance data; and,
+ Provide a formal response to the HHA contact, using the contact information provided in the recalculation request, notifying the HHA of the outcome of the review and recalculation process.
Recalculation and subsequent communication of the results of these determinations would occur as soon as administratively feasible following the submission of requests. We request comment on our proposed quarterly quality report measure review, TPS preview period, and our proposed process for requesting recalculation of the quarterly performance measure scores, and the TPS and payment adjustment. We intend to codify these processes in regulation text in future rulemaking.
Additionally, we will develop and adopt an appeals mechanism under the model through future rulemaking in advance of the application of any payment adjustments.
We propose to codify at 484.315(c) that HHAs in selected states would be required to collect and report information to CMS necessary for the purposes of monitoring and evaluating this model as required by statute.
We intend to use a multilevel approach to evaluation. Here, we intend to conduct analyses at the state, HHA, and patient levels. Based on the state groupings discussed in the section on selection of Medicare certified HHAs, we believe there are several ways in which we can draw comparison groups and remain open to scientifically-sound, rigorous methods for evaluating the effect of the model intervention.
The evaluation effort may require of HHAs participating in the Model additional data specifically for evaluation purposes. Such requirements for additional data to carry out model evaluation would be in compliance with 42 CFR 403.1105 which, as of January 1, 2015, requires entities participating in the testing of a model under section 1115A to collect and report such information, including protected health information (as defined at 45 CFR 160.103), as the Secretary determines is necessary to monitor and evaluate the model. We would consider all Medicare-certified HHAs providing services within a state selected for the Model to be participating in the testing of this model because the competing HHAs would be receiving payment from CMS under the model.
We invite public comments on this proposed evaluation plan.
Section 1895(b)(3)(B)(v)(II) of the Act requires that for 2007 and subsequent years, each HHA submit to the Secretary in a form and manner, and at a time, specified by the Secretary, such data that the Secretary determines are appropriate for the measurement of health care quality. To the extent that an HHA does not submit data in accordance with this clause, the Secretary is directed to reduce the home health market basket percentage increase applicable to the HHA for such year by 2 percentage points. As provided at section 1895(b)(3)(B)(vi) of the Act, depending on the market basket percentage for a particular year, the 2 percentage point reduction under section 1895(b)(3)(B)(v)(I) of the Act may result in this percentage increase, after application of the productivity adjustment under section 1895(b)(3)(B)(vi)(I) of the Act, being less than 0.0 percent for a year, and may result in payment rates under the Home Health PPS for a year being less than payment rates for the preceding year.
Section 2(a) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (the IMPACT Act) (Pub. L. 113-185, enacted on Oct. 6, 2014) amended Title XVIII of the Act, in part, by adding a new section 1899B, which imposes new data reporting requirements for certain post-acute care (PAC) providers, including HHAs. New section 1899B of the Act is titled, “Standardized Post-Acute Care (PAC) Assessment Data for Quality, Payment, and Discharge Planning”. Under section 1899B(a)(1) of the Act, certain post-acute care (PAC) providers (defined in section 1899B(a)(2)(A) of the Act to include HHAs, SNFs, IRFs, and LTCHs) must submit standardized patient assessment data in accordance with section 1899B(b) of the Act, data on quality measures required under section 1899B(c)(1) of the Act, and data on resource use, and other measures required under section 1899B(d)(1) of the Act. The Act also sets out specified application dates for each of the measures. The Secretary must specify the quality, resource use, and other measures no later than the applicable specified application date defined in section 1899B(a)(2)(E) of the Act.
Section 1899B(b) of the Act describes the standardized patient assessment data that PAC providers are required to submit in accordance with section 1899B(b)(1) of the Act; requires the Secretary, to the extent practicable, to match claims data with standardized patient assessment data in accordance with section 1899B(b)(2) of the Act; and requires the Secretary, as soon as practicable, to revise or replace existing patient assessment data to the extent that such data duplicate or overlap with standardized patient assessment data, in accordance with section 1899B(b)(3) of the Act.
Sections 1899B(c)(1) and (d)(1) of the Act direct the Secretary to specify measures that relate to at least five stated quality domains and three stated resource use and other measure domains. Section 1899B(c)(1) of the Act provides that the quality measures on which PAC providers, including HHAs, are required to submit standardized patient assessment data and other necessary data specified by the Secretary must be in accordance with, at least, the following domains:
• Functional status, cognitive function, and changes in function and cognitive function;
• Skin integrity and changes in skin integrity;
• Medication reconciliation;
• Incidence of major falls; and
• Accurately communicating the existence of and providing for the transfer of health information and care preferences of an individual to the individual, family caregiver of the individual, and providers of services furnishing items and services to the individual when the individual transitions (1) from a hospital or Critical Access Hospital (CAH) to another applicable setting, including a PAC provider or the home of the individual, or (2) from a PAC provider to another applicable setting, including a different PAC provider, hospital, CAH, or the home of the individual.
Section 1899B(c)(2)(A) provides that, to the extent possible, the Secretary must require such reporting through the use of a PAC assessment instrument and modify the instrument as necessary to enable such use.
Section 1899B(d)(1) of the Act provides that the resource use and other measures on which PAC providers, including HHAs, are required to submit any necessary data specified by the Secretary, which may include standardized assessment data in addition to claims data, must be in accordance with, at least, the following domains:
• Resource use measures, including total estimated Medicare spending per beneficiary;
• Discharge to community; and
• Measures to reflect all-condition risk-adjusted potentially preventable hospital readmission rates.
Sections 1899B(c) and (d) of the Act indicate that data satisfying the eight measure domains in the IMPACT Act is the minimum data reporting requirement. Therefore, the Secretary may specify additional measures and additional domains.
Section 1899B(e)(1) of the Act requires that the Secretary implement the quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act in phases consisting of measure specification, data collection, and data analysis; the provision of feedback reports to PAC providers in accordance with section 1899B(f) of the Act; and public reporting of PAC providers' performance on such measures in accordance with section 1899B(g) of the Act. Section 1899B(e)(2) of the Act generally requires that each measure specified by the Secretary under section 1899B of the Act be NQF-endorsed, but authorizes an exception under which the Secretary may select non-NQF-endorsed quality measures in the case of specified areas or medical topics determined appropriate by the Secretary for which a feasible or practical measure has not been endorsed by the NQF, as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. Section 1899B(e)(3) of the Act provides that the pre-rulemaking process required by section 1890A of the Act applies to quality, resource use, and other measures specified under sections 1899B(c)(1) and (d)(1) of the Act, but authorizes exceptions under which the Secretary may (1) use expedited procedures, such as ad hoc reviews, as necessary in the case of a measure required with respect to data submissions during the 1-year period before the applicable specified application date, or (2) alternatively, waive section 1890A of the Act in the case of such a measure if applying section 1890A of the Act (including through the use of expedited procedures) would result in the inability of the Secretary to satisfy any deadline specified under section 1899B of the Act with respect to the measure.
Section 1899B(f)(1) of the Act requires the Secretary to provide confidential feedback reports to PAC providers on the performance of such PAC providers with respect to quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act beginning 1 year after the applicable specified application date.
Section 1899B(g) of the Act requires the Secretary to establish procedures for making available to the public information regarding the performance of individual PAC providers with respect to quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) beginning not later than 2 years after the applicable specified application date. The procedures must ensure, including through a process consistent with the process applied under section 1886(b)(3)(B)(viii)(VII) for similar purposes, that each PAC provider has the opportunity to review and submit corrections to the data and information that are to be made public with respect to the PAC provider prior to such data being made public.
Section 1899B(h) of the Act sets out requirements for removing, suspending, or adding quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act. In addition, section 1899B(j) of the Act requires the Secretary to allow for stakeholder input, such as through town halls, open door forums, and mailbox submissions, before the initial rulemaking process to implement section 1899B of the Act.
Section 2(c)(1) of the IMPACT Act amended section 1895 of the Act to address the payment consequences for HHAs with respect to the additional data which HHAs are required to submit under section 1899B of the Act. These changes include the addition of a new section 1895(3)(B)(v)(IV), which requires HHAs to submit the following additional data: (1) For the year beginning on the applicable specified application date and subsequent years, data on the quality, resource use, and other measures required under sections 1899B(c)(1) and (d)(1) of the Act; and (2) for 2019 and subsequent years, the standardized patient assessment data required under section 1899B(b)(1) of the Act. Such data must be submitted in the form and manner, and at the time, specified by the Secretary.
As stated above, the IMPACT Act adds a new section 1899B that imposes new data reporting requirements for certain post-acute care (PAC) providers, including HHAs. Sections 1899B(c)(1) and 1899B(d)(1) collectively require that the Secretary specify quality measures and resource use and other measures with respect to certain domains not later than the specified application date that applies to each measure domain and PAC provider setting. Section 1899B(a)(2)(E) delineates the specified application dates for each measure domain and PAC provider. The IMPACT Act also amends other sections of the Act, including section 1895(b)(3)(B)(v), to require the Secretary to reduce the otherwise applicable PPS payment to a PAC provider that does not report the new data in a form and manner, and at a time, specified by the Secretary. For HHAs, amended section 1895(b)(3)(B)(v) would require the Secretary to reduce the payment update for any HHA that does not satisfactorily submit the new required data.
Under the current HH QRP, the general timeline and sequencing of measure implementation occurs as follows: Specification of measures; proposal and finalization of measures through notice-and-comment rulemaking; HHA submission of data on the adopted measures; analysis and processing of the submitted data; notification to HHAs regarding their quality reporting compliance with respect to a particular year; consideration of any reconsideration requests; and imposition of a payment reduction in a particular year for failure to satisfactorily submit data with respect to that year. Any payment reductions that are taken with respect to a year begin approximately 1 year after the end of the data submission period for that
To the extent that the IMPACT Act could be interpreted to shorten this timeline, so as to require us to reduce HH PPS payment for failure to satisfactorily submit data on a measure specified under section 1899B(c)(1) or (d)(1) of the IMPACT Act beginning with the same year as the specified application date for that measure, such a timeline would not be feasible. The current timeline discussed above reflects operational and other practical constraints, including the time needed to specify and adopt valid and reliable measures, collect the data, and determine whether a HHA has complied with our quality reporting requirements. It also takes into consideration our desire to give HHAs enough notice of new data reporting obligations so that they are prepared to timely start reporting data. Therefore, we intend to follow the same timing and sequence of events for measures specified under sections 1899B(c)(1) and (d)(1) of the Act that we currently follow for other measures specified under the HH QRP. We intend to specify each of these measures no later than the specified application dates set forth in section 1899B(a)(2)(E) of the Act and propose to adopt them consistent with the requirements in the Act and Administrative Procedure Act. To the extent that we finalize a proposal to adopt a measure for the HH QRP that satisfies an IMPACT Act measure domain, we intend to require HHAs to report data on the measure for the year that begins 2 years after the specified application date for that measure. Likewise, we intend to require HHAs to begin reporting any other data specifically required under the IMPACT Act for the year that begins 2 years after we adopt requirements that would govern the submission of that data.
Lastly, on April 1, 2014, the Congress passed the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), which stated the Secretary may not adopt ICD-10 prior to October 1, 2015. On August 4, 2014, HHS published a final rule titled “Administrative Simplification: Change to the Compliance Date for the International Classification of Diseases, 10th Revision (ICD-10-CM and ICD-10-PCS Medical Data Code Sets” (79 FR 45128), which announced October 1, 2015 as the new compliance date. The OASIS-C1 data item set had been previously approved by the Office of Management and Budget (OMB) on February 6, 2014 and scheduled for implementation on October 1, 2014. We intended to use the OASIS-C1 to coincide with the original implementation date of the ICD-10. The approved OASIS-C1 included changes to accommodate coding of diagnoses using the ICD-10-CM coding set and other important stakeholder concerns such as updating clinical concepts, and revised item wording and response categories to improve item clarity. This version included five (5) data items that required the use of ICD-10 codes.
Since OASIS-C1 was revised to incorporate ICD-10 coding, it is not feasible to implement the OASIS-C1/ICD-10 version prior to October 1, 2015, when ICD-10 is scheduled to be implemented. Due to this delay, we had to ensure the collection and submission of OASIS data continued, until ICD-10 could be implemented. Therefore, we have made interim changes to the OASIS-C1 data item set to allow use with ICD-9 until ICD-10 is adopted. The OASIS-C1/ICD-9 version was submitted to OMB for approval until the OASIS-C1/ICD-10 version could be implemented. A 6-month emergency approval was granted on October 7, 2014 and CMS subsequently applied for an extension. The extension of the OASIS-C1/ICD-9 version was reapproved under OMB control number 0938-0760 with a current expiration date of March 31, 2018. It is important to note, that this version of the OASIS will be discontinued once the OASIS-C1/ICD-10 version is approved and implemented. In addition, to facilitate the reporting of OASIS data as it relates to the planned implementation of ICD-10 on October 1, 2015, we submitted a new request for approval to OMB for the OASIS-C1/ICD-10 version under the Paperwork Reduction Act (PRA) process. We are requesting a new OMB control number for the proposed revised OASIS item as announced in the 30-day
We strive to promote high quality and efficiency in the delivery of health care to the beneficiaries we serve. Performance improvement leading to the highest quality health care requires continuous evaluation to identify and address performance gaps and reduce the unintended consequences that may arise in treating a large, vulnerable, and aging population. Quality reporting programs, coupled with public reporting of quality information, are critical to the advancement of health care quality improvement efforts.
We seek to adopt measures for the HH QRP that promotes better, safer, and more efficient care. Valid, reliable, relevant quality measures are fundamental to the effectiveness of our quality reporting programs. Therefore, selection of quality measures is a priority for CMS in all of its quality reporting programs.
The measures selected would address the measure domains as specified in the IMPACT Act and would be in alignment with the
• Better Care: Improve the overall quality of care by making healthcare more patient-centered, reliable, accessible, and safe.
• Healthy People, Healthy Communities: Improve the health of the U.S. population by supporting proven interventions to address behavioral, social, and environmental determinants of health in addition to delivering higher-quality care.
• Affordable Care: Reduce the cost of quality healthcare for individuals, families, employers, and government.
In addition, our measure selection activities for the HH QRP take into consideration input we receive from the Measure Applications Partnership (MAP), convened by the NQF, as part of the established CMS pre-rulemaking process required under section 1890A of the Act. The MAP is a public-private partnership comprised of multi-stakeholder groups convened for the primary purpose of providing input to us on the selection of certain categories of quality and efficiency measures, as required by section 1890A(a)(3) of the Social Security Act (the Act). By February 1st of each year, the NQF must provide that input to us. Input from the MAP is located at
We initiated an Ad Hoc MAP process for the review of the measures under consideration for implementation in
To meet the first specified application date applicable to HHAs under section 1899B(a)(2)(E) of the Act, which is October 1, 2017, we have focused on measures that:
• Correspond to a measure domain in sections 1899B(c)(1) or (d)(1) of the Act and are setting-agnostic: For example falls with major injury and the incidence of pressure ulcers;
• Are currently adopted for 1 or more of our PAC quality reporting programs, are already either NQF-endorsed and in use or finalized for use, or already previewed by the Measure Applications Partnership (MAP) with support;
• Minimize added burden on HHAs;
• Minimize or avoid, to the extent feasible, revisions to the existing items in assessment tools currently in use (for example, the OASIS); and
• Where possible, the avoidance duplication of existing assessment items.
In our selection and specification of measures, we employ a transparent process in which we seek input from stakeholders and national experts and engage in a process that allows for pre-rulemaking input on each measure, as required by section 1890A of the Act. This process is based on a private public partnership, and it occurs via the MAP. The MAP is composed of multistakeholder groups convened by the NQF, our current contractor under section 1890 of the Act, to provide input on the selection of quality and efficiency measures described in section 1890(b)(7)(B). The NQF must convene these stakeholders and provide us with the stakeholders' input on the selection of such measures. We, in turn, must take this input into consideration in selecting such measures. In addition, the Secretary must make available to the public by December 1 of each year a list of such measures that the Secretary is considering under Title XVIII of the Act. As discussed in section V.A. of this proposed rule 1899B(e)(3) provides that the pre-rulemaking process required by section 1890A of the Act applies to the measures required under section 1899B, subject to certain exceptions for expedited procedures or, alternatively, waiver of section 1890A. We initiated an ad hoc MAP process for the review of the quality measures under consideration for proposal, in preparation for adoption of those quality measures into the HH QRP that are required by the IMPACT Act, and that must be implemented by January 1, 2017. The List of Measures under Consideration (MUC List) under the IMPACT Act was made public on February 5, 2015. Under the IMPACT Act, these measures must be standardized so they can be applied across PAC settings and must correspond to measure domains specified in sections 1899B(c)(1) and (d)(1) of the IMPACT Act. The MAP reviewed each IMPACT Act-related quality measure proposed in this proposed rule for the HH QRP, in light of its intended cross-setting use. We refer to sections V.A. and V.C. of this proposed rule for more information on the MAP's recommendations. The MAP's final report, MAP Off-Cycle Deliberations 2015: Measures under Consideration to Implement Provisions of the IMPACT Act: Final Report, is available at
In the absence of NQF endorsement on measures for the home health setting, or measures that are not fully supported by the MAP for the HH QRP, we intend to propose for adoption measures that most closely align with the national priorities discussed above and for which the MAP supports the measure concept. Further discussion as to the importance and high-priority status of these measures in the HH setting is included under each quality measure proposal in this proposed rule. In addition, for measures not endorsed by the NQF, we have sought, to the extent practicable, to adopt measures that have been endorsed or adopted by a national consensus organization, recommended by multi-stakeholder organizations, and/or developed with the input of providers, purchasers/payers, and other stakeholders.
In the CY 2014 HH PPS final rule, (78 FR 72256-72320), we finalized a proposal to add two claims-based measures to the HH QRP, and stated that we would begin reporting the data from these measures to HHAs beginning in CY 2014. These claims based measures are: (1) Rehospitalization during the first 30 days of HH; and (2) Emergency Department Use without Hospital Readmission during the first 30 days of HH. In an effort to align with other updates to Home Health Compare, including the transition to quarterly provider preview reports, we have made the decision to delay the reporting of data from these measures until July 2015 (
(a) We are proposing one standardized cross-setting new measure for CY 2016 to meet the requirements of the IMPACT Act. The proposed quality measure that addresses the domain of skin integrity and changes in skin integrity is the National Quality Forum (NQF)-endorsed measure: Percent of Residents or Patients with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678) (
The IMPACT Act requires the specification of a quality measure to address skin integrity and changes in skin integrity in the home health setting by January 1, 2017. We are proposing the implementation of the quality measure NQF #0678, Percent of Residents or Patients with Pressure Ulcers that are New or Worsened (Short Stay) in the HH QRP as a cross-setting quality measure to meet the requirements of the IMPACT Act for the CY 2018 payment determination and subsequent years. This measure reports the percent of patients with Stage 2 through 4 pressure ulcers that are new or worsened since the beginning of the episode of care.
Pressure ulcers are high-volume in post-acute care settings and high-cost adverse events. According to the 2014 Prevention and Treatment Guidelines published by the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance, pressure ulcer care is estimated to cost approximately $11 billion annually, and between $500 and $70,000 per individual pressure ulcer.
The IMPACT Act requires the specification of quality measures that are harmonized across PAC settings. This requirement is consistent with the NQF Steering Committee report, which stated that to understand the impact of pressure ulcers across settings, quality measures addressing prevention, incidence, and prevalence of pressure ulcers must be harmonized and aligned.
A TEP convened by our measure development contractor provided input on the technical specifications of this quality measure, including the feasibility of implementing the measure across PAC settings. The TEP was supportive of the implementation of this measure across PAC settings and applauded CMS's efforts to standardize this measure for cross-setting development. Additionally, the NQF MAP met on February 9, 2015 and
We propose that data for the standardized quality measure would be collected using the OASIS-C1 with submission through the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system. HHAs began submitting data in January 2015 for the OASIS items used to calculate NQF #0678, the Percent of Residents, or Patients with Pressure Ulcers That Are New or Worsened (Short Stay), as part of the Home Health Quality Initiative to assess the number of new or worsened pressure ulcers in January 2015. By building on the existing reporting and submission infrastructure for HHAs, we intend to minimize the administrative burden related to data collection and submission for this measure under the HH QRP. For more information on HH reporting using the QIES ASAP system, refer to:
Data collected through the OASIS-C1 would be used to calculate this quality measure. Data items in the OASIS-C1 include M1308 (Current Number of Unhealed Pressure Ulcers at Each Stage or Unstageable) and M1309 (Worsening in Pressure Ulcer Status Since SOC/ROC). Data collected through the OASIS-C1 would be used for risk adjustment of this measure. We anticipate risk adjustment items would include, but is not limited to M1850 (Activities of Daily Living Assistance, Transferring), and M1620 (Bowel Incontinence Frequency). OASIS C1 items M1016 (Diagnoses Requiring Medical or Treatment Change Within past 14 Days), M1020 (Primary Diagnoses) and M1022 (Other Diagnoses) would be used to identify patients with a diagnosis of peripheral vascular disease, diabetes, or malnutrition. More information about the OASIS items is available in the OASIS Manual
The calculation of the proposed measure would be based on the items M1308 (Current Number of Unhealed Pressure Ulcers at Each Stage or Unstageable) and M1309 (Worsening in Pressure Ulcer Status Since SOC/ROC). The specifications and data items for NQF #0678, the Percent of Residents or Patients with Pressure Ulcers that are New or Worsened (Short Stay), are available at
We invite public comment on our proposal to adopt NQF #0678 Percent of Residents or Patients with Pressure Ulcers that are New or Worsened (Short Stay) for the HH QRP to fulfill the timeline requirements for implementation under the IMPACT Act, for CY2018 HH payment determination and subsequent years.
As part of our ongoing measure development efforts, we are considering a future update to the numerator of the quality measure NQF #0678, Percent of Residents or Patients with Pressure Ulcers that are New or Worsened (Short Stay). This update would hold providers accountable for the development of unstageable pressure ulcers and suspected deep tissue injuries (sDTIs). Under this proposed change the numerator of the quality measure would be updated to include unstageable pressure ulcers, including sDTIs that are new/developed while the patient is receiving home health care, as well as Stage 1 or 2 pressure ulcers that become unstageable due to slough or eschar (indicating progression to a full thickness [that is, stage 3 or 4] pressure ulcer) after admission. This would be consistent with the specifications of the “New and Worsened Pressure Ulcer” measure for HH patients presented to the MAP on the 2014 MUC list. At this time, we are not proposing the implementation of this change (that is, including sDTIs and unstageable pressure ulcers in the numerator) in the HH QRP, but are soliciting public feedback on this potential area of measure development.
Our measure development contractor convened a cross-setting pressure ulcer TEP that strongly recommended that CMS hold providers accountable for the development of new unstageable pressure ulcers and sDTIs by including these pressure ulcers in the numerator of the quality measure. Although the TEP acknowledged that unstageable pressure ulcers and sDTIs cannot and should not be assigned a numeric stage, panel members recommended that these be included in the numerator of NQF #0678, the Percent of Residents, or Patients with Pressure Ulcers That Are New or Worsened (Short Stay), as a new pressure ulcer if developed during a home health episode. The TEP also recommended that a Stage 1 or 2 pressure ulcer that becomes unstageable due to slough or eschar should be considered worsened because the presence of slough or eschar indicates a full thickness (equivalent to Stage 3 or 4) wound.
In addition, we are also considering whether body mass index (BMI) should be used as a covariate for risk-adjusting NQF #0678 in the home health setting, as is done in other post-acute care settings. We invite public feedback to inform our direction to include unstageable pressure ulcers and sDTIs in the numerator of the quality measure NQF #0678 Percent of Residents or Patients with Pressure Ulcers that are New or Worsened (Short Stay), as well as on the possible collection of height
(b) We have also identified four future, cross-setting measure constructs to potentially meet requirements of the IMPACT Act domains of: (1) All-condition risk-adjusted potentially preventable hospital readmission rates; (2) resource use, including total estimated Medicare spending per beneficiary; (3) discharge to community; and (4) medication reconciliation. These are shown in Table 22; we would like to solicit public feedback to inform future measure development of these constructs as it relates to meeting the IMPACT Act requirements in these areas.
(c) We are working with our measure development and maintenance contractor to identify setting-specific measure concepts for future implementation in the HH QRP that align with or complement current measures and new measures to meet domains specified in the IMPACT Act. In identifying priority areas for future measure enhancement and development, we take into consideration results of environmental scans and resulting gaps analysis for relevant home health quality measure constructs, along with input from numerous stakeholders, including the Measures Application Partnership (MAP), the Medicare Payment Advisory Commission (MedPAC), Technical Expert Panels, and national priorities, such as those established by the National Priorities Partnership, the HHS Strategic Plan, the National Strategy for Quality Improvement in Healthcare, and the CMS Quality Strategy. Based on input from stakeholders, CMS has identified several high priority concept areas for future measure development in Table 23.
These measure concepts are under development, and details regarding measure definitions, data sources, data collection approaches, and timeline for implementation would be communicated in future rulemaking. We invite feedback about these seven high priority concept areas for future measure development.
The HH conditions of participation (CoPs) at § 484.55(d) require that the
It is important to note that to calculate quality measures from OASIS data, there must be a complete quality episode, which requires both a Start of Care (initial assessment) or Resumption of Care OASIS assessment and a Transfer or Discharge OASIS assessment. Failure to submit sufficient OASIS assessments to allow calculation of quality measures, including transfer and discharge assessments, is a failure to comply with the CoPs.
HHAs do not need to submit OASIS data for those patients who are excluded from the OASIS submission requirements. As described in the December 23, 2005 Medicare and Medicaid Programs: Reporting Outcome and Assessment Information Set Data as Part of the Conditions of Participation for Home Health Agencies final rule (70 FR 76202), we defined the exclusion as those patients:
• Receiving only non-skilled services;
• For whom neither Medicare nor Medicaid is paying for HH care (patient receiving care under a Medicare or Medicaid Managed Care Plan are not excluded from the OASIS reporting requirement);
• Receiving pre- or post-partum services; or
• Under the age of 18 years.
As set forth in the CY 2008 HH PPS final rule (72 FR 49863), HHAs that become Medicare certified on or after May 31 of the preceding year are not subject to the OASIS quality reporting requirement nor any payment penalty for quality reporting purposes for the following year. For example, HHAs certified on or after May 31, 2014 are not subject to the 2 percentage point reduction to their market basket update for CY 2015. These exclusions only affect quality reporting requirements and do not affect the HHAs' reporting responsibilities as announced in the December 23, 2005 final rule, Medicare and Medicaid Programs; Reporting Outcome and Assessment Information Set Data as Part of the Conditions of Participation for Home Health Agencies (70 FR 76202).
In the CY 2014 HH PPS Final rule (78 FR 72297), we finalized a proposal to consider OASIS assessments submitted by HHAs to CMS in compliance with HH CoPs and Conditions for Payment for episodes beginning on or after July 1, 2012, and before July 1, 2013 as fulfilling one portion of the quality reporting requirement for CY 2014.
In addition, we finalized a proposal to continue this pattern for each subsequent year beyond CY 2014. OASIS assessments submitted for episodes beginning on July 1st of the calendar year 2 years prior to the calendar year of the Annual Payment Update (APU) effective date and ending June 30th of the calendar year one year prior to the calendar year of the APU effective date, fulfill the OASIS portion of the HH QRP requirement.
Section 1895(b)(3)(B)(v)(I) of the Act states that for 2007 and each subsequent year, the home health market basket percentage increase applicable under such clause for such year shall be reduced by 2 percentage points if a home health agency does not submit data to the Secretary in accordance with subclause (II) with respect to such a year. This pay-for-reporting requirement was implemented on January 1, 2007. In the CY 2015 HH PPS Final rule (79 FR 38387), we finalized a proposal to define the quantity of OASIS assessments each HHA must submit to meet the pay-for-reporting requirement.
We believe that defining a more explicit performance requirement for the submission of OASIS data by HHAs would better meet section 5201(c)(2) of the Deficit Reduction Act of 2005 (DRA), which requires that each home health agency shall submit to the Secretary such data that the Secretary determines are appropriate for the measurement of health care quality. Such data shall be submitted in a form and manner, and at a time, specified by the Secretary for purposes of this clause.
In the CY 2015 HH PPS Final rule (79 FR 38387), we reported information on a study performed by the Department of Health & Human Services, Office of the Inspector General (OIG) in February 2012 to: (1) Determine the extent to which HHAs met federal reporting requirements for the OASIS data; (2) to determine the extent to which states met federal reporting requirements for OASIS data; and (3) to determine the extent to which CMS was overseeing the accuracy and completeness of OASIS data submitted by HHAs. Based on the OIG report we proposed a performance requirement for submission of OASIS quality data, which would be responsive to the recommendations of the OIG.
In response to these requirements and the OIG report, we designed a pay-for-reporting performance system model that could accurately measure the level of an HHA's submission of OASIS data. The performance system is based on the principle that each HHA is expected to submit a minimum set of two matching assessments for each patient admitted to their agency. These matching assessments together create what is considered a quality episode of care, consisting ideally of a Start of Care (SOC) or Resumption of Care (ROC) assessment and a matching End of Care (EOC) assessment. However, it was determined that there are several scenarios that could meet this matching assessment requirement of the new pay-for-reporting performance requirement. These scenarios or quality assessments are defined as assessments that create a quality episode of care during the reporting period or could create a quality episode if the reporting period were expanded to an earlier reporting period or into the next reporting period.
Seven types of assessments submitted by an HHA fit this definition of a quality assessment. These are:
1. A Start of Care (SOC; M0100 = `01') or Resumption of Care (ROC; M0100 = `03') assessment that can be matched to an End of Care (EOC; M0100 = `06', `07', `08', or `09') assessment. These SOC/ROC assessments are the first assessment in the pair of assessments that create a standard quality of care episode describe in the previous paragraph.
2. An End of Care (EOC) assessment that can be matched to a Start of Care (SOC) or Resumption of Care (ROC) assessment. These EOC assessments are the second assessment in the pair of assessments that create a standard quality of care episode describe in the previous paragraph.
3. A SOC/ROC assessment that could begin an episode of care, but the assessment occurs in the last 60 days of the performance period. This is labeled as a Late SOC/ROC quality assessment. The assumption is that the EOC assessment will occur in the next reporting period.
4. An EOC assessment that could end an episode of care that began in the previous reporting period, (that is, an EOC that occurs in the first 60 days of the performance period). This is labeled as an Early EOC quality assessment. The
5. A SOC/ROC assessment that is followed by one or more follow-up assessments, the last of which occurs in the last 60 days of the performance period. This is labeled as an SOC/ROC Pseudo Episode quality assessment.
6. An EOC assessment is preceded by one or more follow-up assessments, the first of which occurs in the first 60 days of the performance period. This is labeled an EOC Pseudo Episode quality assessment.
7. A SOC/ROC assessment that is part of a known one-visit episode. This is labeled as a One-Visit episode quality assessment. This determination is made by consulting HH claims data.
SOC, ROC, and EOC assessments that do not meet any of these definitions are labeled as Non-Quality assessments. Follow-up assessments (that is, where the M0100 Reason for Assessment = `04' or `05') are considered Neutral assessments and do not count toward or against the pay-for-reporting performance requirement.
Compliance with this performance requirement can be measured through the use of an uncomplicated mathematical formula. This pay-for-reporting performance requirement metric has been titled as the “Quality Assessments Only” (QAO) formula because only those OASIS assessments that contribute, or could contribute, to creating a quality episode of care are included in the computation.
The formula based on this definition is as follows:
Our ultimate goal is to require all HHAs to achieve a pay-for-reporting performance requirement compliance rate of 90 percent or more, as calculated using the QAO metric illustrated above. In the CY 2015 HH PPS final rule (79 FR 66074), we proposed implementing a pay-for-reporting performance requirement over a three-year period. After consideration of the public comments received, we adopted as final our proposal to establish a pay-for-reporting performance requirement for assessments submitted on or after July 1, 2015 and before June 30, 2016 with appropriate start of care dates, HHAs must score at least 70 percent on the QAO metric of pay-for-reporting performance requirement or be subject to a 2 percentage point reduction to their market basket update for CY 2017.
HHAs have been statutorily required to report OASIS for a number of years and therefore should have many years of experience with the collection of OASIS data and transmission of this data to CMS. Given the length of time that HHAs have been mandated to report OASIS data and based on preliminary analyses that indicate that the majority of HHAs are already achieving the target goal of 90 percent on the QAO metric, we believe that HHAs would adapt quickly to the implementation of the pay-for-reporting performance requirement, if phased in over a three-year period.
In the CY2015 rule, we did not finalize a proposal to increase the reporting requirement in 10 percent increments over a two-year period until the maximum rate of 90 percent is reached, but instead proposed to analyze historical data to set the reporting requirements. To set the threshold for the 2nd year, we analyzed the most recently available data, from 2013 and 2014, to make a determination about what the pay-for-reporting performance requirement should be. Specifically, we reviewed OASIS data from this time period simulating the pay-for-reporting performance 70 percent submission requirement to determine the hypothetical performance of each HHA as if the pay-for-reporting performance requirement were in effect during the reporting period preceding its implementation. This analysis indicated a nominal increase of 10 percent each year would provide the greatest opportunity for successful implementation versus an increase of 20 percent from year 1 to year 2.
Based on this analysis, we propose to set the performance threshold at 80 percent for the reporting period from July 1, 2016 through June 30, 2017. For the reporting period from July 1, 2017 through June 30, 2018 and thereafter, we propose the performance threshold would be 90 percent.
We provided a report to each HHA of their hypothetical performance under the pay-for-reporting performance requirement during the 2014-2015 pre-implementation reporting period in June 2015. On January 1, 2015, the data submission process for OASIS converted from the current state-based OASIS submission system to a new national OASIS submission system known as the Assessment Submission and Processing (ASAP) System. On July 1, 2015, when the pay-for-reporting performance requirement of 70 percent goes into effect, providers would be required to submit their OASIS assessment data into the ASAP system. Successful submission of an OASIS assessment would consist of the submission of the data into the ASAP system with a receipt of no fatal error messages. Error messages received during submission can be an indication of a problem that occurred during the submission process and could also be an indication that the OASIS assessment was rejected. Successful submission can be verified by ascertaining that the submitted assessment data resides in the national database after the assessment has met all of the quality standards for completeness and accuracy during the submission process. Should one or more OASIS assessments submitted by a HHA be rejected due to an IT/servers issue caused by CMS, we may, at our discretion, excuse the non-submission of OASIS data. We anticipate that such a scenario would rarely, if ever, occur. In the event that a HHA believes, they were unable to submit OASIS assessments due to an IT/server issue on the part of CMS, the HHA should be prepared to provide any documentation or proof available, which demonstrates that no fault on their part contributed to the failure of the OASIS records to transmit to CMS.
The initial performance period for the pay-for-reporting performance requirement would be July 1, 2015 through June 30, 2016. Prior to and during this performance period, we have scheduled Open Door Forums and webinars to educate HHA personnel as needed about the pay-for-reporting performance requirement program and the pay-for- reporting performance QAO metric, and distributed individual provider preview reports. Additionally, OASIS Education Coordinators (OECs) would be trained to provide state-level instruction on this program and metric. We have already posted a report, which provides a detailed explanation of the methodology for this pay-for-reporting QAO methodology. To view this report, go to:
In the CY 2015 HH PPS final rule (79 FR 66031), we stated that the home health quality measures reporting requirements for Medicare-certified agencies include the Home Health Care CAHPS® (HHCAHPS) Survey for the CY 2015 Annual Payment Update (APU). We maintained the stated HHCAHPS data requirements for CY 2015 set out in previous rules, for the continuous monthly data collection and quarterly data submission of HHCAHPS data.
As part of the HHS Transparency Initiative, we implemented a process to measure and publicly report patient experiences with home health care, using a survey developed by the Agency for Healthcare Research and Quality's (AHRQ's) Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program and originally endorsed by the NQF in March 2009 (NQF Number 0517) and recently NQF re-endorsed in 2015. The HHCAHPS survey is part of a family of CAHPS® surveys that asks patients to report on and rate their experiences with health care. The HHCAHPS Survey is approved under OMB Control Number 0938-1066 through May 31, 2017. The Home Health Care CAHPS® (HHCAHPS) survey presents home health patients with a set of standardized questions about their home health care providers and about the quality of their home health care.
Prior to the HHCAHPS survey, there was no national standard for collecting information about patient experiences that enabled valid comparisons across all HHAs. The history and development process for HHCAHPS has been described in previous rules and is also available on the official HHCAHPS Web site at
For public reporting purposes, we report five measures from the HHCAHPS Survey—three composite measures and two global ratings of care that are derived from the questions on the HHCAHPS survey. The publicly reported data are adjusted for differences in patient mix across HHAs. We update the HHCAHPS data on Home Health Compare on
• Patient care (Q9, Q16, Q19, and Q24);
• Communications between providers and patients (Q2, Q15, Q17, Q18, Q22, and Q23); and
• Specific care issues on medications, home safety, and pain (Q3, Q4, Q5, Q10, Q12, Q13, and Q14).
The two global ratings are the overall rating of care given by the HHA's care providers (Q20), and the patient's willingness to recommend the HHA to family and friends (Q25).
The HHCAHPS survey is currently available in English, Spanish, Chinese, Russian, and Vietnamese. The OMB number on these surveys is the same (0938-1066). All of these surveys are on the Home Health Care CAHPS® Web site,
All of the requirements about home health patient eligibility for the HHCAHPS survey and conversely, which home health patients are ineligible for the HHCAHPS survey are delineated and detailed in the
Home health patients are
• Are under the age of 18;
• Are deceased prior to the date the sample is pulled;
• Receive hospice care;
• Receive routine maternity care only;
• Are not considered survey eligible because the state in which the patient lives restricts release of patient information for a specific condition or illness that the patient has; or
• No Publicity patients, defined as patients who on their own initiative at their first encounter with the HHAs make it very clear that no one outside of the agencies can be advised of their patient status, and no one outside of the HHAs can contact them for any reason.
We stated in previous rules that Medicare-certified HHAs are required to contract with an approved HHCAHPS survey vendor. This requirement continues, and Medicare-certified agencies also must provide on a monthly basis a list of all their survey-eligible home health care patients served to their respective HHCAHPS survey vendors. Agencies are not allowed to influence at all how their patients respond to the HHCAHPS survey.
As previously required, HHCAHPS survey vendors are required to attend introductory and all update trainings conducted by CMS and the HHCAHPS Survey Coordination Team, as well as to pass a post-training certification test. Update training is required annually for all approved HHCAHPS survey vendors. We have approximately 30 approved HHCAHPS survey vendors. The most current list of approved HHCAHPS survey vendors is available at
We stated in prior final rules that all approved HHCAHPS survey vendors are required to participate in HHCAHPS oversight activities to ensure compliance with HHCAHPS protocols, guidelines, and survey requirements. The purpose of the oversight activities is to ensure that approved HHCAHPS survey vendors follow the
• Organizational Background and Staff Experience;
• Work Plan;
• Sampling Plan;
• Survey Implementation Plan;
• Data Security, Confidentiality and Privacy Plan; and
• Questionnaire Attachments.
As part of the oversight activities, the HHCAHPS Survey Coordination Team conducts on-site visits to all approved HHCAHPS survey vendors. The purpose of the site visits is to allow the HHCAHPS Coordination Team to observe the entire HHCAHPS Survey implementation process, from the sampling stage through file preparation and submission, as well as to assess data security and storage. The HHCAHPS Survey Coordination Team reviews the HHCAHPS survey vendor's survey systems, and assesses administration protocols based on the
• Survey management and data systems;
• Printing and mailing materials and facilities;
• Telephone call center facilities;
• Data receipt, entry and storage facilities; and
• Written documentation of survey processes.
After the site visits, HHCAHPS survey vendors are given a defined time period in which to correct any identified issues and provide follow-up documentation of corrections for review. HHCAHPS survey vendors are subject to follow-up site visits on an as-needed basis.
In the CY 2013 HH PPS final rule (77 FR 67094, 67164), we codified the current guideline that all approved HHCAHPS survey vendors fully comply with all HHCAHPS oversight activities. We included this survey requirement at § 484.250(c)(3).
In the CY 2015 HH PPS final rule (79 FR 66031), we stated that for the CY 2016 APU, we would require continued monthly HHCAHPS data collection and reporting for four quarters. The data collection period for CY 2016, APU includes the second quarter 2014 through the first quarter 2015 (the months of April 2014 through March 2015). Although these dates are past, we wished to state them in this proposed rule so that HHAs are again reminded of what months constituted the requirements for the CY 2016 APU. HHAs are required to submit their HHCAHPS data files to the HHCAHPS Data Center for the HHCAHPS data from the first quarter of 2015 data by 11:59 p.m., EST on July 16, 2015. This deadline is firm; no exceptions are permitted.
For the CY 2016 APU, we required that all HHAs that had fewer than 60 HHCAHPS-eligible unduplicated or unique patients in the period of April 1, 2013 through March 31, 2014 are exempted from the HHCAHPS data collection and submission requirements for the CY 2016 APU, upon completion of the CY 2016 HHCAHPS Participation Exemption Request form, and upon CMS verification of the HHA patient counts. Agencies with fewer than 60 HHCAHPS-eligible, unduplicated or unique patients in the period of April 1, 2013, through March 31, 2014, were required to submit their patient counts on the HHCAHPS Participation Exemption Request form for the CY 2016 APU posted on
We automatically exempt HHAs receiving Medicare certification after the period in which HHAs do their patient counts. HHAs receiving Medicare certification on or after April 1, 2014 are exempt from the HHCAHPS reporting requirement for the CY 2016 APU. These newly-certified HHAs did not need to complete a HHCAHPS Participation Exemption Request form for the CY 2016 APU.
For the CY 2017 APU, we require continued monthly HHCAHPS data collection and reporting for four quarters. The data collection period for the CY 2017, APU includes the second quarter 2015 through the first quarter 2016 (the months of April 2015 through March 2016). HHAs would be required to submit their HHCAHPS data files to the HHCAHPS Data Center for the second quarter 2015 by 11:59 p.m., EST on October 15, 2015; for the third quarter 2015 by 11:59 p.m., EST on January 21, 2016; for the fourth quarter 2015 by 11:59 p.m., EST on April 21, 2016; and for the first quarter 2016 by 11:59 p.m., EST on July 21, 2016. These deadlines will be firm; no exceptions will be permitted.
For the CY 2017 APU, we require that all HHAs that have fewer than 60 HHCAHPS-eligible unduplicated or unique patients in the period of April 1, 2014 through March 31, 2015 are exempted from the HHCAHPS data collection and submission requirements for the CY 2017 APU, upon completion of the CY 2017 HHCAHPS Participation Exemption Request form, and upon CMS verification of the HHA patient counts. Agencies with fewer than 60 HHCAHPS-eligible, unduplicated or unique patients in the period of April 1, 2014 through March 31, 2015, are required to submit their patient counts on the HHCAHPS Participation Exemption Request form for the CY 2017 APU posted on
We automatically exempt HHAs receiving Medicare certification after the period in which HHAs do their patient counts. HHAs receiving Medicare certification on or after April 1, 2015 are exempt from the HHCAHPS reporting requirement for the CY 2017 APU. These newly-certified HHAs did not need to complete a HHCAHPS Participation Exemption Request form for the CY 2017 APU.
For the CY 2018 APU, we require continued monthly HHCAHPS data collection and reporting for four quarters. The data collection period for the CY 2018, APU includes the second quarter 2016 through the first quarter 2017 (the months of April 2016 through March 2017). HHAs would be required to submit their HHCAHPS data files to the HHCAHPS Data Center for the second quarter 2016 by 11:59 p.m., EST on October 20, 2016; for the third quarter 2016 by 11:59 p.m., EST on January 19, 2017; for the fourth quarter 2016 by 11:59 p.m., EST on April 20, 2017; and for the first quarter 2017 by 11:59 p.m., EST on July 20, 2017. These deadlines will be firm; no exceptions will be permitted.
For the CY 2018 APU, we require that all HHAs that have fewer than 60 HHCAHPS-eligible unduplicated or unique patients in the period of April 1, 2015 through March 31, 2016 are exempted from the HHCAHPS data collection and submission requirements for the CY 2018 APU, upon completion of the CY 2018 HHCAHPS Participation Exemption Request form, and upon CMS verification of the HHA patient counts. Agencies with fewer than 60 HHCAHPS-eligible, unduplicated or unique patients in the period of April 1, 2015 through March 31, 2016, are required to submit their patient counts on the HHCAHPS Participation Exemption Request form for the CY 2018 APU posted on
We automatically exempt HHAs receiving Medicare certification after the period in which HHAs do their patient counts. HHAs receiving Medicare Certification on or after April 1, 2016 are exempt from the HHCAHPS reporting requirement for the CY 2018 APU. These newly-certified HHAs did not need to complete a HHCAHPS Participation Exemption Request form for the CY 2018 APU.
HHAs should monitor their respective HHCAHPS survey vendors to ensure that vendors submit their HHCAHPS data on time, by accessing their HHCAHPS Data Submission Reports on
We will continue HHCAHPS oversight activities as finalized in the CY 2014 rule. In the CY 2013 HH PPS final rule (77 FR 6704, 67164), we codified the current guideline that all approved HHCAHPS survey vendors must fully comply with all HHCAHPS oversight activities. We included this survey requirement at § 484.250(c)(3).
We propose to continue the OASIS and HHCAHPS reconsiderations and appeals process that we have finalized and that we have used for prior periods for the CY 2012, CY 2013, CY 2014, and CY 2015 APU determinations. We have described the reconsiderations process requirements in the CMS Technical Direction Letter that we sent to the affected HHAs, on or in late September. HHAs have 30 days from their receipt of the Technical Direction Letter informing them that they did not meet the OASIS and HHCAHPS requirements for the CY period, to send all documentation that supports their requests for reconsideration to CMS. It is important that the affected HHAs send in comprehensive information in their reconsideration letter/package because we would not contact the affected HHAs to request additional information or to clarify incomplete or inconclusive information. If clear evidence to support a finding of compliance is not present, the 2 percent reduction in the APU would be upheld. If clear evidence of compliance is present, the 2 percent reduction for the APU would be reversed. We notify affected HHAs by December 31st annually for the APU period that begins on January 1st. If we determine to uphold the 2 percent reduction, the HHA may further appeal the 2 percent reduction via the Provider Reimbursement Review Board (PRRB) appeals process. The PRRB contact information is provided to the HHAs receiving letters in December about the CMS reconsideration decisions.
Providers who wish to submit a reconsideration request should continue to follow the reconsideration and appeals process as finalized in the CY 2012, CY 2013, CY 2014, and CY 2015 Home Health Prospective Payment System Rate Update Final Rules.
We are not proposing any changes to the participation requirements, or to the requirements pertaining to the implementation of the Home Health CAHPS® Survey (HHCAHPS). We only updated the information to reflect the dates in the future APU years. We again strongly encourage HHAs to keep up-to-date about the HHCAHPS by regularly viewing the official Web site for the HHCAHPS at
Section 1895(b)(3)(B)(v)(III) of the Act and section 1899B(f) of the IMPACT Act states the Secretary shall establish procedures for making data submitted under subclause (II) available to the public. Such procedures shall ensure that a home health agency has the opportunity to review the data that is to be made public with respect to the agency prior to such data being made public. We recognize that public reporting of quality data is a vital component of a robust quality reporting program and are fully committed to ensuring that the data made available to the public be meaningful and that comparing performance across home health agencies requires that measures be constructed from data collected in a standardized and uniform manner. We also recognize the need to ensure that each home health agency has the opportunity to review the data before publication. Medicare home health regulations, as codified at § 484.250(a), requires HHAs to submit OASIS assessments and Home Health Care Consumer Assessment of Healthcare Providers and Systems Survey® (HHCAHPS) data to meet the quality reporting requirements of section 1895(b)(3)(B)(v) of the Act.
In addition, beginning April 1, 2015 HHAs began to receive Provider Preview Reports (for all Process Measures and Outcome Measures) on a quarterly, rather than annual, basis. The opportunity for providers to review their data and to submit corrections prior to public reporting aligns with the other quality reporting programs and the requirement for provider review under the IMPACT Act. We provide quality measure data to HHAs via the Certification and Survey Provider Enhanced Reports (CASPER reports), which are available through the CMS Health Care Quality Improvement and Evaluation System (QIES).
As part of our ongoing efforts to make healthcare more transparent, affordable, and accountable, the HH QRP has developed a CMS Compare Web site for home health agencies, which identifies home health providers based on the areas they serve. Consumers can search for all Medicare-certified home health providers that serve their city or ZIP code and then find the agencies offering the types of services they need. A subset of the HH quality measures has been publicly reported on the Home Health Compare (HH Compare) Web site since 2003. The selected measures that are made available to the public can be viewed on the HH Compare Web site located at
The Affordable Care Act calls for transparent, easily understood information on provider quality to be publicly reported and made widely available. To provide home health care consumers with a summary of existing quality measures in an accessible format, we plan to publish a star rating based on the quality of care measures for home health agencies on Home Health Compare starting in July 2015. This is part of our plan to adopt star ratings across all Medicare.gov Compare Web sites. Star ratings are currently publicly displayed on Nursing Home Compare, Physician Compare, the Medicare Advantage Plan Finder, and Dialysis Facility Compare, and they are scheduled to be displayed on Hospital Compare in 2015.
The Quality of Patient Care star rating methodology assigns each home health agency a rating between one (1) and five (5) stars, using half stars for adjustment and reporting. All Medicare-certified home health agencies are eligible to receive a Quality of Patient Care star rating providing that they have quality data reported on at least 5 out of the 9 quality measures that are included in the calculation.
Home health agencies would continue to have prepublication access to their agency's quality data, which enables each agency to know how it is
The Quality of Patient Care star ratings methodology was developed through a transparent process the included multiple opportunities for stakeholder input, which was subsequently the basis for refinements to the methodology. An initial proposed methodology for calculating the Quality of Patient Care star ratings was posted on the CMS.gov Web site in December 2014. CMS then held two Special Open Door Forums (SODFs) on December 17, 2014 and February 5, 2015 to present the proposed methodology and solicit input. At each SODF, stakeholders provided immediate input, and were invited to submit additional comments via the Quality of Patient Care star ratings Help Desk mailbox:
Additional information regarding the Quality of Patient Care star rating would be posted on the star ratings Web page at
While this proposed rule contains information collection requirements, this rule does not add new, nor revise any of the existing information collection requirements, or burden estimate. The information collection requirements discussed in this rule for the OASIS-C1 data item set had been previously approved by the Office of Management and Budget (OMB) on February 6, 2014 and scheduled for implementation on October 1, 2014. The extension of OASIS-C1/ICD-9 version was reapproved under OMB control number 0938-0760 with a current expiration date of March 31, 2018. This version of the OASIS will be discontinued once the OASIS-C1/ICD-10 version is approved and implemented. In addition, to facilitate the reporting of OASIS data as it relates to the implementation of ICD-10 on October 1, 2015, CMS submitted a new request for approval to OMB for the OASIS-C1/ICD-10 version under the Paperwork Reduction Act (PRA) process. CMS is requesting a new OMB control number for the proposed revised OASIS item as announced in the 30-day
Because of the large number of public comments we normally receive on
Section 1895(b)(1) of the Act requires the Secretary to establish a HH PPS for all costs of HH services paid under Medicare. In addition, section 1895(b)(3)(A) of the Act requires (1) the computation of a standard prospective payment amount include all costs for HH services covered and paid for on a reasonable cost basis and that such amounts be initially based on the most recent audited cost report data available to the Secretary, and (2) the standardized prospective payment amount be adjusted to account for the effects of case-mix and wage levels among HHAs. Section 1895(b)(3)(B) of the Act addresses the annual update to the standard prospective payment amounts by the HH applicable percentage increase. Section 1895(b)(4) of the Act governs the payment computation. Sections 1895(b)(4)(A)(i) and (b)(4)(A)(ii) of the Act require the standard prospective payment amount to be adjusted for case-mix and geographic differences in wage levels. Section 1895(b)(4)(B) of the Act requires the establishment of appropriate case-mix adjustment factors for significant variation in costs among different units of services. Lastly, section 1895(b)(4)(C) of the Act requires the establishment of wage adjustment factors that reflect the relative level of wages, and wage-related costs applicable to HH services furnished in a geographic area compared to the applicable national average level.
Section 1895(b)(3)(B)(iv) of the Act provides the Secretary with the authority to implement adjustments to the standard prospective payment amount (or amounts) for subsequent years to eliminate the effect of changes in aggregate payments during a previous year or years that was the result of changes in the coding or classification of different units of services that do not reflect real changes in case-mix. Section 1895(b)(5) of the Act provides the Secretary with the option to make changes to the payment amount otherwise paid in the case of outliers because of unusual variations in the type or amount of medically necessary care. Section 1895(b)(3)(B)(v) of the Act requires HHAs to submit data for purposes of measuring health care quality, and links the quality data submission to the annual applicable percentage increase.
Section 421(a) of the MMA requires that HH services furnished in a rural area, for episodes and visits ending on or after April 1, 2010, and before January 1, 2016, receive an increase of 3 percent of the payment amount otherwise made under section 1895 of the Act. Section 210 of the MACRA amended section 421(a) of the MMA to extend the 3 percent increase to the payment amounts for serviced furnished in rural areas for episodes and visits ending before January 1, 2018.
Section 3131(a) of the Affordable Care Act mandates that starting in CY 2014, the Secretary must apply an adjustment to the national, standardized 60-day episode payment rate and other amounts applicable under section 1895(b)(3)(A)(i)(III) of the Act to reflect factors such as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other relevant factors. In addition, section 3131(a) of the Affordable Care Act mandates that rebasing must be phased-in over a 4-year period in equal increments, not to exceed 3.5 percent of the amount (or amounts) as of the date of enactment (2010) under section 1895(b)(3)(A)(i)(III) of the Act, and be fully implemented in CY 2017.
The proposed HHVBP model would apply a payment adjustment based on
We have examined the impacts of this 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 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Act, section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
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 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The net transfer impacts related to the proposed changes in payments under the HH PPS for CY 2016 are estimated to be −$350 million. The savings impacts related to the proposed HHVBP model are estimated at a total projected 5-year gross savings of $380 million assuming a very conservative savings estimate of a 6 percent annual reduction in hospitalizations and a 1.0 percent annual reduction in SNF admissions. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
The update set forth in this rule applies to Medicare payments under HH PPS in CY 2016. Accordingly, the following analysis describes the impact in CY 2016 only. We estimate that the net impact of the proposals in this rule is approximately $350 million in decreased payments to HHAs in CY 2016. We applied a wage index budget neutrality factor and a case-mix weights budget neutrality factor to the rates as discussed in section III.C.3 of this proposed rule; therefore, the estimated impact of the 2016 wage index proposed in section III.C.3 of this proposed rule and the recalibration of the case-mix weights for 2016 proposed in section III.B. of this proposed rule is zero. The −$350 million impact reflects the distributional effects of the 2.3 percent HH payment update percentage ($420 million increase), the effects of the third year of the four-year phase-in of the rebasing adjustments to the national, standardized 60-day episode payment amount, the national per-visit payment rates, and the NRS conversion factor for an impact of −2.5 percent ($470 million decrease), and the effects of the −1.72 percent adjustment for nominal case-mix growth ($300 million decrease). The $350 million in decreased payments is reflected in the last column of the first row in Table 24 as a 0.1 percent decrease in expenditures when comparing CY 2015 payments to estimated CY 2016 payments.
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. For the purposes of the RFA, we estimate that almost all HHAs are small entities as that term is used in the RFA. Individuals and states are not included in the definition of a small entity. The economic impact assessment is based on estimated Medicare payments (revenues) and HHS's practice in interpreting the RFA is to consider effects economically “significant” only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. The majority of HHAs' visits are Medicare-paid visits and therefore the majority of HHAs' revenue consists of Medicare payments. Based on our analysis, we conclude that the policies proposed in this rule will result in an estimated total impact of 3 to 5 percent or more on Medicare revenue for greater than 5 percent of HHAs. Therefore, the Secretary has determined that this HH PPS proposed rule will have a significant economic impact on a substantial number of small entities. Further detail is presented in Table 24, by HHA type and location.
With regards to options for regulatory relief, we note that in the CY 2014 HH PPS final rule we finalized rebasing adjustments to the national, standardized 60-day episode rate, non-routine supplies (NRS) conversion factor, and the national per-visit payment rates for each year, 2014 through 2017 as described in section II.C and III.C.3 of this proposed rule. Since the rebasing adjustments are mandated by section 3131(a) of the Affordable Care Act, we cannot offer HHAs relief from the rebasing adjustments for CY 2016. For the proposed reduction to the national, standardized 60-day episode payment amount of 1.72 percent for CY 2016 described in section III.B.2 of this proposed rule, we believe it is appropriate to reduce the national, standardized 60-day episode payment amount to account for the estimated increase in nominal case-mix in order to move towards more accurate payment for the delivery of home health services where payments better align with the costs of providing such services. In the alternatives considered section below, we note that we considered proposing the full 3.41 percent reduction to the 60-day episode rate in CY 2016 to account for nominal case-mix growth between CY 2012 and CY 2014. However, we instead proposed to reduce the 60-day episode rate by 1.72 percent in CY 2016 and 1.72 percent in CY 2017 to account for estimated nominal case-mix growth between CY 2012 and CY 2014.
Executive Order 13563 specifies, to the extent practicable, agencies should assess the costs of cumulative regulations. However, given potential utilization pattern changes, wage index changes, changes to the market basket forecasts, and unknowns regarding future policy changes, we believe it is neither practicable nor appropriate to forecast the cumulative impact of the rebasing adjustments on Medicare payments to HHAs for future years at this time. Changes to the Medicare program may continue to be made as a result of the Affordable Care Act, or new statutory provisions. Although these changes may not be specific to the HH PPS, the nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes would make it difficult to predict accurately the full scope of the impact upon HHAs for future years
In addition, section 1102(b) of the Act requires us to prepare a RIA if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This proposed rule applies to HHAs. Therefore, the Secretary has determined that the HH PPS proposed rule will not have a significant economic impact on the operations of small rural hospitals.
To test the impact of upside and downside value-based payment adjustments, beginning in calendar year 2018 and in each succeeding calendar year through calendar year 2022, the proposed model would adjust the final claim payment amount for a home health agency for each episode in a calendar year by an amount equal to the applicable percent. For purposes of this proposed rule, we have limited our analysis of the economic impacts to the value-based incentive payment adjustments. Under the proposed model design, the incentive payment adjustments would be limited to the total payment reductions to home health agencies included in the model and would be no less than the total amount available for value-based incentive payment adjustment. Overall, the distributive impact of this proposed rule is estimated at $380 million for CY 2018-2022. Therefore, this proposed rule is economically significant and thus a major rule under the Congressional Review Act. The proposed model would test the effect on quality and costs of care by applying payment adjustments based on HHAs' performance on quality measures. This proposed rule was developed based on extensive research and experience with value-based purchasing models.
Guidance issued by the Department of Health and Human Services interpreting the Regulatory Flexibility Act considers the effects economically ‘significant’ only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. Among the over 1900 HHAs in the selected states that would be expected to be included in the proposed HHVBP model, we estimate that the maximum percent payment adjustment resulting from this proposed rule will only be greater than −5 percent for 10 percent of the HHAs included in the model (using the 8 percent maximum payment adjustment threshold applied in CY2021 and CY2022). As a result, only 2 percent of all HHA providers nationally would be significantly impacted, falling well below the RFA threshold. In addition, only HHAs that are impacted with lower payments are those providers that provide the poorest quality which is the main tenet of the model. This falls well below the threshold for economic significance established by HHS for requiring a more detailed impact assessment under the RFA. Thus, we are not preparing an analysis under the RFA because the Secretary has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural HHAs. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we have identified less than 5 percent of HHAs included in the proposed selected states that primarily serve beneficiaries that reside in rural areas (greater than 50 percent of beneficiaries served). We are not preparing an analysis under section 1102(b) of the Act because the Secretary has determined that the proposed HHVBP model would not have a significant impact on the operations of a substantial number of small rural HHAs.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2015, that threshold is approximately $144 million. This rule will have no consequential effect on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts state law, or otherwise has Federalism implications. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
This proposed rule sets forth updates for CY 2016 to the HH PPS rates contained in the CY 2015 HH PPS final rule (79 FR 66032 through 66118). The impact analysis of this proposed rule presents the estimated expenditure effects of policy changes proposed in this rule. We use the latest data and best analysis available, but we do not make adjustments for future changes in such variables as number of visits or case-mix.
This analysis incorporates the latest estimates of growth in service use and payments under the Medicare HH benefit, based primarily on preliminary Medicare claims data from 2014. We note that certain events may combine to limit the scope or accuracy of our impact analysis, because such an analysis is future-oriented and, thus, susceptible to errors resulting from other changes in the impact time period assessed. Some examples of such possible events are newly-legislated general Medicare program funding changes made by the Congress, or changes specifically related to HHAs. In addition, changes to the Medicare program may continue to be made as a result of the Affordable Care Act, or new statutory provisions. Although these changes may not be specific to the HH PPS, the nature of the Medicare program is such that the changes may interact, and the complexity of the interaction of these changes could make it difficult to predict accurately the full scope of the impact upon HHAs.
Table 24 represents how HHA revenues are likely to be affected by the policy changes proposed in this rule. For this analysis, we used an analytic file with linked CY 2014 HH claims data (as of December 31, 2014) for dates of service that ended on or before December 31, 2014, and OASIS assessments. The first column of Table 24 classifies HHAs according to a number of characteristics including provider type, geographic region, and urban and rural locations. The second column shows the number of facilities in the impact analysis. The third column shows the payment effects of proposed CY 2016 wage index. The fourth column shows the payment
The last column shows the combined effects of all the proposed policies for HH PPS. Overall, it is projected that aggregate payments in CY 2016 will decrease by 1.8 percent. As illustrated in Table 24, the combined effects of all of the changes vary by specific types of providers and by location. We note that some individual HHAs within the same group may experience different impacts on payments than others due to the distributional impact of the CY 2016 wage index, the extent to which HHAs had episodes in case-mix groups where the case-mix weight decreased for CY 2016 relative to CY 2015, the percentage of total HH PPS payments that were subject to the low-utilization payment adjustment (LUPA) or paid as outlier payments, and the degree of Medicare utilization.
Table 25 displays our analysis of the distribution of possible payment adjustments at the 5 percent, 6 percent and 8 percent rates that are being proposed in the model based on 2013-2014 data, providing information on the estimated impact of this proposed rule. We note that this impact analysis is based on the aggregate value of all 9 states identified in section IV.C.2. of this proposed rule by applying the proposed state selection methodology.
Table 26 displays our analysis of the distribution of possible payment adjustments based on 2013-2014 data, providing information on the estimated impact of this proposed rule. We note that this impact analysis is based on the aggregate value of all nine states (identified in section IV.C.2. of this proposed rule) by applying the proposed state selection methodology.
If our methodology is finalized as proposed, all Medicare-certified HHAs that provide services in Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to compete in this model. However, should the methodology we propose in this rule change as a result of comments received during the rulemaking process, it could result in different states being selected for the model. In such an event, we would apply the final methodology and announce the selected states in the final rule. The estimates presented here may also change accordingly.
Value-based incentive payment adjustments for the estimated 1,900 plus HHAs in the proposed selected states that would compete in the HHVBP model are stratified by the size as defined in section F. For example, Arizona has 31 HHAs that do not provide services to enough beneficiaries to be required to complete CAHPS
The next columns provide the distribution of scores by percentile; we see that the value-based incentive percentage payments for home health agencies in Arizona range from −3.3 percent at the 10th percentile to +5.0 percent at the 90th percentile, while the value-based incentive payment at the 50th percentile is 0.56 percent.
The smaller-volume HHA cohorts table identifies that some consideration will have to be made for MD, WA and TN where there are too few HHAs in the smaller-volume cohort and would be included in the larger-volume cohort without being measured on HHCAHPS.
Table 27 provides the payment adjustment distribution based on proportion of dual-eligible beneficiaries, average case mix (using HCC scores), proportion that reside in rural areas, as well as HHA organizational status. Besides the observation that higher proportion of dually-eligible beneficiaries serviced is related to better performance, the payment adjustment distribution is consistent with respect to these four categories.
The TPS score and the payment methodology at the state and size level were calculated so that each home health agency's payment adjustment was calculated as it would be in the model. Hence, the values of each separate analysis in the tables are representative of what they would be if the baseline year was 2013 and the performance year was 2014.
There were 1,931 HHAs in the nine selected states out of 1,991 HHAs that were found in the HHA data sources which yielded the sufficient measures to be included in the model. It is expected that a certain number of HHAs will not be subject to the payment adjustment because they may be servicing too small of a population to report on an adequate number of measures to calculate a TPS.
As described in section III.B.2 of this proposed rule, we considered proposing to reduce the national, standardized 60-day episode payment rate by 3.41 percent in CY 2016 to account for nominal case-mix growth between CY 2012 and CY 2014. If we were to reduce the national, standardized 60-day episode payment rate by 3.41 percent, we estimate that the aggregate impact would be a net decrease of $650 million in payments to HHAs, resulting from a $470 million decrease (−2.5 percent) due to the third year of the Affordable Care Act mandated rebasing adjustments, a $420 million increase (2.3 percent) due to the home health payment update percentage, and a $600 million decrease due to reducing the national, standardized 60-day episode payment rate by 3.41 percent. However, instead of proposing a one-time reduction in the national, standardized 60-day episode payment rate of 3.41 percent in CY 2016 to account for nominal case-mix growth from CY 2012 through CY 2014, we proposed to reduce the national, standardized 60-day episode payment rate by 1.72 percent in CY 2016 and 1.72 percent in CY 2017 to account for nominal case-mix growth from CY 2012 through CY 2014 as outlined in section III.B.2 of this proposed rule.
Section 3131(a) of the Affordable Care Act mandates that starting in CY 2014, the Secretary must apply an adjustment to the national, standardized 60-day episode payment rate and other amounts applicable under section 1895(b)(3)(A)(i)(III) of the Act to reflect factors such as changes in the number of visits in an episode, the mix of services in an episode, the level of intensity of services in an episode, the average cost of providing care per episode, and other relevant factors. In addition, section 3131(a) of the Affordable Care Act mandates that rebasing must be phased-in over a 4-year period in equal increments, not to exceed 3.5 percent of the amount (or amounts) as of the date of enactment (2010) under section 1895(b)(3)(A)(i)(III) of the Act, and be fully implemented in CY 2017. Therefore, in the CY 2014 HH PPS final rule (78 FR 77256), we finalized rebasing adjustments to the national, standardized 60-day episode payment amount, the national per-visit rates and the NRS conversion factor. As we noted in the CY 2014 HH PPS final rule, because section 3131(a) of the Affordable Care Act requires a four year phase-in of rebasing, in equal increments, to start in CY 2014 and be fully implemented in CY 2017, we do not have the discretion to delay, change, or eliminate the rebasing adjustments once we have determined that rebasing is necessary (78 FR 72283).
Section 1895(b)(3)(B) of the Act requires that the standard prospective payment amounts for CY 2016 be increased by a factor equal to the applicable HH market basket update for those HHAs that submit quality data as required by the Secretary. For CY 2016, section 3401(e) of the Affordable Care Act, requires that, in CY 2015 (and in subsequent calendar years), the market basket update under the HHA prospective payment system, as described in section 1895(b)(3)(B) of the Act, be annually adjusted by changes in economy-wide productivity. Beginning in CY 2015, section 1895(b)(3)(B)(vi)(I) of the Act, as amended by section 3401(e) of the Affordable Care Act, requires the application of the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act to the HHA PPS for CY 2015 and each subsequent CY. The −0.6 percentage point productivity adjustment to the
We invite comments on the alternatives discussed in this analysis.
As required by OMB Circular A-4 (available at
Table 28 provides our best estimate of the decrease in Medicare payments under the proposed HHVBP model.
In conclusion, we estimate that the net impact of the HH PPS proposals in this rule is a decrease in Medicare payments to HHAs of $350 million for CY 2016. The $350 million decrease in estimated payments to HHAs for CY 2016 reflects the distributional effects of the 2.3 percent CY 2016 HH payment update percentage ($420 million increase), the proposed reduction to the national, standardized 60-day episode payment rate in CY 2016 of 1.72 percent to account for nominal case-mix growth ($300 million decrease), and the third year of the 4-year phase-in of the rebasing adjustments required by section 3131(a) of the Affordable Care Act of −2.5 percent ($470 million decrease). This analysis, together with the remainder of this preamble, provides an initial Regulatory Flexibility Analysis.
In conclusion, we estimate there will be no net impact of the proposals in this rule in Medicare payments to HHAs for CY 2016. However, the overall economic impact of the HHVBP model provision is an estimated $380 million in total savings from a reduction in unnecessary hospitalizations and SNF usage as a result of greater quality improvements in the HH industry over the life of the proposed model.
Executive Order 13132 on Federalism (August 4, 1999) establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of states, local or tribal governments.
Health facilities, Medicare
Emergency medical services, Health facilities, Health professions, Medicare, and Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, and Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(e) * * *
(1) * * *
(iii) Discharge with goals met and/or no expectation of a return to home health care and the patient returns to home health care during the 60 day episode.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Secs 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
(d)
(2) The PEP adjustment will not apply in situations of transfers among HHAs of common ownership. Those situations will be considered services provided under arrangement on behalf of the originating HHA by the receiving HHA with the common ownership interest for the balance of the 60-day episode. The common ownership exception to the transfer PEP adjustment does not apply if the beneficiary moves to a different MSA or Non-MSA during the 60-day
(3) If the intervening event warrants a new 60-day episode payment and a new physician certification and a new plan of care, the initial HHA receives a partial episode payment adjustment reflecting the length of time the patient remained under its care. A partial episode payment adjustment is determined in accordance with § 484.235.
(e)
(a) * * *
(3) For CY 2011, the adjustment is 3.79 percent.
(4) For CY 2012, the adjustment is 3.79 percent.
(5) For CY 2013, the adjustment is 1.32 percent.
(6) For CY 2016 and CY 2017, the adjustment is 1.72 percent in each year.
(a) CMS updates the unadjusted national 60-day episode payment rate on a fiscal year basis (as defined in section 1895(b)(1)(B) of the Act).
(b) For 2007 and subsequent calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency that submits home health quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount.
(c) For 2007 and subsequent calendar years, in accordance with section 1895(b)(3)(B)(v) of the Act, in the case of a home health agency that does not submit home health quality data, as specified by the Secretary, the unadjusted national prospective 60-day episode rate is equal to the rate for the previous calendar year increased by the applicable home health market basket index amount minus 2 percentage points. Any reduction of the percentage change will apply only to the calendar year involved and will not be taken into account in computing the prospective payment amount for a subsequent calendar year.
(b) The outlier threshold for each case-mix group is the episode payment amount for that group, or the PEP adjustment amount for the episode, plus a fixed dollar loss amount that is the same for all case-mix groups
(e) The fixed dollar loss amount and the loss sharing proportion are chosen so that the estimated total outlier payment is no more than 2.5 percent of total payment under home health PPS.
(f) The total amount of outlier payments to a specific home health agency for a year may not exceed an amount equal to 10 percent of the total payments to the specific agency under home health PPS for the year.
This subpart is established under section 1115A(a)(1) of the Act (42 U.S.C. 1315a), which authorizes the Secretary to test innovative payment and service delivery models to improve coordination, quality, and efficiency of health care services furnished under Title XVIII.
As used in this subpart—
(1) For CY 2018 and 2019, 5 percent.
(2) For CY 2020, 6 percent.
(3) For CY 2021 and 2022, 8 percent.
(1) That has a current Medicare certification; and,
(2) Is being reimbursed by CMS for home health care delivered within any of the states specified in accordance with CMS's selection methodology.
(a)
(b) Nine states are selected in accordance with CMS's selection methodology. All Medicare-certified HHAs that provide services in Massachusetts, Maryland, North Carolina, Florida, Washington, Arizona, Iowa, Nebraska, and Tennessee will be required to compete in this model.
(a) Medicare-certified home health agencies will be evaluated using a starter set of quality measures.
(b) Medicare-certified home health agencies in selected states will be required to report information on New Measures, as determined appropriate by the Secretary, to CMS in the form, manner, and at a time specified by the Secretary.
(c) Medicare-certified home health agencies in selected states will be required to collect and report such information as the Secretary determines is necessary for purposes of monitoring and evaluating the HHVBP model under section 1115A(b)(4) of the Act (42 U.S.C. 1315a).
A Medicare-certified home health agency's Total Performance Score for a model year is calculated as follows:
(a) CMS will award points to the Medicare-certified home health agency for performance on each of the applicable measures in the starter set, other than New Measures.
(b) CMS will award points to the Medicare-certified home health agency for reporting on each of the New Measures in the starter set, worth up to ten percent of the Total Performance Score.
(c) CMS will sum all points awarded for each applicable measure in the starter set, weighted equally at the individual measure level, to calculate a value worth up to 90 percent of the Total Performance Score.
(d) The sum of the points awarded to a Medicare-certified HHA for each applicable measure in the starter set and the points awarded to a Medicare-certified HHA for reporting data on each New Measure is the Medicare-certified HHA's Total Performance Score for the calendar year.
CMS will determine a payment adjustment up to the maximum applicable percentage, upward or downward, under the HHVBP model for each Medicare-certified home health agency based on the agency's Total Performance Score using a linear exchange function. Payment adjustments made under the HHVBP model will be calculated as a percentage of otherwise-applicable payments for home health services provided under section 1895 of the Act (42 U.S.C. 1395fff).
(a)
(b)
(c)
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Notice of proposed rulemaking.
PHMSA is proposing amendments to the pipeline safety regulations to address requirements of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (2011 Act), and to update and clarify certain regulatory requirements. Among other provisions, PHMSA is proposing to add a specific time frame for telephonic or electronic notifications of accidents and incidents and add provisions for cost recovery for design reviews of certain new projects, for the renewal of expiring special permits, and for submitters of information to request PHMSA keep the information confidential. We are also proposing changes to the operator qualification (OQ) requirements and drug and alcohol testing requirements and incorporating consensus standards by reference for in-line inspection (ILI) and Stress Corrosion Cracking Direct Assessment (SCCDA).
Submit comments by September 8, 2015.
Comments should reference Docket No. PHMSA-2013-0163 and may be submitted in the following ways:
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•
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Comments are posted without changes or edits to
Anyone may search the electronic form of all comments received for any of our dockets. You may review DOT's complete Privacy Act Statement published in the
Tewabe Asebe by telephone at 202-366-5523 or by email at
The purpose of this proposed rulemaking action is to strengthen the Federal pipeline safety regulations, and to address sections 9 and 13 of the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011 (2011 Act). The proposal associated with section 9 would limit the accident and incident reporting requirements to within one hour. PHMSA expects that quicker accident and incident reporting would lead to a safety benefit to the public, the environment, and limit property damage. The proposal associated with section 13 would allow PHMSA to recover its costs for design review work PHMSA would conduct on behalf of the operators, which would allow PHMSA to use its limited resources in protecting the public safety. PHMSA is also proposing to expand the existing Operator Qualification (OQ) scope to cover new construction and certain other currently uncovered tasks, require operators use trained and qualified individuals when performing new construction work, and add program effectiveness requirements for operators to gauge the effectiveness of the OQ programs. PHMSA believes that requiring operators to use trained and qualified individuals would decrease human errors. PHMSA is also proposing to provide a renewal procedure for expiring special permits and proposing other minor and administrative changes. The proposed changes are listed in detail below:
• Specifying an operator's accident and incident reporting time to not later than one hour after confirmed discovery and requiring revision or confirmation of initial notification within 48 hours of the confirmed discovery of the accident or incident;
• Setting up a cost recovery fee structure for design review of new gas and hazardous liquid pipelines with either overall design and construction costs totaling at least $2,500,000,000 or that contain new and novel technologies;
• Expanding the existing Operator Qualification (OQ) scope to cover new construction and previously excluded operation and maintenance tasks, addressing the National Transportation Safety Board's (NTSB) recommendation to clarify OQ requirements for control rooms, and extending the requirements to operators of Type A gathering lines in Class 2 locations and Type B onshore gas gathering lines;
• Providing a renewal procedure for expiring special permits;
• Excluding farm taps from the requirements of the Distribution Integrity Management Program (DIMP) requirements while proposing safety requirements for the farm taps;
• Requiring pipeline operators to report to PHMSA permanent reversal of flow that lasts more than 30 days or a change in product (
• Providing methods for assessment tool selection by incorporating consensus standards by reference in part 195 for stress corrosion cracking direct assessment (SCCDA) that were not developed when the Integrity Management (IM) regulations were issued;
• Requiring electronic reporting of drug and alcohol testing results in part 199;
• Modifying the criteria used to make decisions about conducting post-accident drug and alcohol tests and requiring operators to keep for at least three years a record of the reason why post-accident drug and alcohol test was not conducted;
• Adding a procedure to request PHMSA keep submitted information confidential;
• Adding reference to Appendix B of API 1104 related to in-service welding in parts 192 and 195; and
• Aaking minor editorial corrections.
Several of the proposed changes would address sections 9 and 13 of the 2011 Act, which was signed into law on January 3, 2012. (Pub. L. 112-90). Section 9 of the 2011 Act requires PHMSA to specify a time limit for telephonic or electronic reporting of pipeline accidents and incidents. Section 13 of the 2011 Act (codified at 49 U.S.C. 60117) allows PHMSA to prescribe a fee structure and assessment methodology to recover costs associated with design reviews.
PHMSA has estimated annual compliance costs at $3.1 million; less savings to be realized from the removal of farm taps from the DIMP requirements. Annual safety benefits cannot be quantified as readily due to data limitations, but are expected to be $1.6 million per year in avoided incident costs, plus numerous intangible benefits from the improved clarity and consistency of regulations and required post-incident drug and alcohol test decision justification. Although the quantified benefits do not exceed the estimated costs, PHMSA believes that these non-quantified benefits are significant enough to outweigh the costs of compliance. PHMSA believes that updating regulations, providing clarification, and providing methods for assessment tools by incorporating consensus standards all help to improve compliance with pipeline safety regulations and to reduce the likelihood of a serious pipeline incident. In particular, proposed operator qualification provisions ensure that pipeline construction personnel and operations and maintenance personnel have the appropriate skills for the functions they are performing. This would reduce the likelihood of human error-related incidents. At an annual compliance cost of $3.1 million, the proposed changes would be cost effective if they prevented a single fatal incident over a three-year period.
This proposed rulemaking action would amend the Federal pipeline safety regulations to require operators to provide telephonic or electronic notification of an accident or incident at the earliest practicable moment, including the amount of product loss, following confirmed discovery.
PHMSA requires pipeline owners and operators to notify the National Response Center (NRC) by telephone or electronically at the earliest practicable moment following discovery of an incident or accident (§§ 191.5 and 195.52). In an advisory bulletin published on September 6, 2002; 67 FR 57060, PHMSA advised owners and operators of gas and hazardous liquids pipeline systems and liquefied natural gas (LNG) facilities that reporting at the earliest practicable opportunity usually means one to two hours after discovery of the incident.
On January 3, 2012, President Obama signed into law the 2011 Act. Section 9 of the 2011 Act directs PHMSA to require pipeline operators to make incident/accident telephonic notifications at the earliest practicable moment following confirmed discovery of an accident or incident and not later than 1 hour following the time of such confirmed discovery.
PHMSA proposes to revise the pipeline safety regulations to require operators to provide telephonic or electronic notification of an accident or incident at the earliest practicable moment, including the amount of product loss, following the confirmed discovery of an accident or incident, but not later than one hour following the time of such confirmed discovery. Further, we are proposing to require operators to revise or confirm that initial notification within 48 hours of confirmed discovery of the accident or incident. Prompt reporting of a pipeline incident to the NRC is crucial to Federal investigators' ability to investigate and resolve pipeline safety concerns. Once a report is made, investigators must decide at the outset whether a full Federal investigation is necessary. Failure to report promptly hinders the decision making process and could jeopardize the outcome of any subsequent investigation and threaten public safety. Delays in reporting caused by an operator waiting until the operator definitely determines an event meets the reporting criteria would defeat a fundamental purpose of the 2011 Act, which is to give PHMSA and other agencies the earliest opportunity to assess whether an immediate response to a pipeline incident is needed.
As demonstrated by PHMSA's past enforcement actions, “discovery” has been evaluated on a case-by-case basis considering the totality of the circumstances. Because the statute requires reporting after “confirmed discovery,” PHMSA proposes to define the term in §§ 191.3 and 195.2 as “when there is sufficient information to determine that a reportable event has occurred even if an evaluation has not been completed.” After a more thorough investigation, the operator can submit more detailed information in the written incident report. This policy of erring on the side of caution ensures that delays in reporting incidents would be avoided. PHMSA seeks comment on the proposed definition of “confirmed discovery” and how it would affect operators in their evaluation of an incident or accident. In particular, PHMSA is interested in alternative definitions of “confirmed discovery” (
This proposed rulemaking action would amend the Federal pipeline safety regulations to prescribe a fee structure and assessment methodology for recovering costs associated with design reviews of new gas and hazardous liquid pipelines with either overall design and construction costs totaling at least $2,500,000,000 or that contain new and novel technologies.
Section 13 of the 2011 Act allows PHMSA to prescribe a fee structure and assessment methodology to recover costs associated with any project with design review and construction costs totaling at least $2,500,000,000 and for new or novel technologies or design, as determined by the Secretary.
PHMSA issued guidance in January 2013, on its Web site to clarify the meaning of the term “new or novel technologies or design” as meaning, “any products, designs, materials, testing, construction, inspection, or operational procedures that are not addressed in title 49 Code of Federal Regulations (CFR) parts 192, 193, or 195 due to technology or design advances and innovation.” PHMSA developed this definition to include any technologies that are developed or have existed and are being adopted widely due to developments other than technology or innovation.
PHMSA conducts facility design safety reviews in connection with
While PHMSA's pipeline account is funded entirely by user fees on the pipeline industry, PHMSA does not currently recover costs incurred specifically while conducting these reviews for pipeline operators. Section 13 of the 2011 Act permits PHMSA to require the entity or individual proposing the project to pay the costs incurred by PHMSA relating to such reviews.
Historically, PHMSA's pipeline safety costs associated with new pipeline design and construction reviews and inspections have been paid for through Pipeline User Fee collections. As major pipeline construction projects increase, PHMSA's inspection hours and costs have increased on major projects, diverting resources away from other Agency priorities. In this NPRM PHMSA is taking the first step in proposing to exercise the cost recovery authority described in Section 13(a) of the 2011 Act by prescribing a fee structure and assessment methodology that is based on the costs of providing these reviews that are initiated by the pipeline operator. However, in terms of budgetary scoring, Section 13 allows for the collection of the fee as a mandatory receipt. However, the Administration would like to use these fees as an offset for discretionary spending, and as such, PHMSA has proposed that appropriations language in the last several Budgets to make this a discretionary offsetting fee. Neither the Consolidated Appropriations Act of 2014 nor the Consolidated and Further Continuing Appropriations Act of 2015 enacted language that would make this a discretionary offsetting fee. Hence, PHMSA is proposing this portion of the ANPRM under the assumption that Congress will enact a revision to make this a discretionary offsetting fee before PHMSA would issue a final rule to implement the fee.
PHMSA believes that a review of a large project or new technology that has safety benefits in quality control would drain the agency's resources without any cost recovery mechanism. PHMSA has developed a sample master cost recovery agreement that would be used between PHMSA and the applicant for a project proposal meeting the criteria of proposed 49 CFR part 190, subpart D requirements. The sample master cost recovery agreement will be posted on PHMSA's Web site and in Docket No. PHMSA-2013-0163. A master cost recovery agreement would include at a minimum:
(1) Itemized list of direct costs to be recovered by PHMSA;
(2) Scope of work for conducting the facility design safety review and an estimated total cost;
(3) Description of the method of periodic billing, payment, and auditing of cost recovery fees;
(4) Minimum account balance which the applicant must maintain with PHMSA at all times;
(5) Provisions for reconciling differences between total amount billed and the final cost of the design review, including provisions for returning any excess payments to the applicant at the conclusion of the project;
(6) A principal point of contact for both PHMSA and the applicant;
(7) Provisions for terminating the agreement; and
(8) A project reimbursement cost schedule based upon the project timing and scope.
This proposed rulemaking action would amend the Federal pipeline safety regulations in 49 CFR parts 192 and 195 relative to operator qualification requirements. The amendments would include: Expanding the scope of OQ requirements to cover new construction and certain previously excluded operation and maintenance tasks, extending the OQ requirements to operators of Type A gas gathering lines in Class 2 locations, Type B onshore gas gathering lines, and regulated rural hazardous liquid gathering lines, requiring a program effectiveness review, and adding new recordkeeping requirements. The proposed changes would enhance the OQ requirements by clarifying existing requirements and addressing NTSB recommendation to extend operator qualification requirements to control center staff involved in pipeline operational decisions (Safety Recommendation P-12-8).
Sections 101 and 201 of the Pipeline Safety Reauthorization Act of 1988 (Pub. L. 100-561; October 31, 1988) authorize PHMSA to require all individuals responsible for the operation and maintenance of pipeline facilities to be tested for qualifications and to be certified to perform such functions. PHMSA published a final rule on August 27, 1999; 64 FR 46853 for the qualification of pipeline personnel.
Over 650 individuals from various stakeholder groups attended PHMSA's public meeting on OQ History and Milestones in January 2003 in San Antonio, Texas to discuss gaps between the OQ rule and actual operations in the field.
ASME standard, ASME B31Q (“Pipeline Personnel Qualification”) was revised in October 2010, to address many OQ issues identified at the public meeting. An OQ team reviewed the standard in detail and determined that while the standard provided detailed guidance in most areas, PHMSA should instead amend the current regulation to address areas that had not been addressed in the revised ASME standard.
The NTSB issued the following safety recommendation to PHMSA on July 25, 2012, (P-12-8):
Extend operator qualification requirements in Title 49 Code of Federal Regulations Part 195 Subpart G to all hazardous liquid and gas transmission control center staff involved in pipeline operational decisions.
Although our existing Control Room Frequently Asked Questions (B.01, B.03 & B.05) (
PHMSA issued a final rule on March 15, 2006; 71 FR 13289 that revises the methodology used to identify regulated onshore gas gathering lines and implemented a tiered compliance approach to address potential risk. In a final rule issued on June 3, 2008; 73 FR 31634, PHMSA defined the criteria to identify a regulated onshore hazardous liquid gathering line. In both instances, PHMSA allowed a modified approach for recordkeeping, requiring only a description of the processes used to
NTSB issued the following safety recommendation to PHMSA on July 25, 2012, (P-12-7):
Develop requirements for team training of control center staff involved in pipeline operations similar to those used in other transportation modes.
Although not an explicit requirement, a number of the sections in the Control Room Management regulations, along with the inspection guidance and related Frequently Asked Questions, already touch on the concept of team training for control room personnel and others who would likely work together as a team during normal, abnormal, and emergency situations. PHMSA believes a requirement for control room team training would better prepare all individuals who would be reasonably expected to interface with controllers (control room personnel) during normal, abnormal or emergency situations. While the CRM regulations call out certain specific individuals such as controllers, supervisors, and field personnel, understanding of the requirements of CRM and appropriate training is essential for other individuals that interact with controllers, particularly those that may affect the ability of a controller to safely monitor and control the pipeline during normal, abnormal, and emergency situations. Other individuals to which team training might pertain likely vary by operator and control room depending on specific procedures and roles in the control room, but they could include individuals such as technical advisors, engineers, leak detection analysts, and on-call support. These individuals are typically already trained in their specific job function and have some awareness of the roles and responsibilities of controllers. In many cases, they are also included in discussions or meetings that involve control room personnel. However, these individuals may not always get together to be trained on how to work together as a team. Therefore, as recommended by NTSB, PHMSA is proposing to require control room team training in §§ 192.631(h) and 195.446(h).
The industry standard, ASME B31Q, Pipeline Personnel Qualification, defines covered task as “those tasks that can affect the safety or integrity of the pipeline”.
The current rule is not prescriptive and the resulting flexibility built into the performance-based rule makes it difficult to measure operator's compliance with the rule. Under the current regulation, a covered task is an activity, defined by the operator that meets the 4-part test:
(1) Is performed on a pipeline facility;
(2) Is an operations or maintenance task;
(3) Is performed as a requirement of this part; and
(4) Affects the operation or integrity of the pipeline.
Many of the pipeline safety regulations are performance based, rather than prescriptive requirements. The OQ regulations require operators to identify covered tasks for all of their operations and maintenance activities that are required by parts 192 and 195, regardless of whether such activities arise from performance-based regulations or from more prescriptive requirements. It's the operator's responsibility to identify their unique and specific tasks and terminology in both their operations and maintenance documentation, as well as ensure these tasks are covered tasks in the Operator Qualification Program.
Many O&M tasks (part 2 of the 4-part test) that an operator performs are not specifically called out in the regulation (part 3 of the 4-part test).
Performance based tasks may include activities, such as those involved in making repairs (while repairs are called out as a requirement of the regulations, specific terminology such as mud plugging, pipefitting, installing Clockspring, etc. associated with making repairs is not). Making pipeline repairs in a safe manner involves myriad tasks that may vary from one job to another and from one operator to another. While the current performance based regulations provide flexibility for each operator to identify those particular repair tasks, the proposed rule to define covered tasks is clearer and helps to eliminate confusion over whether performance based tasks are “performed as a requirement of this part.” Most of the proposed OQ changes are not significant because the existing sections are renumbered or combined with other sections. However, this proposed rule includes two new requirements: (1) Includes OQ requirements for new constructions by changing the Scope; and (2) adds a new program effectiveness requirement to ensure that operators complete a review of the effectiveness of their OQ program. PHMSA's proposed changes to the OQ rule at parts 192 and 195 are as follows:
1. Change the scope of the OQ rule in §§ 192.801 and 195.501 to revise the method of determining a “covered task.” Instead of determining a covered task by the “4-part test,” PHMSA is proposing to define a covered task as any maintenance, construction or emergency response task the operator identifies as affecting the safety or integrity of the pipeline facility. The “4-part test” omitted important tasks, such as all construction tasks on new pipelines and certain operation and maintenance tasks.
2. Update the “General” sections of §§ 192.809 and 195.509 to remove the implementation dates that no longer affect the implementation requirements for operators. In addition, after they are updated §§ 192.809 and 195.509 are renumbered as §§ 192.805 and 195.505.
3. Change the requirements in §§ 192.805 and 195.505 by adding new definitions, deleting an obsolete date for training requirements and clarify the need for training individuals performing covered tasks. Additionally, we are adding a new requirement for evaluators of individuals performing covered tasks, including training requirements for new construction tasks as the current OQ requirements do not include new construction tasks.
4. Add a “Program Effectiveness” requirement at §§ 192.807 and 195.507 to ensure that operators complete a review of the effectiveness of their OQ program. The review would include ensuring that procedures that were amended have been captured in the necessary portions of the OQ program.
5. Add record requirements in §§ 192.809 and 195.509 that are normally reviewed during the inspection of OQ programs and are necessary to provide a thorough overview of an OQ program. The additional records would include records that document evaluators' performance and program effectiveness.
6. Add a new paragraph (b)(5) to §§ 192.631 and 195.446 to require each
7. Add a new subparagraph in the “Qualification Program” sections as §§ 192.805(b)(7) and 195.505(b)(7) proposing requirements addressing management of change and the communication of those changes. This proposed section would ensure that weaknesses of a program are found and corrections are made with notification to those affected, and
8. Modify §§ 192.9 and 195.11 to require operators to establish and administer an OQ program covering personnel who perform work on Type A gas gathering lines in Class 2 locations, regulated Type B onshore gas gathering lines and regulated hazardous liquids gathering lines in rural locations.
This proposed rulemaking action would amend § 190.341 of the Federal pipeline safety regulations to add procedures for renewing a special permit.
As defined in § 190.341(a), a special permit is an order by which PHMSA waives compliance with one or more of the pipeline safety regulations if it determines that granting the permit would “not be inconsistent with pipeline safety.” Special permits are authorized by statute in 49 U.S.C. 60118(c), and the application process is set forth in § 190.341. PHMSA performs extensive technical analysis on special permit applications and typically conditions a grant of a special permit on the performance of alternative measures that would provide an equal or greater level of safety. PHMSA is committed to public involvement and transparency in special permit proceedings and publishes notice of every special permit application received in the
In the past, PHMSA has included an expiration date for certain special permits depending on the nature of the permit. By doing so, PHMSA is able to ensure that these special permits will be reviewed again no later than the expiration date. This process ensures that a special permit will not continue to be used if it is no longer in the best interest of public safety.
PHMSA is proposing to add a renewal procedure to the pipeline safety regulations for those Special Permits that have expiration dates. This special permit renewal procedure will ensure the permit conditions are still valid for the pipeline and if changes and updates are required to maintain safety and the environment.
This proposed rulemaking action would amend the Federal pipeline safety regulations in 49 CFR part 192 to add a new § 192.740 to cover regulators and overpressure protection equipment for an individual service line that originates from a transmission, gathering, or production pipeline (
On October 29, 2012, PHMSA received a request from the Interstate Natural Gas Association of America (INGAA), asking if PHMSA covers the farm tap issue on the upcoming miscellaneous issue rulemaking. In addition, PHMSA received a February 15, 2013, written letter from the National Association of Pipeline Safety Representatives (NAPSR) requesting an exemption of farm taps from the DIMP requirements as follows:
The letter requested PHMSA to take the following actions relative to the applicability of DIMP to “Farm Taps”:
1. Amend the applicable part 192 sections to exempt those pipelines commonly referred to as “farm taps” (a term originating from industry jargon) from the requirements of Subpart P, Gas Distribution Pipeline Integrity Management; and
2. Amend part 192 to include periodic inspection requirements in a new section covering “pressure regulating and over-pressure-relief equipment” on a pipeline that originates from a transmission, gathering, or production pipeline that serves a service line.
In support of the above, NAPSR offered the following:
• Farm taps are distribution service lines per § 192.3 ;
• During the DIMP rulemaking, little consideration was given to the potential impact or appropriateness of subjecting farm taps to DIMP;
• The risk to the public from a failure on a farm tap is generally lower in Class 1 and Class 2 locations in which farm taps are typically located and operated;
• Currently the regulator and relief equipment with farm taps are not subject to over pressurization protection requirements associated with pressure limiting stations.
This proposal originated with the NAPSR DIMP Implementation Task Force and was subsequently approved by the NAPSR Board in January 2013.
As NAPSR described it, “farm tap” is industry jargon for a pipeline that branches from a transmission, gathering, or production pipeline to deliver gas to a farmer or other landowner. Historically, PHMSA and its predecessor agencies have held that farm taps are service lines—a subset of distribution pipelines. Rulemaking proceedings and responses to requests for interpretation have recognized this dating as far back as 1971.
On December 4, 2009, PHMSA published the DIMP final rule (74 FR 63906) for gas distribution pipelines. That rule applies IM requirements to all distribution pipelines. Unlike the IM requirements for hazardous liquid or gas transmission pipelines, the DIMP requirements do not focus on a subset of pipelines in “high consequence areas,” but instead apply to all distribution pipelines, including farm taps.
Farm taps are mostly located in less-populated areas (Class 1 and 2 locations). The risk to the public from farm taps is generally low, but the risk is dependent upon the service line in which the farm tap is employed, the environment in which it operates, and the consequence of an overpressurization event. DIMP is written to identify needed risk control practices for threats associated with distribution systems, whereas threats to typical farm taps are limited, and most are already addressed within part 192. Therefore, in response to the INGAA and NAPSR requests, PHMSA is proposing to amend part 192 to exempt farm taps from the requirements of part 192, subpart P—Gas Distribution Pipeline Integrity Management. However, to better protect customers served by these lines, PHMSA is proposing to amend part 192, subpart M—Maintenance by adding a new section that prescribes inspection activities under the existing States and Federal pipeline safety inspection programs for pressure regulators and overpressurization protection equipment on service lines that originate from transmission, gathering, or production pipelines. Currently, Federal pipeline safety requirements do
PHMSA published a final rule on November 26, 2010 (75 FR 72878) that established and required participation in the National Registry of Pipeline and LNG Operators. The final rule amended the Federal pipeline safety regulations to require operators to notify PHMSA electronically of the occurrence of certain events no later than 60 days before the event occurs.
In this notice of proposed rulemaking (NPRM), PHMSA proposes to expand the list of events in §§ 191.22 and 195.64 that require electronic notification to include the reversal of flow of product or change in product in a mainline pipeline. This notification is not required for pipeline systems already designed for bi-directional flow, or when the reversal is not expected to last for 30 days or less. The proposed rule would require operators to notify PHMSA electronically no later than 60 days before there is a reversal of the flow of product through a pipeline and also when there is a change in the product flowing through a pipeline. Examples include, but may not be limited to, changing a transported product from liquid to gas, from crude oil to HVL, and vice versa. In addition, a modification is proposed to §§ 192.14 and 195.5 to reflect the 60-day notification and requiring operators to notify PHMSA when over 10 miles of pipeline is replaced because the replacement would be a major modification with safety impacts.
Section 195.452 of the pipeline safety regulations specifies requirements for assuring the integrity of pipeline segments where a hazardous liquid release could affect a high consequence area (referred to in this notice as “covered segments”). Among other requirements, the regulations require that operators of covered segments conduct assessments, which consist of direct or indirect inspection of the pipelines, to detect evidence of degradation. Section 195.452(d) requires operators to conduct a baseline assessment of all covered segments. Section 195.452(j) requires that operators conduct assessments periodically thereafter.
Section 195.452 specifies the techniques that must be used to perform the required periodic IM assessments.
When the IM regulations were established, consensus standards did not exist in addressing how these techniques should be applied. Since then, the American Petroleum Institute (API), National Association of Corrosion Engineers (NACE), and the American Society for Non-Destructive Testing (ASNT) published standards for using ILI and SCCDA as assessment techniques. Also, PHMSA received a petition from NACE requesting that PHMSA incorporate ANSI/NACE Standard RP0204, NACE Standard RP0102-2002, and seven other NACE standards into 49 CFR parts 192 and 195. These referenced consensus standards address the selection of in-line inspection tools for assessing the physical condition of in-service hazardous liquids pipelines. Since the NACE petition, two of these standards have been developed from recommended practices into NACE Standard Practice (SP0102-2010 and NACE SP0204-2008.)
In addition, NTSB issued the following safety recommendation to PHMSA on July 10, 2012, (P-12-3):
Revise Title 49 Code of Federal Regulations 195.452 to clearly state (1) when an engineering assessment of crack defects, including environmentally assisted cracks, must be performed; (2) the acceptable methods for performing these engineering assessments, including the assessment of cracks coinciding with corrosion with a safety factor that considers the uncertainties associated with sizing of crack defects; (3) criteria for determining when a probable crack defect in a pipeline segment must be excavated and time limits for completing those excavations; (4) pressure restriction limits for crack defects that are not excavated by the required date; and (5) acceptable methods for determining crack growth for any cracks allowed to remain in the pipe, including growth caused by fatigue, corrosion fatigue, or stress corrosion cracking as applicable.
This proposed rule would incorporate by reference consensus standards for assessing the physical condition of in-service hazardous liquids pipelines using ILI and SCCDA. Incorporation of the consensus standards would assure better consistency, accuracy and quality in pipeline assessments conducted using these techniques. This proposal addresses those parts of NTSB Recommendation P-12-3—identifying crack defects and seam corrosion by using crack tools and circumferential tools—by incorporating the above cited industry standards. The remainder of NTSB Recommendation P-12-3 will be addressed in PHMSA's rulemaking titled “Pipeline Safety—Safety of On-Shore Hazardous Liquid Pipelines.” Therefore, PHMSA proposes to incorporate by reference the following consensus standards into 49 CFR part 195: API STD 1163, “In-Line Inspection Systems Qualification Standard” (August 2005); NACE Standard Practice SP0102-2010 “Inline Inspection of Pipelines” NACE SP0204-2008 “Stress Corrosion Cracking Direct Assessment;” and ANSI/ASNT ILI-PQ-2010, “In-line Inspection Personnel Qualification and Certification” (2010). Also, PHMSA proposes to allow pipeline operators to conduct assessments using tethered or remote control tools not explicitly discussed in NACE SP0102-2010, provided the operators comply with applicable sections of NACE SP0102-2010.
Note that this proposed rulemaking action addresses only part 195, but PHMSA is considering a similar proposed requirement in 49 CFR part 192.
Incorporation of the consensus standards would assure better consistency, accuracy and quality in pipeline assessments conducted using ILI and SCCDA.
When the part 195 IM requirements were issued, there were no consensus industry standards that addressed ILI. Since then the following standards have been published:
1. In 2002, NACE International published the first consensus industry standard that specifically addressed ILI (NACE Recommended Practice RP0102, “Inline Inspection of Pipelines”). NACE International revised this document in 2010 and republished it as a Standard Practice, SP0102.
PHMSA considers that the consistency, accuracy, and quality of pipeline ILI would be improved by
2. In 2005, the ASNT published ANSI/ASNT ILI-PQ, “In-line Inspection Personnel Qualification and Certification.”
The ASNT standard provides for qualification and certification requirements that are not addressed in part 195. In 2010 ASNT published ANSI/ASNT ILI-PQ with editorial changes. The incorporation of this standard into the Federal pipeline safety regulations would promote a higher level of safety by establishing consistent standards to qualify the equipment, people, processes, and software utilized by the ILI industry. This and the other standards are being used by many operators but not all. This rule would ensure that all operators use these standards. Overall cost would not change, because these consensus standards would help operators eliminate problems before they arise. SCCDA is a technique allowed for gas transmission pipelines but is not specifically addressed in § 195.452 although it is also applicable to hazardous liquid pipelines. This rulemaking action would allow HL operators to use the SCCDA technique and ASNT is one of them. The ASNT standard addresses in detail each of the following aspects, which are not currently addressed in the regulations:
• Requirements for written procedures.
• Personnel qualification levels.
• Education, training, and experience requirements.
• Training programs.
• Examinations (testing of personnel).
• Personnel certification and recertification.
• Personnel technical performance evaluations.
3. In 2005, API published API STD 1163, “In-Line Inspection Systems Qualification Standard.”
This Standard serves as an umbrella document that is to be used with and complements the NACE International and ASNT standards that are incorporated by reference in API STD 1163. The API standard is more comprehensive than the requirements currently in part 195. The incorporation of this standard into the Federal pipeline safety regulations would promote a higher level of safety by establishing a consistent methodology to qualify the equipment, people, processes, and software utilized by the ILI industry. The API standard addresses, in detail, each of the following aspects of ILI inspections:
• Systems qualification process.
• Personnel qualification.
• ILI system selection.
• Qualification of performance specifications.
• System operational validation.
• System results qualification.
• Reporting requirements.
• Quality management system.
4. NACE SP0204-2008 “Stress Corrosion Cracking Direct Assessment.”
SCC is a degradation mechanism in which steel pipe develops closely spaced tight cracks through the combined action of corrosion and tensile stress (circumferential, residual, or applied). These cracks can grow or coalesce to affect the integrity of the pipeline. SCC is one of several threats that can impact pipeline integrity. IM regulations in Part 195 require that pipeline operators assess covered pipe segments periodically to detect degradation from threats that their analyses have indicated could affect the segment. Not all covered segments are subject to an SCC threat, but for those that are, SCCDA is an assessment technique that can be used to address this threat.
Part 195 presently includes no requirements applicable to the use of SCCDA. Experience has shown that pipelines can go through SCC degradation in areas where the surrounding soil has a pH near neutral (referred to as near-neutral SCC). NACE Standard Practice SP0204-2008 addresses near-neutral SCC. In addition, the NACE International recommended practice provides technical guidelines and process requirements that are both more comprehensive and rigorous for conducting SCCDA than are provided by § 192.929 or ASME/ANSI B31.8S.
The NACE standard provides additional guidance as follows:
• The factors that are important in the formation of SCC on a pipeline and what data should be collected;
• Additional factors, such as existing corrosion, which could cause SCC to form;
• Comprehensive data collection guidelines, including the relative importance of each type of data;
• Requirements to conduct close interval surveys of cathodic protection or other aboveground surveys to supplement the data collected during pre-assessment;
• Ranking factors to consider for selecting excavation locations for both near-neutral and high pH SCC;
• Requirements on conducting direct examinations, including procedures for collecting environmental data, preparing the pipe surface for examination, and conducting Magnetic Particle Inspection (MPI) examinations of the pipe; and
• Post assessment analysis of results to determine SCCDA effectiveness and assure continual improvement.
In general, NACE SP0204-2008 provides thorough and comprehensive guidelines for conducting SCCDA and is more comprehensive in scope than Appendix A3 of ASME/ANSI B31.8S. PHMSA believes that requiring the use of NACE SP0204-2008 would enhance the quality and consistency of SCCDA conducted under IM requirements.
SCC has also been the subject of research and development (R&D) programs that have been funded in whole or in part by PHMSA in recent years. PHMSA reviewed the results of several R&D programs concerning SCC as part of its consideration of whether it was appropriate to incorporate the NACE standard into the regulations. Among the reports PHMSA reviewed was “Development of Guidelines for Identification of SCC Sites and Estimation of Re-inspection Intervals for SCC Direct Assessment,” published by Integrity Corrosion Consulting Ltd. in May 2010 (
SCC was also a topic in an advance notice of proposed rulemaking (ANPRM) published by PHMSA on October 18, 2010 (75 FR 63774). The ANPRM addressed several potential changes to the regulations governing the safety of hazardous liquids pipelines. Among other topics, it posed a number of questions concerning SCC, including whether the NACE standard addresses the full life cycle concerns associated with SCC, NACE's efficacy, and whether the NACE standard or any other standards should be adopted to govern the conduct of SCC assessments. PHMSA received a limited number of comments to the ANPRM that addressed the SCC questions. Joint comments from the American Petroleum Institute and the Association of Oil Pipelines (API-AOPL) noted that NACE SP0204-2008 is a reasonable standard but does not address all aspects of SCC control. API-AOPL noted that forthcoming updates of API Standard 1160, “Managing System Integrity for Hazardous Liquid Pipelines,” and API Standard 1163, “In-Line Inspection Systems Qualification Standard,” would be better references to address SCC management. The Texas Pipeline Association recommended against adopting the NACE standard, contending that it is too new for operators to have significant experience with it. The National Association of Pipeline Safety Representatives suggested that PHMSA should require an assessment for SCC any time there is a credible threat of its occurrence; however, API-AOPL suggested that requiring assessment for “any credible threat” was too extreme and that some significance threshold should be used. The National Resources Defense Council suggested the need for special attention to sulfide-assisted SCC in pipelines carrying diluted bitumen (
PHMSA acknowledges that the NACE standard may not address all aspects of SCC management, but PHMSA considers it better to incorporate additional structured guidance that is available now rather than await future standards. There is continual improvement in technology to detect and address various SCC threats. Three different standards organizations are currently working to improve standards on SCC: ASME B31.8, NACE 204 and API 1160. PHMSA participates on these technical committees. As more knowledge is gained on other types of SCC, such as sulfide assisted SCC and when newer standards get published, PHMSA would adopt them.
As for NAPSR's comment on assessing any credible SCC threat, PHMSA believes that any proposed requirements for SCC would need to be considered in a separate rulemaking effort. States always have option to make requirements more stringent. PHMSA will consider incorporating updates to API 1160 once that standard is published. PHMSA will also continue to consider the comments received in response to its ANPRM.
PHMSA is proposing to revise § 195.588, which specifies requirements for the use of external corrosion direct assessment on hazardous liquid pipelines, to include reference to NACE SP0204-2008 for the conduct of SCCDA. The proposal would not require that SCCDA assessments be conducted, but it would require that the NACE standard be followed if an operator elects to perform such assessments. PHMSA has included additional factors that an operator must consider to address these if the operator uses direct pipeline to assess SCC.
PHMSA's pipeline safety regulations at §§ 191.7 and 195.58 require electronic reporting of most pipeline safety reports through the PHMSA Portal. PHMSA proposes to also require electronic reporting for anti-drug testing results required at § 199.119 and alcohol testing results required at § 199.229. Pipeline operators with fewer than 50 covered employees are required to submit these reports only when PHMSA provides written notice. PHMSA proposes to modify these regulations to specify that PHMSA will provide notice to operators in the PHMSA Portal.
The NTSB issued the following safety recommendation to PHMSA (September 26, 2011, NTSB Recommendation P-11-12):
Amend §§ 199.105 and 199.225 to eliminate operator discretion with regard to testing of covered employees. The revised language should require drug and alcohol testing of each employee whose performance either contributed to the accident or cannot be completely discounted as a contributing factor to the accident.
PHMSA proposes to modify §§ 199.105 and 199.225 by requiring drug testing of employees after an accident and allowing exemption from drug testing only when there is sufficient information that establishes the employee(s) had no role in the accident.
PHMSA's regulations require the documentation of decisions not to administer a post-accident alcohol test but the requirement to document decisions not to administer a post-accident drug test is only implied in the regulation, and the implied requirement is generally followed. PHMSA proposes to add a section to the post-accident drug testing regulation to require documentation of the decision and to keep the documentation for at least three years.
When any information is submitted to PHMSA during a rulemaking proceeding, as part of an application for a special permit, or for any other reason, PHMSA may make that information publicly available. PHMSA does not currently have a procedure in the pipeline safety regulations by which a request can be made for confidential treatment of information. PHMSA has such a procedure in its hazardous materials safety regulations. Therefore, for consistency in the way we treat submitted information, PHMSA proposes a procedure where anyone who submits information may request for confidential treatment of that information. As part of the procedure, if PHMSA receives a request for the record(s), PHMSA would conduct a
In accordance with Departmental FOIA regulations, if a request is received for information that has been designated by the submitter as confidential, we would notify the submitter and provide an opportunity to the submitter to submit any written objections. Whenever a decision is made to disclose such information over the objections of a submitter, we would notify the submitter in writing at least five days before the date the information is publicly disclosed.
In 1987, the U.S. Department of Transportation, Office of Pipeline Safety issued Alert Notice ALN-87-01 which advised pipeline owners and operators of a pipeline incident involving the welding of a full encirclement repair sleeve on a 14” API 5L X52 pipeline near King of Prussia, PA. The pipeline failure released thousands of barrels of gasoline and was directly related to cracks developed in a fillet weld of a Type B full encirclement repair sleeve. The metallurgical analysis conducted by Battelle Laboratories concluded hydrogen and stress caused cracking of the excessively hard heat affected material in the carrier pipe. Contributing factors included poor weldability of the carrier pipe due to its high carbon equivalent, a very high cooling rate of the weld due to liquid product being present inside the pipeline during welding, the presence of hydrogen in the welding environment due to the use of cellulosic coated electrodes, residual stresses, and high restraint inherent in the geometry of the sleeve weldment. The alert notice strongly recommended that the use of welding procedures similar to the one that failed (use of cellulosic electrodes) be discontinued and that magnetic particle inspection has been proven to be an accurate method for detecting cracked in-service fillet welds.
In response to this failure and advancements in pipeline and welding engineering, the American Petroleum Institute (API) developed, improved, and now includes Appendix B
Unfortunately, parts 192 and 195 were not modified to include the addition of API 1104 Appendix B as an acceptable section for the development of welding procedures and welder qualification. At the present time, parts 192 and 195 only adopt into Federal Regulation Sections 5, 6, 9 and Appendix A. This proposed rule seeks to rectify this oversight and state the acceptability of developing procedures and qualifying welders to Appendix B of API 1104. Currently, PHMSA does not allow in service welding, but this proposal would allow the operators to follow Appendix B of API 1104 for in service welding. Therefore, PHMSA proposes to revise 49 CFR 192.225, 192.227, 195.214, and 195.222 to add reference to API 1104, Appendix B.
In this NPRM, PHMSA is also proposing to make the following editorial amendments to the pipeline safety regulations:
PHMSA's predecessor agency, the Research and Special Programs Administration, issued a final rule on July 13, 1998; 63 FR 37500 to provide metric equivalents to the English units for informational purposes only. Operators were required to continue using the English units for purposes of compliance and enforcement. The metric equivalent provided in § 192.175(b) “C=(DxPxF/48.33) (C=(3DxPxF/1,000)”—is incorrect. The correct formula is: “C = (3D*P*F)/1000) (C = (3D*P*F*)/6,895)”, where, “C = (3D*P*F)/1000)” is in inches (English unit), and “(C = (3D*P*F*)/6,895)” is in millimeters (metric conversion).
PHMSA published a final rule on November 26, 2010; 75 FR 72878, which established the National Registry of Pipeline and LNG Operators. In the rule, PHMSA inadvertently omitted the inclusion of carbon dioxide in the operating commodity types. To maintain consistency with the rest of part 195, this proposed rule would amend the language in §§ 195.64(a) and 195.64(c)(1)(ii) to correct the term “hazardous liquid” to read “hazardous liquid or carbon dioxide.”
In § 195.248, the conversion to 100 feet is mistakenly stated as 30 millimeters. Therefore, PHMSA proposes to replace the phrase “100 feet (30 millimeters)” to correctly read “100 feet (30.5 meters).”
In addition, low stress pipelines are not specified in § 195.452. Section 195.452 applies to each hazardous liquid pipeline and carbon dioxide pipeline that could affect a high consequence area, including any pipeline located in a high consequence area unless the operator effectively demonstrates by risk assessment that the pipeline could not affect the area. Therefore, PHMSA proposes to add a new paragraph (a)(4) to clarify the applicability of § 195.452 to low stress pipelines as described in § 195.12.
PHMSA currently incorporates by reference into 49 CFR parts 192, 193, and 195 all or parts of more than 60 standards and specifications developed and published by standard developing organizations (SDOs). In general, SDOs update and revise their published standards every 3 to 5 years to reflect modern technology and best technical practices. The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113) directs Federal agencies to use voluntary consensus standards in lieu of government-written standards whenever possible. Voluntary consensus standards are standards developed or adopted by voluntary bodies that develop, establish, or coordinate technical standards using agreed-upon procedures. In addition, Office of Management and Budget (OMB) issued OMB Circular A-119 to implement Section 12(d) of Public Law 104-113 relative to the utilization of consensus technical standards by Federal agencies. This circular provides guidance for agencies participating in voluntary consensus standards bodies and describes procedures for satisfying
In accordance with the preceding provisions, PHMSA has the responsibility for determining, via petitions or otherwise, which currently referenced standards should be updated, revised, or removed, and which standards should be added to 49 CFR parts 192, 193, and 195. Revisions to incorporate by reference materials in 49 CFR parts 192, 193, and 195 are handled via the rulemaking process, which allows for the public and regulated entities to provide input. During the rulemaking process, PHMSA must also obtain approval from the Office of the Federal Register to incorporate by reference any new materials.
On January 3, 2012, President Obama signed the Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011, Public Law 112-90. Section 24 requires the Secretary not to issue guidance or a regulation to incorporate by reference any documents or portions thereof unless the documents or portions thereof are made available to the public, free of charge, on an Internet Web site. 49 U.S.C. 60102(p).
On August 9, 2013, Public Law 113-30 revised 49 U.S.C. 60102(p) to replace “1 year” with “3 years” and remove the phrases “guidance or” and, “on an Internet Web site.”
Further, the Office of the Federal Register issued a November 7, 2014, rulemaking (79 FR 66278) that revised 1 CFR 51.5 to require that agencies detail in the preamble of a proposed rulemaking the ways the materials it proposes to incorporate by reference are reasonably available to interested parties, or how the agency worked to make those materials reasonably available to interested parties. In relation to this proposed rulemaking, PHMSA has contacted each SDO and has requested free public access of each standard that has been proposed for incorporation by reference. Access to these standards will be granted until the end of the comment period for this proposed rulemaking. Access to these documents can be found on the PHMSA Web site at the following URL:
This proposed rule is a non-significant regulatory action under Section 3(f) of Executive Order 12866 (58 FR 51735), and therefore is reviewed by the Office of Management and Budget. This proposed rule is non-significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034) because of substantial congressional, State, industry, and public interest in pipeline safety.
Executive Orders 12866 and 13563 require agencies regulate in the most cost-effective manner, make a reasoned determination that the benefits of the intended regulation justify its costs, and develop regulations that impose the least burden on society. In this notice, PHMSA is proposing to:
• Add a specific time frame for telephonic or electronic notifications of accidents and incidents;
• Establish PHMSA's cost recovery procedures for new projects that cost over $2,500,000,000 or use new and novel technologies;
• Modify operator qualification requirements including addressing a NTSB recommendation to clarify OQ requirements for control rooms;
• Add provisions for the renewal of expiring special permits;
• Exclude farm taps from the requirements of the DIMP requirements while proposing safety requirements for the farm taps
• To address NTSB recommendations for control room team training and other recommendations;
• Require pipeline operators to report to PHMSA permanent reversal of flow that lasts more than 30 days or to a change in product;
• Provide methods for assessment tools by incorporating consensus standards by reference in part 195 for ILI and SCCDA;
• Require electronic reporting of drug and alcohol testing results in part 199;
• Modify the criteria used to make decisions about conducting post-accident drug and alcohol tests and require operators to keep for at least three years a record of the reason why post-accident drug and alcohol test was not conducted;
• Add a procedure to ensure PHMSA keeps submitted information confidential.
• Adding reference to Appendix B of API 1104 related to in-service welding in parts 192 and 195; and
• Making minor editorial corrections.
As a summary of the costs/benefits the annual compliance costs were estimated at approximately $3.1 million, less savings to be realized from the removal of farm taps from the DIMP requirements. Annual safety benefits could not be quantified as readily due to data limitations but were estimated in the range of $1.6 million per year in avoided incident costs, plus numerous intangible benefits from the improved clarity and consistency of regulations and improved abilities to conduct post-incident investigations. Although the quantified benefits do not exceed the quantified costs, PHMSA believes that these non-quantified benefits are significant enough to outweigh the costs of compliance. In particular, improvements to Operator Qualification and post-incident investigation may prevent a future high-consequence event. At an annual compliance cost of $3.1 million, the proposed new Operator Qualification and post-accident testing requirements would be cost-effective if they prevented a single fatal incident over a 3-year period.
A regulatory evaluation containing a statement of the purpose and need for this rulemaking and an analysis of the costs and benefits is available in Docket No. PHMSA-2013-0163.
Under the Regulatory Flexibility Act (5 U.S.C. 601
PHMSA is proposing to amend the regulations to address the 2011 Act's Section 9 (Accident and Incident reporting requirements) to within one hour so that timely actions can be taken to pipeline accidents and incidents, and Section 13 (Cost Recovery) so that PHMSA's limited resources for enforcement and other safety activities are not used for operators design reviews. NTSB recommendations for control room training and drug and alcohol reporting requirements are addressed under this proposed rule. A special permit renewal procedure is proposed so that pipeline operators would have a renewal procedure to follow to renew their expiring special permits. The OQ requirements scope is expanded for new constructions and a program effectiveness review is required so that Operators can review their OQ programs for effectiveness. In addition, other non-substantive changes are
Under the Federal Pipeline Safety Laws, 49 U.S.C. 60101
The Initial Regulatory Flexibility Analysis finds that the proposed rule could affect a substantial number of small entities because of the market structure of the gas and hazardous liquids pipeline industry, which includes many small entities. However, these impacts would not be significant. The OQ provision would entail new costs for small entities in the range of $160.00 per employee per year, or about 0.3% of salary for a typical pipeline employee. The provision to document the reason for not drug testing post-accident would add $74.00 in documentation costs per reportable incident. The other provisions would not add appreciable costs, and at least one provision (Farm Taps) would yield compliance cost savings, though those savings are not expected to be significant.
PHMSA is unaware of any alternatives which would produce smaller economic impacts on small entities while at the same time meeting the objectives of the relevant statutes.
PHMSA is requesting public comments for the Regulatory Flexibility Analysis as follows:
1. Provide any data concerning the number of small entities that may be affected.
2. Provide comments on any or all of the provisions in the proposed rule with regard to (a) the impact of the provisions, if any, and (b) any alternatives PHMSA should consider, paying specific attention to the effect of the rule on small entities.
3. Describe ways in which the rule could be modified to reduce any costs or burdens for small entities.
4. Identify all relevant Federal, state, local, or industry rules or policies that may duplicate, overlap, or conflict with the proposed rule and have not already been incorporated by reference.
PHMSA has analyzed this proposed rule according to the principles and criteria in Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” The funding and consultation requirements of Executive Order 13175 do not apply because this proposed rule does not significantly or uniquely affect the communities of Indian tribal governments or impose substantial direct compliance costs.
Pursuant to 5 CFR 1320.8(d), PHMSA is required to provide interested members of the public and affected agencies with an opportunity to comment on information collection and recordkeeping requests. PHMSA estimates that the proposals in this rulemaking will impact the following information collections:
“Transportation of Hazardous Liquids by Pipeline: Record keeping and Accident Reporting” identified under Office of Management and Budget (OMB) Control Number 2137-0047; “Incident and Annual Reports for Gas Pipeline Operators” identified under Office of Management and Budget (OMB) Control Number 2137-0522; “Qualification of Pipeline Safety Training” identified under Office of Management and Budget (OMB) Control Number 2137-0600; and “National Registry of Pipeline and LNG Operators” identified under Office of Management and Budget (OMB) Control Number 2137-0627.
PHMSA also proposes to create a new information collection to cover the recordkeeping requirement for post-accident drug testing: “Post-Accident Drug Testing for Pipeline Operators.” PHMSA will request a new Control Number from the Office of Management and Budget (OMB) for this information collection.
PHMSA will submit an information collection revision request to OMB for approval based on the requirements that need information collection in this proposed rule. The information collection is contained in the pipeline safety regulations, 49 CFR parts 190 through 199. The following information is provided for each information collection: (1) Title of the information collection; (2) OMB control number; (3) Current expiration date; (4) Type of request; (5) Abstract of the information collection activity; (6) Description of affected public; (7) Estimate of total annual reporting and recordkeeping burden; and (8) Frequency of collection. The information collection burdens are estimated to be revised as follows:
1.
Total Annual Responses: 847.
Total Annual Burden Hours: 52,429.
2.
Total Annual Responses: 12,164.
Total Annual Burden Hours: 92,321.
Frequency of Collection: On occasion.
3.
Total Annual Responses: 31,835
Total Annual Burden Hours: 509,360.
Frequency of Collection: On occasion.
4.
These notifications are estimated to be rare but would fall under the scope of Operator Notifications required by PHMSA as a result of this proposed rule. PHMSA estimates that this new reporting requirement will add .10 new responses and 10 annual burden hours to the currently approved information collection.
Total Annual Responses: 640.
Total Annual Burden Hours: 640.
Frequency of Collection: On occasion.
5.
Total Annual Responses: 609
Total Annual Burden Hours: 1,218.
Frequency of Collection: On occasion.
Requests for copies of these information collections should be directed to Angela Dow, Office of Pipeline Safety (PHP-30), Pipeline and Hazardous Materials Safety Administration, 2nd Floor, 1200 New Jersey Avenue SE., Washington, DC 20590-0001. Telephone: 202-366-1246.
Comments are invited on:
(a) The need for the proposed collection of information for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) The accuracy of the agency's estimate of the burden of the revised collection of information, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques.
Send comments directly to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attn: Desk Officer for the Department of Transportation, 725 17th Street NW., Washington, DC 20503. Comments should be submitted on or prior to September 8, 2015.
PHMSA has determined that the proposed rule would not impose annual expenditures on State, local, or tribal governments of the private sector in excess of $153 million, and thus, does not require an Unfunded Mandates Act analysis.
The National Environmental Policy Act (42 U.S.C. 4321 through 4375) requires that Federal agencies analyze proposed actions to determine whether those actions will have a significant impact on the human environment. The Council on Environmental Quality regulations require Federal agencies to conduct an environmental review considering: (1) The need for the proposed action, (2) alternatives to the proposed action, (3) probable environmental impacts of the proposed action and alternatives, and (4) the agencies and persons consulted during the consideration process (40 CFR 1508.9(b)).
PHMSA's mission is to protect people and the environment from the risks of hazardous materials transportation. The purpose of this proposed rule is to enhance pipeline integrity and safety to lessen the frequency and consequences of pipeline incidents that cause environmental degradation, personal injury, and loss of life.
The need for this action stems from the statutory mandates in Sections 9 and 13 of the 2011 Act, NTSB recommendations, and the need to add new reference material and make non substantive edits. Section 9 of the 2011 Act directs PHMSA to require a specific time limit for telephonic or electronic reporting of pipeline accidents and incidents, and Section 13 of the 2011 Act allows PHMSA to recover costs associated with pipeline design reviews. NTSB has made recommendations regarding the clarification of OQ requirements in control rooms, and to eliminate operator discretion with regard to post-accident drug and alcohol testing of covered employees. In addition, PHMSA's safety regulations require periodic updates and clarifications to enhance compliance and overall safety.
In developing the proposed rule, PHMSA considered two alternatives:
(1) No action, or
(2) Propose revisions to the pipeline safety regulations to incorporate the proposed amendments as described in this document.
Alternative 1:
PHMSA has an obligation to ensure the safe and effective transportation of hazardous liquids and gases by pipeline. The changes proposed in this proposed rule serve that purpose by clarifying the pipeline safety regulations and addressing Congressional mandates and NTSB safety recommendations. A failure to undertake these actions would be non-responsive to the Congressional mandates and the NTSB recommendations. Accordingly, PHMSA rejected the “no action” alternative.
Alternative 2:
PHMSA is proposing to make certain amendments and non-substantive changes to the pipeline safety regulations to add a specific time frame for telephonic or electronic notifications of accidents and incidents and add provisions for cost recovery for design reviews of certain new projects, for the renewal of expiring special permits, and to request PHMSA keep submitted information confidential. We are also proposing changes to the OQ requirements and drug and alcohol testing requirements and proposing methods for assessment tools by incorporating consensus standards by reference for in-line inspection and stress corrosion cracking direct assessment.
The Nation's pipelines are located throughout the United States in a variety of diverse environments; from offshore locations, to highly populated urban sites, to unpopulated rural areas. The pipeline infrastructure is a network of over 2.6 million miles of pipelines that move millions of gallons of hazardous liquids and over 55 billion cubic feet of natural gas daily. The biggest source of energy is petroleum, including oil and natural gas. Together, these commodities supply 65 percent of the energy in the United States.
The physical environments potentially affected by the proposed rule includes the airspace, water resources (
Because the pipelines subject to the proposed rule contain hazardous materials, resources within the physically affected environments, as well as public health and safety, may be affected by pipeline incidents such as spills and leaks. Incidents on pipelines can result in fires and explosions, resulting in damage to the local environment. In addition, since pipelines often contain gas streams laden with condensates and natural gas liquids, failures also result in spills of these liquids, which can cause environmental harm. Depending on the size of a spill or gas leak and the nature of the impact zone, the impacts could vary from property damage and environmental damage to injuries or, on rare occasions, fatalities.
The proposed amendments are improvements to the existing pipeline safety requirements and would have little or no impact on the human environment. On a national scale, the cumulative environmental damage from pipelines would most likely be reduced slightly.
For these reasons, PHMSA has concluded that neither of the alternatives discussed above would result in any significant impacts on the environment.
Preparers: This Environmental Assessment was prepared by DOT staff from PHMSA and Volpe National Transportation Systems Center (Office of the Secretary for Research and Technology (OST-R)).
PHMSA has preliminarily determined that the selected alternative would have a positive, non-significant, impact on the human environment and welcomes comments on PHMSA's conclusion. The preliminary environmental assessment is available in Docket No. PHMSA-2013-0163.
PHMSA has analyzed this proposed rule according to Executive Order 13132 (“Federalism”). The proposed rule does not have a substantial direct effect on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. This proposed rule does not impose substantial direct compliance costs on State and local governments. This proposed rule does not preempt State law for intrastate pipelines. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.
This proposed rule is not a “significant energy action” under Executive Order 13211 (“Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”). It is not likely to have a significant adverse effect on supply, distribution, or energy use. Further, the Office of Information and Regulatory Affairs has not designated this proposed rule as a significant energy action.
Administrative practice and procedure, Penalties, Cost recovery, Special permits.
Incident, Pipeline safety, Reporting and recordkeeping requirements, Reversal of flow.
Control room, Distribution integrity management program, Gathering lines, Incorporation by reference, Operator qualification, Pipeline safety, Safety devices, Security measures.
Ammonia, Carbon dioxide, Control room, Corrosion control, Direct and indirect costs, Gathering lines, Incident,
Alcohol testing, Drug testing, Pipeline safety, Reporting and recordkeeping requirements, Safety, Transportation.
In consideration of the foregoing, PHMSA is proposing to amend 49 CFR parts 190, 191, 192, 195, and 199 as follows:
33 U.S.C. 1321(b); 49 U.S.C. 60101
The additions and revisions read as follows:
(c) * * *
(8) Any other information PHMSA may need to process the application including environmental analysis where necessary.
(d) * * *
(2)
(e)
(2) If, at least 180 days before an existing special permit expires the holder files an application for renewal that is complete and conforms to the requirements of this section, the special permit will not expire until final administrative action on the application for renewal has been taken:
(i) Direct fax to PHMSA at: 202-366-4566; or
(ii) Express mail, or overnight courier to the Associate Administrator for Pipeline Safety, Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE., East Building, Washington, DC 20590.
(f)
(i) A summary report in accordance with the requirements of the original special permit including verification that the grantee's operations and maintenance plan (O&M Plan) is consistent with the conditions of the special permit;
(ii) Name, mailing address and telephone number of the special permit grantee;
(iii) Location of special permit—areas on the pipeline where the special permit is applicable including: diameter, mile posts, county, and state;
(iv) Applicable usage of the special permit—original and future; and
(v) Data for the special permit segment and area identified in the special permit as needing additional inspections to include:
(A) Pipe attributes: Pipe diameter, wall thickness, grade, and seam type; pipe coating including girth weld coating;
(B) Operating Pressure: Maximum allowable operating pressure (MAOP); class location (including boundaries on aerial photography);
(C) High Consequence Areas (HCAs): HCA boundaries on aerial photography;
(D) Material Properties: Pipeline material documentation for all pipe, fittings, flanges, and any other facilities included in the special permit. Material documentation must include: yield strength, tensile strength, chemical composition, wall thickness, and seam type;
(E) Test Pressure: Hydrostatic test pressure and date including pressure and temperature charts and logs and any known test failures;
(F) In-line inspection (ILI): ILI survey results from all ILI tools used on the special permit segments during the previous five years;
(G) Integrity Data and Integration: The following information, as applicable, for the past five (5) years: Hydrostatic test pressure including any known test failures; casings(any shorts); any in-service ruptures or leaks; close interval survey (CIS) surveys; depth of cover surveys; rectifier readings; test point survey readings; AC/DC interference surveys; pipe coating surveys; pipe coating and anomaly evaluations from pipe excavations; SCC, selective seam corrosion and hard spot excavations and findings; and pipe exposures from encroachments;
(H) In-service: Any in-service ruptures or leaks including repair type and failure investigation findings; and
(I) Aerial Photography: Special permit segment and special permit inspection area, if applicable.
(2) PHMSA may request additional operational, integrity or environmental assessment information prior to granting any request for special permit renewal.
(3) The existing special permit will remain in effect until PHMSA acts on the application for renewal by granting or denying the request.
When you submit information to PHMSA during a rulemaking proceeding, as part of your application for special permit or renewal, or for any other reason, we may make that information publicly available unless you ask that we keep the information confidential.
(a) Asking for confidential treatment. You may ask us to give confidential treatment to information you give to the agency by taking the following steps:
(1) Mark “confidential” on each page of the original document you would like to keep confidential.
(2) Send us, along with the original document, a second copy of the original document with the confidential information deleted.
(3) Explain why the information you are submitting is confidential.
(b) PHMSA Decision. PHMSA will decide whether to treat your information as confidential. We will notify you, in writing, of a decision to grant or deny confidentiality at least five days before the information is publicly disclosed, and give you an opportunity to respond
If PHMSA conducts a facility design and/or construction safety review or inspection in connection with a proposal to construct, expand, or operate a gas, hazardous liquid or carbon dioxide pipeline facility, or a liquefied natural gas facility that meets the applicability requirements in § 190.403, PHMSA may require the applicant proposing the project to pay the costs incurred by PHMSA relating to such review, including the cost of design and construction safety reviews or inspections.
The following paragraph specifies which projects will be subject to the cost recovery requirements of this section.
(a) This section applies to any project that—
(1) Has design and construction costs totaling at least $2,500,000,000, as periodically adjusted by PHMSA, to take into account increases in the Consumer Price Index for all urban consumers published by the Department of Labor, based on—
(i) The cost estimate provided to the Federal Energy Regulatory Commission in an application for a certificate of public convenience and necessity for a gas pipeline facility or an application for authorization for a liquefied natural gas pipeline facility; or
(ii) A good faith estimate developed by the applicant proposing a hazardous liquid or carbon dioxide pipeline facility and submitted to the Associate Administrator. The good faith estimate for design and construction costs must include all of the applicable cost items contained in the Federal Energy Regulatory Commission application referenced in § 190.403(a)(1)(i) for a gas or LNG facility. In addition, an applicant must take into account all survey, design, material, permitting, right-of way acquisition, construction, testing, commissioning, start-up, construction financing, environmental protection, inspection, material transportation, sales tax, project contingency, and all other applicable costs, including all segments, facilities, and multi-year phases of the project;
(2) Uses new or novel technologies or design, as defined in § 190.3.
(b) The Associate Administrator may not collect design safety review fees under this section and 49 U.S.C. 60301 for the same design safety review.
(c) The Associate Administrator, after receipt of the design specifications, construction plans and procedures, and related materials, determines if cost recovery is necessary. The Associate Administrator's determination is based on the amount of PHMSA resources needed to ensure safety and environmental protection.
For any new pipeline facility construction project in which PHMSA will conduct a design review, the applicant proposing the project must notify PHMSA and provide the design specifications, construction plans and procedures, project schedule and related materials at least 120 days prior to the commencement of any of the following activities: Construction route surveys, permitting activities, material purchasing and manufacturing, right of way acquisition, offsite facility fabrications, construction equipment move-in activities, onsite or offsite fabrications, personnel support facility construction, and any offsite or onsite facility construction. To the maximum extent practicable, but not later than 90 days after receiving such design specifications, construction plans and procedures, and related materials, PHMSA will provide written comments, feedback, and guidance on the project.
PHMSA and the applicant will enter into an agreement within 60 days after PHMSA received notification from the applicant provided in § 190.405, outlining PHMSA's recovery of the costs associated with the facility design safety review.
(a) A Master Agreement, at a minimum, includes:
(1) Itemized list of direct costs to be recovered by PHMSA;
(2) Scope of work for conducting the facility design safety review and an estimated total cost;
(3) Description of the method of periodic billing, payment, and auditing of cost recovery fees;
(4) Minimum account balance which the applicant must maintain with PHMSA at all times;
(5) Provisions for reconciling differences between total amount billed and the final cost of the design review, including provisions for returning any excess payments to the applicant at the conclusion of the project;
(6) A principal point of contact for both PHMSA and the applicant; and
(7) Provisions for terminating the agreement.
(8) A project reimbursement cost schedule based upon the project timing and scope.
(b) [Reserved]
The fee charged is based on the direct costs that PHMSA incurs in conducting the facility design safety review (including construction review and inspections), and will be based only on costs necessary for conducting the facility design safety review. “Necessary for” means that but for the facility design safety review, the costs would not have been incurred and that the costs cover only those activities and items without which the facility design safety review cannot be completed.
(a) Costs qualifying for cost recovery include, but are not limited to—
(1) Personnel costs based upon total cost to PHMSA;
(2) Travel, lodging and subsistence;
(3) Vehicle mileage;
(4) Other direct services, materials and supplies;
(5) Other direct costs as may be specified in the Master Agreement.
(b) [Reserved]
All PHMSA cost calculations for billing purposes are determined from the best available PHMSA records.
(a) PHMSA bills an applicant for cost recovery fees as specified in the Master Agreement, but the applicant will not be billed more frequently than quarterly.
(1) PHMSA will itemize cost recovery bills in sufficient detail to allow independent verification of calculations.
(2) [Reserved]
(b) PHMSA will monitor the applicant's account balance. Should the account balance fall below the required minimum balance specified in the Master Agreement, PHMSA may request at any time the applicant submit
(c) PHMSA will provide an updated estimate of costs to the applicant on or near October 1st of each calendar year.
(d) Payment of cost recovery fees is due within 30 days of issuance of a bill for the fees. If payment is not made within 30 days, PHMSA may charge an annual rate of interest (as set by the Department of Treasury's Statutory Debt Collection Authorities) on any outstanding debt, as specified in the Master Agreement.
(e) Payment of the cost recovery fee by the applicant does not obligate or prevent PHMSA from taking any particular action during safety inspections on the project.
49 U.S.C. 5121, 60102, 60103, 60104, 60108, 60117, 60118, and 60124, and 49 CFR 1.97.
(a) At the earliest practicable moment following discovery, but no later than one hour after confirmed discovery, each operator must give notice in accordance with paragraph (b) of this section of each incident as defined in § 191.3.
(b) * * *
(5) The amount of product loss.
(c) Within 48 hours after the confirmed discovery of an incident, to the extent practicable, an operator must revise or confirm its initial telephonic notice required in paragraph (b) of this section with a revised estimate of the amount of product released, an estimate of the number of fatalities and injuries, and all other significant facts that are known by the operator that are relevant to the cause of the incident or extent of the damages. If there are no changes or revisions to the initial report, the operator must confirm the estimates in its initial report.
(c) * * *
(1) * * *
(ii) Construction of 10 or more miles of a new or replacement pipeline;
(iv) Reversal of product flow direction when the reversal is expected to last more than 30 days. This notification is not required for pipeline systems already designed for bi-directional flow; or
(v) A pipeline converted for service under § 192.14 of this chapter, or a change in commodity as reported on the annual report as required by § 191.17.
49 U.S.C. 5103, 60102, 60104, 60108, 60109, 60110, 60113, 60118, and 60137; and 49 CFR 1.97.
(c) Type A lines. An operator of a Type A regulated onshore gathering line must comply with the requirements of this part applicable to transmission lines, except the requirements in § 192.150 and in subpart O of this part. An operator must establish and implement an operator qualification program in accordance with Subpart N of this part.
(d) * * *
(8) Establish and implement an operator qualification program in accordance with Subpart N of this part.
(e) * * *
(2) If a regulated onshore gathering line existing on April 14, 2006 was not previously subject to this part, an operator has until the date stated in the second column to comply with the applicable requirement for the line listed in the first column, unless the Administrator finds a later deadline is justified in a particular case:
(c) An operator converting a pipeline from service not previously covered by this part must notify PHMSA 60 days before the conversion occurs as required by § 191.22 of this chapter.
(b) Each pipe-type or bottle-type holder must have minimum clearance from other holders in accordance with the following formula:
(a) Welding must be performed by a qualified welder or welding operator in accordance with welding procedures qualified under section 5, section 12, Appendix A or Appendix B of API Std 1104 (incorporated by reference,
(a) Except as provided in paragraph (b) of this section, each welder or welding operator must be qualified in accordance with section 6, section 12, Appendix A or Appendix B of API Std 1104 (incorporated by reference,
(b) * * *
(3) A controller's role during an emergency, even if the controller is not the first to detect the emergency, including the controller's responsibility to take specific actions and to communicate with others;
(4) A method of recording controller shift-changes and any hand-over of responsibility between controllers; and
(5) The roles, responsibilities and qualifications of others with the authority to direct or supersede the specific technical actions of a controller.
(h) * * *
(4) Training that will provide a controller a working knowledge of the pipeline system, especially during the development of abnormal operating conditions;
(5) For pipeline operating setups that are periodically, but infrequently used, providing an opportunity for controllers to review relevant procedures in advance of their application; and
(6) Control room team training and exercises that include both controllers and other individuals who would reasonably be expected to interact with controllers (control room personnel) during normal, abnormal or emergency situations.
(a) This section applies, except as provided in paragraph (c) of this section, to any service line that originates from a production, gathering, or transmission pipeline that is not operated as part of a distribution system.
(b) Each pressure regulating/limiting device, relief device, automatic shutoff device, and associated equipment must be inspected and tested at least once every 3 calendar years, not exceeding 39 months, to determine that it is:
(1) In good mechanical condition;
(2) Adequate from the standpoint of capacity and reliability of operation for the service in which it is employed;
(3) Set to control or relieve at the correct pressure consistent with the pressure limits of § 192.197; and to limit the pressure on the inlet of the service regulator to 60 psi (414 kPa) gage or less in case the upstream regulator fails to function properly; and
(4) Properly installed and protected from dirt, liquids, or other conditions that might prevent proper operation.
(c) This section does not apply to equipment installed on service lines that only serve engines that power irrigation pumps.
This subpart prescribes the minimum requirements for operator qualification of individuals performing covered tasks as defined in § 192.803 on a pipeline facility.
For purposes of the subpart the following definitions apply:
(1) Indicate a condition exceeding design limits; or
(2) Result in a hazard(s) to persons, property, or the environment.
(1) Written examination;
(2) Oral examination;
(3) Work performance history review;
(4) Observation during;
(i) Performance on the job;
(ii) On the job training; or
(iii) Simulations; and
(5) Other forms of assessment
(1) Perform assigned covered tasks;
(2) Recognize and react to abnormal operating conditions that may be encountered while performing a particular covered task;
(3) Demonstrate technical knowledge required to perform the covered task, such as: equipment selection, maintenance of equipment, calibration and proper operation of equipment, including variations that may be encountered in the covered task performance due to equipment and environmental differences;
(4) Demonstrate the technical skills required to perform the covered task, for example:
(i) Variations required in the covered task performance due to equipment and/or new operations differences or changes;
(ii) Variations required in covered task performance due to conditions or context differences (
(5) Meet the physical abilities required to perform the specific covered task (
(1) Wholesale changes to the program;
(2) Change in evaluation methods (
(3) Increases in evaluation intervals (
(4) Removal of covered tasks (not including combining covered tasks).
(a)
(b)
(1) Identify covered tasks;
(2) Complete the qualification of each individual performing a covered task prior to the individual performing the covered task;
(3) Ensure through evaluation that each individual performing a covered task is qualified to perform the covered task provided that:
(i) Review of work performance history is not used as a sole evaluation method.
(ii) Observation of on-the-job performance is not used as a sole method of evaluation. However, when on-the-job performance is used to complete an individual's competency for a covered task, the operator qualification procedure must define the measures used to determine successful completion of the on-the-job performance evaluation.
(4) Allow any individual who is not qualified to perform a covered task to perform the covered task if directed and observed by a qualified individual within the limitations of the established span of control for the particular covered task.
(5) Evaluate an individual if the operator has reason to believe that the individual's performance of a covered task contributed to an incident as defined in part 191 of this chapter;
(6) Evaluate an individual if the operator has reason to believe that the individual is no longer qualified to perform a covered task;
(7) Establish and maintain a Management of Change program that will communicate changes that affect covered tasks to individuals performing those covered tasks;
(8) Identify all covered tasks and the intervals at which evaluation of an individual's qualifications is needed;
(9) Provide training to ensure that any individual performing a covered task has the necessary knowledge, skills, and abilities to perform the task in a manner that ensures the safety and integrity of the operator's pipeline facilities;
(10) Provide supplemental training for the individual when procedures and specifications are changed for the covered task;
(11) Establish the requirements to be an Evaluator, including the necessary training; and
(12) Develop and implement a process to measure the program's effectiveness in accordance with § 192.805
(c)
(a)
(b)
(1) Evaluate if the qualification program is being implemented and executed as written; and
(2) Establish provisions to amend the program to include any changes necessary to address the findings of the program effectiveness review.
(c)
(1) Number of occurrences caused by any individual whose performance of a covered task(s) adversely affected the safety or integrity of the pipeline due to any of the following deficiencies:
(i) Evaluation was not conducted properly;
(ii) KSAs for the specific covered task(s) were not adequately determined;
(iii) Training was not adequate for the specific covered task(s);
(iv) Change made to a covered task or the KSAs was not adequately evaluated for necessary changes to training or evaluation;
(v) Change to a covered task(s) or the KSAs was not adequately communicated;
(vi) Individual failed to recognize an abnormal operating condition, whether it is task specific or non-task specific, which occurs anywhere on the system;
(vii) Individual failed to take the appropriate action following the recognition of an abnormal operating condition (task specific or non-task specific) that occurs anywhere on the system;
(viii) Individual was not qualified;
(ix) Nonqualified individual was not being directed and observed by a qualified individual;
(x) Individual did not follow approved procedures and/or use approved equipment;
(xi) Span of control was not followed;
(xii) Evaluator or training did not follow program or meet requirements; or
(xiii) The qualified individual supervised more than one covered task at the time.
(2) [Reserved]
Each operator must maintain records that demonstrate compliance with this subpart.
(a)
(1) Identification of qualified individual(s),
(2) Identification of the covered tasks the individual is qualified to perform;
(3) Date(s) of current qualification;
(4) Qualification method(s);
(5) Evaluation to recognize and react to an abnormal operating condition, whether it is task-specific non-task specific, which occurs anywhere on the system;
(6) Name of evaluator and date of evaluation; and
(7) Training required to support an individual's qualification or requalification.
(b)
(1) Program effectiveness reviews;
(2) Program changes;
(3) List of program abnormal operating conditions;
(4) Program management of change notifications;
(5) Covered task list to include all task specific and non-task specific covered tasks;
(6) Span of control ratios for each covered task:
(7) Reevaluation intervals for each covered task;
(8) Evaluations method(s) for each covered task; and
(9) Criteria and training for evaluators.
(c)
(2)
(a)
(b)
49 U.S.C. 5103, 60102, 60104, 60108, 60109, 60118, 60137, and 49 CFR 1.97.
The additions read as follows:
(b) * * *
(23) API Standard 1163, “In-Line Inspection Systems Qualification Standard” 1st edition, August 2005, (API Std 1163), IBR approved for § 195.591.
(d) American Society for Nondestructive Testing, P.O. Box 28518, 1711 Arlingate Lane, Columbus, OH, 43228.
(1) ANSI/ASNT ILI-PQ-2010, “In-line Inspection Personnel Qualification and Certification” (2010), (ANSI/ASNT ILI-PQ), IBR approved for § 195.591.
(2) [Reserved]
(g) * * *
(3) NACE SP0102-2010, Standard Practice, “Inline Inspection of Pipelines” approved March 3, 2010, (NACE SP0102), IBR approved for § 195.591
(4) NACE SP0204-2008, Standard Practice, “Stress Corrosion Cracking Direct Assessment” approved September 18, 2008, (NACE SP0204), IBR approved for § 195.588(c).
(d) An operator converting a pipeline from service not previously covered by this part must notify PHMSA 60 days before the conversion occurs as required by § 195.64
(b) * * *
(11) Establish and implement an operator qualification program in accordance with Subpart G of this part before [DATE ONE YEAR AFTER DATE OF PUBLICATION OF A FINAL RULE IN THE
(a)
(d)
(c) * * *
(1) * * *
(ii) Construction of 10 or more miles of a new or replacement hazardous liquid or carbon dioxide pipeline;
(iii) Reversal of product flow direction when the reversal is expected to last more than 30 days. This notification is not required for pipeline systems already designed for bi-directional flow; or
(iv) A pipeline converted for service under § 195.5, or a change in commodity as reported on the annual report as required by § 195.49.
(a) Except as provided in paragraphs (b) and (c) of this section, each new pipeline and each replacement of line pipe, valve, fitting, or other line component in a pipeline must be designed and constructed to accommodate the passage of an In-Line Inspection tool, in accordance with NACE SP0102-2010, Section 7 (incorporated by reference,
(a) Welding must be performed by a qualified welder or welding operator in accordance with welding procedures qualified under Section 5, section 12, Appendix A or Appendix B of API Std 1104 (incorporated by reference, see § 195.3), or Section IX of the ASME Boiler and Pressure Vessel Code (ASME BPVC) (incorporated by reference,
(a) Each welder or welding operator must be qualified in accordance with section 6, section 12, Appendix A or Appendix B of API Std 1104 (incorporated by reference,
(b) * * *
(3) A controller's role during an emergency, even if the controller is not the first to detect the emergency, including the controller's responsibility to take specific actions and to communicate with others;
(4) A method of recording controller shift-changes and any hand-over of responsibility between controllers; and
(5) The roles, responsibilities and qualifications of others who have the authority to direct or supersede the specific technical actions of controllers.
(h) * * *
(4) Training that will provide a controller a working knowledge of the pipeline system, especially during the development of abnormal operating conditions;
(5) For pipeline operating setups that are periodically, but infrequently used, providing an opportunity for controllers to review relevant procedures in advance of their application; and
(6) Control room team training that includes both controllers and other individuals who would reasonably be expected to interact with controllers (control room personnel) during normal, abnormal or emergency situations.
(a) * * *
(4) Low stress pipelines as specified in § 195.12.
(c) * * *
(1) * * *
(i) * * *
(A) In-Line Inspection tool or tools capable of detecting corrosion, cracks, and deformation anomalies including dents, gouges and grooves. When performing an assessment using an In-Line Inspection Tool, an operator must comply with § 195.591;
(j) * * *
(5) * * *
(i) In-Line Inspection tool or tools capable of detecting corrosion, cracks, and deformation anomalies including dents, gouges and grooves. When performing an assessment using an In-Line Inspection tool, an operator must comply with § 195.591;
This subpart prescribes the minimum requirements for operator qualification of individuals performing covered tasks as defined in § 195.503 on a pipeline facility.
For purposes of this subpart the following definitions apply:
(1) Indicate a condition exceeding design limits; or
(2) Result in a hazard(s) to persons, property, or the environment.
(1) Written examination;
(2) Oral examination;
(3) Work performance history review;
(4) Observation during;
(i) Performance on the job;
(ii) On the job training; or
(iii) Simulations; and
(5) Other forms of assessment
(1) Perform assigned covered tasks;
(2) Recognize and react to abnormal operating conditions that may be encountered while performing a particular covered task;
(3) Demonstrate technical knowledge required to perform the covered task, such as: Equipment selection, maintenance of equipment, calibration and proper operation of equipment, including variations that may be encountered in the covered task performance due to equipment and environmental differences;
(4) Demonstrate the technical skills required to perform the covered task, for example:
(i) Variations required in the covered task performance due to equipment and/or new operations differences or changes;
(ii) Variations required in covered task performance due to conditions or context differences (
(5) Meet the physical abilities required to perform the specific covered task (
(1) Wholesale changes to the program;
(2) Change in evaluation methods (
(3) Increases in evaluation intervals (
(4) Removal of covered tasks (not including combining covered tasks).
(a)
(b)
(1) Identify covered tasks;
(2) Complete the qualification of each individual performing a covered task prior to the individual performing the covered task;
(3)(i) Ensure through evaluation that each individual performing a covered task is qualified to perform the covered task provided that:
(A) Review of work performance history is not used as a sole evaluation method.
(B) Observation of on-the-job performance is not used as a sole method of evaluation. (ii) However, when on-the-job performance is used to complete an individual's competency for covered tasks, the operator qualification procedure must define the measures used to determine successful completion of the on-the-job performance evaluation.
(4) Allow any individual who is not qualified pursuant to this subpart to perform a covered task if directed and observed by a qualified individual within the limitations of the established span of control for the particular covered task;
(5) Evaluate an individual if the operator has reason to believe that the individual's performance of a covered task contributed to an accident as defined in § 195.52;
(6) Evaluate an individual if the operator has reason to believe that the individual is no longer qualified to perform a covered task;
(7) Establish and maintain a Management of Change program that will communicate changes that affect covered tasks to individuals performing those covered tasks;
(8) Identify all covered tasks and the intervals at which evaluation of an individual's qualifications is needed;
(9) Provide training to ensure that any individual performing a covered task has the necessary knowledge, skills, and abilities to perform the task in a manner that ensures the safety and integrity of the operator's pipeline facilities;
(10) Provide supplemental training for the individual when procedures and specifications are changed for the covered task;
(11) Establish the requirements to be an Evaluator, including the necessary training; and
(12) Develop and implement a process to measure the program's effectiveness in accordance with § 195.505
(c)
(a)
(b)
(1) Evaluate if the qualification program is being implemented and executed as written; and
(2) Establish provisions to amend the program to include any changes necessary to address the findings of the program effectiveness review.
(c)
(1) Number of occurrences caused by any individual whose performance of a covered task(s) adversely affected the safety or integrity of the pipeline due to any of the following deficiencies:
(i) Evaluation was not conducted properly;
(ii) KSAs for the specific covered task(s) were not adequately determined;
(iii) Training was not adequate for the specific covered task(s);
(iv) Change made to a covered task or the KSAs was not adequately evaluated for necessary changes to training or evaluation;
(v) Change to a covered task(s) or the KSAs was not adequately communicated;
(vi) Individual failed to recognize an abnormal operating condition, whether it is task-specific or non-task specific, which occurs anywhere on the system;
(vii) Individual failed to take the appropriate action following the recognition of an abnormal operating condition (task-specific or non-task-specific) that occurs anywhere on the system;
(viii) Individual was not qualified;
(ix) Nonqualified individual was not being directed and observed by a qualified individual;
(x) Individual did not follow approved procedures and/or use approved equipment;
(xi) Span of control was not followed;
(xii) Evaluator or training did not follow program or meet requirements; or
(xiii) The qualified individual supervised more than one covered task at the time.
(2) [Reserved]
Each operator must maintain records that demonstrate compliance with this subpart.
(a)
(1) Identification of qualified individual(s),
(2) Identification of the covered tasks the individual is qualified to perform;
(3) Date(s) of current qualification;
(4) Qualification method(s);
(5) Evaluation to recognize and react to an abnormal operating condition, whether it is task-specific or non-task-specific, which occurs anywhere on the system;
(6) Name of evaluator and date of evaluation; and
(7) Training required to support an individual's qualification or requalification.
(b)
(1) Program effectiveness reviews;
(2) Program changes;
(3) List of program abnormal operating conditions;
(4) Program management of change notifications;
(5) Covered task list to include all task-specific and non-task specific covered tasks;
(6) Span of control ratios for each covered task:
(7) Reevaluation intervals for each covered task;
(8) Evaluations method(s) for each covered task; and
(9) Criteria and training for evaluators.
(c)
(ii)
(a) If you use direct assessment on an onshore pipeline to evaluate the effects of external corrosion or stress corrosion cracking, you must follow the requirements of this section. This section does not apply to methods associated with direct assessment, such as close interval surveys, voltage gradient surveys, or examination of exposed pipelines, when used separately from the direct assessment process.
(c) If you use direct assessment on an onshore pipeline to evaluate the effects of stress corrosion cracking, you must develop and follow a Stress Corrosion Cracking Direct Assessment plan that meets all requirements and recommendations of NACE SP0204-2008 (incorporated by reference,
(1)
(i) The effects of a carbonate-bicarbonate environment, including the implications of any factors that promote the production of a carbonate-bicarbonate environment such as soil temperature, moisture, factors that affect the rate of carbon dioxide generation, and/or cathodic protection.
(ii) The effects of cyclic loading conditions on the susceptibility and propagation of SCC in both high-pH and near-neutral-pH environments.
(iii) The effects of variations in applied cathodic protection such as overprotection, cathodic protection loss for extended periods, and high negative potentials.
(iv) The effects of coatings that shield cathodic protection when disbonded from the pipe.
(v) Other factors that affect the mechanistic properties associated with SCC including but not limited to operating pressures, high tensile residual stresses, and the presence of sulfides.
(2)
(3)
(4)
(i) Non-significant SCC, as defined by NACE SP0204-2008, may be mitigated by either hydrostatic testing in accordance with paragraph (b)(4)(ii) of this section, or by grinding out with verification by Non-Destructive Examination (NDE) methods that the SCC defect is removed and repairing the pipe. If grinding is used for repair, the remaining strength of the pipe at the repair location must be determined using ASME/ANSI B31G or RSTRENG and must be sufficient to meet the design requirements of subpart C of this part.
(ii) Significant SCC must be mitigated using a hydrostatic testing program with a minimum test pressure between 100% up to 110% of the specified minimum yield strength of the pipe for a 30 minute spike test immediately followed by a pressure test in accordance with subpart E of this part. The test pressure for the entire sequence must be continuously maintained for at least 8 hours, in accordance with subpart E of this part. Any test failures due to SCC must be repaired by replacement of the pipe segment, and the segment retested until the pipe passes the complete test without leakage. Pipe segments that have SCC present, but that pass the pressure test, may be repaired by grinding in accordance with paragraph (c)(4)(i) of this section.
(5)
(i) Evaluation of discovered crack clusters during the direct examination step in accordance with NACE SP0204-2008, sections 5.3.5.7, 5.4, and 5.5;
(ii) Conditions conducive to creation of the carbonate-bicarbonate environment;
(iii) Conditions in the application (or loss) of cathodic protection that can create or exacerbate SCC;
(iv) Operating temperature and pressure conditions;
(v) Cyclic loading conditions;
(vi) Conditions that influence crack initiation and growth rates;
(vii) The effects of interacting crack clusters;
(viii) The presence of sulfides; and
(ix) Disbonded coatings that shield CP from the pipe.
When conducting in-line inspection of pipelines required by this part, each operator must comply with the requirements and recommendations of API STD 1163-2005,
49 U.S.C. 5103, 60102, 60104, 60108, 60117, and 60118; 49 CFR 1.97.
(b)
(2) If a test required by this section is not administered within the 32 hours following the accident, the operator must prepare and maintain its decision stating the reasons why the test was not promptly administered. If a test required by paragraph (b)(1) of this section is not administered within 32 hours following the accident, the operator must cease attempts to administer a drug test and must state in the record the reasons for not administering the test.
(a) * * *
(5) Records of decisions not to administer post-accident employee drug tests must be kept for at least 3 years.
(a) Each large operator (having more than 50 covered employees) must submit an annual Management Information System (MIS) report to PHMSA of its anti-drug testing using the MIS form and instructions as required by 49 CFR part 40 (at § 40.26 and appendix H to part 40), not later than March 15 of each year for the prior calendar year (January 1 through December 31). The Administrator may require by notice in the PHMSA Portal (
(b) Each report required under this section must be submitted electronically at
Each operator must conduct the following types of alcohol tests for the presence of alcohol:
(a) * * *
(1) As soon as practicable following an accident, each operator must test each surviving covered employee for alcohol if that employee's performance of a covered function either contributed to the accident or cannot be completely discounted as a contributing factor to the accident. The decision not to administer a test under this section must be based on specific information that the covered employee's performance had no role in the cause(s) or severity of the accident.
(b) * * *
(4)
(a) Each large operator (having more than 50 covered employees) must submit an annual MIS report to PHMSA of its alcohol testing results using the MIS form and instructions as required by 49 CFR part 40 (at § 40.26 and appendix H to part 40), not later than March 15 of each year for the prior calendar year (January 1 through December 31). The Administrator may require by notice in the PHMSA Portal (
(c) Each report required under this section must be submitted electronically at
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |