| Page Range | 32761-32986 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 32871 - Government in the Sunshine Act Meeting Notice | |
| 82 FR 32910 - Sunshine Act Meeting | |
| 82 FR 32811 - Sunshine Act Meetings | |
| 82 FR 32762 - Final Format and Summary of Responses to Request for Information Regarding Disclosures for Student Financial Accounts; Announcement of Applicable Dates | |
| 82 FR 32890 - Omaha Public Power District; Fort Calhoun Station, Unit No. 1 | |
| 82 FR 32859 - Information Collection Request: The Department of Homeland Security, Stakeholder Engagement and Cyber Infrastructure Resilience Division (SECIR) | |
| 82 FR 32858 - New Information Collection Request: The Department of Homeland Security, Office of Cybersecurity and Communications, US-CERT.gov Collection | |
| 82 FR 32798 - Arms Sales Notification | |
| 82 FR 32929 - Solicitation of Nominations for Appointment to the National Research Advisory Council | |
| 82 FR 32803 - Annual Updates to the Income Contingent Repayment (ICR) Plan Formula for 2017-William D. Ford Federal Direct Loan Program | |
| 82 FR 32811 - Burney Forest Products, A Joint Venture; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 82 FR 32809 - Combined Notice of Filings | |
| 82 FR 32810 - Combined Notice of Filings | |
| 82 FR 32810 - Combined Notice of Filings #1 | |
| 82 FR 32851 - Equivalency Determination for “Marine Charts,” “Charts,” or “Maps,” “Publications,” and Navigation Functions-Notice of Availability of Navigation and Vessel Inspection Circular 01-16 Change 1 | |
| 82 FR 32761 - Drawbridge Operation Regulation; Connecticut River, East Haddam, CT | |
| 82 FR 32777 - Drawbridge Operation Regulation; Shrewsbury River, Sea Bright, New Jersey | |
| 82 FR 32923 - Proposed Agency Information Collection Activities; Comment Request | |
| 82 FR 32808 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; International Early Learning Study (IELS) 2018 Field Test Data Collection and Main Study Recruitment | |
| 82 FR 32779 - National Maritime Security Advisory Committee-Input To Support Regulatory Reform of Coast Guard Regulations-New Task | |
| 82 FR 32812 - Proposed Agency Information Collection Activities; Comment Request | |
| 82 FR 32814 - Proposed Agency Information Collection Activities; Comment Request | |
| 82 FR 32924 - FY17 Competitive Funding Opportunity; Grants for Buses and Bus Facilities Infrastructure Investment Program | |
| 82 FR 32816 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 82 FR 32812 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 32788 - Aluminum Extrusions From the People's Republic of China: Notice of Second Amended Final Scope Ruling Pursuant to Court Decision | |
| 82 FR 32789 - Marine Mammals; File No. 21018 | |
| 82 FR 32808 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; NCER-NPSAS Grant Study-Connecting Students With Financial Aid (CSFA) 2017: Testing the Effectiveness of FAFSA Interventions on College Outcomes | |
| 82 FR 32861 - Draft Environmental Impact Statement and Draft Barton Springs Edwards Aquifer Conservation District Habitat Conservation Plan | |
| 82 FR 32875 - Proposed Information Collection Request; Federal Contractor Veterans' Employment Report VETS-4212 | |
| 82 FR 32913 - Environmental Impact Statement: DeRenne Avenue in Chatham County, Georgia | |
| 82 FR 32874 - Susan Harwood Training Grant Program, FY 2017 | |
| 82 FR 32914 - Qualification of Drivers; Exemption Applications; Diabetes | |
| 82 FR 32853 - Proposed Flood Hazard Determinations | |
| 82 FR 32852 - Final Flood Hazard Determinations | |
| 82 FR 32919 - Qualification of Drivers; Exemption Applications; Vision | |
| 82 FR 32853 - Proposed Flood Hazard Determinations for Dallas County, Iowa and Incorporated Areas and Warren County, Iowa and Incorporated Areas | |
| 82 FR 32922 - Qualification of Drivers; Exemption Applications; Hearing | |
| 82 FR 32854 - Changes in Flood Hazard Determinations | |
| 82 FR 32918 - Hours of Service of Drivers: Transco, Inc.; Application for Exemption | |
| 82 FR 32916 - Qualification of Drivers; Exemption Applications; Vision | |
| 82 FR 32851 - Tennessee; Major Disaster and Related Determinations | |
| 82 FR 32860 - Intent To Request Approval From OMB of One New Public Collection of Information: Military Severely Injured Joint Support Operations Center (MSIJSOC) and Travel Protocol Office (TPO) Programs | |
| 82 FR 32801 - 36(b)(1) Arms Sales Notification | |
| 82 FR 32872 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection Report of Theft or Loss of Controlled Substance; DEA Form 106 | |
| 82 FR 32872 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Self-Certification, Training, and Logbooks for Regulated Sellers and Mail-Order Distributors of Scheduled Listed Chemical Products; DEA Form 597 | |
| 82 FR 32873 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Registrant Record of Controlled Substances Destroyed; DEA Form 41 | |
| 82 FR 32787 - Request for Nominations of Members To Serve on the Census Scientific Advisory Committee | |
| 82 FR 32786 - Census Scientific Advisory Committee | |
| 82 FR 32796 - 36(b)(1) Arms Sales Notification | |
| 82 FR 32867 - Land Acquisitions; The Chickasaw Nation | |
| 82 FR 32866 - Indian Gaming; Tribal-State Class III Gaming Compact Amendment Taking Effect in the State of Wisconsin | |
| 82 FR 32863 - Land Acquisitions; The Chickasaw Nation | |
| 82 FR 32793 - Arms Sales Notification | |
| 82 FR 32864 - Land Acquisitions; The Cherokee Nation | |
| 82 FR 32790 - Arms Sales Notification | |
| 82 FR 32825 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry; How To Prepare a Pre-Request for Designation | |
| 82 FR 32836 - Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records | |
| 82 FR 32838 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction | |
| 82 FR 32842 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Character-Space-Limited Online Prescription Drug Communications | |
| 82 FR 32832 - Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey, as Used by the Food and Drug Administration | |
| 82 FR 32828 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees | |
| 82 FR 32847 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; E6(R2) Good Clinical Practice; International Council for Harmonisation | |
| 82 FR 32827 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Act Waivers and Reductions | |
| 82 FR 32826 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug User Fee Cover Sheet | |
| 82 FR 32834 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles | |
| 82 FR 32848 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds | |
| 82 FR 32839 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards | |
| 82 FR 32829 - Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug Adverse Event Reporting and Recordkeeping | |
| 82 FR 32780 - Lower Mississippi Waterway Safety Advisory Committee-Input To Support Regulatory Reform of Coast Guard Regulations-New Task | |
| 82 FR 32869 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 82 FR 32867 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 82 FR 32911 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services To Adopt a New Pricing Tier, Tape A and Tape C Tier | |
| 82 FR 32904 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Increase the Trading Rights Fee | |
| 82 FR 32895 - Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of Filing of Proposed Rule Change, Security-Based Swap Submission, or Advance Notice Relating to ICC's Liquidity Risk Management Framework and ICC's Stress Testing Framework | |
| 82 FR 32900 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Order Granting Approval of a Proposed Rule Change To Amend MIAX Options Rules 515, Execution of Orders and Quotes; 515A, MIAX Price Improvement Mechanism (“PRIME”) and PRIME Solicitation Mechanism; and 518, Complex Orders | |
| 82 FR 32906 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Commentary .07 To Rule 904 to Extend the Pilot Program That Eliminated the Position Limits for Options on SPDR S&P 500 ETF | |
| 82 FR 32908 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Commentary .06 to Rule 6.8 To Extend the Pilot Program That Eliminated the Position Limits for Options on SPDR S&P 500 ETF | |
| 82 FR 32893 - Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Eliminate Fees and Rebates for Trades Executed on June 30, 2017 in INET Launch Symbols | |
| 82 FR 32930 - Disciplinary Appeals Board Panel | |
| 82 FR 32786 - Information Collection Activity; Comment Request | |
| 82 FR 32776 - Repeal of Regulations Governing the Public Telecommunications Facilities Program | |
| 82 FR 32785 - Availability of an Environmental Assessment for Field Testing a Vaccine For Use Against Infectious Bursal Disease, Marek's Disease, and Newcastle Disease | |
| 82 FR 32816 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
| 82 FR 32822 - Imperial Paints, LLC; Analysis To Aid Public Comment | |
| 82 FR 32820 - ICP Construction Inc.; Analysis To Aid Public Comment | |
| 82 FR 32823 - YOLO Colorhouse, LLC; Analysis To Aid Public Comment | |
| 82 FR 32818 - Benjamin Moore & Co., Inc.; Analysis To Aid Public Comment | |
| 82 FR 32871 - Brass Sheet and Strip From France, Germany, Italy, and Japan; Scheduling of Expedited Five-Year Reviews | |
| 82 FR 32910 - Submission for OMB Review; Comment Request | |
| 82 FR 32908 - Submission for OMB Review; Comment Request | |
| 82 FR 32905 - Proposed Collection; Comment Request | |
| 82 FR 32900 - Proposed Collection; Comment Request | |
| 82 FR 32910 - Proposed Collection; Comment Request | |
| 82 FR 32790 - Proposed Information Collection; Comment Request; Recreational Angler Survey of Sea Turtle Interactions | |
| 82 FR 32767 - Air Plan Approval; NC; Open Burning and Miscellaneous Revisions | |
| 82 FR 32782 - Air Plan Approval; NC; Open Burning and Miscellaneous Revisions | |
| 82 FR 32771 - Air Plan Approval; Illinois; NAAQS Updates | |
| 82 FR 32783 - Public Hearing for Standards for 2018 and Biomass-Based Diesel Volume for 2019 Under the Renewable Fuel Standard Program | |
| 82 FR 32782 - Air Plan Approval; Illinois; NAAQS Updates | |
| 82 FR 32766 - Production or Disclosure of Material or Information; Adding the Definition of a Record and Clarifying Language Concerning the Timing of Responses to Requests and Specific Categories of Records | |
| 82 FR 32875 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 82 FR 32934 - Incorporation by Reference of American Society of Mechanical Engineers Codes and Code Cases |
Animal and Plant Health Inspection Service
Rural Utilities Service
Census Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Federal Energy Regulatory Commission
Food and Drug Administration
Coast Guard
Federal Emergency Management Agency
Transportation Security Administration
Fish and Wildlife Service
Indian Affairs Bureau
National Park Service
Occupational Safety and Health Administration
Veterans Employment and Training Service
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Federal Transit Administration
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.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the operating schedule that governs the Route 82 Bridge (East Haddam Swing Bridge) across the Connecticut River, mile 16.8, at East Haddam, Connecticut. The Connecticut Department of Transportation submitted a request to reduce scheduled openings of the span for recreational vessels during the boating season and to allow the bridge owner to require six hours notice for bridge openings at night during the winter season. It is expected this change to the regulations will better serve the needs of the community while still continuing to satisfy the reasonable needs of navigation.
This rule is effective August 17, 2017.
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 Mr. James Moore, Project Officer, First Coast Guard District, telephone 212-514-4334,
On March 1, 2017, we published a notice of proposed rulemaking (NPRM) entitled “Drawbridge Operation Regulation; Connecticut River, East Haddam, CT” in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
The Route 82 Bridge (East Haddam Swing Bridge), mile 16.8, across the Connecticut River at East Haddam, Connecticut, offers mariners a vertical clearance of 22 feet at Mean High Water and 25 feet at Mean Low Water when the span is in the closed position. Vertical clearance is unlimited when the span is open. Horizontal clearance is 200 feet. Waterway users include recreational and commercial vessels including tugboat/barge combinations as well as tour/dinner boats. The drawbridge operating regulations are listed at 33 CFR 117.205(c).
The owner of the bridge, the Connecticut Department of Transportation, requested a change to the drawbridge operating regulation because of the increased volume of vehicular traffic across the bridge during peak commuting hours. This increased volume coupled with bridge openings for recreational vessels on the hour as well as the half-hour has resulted in lengthy traffic jams on either side of the bridge, particularly during the morning and evening rush hours. By reducing required openings for recreational vessels, traffic congestion at peak rush hours will dissipate. The Connecticut Department of Transportation also requested that from November 1 to April 30, vessels be required to provide at least six hours of notice for bridge openings between 8 p.m. and 4 a.m. For the last three years there have been no requested openings between these hours during this time of year. Allowing the bridge owner to require such notice will allow for more efficient and economical operation of the bridge.
The Coast Guard believes this change balances the needs of both land-based and marine traffic. The change will enhance vehicular traffic flow without significantly impacting vessel traffic.
The Coast Guard received a total of 16 comments in response to the notice of proposed rulemaking. All comments positively endorsed the proposed regulation change and no objections were noted. As a result, no changes have been made to this final rule.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders, and we discuss First Amendment rights of protesters.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
The Coast Guard has determined this rule is not a significant regulatory action. The bridge will still open on the hour from 6 a.m. to 8 p.m. for recreational craft during the boating season and will open for all vessels with six hours of advance notice between 8 p.m. and 4 a.m. between November 1 and April 30. The minimum 22 foot vertical clearance available at Mean High Water when the bridge is in the closed position is sufficient to allow a majority of recreational traffic to pass without the necessity for an opening. Moreover, the advance notice requirements will be imposed during
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 received no comments from the Small Business Administration on this rule. 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.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this 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 is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, 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.
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 expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.l (series), 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 preliminary 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. Normally such actions are categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction. A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
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; Department of Homeland Security Delegation No. 0170.1.
(c) The draw of the Route 82 Bridge, mile 16.8, at East Haddam, shall operate as follows:
(1)
(2)
Office of Postsecondary Education, Department of Education.
Responses to request for information.
On May 9, 2017, the Department of Education (Department) published in the
The Department is allowing additional time—until January 1, 2018—for institutions to comply with the requirements in 34 CFR 668.164(d)(4)(i)(B)(
Ashley Higgins, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W234, Washington, DC 20202. Telephone: (202) 453-6097 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
The Secretary received 10 written responses to the RFI and is using this feedback to announce the final format, content, and update requirements that institutions may choose to follow to satisfy the requirements of § 668.164(d)(4)(i)(B)(
We also remind institutions that the Consumer Financial Protection Bureau's (CFPB's) short-form template was not drafted to implement the Department's cash management regulations; accordingly, institutions using that template should not regard it as authorizing T1 or T2 arrangements that impose any fees otherwise prohibited under § 668.164(e) or (f), as applicable.
• The institution's disclosures must list the following fees: Periodic fees, per purchase fees (including point-of-sale fees), ATM withdrawal fees, cash reload fees, overdraft fees, ATM balance inquiry fees, customer service fees, and inactivity fees. These fees are referred to as “static fees” because all institutions using the Secretary's format must list these fees in the disclosures, even if the amount of the fee is zero or the fee relates to a feature that is not offered as part of the specific account. In cases where the amount of any fee could vary, the disclosures must show the highest amount the account provider may charge for that fee, followed by a symbol, such as an asterisk, linked to a statement explaining that the fee could be lower depending on how and where the account is used. The asterisk would be included, for example, if point-of-sale fees differ depending on whether the cardholder is required to provide a PIN or signature. In cases where a static fee is not imposed, the institution may demonstrate that the fee is not applicable by placing “N/A” or an equivalent designation in the appropriate field.
• The disclosures must include the number of fee types the accountholder may be charged under the specific account program, excluding those fees that are either disclosed on the form or in close proximity as described below.
• The disclosures must also list the two additional fee types, if any, that generated the highest revenue from account holders during the previous 24 months excluding static fees, any purchase price, any activation fees and any fee types that generated less than five percent of the total revenue from accountholders, as well as the amounts of such additional fees. The two additional fee types would be determined for the specific financial account program or across programs with the same fee schedule. Institutions must ensure that the financial account provider reviews their fee revenue periodically and that they assist the institution in updating the disclosures if needed.
• The disclosures must include statements regarding FDIC/NCUA insurance and a link to the terms and conditions of the account.
• The disclosures must include a written statement that students do not have to accept the account offered under a T1 or T2 arrangement and may recommend that students ask about other ways to receive their Federal student aid.
• In close proximity to the disclosures, though not necessarily within the disclosures, the institution must disclose the financial account provider's name; the name of the account; for T2 accounts, any purchase price for the account (such as a fee for acquiring an access device or a replacement for an access device); and any fee for activating the account. If the financial account is a T1 account, the institution must also use this space to disclose that a student account holder may access his or her title IV, HEA program funds in part and in full up to the account balance via domestic withdrawals and transfers free of charge, during the student's entire period of enrollment following the date that such title IV, HEA program funds are deposited or transferred to the financial account, as required under § 668.164(e)(2)(v)(C). We also remind institutions that T1 accounts may not charge fees for opening or activating the financial account or initially receiving or activating an access device, nor for overdrafts or fees assessed on point-of-sale transactions.
You may also access documents of the Department published in the
Postal Service
Final rule.
The Postal Service is adding the definition of a record to its regulations concerning the Freedom of Information Act. The Postal Service is deleting language in order to clarify the timing of responses to requests. The Postal Service is also adding two words to two provisions in its Freedom of Information Act regulations concerning special categories of records, for clarification purposes.
Natalie A. Bonanno, Chief Counsel, Federal Compliance,
On November 30, 2016 (81 FR 86270), the Postal Service published its revised Freedom of Information Act (FOIA) regulations to comply with the FOIA Improvement Act of 2016 (FOIAIA), effective December 27, 2016. In response to public comments, the Postal Service published an additional change to these regulations on January 10, 2017 (82 FR 2896). After further review, the Postal Service published miscellaneous technical corrections to its regulations on March 8, 2017 (82 FR 12921). The Postal Service is now adding a record definition, deleting language from the timing of responses to requests, and adding two words to two provisions in its Freedom of Information Act regulations concerning records relating to specifically identified customers, for clarification purposes.
Administrative practice and procedure, Courts, Freedom of information, Government employees.
For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I as follows:
5 U.S.C. 552; 5 U.S.C. App. 3; 39 U.S.C. 401, 403, 410, 1001, 2601; Pub. L. 114-185.
(a)
(2) Requests made by individuals for records about themselves under the Privacy Act of 1974, 5 U.S.C. 552a, are processed under part 266 of this chapter as well as under this subpart.
(3) It is the policy of the Postal Service to make its official records available to the public to the maximum extent consistent with the public interest. This policy requires a practice of full disclosure of those records that are covered by the requirements of the FOIA, subject only to the specific exemptions required or authorized by law. The exemptions from mandatory disclosure for various types of records provided by 5 U.S.C. 552(b) and 39 U.S.C. 410(c) reflect the fact that under some circumstances, the public interest may be better served by leaving the disclosure of particular records to the discretion of the Postal Service rather than by requiring their disclosure. This Postal Service policy does not create any right enforceable in court.
(4) Nothing in this subpart shall be construed to entitle any person, as of right, to any service or to the disclosure of any record to which such person is not entitled under the FOIA.
(b) Definitions—(1)
(A) Recorded, regardless of media, format, or physical characteristics, including electronic data; and
(B) In the custody or control of the Postal Service.
(ii) The definition of a record does not include any discrete, distinct, or segregable grouping of information created at the discretion of an employee primarily for the employee's convenience and not disclosed to other employees. The definition of a record is not the same as a “document;” a single “document” may be a single record or it may include multiple records and groupings of information that do not constitute records as defined in this section.
(2)
(a)
(d)
(5)
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking final action to approve several revisions to the North Carolina State Implementation Plan (SIP) submitted by the State of North Carolina through the North Carolina Department of Environmental Quality (formerly the North Carolina Department of Environment and Natural Resources (NCDENR)), Division of Air Quality (DAQ), on October 14, 2004, March 24, 2006, and January 31, 2008. The revisions include changes to several regulations and the addition of a new section to the Exclusionary Rules of the North Carolina SIP. These revisions are part of North Carolina's strategy to meet and maintain the national ambient air quality standards (NAAQS). This action is being taken pursuant to the Clean Air Act (CAA or Act) and its implementing regulations.
This direct final rule is effective September 18, 2017 without further notice, unless EPA receives adverse comment by August 17, 2017. If adverse comment is received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2007-0085 at
Sean Lakeman or Nacosta C. Ward, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached via telephone
On October 14, 2004, March 24, 2006, and January 31, 2008, the State of North Carolina, through NCDENR, submitted revisions to the North Carolina SIP. These submissions pertain to revisions adopted by the North Carolina Environmental Management Commission (EMC) on March 11, 2004, November 10, 2005, and July 11, 2007, respectively. Of the revisions adopted, EPA is taking direct final action on the changes to the following regulations: 15A NCAC Subchapter 2D—Air Pollution Control Requirements, Section .0101,
The changes that are the subject of this direct final rulemaking include an addition to the SIP of a new exclusionary rule for air curtain burners, amendments to existing definitions and additions of new definitions, amendments to open burning rules to account for new nonattainment areas, amendments to permitting rules to make them consistent with recent statutory changes, as well as modifications to other rules for clarifications, updates, and corrections. Detailed descriptions of the changes are below:
1. Regulation 15A NCAC 2D, Section .0101,
• A definition of “administrator” is added and contains two exceptions to whom it is referencing. The exceptions are for certain rules to specify who the administrator is for that rule and when EPA's delegation or approval specifically states that EPA's authority is retained by the EPA Administrator and that authority is not included in the delegation or approval. The definitions have been renumbered to reflect this addition.
• 2D, Section .0101 is amended to include the definition of fine particulate matter “PM
• 2Q, Section .0103 is also amended to change the definition of “construction” to exclude construction for permitting purposes in order to incorporate the activities defined by North Carolina statutes. Those activities defined in this change are clearing and grading; building access roads, driveways, and specified parking lots, building and installing underground pipe work; or the building of ancillary structures.
2. Regulations 15A NCAC 2D, Section .0103,
3. Regulation 15A NCAC 2D, Section .1901,
4. Regulation 15A NCAC 2D Sections .1902,
• These rules are amended to account for new nonattainment and forecast areas and to include forecasts for PM
○ In Section .1902, definitions of “initiated,” “nonattainment area,” “off-site,” “air quality action day code `orange' or above,” “air quality action day,” “smoke management plan,” “pile,” and “permanent site” have been added.
○ In Sections .1902 and .1903, the definition of “ozone forecast area” is replaced by “air quality forecast area.”
○ In Section .1903, the definition of “ozone action day” is replaced by “air quality action day.”
○ Other Amendments under Section .1902:
• New forecast areas are added under the new definition “air quality forecast area.”
○ Other Amendments under Section .1903:
This section is amended to:
• Give the regional office supervisor the discretion to allow or disallow such burning of land clearing debris within less than 1000 feet from a dwelling;
• remove the regional office supervisor's ability to allow fires to be initiated between 6 p.m. and 8 a.m. under favorable meteorological conditions; and
• allow fires purposely set for the instruction and training of personnel at permanent fire-fighting training facilities.
• The title of this section has been changed to
• This section has also been reorganized to read more logically.
5. Regulation 15A NCAC 2D, Section .2001,
6. Regulation 15A NCAC 2Q, Sections .0304,
7. Regulation 15A NCAC 2Q, Section .0806,
8. Regulation 15A NCAC 2Q, Section .0808,
9. Regulation 15A NCAC 2Q, Section .0810,
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of 15A NCAC Subchapter 2D—
Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
EPA is approving the aforementioned revisions to the North Carolina SIP submitted by the State of North Carolina on October 14, 2004, March 24, 2006, and January 31, 2008, pursuant to section 110 because these revisions are consistent with the CAA and EPA policy. Changes to the other sections in these submissions will be processed in a separate action, as appropriate, for approval into the North Carolina SIP. As noted above, EPA is not taking action on changes to 15A NCAC Subchapter 2D—Air Pollution Control Requirements, Section .1201,
EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this
If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All adverse comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 18, 2017 and no further action will be taken on the proposed rule.
Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the Agency may adopt as final those provisions of the rule that are not the subject of an adverse comment. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 18, 2017. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and addition read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2015 primary National Ambient Air Quality Standard (NAAQS) for ozone (O
This direct final rule will be effective September 18, 2017, unless EPA receives adverse comments by August 17, 2017. If adverse comments are received, EPA will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2016-0512, EPA-R05-OAR-2016-0522, or EPA-R05-2017-0322 at
Michelle Becker, Life Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-3901,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
Section 109 of the Clean Air Act (CAA) requires EPA to establish national primary (protective of human health) and secondary (protective of human welfare) air quality standards for pollutants for which air quality criteria have been issued under Section 108 of the CAA (the criteria pollutants
On August 9, 2016, the Illinois Environmental Protection Agency (IEPA) submitted to EPA for approval as SIP revisions: updating Illinois' ambient air quality standards by revoking the 1997 O
On August 11, 2016, IEPA submitted to EPA for approval as SIP revisions additional updates to the methods used by Illinois to monitor air quality for several NAAQS. These updates correspond to EPA's revised monitoring methods promulgated during the period of January 1, 2014, through December 18, 2014. The IPCB adopted these rule revisions on March 5, 2015.
On May 30, 2017, IEPA submitted to EPA for approval as SIP revisions additional updates to the methods used by Illinois to monitor air quality for several NAAQS. These updates correspond to EPA's revised monitoring methods promulgated during the period of January 1, 2016, through July 13, 2016. The IPCB adopted these rule revisions on January 19, 2017.
The proposed SIP revisions would update Illinois air pollution control regulations to be “identical-in-substance” to EPA rulemakings related to the NAAQS that occurred between January 1, 2014 and July 13, 2016.
Illinois amended 35 IAC 243.105 to incorporate changes to the schedule for flagging data and submitting exceptional events demonstrations considered for initial area designations (80 FR 65292, October 26, 2015). The changes include the addition of 243.105(c)(2)(F), which identifies 243.Table A as the data submission process for a new or revised NAAQS. Also, 243.105(c)(3)(A) was revised to include an exception to the timing requirements for demonstration submissions that are allowed under 243.105(c)(2)(F).
Illinois revised this section to incorporate by reference EPA's updated “List of Designated Reference and Equivalent Methods” from January 1, 2014, to July 13, 2016. EPA issued updated versions of the “List of Designated Reference and Equivalent Methods” that included new Federal Equivalent Methods (FEMs) and Federal Reference Methods (FRMs) for monitoring of Carbon Monoxide (CO), Lead (Pb), oxides of nitrogen (NO
The list with all approved FEMs and FRMs is located at:
Illinois also added a statement to 35 IAC 243.108 that the incorporation by reference of EPA's promulgated monitoring methods “includes the following USEPA methods designations that occurred after June 17, 2016: 81 FR 45284 (July 13, 2016).”
Additionally, Illinois updated 35 IAC 243.108 to incorporate by reference the 2016 versions of appendices A-1, A-2, B, C, D, F, G, H, I, J, K, L, N, O, P, Q, R, S, T and U of 40 CFR part 50. These appendices contain the reference monitoring methods for and the “interpretation” of (
EPA made two changes in the 2015 versions of these appendices relative to the 2013 versions.
Illinois updated 35 IAC 243.120 to incorporate by reference the 2015 versions of 40 CFR 50, the changes to which are discussed above. Additionally, Illinois corrected a citation in subsection (a)(2) to 40 CFR 50.6, which contains the PM
Illinois added subsection (b) to incorporate the 2015 primary and secondary eight-hour NAAQS for ozone. The 2015 NAAQS for ozone is 70 parts per billion, determined by calculating the three-year average of the annual fourth-highest daily maximum eight-hour average (October 26, 2015, 80 FR 65292).
Additionally, Illinois removed subsection (a) “1997 Primary and Secondary Eight-Hour NAAQS for Ozone,” and renumbered former subsection (b), “2008 Primary and Secondary Eight-Hour NAAQS for Ozone” to new subsection (a). This was in response to EPA's promulgation of “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule), where EPA, among other things, revised the 1997 O
Consistent with 40 CFR 50.19(c), the revised O
Illinois amended Table A to update the flagging and document submission deadlines for exceptional events demonstrations considered for initial area designations for O
The flagging and initial event description deadlines for data years one, two and three depend on the following conditions: (1) If state and tribal initial designation recommendations for a new/revised NAAQS are due August through January, then the flagging and initial event description deadline will be the July 1 prior to the recommendation deadline; (2) if state and tribal recommendations for a new/revised NAAQS are due February through July, then the flagging and initial event description deadline will be the January 1 prior to the recommendation deadline. The exceptional events demonstration submittal deadline for data years one, two and three is no later than the date state and tribal recommendations are due to EPA. Flagging, initial event description and exceptional events demonstration submittal deadline for data year four, and, where applicable, data year five is by the last day of the month that is one year and seven months after promulgation of a new/revised NAAQS. The two exceptions to this deadline are: (1) If EPA follows a three-year designation schedule, the deadline is two years and seven months after promulgation of a new/revised NAAQS; (2) if EPA notifies the state/tribe that it intends to complete the initial area designations process according to a schedule between two and three years, the deadline is five months prior to the date specified for final designations decisions in such EPA notification. The flagging and demonstration submittal deadlines are the same as the deadlines provided in Table 2 in 40 CFR 50.14.
Illinois held a public hearing for the rule changes discussed in the August 9, 2016, submittal on February 18, 2016. Illinois held a public hearing for the rule revisions discussed in the August 11, 2016, submittal on January 8, 2015. Illinois held a public hearing for the rule revisions discussed in the May 30, 2017 submittal on December 7, 2016. Three comments pertaining to these submittals were received. The comments related to minor administrative issues and typographical errors, which were addressed by Illinois. No adverse comments were received.
EPA finds the state's requested SIP revisions to be approvable because the state's rule revisions make the state's air quality standards and associated monitoring requirements identical-in-substance to EPA's promulgated NAAQS and monitoring methods as revised through July 13, 2016.
Additionally, EPA finds that the specified exceptional event flagging and demonstration submittal deadlines are approvable because they are consistent with the deadlines in 40 CFR 50.14.
EPA is approving the submitted rule revisions as revisions of the Illinois SIP. Specifically, we are approving 35 IAC sections 243.105, 243.108, 243.120, 243.125, and 243.Table A revised as discussed above, and we are incorporating by reference these revised rules into the Illinois SIP.
We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
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 Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• 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 (Public Law 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, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
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 18, 2017. 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. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions read as follows:
(c) * * *
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of proposed rulemaking (NPRM).
The National Telecommunications and Information Administration (NTIA) issues this NPRM to propose the repeal of its regulations governing the Public Telecommunications Facilities Program (PTFP). The PTFP is a competitive grant program that helps public broadcasting stations, state and local governments, Indian Tribes, and nonprofit organizations to construct public television and radio stations. As of Fiscal Year 2011, no funds have been available for PTFP grants. NTIA is proposing to repeal its regulations governing the PTFP because the regulations are unnecessary and obsolete.
Comments must be received by August 17, 2017 at 5:00 p.m. Eastern Standard Time.
The public may submit comments identified by [170627596-7596-01] by email to
Milton Brown, Deputy Chief Counsel, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4713, Washington, DC 20230; telephone: (202) 482-1816; facsimile: (202) 501-8013; or email:
The PTFP is a competitive grant program that supports the planning and construction of public telecommunications facilities.
For the past seven years, no funds have been available for PTFP grants. In 2010, the Department of Commerce found that the majority of PTFP grants had assisted digital television conversion projects which had concluded, and that support for public broadcasters was available from other sources.
As a result of the lack of funding, NTIA began the orderly shutdown of the PTFP thereafter. NTIA has not processed applications or awarded any additional grants under the PTFP since that time. NTIA has continued to monitor PTFP grants it awarded before Fiscal Year 2011 to ensure taxpayer funds have been utilized in the most responsible and efficient manner.
The public may submit comments identified by [170627596-7596-01] by email to
Congress authorized NTIA to establish regulations “as may be necessary to carry out” the PTFP.
The proposed repeal of the regulations governing the PTFP is not a significant regulatory action as defined by Executive Order 12866.
The proposed repeal of the regulations governing the PTFP does not contain policies with federalism implications sufficient to warrant preparation of a federalism assessment under Executive Order 13132.
The proposed repeal of regulations governing the PTFP will not have a significant economic impact on a substantial number of small entities. NTIA estimates that the proposed repeal of the regulations governing PTFP will impact no small entities. The proposed repeal of the regulations governing PTFP does not include reporting, recordkeeping, or other compliance requirements; therefore, no small entities will be subject to such requirements. Thus, the Chief Counsel for Regulation of the Department of Commerce is providing a certification to the Chief Counsel for Advocacy of the Small Business Administration in accordance with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)).
The proposed repeal of the regulations governing the PTFP contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 is not required. In 2013, OMB approved NTIA's requests to discontinue the following collections associated with the regulations governing the PTFP: OMB Control Numbers 0660-0003, 0660-0001, and 0605-0001; consequently, NTIA has no active collections associated with its regulations governing the PTFP.
Administrative procedure, Grant programs—communications, Reporting and recordkeeping requirements, Telecommunications.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to modify the operating schedule that governs the Monmouth County Highway Bridge (alternatively referred to as the “Sea Bright Bridge” or the “S-32 Bridge”) across the Shrewsbury River, mile 4.0 at Sea Bright, New Jersey. The bridge owner submitted a request to reduce scheduled openings of the span and include Fridays within the seasonal weekend operating schedule for the bridge. It is expected this change to the regulations will better serve the needs of the community while continuing to meet the reasonable needs of navigation.
Comments and related material must reach the Coast Guard on or before September 18, 2017.
You may submit comments identified by docket number USCG-2017-0460 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or email Mr. James Moore, Project Officer, First Coast Guard District, telephone 212-514-4334, email
The Monmouth County Highway Bridge, mile 4.0, across the Shrewsbury River at Sea Bright, New Jersey, offers mariners a vertical clearance of 15 feet at Mean High Water and 17 feet at Mean Low Water when the span is in the closed position. Vertical clearance is unlimited when the draw is open. Horizontal clearance is 75 feet. Waterway users include recreational and a limited number of commercial vessels including tug/barge combinations.
The existing drawbridge regulation, 33 CFR 117.755, requires the draw of the Monmouth County Highway Bridge to open as follows:
The draw shall open on signal at all times; except that, from May 15 through September 30, on Saturday, Sunday and holidays, between 9 a.m. and 7 p.m., the draw need open only on the hour and half hour.
This regulation has been in effect since July 6, 2010. The owner of the bridge, the Monmouth County Board of Chosen Freeholders, requested a change to the drawbridge operating regulations given the increased volume of vehicular traffic crossing the bridge associated with the summer months. This increased vehicular traffic coupled with bridge openings for vessels on the hour as well as the half-hour has resulted in lengthy traffic jams on either side of the bridge during peak travel hours. Traffic congestion will be relieved through reduction of required bridge openings for vessels.
Monmouth County also requested that from May 15 to September 30 the modified operating regulations presently encompassing Saturdays, Sundays and holidays be expanded to include Fridays as well. Given the volume of vehicular traffic crossing the bridge at the beginning of the weekend, starting the modified weekend operating schedule on Friday will allow for more efficient and economical operation of the bridge.
Members of the public attending a meeting held in Rumson, New Jersey on April 5, 2016 indicated a desire to modify the operating regulations based on repeated experience with traffic jams on either side of the bridge associated with seasonal waterway traffic patterns. Analysis furnished by Monmouth County confirms that the seasonal nature of bridge openings negatively impacts the efficient flow of vehicular traffic. Moreover, the study indicates that reducing the number of scheduled openings for vessels will not significantly affect the movement of waterway traffic. It was also noted that vehicular traffic builds significantly on each successive Friday leading into the weekend over the course of the summer. Based on the analysis provided, the Coast Guard proposes to permanently change the drawbridge operating regulation 33 CFR 117.755.
The proposed rule would allow the Monmouth County Highway Bridge to open as follows: The draw shall open on signal at all times; except that, from May 15 through September 30, on Friday, Saturday, Sunday and holidays, between 9 a.m. and 7 p.m., the draw need only open on the hour.
We developed this proposed rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on these statutes and Executive Orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
The Coast Guard believes this rule is not a significant regulatory action. The bridge will open on the hour from 9 a.m. to 7 p.m. during Friday, Saturday, Sunday and Holidays throughout the summertime boating season, while still opening on signal during evening hours as well as through the autumn, winter and spring months. The minimum 15 foot vertical clearance available while the bridge is in the closed position is sufficient to allow a significant number of recreational vessels to safely and expeditiously pass through the draw without opening.
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 proposed rule would not have a significant economic impact on a substantial number of small entities.
For the reasons stated in Sections III. and IV. A. above, this proposed rule will not pose a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would call 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 proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule will not result in such an expenditure, we do discuss the effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01, and Commandant Instruction M16475.l (series), 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 preliminary 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 proposed rule simply promulgates the operating regulations or procedures for drawbridges. Normally such actions are
A preliminary Record of Environmental Consideration and a Memorandum for the Record are not required for this proposed rule. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice and all public comments are in our online docket at
Bridges.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(a) The draw shall open on signal at all times; except that, from May 15 through September 30, on Friday, Saturday, Sunday and holidays, between 9 a.m. and 7 p.m., the draw need open only on the hour.
U.S. Coast Guard, Department of Homeland Security.
Announcement of new task assignment for the National Maritime Security Advisory Committee (NMSAC); teleconference meeting.
The U.S. Coast Guard is issuing a new task to the National Maritime Security Advisory Committee (NMSAC). The U.S. Coast Guard is asking NMSAC to help the agency identify existing regulations, guidance, and collections of information (that fall within the scope of the Committee's charter) for possible repeal, replacement, or modification. This tasking is in response to the issuance of Executive Orders 13771, “Reducing Regulation and Controlling Regulatory Costs; 13777, “Enforcing the Regulatory Reform Agenda;” and 13783, “Promoting Energy Independence and Economic Growth.” The full Committee is scheduled to meet by teleconference on August 24, 2017, to discuss this tasking. This teleconference will be open to the public. The U.S. Coast Guard will consider NMSAC recommendations as part of the process of identifying regulations, guidance, and collections of information to be repealed, replaced, or modified pursuant to the three Executive Orders discussed above.
The full Committee is scheduled to meet by teleconference on August 24, 2017, from 11 a.m. to 12 p.m. EDT. Please note that this teleconference may adjourn early if the Committee has completed its business.
To join the teleconference or to request special accommodations, contact the individual listed in the
Mr. Ryan Owens, Alternate Designated Federal Officer of the National Maritime Security Advisory Committee,
The U.S. Coast Guard is issuing a new task to NMSAC to provide recommendations on whether existing regulations, guidance, and information collections (that fall within the scope of the Committee's charter) should be repealed, replaced, or modified. NMSAC will then provide advice and recommendations on the assigned task and submit a final recommendation report to the U.S. Coast Guard.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” Under that Executive Order, for every one new regulation issued, at least two prior regulations must be identified for elimination, and the cost of planned regulations must be prudently managed and controlled through a budgeting process. On February 24, 2017, the President issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” That Executive Order directs agencies to take specific steps to identify and alleviate unnecessary regulatory burdens placed on the American people. On March 28, 2017, the President issued Executive Order 13783, “Promoting Energy Independence and Economic Growth.” Executive Order 13783 promotes the clean and safe development of our Nation's vast energy resources, while at the same time avoiding agency actions that unnecessarily encumber energy production.
When implementing the regulatory offsets required by Executive Order 13771, each agency head is directed to prioritize, to the extent permitted by law, those regulations that the agency's Regulatory Reform Task Force identifies as outdated, unnecessary, or ineffective in accordance with Executive Order 13777. As part of this process to comply with all three Executive Orders, the U.S. Coast Guard is reaching out through multiple avenues to interested individuals to gather their input about what regulations, guidance, and information collections, they believe may need to be repealed, replaced, or modified. On June 8, 2017, the U.S. Coast Guard issued a general notice in the
NMSAC is tasked to:
Provide input to the U.S. Coast Guard on all existing regulations, guidance, and information collections that fall within the scope of the Committee's charter.
1. One or more subcommittees/working groups, as needed, will be established to work on this tasking in accordance with the Committee charter and bylaws. The subcommittee(s) shall terminate upon the approval and submission of a final recommendation to the U.S. Coast Guard from the parent Committee.
2. Review regulations, guidance, and information collections and provide recommendations whether an existing rule, guidance, or information collection should be repealed, replaced or modified. If the Committee recommends modification, please provide specific recommendations for how the regulation, guidance, or information collection should be modified. Recommendations should include an explanation on how and to what extent repeal, replacement or modification will reduce costs or burdens to industry and the extent to which risks to health or safety would likely increase.
a. Identify regulations, guidance, or information collections that potentially impose the following types of burden on the industry:
i. Regulations, guidance, or information collections imposing administrative burdens on the industry.
ii. Regulations, guidance, or information collections imposing burdens in the development or use of domestically produced energy resources. “Burden,” for the purposes of compliance with Executive Order 13783, means “to unnecessarily obstruct, delay, curtail, or otherwise impose significant costs on the siting, permitting, production, utilization, transmission, or delivery of energy resources.”
b. Identify regulations, guidance, or information collections that potentially impose the following types of costs on the industry:
i. Regulations, guidance, or information collections imposing costs that are outdated (such as due to technological advancement), or are no longer necessary.
ii. Regulations, guidance, or information collections imposing costs which are no longer enforced as written or which are ineffective.
iii. Regulations, guidance, or information collections imposing costs tied to reporting or recordkeeping requirements that impose burdens that exceed benefits. Explain why the reporting or recordkeeping requirement is overly burdensome, unnecessary, or how it could be modified.
c. Identify regulations, guidance, and information collections that the Committee believes have led to the elimination of jobs or inhibits job creation within a particular industry.
3. All regulations, guidance, and information collections, or parts thereof, recommended by the Committee should be described in sufficient detail (by section, paragraph, sentence, clause, etc.) so that it can readily be identified. Data (quantitative or qualitative) should be provided to support and illustrate the impact, cost, or burden, as applicable, for each recommendation. If the data is not readily available, the Committee should include information as to how such information can be obtained either by the Committee or directly by the Coast Guard.
All meetings associated with this tasking, both full Committee meetings and subcommittee/working groups, are open to the public. A public oral comment period will be held during the August 24, 2017, teleconference. Public comments or questions will be taken at the discretion of the Designated Federal Officer; commenters are requested to limit their comments to 3 minutes. Please contact the individual listed in the
U.S. Coast Guard, Department of Homeland Security.
Announcement of new task assignment for the Lower Mississippi Waterway Safety Advisory Committee (LMRWSAC); teleconference meeting.
The U.S. Coast Guard is issuing a new task to the Lower Mississippi Waterway Safety Advisory Committee (LMRWSAC). The U.S. Coast Guard is asking LMRWSAC to help the agency identify existing regulations, guidance, and collections of information (that fall within the scope of the Committee's charter) for possible repeal, replacement, or modification. This tasking is in response to the issuance of Executive Orders 13771, “Reducing Regulation and Controlling Regulatory Costs; 13777, “Enforcing the Regulatory Reform Agenda;” and 13783, “Promoting Energy Independence and Economic Growth.” The full Committee is scheduled to meet by teleconference on August 2, 2017, to discuss this tasking. This teleconference will be open to the public. The U.S. Coast Guard will consider LMRWSAC recommendations as part of the process of identifying regulations, guidance, and collections of information to be repealed, replaced, or modified pursuant to the three Executive Orders discussed above.
The full Committee is scheduled to meet by teleconference on August 2, 2017, from 9 a.m. to 10 a.m. CST. Please note that this teleconference may adjourn early if the Committee has completed its business.
To join the teleconference or to request special accommodations, contact the individual listed in the
Lieutenant Brian Porter, Alternate Designated Federal Officer of the Lower Mississippi Waterway Advisory Committee, telephone (504) 365-2375, or email
The U.S. Coast Guard is issuing a new task to LMRWSAC to provide recommendations on whether existing regulations, guidance, and information collections (that fall within the scope of the Committee's charter) should be repealed, replaced, or modified. LMRWSAC will then provide advice and recommendations on the assigned task and submit a final recommendation report to the U.S. Coast Guard.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” Under that Executive Order, for every one new regulation issued, at least two prior regulations must be identified for elimination, and the cost of planned regulations must be prudently managed and controlled through a budgeting process. On February 24, 2017, the President issued Executive Order 13777, “Enforcing the Regulatory Reform Agenda.” That Executive Order directs agencies to take specific steps to identify and alleviate unnecessary regulatory burdens placed on the American people. On March 28, 2017, the President issued Executive Order 13783, “Promoting Energy Independence and Economic Growth.” Executive Order 13783 promotes the clean and safe development of our Nation's vast energy resources, while at the same time avoiding agency actions that unnecessarily encumber energy production.
When implementing the regulatory offsets required by Executive Order 13771, each agency head is directed to prioritize, to the extent permitted by law, those regulations that the agency's Regulatory Reform Task Force identifies as outdated, unnecessary, or ineffective in accordance with Executive Order 13777. As part of this process to comply with all three Executive Orders, the U.S. Coast Guard is reaching out through multiple avenues to interested individuals to gather their input about what regulations, guidance, and information collections, they believe may need to be repealed, replaced, or modified. On June 8, 2017, the U.S. Coast Guard issued a general notice in the
LMRWSAC is tasked to:
Provide input to the U.S. Coast Guard on all existing regulations, guidance, and information collections that fall within the scope of the Committee's charter.
1. One or more subcommittees/working groups, as needed, will be established to work on this tasking in accordance with the Committee charter and bylaws. The subcommittee(s) shall terminate upon the approval and submission of a final recommendation to the U.S. Coast Guard from the parent Committee.
2. Review regulations, guidance, and information collections and provide recommendations whether an existing rule, guidance, or information collection should be repealed, replaced or modified. If the Committee recommends modification, please provide specific recommendations for how the regulation, guidance, or information collection should be modified. Recommendations should include an explanation on how and to what extent repeal, replacement or modification will reduce costs or burdens to industry and the extent to which risks to health or safety would likely increase.
a. Identify regulations, guidance, or information collections that potentially impose the following types of burden on the industry:
i. Regulations, guidance, or information collections imposing administrative burdens on the industry.
ii. Regulations, guidance, or information collections imposing burdens in the development or use of domestically produced energy resources. “Burden,” for the purposes of compliance with Executive Order 13783, means “to unnecessarily obstruct, delay, curtail, or otherwise impose significant costs on the siting, permitting, production, utilization, transmission, or delivery of energy resources.”
b. Identify regulations, guidance, or information collections that potentially impose the following types of costs on the industry:
i. Regulations, guidance, or information collections imposing costs that are outdated (such as due to technological advancement), or are no longer necessary.
ii. Regulations, guidance, or information collections imposing costs which are no longer enforced as written or which are ineffective.
iii. Regulations, guidance, or information collections imposing costs tied to reporting or recordkeeping requirements that impose burdens that exceed benefits. Explain why the reporting or recordkeeping requirement is overly burdensome, unnecessary, or how it could be modified.
c. Identify regulations, guidance, and information collections that the Committee believes have led to the elimination of jobs or inhibits job creation within a particular industry.
3. All regulations, guidance, and information collections, or parts thereof, recommended by the Committee should be described in sufficient detail (by section, paragraph, sentence, clause, etc.) so that it can readily be identified. Data (quantitative or qualitative) should be provided to support and illustrate the impact, cost, or burden, as applicable, for each recommendation. If the data is not readily available, the Committee should include information as to how such information can be obtained either by the Committee or directly by the Coast Guard.
All meetings associated with this tasking, both full Committee meetings and subcommittee/working groups, are open to the public. A public oral comment period will be held during the August 2, 2017, teleconference. Public comments or questions will be taken at the discretion of the Designated Federal Officer; commenters are requested to limit their comments to 3 minutes. Please contact the individual listed in the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is approving revised rules submitted by the State of Illinois as State Implementation Plan (SIP) revisions. The submitted rules update Illinois' ambient air quality standards to include the 2015 primary National Ambient Air Quality Standard (NAAQS) for ozone (O
Comments must be received on or before August 17, 2017.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2016-0512, EPA-R05-OAR-2016-0522, or EPA-R05-2017-0322 at
Michelle Becker, Life Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-3901,
In the Final Rules section of this issue of the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve several revisions to the North Carolina State Implementation Plan (SIP) submitted by the State of North Carolina, through the North Carolina Department of Environmental Quality (formerly the North Carolina Department of Environment and Natural Resources), Division of Air Quality, on October 14, 2004, March 24, 2006, and
Written comments must be received on or before August 17, 2017.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2007-0085 at
Sean Lakeman or Nacosta C. Ward, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached via telephone at (404) 562-9043 or via electronic mail at
In the Final Rules section of this issue of the
Environmental Protection Agency (EPA).
Announcement of public hearing.
The Environmental Protection Agency (EPA) is announcing a public hearing to be held in Washington, DC on August 1, 2017 for the proposed rule “Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019.” This proposed rule will be published separately in the
The public hearing will be held on August 1, 2017, at the location noted below under
The hearing will be held at the following location: Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue NW., Washington, DC, USA, 20001 (phone number 202-737-1234). A complete set of documents related to the proposal will be available for public inspection through the Federal eRulemaking Portal:
Julia MacAllister, Office of Transportation and Air Quality, Assessment and Standards Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4131; Fax number: (734) 214-4816; Email address:
The proposal for which EPA is holding the public hearing will be published separately in the
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2017-0091. The EPA has also
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment concerning authorization to ship for the purpose of field testing, and then to field test, an unlicensed Bursal Disease-Marek's Disease-Newcastle Disease Vaccine, Serotype 3, Live Marek's Disease Vector. Based on the environmental assessment, risk analysis, and other relevant data, we have reached a preliminary determination that field testing this veterinary vaccine will not have a significant impact on the quality of the human environment. We are making the documents available to the public for review and comment.
We will consider all comments that we receive on or before August 17, 2017.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
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, fax (301) 734-4314.
For information regarding the environmental assessment or the risk analysis, or to request a copy of the environmental assessment (as well as the risk analysis with confidential business information redacted), contact Dr. Patricia L. Foley, Risk Manager, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010; phone (515) 337-6100, fax (515) 337-6120.
Under the Virus-Serum-Toxin Act (21 U.S.C. 151
APHIS issues licenses to qualified establishments that produce veterinary biological products and issues permits to importers of such products. APHIS also enforces requirements concerning production, packaging, labeling, and shipping of these products and sets standards for the testing of these products. Regulations concerning veterinary biological products are contained in 9 CFR parts 101 to 124.
A field test is generally necessary to satisfy prelicensing requirements for veterinary biological products. Prior to conducting a field test on an unlicensed product, an applicant must obtain approval from APHIS, as well as obtain APHIS' authorization to ship the product for field testing.
To determine whether to authorize shipment and grant approval for the field testing of the unlicensed product referenced in this notice, APHIS considers the potential effects of this product on the safety of animals, public health, and the environment. Based upon a risk analysis and other relevant data, APHIS has prepared an environmental assessment (EA) concerning the field testing of the following unlicensed veterinary biological product:
The above-mentioned product is a live Marek's Disease serotype 3 vaccine virus containing a gene from the Newcastle disease virus and a gene from the infectious bursal disease virus. The attenuated vaccine is intended for use in healthy 18-day-old chicken embryos by the
The EA has been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
We are publishing this notice to inform the public that we will accept written comments regarding the EA from interested or affected persons for a period of 30 days from the date of this notice. Unless substantial issues with adverse environmental impacts are raised in response to this notice, APHIS intends to issue a finding of no significant impact (FONSI) based on the EA and authorize shipment of the above product for the initiation of field tests following the close of the comment period for this notice.
Because the issues raised by field testing and by issuance of a license are identical, APHIS has concluded that the EA that is generated for field testing would also be applicable to the proposed licensing action. Provided that the field test data support the conclusions of the original EA and the issuance of a FONSI, APHIS does not intend to issue a separate EA and FONSI to support the issuance of the associated product license, and would determine that an environmental impact statement need not be prepared. APHIS intends to issue a veterinary biological product license for this vaccine following satisfactory completion of the field test, provided no adverse impacts on the human environment are identified and provided the product meets all other requirements for licensing.
21 U.S.C. 151-159.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture's Rural Utilities Service (RUS), invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by September 18, 2017.
Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., Stop 1522, Room 5164-S, Washington, DC 20250-1522. Telephone: (202) 690-4492, Facsimile: (202) 720-8435. Email:
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that the Agency is submitting to OMB for extension. 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 will have practical utility; (b) 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; (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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., Room 5164-S, Stop 1522, Washington, DC 20250-1522. Telephone: (202) 690-4492, Facsimile: (202) 720-8435, Email:
The Household Water Well System (HWWS) Grant Program makes grants to qualified private non-profit organizations which will help homeowners finance the cost of private wells. As the grant recipient, non-profit organizations will establish a revolving loan fund lending program to provide water well loans to individuals who own or will own private wells in rural areas. The individual loan recipients may use the funds to construct, refurbish, and service their household well systems for an existing home.
The collection of information consists of the materials to file a grant application with the agency, including forms, certifications and required documentation.
Copies of this information collection can be obtained from Rebecca Hunt, Management Analyst, Program Development and Regulatory Analysis, at (202) 205-3660; FAX: (202) 720-8435.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Bureau of the Census, Department of Commerce.
Notice of public meeting.
The Bureau of the Census (Census Bureau) is giving notice of a meeting of the Census Scientific Advisory Committee (C-SAC). The Committee will address policy, research, and technical issues relating to a full range of Census Bureau programs and activities, including communications, decennial, demographic, economic, field operations, geographic, information technology, and statistics. The C-SAC will meet in a plenary session from September 14-15, 2017. Last minute changes to the schedule are possible, which could prevent giving advance public notice of schedule adjustments. Please visit the Census Advisory Committees Web site for the most current meeting agenda at:
September 14-15, 2017. On Thursday, September 14, the meeting will begin at approximately 8:30 a.m. and end at approximately 5:00 p.m. On Friday, September 14, the meeting will begin at approximately 8:30 a.m. and end at approximately 3:00 p.m.
The meeting will be held at the U.S. Census Bureau Auditorium, 4600 Silver Hill Road, Suitland, Maryland 20746.
Tara Dunlop Jackson, Branch Chief for Advisory Committees, Customer Liaison and Marketing Services Office,
The members of the C-SAC are appointed by the Director, U.S. Census Bureau. The Committee provides scientific and technical expertise, as appropriate, to address Census Bureau program needs and objectives. The Committee has been established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2, Section 10).
All meetings are open to the public. A brief period will be set aside at the meeting for public comment on September 15. However, individuals with extensive questions or statements must submit them in writing to:
If you plan to attend the meeting, please register by Monday, September 11, 2017. You may access the online registration from the following link:
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should also be directed to the Committee Liaison Officer as soon as known, and preferably two weeks prior to the meeting.
Due to increased security and for access to the meeting, please call 301-763-9906 upon arrival at the Census Bureau on the day of the meeting. A photo ID must be presented in order to receive your visitor's badge. Visitors are not allowed beyond the first floor.
Bureau of the Census, Commerce.
Notice of request for nominations.
The Bureau of the Census (Census Bureau) is requesting nominations of individuals and organizations to the Census Scientific Advisory Committee. The Census Bureau will consider nominations received in response to this notice, as well as from other sources. The
Please submit nominations by August 11, 2017.
Please submit nominations by email to the
Tara Dunlop Jackson, Branch Chief for Advisory Committees, Customer Liaison Marketing Services Offices, Department of Commerce, U.S. Census Bureau, Room 8H177, 4600 Silver Hill Road, Washington, DC 20233, telephone (301) 763-5222 or
The Census Scientific Advisory Committee was established in accordance with the Federal Advisory Committee Act (Title 5, United States Code (U.S.C.), Appendix 2). The following provides information about the committee, membership, and the nomination process.
1. The Census Scientific Advisory Committee advises the Director of the U.S. Census Bureau on the uses of scientific developments in statistical data collection, statistical analysis, survey methodology, geospatial analysis, econometrics, cognitive psychology, and computer science as they pertain to the full range of Census Bureau programs and activities (including: Communications, decennial, demographic, economic, field operations, geographic, information technology, and statistics).
2. The Census Scientific Advisory Committee provides scientific and technical expertise from the following disciplines: Demography, economics, geography, psychology, statistics, survey methodology, social and behavioral sciences, Information Technology and computing, marketing, communications, and other fields of expertise, as appropriate, to address Census Bureau program needs and objectives. This expertise is necessary to ensure that the Census Bureau continues to provide relevant and timely statistics used by federal, state, and local governments as well as business and industry in an increasingly technologically-oriented society.
3. The Census Scientific Advisory Committee functions solely as an advisory body under the Federal Advisory Committee Act.
4. The Census Scientific Advisory Committee reports to the Director of the Census Bureau.
1. The Census Scientific Advisory Committee consists of up to 21 members and one Chair appointed by the Director of the Census Bureau.
2. Members are appointed for a three-year term with staggered term-end dates.
3. Members shall serve as either Special Government Employees (SGEs) or Representatives. SGEs will be subject to the ethical standards applicable to SGEs. Members will be individually advised of the capacity in which they serve through appointment letters. Committee membership will be reevaluated at the conclusion of the three-year term with the prospect of member renewal, active attendance and participation in meetings, administrative compliance, Census Bureau needs, and the Director's concurrence will also be factors in renewals.
4. Committee members are selected in accordance with applicable Department of Commerce guidelines. The Census Scientific Advisory Committee aims to have balanced representation, considering such factors as geography, technical, and scientific expertise. The Advisory Committee will include members from diverse backgrounds, including academia and private enterprise, which are further diversified by business type or industry, geography, and other factors.
5. No employee of the federal government can serve as a member of the Census Scientific Advisory Committee.
1. Members of the Census Scientific Advisory Committee serve without compensation, but receive reimbursement for committee-related travel and lodging expenses.
2. The Census Scientific Advisory Committee meets once or twice a year, budget permitting. Additional meetings may be held as deemed necessary by the Census Director or Designated Federal Official. All Advisory Committee meetings are open to the public in accordance with the Federal Advisory Committee Act.
1. Nominations are requested as described above.
2. Nominees must have scientific and technical expertise in such areas as demography, economics, geography, psychology, statistics, survey methodology, social and behavioral sciences, Information Technology, computing, or marketing. Such knowledge and expertise are needed to provide advice and recommendations to the Director of the Census Bureau on the trends, uses, and application of scientific innovations and developments in relation to the full range of Census Bureau programs and activities.
3. Individuals, groups, and/or organizations may submit nominations on behalf of individual candidates. A summary of the candidate's qualifications (resumé or curriculum vitae) must be included along with the nomination letter. Nominees must be able to actively participate in the tasks of the Census Scientific Advisory Committee, including, but not limited to, regular meeting attendance, committee meeting discussant responsibilities, review of materials, as well as participation in conference calls, webinars, working groups, and/or special committee activities.
4. Nominations of organizations may come from individuals or organizations. Organizations also may self-nominate. A summary of the organization's qualifications and the experience that qualifies it for membership should be included in the nomination letter. Nominated organizations must be able to actively participate in the tasks of the Census Scientific Advisory Committee, including, but not limited to, regular meeting attendance, review of materials, and participation in conference calls, webinars, working groups, and special committee activities.
5. The Department of Commerce is committed to equal opportunity in the workplace and seeks diverse Advisory Committee membership.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 28, 2017, the Court of Appeals for the Federal Circuit (Federal Circuit) reversed the Court of International Trade (CIT) and sustained the Department of Commerce's (Department) original scope ruling in which it found that Meridian Products LLC's (Meridian) refrigerator/freezer trim kits did not satisfy the finished goods kit exclusion under the antidumping (AD) and countervailing duty (CVD) orders covering aluminum extrusions from the People's Republic of China (PRC). The Department is therefore issuing a second amended final scope ruling.
Effective July 18, 2017.
James Terpstra, AD/CVD Operations, Office III, Enforcement and Compliance, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: 202-482-3965.
On December 17, 2012, the Department issued its Final Scope Ruling on Refrigerator Trim Kits in which it determined that the refrigerator/freezer trim kits imported by Meridian did not meet the scope exclusions for “finished merchandise” and “finished goods kits.”
As discussed in detail in the Third Remand Results,
In the Third Remand Results, the Department found, in accordance with the Court's instructions in
On March 28, 2017, the Federal Circuit reversed the CIT and sustained the Department's original scope ruling in which it found that Meridian's refrigerator/freezer trim kits did not satisfy the finished goods kit exclusion under the
Because there is now a final and conclusive court decision which reinstates the Department's original scope ruling, we are amending the
Accordingly, the Department will instruct Customs and Border Protection to continue to suspend liquidation of Meridian's refrigerator/freezer trim kits until appropriate liquidation instructions are sent. As of the date of publication of this notice in the
This notice is issued and published in accordance with sections 516A(c)(1) and (e)(1) of the Tariff Act of 1930, as amended.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Brent Stewart, Ph.D., Hubbs-SeaWorld Research Institute, 2595 Ingraham Street, San Diego, CA 92109 has applied in due form for a permit to conduct research on pinnipeds in California.
Written, telefaxed, or email comments must be received on or before August 17, 2017.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are available 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.
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.
Sara Young or Carrie Hubard, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a five-year permit to study three species of pinnipeds in California. The objectives of the research are to continue long-term research on the comparative ecology, demography, community ecology, foraging patterns, pathology and phenology of California pinnipeds and to further characterize the resource and habitats used by each species, including patterns of spatial and temporal similarities and differences California sea lions (
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 Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before September 18, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Melissa Cook, NOAA's National Marine Fisheries Service (NMFS), Southeast Fisheries Science Center (SFSC), 3209 Frederic Street, Pascagoula, MS, 39567, (228) 549-1628, or
NOAA NMFS would like to conduct an intercept survey to assess the extent of interactions between recreational anglers on piers and other shore-based fishing structures, and sea turtles. This survey will also assess the feasibility of an intercept survey for this purpose in terms response rates and data collection. The survey will be administered on piers and other fixed structures nationwide, but focused within NOAA Fisheries Greater Atlantic Region and Southeast Region, and will survey approximately 36,000 individual recreational fishermen. The respondents will be verbally asked a series of questions, no longer than 5 minutes, and the interviewer will record answers.
The survey will be implemented through verbal interviews.
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 (including hours and cost) of the proposed collection of information; (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 respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Kathy Valadez, (703) 697-9217 or Pamela Young, (703) 697-9107; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-33 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
One (1) C-17 Transport Aircraft
Four (4) Engines, Turbofan F-117-PW-100
Also included in the proposed sale are one (1) AN/AAR-47 Missile Warning System, one (1) AN/ALE-47 Countermeasures Dispensing System (CMDS), one (1) AN/APX-119 Identification Friend or Foe (IFF) Transponder, precision navigation equipment, spare and repair parts, maintenance, support and test equipment, publications and technical documentation, warranty, quality assurance, ferry support, U.S. Government and contractor engineering, logistics and technical support services, and other related elements of logistics and program support.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Government of India has requested the possible sale of one (1) C-17 transport aircraft with four (4) Turbofan F-117-PW-100 engines. The sale would also include one (1) AN/AAR-47 Missile Warning System, one (1) AN/ALE-47 Countermeasures Dispensing System (CMDS), one (1) AN/APX-119 Identification Friend or Foe (IFF) Transponder, precision navigation equipment, spare and repair parts, maintenance, support and test equipment, publications and technical documentation, warranty, Quality Assurance, ferry support, U.S. Government and contractor engineering, logistics and technical support services, and other related elements of logistics and program support. The estimated cost is $366.2 million.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to strengthen the U.S.-India relationship and to improve the security of an important partner which has been, and continues to be, an important force for economic progress and stability in South Asia.
The proposed sale will improve India's capability to meet current and future strategic airlift requirements. India lies in a region prone to natural disasters and will use the additional capability for Humanitarian Assistance and Disaster Relief (HA/DR). In addition, through this purchase India will be able to provide more rapid strategic combat airlift capabilities for its armed forces. India currently operates C-17 aircraft and will have no difficulty absorbing this aircraft into its armed forces.
The proposed sale will not alter the basic military balance in the region.
The principal contractor will be the Boeing Company, Chicago, IL. The purchaser typically requests offsets. Any offset agreement will be defined in negotiations between the purchaser and the contractor.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government personnel or contractor representatives to India.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Boeing C-17A Globemaster III military airlift aircraft is the most flexible cargo aircraft to enter the U.S. Air Force fleet. The C-17 is capable of strategic delivery of up to 170,900 pounds of personnel and/or equipment to main operating bases or forward operating locations. The aircraft is also capable short field landings with a full cargo load. The aircraft can perform tactical airlift and airdrop missions as well as transport litters and ambulatory patients during aeromedical evacuation when required. A fully integrated electronic cockpit and advanced cargo delivery system allow a crew of three: Pilot, co-pilot, and loadmaster, to operate the aircraft on any type of mission.
2. The AN/AAR-47 is a small, lightweight, passive, electro-optic, threat warning device used to detect surface-to-air missiles fired at helicopters and low-flying fixed-wing aircraft and automatically provide countermeasures, as well as audio and visual-sector warning messages to the aircrew. The basic system consists of multiple Optical Sensor Converter (OSC) units, a Computer Processor (CP) and a Control Indicator (CI). The set of OSC units, which normally consists of four, is mounted on the aircraft exterior to provide omni-directional protection. The OSC detects the rocket plume of missiles and sends appropriate signals to the CP for processing. The CP analyzes the data from each OSC and automatically deploys the appropriate countermeasures. The CP also contains comprehensive Built-in-Test (BIT) circuitry. The CI displays the incoming direction of the threat, so that the pilot can take appropriate action. Hardware is UNCLASSIFIED. Software is SECRET. Technical data and documentation to be provided are UNCLASSIFIED.
3. The AN/ALE-47 Countermeasures Dispensing System (CMDS) is an integrated, threat-adaptive, software-programmable dispensing system capable of dispensing chaff, flares, and active radio frequency expendables. The threats countered by the CMDS include radar-directed anti-aircraft artillery (AAA), radar command-guided missiles, radar homing guided missiles, and infrared (IR) guided missiles. The system is internally mounted and may be operated as a stand-alone system or may be integrated with other on-board electronic warfare and avionics systems. The AN/ALE-47 uses threat data received over the aircraft interfaces to assess the threat situation and to determine a response. Expendable decoys tailored to the immediate aircraft and threat environment may be dispensed using one of four operational modes. The hardware, technical data, and documentation to be provide are UNCLASSIFIED.
4. The AN/APX-119 Identification Friend or Foe (IFF) Digital Transponder is an identification system designed for command and control. It enables military and civilian air traffic control interrogation systems to identify aircraft. The hardware, technical data, and documentation to be provided are UNCLASSIFIED.
5. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used
6. A determination has been made that the Government of India can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This proposed sale is necessary to the furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
7. All defense articles and services listed in this transmittal are authorized for release and export to the Government of India.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Kathy Valadez, (703) 697-9217 or Pamela Young, (703) 697-9107; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 17-12 with attached Policy Justification and Sensitivity of Technology.
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The Government of Australia requested the sale of up to five (5) Gulfstream G-550 aircraft modified to integrate Airborne Intelligence, Surveillance, Reconnaissance, and Electronic Warfare (AISREW) mission systems, Global Positioning System (GPS) capability, secure communications, aircraft defensive systems, and whole life costs of airborne and ground segments.
This proposed sale includes up to five (5) AN/AAQ-24 (V)N Large Aircraft Infrared Countermeasures (LAIRCM) systems, and additional sub-component spares. Each prime LAIRCM system will consist of: one (1) Guardian Laser Terminal Assemblies (GLTA), five (5) Infrared Missile Warning Sensors, (IRMWS), one (1) LAIRCM System Processor Replacements (LSPR) MDE items, one (1) LAIRCM System Processor Replacements (LSPR), one (1) Control Indicator Unit Replacement (CIUR), one (1) Smart Card Assembly (SCA), one (1) High Capacity Card (HCC), and one (1) User Data Memory (UDM) card. Also included are: MX-20 HD Electro-Optical and Infrared systems, Osprey 50 AESA Radars, AISREW equipment, secure communications equipment, and Identification Friend or Foe (IFF) Systems. These systems will be installed on up to five (5) G-550 aircraft.
Also included in this sale are up to five (5) G-550 Aircraft, CIURs, SCAs, HCCs and UDM cards, AN/ALE-47 Countermeasure Dispenser Sets (CMDS), MX-20HD Electro-Optical and Infra-Red systems, Osprey 50 AESA Radars, AISREW ISR equipment, Secure Communications equipment, Identification Friend or Foe Systems, aircraft modification and integration, ground systems for data processing and crew training, ground support equipment, publications and technical data, U.S. Government and contractor engineering, technical and logistics support services, flight test and certification, and other related elements of logistical and program support.
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* As defined in Section 47(6) of the Arms Export Control Act.
The Government of Australia requested the possible sale of up to five (5) Gulfstream G-550 aircraft modified to integrate Airborne Intelligence, Surveillance, Reconnaissance, and Electronic Warfare (AISREW) mission systems, Global Positioning System (GPS) capability, secure communications, aircraft defensive systems; spares, including whole life costs of airborne and ground segments; aircraft modification and integration; ground systems for data processing and crew training; ground support equipment; publications and technical data; U.S. Government and contractor engineering, technical and logistics support services; flight test and certification; and other related elements of logistical and program support. The total estimated program cost is $1.3 billion.
This sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a major contributor to political stability, security, and economic development in the Western Pacific. Australia is an important Major non-NATO Ally and partner that contributes significantly to peacekeeping and humanitarian operations around the world. It is vital to the U.S. national interest to assist our ally in developing and maintaining a strong and ready self-defense capability.
The proposed sale supports and complements the ongoing efforts of Australia to modernize its Electronic Warfare capability and increases interoperability between the U.S. Air Force and the Royal Australian Air Force (RAAF). Australia will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment does not alter the basic military balance in the region.
The prime contractors will be L3 of Greenville, TX. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale may require the assignment of up to six (6) U.S. contractor representatives to Australia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. This sale will involve the release of sensitive technology to Australia. Sensitive and/or classified (up to SECRET) elements of the proposed sale include the AN/AAQ-24 (V)N Large Aircraft Infrared Countermeasures (LAIRCM) systems, Embedded/GPS/INS (EGI) with security devices, Airborne, Multifunctional Information Distribution Systems—Joint Tactical Radio System (MIDS JTRS), AN/ALE-47 Countermeasure Dispenser Set (CMDS), MX-20HD Electro-Optical and Infra-Red systems, Osprey 50 AESA Radars, and Airborne Intelligence, Surveillance, Reconnaissance and Electronic (AISREW) mission system.
2. The AN/AAQ-24 (V)N LAIRCM is a self-contained, directed energy countermeasures system designed to protect aircraft from infrared (IR)-guided surface-to-air missiles. The system features digital technology and micro-miniature solid state electronics. The system operates in all conditions, detecting incoming missiles and jamming infrared-seeker equipped missiles with aimed bursts of laser energy. The LAIRCM system consists of multiple Infrared Missile Warning System (IRMWS) Sensors, Guardian Laser Turret Assembly (GLTA), LAIRCM System Processor Replacement (LSPR), Control Indicator Unit Replacement
The set of IRMWS Sensor units are mounted on the aircraft exterior to provide omni-directional protection. The IRMWS Sensor warns of threat missile approach by detecting radiation associated with the rocket motor. The IRMWS is a small, lightweight, passive, electro-optic, threat warning device used to detect surface-to-air missiles fired at helicopters and low-flying fixed-wing aircraft and automatically provides countermeasures, as well as audio and visual warning messages to the aircrew. The basic system consists of multiple IRMWS Sensor units, one (1) GLTA, LSPR and CIUR. The set of IRMWS units (each A-330 MRTT has five (5)) mounted on the aircraft exterior to provide omni-directional protection. Hardware is UNCLASSIFIED. Software is SECRET. Technical data and documentation to be provided are UNCLASSIFIED.
3. Multifunctional Information Distribution System-Joint Tactical Radio System (MIDS JTRS) is an advanced Link-16 command, control, communications, and intelligence (C3I) system incorporating high-capacity, jam-resistant, digital communication links for exchange of near real-time tactical information, including both data and voice, among air, ground, and sea elements. The MIDS JTRS terminal hardware, publications, performance specifications, operational capability, parameters, vulnerabilities to countermeasures, and software documentation are classified CONFIDENTIAL. The classified information to be provided consists of that which is necessary for the operation, maintenance, and repair (through intermediate level) of the data link terminal, installed systems, and related software.
4. The AN/ALE-47 Countermeasure Dispenser Set (CMDS) provides an integrated threat-adaptive, computer controlled capability for dispensing chaff, flares, and active radio frequency expendables. The AN/ALE-47 system enhances aircraft survivability in sophisticated threat environments.
The threats countered by the CMDS include radar-directed anti-aircraft artillery (AAA), radar command-guided missiles, radar homing guided missiles, and infrared (IR) guided missiles. The system is internally mounted and may be operated as a stand-alone system or may be integrated with other on-board Electronic Warfare (EW) and avionics systems. The AN/ALE-47 uses threat data received over the aircraft interfaces to assess the threat situation and determine a response. Expendable routines tailored to the immediate aircraft and threat environment may be dispensed using one of four operational modes. Hardware is UNCLASSIFIED. Software is SECRET. Technical data and documentation to be provided is UNCLASSIFIED.
5. The Embedded GPS-INS (EGI) LN-200 is a sensor that combines GPS and inertial sensor inputs to provide accurate location information for navigation and targeting. The EGI LN-200 is UNCLASSIFIED. The GPS crypto-variable keys needed for the highest GPS accuracy are classified up to SECRET.
6. Wescam MX-20HD is a gyro-stabilized, multi-spectral, multi-field of view Electro-Optical/Infrared (EO/IR) system. The systems provide surveillance laser illumination and laser designation through use of an externally mounted turret sensor unit and internally mounted master control. Sensor video imagery is displayed in the aircraft real time and may be recorded for subsequent ground analysis. Hardware is UNCLASSIFED. Technical data and documentation to be provided is UNCLASSIFIED.
7. The Osprey family of surveillance radars provides second generation Active Electronically Scanned Array (AESA) surveillance capability as the primary sensor on airborne assets. The Osprey radars are at a high technology readiness level and are in production for fixed and rotary wing applications. This Osprey configuration employs a side-looking radar. Osprey radars provide a genuine multi-domain capability, with high performance sea surveillance, notably against “difficult targets, land surveillance with wide swath, very high resolution ground mapping small and low speed ground target indication, high performance air to air surveillance, tracking and intercept.
8. The AISREW mission system provides near-real-time information to tactical forces, combatant commanders and national-level authorities across the spectrum of conflict. The mission system can forward gathered information in a variety of formats via secured communications systems. Most hardware used in this AISREW system is generic and commercially available. However, if any of the specialized hardware or publications are lost, the information could provide insight into many critical U.S. capabilities. Information gained could be used to develop countermeasures as well as offensive and defensive counter-tactics.
9. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures or equivalent system which might reduce system effectiveness or be used in the development of a system with similar or advanced capabilities.
10. A determination has been made that Australia can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
11. All defense articles and services listed in this transmittal have been authorized for release and export to Australia.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification.
Kathy Valadez, (703) 697-9217 or Pamela Young, (703) 697-9107; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-75 with attached Policy Justification and Sensitivity of Technology.
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* As defined in Section 47(6) of the Arms Export Control Act.
TECRO requested a possible sale of SRP Operations and Maintenance follow-on sustainment package that includes, contractor logistics support (sustainment); engineering services and technical updates to address equipment obsolescence; transportation and material costs associated with contractor repair and return services; spare and repair parts; support and test equipment; publications and technical documentation personnel training and training equipment; U.S. Government and contractor engineering; technical and logistics support services; and other related elements of logistical and program support. The total estimated program cost is $400 million.
This proposed sale is consistent with United States law and policy as expressed in Public Law 96-8.
This proposed sale contributes to the foreign policy and national security of the United States by helping to improve the security and defensive capability of the recipient, which has been and continues to be an important force for political stability, military balance, and economic progress in the region.
The proposed sale improves the recipient's capability to provide early warning against current and future airborne threats. The SRP is a key component to the recipient's Command, Control, Communications, Computers, Intelligence Surveillance and Reconnaissance architecture. It will use the requested updates and sustainment as a defensive deterrent to regional threats and to strengthen its homeland defense. This potential sale will not introduce new capabilities, but will continue a similar sustainment package to one currently in place.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
Currently, market research is being conducted to determine the viability of a qualified contractor in accordance with Federal Acquisition Regulations. The purchaser typically requests offsets, but any offsets will be determined between the purchaser and the contractor.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives outside the United States.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
1. The purchaser currently owns an Early Warning Radar (EWR) that serves as a critical element to its Command, Control, Communications, Computers, Intelligence, Surveillance, and Reconnaissance (C4ISR) infrastructure. The radars provide a robust capability to detect, acquire, and track theater ballistic missiles, air breathing targets, and cruise missile threats. The system is able to operate in severe clutter and jamming environments amid high levels of background radio frequency interference. The follow on sustainment package requested will not introduce new capabilities.
2. The highest classification of the hardware to be exported is UNCLASSIFIED. The highest classification of the technical documentation to be exported is SECRET. There are technical manuals as well as Engineering Change Proposals, drawings, and specifications required as part of the sustainment updates. Components requiring depot level maintenance will be shipped to the U.S. for servicing. The highest level of software to be exported is UNCLASSIFIED.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification. Moreover, the benefits to be derived from this sale, as outlined in the Policy Justification, outweigh the potential damage that could result if the sensitive technology were revealed to unauthorized persons.
5. All defense articles and services listed in this transmittal are authorized for release and export to the Taipei Economic and Cultural Representative Office (TECRO) in the United States.
1.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
Kathy Valadez, (703) 697-9217 or Pamela Young, (703) 697-9107; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-69 with attached Policy Justification and Sensitivity of Technology.
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* As defined in Section 47(6) of the Arms Export Control Act.
Taiwan has requested a possible sale of forty-six (46) MK 48 Mod 6AT Heavyweight Torpedoes (HWT). This sale will include HWT containers, torpedo support, torpedo spare parts, publications, training, weapon system support, engineering and technical assistance. The total estimated program cost is $250 million.
This proposed sale is consistent with United States law and policy, as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic and security interests by supporting the recipient's continuing efforts to modernize its armed forces and enhance its defensive capabilities. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense. The recipient will have no difficulty absorbing this equipment into its armed forces.
There are no prime contractors associated with this case as all materials will be procured from U.S. Navy stocks. There are no known offset agreements proposed in connection with this potential sale.
It is estimated that during implementation of this proposed sale a number of U.S. Government and contractor representatives will be assigned to the recipient or travel there intermittently during the program.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The MK 48 Heavy Weight Torpedo (HWT) has been in service in the U.S. Navy (USN) since 1972. This sale furnishes the MK 48 Mod 6 Advanced Technology (AT) version of the system. The purchaser currently does not have this weapon system in its inventory. The proposed sale consists of 46 HWTs, containers, spare and repair parts, weapons system support and integration, personnel training, training equipment, test equipment, U.S. Government and contractor engineering, technical and logistics support services and other related elements of logistical support.
a. There is no Critical Program Information associated with the MK 48 Mod 6AT HWT hardware, technical documentation or software. The highest classification of the hardware to be exported is SECRET. The highest classification of the technical manual that will be exported is CONFIDENTIAL. The technical manual is required for operation of the MK 48 Mod 6AT HWT. The highest classification of the software to be exported is SECRET. The MK 48 Mod 6AT HWT meets Anti-Tampering requirements.
2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in development of a system with similar or advanced capabilities.
3. A determination has been made that the recipient country can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives in the Policy justification.
4. All defense articles and services listed in this transmittal have been authorized for release and export to Taipei Economic and Cultural Representative Office (TECRO) in the United States.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification.
Kathy Valadez, (703) 697-9217 or Pamela Young, (703) 697-9107; DSCA/DSA-RAN.
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-74 with attached Policy Justification.
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Major Defense Equipment (MDE):
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* As defined in Section 47(6) of the Arms Export Control Act.
TECRO requested a possible sale of fifty (50) AGM-88B HARMs and ten (10) AGM-88B Training HARMs. This request also includes: HARM integration, LAU-l 18A Launchers, missile containers, spare and repair parts, support and test equipment, Joint Mission Planning System update, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor engineering, technical and logistics support services, and other related elements of logistical and program support. The total estimated program cost is $147.5 million.
This proposed sale is consistent with U.S. law and policy as expressed in Public Law 96-8.
This proposed sale serves U.S. national, economic, and security interests by supporting the recipient's continuing efforts to modernize its armed forces and to maintain a credible defensive capability. The proposed sale will help improve the security of the recipient and assist in maintaining political stability, military balance, and economic progress in the region.
The proposed sale will improve the recipient's capability in current and future defensive efforts. The recipient will use the enhanced capability as a deterrent to regional threats and to strengthen homeland defense. The recipient will have no difficulty absorbing this equipment into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
Currently, market research is being conducted to determine the viability of a qualified contractor in accordance with Federal Acquisition Regulations. The purchaser typically requests offsets, but any offsets will be determined between the purchaser and the contractor.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives outside the United States.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(iii)
1. AGM-88B High-Speed Anti-Radiation Missile (HARM) is a supersonic air-to-surface missile designed to seek and destroy enemy radar-equipped air defense systems. HARM has a proportional guidance system that hones in on enemy radar emissions through a fixed antenna and seeker head in the missile nose. The missile consists of four sections; guidance section, warhead, control section, and rocket motor.
2. The highest classification of the hardware to be exported is SECRET. The highest classification of the technical documentation to be exported is SECRET, but no radar cross section and infrared signature data nor U.S.-only tactics or tactical doctrine will be disclosed. The highest classification of the software to be exported is SECRET; however, no software source code will be disclosed. All reprogramming of missile microprocessor memories must be accomplished by U.S. Government personnel or U.S. Government approved contractors.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification. Moreover, the benefits to be derived from this sale, as outlined in the Policy Justification, outweigh the potential damage that could result if the sensitive technology were revealed to unauthorized persons. A determination has been made that the recipient country can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification and in accordance with the Taiwan Relations Act.
5. All defense articles and services listed in this transmittal are authorized for release and export to the Taipei Economic and Cultural Representative Office (TECRO) in the United States.
Federal Student Aid, Department of Education.
Notice.
The Secretary announces the annual updates to the ICR plan formula for 2017, as required by 34 CFR 685.209(b)(1)(ii)(A), to give notice to Direct Loan borrowers and the public regarding how monthly ICR payment amounts will be calculated for the 2017-2018 year.
The adjustments to the income percentage factors for the ICR plan
Ian Foss, U.S. Department of Education, 830 First Street NE., Room 113H2, Washington, DC 20202. Telephone: (202) 377-3681 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service, toll free, at 1-800-877-8339.
Under the William D. Ford Federal Direct Loan (Direct Loan) Program, borrowers may choose to repay their non-defaulted loans (Direct Subsidized Loans, Direct Unsubsidized Loans, Direct PLUS Loans made to graduate or professional students, and Direct Consolidation Loans) under the ICR plan. The ICR plan bases the borrower's repayment amount on the borrower's income, family size, loan amount, and the interest rate applicable to each of the borrower's loans.
ICR is one of several income-driven repayment plans. Other income-driven repayment plans include the Income-Based Repayment (IBR) plan, the Pay As You Earn Repayment (PAYE plan, and the Revised Pay As You Earn Repayment (REPAYE) plan. The IBR, PAYE, and REPAYE plans provide lower payment amounts than the ICR plan for most borrowers.
A Direct Loan borrower who repays his or her loans under the ICR plan pays the lesser of: (1) The amount that he or she would pay over 12 years with fixed payments multiplied by an income percentage factor; or (2) 20 percent of discretionary income.
Each year, to reflect changes in inflation, we adjust the income percentage factor used to calculate a borrower's ICR payment. We use the adjusted income percentage factors to calculate a borrower's monthly ICR payment amount when the borrower initially applies for the ICR plan or when the borrower submits his or her annual income documentation, as required under the ICR plan. This notice contains the adjusted income percentage factors for 2017, examples of how the monthly payment amount in ICR is calculated, and charts showing sample repayment amounts based on the adjusted ICR plan formula. This information is included in the following three attachments:
•
•
In Attachment 1, to reflect changes in inflation, we have updated the income percentage factors that were published in the
The income percentage factors reflected in Attachment 1 may cause a borrower's payments to be lower than they were in prior years, even if the borrower's income is the same as in the prior year. However, the revised repayment amount more accurately reflects the impact of inflation on the borrower's current ability to repay.
You may also access documents of the Department published in the
20 U.S.C. 1087
General notes about the examples in this attachment:
• We have a calculator that borrowers can use to estimate what their payment amounts would be under the ICR plan. The calculator is called the “Repayment Estimator” and is available at StudentLoans.gov. This calculator provides a detailed, individualized assessment of a borrower's loans and repayment plan options, including the ICR plan.
• The interest rates used in the examples are for illustration only. The actual interest rates on an individual borrower's Direct Loans depend on the loan type and when the postsecondary institution first disbursed the Direct Loan to the borrower.
• The Poverty Guideline amounts used in the examples are from the 2017 U.S. Department of Health and Human Services (HHS) Poverty Guidelines for the 48 contiguous States and the District of Columbia. Different Poverty Guidelines apply to residents of Alaska and Hawaii. The Poverty Guidelines for 2017 were published in the
• All of the examples use an income percentage factor corresponding to an adjusted gross income (AGI) in the table in Attachment 1. If your AGI is not listed in the income percentage factors table in Attachment 1, calculate the applicable income percentage by following the instructions under the “Interpolation” heading later in this attachment.
• Married borrowers may repay their Direct Loans jointly under the ICR plan. If a married couple elects this option, we add the outstanding balance on the Direct Loans of each borrower and we add together both borrowers' AGIs to determine a joint ICR payment amount. We then prorate the joint payment amount for each borrower based on the proportion of that borrower's debt to the total outstanding balance. We bill each borrower separately.
• For example, if a married couple, John and Sally, has a total outstanding Direct Loan debt of $60,000, of which $40,000 belongs to John and $20,000 to Sally, we would apportion 67 percent of the monthly ICR payment to John and the remaining 33 percent to Sally. To take advantage of a joint ICR payment, married couples need not file taxes jointly; they may file separately and subsequently provide the other spouse's tax information to the borrower's Federal loan servicer.
The formula to amortize a loan with a standard schedule (in which each payment is the same over the course of the repayment period) is as follows:
In the formula—
• M is the monthly payment amount;
• P is the outstanding principal balance of the loan at the time the calculation is performed;
• I is the annual interest rate on the loan, expressed as a decimal (for example, for a loan with an interest rate of 6 percent, 0.06); and
• N is the total number of months in the repayment period (for example, for a loan with a 12-year repayment period, 144 months).
For example, assume that Billy has a $10,000 Direct Unsubsidized Loan with an interest rate of 6 percent.
The remainder of the examples in this attachment will only show the results of the formula.
Joseph and Susan have a combined AGI of $84,340 and are repaying their loans jointly under the ICR plan (for general information regarding joint ICR payments for married couples, see the fifth and sixth bullets under the heading “General notes about the examples in this attachment”).
For Susan, the monthly payment amount will be:
The result is the income percentage factor that we will use to calculate Joan's monthly repayment amount under the ICR plan.
Below are two charts that provide first-year payment amount estimates for a variety of loan debt sizes and incomes under all of the income-driven repayment plans and the 10-Year Standard Repayment Plan. The first chart is for single borrowers who have a family size of one. The second chart is for a borrower who is married or a head of household and who has a family size of three. The ICR plan calculations assume that the loan debt has an interest rate of 6 percent. For married borrowers, the calculations assume that the borrower files a joint Federal income tax return with his or her spouse and that the borrower's spouse does not have Federal student loans. A field with a
Institute of Education Sciences (IES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before August 17, 2017.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
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.
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before August 17, 2017.
To access and review all the documents related to the information
For specific questions related to collection activities, please contact NCES Information Collections at
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 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:
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:
Take notice that the Commission received the following exempt wholesale generator filings:
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 Burney Forest Products, A Joint Venture`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 August 1, 2017.
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
Federal Election Commission.
Thursday, July 13, 2017 at 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting was open to the public.
82 FR 31779.
Proposed Interim Enforcement Policy on Use of Campaign Funds by Members of Congress for Residential Security Systems.
Judith Ingram, Press Officer; Telephone: (202) 694-1220.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 10, 2017.
A. Federal Reserve Bank of Richmond (Adam M. Drimer, Assistant Vice President) 701 East Byrd Street, Richmond, Virginia 23261-4528. Comments can also be sent electronically to or
1.
B. Federal Reserve Bank of Minneapolis (Brendan S. Murrin, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
Board of Governors of the Federal Reserve System, July 13, 2017.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) invites comment on a proposal to extend for three years, with revision, the Consolidated Financial Statements for Holding Companies (FR Y-9C) (OMB No. 7100-0128), the Parent Company Only Financial Statements for Large Holding Companies (FR Y-9LP) OMB No. 7100-0128), the Parent Company Only Financial Statements for Small Holding Companies FR Y-9SP) (OMB No. 7100-0128), the Financial Statements of U.S. Nonbank Subsidiaries Held by Foreign Banking Organizations (FR Y-7N) (OMB No. 7100-0125), and the Consolidated Report of Condition and Income for Edge and Agreement Corporations (FR 2886b) (OMB No. 7100-0086).
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.
Comments must be submitted on or before September 18, 2017.
You may submit comments, identified by
•
•
•
•
•
All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at:
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 Board invites public comment on the following information collection, which is being reviewed under
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposed revisions prior to giving final approval.
1. Consolidated Financial Statements for Holding Companies, Parent Company Only Financial Statements for Large Holding Companies, Parent Company Only Financial Statements for Small Holding Companies, Financial Statement for Employee Stock Ownership Plan Holding Companies, and the Supplemental to the Consolidated Financial Statements for Holding Companies.
• Deleting of existing data items from Schedule HI-B, Part I Charge-Offs and Recoveries on Loans and Leases and Changes in Allowance for Loans and Lease Losses, of the FR Y-9C report that pertain to charge-offs and recoveries on loans to U.S. banks and foreign banks.
• Deleting of existing data items from Schedule HC-M, Memoranda, and Schedule HC-N, Past Due and Nonaccrual Loans, and Leases and Other Assets of the FR Y-9C that pertain to certain loans covered by loss-sharing agreements with the FDIC.
• Increasing one reporting threshold and adding one new reporting threshold on the FR Y-9C for certain data items on Schedule HI, Consolidated Income Statement.
• Eliminating extraordinary items on the FR Y-9LP, FR Y-7N and FR 2886b.
• Revising data items for the reclassification of certain tax benefits on the FR Y-9C, FR Y-9LP, FR Y-7N, and FR 2886b.
• Adding one new data item to Schedule SI of the FR Y-9SP to collect information pertaining to discontinued operations.
• Revising one control total and adding two control totals on Schedule HC-C and HC-N of the FR Y-9C report.
• Revising captions and instructions to replace “Loans net of unearned income” with “Loans held for investment” across all applicable regulatory reports.
2.
3.
Board of Governors of the Federal Reserve System.
Notice, request for comment.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) invites comment on a proposal to extend for three years, with revision, the Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11; OMB No. 7100-0244), the Abbreviated Financial Statements of U.S. Nonbank Subsidiaries of U.S. Holding Companies (FR Y-11S; OMB No. 7100-0244), the Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314; OMB No. 7100-0073), and the Abbreviated Financial Statements of Foreign Subsidiaries of U.S. Banking Organizations (FR 2314S; OMB No. 7100-0073).
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all
Comments must be submitted on or before September 18, 2017.
You may submit comments, identified by
•
•
•
•
•
All public comments are available from the Board's Web site at
Additionally, commenters may send a copy of their comments to the OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503 or by fax to (202) 395-6974.
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Federal Reserve Board's public Web site at:
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 Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on all aspects of the proposal, including:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Federal Reserve should modify the proposed revisions prior to giving final approval.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than August 1, 2017.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
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Federal Trade Commission (“Commission” or “FTC”).
Notice.
The FTC proposes to conduct a study to examine consumer perception of class action notices (“Notice Study”). This is the second of two notices required under the Paperwork Reduction Act (“PRA”) seeking public comments on proposed research before requesting Office of Management and Budget (“OMB”) review and clearance of the collection of information discussed herein.
Comments must be received on or before August 17, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Robin Moore and Colin MacDonald, Attorneys, 202-326-2167 (Moore) or 202-326-3192 (MacDonald), Division of Enforcement, Bureau of Consumer Protection, Federal Trade Commission.
The Class Action Fairness Project strives to protect injured consumers from settlements that provide them with little to no benefit and to protect businesses from the incentives such settlements may create for the filing of frivolous lawsuits. As part of this program, the FTC monitors class actions and files amicus briefs or intervenes in appropriate cases;
On May 5, 2015, the FTC published the first notice regarding this study in the
To further the above-noted goals, the FTC staff proposes to conduct an Internet-based consumer research study to explore consumer perceptions of class action notices. Based on marketplace trends identified through review of class action settlements and discussions with notice administrators, the study will focus on notices sent to individual consumers via email. Using a treatment-effect methodology, the study will examine whether variables such as the email address of the sender and subject line impact respondents' perception of and willingness to open an email notification. The proposed study will also gauge consumer comprehension of the options conveyed by the notice, including the process for participating in the settlement and the implications of consumers' choices. In the May 5, 2015,
Having considered the costs and benefits of various data collection methods, FTC staff has concluded that an Internet panel with nationwide coverage will provide the most efficient way to collect data to meet the research objectives within a feasible budget. Thus, the Commission proposes to collect responses from a broad spectrum of the U.S. adult population. Participants will be drawn from an Internet panel maintained by a commercial firm that operates the panel. All participation will be voluntary. While the results will not be generalizable to the U.S. population, comparing the responses to various treatments should provide useful insight into consumer understanding of the claims being considered.
Under the PRA, 44 U.S.C. 3501-3521, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party.
Pursuant to Section 3507 of the PRA and OMB regulations, 5 CFR part 1320, that implement the PRA, the Commission is providing this second opportunity for public comment. All comments should be filed as prescribed in the Request for Comment part of the
As before, staff estimates that respondents will require, on average, approximately 20 minutes to complete
Staff is revising its overall estimate of burden to include those responders who do not complete the questionnaire and pretest. Staff projects that those who will prematurely end the process will do so in less than one minute. The staff anticipates that 60 percent of those invited to participate in the study will complete the questionnaire. Accordingly, the contractor might contact as many as 13,333 people to achieve the study's goal of surveying 8,000 respondents, which would result in an additional 89 hours total. [(13,333 total contacts—8,000 people completing the questionnaire) × 1 minute each]. For the pretest, the staff estimates that an additional 67 people will prematurely end the process, which totals an additional 1 hour [(167 total contacts—100 persons completing the pretest) × 1 minute each]. Cumulatively, complete and partial surveying of 13,333 people will total about 2,756 hours and complete and partial pretesting will total 39 hours, for an overall total of 2,795 hours. The cost per respondent should be negligible. Participation will not require start-up, capital, or labor expenditures.
As noted above, the Commission received two comments regarding the proposed collections of information.
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 17, 2017. Write “Class Action Notice Consumer Perception Study, Project No. P024210” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Class Action Notice Consumer Perception Study, Project No. P024210” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610, Washington, DC 20024. If possible, please submit your paper comment to the Commission by courier or overnight service.
Comments on any proposed information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead can also be sent via email to
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site to read this Notice. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before August 17, 2017. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act,
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 10, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Katherine E. Johnson (202-326-2185), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 11, 2017), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 10, 2017. Write “In the Matter of Benjamin Moore & Co., Inc., File No. 1623079” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, write “In the Matter of Benjamin Moore & Co., Inc., File No. 1623079” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC. 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Benjamin Moore & Co., Inc. (“respondent”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
This matter involves respondent's marketing, sale, and distribution of purportedly “emission-free” paints. Emission is any compound emitted from paint during application or thereafter and includes volatile organic compounds (or VOCs). According to the FTC complaint, respondent made unsubstantiated representations that Natura paints: (1) Are emission-free; (2) are emission-free during or immediately after painting; (3) will not emit any chemical or substance, including VOCs, that causes material harm to consumers, including sensitive populations such as babies and allergy and asthma sufferers; and (4) will not emit any chemical or substance, including VOCs, during or immediately after painting, that causes material harm to consumers, including sensitive populations such as babies and allergy and asthma sufferers. The FTC also alleges that respondent used its Green Promise seal without adequately disclosing that respondent awarded the seal to its own product. Consumers likely interpret such seals as a claim that an independent third party certified the product. The FTC further alleges that respondent provided independent retailers with promotional materials containing the same claims it made to consumers. Thus, the complaint alleges that respondent engaged in deceptive practices in violation of Section 5(a) of the FTC Act.
The proposed consent order contains five provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits emission-free and VOC-free claims unless both content and emission are actually zero or at trace levels. The orders define “emission” to include all emissions (not just VOCs that cause smog). This definition reflects the Commission's Enforcement Policy Statement and consumer expectations: Consumers are likely concerned about the potential health effects from exposure to chemical emissions found in indoor air, not just VOCs that affect outdoor air quality. The order defines “trace level of emission” to mean (1) no intentionally added VOC, (2) emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health, and (3) emission of the covered product does not result in more than harmless concentrations of any compound higher than would be found under normal conditions in the typical residential home without interior architectural coating. Part II prohibits misleading representations regarding emission, VOC levels, odor, and any general environmental and health benefit of paints. The order requires competent and reliable scientific evidence to substantiate these representations. Parts IV and V prohibit respondent from misrepresenting third-party certifications and failing to adequately disclose a material connection. Part VI prohibits respondent from providing third parties with the means and instrumentalities to make false, unsubstantiated, or otherwise misleading representations of material fact regarding paints, including any representation prohibited by Parts I, II, IV or V.
To correct allegedly existing unsubstantiated zero emission and VOC claims and deceptive certification claims, Part III requires the respondent to send letters to its dealers and distributors, instructing them to place placards next to paint cans and at point of sale.
Parts VII through XI are reporting and compliance provisions. Part VII mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VIII requires that respondent submit compliance reports to the FTC within sixty (60) days of the order's issuance and submit additional reports when certain events occur. Part IX requires that respondent must create and retain certain records for five (5) years. Part X provides for the FTC's continued compliance monitoring of respondent's activity during the order's effective dates. Part XI is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.
If the Commission finalizes the agreement's proposed order, it plans to propose harmonizing with this order the consent orders issued in the PPG Architectural Finishes, Inc. (Docket No. C-4385) and The Sherwin-Williams Company (Docket No. C-4386) matters. Specifically, the Commission plans to issue orders to show cause why those matters should not be modified pursuant to Section 3.72(b) of the Commission Rules of Practice, 16 CFR 3.72(b).
The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 10, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Megan Gray (202-326-3408), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 10, 2017. Write “In the Matter of ICP Construction Inc., File No. 162-3081” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, write “In the Matter of ICP Construction Inc., File No. 162-3081” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from ICP Construction Inc., formerly known as California Products Corp., d/b/a/Muralo Paints, a corporation (“respondent”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
This matter involves respondent's marketing, sale, and distribution of purportedly “VOC-free” paints. “VOC” is the abbreviation for volatile organic compounds. VOC-free includes claims such as “zero VOCs,” “0 VOCs,” and “No VOCs.” According to the FTC complaint, respondent made unsubstantiated representations that its paints: (1) Are VOC-free; (2) are VOC-free during or immediately after painting; (3) will not emit any chemical or substance, including VOCs, that causes material harm to consumers, including sensitive populations such as babies; and (4) will not emit any chemical or substance, including VOCs, during or immediately after painting, that causes material harm to consumers, including sensitive populations such as babies. The FTC also alleges that respondent used its ECO ASSURANCE seal without adequately disclosing that respondent awarded the seal to its own product. Consumers likely interpret the seal as a claim that an independent third party certified the product. The FTC further alleges that respondent provided independent retailers with promotional materials containing the same claims it made to consumers. Thus, the complaint alleges that respondent engaged in deceptive practices in violation of Section 5(a) of the FTC Act.
The proposed consent order contains five provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits emission-free and VOC-free claims unless both content and emission are actually zero or at trace level. The orders define “emission” to include all emissions (not just VOC that causes smog). This definition reflects the Commission's Enforcement Policy Statement and consumer expectations: Consumers are likely concerned about the potential health effects from exposure to chemical emission found in indoor air, not just VOC that affect outdoor air quality. The order defines “trace level of emission” to mean (1) no intentionally added VOC, (2) emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health, and (3) emission of the covered product does not result in more than harmless concentrations of any compound higher than would be found under normal conditions in the typical residential home without interior architectural coating. Part II prohibits misleading
To correct existing unsubstantiated zero-VOC claims and deceptive certification claims, Part III requires the respondent to send letters to its dealers and distributors, instructing them to post placards next to paint cans and at point of sale.
Parts VII through XI are reporting and compliance provisions. Part VII mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VIII requires that respondent submit compliance reports to the FTC within sixty (60) days of the order's issuance and submit additional reports when certain events occur. Part IX requires that respondent must create and retain certain records for five (5) years. Part X provides for the FTC's continued compliance monitoring of respondent's activity during the order's effective dates. Part XI is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.
If the Commission finalizes the agreement's proposed order, it plans to propose harmonizing with this order the consent orders issued in the PPG Architectural Finishes, Inc. (Docket No. C-4385) and The Sherwin-Williams Company (Docket No. C-4386) matters. Specifically, the Commission plans to issue orders to show cause why those matters should not be modified pursuant to Section 3.72(b) of the Commission Rules of Practice, 16 CFR 3.72(b).
The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 10, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Alejandro Rosenberg (202-326-2698), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 11, 2017), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 10, 2017. Write “In the Matter of Imperial Paints, LLC, File No. 1623080” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, write “In the Matter of Imperial Paints, LLC, File No. 1623080” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC. 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Imperial Paints, LLC, a limited liability company (“respondent”), doing business as Lullaby Paints and Ecos Paints.
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
This matter involves respondent's marketing, sale, and distribution of purportedly “VOC-free” paints. “VOC” is the abbreviation for volatile organic compounds. VOC-free includes claims such as “zero VOCs,” “0 VOCs,” and “No VOCs.” According to the FTC complaint, respondent made unsubstantiated representations that its paints: (1) Are VOC-free; (2) are VOC-free during or immediately after painting; (3) will not emit any chemical or substance, including VOCs, that causes material harm to consumers, including sensitive populations such as babies, pregnant women, and allergy and asthma sufferers; and (4) will not emit any chemical or substance, including VOCs, during or immediately after painting, that causes material harm to consumers, including sensitive populations such as babies, pregnant women, and allergy and asthma sufferers. The FTC further alleges that respondent provided independent retailers with promotional materials containing the same claims it made to consumers. Thus, the complaint alleges that respondent engaged in deceptive practices in violation of Section 5(a) of the FTC Act.
The proposed consent order contains three provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits emission-free and VOC-free claims unless both content and emissions are actually zero or at trace levels. The orders define “emission” to include all emissions (not just VOCs that cause smog). This definition reflects the Commission's Enforcement Policy Statement and consumer expectations: consumers are likely concerned about the potential health effects from exposure to chemical emissions found in indoor air, not just VOCs that affect outdoor air quality. The order defines “trace level of emission” to mean (1) no intentionally added VOC, (2) emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health, and (3) emission of the covered product does not result in more than harmless concentrations of any compound higher than would be found under normal conditions in the typical residential home without interior architectural coating. Part II prohibits misleading representations regarding emission, VOC levels, odor, and any general environmental and health benefit of paints. The order requires competent and reliable scientific evidence to substantiate these representations. Part IV prohibits respondent from providing third parties with the means and instrumentalities to make false, unsubstantiated, or otherwise misleading representations of material fact regarding paints, including any representation prohibited by Parts I or II.
To correct existing unsubstantiated zero emission and VOC claims, Part III requires the respondent to send letters to its dealers and distributors, instructing them to put stickers on paint cans to obscure allegedly unsubstantiated emission and VOC claims.
Part V through IX are reporting and compliance provisions. Part V mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VI requires that respondent submit compliance reports to the FTC within sixty (60) days of the order's issuance and submit additional reports when certain events occur. Part VII requires that respondent must create and retain certain records for five (5) years. Part VIII provides for the FTC's continued compliance monitoring of respondent's activity during the order's effective dates. Part IX is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.
If the Commission finalizes the agreement's proposed order, it plans to propose harmonizing with this order the consent orders issued in the PPG Architectural Finishes, Inc. (Docket No. C-4385) and The Sherwin-Williams Company (Docket No. C-4386) matters. Specifically, the Commission plans to issue orders to show cause why those matters should not be modified pursuant to Section 3.72(b) of the Commission Rules of Practice, 16 CFR 3.72(b).
The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.
By direction of the Commission.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 10, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Katherine E. Johnson (202-326-2185), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 11, 2017), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 10, 2017. Write “In the Matter of YOLO Colorhouse, LLC, File No. 162-3082” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, write “In the Matter of YOLO Colorhouse, LLC, File No. 162-3082” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from YOLO Colorhouse, LLC, a limited liability company (“respondent”).
The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement or make final the agreement's proposed order.
This matter involves respondent's marketing, sale, and distribution of
The proposed consent order contains three provisions designed to prevent respondent from engaging in similar acts and practices in the future. Part I prohibits emission-free and VOC-free claims unless both content and emissions are actually zero or at trace levels. The orders define “emission” to include all emissions (not just VOCs that cause smog). This definition reflects the Commission's Enforcement Policy Statement and consumer expectations: consumers are likely concerned about the potential health effects from exposure to chemical emissions found in indoor air, not just VOCs that affect outdoor air quality. The order defines “trace level of emission” to mean (1) no intentionally added VOC, (2) emission of the covered product does not cause material harm that consumers typically associate with emission, including harm to the environment or human health, and (3) emission of the covered product does not result in more than harmless concentrations of and compound higher than would be found under normal conditions in the typical residential home without interior architectural coating. Part II prohibits misleading representations regarding emission, VOC levels, odor, and any general environmental and health benefit of paints. The order requires competent and reliable scientific evidence to substantiate these representations. Part IV prohibits respondent from providing third parties with the means and instrumentalities to make false, unsubstantiated, or otherwise misleading representations of material fact regarding paints, including any representation prohibited by Parts I or II.
To correct existing unsubstantiated zero emission and VOC claims, Part III requires the respondent to send letters to its dealers and distributors, instructing them to put stickers on paint cans to obscure allegedly unsubstantiated emission and VOC claims.
Parts V through IX are reporting and compliance provisions. Part V mandates that respondent acknowledge receipt of the order, distribute the order to certain employees and agents, and secure acknowledgments from recipients of the order. Part VI requires that respondent submit compliance reports to the FTC within sixty (60) days of the order's issuance and submit additional reports when certain events occur. Part VII requires that respondent must create and retain certain records for five (5) years. Part VIII provides for the FTC's continued compliance monitoring of respondent's activity during the order's effective dates. Part IX is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.
If the Commission finalizes the agreement's proposed order, it plans to propose harmonizing with this order the consent orders issued in the PPG Architectural Finishes, Inc. (Docket No. C-4385) and The Sherwin-Williams Company (Docket No. C-4386) matters. Specifically, the Commission plans to issue orders to show cause why those matters should not be modified pursuant to Section 3.72(b) of the Commission Rules of Practice, 16 CFR 3.72(b).
The purpose of the analysis is to aid public comment on the proposed order. It is not intended to constitute an official interpretation of the proposed order or to modify its terms in any way.
By direction of the Commission.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Since its establishment on December 24, 2002, the FDA Office of Combination Products (OCP) has served as a resource for sponsors at various stages of development of their product. Sponsors often seek OCP feedback on whether their medical product will be regulated as a drug, a device, a biologic,
There are two ways that a sponsor can receive such feedback from OCP. One option is to submit an RFD to receive a formal, binding determination for the sponsor's product with respect to classification and/or center assignment that may be changed under conditions specified in section 563 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-2) and 21 CFR 3.9 in the regulations. The RFD process is codified in 21 CFR part 3, and OCP has issued a guidance about this process (see “How to Write a Request for Designation” at
Many sponsors seek to utilize the flexibility of more approachable ways to interact with OCP and the medical product Agency Centers to obtain feedback from the Agency before submitting a marketing application to the Agency. Over time, these informal methods of obtaining feedback have become increasingly customary with sponsors, and for some, even preferable to the formal RFD process. Accordingly, FDA is enhancing the transparency and consistency of this process, which will now be called the “Pre-Request for Designation (Pre-RFD) Program.”
This draft guidance describes this structured process with clear recommendations for sponsors wishing to submit Pre-RFDs. It also provides the process for review of Pre-RFDs by FDA staff, the general timeframes for sponsors to receive feedback from OCP, and the process for scheduling teleconferences and meetings in relation to a Pre-RFD.
This draft guidance describes how to prepare a Pre-RFD. The guidance provides recommendations regarding the information that should be submitted in a Pre-RFD request and procedures that should be followed for meetings or conference calls between OCP, the Centers, and industry representatives or sponsors.
The proposed collections of information are necessary to allow the Agency to receive Pre-RFD requests in order to implement this voluntary submission program.
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 740 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-12), FDA has the authority to assess and collect application fees from each person who submits certain new animal drug applications or certain supplemental animal drug applications. The Animal Drug User Fee cover sheet (Form FDA 3546) is designed to collect the minimum necessary information to determine whether a fee is required for the review of an application or supplement or whether an application fee waiver was granted, to determine the amount of the fee required, and to assure that each animal drug user fee payment is appropriately linked to the
In the
The estimates in table 1 are based on our experience with new animal drug applications and supplemental animal drug applications and the average number of Animal Drug User Fee cover sheets submitted during fiscal years 2013-2015. We estimate 21 respondents will each submit a cover sheet (Form FDA 3546) for a total of 21 responses. We calculate a reporting burden of 1 hour per response, for a total of 21 hours. The burden hours are increased. The overall increase in burden hours (by 4 hours) is due to the normal variation in the number of Animal Drug User Fee cover sheets submitted to FDA.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Enacted on November 18, 2003, the Animal Drug User Fee Act (Pub. L. 108-130) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 740 of the FD&C Act (21 U.S.C 379j-12), which requires that FDA assess and collect user fees with respect to new animal drug applications for certain applications, products, establishments, and sponsors. It also requires the Agency to grant a waiver from, or a reduction of, those fees in certain circumstances. Thus, to implement this statutory provision of ADUFA, FDA developed a guidance entitled “Guidance for Industry: Animal Drug User Fees and Fee Waivers and Reductions.” This document provides guidance on the types of fees FDA is authorized to collect under ADUFA, and how to request waivers and reductions from FDA's animal drug user fees. Further, this guidance also describes the types of fees and fee waivers and reductions; what information FDA recommends be submitted in support of a request for a fee waiver or reduction; how to submit such a request; and FDA's process for reviewing requests. FDA uses the information submitted by respondents to determine whether to grant the requested fee waiver or reduction.
Respondents to this collection of information are new animal drug sponsors. Requests for waivers or reductions may be submitted by a person paying any of the animal drug user fees assessed, including application fees, product fees, establishment fees, or sponsor fees.
In the
FDA estimates the burden of this collection of information as follows:
Based on FDA's database system, from fiscal year (FY) 2014 to 2016 there were an estimated 177 sponsors subject to ADUFA. However, not all sponsors will have any submissions in a given year and some may have multiple submissions. The total number of waiver requests is based on the average number of submission types received by FDA in FY 2014 to 2016. The burden has not changed since the last OMB approval.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Jonnalynn Capezutto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 201, 505, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 355, and 371), FDA has the authority to issue regulations governing the use of radioactive drugs for basic scientific research. Section 361.1 (21 CFR 361.1) sets forth specific regulations regarding the establishment and composition of Radioactive Drug Research Committees (RDRCs) and their role in approving and monitoring basic research studies utilizing radiopharmaceuticals. No basic research study involving any administration of a radioactive drug to research subjects is permitted without the authorization of an FDA-approved RDRC (§ 361.1(d)(7)). The type of research that may be undertaken with a radiopharmaceutical drug must be intended to obtain basic information and not to carry out a clinical trial for safety or efficacy. The types of basic research permitted are specified in the regulation, and include studies of metabolism, human physiology, pathophysiology, or biochemistry.
Section 361.1(c)(2) requires that each RDRC shall select a chairman, who shall sign all applications, minutes, and reports of the committee. Each committee shall meet at least once each quarter in which research activity has been authorized or conducted. Minutes shall be kept and shall include the numerical results of votes on protocols involving use in human subjects. Under § 361.1(c)(3), each RDRC shall submit an annual report to FDA. The annual report shall include the names and qualifications of the members of, and of any consultants used by, the RDRC, using Form FDA 2914, and a summary of each study conducted during the preceding year, using Form FDA 2915.
Under § 361.1(d)(5), each investigator shall obtain the proper consent required under the regulations. Each female research subject of childbearing potential must state in writing that she is not pregnant, or on the basis of a pregnancy test be confirmed as not pregnant.
Under § 361.1(d)(8), the investigator shall immediately report to the RDRC all adverse effects associated with use of the drug, and the committee shall then report to FDA all adverse reactions probably attributed to the use of the radioactive drug.
Section 361.1(f) sets forth labeling requirements for radioactive drugs.
Types of research studies not permitted under this regulation are also specified, and include those intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety or effectiveness of the drug in humans for such purposes (
The primary purpose of this collection of information is to determine whether the research studies are being conducted in accordance with required regulations and that human subject safety is assured. If these studies were not reviewed, human subjects could be subjected to inappropriate radiation or pharmacologic risks. Respondents to this information collection are the chairperson(s) of each individual RDRC, investigators, and participants in the studies. The burden estimates are based on FDA's experience with these reporting and recordkeeping requirements and the number of submissions received by FDA under the regulations over the past 3 years.
In the
We therefore estimate the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 18, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
Under the 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. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
With regard to adverse events and product/manufacturing defects associated with approved new animal drugs, section 512(l) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(l)) requires applicants with approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to establish and maintain records and reports of data relating to experience with uses of such drug, or with respect to animal feeds bearing or containing such drug, to facilitate a determination under section 512(e) as to whether there may be grounds for suspending or withdrawing approval of the NADA or ANADA under section 512(e) or 512(m)(4). Sections 571(e)(3) and 512(e)(2) of the FD&C Act (21 U.S.C. 360ccc(e)(3) and 360b(e)(2)) require that applicants with conditionally approved new animal drug applications (CNADAs) maintain adequate records and make reports in accordance with a regulation or order issued under section 512(l). Finally, section 512(m)(5) of the FD&C Act requires an applicant for a license to manufacture animal feeds bearing or containing new animal drugs to maintain adequate records and make reports “as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine” whether there may be grounds for suspending or withdrawing approval of the new animal drug under section 512(e) or a license to manufacture animal feeds bearing or containing new animal drugs under section 512(m)(4).
Section 514.80 of our regulations (21 CFR 514.80) sets forth the recordkeeping and reporting requirements for applicants and nonapplicants of approved NADAs and ANADAs. Section 510.301 of our regulations (21 CFR 510.301) sets forth the recordkeeping and reporting requirements for licensed medicated feed manufacturing facilities.
Section 514.80 requires applicants to keep records of and report to us data, studies, and other information concerning experience with new animal drugs for each approved NADA and ANADA. Following complaints from animal owners or veterinarians or following their own detection of a problem, applicants are required to submit adverse event reports and product defect reports under § 514.80(b)(1), (b)(2)(i) and (ii), (b)(3), and (b)(4)(iv)(A) on Form FDA 1932. Form FDA 1932a (the voluntary reporting form) is used by veterinarians and the general public to submit adverse event reports, product defects, and lack of effectiveness complaints directly to FDA. Form FDA 2301 is used by applicants to submit the required transmittal of periodic reports (§ 514.80(b)(4)); special drug experience reports (§ 514.80(b)(5)(i)); promotional material for new animal drugs (§ 514.80(b)(5)(ii)); and distributor statements (§ 514.80(b)(5)(iii)). We review the records and reports required in § 514.80 and the voluntary reports to facilitate a determination under section 512(e) of the FD&C Act as to whether there may be grounds for suspending or withdrawing approval of the new animal drug. We have made minor editorial revisions to Form FDA 1932a, to clarify how to report adverse drug events associated with compounded products using that form. Submitters are already reporting adverse drug events associated with compounded products on Form FDA 1932a. The clarifications include: The addition of a new question, “Is this a compounded product”; the addition of a new field to allow the submitter to provide product strength, “Strength of Active Ingredient(s)”; modifying the title of the existing field requesting the name of manufacturer, so that it reads, “Name of Manufacturer or Compounding Pharmacy/Compounder of Suspected Product”; and a request for contact information for the manufacturer or compounder. We estimate that the revisions will not change the average amount of time necessary to complete the form.
As noted, sections 571(e)(3) and 512(e)(2) of the FD&C Act require that applicants for CNADAs maintain adequate records and make reports in accordance with a regulation or order issued under section 512(l) of the FD&C Act. Moreover, section 512(l) requires submission of such information as required “by general regulation, or by order . . .” Conditional approval letters explicitly establish an order requiring the submission of postmarketing information in accordance with the requirements of § 514.80. Applicants submit adverse event reports and product defect reports on Form FDA 1932.
Section 510.301 requires a licensed medicated feed manufacturer to keep records of and report to us information concerning experience with animal feeds bearing or containing approved new animal drugs. Under § 510.301(a), a licensed medicated feed manufacturer must immediately report to us information concerning any mixup in the new animal drug or its labeling; any bacterial or significant chemical, physical, or other change or deterioration in a drug; and any failure of one or more distributed batches of a drug to meet the specifications established for it. Under § 510.301(b), a licensed medicated feed manufacturer must report to us within 15 working days of receipt of information concerning any unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidence or severity thereof, and any unusual failure of the new animal drug to exhibit its expected pharmacological activity. OMB initially approved the information collection provisions of § 510.301 under control number 0910-0012. That approval was subsequently consolidated into this collection in 2004. We reviewed the records and reports required by § 510.301 to facilitate a determination as to whether there may be grounds for suspending or withdrawing approval of the new animal drug under section 512(e) of the FD&C Act, or grounds for revoking a license to manufacture medicated feed under section 512(m)(4).
Since the consolidation of the 0910-0012 collection into this collection in 2004, we have included the estimated number of medicated feed adverse event reports as part of our estimate of the number of all mandatory adverse event reports for new animal drugs. To improve the clarity of our estimates we have added a row to table 1, on which we separately report our estimates of medicated feed reports.
The continuous monitoring of approved NADAs, ANADAs, CNADAs, and animal feeds bearing or containing new animal drugs affords the primary means by which we obtain information regarding potential problems with the safety and efficacy of marketed approved new animal drugs, as well as potential product/manufacturing problems. Postapproval marketing surveillance is important because data previously submitted to us may not be adequate as animal drug effects can change over time and less apparent effects may take years to manifest.
FDA estimates the burden of this collection of information as follows:
We base our reporting estimates on our experience with adverse event reporting for approved new animal drugs and the number of reports received in the previous 3 years.
We base our recordkeeping estimates on our experience with adverse event reporting for approved new animal drugs and the number of reports received in the previous 3 years. Since the consolidation of the 0910-0012 collection into this collection in 2004, we have included the estimated recordkeeping burden for medicated feed adverse event reports as part of our estimate of the recordkeeping burden of all mandatory adverse event reports for new animal drugs. To improve the clarity of our estimates we have added a row to table 2, on which we separately report our recordkeeping estimate for medicated feed adverse event reports (20 hours).
The burden of this collection has changed. Due to the addition of a new row to table 1 and a new row to table 2, there was a slight increase in the estimated number of reports submitted to FDA under total annual responses (by 7.8 responses). The overall decrease in burden hours (by 1.75 hours) is due to the normal variation in the submission of reports to FDA.
We continually strive to improve our systems for collecting and analyzing drug experience reports and adverse event reports. To that end, we have developed an electronic submission system by which Form FDA 2301 may be submitted to the Agency. For Form FDA 1932a, we have a fillable electronic form available online, which can be submitted by email to FDA Center for Veterinary Medicine. We specifically invite comment from respondents on the utility of these reporting forms. Electronic adverse event reporting for approved new animal drugs (including mandatory reporting under § 514.80(b) and voluntary reporting) has been approved under OMB control number 0910-0645. Reporting and recordkeeping associated with the index of legally marketed unapproved new animal drugs for minor species (21 CFR part 516) is approved under OMB control number 0910-0620.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 18, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
Under the 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. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
We are seeking to renew OMB approval of the Health and Diet Survey, which is a voluntary consumer survey intended to gauge and to track consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. OMB approved this collection as a generic collection on December 5, 2014. The authority for FDA to collect the information derives from FDA's Commissioner of Food and Drugs authority provided in section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
We will use the Health and Diet Survey findings to test and refine our ideas, but will generally conduct further
This survey has been repeated approximately every 3 to 5 years over the course of the past 3 decades for the purpose of tracking changes and trends in public opinions and consumer behavior, with some new questions added or omitted or partially modified in each iteration in response to emerging and current events or issues. In the next 3 years, we plan to field this survey two to three times. We will use the information from the Health and Diet Survey to evaluate and develop strategies and programs to encourage and help consumers adopt healthy diets and lifestyles. The information will also help FDA evaluate and track consumer awareness and behavior as outcome measures of their achievement in improving public health.
FDA estimates the burden of this collection of information as follows:
We base our estimate of the number of respondents and the average burden per response on our experience with previous Health and Diet Surveys and we estimate that the burden for this information collection has increased by 580 hours (from 1,882 to 2,462 hours) since the last OMB approval. The increase is due to an expected increase in the number of participants completing the survey screener (from 30,000 to 40,000 participants) and number of participants taking the survey (from 3,000 to 4,000). We will use a cognitive interview screener with 100 individuals to recruit prospective interview participants. We estimate that it will take a screener respondent approximately 5 minutes (0.08 hours) to complete the cognitive interview screener, for a total of 8 hours. We will conduct cognitive interviews with 18 participants. We estimate that it will take a participant approximately 1 hour to complete the interview, for a total of 18 hours. Prior to the administration of the Health and Diet Survey, the Agency plans to conduct a pretest to identify and resolve potential survey administration problems. We will use a pretest screener with 2,000 individuals; we estimate that it will take a respondent approximately 2 minutes (0.033 hours) to complete the pretest screener, for a total of 66 hours. The pretest will be conducted with 200 participants; we estimate that it will take a participant 15 minutes (0.25 hours) to complete the pretest, for a total of 50 hours. We will use a survey screener to select an eligible adult respondent in each household reached by landline telephone numbers to participate in the survey. A total of 40,000 individuals in the 50 states and the District of Columbia will be screened by telephone. We estimate that it will take a respondent 2 minutes (0.033 hours) to complete the screening, for a total of 1,320 hours. We estimate that 4,000 eligible adults will participate in the survey, each taking 15 minutes (0.25 hours), for a total of 1,000 hours. Thus, the total estimated burden is 2,462 hours.
We are requesting this burden for unplanned surveys so as not to restrict our ability to gather information on consumer attitudes, awareness, knowledge, and behavior regarding various topics related to health, nutrition, physical activity, and product labeling. This ability will help the Agency identify and respond to emerging issues in a more timely manner.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency.
Statutory requirements for cGMPs for Type A medicated articles have been codified in part 226 (21 CFR part 226). Type A medicated articles, which are not manufactured in accordance with these regulations, are considered adulterated under section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)). Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (
The required records are used by both the respondents and FDA. The records are used by manufacturers of Type A medicated articles to verify that appropriate control measures have been maintained, or that appropriate corrective actions were taken if the control measures were not maintained. Such verification activities are essential to ensure that the cGMP system is working as planned. We review the records during the conduct of periodic plant inspections. This information is needed so that we can monitor drug usage and possible misformulation of Type A medicated articles. The information could also prove useful to us in investigating product defects when a drug is recalled. In addition, we will use the cGMP criteria in part 226 to determine whether or not the systems used by manufacturers of Type A medicated articles are adequate to assure that their medicated articles meet the requirements of the FD&C Act as to safety and also meet the article's claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act. The respondents for Type A medicated articles are pharmaceutical firms that manufacture both human and veterinary drugs, those firms that produce only veterinary drugs, and commercial feed mills.
In the
We based our estimate of the time required for record preparation and maintenance on our communications with industry. We derived additional information needed to calculate the total burden hours (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 18, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 18, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the 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. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed
Under the Public Health Service Act (42 U.S.C. 262), FDA may only approve a biologics license application for a biological product that is safe, pure, and potent. When a biological product is approved and enters the market, the product is introduced to a larger patient population in settings different from clinical trials. New information generated during the postmarketing period offers further insight into the benefits and risks of the product, and evaluation of this information is important to ensure its safe use. FDA issued the Adverse Experience Reporting (AER) requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA's AERS is to identify potentially serious safety problems with licensed biological products. Although premarket testing discloses a general safety profile of a biological product's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. In addition, production and/or distribution problems have contaminated biological products in the past. AER reports are obtained from a variety of sources, including manufacturers, patients, physicians, foreign regulatory agencies, and clinical investigators. Identification of new and unexpected safety issues through the analysis of the data in AERS contributes directly to increased public health protection. For example, evaluation of these safety issues enables FDA to take focused regulatory action. Such action may include, but is not limited to, important changes to the product's labeling (such as adding a new warning), coordination with manufacturers to ensure adequate corrective action is taken, and removal of a biological product from the market when necessary.
Section 600.80(c)(1) requires licensed manufacturers or any person whose name appears on the label of a licensed biological product to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These reports are known as postmarketing 15-day Alert reports. This section also requires licensed manufacturers to submit any followup reports within 15 calendar days of receipt of new information or as requested by FDA, and if additional information is not obtainable, to maintain records of the unsuccessful steps taken to seek additional information. In addition, this section requires that a person who submits an adverse action report to the licensed manufacturer rather than to FDA, maintain a record of this action. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if the licensed manufacturer concludes that there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports are submitted annually, since a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(k) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, the fill lot numbers for the total number of dosage units of each strength or potency distributed (
Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product, including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections. Section 600.12 requires, among other things, that records be made concurrently with the performance of each step in the manufacture and distribution of products. These records must be retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, under § 600.12, manufacturers must maintain records relating to the sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing responsibility with respect to a product. Under § 600.12(b)(2), manufacturers are also required to maintain complete records pertaining to the recall from distribution of any product. Furthermore, § 610.18(b) (21 CFR 610.18(b)) requires, in part, that the results of all periodic tests for verification of cultures and determination of freedom from extraneous organisms be recorded and retained. The recordkeeping requirements for §§ 610.12(g), 610.13(a)(2), 610.18(d), 680.2(f), and 21 CFR 680.3(f) are approved under OMB control number 0910-0139.
Respondents to this collection of information include manufacturers of biological products (including blood and blood components) and any person
FDA estimates the burden of this collection of information as follows:
In table 2 the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA's database system, there were 263 licensed manufacturers of biological products in FY 2016. However, the number of recordkeepers listed for § 600.12(a) through (e) excluding (b)(2) is estimated to be 114. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under § 606.160 in OMB control number 0910-0116. The total annual records is based on the annual average of lots released in FY 2016 (7,198), number of recalls made (575), and total number of adverse experience reports received (305,951) in FY 2016. The hours per record are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
The burden for this information collection has changed since the last OMB approval. Because of an increase in the number of AER reports we have received during the past 3 years, we have increased our reporting and recordkeeping burden estimates.
Food and Drug Administration, HHS.
Notice; correction.
The Food and Drug Administration (FDA) is correcting a notice that appeared in the
Florine Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.
In the
1. On page 68429, in table 1, the entry for ANDA 074123 is removed.
2. On page 68431, in table 1, the entry for ANDA 080828 is removed.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726.
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Voluntary National Retail Food Regulatory Program Standards (the Program Standards) define nine essential elements of an effective regulatory program for retail food establishments, establish basic quality control criteria for each element, and provide a means of recognition for the State, local, territorial, tribal and Federal regulatory programs that meet the Program Standards. The program elements addressed by the Program Standards are as follows: (1) Regulatory foundation; (2) trained regulatory staff; (3) inspection program based on Hazard Analysis and Critical Control Point (HACCP) principles; (4) uniform inspection program, (5) foodborne illness and food defense preparedness and response; (6) compliance and enforcement; (7) industry and community relations; (8) program support and resources; and (9) program assessment. Each standard includes a list of records needed to document conformance with the standard (referred to in the Program Standards document as “quality records”) and has one or more corresponding forms and worksheets to facilitate the collection of information needed to assess the retail food regulatory program against that standard. The respondents are State, local, territorial, tribal, and potentially other Federal regulatory Agencies. Regulatory Agencies may use existing available records or may choose to develop and use alternate forms and worksheets that capture the same information.
In the course of their normal activities, State, local, territorial, tribal, and Federal regulatory Agencies already collect and keep on file many of the records needed as quality records to document compliance with each of the Program Standards. Although the detail and format in which this information is collected and recorded may vary by jurisdiction, records that are kept as a usual and customary part of normal Agency activities include inspection records, written quality assurance procedures, records of quality assurance checks, staff training certificates and other training records, a log or database of food-related illness or injury complaints, records of investigations resulting from such complaints, an inventory of inspection equipment, records of outside audits, and records of outreach efforts (
In April 2016, the Conference for Food Protection (CFP) recommended that FDA make a change in Program Standard #4—Uniform Inspection Program, more specifically to change Program Standard #4's Program Self-Assessment and Verification Audit Form. Once changes have been incorporated into the 2017 version, it will be available on FDA's Web site.
With this change, in order to achieve conformance to Program Standard #4, jurisdictions must achieve an overall inspection program performance rating for 20 elements as opposed to 10 elements that were previously required. The previous 10 elements had several criteria under one program element. The change to 20 elements allows the Standard to clearly delineate out each criterion individually rather than having several criteria under one program element. This streamlines and clarifies the process in meeting the standard. As a result, the assessment review of each inspector's work will now be required for three joint inspections as opposed to the previously required two.
State, local, territorial, tribal and Federal regulatory Agencies that enroll in the Program Standards and seek listing in the FDA National Registry are required to report to FDA on the completion of the following three management tasks outlined in the Program Standards: (1) Conducting a program self-assessment; (2) conducting a risk factor study of the regulated industry; and (3) obtaining an independent outside audit (verification audit). The results are reported on forms formerly known as Forms FDA 3519 and FDA 3520. Currently FDA is working to consolidate both Forms FDA 3519 “FDA National Registry Report” and FDA 3520 “Permission to Publish in National Registry” into one form thereby reducing the burden by 50 percent. The new Form FDA 3958 “Voluntary National Retail Food Regulatory Program Standards FDA National Registry Report” will be provided in the Program Standards document, and will also be provided on FDA's Web site at:
In the
(Comment 1) One commenter noted that achieving all of the standards under the existing program lasts only 2 years, and then a state regulatory program has to start all over again. The commenter indicated standards certification should last for 7 years, and then there would be more incentive to achieve some or all of the standards.
(Response 1) The purpose of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) is to establish best practices for regulatory programs that license and inspect foodservice and retail food establishments. Jurisdictions are encouraged to use the Retail Program Standards to improve program management and to implement best practices that enhance the quality of public health services provided to stakeholders. Effective use of the Retail Program Standards will enable a jurisdiction to make lasting programmatic improvements to their retail food protection program. While meeting all nine standards is a significant accomplishment, the true intent is continual program improvement across all standards during varied time frames. There are general procedures for enrolling in the Retail Program Standards and maintaining active participation. Though timelines may vary depending on jurisdictional needs and priorities at any given time, the general administrative procedure is that within the first year of enrollment the jurisdiction will conduct a self-assessment using the criteria in the nine Retail Program Standards. As part of the continuous improvement process, jurisdictions review the self-assessment to determine program areas that need improvements and will provide the greatest health benefit. To maintain active participation in the Retail Program Standards and listing on the National Registry, the participating jurisdiction must conduct a self-assessment every 60 months. FDA works in conjunction with the Conference for Food Protection (CFP) in a process whereby representatives from the food industry, government, academia, consumer and professional organizations identify and address emerging problems of food safety in an open forum and formulate recommendations biennially to enhance the Retail Program Standards. These recommendations are then submitted to FDA for consideration to be incorporated into the newest edition of the FDA Food Code or the Retail Program Standards. Issues may be submitted by anyone who has an interest or concern about food safety. For an overview of the CFP please go to:
(Comment 2) Another commenter thanked the FDA for the opportunity to provide the comments on the proposed FDA Voluntary Standards. They stated that it was great to have these standards for health officials to do their absolute best for their community, and provided their comments to FDA on behalf of a trade quality assurance group.
(Response 2) FDA appreciates the continued support from the retail food industry for the Retail Program Standards. FDA works in conjunction with the CFP in a process whereby representatives from consumer and professional organizations, food industry, government, and academia identify and address emerging problems of food safety in an open forum and formulate recommendations. These recommendations are then submitted to FDA for consideration to be incorporated into the newest editions of the FDA Food Code or the Retail Program Standards. Issues may be submitted directly to CRP as there is a clear defined process and template for issue submittal. For an overview of the CFP and instructions on how to submit an issue, use the following link:
FDA's recordkeeping burden estimate includes time required for a State, local, territorial, tribal, or Federal Agency to review the instructions in the Program Standards, compile information from existing sources, and create any records recommended in the Program Standards that are not already kept in the normal course of the Agency's usual and customary activities. Sample worksheets are provided to assist in this compilation. In estimating the time needed for the program self-assessment (Program Standards 1 through 8, shown in table 1), FDA considered responses from four State and three local jurisdictions that participated in an FDA Program Standards Pilot study. Table 2 shows the estimated recordkeeping burden for the completion of the baseline data collection, and table 3 shows the estimated recordkeeping burden for the verification audit.
FDA estimates the burden of this collection of information as follows:
FDA bases its estimates of the number of recordkeepers and the hours per record on its experience with the Program Standards over the past 16 years. As of September 30, 2016, 711 jurisdictions were enrolled in the Program Standards. However, based upon the level of ongoing support provided by FDA to enrolled jurisdictions and the number of forms submitted annually, FDA estimates that no more than 500 jurisdictions actively participate in the Program Standards during any given year. There are approximately 3,000 jurisdictions in the United States and its territories that have retail food regulatory programs. Enrollment in the Program Standards is voluntary and, therefore, FDA does not expect all jurisdictions to participate.
FDA bases its estimate of the hours per record on the recordkeeping estimates for the management tasks of self-assessment, risk factor study, and verification audit (tables 1, 2, and 3) that enrolled jurisdictions must perform a total of 471.45 hours (92.3 + 333 + 46.15 = 471.45). Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period. Therefore FDA estimates that, annually, 500 recordkeepers will spend 94.29 hours (471.45 ÷ 5 = 94.29) performing the required recordkeeping for a total of 47,145 hours as shown in table 4.
Previously, FDA required regulatory jurisdictions that participate in the Program Standards to submit two forms annually: Form FDA 3519, “FDA National Registry Report,” and Form FDA 3520, “Permission to Publish in National Registry.” FDA created a new consolidated FDA Form 3958 that has four parts: Part 1 requires the name and address of the jurisdiction; name and contact information for the contact
FDA estimates the reporting burden for this collection of information as follows:
FDA bases its estimates of the number of respondents and the hours per response on its experience with the Program Standards. As explained previously, FDA estimates that no more than 500 regulatory jurisdictions will participate in the Program Standards in any given year. FDA estimates a total of 6 minutes annually for each enrolled jurisdiction to complete the form. FDA bases its estimate on the small number of data elements on the form and the ease of availability of the information. FDA estimates that, annually, 500 regulatory jurisdictions will submit one Form FDA 3958 for a total of 500 annual responses. Each submission is estimated to take 0.1 hour (or 6 minutes) per response for a total of 50 hours. In addition, FDA estimates that, annually, 500 regulatory jurisdictions will submit three requests for documentation of successful completion of staff training using the CFP Training Plan and Log for a total of 1,500 annual responses. Each submission is estimated to take 0.1 hour (or 6 minutes) per response for a total of 150 hours. The total reporting burden for this information collection is 200 hours.
Thus, the total hourly burden for this information collection is 47,345 hours (47,145 recordkeeping hours and 200 reporting hours).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Under the FD&C Act and implementing
Prescription drug regulations require a fair balance of the content and prominence of risk and benefit information in prescription drug product claim promotion. The rise of Internet communications that have character space limitations, such as sponsored link promotion and microblog messaging, has led to questions about how to use these communications for prescription drug promotion while complying with the fair balance requirements. In 2014, FDA released a draft guidance entitled, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices,” (Ref. 1) which states:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
The concept of linking to risk information by providing substantive product risk information on a landing page (“link to the risk information”), rather than presenting substantive risk information together with product benefit information within the character-space-limited communication, has been the subject of legislation and has been discussed as an option by some in industry and media (for example, Refs. 2-5).
The studies are designed to address the question of whether substantive risk information in the character-space-limited communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient. Within each study, we will manipulate whether or not substantive risk information appears in the character-space-limited communication.
Another factor to consider is that when consumers turn to the Internet for information, they are driven by different goals. These goals can affect what information they pay attention to and what kind of information they find (Refs. 6-8). Therefore, we will also manipulate whether participants are instructed to browse the information or to search for specific information.
Two pretests will be conducted to test the goal instructions, stimuli, questionnaire, and procedure. In studies 1-4, participants will be randomly assigned to one experimental condition and will view the corresponding study materials (tables 1-4). Across all studies, we will examine two different character-space-limited formats and two medical conditions. For pretest 1 and study 1, the study materials will be a character-space-limited communication about a fictional weight loss drug, embedded in a Google search page about weight loss. The study 2 materials will be a character-space-limited communication about a fictional drug to treat migraine, embedded in a Google search page about migraine. The study 3 materials will be a character-space-limited communication about a fictional weight loss drug, embedded in a Twitter search page about weight loss. The pretest 2 and study 4 materials will be a character-space-limited communication about a fictional drug to treat migraine, embedded in a Twitter search page about migraine.
All study materials will allow for scrolling and clicking on any links. The study materials will be accessible by participants only. After viewing the study materials, participants will complete a questionnaire that assesses participants' retention of the risk information and their perceptions of the drug's risks and benefits. We will also measure covariates such as demographics and health literacy. The questionnaires are available upon request.
We hypothesize that participants who see substantive risk information in the character-space-limited communication, compared with link-only participants, will have greater retention of the risk included in the communication and higher perceived risk. We will explore whether including substantive risk information in the character-space-limited communication affects the likelihood that participants notice the communication or click the link to the risk information. We hypothesize that participants with a search goal, compared with a browse goal, will have greater retention of the benefit and risk information and higher perceived risk because they will be more likely to notice the character-space-limited communication and to click the link to the risk information. We will test these hypotheses in studies 1-4 to determine whether these effects hold across different medical conditions and different character-space-limited platforms. To test these hypotheses, we will conduct inferential statistical tests such as logistic regression and analysis of variance.
All participants will be 18 years of age or older. We will exclude individuals who work in healthcare or marketing. Half of the studies will have a sample of participants who self-report needing to lose 30 pounds or more; the other half will have a sample of participants who self-report suffering from migraines. We selected these samples to increase the likelihood that participants will be interested in the fictitious study drugs and therefore motivated to pay attention during the study. The studies will be conducted with an Internet panel. With the sample sizes described in the tables, we will have sufficient power to detect small-sized effects in studies 1-4 (table 5).
FDA estimates the burden of this collection of information as follows:
In the
Four comments addressed topic 1 with respect to the practical utility of the study stimuli and real-world application. FDA's goal is always to regulate prescription drug promotion in support of our public health mission. We are not aware of any studies, to date, that specifically assess the general question of whether a link to prescription drug information can effectively convey the risks associated with a drug when benefit claims about that drug are made within character-space-limited communications. This concept has been suggested in various ways by our stakeholders, and we feel that it is important to gain further insight into this potential practice. We appreciate the considerations these comments have put forth; however, we feel that the current objective is important and will maintain it for this project.
One comment stated that a balance of risk and benefit is not needed in a character-space-limited communication. The proposed research is designed to test this question.
One comment encouraged dissemination of our results and requested we indicate a subsequent use for this information collection. We plan to disseminate our results via our Web site and peer-reviewed publication. FDA will use the information from this study to inform its understanding and regulation of prescription drug promotion. Results from studies we conduct are evaluated within the broader context of research and findings from other sources.
Several comments suggested ways to enhance the study design. Four comments suggested alternate study objectives, such as testing risk icons, testing different kinds of character-space-limited communications, and testing direct-to-consumer promotion in the presence of misinformation about the product. We appreciate these suggestions for future studies. However, we feel the current objectives are important and will maintain them for this project.
Two comments recommended including mobile displays. We agree and will recruit an equal number of participants who are using mobile and non-mobile devices. This will not change the study burden.
One comment suggested manipulating whether the landing page includes only risk information or whether it includes risk and benefit information. We have taken this suggestion and revised the study design. This does not change the study burden.
One comment suggested evaluating participant engagement with the stimuli. We plan to measure engagement variables such as clicking links and scrolling.
One comment suggested that the issue we should be studying is whether consumers know that drugs generally have risks rather than whether consumers know the specifics risks associated with a drug. We believe the purpose of communicating the drug's specific risk information is so consumers can make informed decisions based on both the drug's benefits and risks.
One comment suggested FDA conduct background research before conducting the proposed research. We appreciate these suggestions, and note that FDA has undertaken a content analysis of mobile prescription drug promotion (
One comment suggested explicitly telling participants to search for drug risk information. We will use random assignment to instruct participants either to search or browse for information. However, we will not instruct participants to search for risk information, specifically, because we are interested in how individuals respond to character-space-limited communications with and without risk information rather than whether participants can find risk information when they are instructed to search for it.
One comment suggested that the browse/search goal construct was not relevant because approximately half of U.S. Internet users have searched for medical information online and because this construct hasn't been studied in the realm of prescription drug information before. The comment asserts that consumers are unlikely to browse health information online. This comment assumes that only consumers actively searching for prescription drug information will be exposed to
One comment suggested adding a general population sample. We chose to recruit individuals with the medical condition being advertised to increase the likelihood that participants will be engaged with the browse and search tasks. Weight concerns and migraine affect large segments of the population. To reduce burden, we do not plan to add a general population sample.
One comment suggested that we change the “browse2” instruction so that it discusses browsing information in general rather than referring to a topic. We made this change.
Several comments suggested ways to enhance the study stimuli. Four comments suggested testing Twitter cards or photos embedded in tweets that would expand the space available to communicate risk information. Sponsors are permitted to promote their products on platforms using additional multimedia components, and we appreciate these suggestions for future studies. However, the current study aims to address the more general question of whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within character-space-limited communications used in prescription drug promotion.
One comment addressed the content surrounding the character-space-limited communication. The other links and tweets will replicate real-world searches, including links to general health information Web sites and links to Web sites for other (non-prescription) treatments. The surrounding content will not differ across condition for experimental control.
One comment suggested using high-visibility techniques to communicate risks. We appreciate this suggestion but we intend to make the prominence of the risk and benefit information comparable in these studies.
One comment suggested formatting the landing page to optimize readability (
One comment suggested using “decoy” links/tweets and suggested randomizing the order of the links/tweets to decrease bias. We will have nine other links or tweets, for a total of ten to simulate one search page. To make the stimuli as close to real-world online searches as possible, the sponsored link will always appear at the top of the search results. To keep the stimuli similar across studies, the tweet will also appear at the top of the page. The order will remain constant across conditions in all studies.
One comment suggested changing “Important Risk Information” to “See Important Risk Information” to include a “call to action.” We have made this change.
Several comments had suggestions for how we ask our questions. Two comments suggested changes to our medical condition screening questions. These questions come from the National Health Interview Survey and the National Health and Nutrition Examination Survey. We plan to keep these questions “as is” so we can compare our samples to these national samples. We will change the description of our samples to match these questions.
Two comments suggested adding a “don't know” option or letting some participants opt out of the first series of questions. We added a “don't know” option to these questions. We will use cognitive interviews and pretests to assess whether we need to make additional changes, including other minor wording changes suggested in the comments.
Two comments suggested moving, editing, or deleting specific questions (such as perceptions and intentions). We moved the items as suggested, and will flag these items for potential editing or removal based on cognitive interview and pretest results.
One comment suggested screening out participants who had never used Google or Twitter and participants with low health literacy. We added a screening question regarding Internet usage. We do not plan to screen based on literacy, but rather we will examine whether literacy moderates any effects.
One comment suggested defining “serious side effect” for consumers; however, previous FDA research found that consumers were able to understand this concept (Ref. 9).
One comment addressed topic 4. This comment suggested conducting 20 hour-long qualitative interviews per study rather than conducting pretests. To clarify, we will conduct nine hour-long qualitative interviews to cognitively test the study stimuli and materials. We will use the pretests to test and select the browse and search goal instructions for the main studies and to pilot the main studies.
The following references are on display in the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733;
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection request supports Agency guidance entitled “E6(R2) Good Clinical Practice” (ICH E6(R2)), which was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. ICH E6(R2) amends the ICH guidance entitled “E6 Good Clinical Practice: Consolidated Guidance” (issued in April 1996) to encourage implementation of improved and more-efficient approaches to clinical trial design, conduct, oversight, recording, and reporting that are intended to increase clinical trial quality and efficiency while continuing to ensure human subject protection and reliability of trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. The guidance includes additions to ICH E6(R1) that are identified as “ADDENDUM” and are marked with vertical lines on both sides of the text.
In table 1, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will develop approximately 1,457 quality management systems per year (as described in ICH E6(R2) in section 5.0, including sections 5.0.1 to 5.0.7). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 87,420 hours annually. The estimated number of sponsors who will develop a quality management system, as described in ICH E6(R2), is based on the number of annual investigational new drug applications (INDs) and new drug applications (NDAs) submitted to the Center for Drug Evaluation and Research. The estimated number of hours it will take to develop a quality management system is based on FDA interactions with sponsors about activities that support drug development plans.
In table 2, we estimate that approximately 1,457 sponsors of clinical trials of human drugs will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report (as described in section 5.0.7 of ICH E6(R2)). We further estimate that sponsors will submit approximately 4.6 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 20,107 reporting hours annually. These estimates are based on FDA's past experiences with INDs and NDAs.
In table 3, we estimate that approximately 218 sponsors of clinical trials of biological products will develop approximately 218 quality management systems per year (as described in ICH E6(R2) in section 5.0, including sections 5.0.1 to 5.0.7). We further estimate that it will take sponsors approximately 60 hours to develop and implement each quality management system, totaling 13,080 hours annually. The estimated number of sponsors who will develop a quality management system, as described in ICH E6(R2), is based on the number of annual INDs and biologics license application (BLAs) submitted to the Center for Biologics Evaluation and Research. The estimated number of hours it will take to develop a quality management system is based on FDA interactions with sponsors about activities that support drug development plans.
In table 4, we estimate that approximately 218 sponsors of clinical trials of biological products will describe the quality management approach implemented in a clinical trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in a clinical study report (as described in section 5.0.7 of ICH E6(R2)). We further estimate that sponsors will submit approximately 3.69 responses per respondent and that it will take sponsors 3 hours to complete this reporting task, totaling 2,413 reporting hours annually. As described previously, these estimates are based on past experiences with INDs and BLAs submitted to the Agency.
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by August 17, 2017.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue current good manufacturing practice (cGMP) regulations for drugs, including medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21 CFR part 225). Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act. Under part 225, a manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (
This information is needed so that FDA can monitor drug usage and possible misformulation of medicated feeds to investigate violative drug residues in products from treated animals and to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP criteria in part 225 to determine whether or not the systems and procedures used by manufacturers of medicated feeds are adequate to assure that their feeds meet the requirements of the FD&C Act as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter or because of carcinogenic concerns. Conversely, a license is not required and the recordkeeping requirements are less demanding for those medicated feeds for which FDA has determined that the drugs used in their manufacture need less control. Respondents to this collection of information are commercial feed mills and mixer-feeders.
In the
FDA estimates the burden of this collection of information as follows:
We based our estimate of the time required for record preparation and maintenance on our communications with industry. We derived additional information needed to calculate the total burden hours (
Coast Guard, DHS.
Notice of availability.
The Coast Guard (USCG) is announcing, the availability of Navigation and Vessel Inspection Circular (NVIC) 01-16 change 1. The NVIC provides that display of certain electronic charts and publications will meet—as an equivalency—the “marine charts,” “charts,” “maps,” or “publications” carriage requirements and provides for an equivalency for position fixing and plotting. USCG intends, by this policy, to provide a path for U.S. flagged vessels to replace paper charts and most hard copy publications if so desired.
Please address questions or feedback concerning this policy to LCDR Matthew Walter, telephone 202-372-1565 or email
In response to recommendations from Coast Guard Federal Safety Advisory Committees, industry stakeholders and agency partners, the Coast Guard updated its original policy on electronic charts and publications. Navigation and Vessel Inspection Circular (NVIC) 01-16 change 1 is revised to focus on the equivalency determination for charts, publications and, newly added, navigation functions. It only accepts certain electronic charts as described. It requires vessels that operate offshore to display charts on certain systems. It describes the minimum performance requirements for equipment receiving position information and restates our policy on electronic navigation publications.
Title 33 of the Code of Federal Regulations requires “currently corrected marine charts” of a large enough scale and with enough detail to make safe navigation possible. In 2002, the Coast Guard authorized U.S. flagged SOLAS-compliant vessels to use an Electronic Chart Display and Information System (ECDIS) in lieu of paper charts.
Title 33 of the CFR 164 also requires that some vessels fix their position
Additionally, NVIC 01-16 change 1 also provides guidance to marine inspectors regarding how to identify approved and/or appropriate electronic charts, display systems, position information and electronic publications. Finally, this Circular recommends practices that vessel owners and operators should consider when navigating with the assistance of electronics.
This Circular is not a substitute for applicable legal requirements, nor is it itself a rule. It does not provide equivalence for the purposes of SOLAS certificates. Mariners are responsible to safely navigate and follow applicable regulatory requirements.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-4320-DR), dated June 23, 2017, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that, in a letter dated June 23, 2017, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Tennessee resulting from severe storms, straight-line winds, and flooding during the period of May 27-28, 2017, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance be supplemental, any Federal funds provided under the Stafford Act for Hazard Mitigation will be limited to 75 percent of the total eligible costs. Federal funds provided under the Stafford Act for Public Assistance also will be limited to 75 percent of the total eligible costs, with the exception of projects that meet the eligibility criteria for a higher Federal cost-sharing percentage under the Public Assistance Alternative Procedures Pilot Program for Debris Removal implemented pursuant to section 428 of the Stafford Act.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Warren J. Riley, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Tennessee have been designated as adversely affected by this major disaster:
Blount, Cumberland, Fayette, Knox, Loudon, Morgan, Putnam, Rhea, Roane, Sevier, Shelby, and Smith Counties for Public Assistance.
All areas within the State of Tennessee are eligible for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Final notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of November 3, 2017 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
I. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Proposed notice; withdrawal.
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed notice concerning proposed flood hazard determinations, which may include the addition or modification of any Base Flood Elevation, base flood depth, Special Flood Hazard Area boundary or zone designation, or regulatory floodway (herein after referred to as proposed flood hazard determinations) on the Flood Insurance Rate Maps and, where applicable, in the supporting Flood Insurance Study reports for Dallas County, Iowa and Incorporated Areas and Warren County, Iowa and Incorporated Areas.
This withdrawal is effective July 18, 2017.
You may submit comments, identified by Docket No. FEMA-B-1604, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
On April 4, 2016, FEMA published a proposed notice at 81 FR 19232, proposing flood hazard determinations for Dallas County, Iowa and Incorporated Areas and Warren County, Iowa and Incorporated Areas. FEMA is withdrawing the proposed notice.
42 U.S.C. 4104; 44 CFR 67.4.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before October 16, 2017.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each
You may submit comments, identified by Docket No. FEMA-B-1714, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
I. Non-watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR). The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will become effective on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW., Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
National Protection and Programs Directorate, DHS.
60-Day notice and request for comments.
The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), National Cybersecurity and Communications Integration Center (NCCIC), United States Computer Emergency Readiness Team (US-CERT) will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted until September 18, 2017. This process is conducted in accordance with 5 CFR 1320.1.
Written comments and questions about this Information Collection Request should be forwarded to DHS/NPPD/CS&C/NCCIC/US-CERT, 245 Murray Lane, SW., Mail Stop 0640, Arlington,VA 20598-0640. Emailed requests should go to
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US-CERT is responsible for performing, coordinating, and supporting response to information security incidents, which may originate outside the Federal community and affect users within it, or originate within the Federal community and affect users outside of it. Often, therefore, the effective handling of security incidents relies on information sharing among individual users, industry, and the Federal Government, which may be facilitated by and through US-CERT.
US-CERT fulfills the role of the Federal information security incident center for the United States Federal Government as defined in the Federal Information Security Modernization Act of 2014. Each Federal agency is required to notify and consult with US-CERT regarding information security incidents involving the information and information systems (managed by a Federal agency, contractor, or other source) that support the operations and assets of the agency. Additional entities report incident information to US-CERT voluntarily.
Per the Federal Information Security Modernization Act of 2014, as codified in subchapter II of chapter 35 of title 44 of the United States Code, US-CERT must inform operators of agency information systems about current and potential information security threats and vulnerabilities. Per the Homeland Security Act, as amended, the NCCIC, of which US-CERT and ICS-CERT are a part, is required to be the Federal civilian interface for sharing cybersecurity risks, incidents, analysis, and warnings for federal and non-Federal entities.
OMB is particularly interested in comments that:
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
National Protection and Programs Directorate, DHS.
60-day notice and request for comments.
The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), Stakeholder Engagement & Cyber Infrastructure Resilience Division (SECIR), will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted until September 18, 2017. This process is conducted in accordance with 5 CFR 1320.1.
Written comments and questions about this Information Collection Request should be forwarded to DHS/NPPD/CS&C/SECIR, 4200 Wilson Blvd., Mail Stop 0412, Arlington,VA 22203-0412. Emailed requests should go to
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Section 227 of the Homeland Security Act authorizes the National Cybersecurity and Communications Integration Center (NCCIC) within NPPD as a “Federal civilian interface for the multi-directional and cross-sector sharing of information related to . . . cybersecurity risks.” 6 U.S.C. 148(c)(1). This authority applies to Federal and non-Federal entities, including the private sector, small and medium businesses, sectors of critical infrastructure, and information sharing organizations. This provision includes the authority to receive, analyze and disseminate information about cybersecurity risks and incidents and to provide guidance, assessments, incident response support, and other technical assistance upon request and codifies NPPD's coordinating role among federal and non-federal entities. 6 U.S.C. 148.
As part of its information sharing responsibilities with non-Federal entities, the National Defense Authorization Act For Fiscal Year 2017 amended the Homeland Security Act to authorize the Department to specifically focus on small businesses. See Public Law 114-328 (2017). Specifically, the Act authorizes NPPD to “leverage small business development centers to provide assistance to small business concerns by disseminating information
Consistent with these authorities, E.O. 13636 directs the Department to increase its cybersecurity information sharing efforts with the private sector and consult on and promote the National Institute of Standards and Technology (NIST) Cybersecurity Framework. To facilitate the Department's promotion of the NIST Cybersecurity Framework, the E.O. directs the Secretary to establish a voluntary program to support the adoption of the Framework in coordination with Sector Specific Agencies, which in turn “shall coordinate with Sector Coordinating Councils to review the Cybersecurity Framework and, if necessary, develop implementation guidance or supplemental materials to address sector-specific risks and operating environments.” E.O. No. 13636, 78 FR 11739 (2013).
Accordingly, the Information Technology (IT) Sector, represented by industry via the IT Sector Coordinating Council (SCC) and by Government via the IT Government Coordinating Council (GCC), established the IT Sector Small and Midsized Business (SMB) Cybersecurity Best Practices Working Group (“Working Group”) to develop best practices for implementing the NIST Cybersecurity Framework in the SMB community. The Working Group, which consists of industry and government representatives, developed the SMB Cybersecurity Survey to determine Return on Investment (ROI) metrics for NIST Cybersecurity Framework adoption among SMB stakeholders. This process will assess the effectiveness of the NIST Cybersecurity Framework. This process will also establish a baseline for ROI metrics, which have not previously existed in the SMB community. The IT Sector-Specific Agency (SSA), headquartered in DHS CS&C, is supporting the Working Group's survey development.
DHS is not administering, controlling or soliciting the collection of the information via the survey. The IT SCC will administer the survey and anonymize the data, which will then be sent to DHS for analysis. DHS is not administering or soliciting the collection of information via the survey. The analysis will determine ROI information for NIST Cybersecurity Framework adoption in the SMB community. The results of this analysis will be used to provide the SMB community with best practices on how to use the Cybersecurity Framework for business protection and risk management.
The questionnaire will be distributed to SMBs and is a two-part survey. Questions 1-11 of the survey are for an organization's leadership, as these questions pertain to high level information about the company (core function, number of employees, etc.). The remaining questions are intended for the Chief Information Services Officer (CISO) and/or appropriate IT staff, as these questions are technical and ask about the IT security of the company.
The private sector will collect Point of Contact (POC) information through the survey instrument, but will not include that information on the anonymized dataset they submit to DHS. DHS will use anonymized data to conduct their analysis. The IT SCC will administer the survey.
The intent is for DHS to only receive derivative products—anonymized micro-dataset to come up with the summary statistics, or aggregated summary results. The IT SCC will conduct the actual data collection. DHS will aid with the statistical analysis where needed, but would not be working with the individual responses to the questionnaire. Even if the POC question does get included in the questionnaire, DHS would not be collecting or retaining PII.
Once the survey is administered by the private sector partners of the IT SCC to the member organizations, the collected raw inputs will be compiled and the resulting dataset will be processed by the private sector partners to (a) assign unique random identifiers to each of the responses, (b) scrub any PII from the microdata, (c) QA against the raw input. These processing steps (a-c) will be implemented PRIOR to handing the dataset to DHS for statistical analysis. This survey represents a new collection.
OMB is particularly interested in comments that:
1. 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;
2. 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;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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,
Transportation Security Administration, DHS.
60-Day notice.
The Transportation Security Administration (TSA) invites public comment on a new Information Collection Request (ICR) abstracted below, that we will submit to the Office of Management and Budget (OMB) for approval in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of travel information to TSA to provide wounded warriors, severely injured military personnel, and certain other travelers with assistance through the airport security screening process.
Send your comments by September 18, 2017.
Comments may be emailed to
Christina A. Walsh at the above address, or by telephone (571) 227-2062.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
The Transportation Security Administration (TSA) established the Military Severely Injured Joint Support Operations Center (MSIJSOC) and the Travel Protocol Office (TPO) programs to support and facilitate the movement of wounded warriors, severely injured military personnel, veterans and other travelers requiring an escort through the airport security screening process. The MSIJSOC and TPO programs are available at commercial airports within the continental United States and its territories.
The MSIJSOC program works with passengers who are wounded warriors, severely injured military members, and veterans. Once flight arrangements are made with the airlines, the traveler, his or her family, or other representative may contact the TSA Cares Hotline no later than 72 hours prior to their scheduled flight time with the details of the itinerary. TSA will collect the traveler's name, travel itinerary (flight departure and arrival information), and a point-of-contact's mobile phone number. Once TSA collects this information, TSA Cares will contact MSIJSOC, where the staff will vet the request via the appropriate Wounded Warrior Care Coordinator to verify the wounded warriors, severely injured military members, and veterans' eligibility. After verifying eligibility, the MSIJSOC will contact the respective TSA official at the appropriate airport for action.
Additionally, the TPO program facilitates the movement of foreign dignitaries, accredited Ambassadors to the United States and others who may require an escort through the airport security screening process. These travelers may contact the TPO office by submitting a request for travel support via telephone. Travelers and their points-of-contact should submit their travel support requests no later than 72 hours prior to the respective scheduled flight to allow TSA to make timely notification regarding the travel. TSA will collect the traveler's name, travel itinerary (flight departure and arrival information), and a point-of-contact's mobile phone number.
The estimated annual burden for this collection is 467 hours. The estimated number of annual respondents is 5,600 with each response taking approximately 0.0833 hours (5600 × 0.0833).
Fish and Wildlife Service, Interior.
Notice of availability: notice of receipt of a permit application; and announcement of a public meeting.
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft environmental impact statement (dEIS), which evaluates the impacts of, and alternatives to, the proposed Barton Springs Edwards Aquifer Conservation District (BSEACD) Habitat Conservation Plan (dHCP) for federally-listed Barton Springs salamander (BSS) and Austin blind salamander (ABS) (collectively, covered species) incidental take in portions of Travis and Hays Counties, Texas, where pumping withdrawals are implemented, authorized, or permitted by BSEACD. We also announce that we will hold a public meeting on this project.
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○ U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758, 512/490-0057.
○ U.S. Fish and Wildlife Service, 500 Gold Avenue SW., Albuquerque, NM 87102, Room 6034, 505/248-6920.
○ Department of the Interior, Natural Resources Library, 1849 C. St. NW., Washington, DC 20240.
Persons wishing to review the application may obtain a copy by writing to the Regional Director, U.S. Fish and Wildlife Service, P.O. Box 1306, Room 6034, Albuquerque, NM 87103 (Attention: Branch of Environmental Review).
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• For how to view comments on the EIS from the Environmental Protection Agency (EPA), or for information on EPA's role in the EIS process, see EPA's Role in the EIS Process under
• We will also accept written and oral comments at the public meeting (see
We request that you send comments by only the methods described above. We will post all information received on
Field Supervisor, U.S. Fish and Wildlife Service, 10711 Burnet Road, Suite 200, Austin, TX 78758 or (512) 490-0057.
In addition to this notice of the dEIS, EPA is publishing a notice announcing the dEIS, as required under section 309 of the Clean Air Act (42 U.S.C. 7401
We initially prepared a notice of intent (NOI) to prepare an environmental impact statement (EIS), which was published in the
The proposed action involves the issuance of an ITP by the Service for the covered activities in the permit area, pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973 (Act), as amended. The ITP would cover “take” of the covered species associated with permitted pumping occurring within the permit area.
The requested term of the ITP is 20 years. To meet the requirements of a section 10(a)(1)(B) ITP, the applicant developed and proposes to implement their dHCP, which describes the conservation measures the applicant has agreed to undertake to minimize and mitigate for the impacts of the proposed incidental take of the covered species to the maximum extent practicable, and ensure that incidental take will not appreciably reduce the likelihood of the survival and recovery of these species in the wild.
Four alternatives to the proposed action we are considering as part of this process are:
Section 9 of the Act and its implementing regulations prohibit “take” of fish and wildlife species listed as threatened or endangered under section 4 of the Act. However, section 10(a) of the Act authorizes us to issue permits to take listed wildlife species where such take is incidental to, and not the purpose of, otherwise lawful activities and where the applicant meets certain statutory requirements.
The Service will hold a public meeting during the public comment period. The date, time, and location of the meeting will be noticed in local newspapers at least two weeks before the meeting and will also be posted on the following Web site:
In addition, EPA is publishing a notice announcing the dEIS, as required under section 309 of the Clean Air Act. The publication date of EPA's notice of availability is the official start of the public comment period for the dEIS. Under the Clean Air Act, EPA also must subsequently announce the final EIS via the
EPA also serves as the repository (EIS database) for EISs prepared by Federal agencies and provides notice of their availability in the
The notice of availability is the start of the 60-day public comment period for draft EISs. For more information, see
Written comments we receive become part of the public record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. We will not consider anonymous comments. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
We provide this notice under section 10(c) of the Act and its implementing regulations (50 CFR 17.22 and 17.32) and NEPA and its implementing regulations (40 CFR 1506.6).
Bureau of Indian Affairs, Interior.
Notice.
This notice informs the public that the Principal Deputy Assistant Secretary—Indian Affairs proclaimed approximately 30.03 acres, more or less, of land near the Town of Willis, Marshall County, Oklahoma (Willis Site) in trust for the Chickasaw Nation for gaming and other purposes on January 19, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Bureau of Indian Affairs, MS-3657 MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 219-4066.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On January 19, 2017, the Principal Deputy Assistant Secretary—Indian Affairs issued a decision to accept the Willis Site, consisting of approximately 30.03 acres, more or less, of land in trust for the Chickasaw Nation (Nation), under the authority of the Indian Reorganization Act, 25 U.S.C. 5108. The Principal Deputy Assistant Secretary—Indian Affairs determined that Nation's request also meets the requirements of the Indian Gaming Regulatory Act's “Oklahoma exception,” 25 U.S.C. 2719(a)(2)(A)(i), to the general prohibition contained in 25 U.S.C. 2719(a) on gaming on lands acquired in trust after October 17, 1988.
The Principal Deputy Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will
The 30.03 acres, more or less, are located in Marshall County, Oklahoma, and are described as follows:
A parcel or tract of land in the Southeast Quarter of Section 1, Township 8 South, Range 4 East, of the Indian Meridian, Marshall County, Oklahoma, more particularly described as follows:
Commencing at the Southeast corner of said Southeast Quarter;
THENCE South 89°30′30″ West, along the South line of said Southeast Quarter, a distance of 787.65 feet to a point on the easterly right of way line of State Highway 99 (U.S. Highway 377) as shown on Federal Aid Secondary Project No. S-896 (2) (3)-S Plans (SWO 2294 (1)), said point being North 89°30′30″ East 1857.50 feet from the Southwest Corner of said Southeast Quarter;
THENCE along said easterly right of way line, the following eight (8) courses:
1. North 04°26′00″ West a distance of 50.12 feet;
2. North 86°03′31″ West a distance of 323.45 feet;
3. North 04°26′00″ West a distance of 237.02 feet;
4. North 06°52′36″ East a distance of 305.94 feet;
5. North 04°26′00″ West a distance of 580.00 feet;
6. North 15°44′36″ West a distance of 9.87 feet to the POINT OF BEGINNING;
7. continuing North 15°44′36″ West, a distance of 372.55 feet;
8. North 04°26′00″ West a distance of 940.17 feet;
THENCE North 89°29′14″ East, parallel with the North line of said Southeast Quarter, a distance of 1078.65 feet;
THENCE South 00°39′14″ East, parallel with the East line of said Southeast Quarter, a distance of 135.71 feet;
THENCE South 89°20′46″ West a distance of 30.00 feet;
THENCE South 00°39′14″ East, parallel with the East line of said Southeast Quarter, a distance of 552.00 feet;
THENCE South 03°47′57″ East a distance of 330.34 feet;
THENCE South 04°34′12″ East a distance of 280.92 feet;
THENCE South 89°30′30″ West, parallel with the South line of said Southeast Quarter, a distance of 927.00 feet to the POINT OF BEGINNING. Said described tract of land contains an area of 1,036,772 square feet or 29.9994 acres, more or less. SURFACE ONLY.
A tract of land in the Southeast Quarter (SE/4) of Section One (1), Township Eight (8) South, Range Four (4) East, Indian Meridian, Marshall County, Oklahoma, being more particularly described as follows:
Commencing at the Southeast corner of the Southeast Quarter of said Section 1; Thence N89°49′51″ W, along the South line of the Southeast Quarter, a distance of 791.92 feet to a point on the East Right-of-Way line of State Highway No. 99 as filed in Book 233 on Page 646 and Book 232 on Page 100 in the Office of the County Clerk, Marshall County, Oklahoma;
THENCE along said East Right-of-Way line for the following Eight (8) courses:
1. Thence N03°46′26″ W., a distance of 49.96 feet;
2. Thence N85°24′26″ W., a distance of 319.80 feet;
3. Thence N03°46′26″ W., a distance of 237.30 feet;
4. Thence N07°32′34″ E., a distance of 306.00 feet;
5. Thence N03°46′26″ W., a distance of 580.00 feet;
6. Thence N15°04′26″ W., a distance of 9.87 feet to the POINT OF BEGINNING;
7. Thence continuing N15°04′26″ W., a distance of 372.63 feet;
8. Thence N03°46′26″ W., a distance of 940.17 feet; Thence S89°53′31″ E. along the North line of a Tract as filed in Book 1003 on Page 08 in the Office of the County Clerk and being parallel with the North line of the Southeast Quarter, a distance of 1079.22 feet to a point on the West line of a tract of land as filed in Book 606 on Page 237 in the office of the County Clerk; Thence S00°00′21″ W., along the West line of said aforementioned tract, a distance of 136.49 feet to the Southwest Corner thereof; Thence N89°59′39″ W., along the North line of a tract of land as described and filed in Book 853 on Page 26 in the Office of the County Clerk, a distance of 30.00 feet to the Northwest Corner thereof; Thence S00°00′21″ W., along the West line of said tract as filed in Book 853 on Page 26 and along the West line of a tract of land as filed in Book 780 on Page 166 in the Office of the County Clerk, a distance of 552.00 feet to the Southwest Corner of the aforementioned Tract; Thence S03°08′23″ E., along the West line of a tract of land as filed in Book 679 on Page 178 in the Office of the County Clerk, a distance of 330.27 feet to the Southwest Corner thereof; Thence S03°54′49″ E., along the West line of a tract of land as filed in Book 358 on Page 231 in the Office of the County Clerk, a distance of 281.05 feet;
THENCE N89°49′51″ W., parallel with the South line of the Southeast Quarter, a distance of 927.64 feet to the POINT OF BEGINNING, having an area of 30.03 Acres. All bearings contained in this legal description were based upon True North by GPS Observation. Prepared on this date, DECEMBER 27, 2013 by Obert D. Bennett, RPLS No. 1471 Oklahoma. SURFACE ONLY.
Bureau of Indian Affairs, Interior.
Notice.
The Principal Deputy Assistant Secretary—Indian Affairs made a final agency determination to acquire 51.35 acres, more or less, located in Sequoyah County, Oklahoma (the Parcels) in trust for the Cherokee Nation for gaming and other purposes on January 19, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Bureau of Indian Affairs, MS-3657 MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 219-4066.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Principal Deputy Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12 (c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On January 19, 2017, the Assistant Secretary—Indian Affairs issued a decision to accept the Parcels, consisting of approximately 51.35 acres, more or less, of land in trust for the Nation, under the authority of the Indian Reorganization Act, 25 U.S.C. 5108. The Principal Deputy Assistant Secretary—Indian Affairs determined that the Nation's request also meets the requirements of the Indian Gaming
The Principal Deputy Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will immediately acquire title to the Parcels in the name of the United States of America in trust for the Nation upon fulfillment of Departmental requirements.
The 51.35 acres, more or less, are located in Sequoyah County, Oklahoma, and are described as follows:
A part of Section 23, Township 11 North, Range 26 East, I.B.&M., Sequoyah County, Oklahoma, more particularly described as follows:
Beginning at the NW corner of said S2 SW4 SW4; thence East along the North line of said S2 SW4 SW4 751.6 feet; thence South 02°40′ West 451.7 feet to a point on the North right of way line of a frontage road for U.S. Highway 64; thence along said right of way line South 89°50′ West 67.3 feet; thence South 01°31′ East 23.5 feet; thence South 88°29′ West 260.6 feet; thence North 81° 53′ West 51.0 feet; thence South 88°29′ West 353.3 feet to the West line of said S2 SW4 SW4; thence North 0°02′ East along said West line 483.9 feet to the Point of Beginning.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
A Tract of land that is a part of the S/2 SW/4 SW/4 of Section Twenty-Three (23), Township Eleven (11) North, Range Twenty-Six (26) East of the Indian Meridian, Sequoyah County, State of Oklahoma, according to the United States Government Survey Thereof, being more particularly described as follows:
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S. 04°09′44″ E. 1985.58 feet to the Northwest corner of said S/2 SW/4 SW/4, said Northwest corner being the Point of Beginning;
Thence along the North Line of said S/2 SW/4 SW/4 N. 86°16′37″ E. 751.58 feet; thence S. 01°18′13″ E. 456.76 feet to the North Right of Way of State Highway 64; thence along said Highway Right of Way the following five courses; thence S. 86°34′00″ W. 67.27 feet; thence S. 04°47′00″ E. 23.50 feet; thence S. 85°02′08″ W. 249.66 feet; thence N. 83°39′15″ W. 51.00 feet; thence S. 85°02′09″ W. 362.01 feet to the West line of said S/2 SW/4 SW/4; thence along said West Line N. 04°09′44″ W. 483.83 feet to the Point of Beginning, containing 8.13 acres more or less.
Basis of Bearing: Bearings Based True North, the West Line of the Southwest Quarter of Section 23, T11N, R26E Having a Bearing of N04°09′44″ W.
AND
Commencing at the NW Corner of said S2 SW4 SW4; thence running East along the North line of said S2 SW4 SW4, 1257.11 feet; thence South 01°16′00″ West 250.28 feet to the Point of Beginning;
Thence South 88°44′00″ East 60.00 feet to the East line of said S2 SW4 SW4; thence South 01°16′00″ West along said East line 36.18 feet to the North right of way line of U.S. Highway 64 frontage road; thence South 69°37′00″ West along said right of way line 64.55 feet; thence North 01°16′00″ East 60.00 feet to the Point of Beginning.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
A Tract of land that is a part of the S/2 SW/4 SW/4 of Section Twenty-Three (23), Township Eleven (11) North, Range Twenty-Six (26) East of the Indian Meridian, Sequoyah County, State of Oklahoma, according to the United States Government Survey Thereof, being more particularly described as follows:
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S. 04°09′44″ E. 1985.58 feet to the Northwest corner of said S/2 SW/4 SW/4; thence along the North Line thereof N. 86°16′37″ E. 1324.38 feet to the East line of said S/2 SW/4 SW/4; thence along said East Line S04°11′12″ E. 253.32 feet to the point of Beginning;
Thence continuing along said East Line S04°11′12″ E. 36.22 feet to the North Right of Way of State Highway 64; thence along said Highway Right of Way S. 65°09′59″ W. 64.15 feet; thence leaving said Right of Way N. 04°11′12″ W. 60.00 feet; thence N. 86°51′17″ E. 60.00 feet to the Point of Beginning containing 0.07 acres more or less.
Basis of Bearing: Bearings Based True North, the West Line of the Southwest Quarter of Section 23, T11N, R26E Having a Bearing of N04°09′44″ W.
Beginning at a point 1,044.61 feet East of the NW corner of the S2 SW4 SW4; thence North 207 feet; thence South 86°28′59″ East 277.74 feet to the East line of said SW4 SW4; thence South 01°16′00″ West along said East line, 441.64 feet; thence North 88°44′00″ West 60.00 feet; thence South 01°16′00″ West 60.00 feet to the North right-of-way line of US. Highway 64 Frontage Road; thence South 69°37′00″ West along said Frontage Road 219.38 feet; thence North 386.61 feet to the POINT OF BEGINNING.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
A Tract of land that is a part of the E/2 SW/4 SW/4 of Section Twenty-Three (23), Township Eleven (11) North, Range Twenty-Six (26) East of the Indian Meridian, Sequoyah County, State of Oklahoma, according to the United States Government Survey Thereof, being more particularly described as follows:
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S 04°09′44″ E. 1985.58 feet to the Northwest corner of said S/2 SW/4 SW/4; thence along the North Line thereof N 86°16′37″ E. 1045.67 feet to the Point of Beginning;
Thence N. 04°01′38″ W. 205.68 feet; thence N. 89°45′38″ E. 278.78 feet to the East line of said S/2 SW/4 SW/4; thence along said East line S. 04°11′12″ E. 442.07 feet; thence leaving said East Line S. 86°51′17″ W. 60.00 feet; thence S. 04°11′12″ E. 60.00 feet to the north Highway Right of Way Line of State Highway 64; thence along said Highway Right of Way S. 65°05′59″ W. 234.98 feet; thence leaving said Right of Way N. 04°01′38″ W. 397.60 feet to the Point of Beginning containing 3.40 acres more or less.
Beginning at an existing monument marking the NE corner of the SW4 SW4; Thence along the East line of said Forty Acres, South 02°08′14″ East 453.72 feet to a set rebar with cap; Thence leaving said East line, South 88°17′13″ West 278.41 feet; Thence South 01°44′16″ East 2.00 feet; Thence South 88°29′39″ West 39.95 feet to an existing p/k nail; Thence North 03°12′26″ West 456.02 feet to a set rebar with cap on the North line of the SW4 SW4; Thence along said North line North 88°20′22″ East 326.89 feet to the Point of Beginning.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
A Tract of land that is a part of the E/2 SW/4 SW/4 of Section Twenty-
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S. 04°09′44″ E. 1323.76 feet to the Northwest corner of the SW/4 SW/4; thence along the North Line thereof N. 86°17′13″ E. 1009.38 feet to the Point of Beginning;
Thence continuing along said North line N. 86°17′13″ E. 314.71 feet to the Northeast corner of said SW/4 SW/4; thence along the East Line thereof S. 04°11′12″ E. 455.68 feet; thence leaving said East Line S 86°13′44″ W. 278.12 feet; thence S. 03°45′23″ E. 2.000 feet; thence S. 86°14′35″ W. 40.01 feet; thence N. 03°45′23″ W. 457.97 feet to the Point of Beginning containing 3.31 acres more or less.
AND
Commencing at the NE corner of SW4 SW4; Thence South 02°07′21″ East along the East line of said SW a distance 453.72 feet to the Point of Beginning;
Thence continuing South 02°07′21″ East along said East line a distance of 17.15 feet; Thence North 88°12′18″ West a distance of 278.47 feet; Thence North 88°15′48″ East a distance of 277.83 feet to the Point of Beginning.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S. 04°09′44″ E. 1323.76 feet to the Northwest corner of the SW/4 SW/4; thence along the North Line thereof N. 86°17′13″ E. 1324.09 feet to the Northeast corner of said SW/4 SW/4; thence along the East Line of said SW/4 SW/4 S. 04°11′12″ E. 455.68 feet to the Point of Beginning;
Thence continuing along said East line S. 04°11′12″ E. 17.17 feet; thence S. 89°45′38″ W. 278.78 feet; thence N. 86°13′44″ E. 278.12 feet to the Point of Beginning containing 0.05 acres more or less.
Beginning at an existing monument marking the SW Corner of the NE4 SW4; Thence along the West line North 02°06′07″ West 661.46 feet to a set rebar with cap; Thence leaving said West line North 88°20′39″ East 1324.70 feet to a set rebar with cap on the East line of the NE4 SW4; Thence along the East line of the SW4 South 02°07′34″ East 1030.15 feet to a set rebar with cap on the North right of way line of Interstate 40; Thence leaving said East line and along said right of way line South 68°22′49″ West 89.84 feet to a right of way marker; Thence South 56°48′43″ West 249.44 feet to a right of way marker; Thence around a curve to the right having a radius of 1789.86 feet and subtended by a chord bearing and distance of South 59°38′43″ West 176.96 feet to a set rebar with cap; Thence leaving said right of way line North 02°07′33″ West 162.99 feet to a set rebar with cap; Thence South 88°20′39″ West 420 feet to a set rebar with cap; Thence South 02°07′33″ East 210 feet to a set rebar with cap; Thence South 88°20′39″ West 450.56 feet along the West line of the SE4 SW4; Thence along said West line North 02°08′14″ West 661.81 feet to the Point of Beginning.
ALSO FURTHER DESCRIBED IN SURVEY Approved 10-13-2014 by Licensed Professional Land Surveyor #1199 Richard Wright as follows:
A Tract of land that is a part of the E/2 SW/4 of Section Twenty-Three (23), Township Eleven (11) North, Range Twenty-Six (26) East of the Indian Meridian, Sequoyah County, State of Oklahoma, according to the United States Government Survey thereof, being more particularly described as follows:
Commencing at the Northwest Corner of said SW/4; thence along the West Line thereof S. 04°09′44″ E. 1323.76 feet to the Northwest corner of the SW/4 SW/4; thence along the North Line thereof N. 86°17′13″ E. 1324.09 feet to the Northeast corner of said SW/4 SW/4, said Northeast corner being the Point of Beginning; Thence along the West Line of said E/2 SW/4 N. 04°08′39″ W. 661.89 feet; thence leaving said West Line N. 86°17′55″ E. 1324.10 feet to the East Line of said SW/4; thence along said East Line S. 04°08′34″ E. 1030.53 feet to the North Right of Way of State Highway 64; thence along said Highway Right of Way the following three courses; thence S. 65°57′03″ W. 88.98 feet to a Concrete Right of Way Monument; Thence S. 54°46′36″ W. 249.44 feet to a Concrete Right of Way Monument; thence on a curve to the right having a radius of 1789.86 feet, an arc length of 177.03 feet, a chord bearing of S. 57°36′36″ W., and a chord length of 176.96 feet; thence leaving said Right of Way N. 03°55′59″ W. 163.08 feet; thence S. 86°18′50″ W. 419.94 feet; thence S. 04°08′51″ E. 209.99 feet; thence S. 86°19′08″ W. 451.05 feet to said West Line of E/2 SW/4; thence along said West Line N. 04°11′12″ W. 661.59 feet to the Point of Beginning, containing 36.39 acres more or less.
Bureau of Indian Affairs, Interior.
Notice.
This notice announces that the Tribal-State Class III Gaming Compact Amendment entered into between the Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Indian Reservation of Wisconsin and the State of Wisconsin is taking effect.
This notice takes effect July 18, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Assistant Secretary—Indian Affairs, Washington, DC 20240, (202) 219-4066.
Section 11 of the Indian Gaming Regulatory Act (IGRA) requires the Secretary of the Interior (Secretary) to publish in the
Bureau of Indian Affairs, Interior.
Notice.
The Principal Deputy Assistant Secretary—Indian Affairs made a final agency determination to acquire 30.05 acres, more or less, of land near the Town of Terral, Jefferson County, Oklahoma (Terral Site) in trust for the Chickasaw Nation for gaming and other purposes on January 19, 2017.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Bureau of Indian Affairs, MS-3657 MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 219-4066.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On January 19, 2017, the Principal Deputy Assistant Secretary—Indian Affairs issued a decision to accept the Terral Site, consisting of approximately 30.05 acres, more or less, of land in trust for the Chickasaw Nation (Nation), under the authority of the Indian Reorganization Act, 25 U.S.C. 5108. The Principal Deputy Assistant Secretary—Indian Affairs determined that Nation's request also meets the requirements of the Indian Gaming Regulatory Act's “Oklahoma exception,” 25 U.S.C. 2719(a)(2)(A)(i), to the general prohibition contained in 25 U.S.C. 2719(a) on gaming on lands acquired in trust after October 17, 1988.
The Principal Deputy Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will immediately acquire title to the Terral Site in the name of the United States of America in trust for the Nation upon fulfillment of Departmental requirements.
The 30.05 acres, more or less, are located in Jefferson County, Oklahoma, and are described as follows:
A tract of land in the South Half (S/2) of the Southeast Quarter (SE/4) of Section Four (4), Township Eight (8) South, Range Seven (7) West, Indian Base and Meridian, Jefferson County, Oklahoma, being more particularly described as follows: Commencing at the Southeast Corner of said Section 4;
Thence N. 89°55′53″ W., along the South line of the Southeast Quarter, a distance of 800.90 feet to the POINT OF BEGINNING; Thence continuing N. 89°55′53″ W., along the South line of the Southeast Quarter, a distance of 923.58 feet to a point on the Easterly Right of Way line of U.S. Highway No. 81 as filed in the Office of the County Clerk, Jefferson County, Oklahoma on a Warranty Deed in Book 489 on Page 289; Thence along said Easterly Right of Way line of U.S. Highway No. 81 for the following Four (4) Courses,
1. Thence N. 00°48′14″ E., a distance of 656.17 feet;
2. Thence N. 27°10′10″ W., a distance of 164.04 feet;
3. Thence with a non-tangent curve, turning to the Left with an arc length of 424.41 feet, with a radius of 2431.83 feet, with a chord bearing of N. 21°43′54″ W., with a chord length of 423.87 feet;
4. Thence N. 35°29′11″ W., a distance of 156.29 feet to a point on the North line of the South Half of the Southeast Quarter; Thence S. 89°58′49″ E., along the North line of the South Half of the Southeast Quarter, a distance of 1233.24 feet; Thence S. 00°09′38″ E., parallel with the West line of the Southeast Quarter of the Southeast Quarter, a distance of 1323.74 feet to the POINT OF BEGINNING, containing 30.05 Acres more or less. This legal description was based upon True North as determined by GPS Observation. Prepared by Obert D. Bennett, RPLS No. 1471 on December 19, 2013. SURFACE ONLY.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before June 10, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by August 2, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before June 10, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
Nominations submitted by State Historic Preservation Officers:
In the interest of preservation, a SHORTENED comment period has been requested for the following resource(s):
A request for removal has been made for the following resource(s):
An additional documentation has been received for the following resource(s):
Nominations submitted by Federal Preservation Officers:
The State Historic Preservation Officer reviewed the following nomination and responded to the Federal Preservation Officer within 45 days of receipt of the nomination and supports listing the property in the National Register of Historic Places.
36 CFR 60.13.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before June 17, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by August 2, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 7228, Washington, DC 20240.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before June 17, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
Nominations submitted by State Historic Preservation Officers:
An additional documentation has been received for the following resource(s):
36 CFR 60.13
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before June 24, 2017, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by August 2, 2017.
Comments may be sent via U.S. Postal Service and all other carriers to the National Register of Historic
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before June 24, 2017. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
Nominations submitted by State Historic Preservation Officers:
An additional documentation has been received for the following resource(s):
Nominations submitted by Federal Preservation Officers:
The State Historic Preservation Officer reviewed the following nomination(s) and responded to the Federal Preservation Officer within 45 days of receipt of the nomination(s) and supports listing the property(ies) in the National Register of Historic Places.
36 CFR 60.13
United States International Trade Commission.
July 20, 2017 at 10:30 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: None.
2. Minutes.
3. Ratification List.
4. Vote in Inv. No. 731-TA-1330 (Final) (Dioctyl Terephthalate (DOTP) from Korea). The Commission is currently scheduled to complete and file its determination and views of the Commission by August 2, 2017.
5. Outstanding action jackets: None.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty orders on brass sheet and strip from France, Germany, Italy, and Japan would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
Mary Messer ((202) 205-3193), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These reviews are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until August 17, 2017.
If you have comments 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 Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812 or sent to
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:
Overview of this information collection:
1.
2.
3.
4.
5.
6.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until August 17, 2017.
If you have comments 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 Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812 or send to
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:
Overview of this information collection:
1.
2.
3.
4.
5.
6.
If additional information is required please contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until August 17, 2017.
If you have comments 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 Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812 or sent to
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:
Overview of this information collection:
1.
2.
3.
4.
5.
6.
If additional information is required please contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
Occupational Safety and Health Administration (OSHA), Labor.
Notice of availability of funds and funding opportunity announcement (FOA) for Targeted Topic Training grants.
SHTG-FY-17-01 (Targeted Topic grants)
17.502
This notice announces availability of approximately $10.5 million for Susan Harwood Training Program grants. The funding opportunity announcement is available for Targeted Topic Training grants. Funding Opportunity Number SHTG-FY-17-01 will cover the two types of Targeted Topic Training grants: (1) Targeted Topic Training and (2) Training and Educational Materials Development grants.
Grant applications for Targeted Topic Training grants must be received electronically by the
The complete Susan Harwood Training Grant Program funding opportunity announcement and all information needed to apply are available at the
Questions regarding the funding opportunity announcement should be emailed to
To obtain further information on the Susan Harwood Training Grant Program, visit the OSHA Web site at:
Questions regarding
Thomas Galassi, Acting Deputy Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is Section 21 of the Occupational Safety and Health Act of 1970, (29 U.S.C. 670), Public Law 113-235, and Secretary of Labor's Order No. 1-2012 (77 FR 3912).
Veterans' Employment and Training Service (VETS), Labor.
Notice.
The Veterans' Employment and Training Service (VETS) is announcing an opportunity for public comment on a proposed collection of information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Comments must be submitted by September 18, 2017.
Follow the instructions for submitting comments.
Receipt of submissions, whether by U.S. Mail, email, or FAX transmittal, will not be acknowledged; however, the sender may request confirmation that a submission has been received by telephoning VETS at (202) 693-4731 (VOICE) (this is not a toll-free number) or (202) 693-4760 (TTY/TDD).
All comments received, including any personal information provided, will be available for public inspection during normal business hours at the above address. People needing assistance to review comments will be provided with appropriate aids such as readers or print magnifiers.
Kenan Torrans, Deputy Director, Compliance and Investigations, VETS, U.S. Department of Labor, Room S-1212, 200 Constitution Avenue NW., Washington, DC 20210, or by email at:
I.
The regulations in 41 CFR part 61-300 require contractors and subcontractors with a covered Federal contract entered into or modified in the amount of $150,000 or more to use the Federal Contractor Veterans' Employment Report VETS-4212 form for reporting information on their employment of covered veterans under VEVRAA.
The VETS-4212 Report is currently approved under OMB No. 1293-0005.
II.
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
III.
Electronic Submission—20 minutes.
Paper Submission—40 minutes.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued, from June 20,
Comments must be filed by August 17, 2017. A request for a hearing must be filed by September 18, 2017.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Lynn Ronewicz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1927, email:
Please refer to Docket ID NRC-2017-0158, facility name, unit number(s), plant docket number, application date, and subject, when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2017-0158, facility name, unit number(s), plant docket number, application date, and subject, in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 60 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or federally recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC's Web site at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland, 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change to the PVNGS Cyber Security Plan implementation schedule is administrative in nature. This proposed change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components (SSCs) relied upon to mitigate the consequences of postulated accidents, and has no impact on the probability or consequences of an accident previously evaluated.
Therefore, the proposed change will not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change to the PVNGS Cyber Security Plan implementation schedule is administrative in nature. This proposed change does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the SSCs relied upon to mitigate the consequences of postulated accidents, and does not create the possibility of a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Plant safety margins are established through limiting conditions for operation, limiting safety systems settings, and safety limits specified in the [T]echnical [S]pecifications [TSs]. The proposed change to the PVNGS Cyber Security Plan implementation schedule is administrative in nature. Since the proposed change is administrative in nature, there are no changes to these established safety margins.
Therefore, the proposed change does not involve a significant reduction in a margin of safety as defined in the basis for any TS.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff
The proposed change does not adversely affect accident initiators or precursors nor alter the design assumptions, conditions, or configuration of the facility. The proposed change does not alter or prevent the ability of structures, systems, and components (SSCs) to perform their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits. The proposed change revises the TS for the [CRVS], which is a mitigation system designed to minimize unfiltered air leakage into the CRE and to filter the CRE atmosphere to protect the CRE occupants in the event of accidents previously analyzed. An important part of the [CRVS] is the CRE boundary. The [CRVS] is not an initiator or precursor to any accident previously evaluated. Therefore, the probability of any accident previously evaluated is not increased. Performing tests to verify the operability of the CRE boundary and implementing a program to assess and maintain CRE habitability ensure that the [CRVS] is capable of adequately mitigating radiological consequences to CRE occupants during accident conditions, and that the [CRVS] will perform as assumed in the consequence analyses of design basis accidents. Thus, the consequences of any accident previously evaluated are not increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed change does not impact the accident analysis. The proposed change does not alter the required mitigation capability of the [CRVS], or its functioning during accident conditions as assumed in the licensing basis analyses of design basis accident radiological consequences to CRE occupants. No new or different accidents result from performing the new surveillance or following the new program. The proposed change does not involve a physical alteration of the plant (
Therefore, this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The proposed change does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The proposed change does not affect safety analysis acceptance criteria. The proposed change will not result in plant operation in a configuration outside the design basis for an unacceptable period of time without compensatory measures. The proposed change does not adversely affect systems that respond to safely shut down the plant and to maintain the plant in a safe shutdown condition.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed amendment would modify the VY facility operating license by revising the emergency plan and EAL scheme. VY has permanently ceased power operations and is permanently defueled. The proposed amendment is conditioned on all spent nuclear fuel being removed from wet storage in the SFP and placed in dry storage within the ISFSI. Occurrence of postulated accidents associated with spent fuel stored in a SFP is no longer credible in a SFP devoid of fuel. The proposed amendment has no effect on plant structures, systems, or components (SSC) and therefore can neither affect the capability of any plant SSC to perform its design function nor increase the likelihood of the malfunction of any plant SSC. The proposed amendment would have no effect on any of the previously evaluated accidents in the VY Defueled Safety Analysis Report or the Holtec HI-STORM 100 Final Safety Analysis Report.
Because VY has permanently ceased power operations, the generation of fission products has largely ceased and the remaining source term continues to decay. This source term decay continues to significantly reduce the consequences of previously evaluated postulated accidents. Furthermore, previously generated source term materials such as reactor water cleanup resins have been removed from the site in accordance with applicable regulations and permitting requirements.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed amendment constitutes a revision of the emergency planning function commensurate with the ongoing and anticipated reduction in radiological source term at VY.
The proposed amendment does not involve a physical alteration of the plant. No new or different types of equipment will be installed and there are no physical modifications to existing equipment as a result of the proposed amendment. Similarly, the proposed amendment would not physically change any SSC involved in the mitigation of any postulated accidents. Thus, no new initiators or precursors of a new or different kind of accident are created. Furthermore, the proposed amendment does not create the possibility of a new failure mode associated with any equipment or personnel failures. The credible events for the ISFSI remain unchanged.
Therefore, the proposed amendments do not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
Because the 10 CFR part 50 license for VY no longer authorizes operation of the reactor or emplacement or retention of fuel into the reactor vessel, as specified in 10 CFR 50.82(a)(2), the postulated accidents associated with reactor operation are no longer credible. In addition, with all spent nuclear fuel transferred out of wet storage from the SFP and placed in dry storage within the ISFSI, a fuel handling accident is no longer credible during dry storage of spent nuclear fuel. Therefore, there are no credible events that would result in radiological releases beyond the site boundary exceeding the exposure levels in U.S. EPA's “Protective Action Guide and Planning Guidance for Radiological Incidents,” dated January 2017.
The proposed amendment does not involve a change in the plant's design, configuration, or operation. The proposed amendment does not affect either the way in which the plant SSCs perform their safety function or their design margins. Because there is no change to the physical design of the facility, there is no change to these margins.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change to the CSP Implementation Schedule does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and has no impact on the probability or consequences of an accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change to the CSP Implementation Schedule does not alter accident analysis assumptions, add any initiators, or affect the function of plant systems or the manner in which systems are operated, maintained, modified, tested, or inspected. The proposed change does not require any plant modifications which affect the performance capability of the structures, systems, and components relied upon to mitigate the consequences of postulated accidents and does not create the possibility of a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Plant safety margins are established through limiting conditions for operation, limiting safety system settings, and safety limits specified in the technical specifications. The proposed change to the CSP Implementation Schedule does not involve these items. In addition, the milestone date delay for full implementation of the CSP has no substantive impact because other measures have been taken which provide adequate protection during this period of time. Because there is no change to established safety margins as a result of this change, the proposed change does not involve a significant reduction in a margin of safety.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The use of the non-seismic Boric Acid Recovery System (BARS) to recirculate and filter the RWST water does not involve any changes or create any new interfaces with the reactor coolant system or main steam system piping. Therefore, the connection of the BARS Purification Loop to the RWST would not affect the probability of these accidents occurring. The BARS is not credited for safe shutdown of the plant or accident mitigation. Administrative controls ensure that the BARS can be isolated as necessary and in sufficient time to assure that the RWST volume will be adequate to perform the safety function as designed. Since the RWST will continue to perform its safety function and overall system performance is not affected, the consequences of the accident are not increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The design of the RWST and the SFP [Spent Fuel Pool] Purification Loop has been revised to allow recirculation and purification using the BARS for a short period of time (not to exceed 30 days per fuel cycle) for the next fuel cycle. The BARS takes RWST water in and processes it out without additional connections that could affect other systems and without an impact from its installation. Procedures for the operation of the plant, including the BARS, will not create the possibility of a new or different type of accident. Contingent upon manual operator action, a BARS line break will not result in a loss of the RWST safety function. Similarly, an active or passive failure in the BARS will not affect safety related structures, systems or components.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The SFP Purification Loop and recirculation and purification of the RWST water using the BARS is not credited for safe shutdown of the plant or accident mitigation. RWST volume will be maximized prior to purification and timely operator action can be taken to isolate the non-seismic system from the RWST to assure it can perform its function. This will result in no significant reduction in the margin of safety.
Therefore the proposed change does not significantly reduce the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed amendment would allow the use of Optimized ZIRLO
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The use of Optimized ZIRLO
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed amendment will not involve a significant reduction in the margin of safety. NRC-approved Topical Report WCAP-12610-P-A & CENPD-404-P-A, Addendum 1-A, demonstrated that the material properties of the Optimized ZIRLO
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
No setpoint values or PMS actuations are proposed to be changed by this activity. Nor are any values assumed in the safety analysis changed. This is an administrative change to standardize the PMS setpoint designators. The proposed amendment does not affect the prevention and mitigation of abnormal events,
These proposed changes have no adverse impact on the support, design, or operation of mechanical and fluid systems. The response of systems to postulated accident conditions is not adversely affected and remains within response time assumed in the accident analysis. There is no change to the predicted radioactive releases due to normal operation or postulated accident conditions. Consequently, the plant response to previously evaluated accidents or external events is not adversely affected, nor does the proposed change create any new accident precursors.
Therefore, the requested amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes do not involve a new failure mechanism or malfunction, which affects [a structure, system, component (SSC)] accident initiator, or interface with any SSC accident initiator or initiating sequence of events considered in the design and licensing bases. There is no adverse effect on radioisotope barriers or the release of radioactive materials. The proposed amendment does not adversely affect any accident, including the possibility of creating a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed changes do not create the possibility of a new or different type of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
No setpoint values or PMS actuations are proposed to be changed by this activity. This is an administrative change to standardize the PMS setpoint designators. The proposed changes would not affect any safety-related design code, function, design analysis, safety analysis input or result, or existing design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the requested changes.
Therefore the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed changes to COL Appendix C (and plant-specific Tier 1) Table 2.7.2-2, Updated Final Safety Analysis Report (UFSAR) Table 9.2.7-1, and associated UFSAR design information to identify the revised equipment parameters for the nuclear island nonradioactive ventilation system (VBS) air handling units (AHUs) and radiologically controlled area (RCA) ventilation system (VAS) unit coolers and reduced chilled water system (VWS) cooling coil flow rates does not adversely impact the
No safety-related structure, system, component (SSC) or function is adversely affected by this change. The change does not involve an interface with any SSC accident initiator or initiating sequence of events, and thus, the probabilities of the accidents evaluated in the plant-specific UFSAR are not affected. The proposed changes do not involve a change to the predicted radiological releases due to postulated accident conditions, thus, the consequences of the accidents evaluated in the UFSAR are not affected. The proposed changes do not increase the probability or consequences of an accident previously evaluated as the VWS, VBS and VAS do not provide safety-related functions and the functions of each system to support required room environments are not changed.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes to COL Appendix C (and plant-specific Tier 1) Table 2.7.2-2, UFSAR Table 9.2.7-1, and associated UFSAR design information to identify the revised equipment parameters for VBS AHUs and VAS unit coolers and reduced VWS cooling coil flow rates do not affect any safety-related equipment, and do not add any new interfaces to safety-related SSCs. The VWS function to provide chilled water is not adversely impacted. The function of the VAS to provide ventilation and cooling to maintain the environment of the serviced areas within the design temperature range is not adversely impacted by this change. No system or design function or equipment qualification is affected by these changes as the change does not modify the operation of any SSCs. The changes do not introduce a new failure mode, malfunction or sequence of events that could affect safety or safety-related equipment. Revised equipment parameters, including the reduced cooling coil flow rates, do not adversely impact the function of associated components.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The changes to COL Appendix C (and plant-specific Tier 1) Table 2.7.2-2, UFSAR Table 9.2.7-1, and associated UFSAR design information do not affect any other safety-related equipment or fission product barriers. The requested changes will not adversely affect compliance with any design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the requested changes as previously evaluated accidents are not impacted.
Therefore, the proposed amendment does not involve a significant reduction in the margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed amendment to the TS [Technical Specification] does not affect the initiators of any analyzed accident. In addition, operation in accordance with the proposed amendment to the TS ensures that the previously evaluated accidents will continue to be mitigated as analyzed. The proposed amendment does not adversely affect the design function or operation of any structures, systems, and components important to safety.
The probability or consequences of accidents previously evaluated in the UFSAR [Updated Final Safety Analysis Report] are unaffected by this proposed amendment because there is no change to any equipment response or accident mitigation scenario. There are no new or additional challenges to fission product barrier integrity.
Therefore, it is concluded that the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed amendment does not involve a physical alteration of the plant (no new or different type of equipment will be installed). The proposed amendment does not create any new failure modes for existing equipment or any new limiting single failures. The proposed amendment does not involve a change in the methods governing normal plant operation and all safety functions will continue to perform as previously assumed in accident analyses. Thus, the proposed amendment does not adversely affect the design function or operation of any structures, systems, and components important to safety.
No new accident scenarios, failure mechanisms, or limiting single failures are introduced due to the proposed amendment. The proposed amendment does not challenge the performance or integrity of any safety-related system.
Therefore, it is concluded that the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed changes involve a significant reduction in a margin of safety?
The margin of safety associated with the acceptance criteria of any accident is unchanged. The proposed amendment will have no affect on the availability, operability, or performance of the safety-related systems and components. No change is being made to the requirement to perform the surveillance. The NOTE in the surveillance is being changed to clarify when the initial surveillance after refueling is to be performed. The Technical Specification Limiting Condition for Operation (LCO) limits are not being changed.
The proposed amendment will not adversely affect the operation of plant equipment or the function of equipment assumed in the accident analysis.
Therefore, it is concluded that the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
Pursuant to the provisions of 10 CFR 52.63(b)(1), an exemption from elements of the design as certified in the 10 CFR part 52, appendix D, design certification rule is also requested for the plant-specific Design Control Document Tier 1 material departures.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed modification changes would clarify the boundaries for the portion of the nonsafety-related FPS required to remain functional following a SSE for manual firefighting in areas with SSE equipment, and the addition of two new open-nozzle suppression systems with associated system isolation valves to provide adequate spray coverage to accommodate the final cable tray location, configuration and quantity. These changes do not affect any accident initiating event or component failure, thus the probabilities of the accidents previously evaluated are not adversely affected. No function used to mitigate a radioactive material release and no radioactive material release source term is involved, thus the radiological releases in the accident analyses are not adversely affected. Therefore, the proposed amendment does not involve an increase in the probability or consequences of an accident previously evaluated.
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed clarification of the boundaries for the portion of the nonsafety-related FPS required to remain functional following a SSE for manual firefighting in areas with equipment required for safe shutdown following an SSE does not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The proposed changes affect the physical design and operation of the FPS, including as-installed inspections, testing, and maintenance requirements, as described in the Updated Final Safety Analysis Report (UFSAR) due to the addition of two open-nozzle suppression systems with associated system isolation valves. However, the additional open-nozzle suppression systems with associated system isolation valves are similar in design and function as the existing cable tray suppression systems and raceway covers. Therefore, the operation of the FPS is not affected. These proposed changes do not adversely affect any other SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that results in significant fuel cladding failures.
Therefore, the requested amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed clarification of the boundaries for the portion of the FPS required to remain functional following a SSE, and the addition of two new open-nozzle suppression systems with associated system isolation valves do not affect any safety or accident analysis as the FPS is a nonsafety-related system. The only function of the FPS following a design basis earthquake is to provide water for hose valves for manual firefighting in safe shutdown equipment areas. The proposed changes continue to meet the existing design basis, design function, regulatory criterion, or analyses. Therefore, the proposed changes satisfy the same design functions in accordance with the codes and standards currently stated in the UFSAR. These changes do not adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin. No safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed changes, and no margin of safety is reduced.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
Pursuant to the provisions of 10 CFR 52.63(b)(1), an exemption from elements of the design as certified in the 10 CFR part 52, appendix D, design certification rule is also requested for the plant-specific DCD Tier 1 material departures.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed changes do not affect the operation of any systems or equipment that initiate an analyzed accident or alter any structures, systems, and components (SSCs) accident initiator or initiating sequence of events. The VES design changes involve: (1) Addition of an automatic and manual, Class 1E, electrical load shed of nonessential nonsafety-related equipment within the main control room envelope (MCRE); and (2) adding a description of the requirements for maintaining habitability of the MCRE beyond 72 hours following a Design Basis Accident to the design and licensing basis. Neither planned or inadvertent operation nor failure of the VES is an accident initiator or part of an initiating sequence of events for an accident previously evaluated. For example, if VES actuation occurs from a loss of power
The proposed changes do not have an adverse impact on the ability of the VES to perform its design functions. The design of the VES continues to meet the same regulatory acceptance criteria, codes, and standards as required by the UFSAR. In addition, the changes maintain the capability of the VES to mitigate the consequences of an accident in conformance with the applicable regulatory acceptance criteria, and there is no adverse effect on any safety-related SSC or function used to mitigate an accident. The changes do not affect the prevention and mitigation of other abnormal events,
Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes do not affect the operation of any systems or equipment that may initiate a new or different kind of accident, or alter any SSC such that a new accident initiator or initiating sequence of events is created. The VES design changes involve: (1) Addition of an automatic and manual, Class 1E, electrical load shed of nonessential nonsafety-related equipment within the MCRE; and (2) adding a description of the requirements for maintaining habitability of the MCRE beyond 72 hours following a DBA to the design and licensing basis. Although a new failure mode of the VES is created by the addition of the MCR Load Shed Panels, neither planned nor inadvertent operation nor failure of the VES is an accident initiator or part of an initiating sequence of events for a new or different kind of accident. In addition, these proposed changes do not adversely affect any other VES or SSC design functions or methods of operation in a manner that results in a new failure mode, malfunction, or sequence of events that affect safety-related or nonsafety-related equipment. Therefore, this activity does not allow for a new fission product release path, result in a new fission product barrier failure mode, or create a new sequence of events that result in significant fuel cladding failures.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The changes to the VES description and associated COL Appendix A Technical Specification changes provide continued verification that; the VES design functions to maintain heat loads inside the MCRE within design-basis assumptions to limit the heat up of the room, a 72-hour supply of breathable-quality air for the occupants of the MCRE is readily available, and the MCRE pressure boundary is maintained at a positive pressure with respect to the surrounding areas. The changes support the system's intended design functions and continue to meet the regulatory requirements for protecting public health and safety.
The proposed changes also maintain existing safety margins. The proposed changes do not adversely affect VES design requirements and design functions. The proposed changes maintain existing safety margin through continued application of the existing requirements of the UFSAR, while adding additional design features and controls that maintain VES design functions required to meet the existing safety margins. Therefore, the proposed changes satisfy the same design functions in accordance with the same codes and standards as stated in the UFSAR. These changes do not adversely affect any design code, function, design analysis, safety analysis input or result, or design/safety margin.
Therefore, the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Keeping the thermal overload protection (TOP) devices bypassed during surveillance testing does not introduce the possibility of a change in the frequency of an accident because failure of a single safety-related motor-operated valve (MOV) is not, by itself, an initiator of any previously evaluated design basis accident. Valves are active components that either position to “open” or “close” as required to fulfill safety functions. As such, safety-related MOVs are subject to single active failures, but such failures are not accident initiators. (For safety-related systems, redundancy in the design ensures that failure of a valve to open or to close on demand, as applicable, will not prevent fulfillment of the safety function(s). However, the associated safety functions are for accident mitigation/response, and while an MOV failure can affect such functions (without loss of the overall function), a single MOV failure cannot by itself initiate any accident previously evaluated in the FSAR.)
Furthermore, the change does not result in an increase in the consequences of an accident previously evaluated in the FSAR. The proposed change would permit MOV TOP devices to remain bypassed during surveillance stroke testing but not during valve maintenance. In regard to the bypassing of TOP devices during testing, the potential for valve damage is of greater concern during valve maintenance activities (when work has been done on the affected valve(s)) than it is for surveillance stroke tests. It may be assumed that the low probability of valve damage resulting from—or occurring during—surveillance valve stroke tests (with the TOP devices bypassed) does not change the single-failure assumptions already considered in the plant's design and accident analyses. As previously noted, redundancy in the design of safety-related systems ensures that failure of a valve to open or close on demand, as applicable, will not prevent fulfillment of the safety function(s). Accordingly, it may be concluded that the provisions for bypassing TOP devices during MOV surveillance testing does not require any changes to assumptions regarding MOV availability, single-failure protection, or the associated systems' capabilities for performing accident mitigation functions. With no changes to such assumptions, the proposed change does not result in more than a minimal increase in the consequences of an accident previously evaluated in the FSAR.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
NRC [RG] 1.106, Revision 1 [“Thermal Overload Protection for Electric Motors on Motor-Operated Valves”], requires the removal of MOV thermal overload relay bypass jumpers during both maintenance and
Keeping the [TOP] devices bypassed during surveillance testing does not introduce the possibility of an accident of a different type than any previously evaluated in the FSAR. Although there could be a slight increase in the probability of valve damage due to the proposed change, any such failure would not be of a different kind or nature than what may already be experienced by an MOV. Thus, no new failure modes or initiators of a different type of accident are introduced. The single active failure of a[n] [MOV] is already considered in the accident analysis assumptions described in the FSAR, and the failure of a single MOV is not by itself an accident initiator.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
No, this change does not affect design basis limits for a fission product barrier. No changes to the accident analyses, including any associated assumptions, are required or being made for the proposed change. Because of redundancy incorporated into the plant design (for single-failure protection), the failure of a single [MOV] will not result in the loss of any overall safety function.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation, and/or Environmental Assessment, as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 22, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 27, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 27, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 30, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 30, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 23, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 21, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 23, 2017
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2017
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 20, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 20, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2017.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 28, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 27, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 30, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 27, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2017.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 29, 2017.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a October 7, 2016, request from Omaha Public Power District (OPPD or the licensee), from certain regulatory requirements. The exemption would permit a certified fuel handler (CFH), in addition to a licensed senior operator, to approve the emergency suspension of security measures for Fort Calhoun Station, Unit No. 1 (FCS) during certain emergency conditions or during severe weather.
The exemption was issued on July 7, 2017.
Please refer to Docket ID NRC-2017-0160 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
James Kim, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-4125; email:
Omaha Public Power District (OPPD) is the holder of Renewed Facility Operating License No. DPR-40 for Fort Calhoun Station (FCS). The license provides, among other things, that the facility is subject to all rules, regulations, and orders of the NRC now or hereafter in effect. The facility consists of a pressurized-water reactor located in Washington County, Nebraska.
By letter dated August 25, 2016 (ADAMS Accession No. ML16242A127), OPPD submitted a certification to the NRC indicating it would permanently cease power operations at FCS on October 24, 2016. On October 24, 2016, OPPD permanently ceased power operation at FCS. On November 13, 2016 (ADAMS Accession No. ML16319A254), OPPD certified that it had permanently defueled the FCS reactor vessel.
In accordance with § 50.82(a)(1)(i) and (ii), and § 50.82(a)(2) of title 10 of the
By letter dated June 21, 2017 (ADAMS Accession No. ML17144A246), the NRC approved the Certified Fuel Handler Training and Retraining Program for FCS that supports the exemption request discussed herein. The CFH Training and Retraining Program is to be used to satisfy training requirements for the plant personnel responsible for supervising and directing the monitoring, storage, handling, and cooling of irradiated nuclear fuel in a manner consistent with ensuring the health and safety of the public. As stated in section 10 CFR 50.2, “Definitions,” CFHs are qualified in accordance with an NRC-approved training program.
On October 7, 2016 (ADAMS Accession No. ML16281A469), the licensee requested an exemption from § 73.55(p)(1)(i) and (ii), pursuant to § 73.5, “Specific exemptions.” The current § 73.55(p)(1)(i) and (ii) regulations state that a licensed senior operator, as a minimum, must approve the suspension of security measures during certain situations. The proposed exemption would authorize an CFH, in addition to the licensed senior operator, to approve the suspension of security measures under 10 CFR 73.55(p)(1)(i) and (ii) at FCS.
The NRC's regulations related to security address the potential need to suspend security or safeguards measures under certain conditions. Accordingly, 10 CFR 50.54(x) and (y), first published in 1983, allow a licensee to take reasonable steps in an emergency that deviate from license conditions when those steps are “needed to protect the public health and safety” and there are no conforming comparable measures (48 FR 13966; April 1, 1983). As originally issued, the deviation from license conditions had to be approved by, as a minimum, a licensed senior operator. In 1986, in its final rule, “Miscellaneous Amendments Concerning the Physical Protection of Nuclear Power Plants” (51 FR 27817; August 4, 1986), the Commission issued § 73.55(a), which provided that the licensee may suspend any safeguards measures pursuant to § 73.55 in an emergency when this action is immediately needed to protect the public health and safety and no action consistent with license conditions and technical specifications that can provide adequate or equivalent protection is immediately apparent. The regulation further required that this suspension be approved as a minimum by a senior licensed operator prior to taking action.
In 1996, the NRC made a number of regulatory changes to address decommissioning. One of the changes was to amend § 50.54(x) and (y) to authorize a non-licensed operator called a “Certified Fuel Handler,” in addition to a licensed senior operator, to approve such protective steps. In addressing the role of the CFH during emergencies in § 50.54(y), the Commission stated in the proposed rule, “Decommissioning of Nuclear Power Reactors” (60 FR 37374; July 20, 1995):
• A nuclear power reactor that has permanently ceased operations and no longer has fuel in the reactor vessel does not require a licensed individual to monitor core conditions.
• A certified fuel handler at a permanently shutdown and defueled nuclear power reactor undergoing decommissioning is an individual who has the requisite knowledge and experience to evaluate plant conditions and make these judgments.
In the 1996 final rulemaking, “Decommissioning of Nuclear Power Reactors” (61 FR 39278; July 29, 1996), the NRC added the following definition to § 50.2: “
In the 2009 final rule, “Power Reactor Security Requirements” (74 FR 13926; March 27, 2009), the NRC moved the security suspension requirements from § 73.55(a) to § 73.55(p)(1)(i) and (ii). The role of a CFH was not discussed in this rulemaking, so the suspension of security measures in accordance with § 73.55(p) continued to require approval as a minimum by a licensed senior operator, even for a site that otherwise is no longer operational.
However, pursuant to § 73.5, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 73, as it determines are authorized by law and will not endanger life or property or the common defense and security, and are otherwise in the public interest.
The requested exemption from § 73.55(p)(1)(i) and (ii) would allow a CFH, in addition to a licensed senior operator, to approve the suspension of security measures, under certain emergency conditions or severe weather. The NRC's current regulations in 50.54(y) allow a CFH to suspend security measures under certain conditions. Granting the exemption would align the licensee's practice under 73.55(p) with what is done under 50.54(y).
Consistent with 10 CFR 73.5, the Commission is allowed to grant exemptions from the regulations in 10 CFR part 73, as authorized by law. The NRC staff has determined that granting the licensee's proposed exemption will not result in a violation of the Atomic Energy Act of 1954, as amended, or other laws. Therefore, the exemption is authorized by law.
Modifying the requirement to allow a CFH, in addition to a licensed senior operator, to approve suspension of security measures during emergencies or severe weather will not endanger life or property or the common defense and security for the reasons described in this section.
First, the requested exemption would not exempt the licensee from meeting the requirements set forth in 10 CFR 73.55(p)(2) that the “[s]uspended security measures must be reinstated as soon as conditions permit.” Therefore, the exemption would not prevent the licensee from meeting the underlying purpose of § 73.55(p)(1)(i) to protect public health and safety even after the exemption is granted.
Second, the suspension for non-weather emergency conditions under § 73.55(p)(1)(i) will continue to be invoked only “when this action is immediately needed to protect the public health and safety and no action consistent with license conditions and technical specifications that can provide adequate or equivalent protection is immediately apparent.” Therefore, the exemption would not prevent the licensee from meeting the underlying purpose of § 73.55(p)(1)(i) to protect public health and safety even after the exemption is granted.
Third, the suspension for severe weather under § 73.55(p)(1)(ii) will continue to be used only when “the suspension of affected security measures is immediately needed to protect the personal health and safety of security force personnel and no other immediately apparent action consistent with the license conditions and technical specifications can provide adequate or equivalent protection.” The requirement to receive input from the security supervisor or manager will remain. Therefore, the exemption would not prevent the licensee from meeting the underlying purpose of § 73.55(p)(1)(ii) to protect the health and safety of the security force.
Fourth, by letter dated June 21, 2017, the NRC approved OPPD's CFH training and retraining program for the FCS facility. The NRC staff found that, among other things, the program addresses the safe conduct of decommissioning activities, safe handling and storage of spent fuel, and the appropriate response to plant emergencies. Because the CFH will be sufficiently trained and qualified under an NRC-approved program, the NRC staff considers a CFH to have sufficient knowledge of operational and safety concerns, such that allowing a CFH to suspend security measures during emergencies or severe weather will not result in undue risk to public health and safety.
In addition, the exemption does not reduce the overall effectiveness of the licensee's physical security plan or affect the licensee's ability to protect special nuclear material at FCS. Thus, the exemption would not have an adverse effect on the common defense and security. For the reasons set forth above, the NRC staff has concluded that the exemption would not reduce security measures currently in place to protect against radiological sabotage. Therefore, modifying the requirement to allow a CFH, in addition to a licensed senior operator, to approve the suspension of security measures in an emergency or during severe weather, does not adversely affect public health and safety issues or the assurance of the common defense and security.
NRC regulations currently require that a licensed senior operator at a minimum must approve the suspension of security measures in 10 CFR 73.55(p)(1)(i) and (ii). However, since FCS is shutdown, the licensee is not required to have a licensed senior operator onsite. Therefore, it is unclear how the licensee would implement emergency or severe weather suspensions of security measures in the absence of a licensed senior operator. Omaha Public Power District's proposed exemption would allow a certified fuel handler, in addition to a licensed senior operator, to approve suspension of security measures in an emergency when “immediately needed to protect the public health and safety” or during severe weather when “immediately needed to protect the personal health and safety of security force personnel.” Granting this exemption request to authorize a CFH to approve temporary suspension of security regulations during an emergency or severe weather would align with the comparable authority given to the CFH in 10 CFR 50.54(y).
This exemption is in the interest of the public for two reasons. First, the exemption provides the licensee with an efficient and rational method for invoking the temporary suspension of security matters that may be needed for protecting public health and safety or the safety of the security forces during emergencies and severe weather. Additionally, the consistent and efficient regulation of nuclear power plants serves the public interest by assuring consistency between the security regulations in 10 CFR part 73 and the operating reactor regulations in 10 CFR part 50, as well as the requirements concerning licensed operators in 10 CFR part 55. The NRC staff has determined that granting the licensee's proposed exemption would allow the licensee to designate a CFH with the appropriate qualifications for a permanently shutdown and defueled reactor to approve the suspension of security measures during an emergency to protect the public health and safety, and during severe weather to protect the safety of the security force. These provisions are consistent with the authority provided by § 50.54(y). Therefore, the exemption is in the public interest.
The NRC's approval of the exemption from certain security requirements belongs to a category of actions that the Commission, by rule or regulation, has declared to be a categorical exclusion, after first finding that the category of actions does not individually or cumulatively have a significant effect on the human environment. Specifically, the exemption is categorically excluded from further analysis under § 51.22(c)(25).
Under § 51.22(c)(25), the granting of an exemption from the requirements of any regulation of chapter I to 10 CFR is a categorical exclusion provided that (i) there is no significant hazards consideration; (ii) there is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite; (iii) there is no significant increase in individual or cumulative public or occupational
The Director, Division of Operating Reactor Licensing, Office of Nuclear Reactor Regulation, has determined that approval of the exemption request in accordance with § 51.22(c)(25), involves no significant hazards consideration because permitting a CFH, in addition to a licensed senior operator, to approve the suspension of security requirements at a defueled shutdown power plant does not (1) involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. Also there will be no significant change in the types or a significant increase in the amounts of any effluents that may be released offsite as well as no significant increase in individual or cumulative public or occupational radiation exposure. The exempted regulation is not associated with construction, so there is no significant construction impact. The exempted regulation neither concerns the source term (
Therefore, pursuant to § 51.22(b) and (c)(25), no environmental impact statement or environmental assessment need be prepared in connection with the approval of this exemption request.
Accordingly, the Commission has determined that, pursuant to 10 CFR 73.5, the exemption is authorized by law and will not endanger life or property or the common defense and security, and is otherwise in the public interest. Therefore, the Commission hereby grants the licensee's request for an exemption from the requirements of 10 CFR 73.55(p)(1)(i) and (ii), to authorize that the suspension of security measures at FCS must be approved as a minimum by either a licensed senior operator or a certified fuel handler.
The exemption is effective upon receipt.
For the Nuclear Regulatory Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Schedule of Fees to eliminate fees and rebates for trades executed on June 30, 2017 in INET Launch Symbols.
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 purpose of the proposed rule change is to amend the Schedule of Fees to eliminate fees and rebates for trades executed on June 30, 2017 in the following symbols: ACN, ACOR, AEO, AFSI, AMJ, AOBC, BKD, BTE, BV, CBI, CCL, CLR, CME, CNQ, ADM, ADSK, AGNC, ASHR, BBT, BK, BSX, CIEN, and IBM (“INET Launch Symbols”).
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes that it is reasonable and equitable to eliminate fees and rebates for INET Launch Symbols during the initial launch of the Exchange's re-platformed trading system. Eliminating fees and rebates in the INET Launch System during the launch will simplify the Exchange's billing and serve as an inducement for members to trade the first symbols migrated to the INET trading system. Because the Exchange is offering free executions in these symbols, volume executed in INET Launch Symbols on June 30, 2017 will not be counted towards any volume based tiers. Similar treatment was afforded to the first symbol launched on the Nasdaq GEMX, LLC INET trading system,
In accordance with Section 6(b)(8) of the Act,
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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 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 principal purpose of the proposed rule change is to revise the ICC Liquidity Risk Management Framework and the ICC Stress Testing Framework. These revisions do not require any changes to the ICC Clearing Rules (“Rules”).
In its filing with the Commission, ICC 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. ICC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
ICC proposes revisions to its Liquidity Risk Management Framework and to its Stress Testing Framework. ICC believes such revisions will facilitate the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions for which it is responsible. The proposed revisions are described in detail as follows.
ICC proposes to revise its Liquidity Risk Management Framework in order to make revisions to its liquidity monitoring program in order to enhance compliance with U.S. Commodity Futures Trading Commission (“CFTC”) regulations including 17 CFR 39.11, 17 CFR 39.33 and 17 CFR 39.36.
ICC proposes to reorganize the format of the Liquidity Risk Management Framework to consist of three elements: Liquidity Risk Management Model; Measurement and Monitoring; and Governance. The “Regulatory Requirements” section, previously included as an element of the framework, will be deleted; however, the regulatory requirements applicable to liquidity risk management are still referenced in the framework. The changes to each element of the Liquidity Risk Management Framework are described below.
ICC proposes to enhance the description of the components which comprise its liquidity risk management model. As revised, the liquidity risk management model now includes, but is not limited to, the following components: Currency-specific risk requirements; acceptable collateral; liquidity requirements; collateral valuation methodology; investment strategy; Clearing Participant (“CP”) deposits as a liquidity pool; liquidity facilities (including committed repo facilities and committed foreign exchange (“FX”) facilities); and liquidity waterfall. Each of these components are described thoroughly within the Liquidity Risk Management Framework, and changes to each component are described below.
ICC proposes to add language to the `currency-specific risk requirements' section to cross reference ICC's current policy of maintaining cash and collateral assets posted by CPs (on behalf of themselves and/or their clients) to meet currency-specific Initial Margin (“IM”) and GF requirements, to ensure ICC has sufficient total resources in the required currencies of denomination.
The `acceptable collateral' section remains the same, and notes that CPs may post IM and GF deposits that meet ICC's acceptable collateral criteria as described in ICC's Treasury Operations Policies and Procedures and Schedule 401 of the ICC Rules.
The `liquidity requirements' section sets forth ICC's liquidity requirements for house/proprietary accounts and client-related accounts. Such requirements are also set forth in ICC's Treasury Operations Policies and Procedures and Schedule 401 of the ICC Rules. The `liquidity requirements' section will reflect the changes to ICC's liquidity thresholds for Euro (“EUR”) denominated products set forth in filing SR-ICC-2017-002.
The `collateral valuation methodology' section remains substantially the same, and sets forth the method by which ICC prices the
The `investment strategy section' remains substantially the same, and sets forth a summary of ICC's investment strategy. ICC proposes revisions to the `investment strategy' section to note that when beneficial, ICC diversifies its cash investments across multiple depository institutions to reduce its liquidity exposure to any single depository.
The `CP deposits as a liquidity pool' section remains substantially the same, and refers to the ability of ICC, pursuant to ICC Rules 402 and 804, to borrow GF and house origin IM cash deposits of non-defaulting CPs and pledge non-cash and cash assets of an equivalent value deposited by the defaulting and/or non-defaulting CP(s) as collateral for this loan.
ICC proposes revisions to the `liquidity facilities' section to add reference to its committed repurchase facilities (as opposed to committed repurchase agreements). ICC added reference to its recently available committed FX facilities for converting USD cash to EUR cash. ICC also proposes removing reference to FX Swaps, Immediate FX Spot Transactions, because these arrangements do not count as “qualifying liquidity resources” under CFTC Regulation 39.33,
Under the `liquidity waterfall' section, ICC proposes revisions to its definition of Available Liquidity Resources (“ALR”) to note that ALR consist of the available deposits currently in cash of the required denomination, and the cash equivalent of the available deposits in collateral types that ICC can convert to cash, in the required currency of denomination, using all sources of liquidity available to it. For reference, the liquidity waterfall classifies ALR on any given day into four Levels. Level One includes the House IM and GF cash deposits of the defaulting CP. Level Two includes GF cash deposits of: (i) ICC; and (ii) non-defaulting CPs, which until ICC has consumed the cash equivalent value of all defaulting CPs' IM and GF deposits, are available to ICC after pledging an equivalent value of non-cash assets (or cash assets in a different currency) from the defaulting CP's IM deposits or GF deposits. Level Three includes House IM cash deposits of the non-defaulting CPs, which are available to ICC after pledging an equivalent value of non-cash assets (or cash assets in a different currency) from the defaulting CP's IM deposits or GF deposits. Level Three cash used by ICC is always a loan, against which it must provide the equivalent Pledgeable Collateral from the GF deposits of the non-defaulting CPs and ICC, and/or from the IM and/or GF deposits of the defaulting CPs.
Level Four includes ICC's committed repo facilities to convert U.S. Treasuries to USD cash and ICC's committed FX facilities to convert USD cash to EUR cash. Note that when determining ALR for stress testing analyses purposes, to account for the risk associated with Foreign Exchange (“FX”) rate fluctuations,
ICC noted that ICC's liquidity stress testing and historical liquidity analysis scenarios do not consider any tolerance for delayed payouts. ICC also noted that, during a default management period, ICC may initiate the liquidation of non-cash collateral and/or conversion of cash collateral into the required currencies of denomination, so that ICC has additional ALR to use according to the liquidity waterfall on subsequent days of default management and/or is able to pay back some or all of the cash previously borrowed in Levels Two to Four of the liquidity waterfall.
ICC proposes changes to the `methodology' section to change the calculation for available liquidity resources. In the historical and stress testing analysis, ICC proposes replacing the estimation of minimum available liquid resources based on risk requirements with the observation of cash and collateral on deposit (excluding cash that will be unavailable by the applicable ICC Payout Deadline because it has been invested by ICC). As such, ICC proposes removing the section from the Liquidity Risk Management Framework which described the process for computing the estimation of minimum available liquid resources. In addition, ICC proposes removing other references throughout the framework related to the estimation of minimum available liquid resources. ICC is changing its approach based on feedback from the CFTC, to ensure consistency with CFTC regulations, including CFTC Regulation 39.33.
ICC also proposes additional changes to the `methodology' section. Among other things, the proposed revisions will clarify that ICC's measurement and monitoring methodology assesses the adequacy of ICC's established liquidity resources in response to historically observed and hypothetically created (forward looking) scenarios with risk horizons up to and including 6-days. The analyzed scenarios feature assumptions that directly impact the ability of ICC to meet its payment obligations. From available IM and GF collateral on deposit on the day of the considered default(s), the analysis determines currency-specific ALR by liquidity waterfall level, and compares these ALRs to the currency-specific Liquidity Obligations resulting from the analyzed scenarios on each day of the considered time horizon. To be conservative, the analysis assumes no client-related ALR and that only the day-1 ALR are available throughout the considered time horizon (
ICC proposes changes to the `historical analysis' section of the framework. ICC proposes adding language to note that, as part of its historical liquidity analysis, ICC analyzes historical data sets to assess
ICC proposes the use of the Basel Traffic Light System
ICC proposes additional enhancements to the `historical analysis' section to consider the simultaneous default of the two worst-case Affiliate Groups (“AGs”)
ICC proposes enhancements to the `historical analysis' section to note that, for each day of its historical analysis, and on a currency specific basis, the Risk Department explores predefined cover-2 scenarios considering the default of the CPs within two AGs creating the largest remaining Liquidity Obligation after applying the IM and GF cash deposits of each constituent CP to that CP's Liquidity Obligation. ICC's cover-2 analysis considers the liquidity resources provided by the defaulting CPs, the GF and IM liquidity resources provided by the non-defaulting CPs and ICC, and any externally available liquidity resources.
ICC proposes clarifying changes to the `historical analysis section' to note that the prices considered for historical analysis purposes are “dirty” prices as they include riskless (deterministic) payments (
ICC proposes changes to the `stress testing' section of the framework. Under the previously approved framework, ICC used predefined scenarios believed to be potential market outcomes historically observed, but with a very low probability of occurrence, as well as scenarios that replicated observed instrument price changes during the Lehman Brothers default. ICC also used predefined scenarios designed to test the performance of the risk methodology under extreme conditions, which ICC did not expect the market to realize.
ICC proposes re-categorizing and adding to the stress testing scenarios set forth in the `stress testing' section of the framework. Under the revised framework, ICC has enhanced its description of its historically observed extreme but plausible market scenarios, to note that the scenarios define spread or price shocks based on observations during specific historical events. The historical data set from which ICC derives the proposed scenarios will continue to begin on April 1, 2007 and include periods of extreme market events such as the Bear Stearns collapse, the Lehman Brothers default, the 2009 Credit Crisis, the US “Flash Crash” event, and the European Sovereign Crisis. The scenarios are similar to the stress testing currently performed under the financial resources Stress Testing Framework.
ICC proposes eliminating all scenarios not expected to be realized as market outcomes (
ICC also proposes revising the `stress testing' section of the framework to add a number of hypothetically constructed (forward looking) extreme but plausible market scenarios comprised of a given historically observed extreme but plausible market scenario and additional stress enhancements representing forward looking hypothetical adverse market events. Specifically, two sets of hypothetically constructed (forward looking) extreme but plausible market scenarios are proposed: Loss-given default scenarios, and one-service-provider-down scenarios. The loss-given default scenarios consider the addition of up to three adverse credit events including the holder of the considered portfolio, one additional CP name and one additional non-CP name. The one-service-provider-down scenarios consider a reduction in ALR designed to represent ICC's worst-case exposure to a single service provider at which it maintains cash deposits or investments, due to ICC's potential inability to access those deposits and/or investments when required. ICC proposes that the reduction in ALR used in the one-service-provider-down scenarios is based on ICC's analysis of the diversification of its deposits and investments across its multiple service providers.
ICC proposes revisions to the `stress testing' section to further describe its analysis under the above referenced scenarios. ICC proposes revisions to consider the simultaneous default of the
ICC proposes enhancements to the `stress testing' section to describe its cover-N analysis in which, for each scenario, it first considers the default of one AG, then the defaults of two AGs, then three AGs, and so forth. The sequence of selecting AGs is based on the remaining Liquidity Obligation associated with the constituent CP's portfolios after applying the IM and GF cash deposits of each constituent CP to its own Liquidity Obligation. AGs are sequenced from largest to smallest remaining Liquidity Obligation. For each set of AGs considered to be in a state of default (1 AG, 2 AGs, 3 AGs, etc.), ICC compares the total remaining Liquidity Obligation to the remaining liquidity resources to determine if there are sufficient resources to meet the obligation. In this way, ICC determines how many AGs it would require to be in a state of default to consume all available liquidity resources.
To determine the Liquidity Obligations in the above analysis, ICC applies the stress scenarios to actual cleared portfolios to determine a currency-specific profit/loss for each CP, representing the largest cumulative loss over the specified risk horizon. The considered profit/loss in the analysis is the sum of the upfront fee changes corresponding to the clean prices associated with the hypothetical scenarios, and excluding the riskless (deterministic) payments.
To determine ICC's liquidity needs for each scenario, the Risk Department computes Liquidity Obligations for FCM/BD CPs by combining the net payments for house and client origin accounts. For the purposes of selecting defaulting AGs, the Risk Department does not offset client origin losses with house origin gains, or offset house origin losses with client origin gains.
The `required analysis' section remains substantially the same. The ICC Risk Department executes stress testing daily, with weekly reporting to different audiences depending on the results. The Risk Department also executes monthly historical liquidity adequacy analyses and reviews the results monthly, with monthly reporting to different audiences depending on the results.
The `interpretation of results and potential actions' section remains substantially the same. Depending on the scenarios and the frequency and severity of any resulting deficiencies, the Risk Department may choose to make appropriate enhancements to its model. Before enhancing its liquidity risk management model, ICC first discusses such enhancements with its senior management team, and subsequently consults with its Risk Working Group and Risk Committee before submitting to the Board of Managers for approval.
ICC proposes changing the `materiality and reporting framework' section to note that, at each Risk Committee meeting, the Risk Department provides a summary of historical liquidity analysis and liquidity stress testing analysis, which demonstrates the adequacy of ICC's liquidity resources to cover Liquidity Obligations over N-days. Such analyses will also include any instance where Level Three resources were required to meet Liquidity Obligations in response to any of the considered historical liquidity or liquidity stress testing scenarios.
ICC proposes revisions to the `materiality and reporting framework' to note that, when exceedances of funded and/or unfunded resources are identified, the Risk Department is required to report them to the senior management team and the ICC Risk Committee, and i) demonstrate breaches do not highlight a significant liquidity risk management weaknesses, or ii) recommend specific liquidity risk management model enhancements that produce an adequate increase in funded and/or unfunded liquidity resources under the identified scenario(s). In addition to the reporting described above, the Risk Department will also report to the Risk Committee any instances where the Basel Traffic Light System categorizes the number of observed exceedances in its individual AG historical analysis as being in the predefined “red zone”. In these instances, the Risk Department will discuss with the Risk Committee the appropriateness of its liquidity thresholds, and if appropriate, make revisions.
ICC proposes revisions to the `model validation' section to note that its Liquidity Risk Management Framework is under the purview of the Model Validation Framework, and subject to initial validations.
ICC proposes revisions to its Stress Testing Framework to unify the stress testing scenarios with the liquidity stress testing scenarios set forth in the Liquidity Risk Management Framework. ICC operates its stress testing and liquidity stress testing on a unified set of stress testing scenarios and system. As such, revisions to the stress testing scenarios are necessary to ensure scenario unification, following changes to the Liquidity Risk Management Framework. Such changes are consistent with recently issued guidance for certain principles and key considerations in the Committee on Payments and Market Infrastructures-Board of the International Organization of Securities Commissions Principles for Financial Market Infrastructures
ICC proposes to introduce Risk Factor specific scenarios for all stress test scenarios. Previously, corporate single names were considered at the sector level (as opposed to the Risk Factor level). This change is reflected throughout the framework.
ICC also proposes to add clarifying language to note that the predefined stress testing scenarios set forth in its Stress Testing Framework are applied to all cleared instruments, and that name-specific scenarios are applied to all sovereign and corporate reference entities.
ICC also proposes revisions to extend ICC's margin risk horizon up to 6-days, to account for the risk associated with clearing Asia Pacific products. This change will apply throughout the framework; the risk horizon is reflected as “N-day” where N≥5 is the margin risk horizon or Margin Period of Risk (MPOR). The margin risk horizon is based on the greatest MPOR (rounded
ICC also proposes to revise its description of the “Historically Observed Extreme but Plausible Market Scenarios” to note that the stress spread changes considered as part of each scenario are extracted from the market history of the most actively traded instrument for the considered Risk Factors.
ICC proposes to revise the “Hypothetically Constructed (Forward Looking) Extreme but Plausible Market Scenarios” to ensure consistency with the loss-given default stress scenario set forth in the Liquidity Risk Management Framework, which combines a given historically observed extreme but plausible market scenario with explicit Jump-to-Default events. The proposed revisions specify that there will be up to two reference entities selected for a hypothetical adverse credit event.
ICC proposes to revise the description of the discordant scenarios (
Section 17A(b)(3)(F) of the Act
Further, the changes to the Stress Testing Framework to unify the stress testing scenarios with the stress testing scenarios set forth in the Liquidity Risk Management Framework are necessary following recent changes to the Liquidity Risk Management Framework, as ICC operates its stress testing and liquidity stress testing on a unified set of stress testing scenarios and system. ICC's stress testing practices will continue to ensure the adequacy of systemic risk protections. As such, the proposed rule changes are designed to promote the prompt and accurate clearance and settlement of securities transactions, derivatives agreements, contracts, and transactions within the meaning of Section 17A(b)(3)(F)
ICC does not believe the proposed rule changes would have any impact, or impose any burden, on competition. The Liquidity Risk Management Framework and the Stress Testing Framework apply uniformly across all CPs. Therefore, ICC does not believe the proposed rule changes impose any burden on competition that is inappropriate in furtherance of the purposes of the Act.
Written comments relating to the proposed rule change have not been solicited or received. ICC will notify the Commission of any written comments received by ICC.
Within 45 days of the date of publication of this notice in the
(A) By order approve or disapprove such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be 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.
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICC-2017-011 and should be submitted on or before August 2, 2017.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Form ADV-H under the Investment Advisers Act of 1940.” Rule 203-3 (17 CFR 275.203-3) under the Investment Advisers Act of 1940 (15 U.S.C. 80b) requires that registered advisers requesting either a temporary or continuing hardship exemption submit the request on Form ADV-H. Rule 204-4 (17 CFR 275.204-4) under the Investment Advisers Act of 1940 requires that exempt reporting advisers requesting a temporary hardship exemption submit the request on Form ADV-H. The purpose of this collection of information is to permit advisers to obtain a hardship exemption to not complete an electronic filing. The temporary hardship exemption that is available to registered advisers under rule 203-3 and exempt reporting advisers under rule 204-4 permits these advisers to make late filings due to unforeseen computer or software problems. The continuing hardship exemption available to registered advisers under rule 203-3 permits advisers to submit all required electronic filings on hard copy for data entry by the operator of the IARD.
The Commission has estimated that compliance with the requirement to complete Form ADV-H imposes a total burden of approximately one hour for an adviser. Based on our experience, we estimate that we will receive two Form ADV-H filings annually from registered investment advisers and one Form ADV-H filing annually from exempt reporting advisers. Based on the 60 minute per respondent estimate, the Commission estimates a total annual burden of 3 hours for this collection of information.
Rule 203-3, rule 204-4, and Form ADV-H do not require recordkeeping or records retention. The collection of information requirements under the rule and form are mandatory. The information collected pursuant to the rule and Form ADV-H consists of filings with the Commission. These filings are not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written 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 will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
On May 12, 2017, Miami International Securities Exchange, LLC (“MIAX Options” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to establish three new types of complex orders,
The Exchange proposes to define a cC2C Order as a type of complex order that is comprised of one Priority Customer
The Exchange will determine, on a class-by-class basis, the option classes in which cC2C Orders are available for trading on the Exchange, and will announce such classes to Members via Regulatory Circular.
The Exchange proposes to define a cQCC Order as a type of complex order that is identified as being part of a qualified contingent trade
The Exchange will reject a cQCC Order if, at the time of receipt of the cQCC Order, (i) the strategy is subject to a cPRIME Auction pursuant to proposed Interpretations and Policies .12 to Rule 515A, or to a Complex Auction pursuant to Rule 518(d); or (ii) any component of the strategy is subject to a SMAT Event as described in Rule 518(a)(16).
The Exchange will determine, on a class-by-class basis, the option classes in which cQCC Orders are available for trading on the Exchange, and will announce such classes to Members via Regulatory Circular.
PRIME is a price-improvement mechanism pursuant to which a Member (“Initiating Member”) electronically submits an order that it represents as agent (an “Agency Order”) into a PRIME Auction (“Auction”). The Initiating Member, in submitting an Agency Order, must be willing to either (i) cross the Agency Order at a single price (a “single-price submission”) against principal or solicited interest, or (ii) automatically match (“auto-match”), against principal or solicited interest, the price and size of responses to a Request for Response (“RFR”) that is broadcast to MIAX Options participants up to an optional designated limit price.
As described below, the Exchange proposes to add a cPRIME order type
The initiating price for a cPRIME Agency Order must be better than the icMBBO for the strategy and any other complex orders on the Strategy Book.
The RFR period for cPRIME Auctions will be independent from the RFR for PRIME Auctions and will last for a period of time as set forth in Rule 515A(a)(2)(i)(C).
The Exchange proposes to not apply the size and bid/ask differential and conclusion of auction provisions contained in Rule 515A(a)(1)(iii) and (iv) to cPRIME Orders.
At the conclusion of a cPRIME Auction, the Exchange will apply the order allocation provisions applicable to the simple PRIME Auction,
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 change.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange and, in particular, with Section 6(b) of the Act.
The Commission believes that the Exchange's proposed cC2C rules are consistent with the Act. They allow for the crossing of complex orders in a manner similar to other crossing rules that the Commission has previously approved for other exchanges and do not appear to raise any novel or significant issues.
The Commission believes that the Exchange's proposed cQCC rules, which would permit complex orders to participate in a clean cross of the options leg of a subset of qualified contingent trades in a similar manner as QCC Orders already permitted on the Exchange, are appropriate and consistent with the Act.
By allowing MIAX Options Members to enter complex orders into PRIME, the Commission believes that the proposal could provide opportunities for complex orders to receive price improvement. Under the proposal, a complex order entered into a cPRIME Auction must be stopped at a price that is better than the icMBBO for the strategy and any other complex orders on the Strategy Book.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with Sections 6(b)(5) and 6(b)(8) of the Act.
It is therefore ordered, 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 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's trading rights fee at Rule 7001(a) to increase the fee from $1,000 per month to $1,250 per month, as described further below. While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on July 1, 2017.
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 purpose of the proposed rule change is to increase its monthly trading rights fee under Rule 7001(a). The trading rights fee is assessed on all Nasdaq members and helps defray the cost of regulating the Nasdaq market. The Exchange last increased the fee in 2012,
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
Nasdaq believes that the fee change is reasonable because the increased fee continues to be less than the analogous fees of other markets. For example, the Exchange's membership fees will continue to remain substantially lower than the analogous fees assessed by the New York Stock Exchange for membership, which assesses an annual fee of $50,000 for the first license held by a member organization. The Exchange believes that the proposed fee increase is an equitable allocation and is not unfairly discriminatory because the Exchange must adjust fees from time to time so that it can continue to cover costs and to make a profit on the products and services it offers. The proposed increased fee will apply to all members and it will allow the Exchange to cover the costs of providing its members with a well-regulated market. These costs include investing in the systems and people that support oversight of the market
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. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or
In this instance, the proposed changes to the trading rights fee does [sic] not impose a burden on competition because membership in, and use of, the Exchange is wholly voluntary and the Exchange is subject to significant competition from other exchanges and other trading venues. If the proposed fee increase is unattractive to members, it is likely that the Exchange will lose membership and market share as a result. Moreover, the Exchange must increase fees to cover the costs associated with maintaining and enhancing its regulatory programs to ensure that the Exchange remains a well-regulated trading venue. Thus, to the extent that the fee does represent a burden on competition, such burden is necessary to further purposes of the Act. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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: (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.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Rule 203-2 (17 CFR 275.203-2) and Form ADV-W (17 CFR 279.2) under the Investment Advisers Act of 1940 (15 U.S.C. 80b).” Rule 203-2 under the Investment Advisers Act of 1940 establishes procedures for an investment adviser to withdraw its registration or pending registration with the Commission. Rule 203-2 requires every person withdrawing from investment adviser registration with the Commission to file Form ADV-W electronically on the Investment Adviser Registration Depository (“IARD”). The purpose of the information collection is to notify the Commission and the public when an investment adviser withdraws its pending or approved SEC registration. Typically, an investment adviser files a Form ADV-W when it ceases doing business or when it is ineligible to remain registered with the Commission.
The respondents to the collection of information are all investment advisers that are registered with the Commission or have applications pending for registration. The Commission has estimated that compliance with the
Rule 203-2 and Form ADV-W do not require recordkeeping or records retention. The collection of information requirements under the rule and form are mandatory. The information collected pursuant to the rule and Form ADV-W are filings with the Commission. These filings are not kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written comments are invited on: (a) Whether the documentation of information is necessary 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 collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Commentary .07 to Rule 904 to extend the pilot program that eliminated the position limits for options on SPDR S&P 500 ETF (“SPY”) (“SPY Pilot Program”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those 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 proposes to amend Commentary .07 to Rule 904 to extend the time period of the SPY Pilot Program,
This filing does not propose any substantive changes to the SPY Pilot Program. In proposing to extend the SPY Pilot Program, the Exchange reaffirms its consideration of several factors that supported the original proposal of the SPY Pilot Program, including (1) the availability of economically equivalent products and their respective position limits, (2) the liquidity of the option and the underlying security, (3) the market capitalization of the underlying security and the related index, (4) the reporting of large positions and requirements surrounding margin, and (5) the potential for market on close volatility.
In the July 2016 Extension, the Exchange stated that if it were to propose an extension, permanent approval or termination of the program, the Exchange would submit, along with any filing proposing such amendments to the program, a report providing an analysis of the SPY Pilot Program covering the period since the previous extension (the “Pilot Report”). Accordingly, the Exchange is submitting a Pilot Report detailing the Exchange's experience with the SPY Pilot Program for the period covering twelve (12) months from June 2016 to May 2017. The Pilot Report is attached as Exhibit 3 to this filing [sic]. The Exchange notes that it is unaware of any problems created by the SPY Pilot Program and does not foresee any as a result of the proposed extension. In extending the SPY Pilot Program, the Exchange states that if it were to propose another extension, permanent approval or termination of the program, the Exchange will submit another Pilot Report covering the period since the previous extension, which will be submitted at least 30 days before the end of the proposed extension. If the SPY Pilot Program is not extended or
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
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. The proposed rule change is not designed to address any aspect of competition, whether between the Exchange and its competitors, or among market participants. Instead, the proposed rule change is designed to allow the SPY Pilot Program to continue uninterrupted. Additionally, the Exchange expects all other SROs that currently have rules regarding the SPY Pilot Program to also extend the pilot program for an additional year.
No written comments were solicited or received with respect to the proposed rule change.
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 and Rule 19b-4(f)(6) thereunder.
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under 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 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.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Registered broker-dealers use Form BDW (17 CFR 249.501a) to withdraw from registration with the Commission, the self-regulatory organizations, and the states. On average, the Commission estimates that it would take a broker-dealer approximately one hour to complete and file a Form BDW to withdraw from Commission registration as required by Rule 15b6-1. The Commission estimates that approximately 380 broker-dealers withdraw from Commission registration annually
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Commentary .06 to Rule 6.8 to extend the pilot program that eliminated the position limits for options on SPDR S&P 500 ETF (“SPY”) (“SPY Pilot Program”). The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those 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 proposes to amend Commentary .06 to Rule 6.8 to extend the time period of the SPY Pilot Program,
This filing does not propose any substantive changes to the SPY Pilot Program. In proposing to extend the SPY Pilot Program, the Exchange reaffirms its consideration of several factors that supported the original proposal of the SPY Pilot Program, including (1) the availability of economically equivalent products and their respective position limits, (2) the liquidity of the option and the underlying security, (3) the market capitalization of the underlying security and the related index, (4) the reporting of large positions and requirements surrounding margin, and (5) the potential for market on close volatility.
In the July 2016 Extension, the Exchange stated that if it were to propose an extension, permanent approval or termination of the program, the Exchange would submit, along with any filing proposing such amendments to the program, a report providing an analysis of the SPY Pilot Program covering the period since the previous
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
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. The proposed rule change is not designed to address any aspect of competition, whether between the Exchange and its competitors, or among market participants. Instead, the proposed rule change is designed to allow the SPY Pilot Program to continue uninterrupted. Additionally, the Exchange expects all other SROs that currently have rules regarding the SPY Pilot Program to also extend the pilot program for an additional year.
No written comments were solicited or received with respect to the proposed rule change.
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 and Rule 19b-4(f)(6) thereunder.
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under 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 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.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Rule 0-2 and Form ADV-NR under the Investment Advisers Act of 1940.” Rule 0-2 and Form ADV-NR facilitate service of process to non-resident investment advisers and exempt reporting advisers and their non-resident general partners or non-resident managing agents. The Form requires these persons to designate the Commission as agent for service of process. The purpose of this collection of information to obtain appropriate consent to permit the Commission and other parties to bring actions against non-resident partners and agents for violations of the federal securities laws and to enable the commencement of legal and/or regulatory actions against investment advisers that are doing business in the United States, but are not residents.
The respondents to this information collection would be each non-resident general partner or non-resident managing agent of an SEC-registered adviser and each non-resident general partner or non-resident managing agent of an exempt reporting adviser. The Commission has estimated that compliance with the requirement to complete Form ADV-NR imposes a total burden of approximately 1.0 hours for an adviser. Based on our experience with these filings, we estimate that we will receive 36 Form ADV-NR filings annually. Based on the 1.0 hours per respondent estimate, the Commission staff estimates a total annual burden of 36 hours for this collection of information.
Rule 0-2 and Form ADV-NR do not require recordkeeping or records retention. The collection of information requirements under the rule and form is mandatory. The information collected pursuant to the rule and Form ADV-NR is a filing with the Commission. This filing is not kept confidential and must be preserved until at least three years after termination of the enterprise. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written 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 will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication. An agency 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.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a closed meeting on Thursday, July 20, 2017 at 2 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
Commissioner Stein, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matters of the closed meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Resolution of litigation claims; and
Other matters relating to enforcement proceedings.
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 Brent J. Fields from the Office of the Secretary at (202) 551-5400.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
On June 9, 2005, effective August 29, 2005 (
There are approximately 304 respondents
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services (“Fee Schedule”) to adopt a new pricing tier, Tape A and Tape C Tier. The Exchange proposes to implement the fee changes effective July 3, 2017. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization 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 those 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 proposes to amend the Fee Schedule, as described below, and implement the fee changes on July 3, 2017.
The Exchange proposes to introduce a new pricing tier—Tape A and Tape C Tier—for securities with a per share price of $1.00 or above.
As proposed, a new Tape A and Tape C Tier credit of $0.0028 per share for orders that provide liquidity in Tape A and Tape C Securities would be applicable to ETP Holders and Market Makers, that, on a daily basis, measured monthly, (1) directly execute providing volume in Tape A Securities during the billing month (“Tape A Adding ADV”) that is at least 2 million shares ADV over the ETP Holder's or Market Maker's first quarter 2017 Tape A Adding ADV,
For ETP Holders that qualify for the proposed new Tape A and Tape C Tier, Tiered or Basic Rates would apply to all other fees and credits, based on the firm's qualifying levels, and if an ETP Holder qualifies for more than one tier in the Fee Schedule, the Exchange would apply the most favorable rate available under such tiers.
Additionally, the Exchange recently adopted the Tape C Tier 3 pricing tier that references the applicability of a $0.0002 per share credit to ETP Holders and Market Makers that qualify for that pricing tier.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any significant problems that market participants would have in complying with the proposed changes.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes the proposed Tape A and Tape C Tier is reasonable and equitably allocated because it would apply to ETP Holders and Market Makers that provide liquidity in Tape A, Tape B and Tape C Securities to the Exchange and is designed to incentivize these market participants to increase the orders sent directly to the Exchange and therefore provide liquidity that supports the quality of price discovery and promotes market transparency. The Exchange believes the new Tape A and Tape C Tier is equitable because the proposed new tier would be available to all similarly situated ETP Holders and Market Makers on an equal basis and the proposed new tier provides a credit that is reasonably related to the value of an exchange's market quality associated with higher volumes. The Exchange currently provides a comparable credit for orders that provide liquidity in Tape B Securities to ETP Holders and Market Makers that meet the requirements of Tape B Tier 2 and with this proposed rule change, the Exchange would extend the availability of a similar credit to ETP Holders and Market Makers in Tape A and Tape C Securities.
The Exchange further believes that the proposed Tape A and Tape C Tier is reasonable, equitable and not unfairly discriminatory because the Exchange has previously implemented pricing tiers that target a particular segment of securities. For example, to qualify for the Step Up Tier, ETP Holders and Market Makers are required to set a new NYSE Arca Best Bid or Offer with at least 25% in each of the ETP Holder's or Market Maker's Tape A, Tape B and Tape C providing ADV.
The Exchange also believes that the requirement to execute providing volume in Tape A and Tape C Securities during the billing month that is at least 2 million shares ADV over the ETP Holder's and Market Maker's first quarter 2017 adding ADV in each of Tape A and Tape C Securities is reasonable as it would provide incentives for adding liquidity in Tape A and Tape C Securities and strengthen market quality in those securities. The Exchange further believes that the requirement to execute providing volume in Tape A and Tape C Securities for the proposed Tape A and Tape C Tier is equitable and not unfairly discriminatory because it would apply uniformly to all similarly situated ETP Holders and Market Makers.
The Exchange believes that the proposed rule change regarding Tape A and Tape C credits would create an added incentive for ETP Holders and Market Makers to execute additional orders on the Exchange. The Exchange believes that the proposed change is equitable and not unfairly discriminatory because providing incentives for orders in exchange-listed securities that are executed on a registered national securities exchange (rather than relying on certain available off-exchange execution methods) would contribute to investors' confidence in the fairness of their transactions and would benefit all investors by deepening the Exchange's liquidity pool, supporting the quality of price discovery, promoting market transparency and improving investor protection.
The Exchange believes that the non-substantive change to add the word “directly” in front of “execute” in current Tape C Tier 3 pricing tier removes impediments to and perfects the mechanism of a free and open market by providing clarity and adding transparency to the Exchange's rules. The Exchange believes the proposed amendment to the Fee Schedule is both reasonable and equitable because ETP Holders and Market Makers would benefit from clear guidance in the rule text describing the manner in which the Exchange's fees and credits would be assessed.
Volume-based rebates and fees such as the ones currently in place on the Exchange, and as proposed herein, have been widely adopted in the cash equities markets and are equitable because they are open to all ETP Holders and Market Makers on an equal basis and provide additional benefits or discounts that are reasonably related to the value to an exchange's market quality associated with higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns, and introduction of higher volumes of orders into the price and volume discovery processes. The Exchange believes that the proposed introduction of Tape A and Tape C Tier will provide such enhancements in market quality on the Exchange's equity
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees and rebates to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees and credits in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. As a result of all of these considerations, the Exchange does not believe that the proposed changes will impair the ability of ETP Holders or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such 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 under Section 19(b)(2)(B)
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.
Federal Highway Administration (FHWA), United States Department of Transportation (USDOT).
Notice of Intent.
The FHWA is issuing this notice to advise the public that an EIS will be prepared for proposed improvements along I-516/SR21/CS 1503/DeRenne Avenue. The project would begin approximately 0.72 mile west of Mildred Street and end west of the Harry S. Truman Parkway ramps at DeRenne Avenue, for a project corridor of approximately 2.6 miles.
Jennifer Giersch, Federal Highway Administration, 61 Forsyth Street SW., Suite 17T100, Atlanta, Georgia 30303,
David Moyer, P.E., Project Manager, Georgia Department of Transportation, 600 West Peachtree Street, 25th Floor, Atlanta, Georgia 30308,
Eric Duff, State Environmental Administrator, Georgia Department of Transportation, One Georgia Center, 600 West Peachtree Street NW., 25th Floor, Atlanta, Georgia 30308.
Ryan Perry, Ph.D., NEPA Analyst, Georgia Department of Transportation, One Georgia Center, 600 West Peachtree Street NW., 16th Floor, Atlanta, Georgia 30308.
The FHWA, in cooperation with the Georgia Department of Transportation (GDOT), will prepare an Environmental Impact Statement (EIS) for proposed improvements along I-516/SR 21/CS 1503/DeRenne Avenue and Hampstead Avenue. An evaluation under Section 4(f) of the DOT Act of 1966 may also be required due to the potential for impacts to resources eligible for the National Register of Historic Places. The project is being developed to alleviate congestion and improve mobility along the I-516 and SR 21/CS 1503/DeRenne Avenue corridor. Proposed project elements may include modifications at the interchange of I-516 and SR 21, improvements along roads adjacent to DeRenne Avenue, intersection upgrades, and improvements along DeRenne Avenue.
A study corridor large enough to incorporate detailed studies for the full range of alternatives to be considered for the project will be evaluated. The EIS will be prepared in accordance with the National Environmental Policy Act (NEPA: 42 U.S.C. 4321
Public involvement is a critical component of NEPA project development. To date, outreach efforts have included development of a local Steering Committee, a Public Information Open House, targeted outreach within several communities along the project corridor, and a field site visit with public walk-through. To ensure that the full range of issues related to this proposed action are addressed and all significant issues identified, public outreach and involvement will continue, and comments and suggestions are invited from all interested parties. Specific efforts to encourage involvement by, and solicit comments from, minority and low-income populations in the project study area will continue through the EIS process. A public hearing will be held after the completion of the Draft EIS, and the EIS will be made available for review by federal and state resource agencies and the public. Project information, comments, video, and concepts will be maintained throughout the EIS process on an existing link through the City of Savannah Web site (
Additional agency coordination will begin with publication of the NOI, followed by initial contact and scoping occurring within 45 to 60 days after publication of the NOI and continuing coordination throughout the EIS process.
Regulations implementing NEPA, as well as the provisions of SAFETEA-LU and MAP-21, call for enhanced agency and public involvement in the EIS process. An invitation to all Federal and non-Federal agencies and Native American tribes that may have an interest in the proposed project will be extended. In the event that an agency or tribe is not invited and would like to participate, please contact Ryan Perry at the contact information listed above.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to renew exemptions of 145 individuals from its prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals with ITDM to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions was effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On May 15, 2017, FMCSA published a notice announcing its decision to renew exemptions for 145 individuals from the insulin-treated diabetes mellitus prohibition in 49 CFR 391.41(b)(3) to operate a CMV in interstate commerce and requested comments from the public (82 FR 22382). The public comment period ended on June 14, 2017, and no comments were received.
As stated in the previous notice, FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(3).
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.
FMCSA received no comments in this preceding.
Based upon its evaluation of the 145 renewal exemption applications and that no comments were received, FMCSA confirms its' decision to exempt the following drivers from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce in 49 CFR 391.41(b)(3).
As of June 2, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 11 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (76 FR 20073; 76 FR 32015):
The drivers were included in Docket No. FMCSA-2011-0080. Their exemptions are effective as of June 2, 2017, and will expire on June 2, 2019.
As of June 6, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 21 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (80 FR 26133; 80 FR 60743):
The drivers were included in Docket No. FMCSA-2015-0058. Their exemptions are effective as of June 6, 2017, and will expire on June 6, 2019.
As of June 8, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 19 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (72 FR 12656; 72 FR 31875):
The drivers were included in Docket No. FMCSA-2006-26601. Their exemptions are effective as of June 8, 2017, and will expire on June 8, 2019.
As of June 11, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 41 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (78 FR 20381; 78 FR 35088; 80 FR 26979; 80 FR 45575):
The drivers were included in one of the following docket Nos: FMCSA-2013-0015; FMCSA-2015-0059. Their exemptions are effective as of June 11, 2017, and will expire on June 11, 2019.
As of June 12, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following nine individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (74 FR 19271; 74 FR 28096):
The drivers were included in Docket No. FMCSA-2009-0115. Their exemptions are effective as of June 12, 2017, and will expire on June 12, 2019.
As of June 20, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 25 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (78 FR 22599; 78 FR 24795; 78 FR 37272; 78 FR 37273):
The drivers were included in docket Nos: FMCSA-2013-0016; FMCSA-2013-0017. Their exemptions are effective as of June 20, 2017, and will expire on June 20, 2019.
As of June 24, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 12 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (76 FR 25769; 76 FR 37171):
The drivers were included in docket No. FMCSA-2011-0103. Their exemptions are effective as of June 24, 2017, and will expire on June 24, 2019.
As of June 28, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following seven individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (76 FR 21792; 76 FR 37882):
The drivers were included in docket No. FMCSA-2011-0093. Their exemptions are effective as of June 28, 2017, and will expire on June 28, 2019.
In accordance with 49 U.S.C. 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
FMCSA announces its decision to renew exemptions for 120 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Each group of renewed exemptions was effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
On May 15, 2017, FMCSA published a notice announcing its decision to renew exemptions for 120 individuals from the vision requirement in 49 CFR 391.41(b)(10) to operate a CMV in interstate commerce and requested comments from the public (82 FR 22379). The public comment period ended on June 14, 2017, and no comments were received.
As stated in the previous notice, FMCSA has evaluated the eligibility of these applicants and determined that renewing these exemptions would achieve a level of safety equivalent to or greater than the level that would be achieved by complying with the current regulation 49 CFR 391.41(b)(10).
The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to driver a CMV if that person:
Has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber.
FMCSA received no comments in this preceding.
As of June 4, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 38 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (65 FR 66286; 65 FR 78256; 66 FR 13825; 66 FR 16311; 67 FR 68719; 68 FR 2629; 68 FR 13360; 68 FR 19598; 68 FR 33570; 69 FR 33997; 69 FR 61292; 69 FR 64806; 69 FR 71100; 70 FR 2705; 70 FR 12265; 70 FR 16887; 70 FR 25878; 71 FR 63379; 72 FR 184; 72 FR 1050; 72 FR 1051; 72 FR 1053; 72 FR 5489; 72 FR
The drivers were included in one of the following docket Nos.: FMCSA-2000-7918; FMCSA-2000-8398; FMCSA-2002-12844; FMCSA-2003-14504; FMCSA-2004-17984; FMCSA-2004-19477; FMCSA-2006-26066; FMCSA-2008-0398; FMCSA-2009-0054; FMCSA-2011-0010; FMCSA-2012-0337; FMCSA-2013-0022; FMCSA-2013-0024; FMCSA-2014-0299; FMCSA-2014-0300; FMCSA-2014-0302; FMCSA-2014-0303; FMCSA-2014-0304; FMCSA-2014-0305. Their exemptions are effective as of June 4, 2017, and will expire on June 4, 2019.
As of June 6, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 27 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (78 FR 20376; 78 FR 34141; 80 FR 26139; 80 FR 29149; 80 FR 48409):
The drivers were included in one of the following docket Nos: FMCSA-2013-0025; FMCSA-2015-0048. Their exemptions are effective as of June 6, 2017, and will expire on June 6, 2019.
As of June 12, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following eight individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (74 FR 19267; 74 FR 28094; 76 FR 32016; 76 FR 32703; 80 FR 25768):
The drivers were included in one of the following docket Nos: FMCSA-2008-0106; FMCSA-2009-0086. Their exemptions are effective as of June 12, 2017, and will expire on June 12, 2019.
As of June 13, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 11 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (70 FR 17504; 70 FR 30997; 72 FR 21313; 72 FR 27624; 72 FR 32703; 74 FR 23472; 76 FR 32017; 78 FR 32708; 80 FR 29154):
The drivers were included in one of the following docket Nos: FMCSA-2005-20560; FMCSA-2007-27515. Their exemptions are effective as of June 13, 2017, and will expire on June 13, 2019.
As of June 20, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following eight individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (72 FR 21313; 72 FR 32703; 74 FR 11988; 74 FR 19267; 74 FR 21427; 74 FR 23472; 74 FR 28094; 76 FR 21796; 76 FR 32016; 76 FR 32017; 78 FR 12815; 78 FR 16912; 78 FR 22596; 78 FR 22598; 78 FR 22602; 78 FR 29431; 78 FR 32703; 78 FR 32708; 78 FR 37274; 80 FR 31635):
The drivers were included in one of the following docket Nos: FMCSA-2007-27515; FMCSA-2009-0054; FMCSA-2009-0086; FMCSA-2013-0022; FMCSA-2013-0024; FMCSA-2013-0026. Their exemptions are effective as of June 20, 2017, and will expire on June 20, 2019.
As of June 26, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 14 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (63 FR 66226; 64 FR 16517; 65 FR 20245; 65 FR 45817; 65 FR 57230; 65 FR 77066; 66 FR 17743; 66 FR 17994; 66 FR 33990; 67 FR 57266; 68 FR 35772; 70 FR 2701; 70 FR 16887; 70 FR 17504; 70 FR 30997; 70 FR 33937; 72 FR 12666; 72 FR 25831; 72 FR 32705; 74 FR 15586; 74 FR 26464; 76 FR 21796; 76 FR 34135; 78 FR 34140; 80 FR 33009):
The drivers were included in one of the following docket Nos: FMCSA-1998-4334; FMCSA-2000-7006; FMCSA-2000-7363; FMCSA-2001-9258; FMCSA-2005-20027; FMCSA-2005-20560; FMCSA-2007-27333. Their exemptions are effective as of June 26, 2017, and will expire on June 26, 2019.
As of June 28, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 11 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (76 FR 25766; 76 FR 37885; 78 FR 37270; 80 FR 31640):
The drivers were included in docket No. FMCSA-2011-0092. Their exemptions are effective as of June 28, 2017, and will expire on June 28, 2019.
As of June 30, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following three individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (65 FR 78256; 66 FR 16311; 68 FR 13360; 70 FR 2701; 70 FR 16887; 70 FR 17504; 70 FR 30997; 70 FR 37891; 72 FR 27624; 72 FR 34062; 74 FR 26471; 76 FR 34133; 78 FG 57677; 80 FR 31962):
The drivers were included in one of the following docket Nos: FMCSA-2000-8398; FMCSA-2005-20027; FMCSA-2005-20560. Their exemptions are effective as of June 30, 2017, and will expire on June 30, 2019.
In accordance with 49 U.S.C. 31315, each exemption will be valid for two years from the effective date unless revoked earlier by FMCSA. The exemption will be revoked if the following occurs: (1) the person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained prior to being granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136 and 31315.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final determination; denial of application for exemption.
FMCSA announces its decision to deny the application of Transco, Inc. (Transco) (USDOT # 1062707) for an exemption from the 30-minute rest break provision of the Agency's hours-of-service (HOS) regulations for commercial motor vehicle (CMV) drivers. Transco asked that its drivers be permitted to comply with the 30-minute rest break requirement while performing “on-duty, not-driving” tasks. Due to the nature of its operations, Transco believes that compliance with the 30-minute rest break provision negatively impacts the overall safety and general health of its CMV drivers. FMCSA has analyzed the exemption application and public comments, and has determined that the applicant would not achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption.
FMCSA denied the application for exemption by letter dated February 27, 2017, after notice and opportunity for public comment.
For information concerning this notice, contact Mr. Thomas Yager, Chief, FMCSA Driver and Carrier Operations Division; Office of Carrier, Driver and Vehicle Safety Standards; Telephone: 614-942-6477. Email:
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain Federal Motor Carrier Safety Regulations (FMCSRs). FMCSA must publish a notice of each exemption request in the
FMCSA reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency and the reasons for denying an application must be published in the
On December 27, 2011 (76 FR 81133), FMCSA published a final rule amending its hours-of-service (HOS) regulations for drivers of property-carrying CMVs. The rule included a provision requiring many CMV drivers to take a rest break during the work day. Drivers may drive a CMV only if 8 hours or less have passed since the end of the driver's last off-duty or sleeper-berth period of at least 30 minutes. FMCSA did not specify when drivers must take the 30-minute break, but the rule requires that they wait no longer than 8 hours after the last off-duty or sleeper-berth period of that length or longer to take the break if they want to continue driving (49 CFR 395.3(a)(3)(ii)).
Transco seeks an exemption from the 30-minute rest break provision. Transco, operating through McLane Company, Inc., employs over 4,000 drivers who deliver freight from distribution centers to grocery stores and restaurants throughout the United States. Transco drivers make an average of nine stops per day during which they offload freight to customers. Transco contends that because its operations differ greatly from long-haul operations it should not be subject to the rest break requirement. It contends that the frequent stops serve the purpose of the 30-minute rest break because they break the monotony and stress of driving for Transco's drivers. Transco argues that physically-active offloading is in fact better for the health of its drivers than 30 minutes free of
On September 28, 2016, FMCSA published Transco's application for exemption and requested public comment (81 FR 66734). The Agency received 54 comments to the docket, mostly from CMV drivers. More than 40 of the comments opposed the Transco application for exemption. The principal concern of the CMV drivers was that the exemption would convert obvious on-duty time to off-duty time. The Advocates for Highway and Auto Safety expressed concern that rigorous physical activity (loading and unloading) would be substituted for the respite from driver duties provided by the 30-minute rest break. The International Brotherhood of Teamsters opposed the application. It pointed out that the applicant described the typical driver workday as being 19 hours long, making the rest break even more critical to safety and driver health.
When FMCSA proposed the provision requiring a 30-minute rest break, it relied upon research indicating that periods free from work responsibilities are followed by improved work performance. The research showed that this improvement was experienced regardless of the precise nature of the worker's duties. FMCSA believes that, whatever the relative degree of monotony associated with long-haul and local-delivery driving, the fact is that both types of drivers are susceptible to fatigue as the workday progresses. The Agency believes that rest breaks provide a benefit to both types of drivers, and that safety is improved by allowing drivers to take a break from their duties during the work day. The rest break is especially important for Transco drivers because they accumulate fatigue both from the lifting of their unloading tasks and from 19-hour days.
For these reasons, FMCSA has denied the applicant's request for exemption.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 125 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirement in one eye.
Each group of renewed exemptions was effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before August 17, 2017.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2000-7006; FMCSA-2001-9258; FMCSA-2001-9561; FMCSA-2002-11714; FMCSA-2002-13411; FMCSA-2003-14504; FMCSA-2003-15268; FMCSA-2004-17984; FMCSA-2005-20560; FMCSA-2005-21254; FMCSA-2006-26653; FMCSA-2007-2663; FMCSA-2007-27897; FMCSA-2008-0266; FMCSA-2009-0086; FMCSA-2009-0121; FMCSA-2010-0354; FMCSA-2010-0372; FMCSA-2010-0385; FMCSA-2011-0010; FMCSA-2011-0024; FMCSA-2011-0057; FMCSA-2011-0092; FMCSA-2011-0102; FMCSA-2011-0140; FMCSA-2011-0141; FMCSA-2013-0021; FMCSA-2013-0025; FMCSA-2013-0027; FMCSA-2013-0028; FMCSA-2013-0029; FMCSA-2014-0002; FMCSA-2014-0010; FMCSA-2014-0302; FMCSA-2014-0305; FMCSA-2015-0048; FMCSA-2015-0049; FMCSA-2015-0052; FMCSA-2015-0053; FMCSA-2015-0055 using any of the following methods:
•
•
•
•
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the two-year period.
The physical qualification standard for drivers regarding vision found in 49 CFR 391.41(b)(10) states that a person is physically qualified to driver a CMV if that person:
Has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of a least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing red, green, and amber.
The 125 individuals listed in this notice have requested renewal of their exemptions from the vision standard in 49 CFR 391.41(b)(10), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the 125 applicants has satisfied the renewal conditions for obtaining an exemption from the vision requirement (65 FR 20245; 65 FR 57230; 66 FR 17743; 66 FR 30502; 66 FR 33990; 66 FR 41654; 67 FR 15662; 67 FR 37907; 67 FR 57266; 67 FR 76439; 68 FR 10298; 68 FR 19598; 68 FR 33570; 68 FR 35772; 68 FR 37197; 68 FR 44837; 68 FR 48989; 69 FR 26206; 69 FR 33997; 69 FR 52741; 69 FR 61292; 70 FR 7545; 70 FR 17504; 70 FR 25878; 70 FR 30997; 70 FR 30999; 70 FR 33937; 70 FR 41811; 70 FR 42615; 70 FR 46567; 71 FR 26601; 71 FR 55820; 71 FR 62147; 72 FR 7812; 72 FR 8417; 72 FR 27624; 72 FR 28093; 72 FR 32705; 72 FR 36099; 72 FR 39879; 72 FR 40359; 72 FR 40360; 72 FR 40362; 72 FR 52419; 73 FR 36955; 73 FR 51689; 73 FR 63047; 74 FR 6211; 74 FR 19267; 74 FR 19270; 74 FR 20253; 74 FR 26461; 74 FR 26464; 74 FR 26466; 74 FR 28094; 74 FR 34074; 74 FR 34395; 74 FR 34630; 74 FR 34632; 75 FR 36779; 75 FR 66423; 75 FR 72863; 75 FR 77492; 76 FR 2190; 76 FR 5425; 76 FR 7894; 76 FR 9856; 76 FR 9865; 76 FR 17481; 76 FR 18824; 76 FR 20076; 76 FR 20078; 76 FR 21796; 76 FR 25762; 76 FR 25766; 76 FR 28125; 76 FR 29022; 76 FR 29024; 76 FR 29026; 76 FR 37168; 76 FR 37169; 76 FR 37173; 76 FR 37885; 76 FR 40445; 76 FR 44082; 76 FR 44652; 76 FR 44653; 76 FR 49531; 76 FR 50318; 76 FR 53710; 77 FR 38384; 77 FR 74273; 78 FR 800; 78 FR 10251; 78 FR 14410; 78 FR 16762; 78 FR 20376; 78 FR 20379; 78 FR 24300; 78 FR 24798; 78 FR 27281; 78 FR 30954; 78 FR 34141; 78 FR 34143; 78 FR 37270; 78 FR 41188; 78 FR 46407; 78 FR 51268; 78 FR 51269; 78 FR 52602; 78 FR 56993; 78 FR 57679; 79 FR 4531; 79 FR 10608; 79 FR 22003; 79 FR 24298; 79 FR 35218; 79 FR 51643; 79 FR 64001; 79 FR 73687; 80 FR 603; 80 FR 12248; 80 FR 15863; 80 FR 16500; 80 FR 18696; 80 FR 22773; 80 FR 25766; 80 FR 26139; 80 FR 26320; 80 FR 29149; 80 FR 29152; 80 FR 31636; 80 FR 31957; 80 FR 33007; 80 FR 35699; 80 FR 36395; 80 FR 36398; 80 FR 37718; 80 FR 40122; 80 FR 41547; 80 FR 41548; 80 FR 44185; 80 FR 44188; 80 FR 45573; 80 FR 48404; 80 FR 48409; 80 FR 48413; 80 FR 62161; 80 FR 62163). They have submitted evidence showing that the vision in the better eye continues to meet the requirement specified at 49 CFR 391.41(b)(10) and that the vision impairment is stable. In addition, a review of each record of safety while driving with the respective vision deficiencies over the past two years indicates each applicant continues to meet the vision exemption requirements. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of two years is likely to achieve a level of safety equal to that existing without the exemption.
In accordance with 49 U.S.C. 31136(e) and 31315, the following groups of drivers received renewed exemptions in the month of July and are discussed below.
As of August 8, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 49 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (65 FR 20245; 65 FR 57230; 66 FR 30502; 66 FR 33990; 66 FR 41654; 67 FR 15662; 67 FR 37907; 67 FR 57266; 67 FR 76439; 68 FR 10298; 68 FR 19598; 68 FR 33570; 68 FR 44837; 69 FR 26206; 69 FR 33997; 69 FR 52741; 69 FR 61292; 70 FR 7545; 70 FR 17504; 70 FR 25878; 70 FR 30997; 70 FR 41811; 71 FR 26601; 71 FR 55820; 71 FR 62147; 72 FR 7812; 72 FR 8417; 72 FR 27624; 72 FR 28093; 72 FR 36099; 72 FR 39879; 72 FR 40362; 72 FR 52419; 73 FR 36955; 73 FR 51689; 73 FR 63047; 74 FR 6211; 74 FR 19267; 74 FR 19270; 74 FR 20253; 74 FR 26461; 74 FR 26466; 74 FR 28094; 74 FR 34395; 74 FR 34630; 75 FR 36779; 75 FR 66423; 75 FR 72863; 75 FR 77492; 76 FR 2190; 76 FR 5425; 76 FR 7894; 76 FR 9856; 76 FR 9865; 76 FR 17481; 76 FR 18824; 76 FR 20076; 76 FR 20078; 76 FR 21796; 76 FR 25762; 76 FR 25766; 76 FR 28125; 76 FR 29024; 76 FR 29026; 76 FR 37168; 76 FR 37173; 76 FR 37885; 76 FR 44652; 77 FR 38384; 77 FR 74273; 78 FR 800; 78 FR 10251; 78 FR 14410; 78 FR 16762; 78 FR 20376; 78 FR 20379; 78 FR 24300; 78 FR 24798; 78 FR 27281; 78 FR 30954; 78 FR 34141; 78 FR 37270; 78 FR 41188; 78 FR 46407; 78 FR 51269; 78 FR 56993; 78 FR 57679; 79 FR 10608; 79 FR 22003; 79 FR 24298; 79 FR 35218; 79 FR 51643; 79 FR 64001; 79 FR 73687; 80 FR 603; 80 FR 12248; 80 FR 15863; 80 FR 16500; 80 FR 18696; 80 FR 22773; 80 FR 25766; 80 FR 26139; 80 FR 26320; 80 FR 29149; 80 FR 29152; 80 FR 31636; 80 FR 31957; 80 FR 33007; 80 FR 35699; 80 FR 36395; 80 FR 36398; 80 FR 37718; 80 FR 45573; 80 FR 48404; 80 FR 48409; 80 FR 48413):
The drivers were included in one of the following docket Nos: FMCSA-2000-7006; FMCSA-2001-9561; FMCSA-2002-11714; FMCSA-2002-13411; FMCSA-2003-14504; FMCSA-2004-17984; FMCSA-2005-20560; FMCSA-2006-26653; FMCSA-2007-2663; FMCSA-2007-27897; FMCSA-2008-0266; FMCSA-2009-0086; FMCSA-2009-0121; FMCSA-2010-0354; FMCSA-2010-0372; FMCSA-2010-0385; FMCSA-2011-0010; FMCSA-2011-0024; FMCSA-2011-0057; FMCSA-2011-0092; FMCSA-2013-0021; FMCSA-2013-0025; FMCSA-2013-0027; FMCSA-2013-0028; FMCSA-2014-0002; FMCSA-2014-0010; FMCSA-2014-0302; FMCSA-2014-0305; FMCSA-2015-0048; FMCSA-2015-0049; FMCSA-2015-0052. Their exemptions are effective as of August 8, 2017, and will expire on August 8, 2019.
As of August 10, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following four individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (80 FR 31636; 80 FR 48413):
The drivers were included in one of the following docket Nos: FMCSA-2001-9258; FMCSA-2005-21254. Their exemptions are effective as of August 10, 2017, and will expire on August 10, 2019.
As of August 12, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following six individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (76 FR 37169; 76 FR 50318; 79 FR 4531; 80 FR 41548):
The drivers were included in docket No. FMCSA-2011-0140. Their exemptions are effective as of August 12, 2017, and will expire on August 12, 2019.
As of August 13, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 11 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (80 FR 40122; 80 FR 62163):
The drivers were included in docket No. FMCSA-2015-0053. Their exemptions are effective as of August 13, 2017, and will expire on August 13, 2019.
As of August 15, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 11 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (66 FR 30502; 66 FR 41654; 68 FR 37197; 68 FR 44837; 68 FR 48989; 70 FR 41811; 70 FR 42615; 72 FR 40360; 74 FR 34632; 76 FR 49531; 79 FR 4531; 80 FR 44185):
The drivers were included in one of the following docket Nos: FMCSA-2001-9561; FMCSA-2003-15268. Their exemptions are effective as of August 15, 2017, and will expire on August 15, 2019.
As of August 23, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 21 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (76 FR 29022; 76 FR 44082; 78 FR 20376; 78 FR 34141; 78 FR 34143; 78 FR 51268; 78 FR 52602):
The drivers were included in one of the following docket Nos: FMCSA-2011-0102; FMCSA-2013-0025; FMCSA-2013-0029. Their exemptions are effective as of August 23, 2017, and will expire on August 23, 2019.
As of August 25, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 20 individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (80 FR 44188; 80 FR 62161):
The drivers were included in docket No. FMCSA-2015-0055. Their exemptions are effective as of August 25, 2017, and will expire on August 25, 2019.
As of August 29, 2017, and in accordance with 49 U.S.C. 31136(e) and 31315, the following three individuals have satisfied the conditions for obtaining a renewed exemption from the vision requirements (76 FR 40445; 76 FR 53710; 79 FR 4531):
The drivers were included in docket No. FMCSA-2011-0141. Their exemptions are effective as of August 29, 2017, and will expire on August 29, 2019.
The exemptions are extended subject to the following conditions: (1) Each driver must undergo an annual physical examination (a) by an ophthalmologist or optometrist who attests that the vision in the better eye continues to meet the requirements in 49 CFR 391.41(b)(10), and (b) by a certified Medical Examiner, as defined by 49 CFR 390.5, who attests that the driver is otherwise physically qualified under 49 CFR 391.41; (2) each driver must provide a copy of the ophthalmologist's or optometrist's report to the Medical Examiner at the time of the annual medical examination; and (3) each
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 125 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the vision requirement in 49 CFR 391.41(b)(10), subject to the requirements cited above (49 CFR 391.64(b)). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for two individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these hard of hearing and deaf individuals to continue to operate CMVs in interstate commerce.
The renewed exemptions were effective on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before August 17, 2017.
Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2014-0383; FMCSA-2013-0102 using any of the following methods:
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Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the two-year period.
The physical qualification standard for drivers regarding hearing found in 49 CFR 391.41(b)(11) states that a person is physically qualified to driver a CMV if that person:
First perceives a forced whispered voice in the better ear at not less than 5 feet with or without the use of a hearing aid or, if tested by use of an audiometric device, does not have an average hearing loss in the better ear greater than 40 decibels at 500 Hz, 1,000 Hz, and 2,000 Hz with or without a hearing aid when the audiometric device is calibrated to American National Standard (formerly ASA Standard) Z24.5-1951.
49 CFR 391.41(b)(11) was adopted in 1970, with a revision in 1971 to allow drivers to be qualified under this standard while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36 FR 12857 (July 3, 1971).
The two individuals listed in this notice have requested renewal of their exemptions from the hearing standard in 49 CFR 391.41(b)(11), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the twelve applicants has satisfied the renewal conditions for obtaining an exemption from the hearing requirement (80 FR 57032; 80 FR 60747). In addition, for Commercial Driver's License (CDL) holders, the Commercial Driver's License Information System (CDLIS) and the Motor Carrier Management Information System (MCMIS) are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency (SDLA). These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce.
The two drivers in this notice remain in good standing with the Agency and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. FMCSA has concluded that renewing the exemptions for each of these applicants is likely to achieve a level of safety equal to that existing without the exemption. Therefore, FMCSA has decided to renew each exemption for a two-year period. In accordance with 49 U.S.C. 31136(e) and 31315, each driver has received a renewed exemption.
As of May 8, 2017, Mark Dickson (TX), has satisfied the renewal conditions for obtaining an exemption from the requirement in 49 CFR 391.41(b)(11), from driving CMVs in interstate commerce (80 FR 18697).
The driver was included in FMCSA-2014-0383. The exemption was effective on May 8, 2017, and will expire on May 8, 2019.
As of May 21, 2017, Timothy Gallagher (PA), has satisfied the renewal conditions for obtaining an exemption from the requirement in 49 CFR 391.41(b)(11), from driving CMVs in interstate commerce (78 FR 22768).
The driver was included in FMCSA-2014-0102. The exemption was effective on May 21, 2017, and will expire on May 21, 2019.
The exemptions are extended subject to the following conditions: (1) Each driver must report any crashes or accidents as defined in 49 CFR 390.5; and (2) report all citations and convictions for disqualifying offenses under 49 CFR part 383 and 49 CFR 391 to FMCSA. In addition, the driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The driver is prohibited from operating a motorcoach or bus with passengers in interstate commerce. The exemption does not exempt the individual from meeting the applicable CDL testing requirements. Each exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
Based upon its evaluation of the nine exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the hearing requirement in 49 CFR 391.41(b)(11). In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice and comment request.
Under the Paperwork Reduction Act of 1995 (PRA), this notice announces that FRA is forwarding the Information Collection Request (ICR) abstracted below to the Office of Management and Budget (OMB) for review and comment. The ICR describes the information collection and its expected burden.
Comments must be submitted on or before August 17, 2017.
Send comments regarding these information collections to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: FRA Desk Officer. Comments may also be sent via email to OMB at the following address:
Ms. Kim Toone, Information Collection Clearance Officer, Office of Administration, Office of Information Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop 35, Washington, DC 20590 (Telephone: (202) 493-6132). (This telephone number is not toll free.)
The PRA, 44 U.S.C. 3501-3520, and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8, and 1320.10. On April 18, 2017, FRA published a 60-day notice in the
Before OMB decides whether to approve this proposed collection of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.10. Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.10;
The summary below describes the ICR and its expected burden. FRA is submitting the new request for clearance by OMB as the PRA requires.
The proposed study is a needs assessment designed to understand the current state of railroading industry use and application of ICT. As such, this study asks broad questions about ICT. The main objectives of this study are to: (1) Determine how Transportation, Yard and Engineer railroaders use ICT; (2) identify ways to reach this population with future ICT-based education and communication efforts; and (3) develop baseline awareness data for FRA's research, development and technology programs.
A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this notice in the
44 U.S.C. 3501-3520.
Federal Transit Administration (FTA), DOT.
Notice of funding opportunity (NOFO).
The Federal Transit Administration (FTA) announces the opportunity to apply for approximately $226.5 million in Fiscal Year (FY) 2017 funds under Grants for Buses and Bus Facilities Infrastructure Investment Program (CFDA#20.526). As required by federal transit law and subject to funding availability, funds will be awarded competitively to assist in the financing of capital projects to replace, rehabilitate, purchase or lease buses and related equipment, and to rehabilitate, purchase, construct or lease bus-related facilities. Projects may include costs incidental to the acquisition of buses or to the construction of facilities, such as the costs of related workforce development and training activities, and project administration expenses. FTA may award additional funds if they are made available to the program prior to the announcement of project selections.
Complete proposals must be submitted electronically through the GRANTS.GOV “APPLY” function by 11:59 p.m. on August 25, 2017. Prospective applicants should initiate the process by registering on the GRANTS.GOV Web site promptly to ensure completion of the application process before the submission deadline. Instructions for applying can be found on FTA's Web site at
Mark Bathrick, FTA Office of Program Management, 202-366-9955, or
Section 5339(b) of Title 49, United States Code, as amended by the Fixing America's Surface Transportation (FAST) Act (Pub. L. 114-94, Dec. 4, 2015), authorizes FTA to award funds under the Buses and Bus Facilities Infrastructure Investment Program (Bus and Bus Infrastructure Program) through a competitive process, as described in this notice, for capital projects to replace, rehabilitate, purchase or lease buses and related equipment and to rehabilitate, purchase, construct or lease bus-related facilities.
The purpose of the Bus and Bus Infrastructure Program is to assist in the financing of buses and bus facilities capital projects, including replacing, rehabilitating, purchasing or leasing buses or related equipment, and rehabilitating, purchasing, constructing or leasing bus-related facilities.
The Bus and Bus Infrastructure Program provides funds to designated recipients that allocate funds to fixed route bus operators, and to States, and local governmental authorities that operate fixed route bus service. FTA also may award grants to eligible recipients for projects to be undertaken by subrecipients that are public agencies or private non-profit organizations engaged in public transportation. In accordance with 49 U.S.C. 5339(b)(2), FTA will “consider the age and condition of buses, bus fleets, related equipment, and bus-related facilities” in selecting projects for funding. FTA may prioritize projects that demonstrate how they will address significant repair and maintenance needs, improve the safety of transit systems, and deploy connective projects that include advanced technologies to connect bus systems with other networks.
Federal transit law at 49 U.S.C. 5338(a)(2)(M) authorizes $283,600,000 in FY 2017 funds for the Section 5339(b) Bus and Bus Infrastructure Program and the 5339(c) Low or No Emission Grants (Low-No) Program. Of this amount, 0.75 percent, or $2,127,000, has been reserved for program oversight in accordance with 49 U.S.C. 5338(f)(1)(H). Of the amount available for grants, FTA separately announced the availability of $55 million for Low-No Grants and is making the remaining $226,473,000 available through this notice for competitive grants under the Bus and Bus Infrastructure Program.
As required under 49 U.S.C. 5339(b)(5), a minimum of 10 percent of the amount awarded under the Bus and
FTA will grant pre-award authority to incur costs for selected projects beginning on the date that project selections are announced. Funds are only available for projects that have not incurred costs prior to the selection of projects and will remain available for obligation until September 30, 2020.
Under 49 U.S.C. 5339(b)(1), eligible applicants include designated recipients that allocate funds to fixed route bus operators, states or local governmental entities that operate fixed route bus service, and Indian tribes. Except for projects proposed by Indian tribes, proposals for projects in rural (non-urbanized) areas must be submitted as part of a consolidated State proposal. Under 49 U.S.C. 5339(b)(3), states and other eligible applicants may also submit consolidated proposals for projects in urbanized areas. The submission of the statewide application shall not preclude the submission and consideration of any application from other eligible recipients in an urbanized area in a State. Proposals may contain projects to be implemented by the recipient or its subrecipients.
To be considered eligible, applicants must be able to demonstrate the requisite legal, financial and technical capabilities to receive and administer Federal funds under this program. Eligible subrecipients under this program include all otherwise eligible applicants and private nonprofit organizations engaged in public transportation.
The maximum federal share for projects selected under the Bus and Bus Infrastructure Program is 80 percent of the net project cost, unless noted below by one of the exceptions. FTA may prioritize projects proposed with a higher local share.
Eligible sources of local match include the following: Cash from non-Government sources other than revenues from providing public transportation services; revenues derived from the sale of advertising and concessions; amounts received under a service agreement with a State or local social service agency or private social service organization; revenues generated from value capture financing mechanisms; or funds from an undistributed cash surplus; replacement or depreciation cash fund or reserve; or new capital. In addition, transportation development credits or documentation of in-kind match may substitute for local match if identified in the application.
Under 49 U.S.C. 5339(b)(1), eligible projects are capital projects to replace, rehabilitate purchase, or lease buses, vans, and related equipment, and capital projects to rehabilitate, purchase, construct, or lease bus-related facilities.
Recipients are permitted to use up to 0.5 percent of their requested grant award for workforce development activities eligible under 49 U.S.C. 5314(b) and an additional 0.5 percent for costs associated with training at the National Transit Institute. Applicants must identify the proposed use of funds for these activities in the project proposal and identify them separately in the project budget.
Applications must be submitted electronically through GRANTS.GOV. General information for submitting applications through GRANTS.GOV can be found at
A complete proposal submission consists of
An applicant may submit multiple project proposals in a single submission, and if doing so must include all project proposals on a single supplemental form. To add additional projects, select the “add project” button and complete a separate “project detail” section for each project. FTA will only accept one supplemental form per submission.
The supplemental form must be submitted as an attachment to the SF424 Mandatory Form. All project proposals will be evaluated separately, regardless of whether they are submitted as a single submission.
An applicant may submit additional supporting documentation for each project proposal as attachments. Any supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed.
Information such as proposer name, Federal amount requested, local match amount, description of areas served, etc. may be requested in varying degrees of detail on both the SF424 form and Supplemental Form. Proposers must fill in all fields unless stated otherwise on the forms. Applicants should not place N/A or “refer to attachment” in lieu of typing in responses in the field sections. If information is copied into the supplemental form from another source, applicants should verify that pasted text is fully captured on the supplemental form and has not been truncated by the character limits built into the form. Proposers should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields on the forms, and ensure that the federal and local amounts specified are consistent.
The SF424 Mandatory Form and the Supplemental Form will prompt applicants for the required information, including:
a. Applicant Name
b. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number
c. Key contact information (including contact name, address, email address, and phone)
d. Congressional district(s) where project will take place
e. Project Information (including title, an executive summary, and type)
f. A detailed description of the need for the project
g. A detailed description on how the project will support the Bus Infrastructure Program's objectives
h. Evidence that the project is consistent with local and regional planning objectives
i. Evidence that the applicant can provide the local cost share
j. A description of the technical, legal, and financial capacity of the applicant
k. A detailed project budget
l. An explanation of the scalability of the project
m. Details on the local matching funds
n. A detailed project timeline
Each applicant is required to: (1) Be registered in SAM before submitting an application; (2) provide a valid unique entity identifier in its application; and (3) continue to maintain an active SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA. These requirements do not apply if the applicant: (1) Is an individual; (2) is excepted from the requirements under 2 CFR 25.110(b) or (c); or (3) has an exception approved by FTA under 2 CFR 25.110(d). FTA may not make an Award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time FTA is ready to make an Award, FTA may determine that the applicant is not qualified to receive an Award and use that determination as a basis for making a Federal award to another applicant. All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but since there could be unexpected steps or delays (for example, if you need to obtain an Employer Identification Number), FTA recommends allowing ample time, up to several weeks, for completion of all steps. For additional information on obtaining a unique entity identifier, please visit
Project proposals must be submitted electronically through GRANTS.GOV by 11:59 p.m. Eastern on August 25, 2017. Mail and fax submissions will not be accepted.
FTA urges proposers to submit applications at least 72 hours prior to the due date to allow time to receive the validation messages and to correct any problems that may have caused a rejection notification. FTA will not accept submissions after the stated deadline, as determined through the timestamp assigned to the application upon receipt in GRANTS.GOV. GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV Web site. Deadlines will not be extended due to scheduled Web site maintenance.
Within 48 hours after submitting an electronic application, the applicant should receive three email messages from GRANTS.GOV: (1) Confirmation of successful transmission to GRANTS.GOV, (2) confirmation of successful validation by GRANTS.GOV, and (3) confirmation of successful validation by FTA. If confirmations of successful validation are not received or a notice of failed validation or incomplete materials is received, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, include all original attachments regardless of which attachments were updated and check the box on the supplemental form indicating this is a resubmission.
Proposers are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline. Registration is a multi-step process, which may take several weeks to complete before an application can be submitted. Registered proposers may still be required to take steps to keep their registration up to date before submissions can be made successfully: (1) Registration in the System for Award Management (SAM) is renewed annually; and, (2) persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions.
Funds under this NOFO cannot be used to reimburse applicants for otherwise eligible expenses incurred prior to FTA award of a Grant Agreement until FTA has issued pre-award authority for selected projects or unless FTA has issued a “Letter of No Prejudice” for the project before the expenses are incurred.
Applicants are encouraged to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the program and meets all relevant program requirements. The applicant must provide a clear explanation of how the project budget would be affected by a reduced award. FTA may award a lesser amount whether or not a scalable option is provided.
FTA will evaluate project proposals for the Bus and Bus Infrastructure Program based on the criteria described in this notice. Projects will be evaluated primarily on the responses provided in the supplemental form. Additional information may be provided to support the responses; however, any additional documentation must be directly referenced on the supplemental form, including the file name where the additional information can be found.
Applicants must demonstrate how the proposed project will address an unmet need for capital investment in bus vehicles and/or supporting facilities, enhance the safety of the transit system for transit vehicle operators, riders, and the general public, or improve the connectivity of bus systems with other networks through the use of deployment-ready information technologies. For example, an applicant may demonstrate a substantial backlog of deferred capital investment, insufficient size or capacity of maintenance facilities, excessive reliance on vehicles that are beyond their intended service life, a vehicle fleet that is insufficient to meet current ridership demands, or passenger facilities that are insufficient for their current use. For safety, an applicant may demonstrate safety concerns with vehicles, equipment, or facilities that are beyond their intended useful life, or that are no longer appropriate for use due to safety concerns. To improve connectivity, bus systems may deploy Intelligent Transportation Systems (ITS)
Applications will be evaluated based on how well they describe how the proposed project will improve the condition of the transit system, improve the reliability of transit service for its riders, and/or enhance access and mobility within the service area.
System Condition: FTA will evaluate the potential for the project to improve the condition of the transit system by repairing and/or replacing assets that are in poor condition or have surpassed their minimum or intended useful life benchmarks, lowering the average age of vehicles in the fleet, and/or reducing the cost of maintaining outdated vehicles, facilities and equipment. Applicants should document how the project's asset(s) will be operated, inspected, maintained, rehabilitated, and replaced to manage the asset's performance, risks, and costs over its life cycle to provide safe, cost-effective, and reliable public transportation.
Service Reliability: FTA will evaluate the potential for the project to reduce the frequency of breakdowns or other service interruptions as caused by the age and condition of the agency's bus fleet. Applicants should document their current service reliability metrics and benchmark goals, including their strategy for improving reliability with or without the award of Bus Infrastructure Program funds.
Enhanced Access and Mobility: FTA will evaluate the potential for the project to improve access to employment opportunities, education, and other services. FTA will also evaluate the potential for the project to improve mobility for the transit riding public, such as through improved headways, creation of new transportation choices, or eliminating gaps in the current route network. Proposed benefits should be based on documented ridership demand and be well-described or documented through a study or route planning proposal.
Applicants must demonstrate how the proposed project will be consistent with local and regional long-range planning documents and local government priorities. This will involve assessing whether the project is consistent with the transit priorities identified in the long-range plan; and/or contingency/illustrative projects included in that plan; or the locally developed human services public transportation coordinated plan. Applicants are not required to submit copies of such plans, but should describe how the project will support regional goals. Additional consideration will be given to applications including support letters from local and regional planning organizations, local government officials, public agencies, and/or non-profit or private sector partners attesting to the consistency of the proposed project with these plans. Applicants may also address how the proposed project will impact overall system performance, asset management performance, or specific performance measures tracked and monitored by the applying entity to demonstrate how the proposed project will address local and regional planning priorities.
Evidence of additional local or regional prioritization (
Applicants must identify the source of the local cost share and describe whether such funds are currently available for the project or will need to be secured if the project is selected for funding. FTA will consider the availability of the local cost share as evidence of local financial commitment to the project. Additional consideration will be given to those projects for which local funds have already been made available or reserved. Applicants should submit evidence of the availability of funds for the project, for example by including a board resolution, letter of support from the State, or other documentation of the source of local funds such as a budget document highlighting the line item or section committing funds to the proposed project.
Projects will be evaluated based on the extent to which the project is ready to implement within a reasonable period of time and whether the applicant's proposed implementation plans are reasonable and complete.
In assessing whether the project is ready to implement within a reasonable period of time, FTA will consider whether the project qualifies for a Categorical Exclusion (CE), or whether the required environmental work has been initiated or completed for projects that require an Environmental Assessment (EA) or Environmental Impact Statement (EIS) under the National Environmental Policy Act of 1969 (NEPA), as amended. The proposal must also state whether grant funds can be obligated within 12 months from time of award, if selected, and indicate the timeframe under which the Metropolitan Transportation Improvement Program (TIP) and/or Statewide Transportation Improvement Program (STIP) can be amended to include the proposed project. Additional consideration will be given to projects for which grant funds can be obligated within 12 months from time of award.
In assessing whether the proposed implementation plans are reasonable and complete, FTA will review the proposed project implementation plan, including all necessary project milestones and the overall project timeline. For projects that will require formal coordination, approvals or permits from other agencies or project partners, the applicant must demonstrate coordination with these organizations and their support for the project, such as through letters of support.
Applicants must demonstrate that they have the technical, legal and financial capacity to undertake the project. FTA will review relevant oversight assessments and records to determine whether there are any outstanding legal, technical, or financial
In addition to other FTA staff that may review the proposals, a technical evaluation committee will evaluate proposals based on the published evaluation criteria. Based on the findings of the technical evaluation committee, the FTA Administrator will determine the final selection of projects for program funding. FTA may consider geographic diversity, diversity in the size of the transit systems receiving funding, and/or the applicant's receipt of other discretionary awards in determining the allocation of program funds. FTA may prioritize projects that have a higher local financial commitment. FTA may prioritize projects that demonstrate how they will address significant repair and maintenance needs, improve the safety of transit systems, and deploy connective projects that include advanced technologies to connect bus systems with other networks. FTA may prioritize projects in rural areas. Not less than 10 percent of the Bus and Bus Infrastructure Program funds will be distributed to projects in rural areas. In addition, FTA will not award more than 10 percent of the funds to a single grantee.
Subsequent to an announcement by the FTA Administrator of the final project selections, which will be posted on the FTA Web site, FTA will publish a list of the selected projects, a summary of final scores for selected projects, Federal award amounts and recipients in the
At the time the project selections are announced, FTA will extend pre-award authority for the selected projects. There is no blanket pre-award authority for these projects before announcement.
Funds under the Bus and Bus Infrastructure Program are available to designated recipients that allocate funds to fixed route bus operators, or state or local governmental entities, including Indian tribes, that operate fixed route bus service. There is no minimum or maximum grant award amount; however, FTA intends to fund as many meritorious projects as possible. Only proposals from eligible recipients for eligible activities will be considered for funding. Due to funding limitations, proposers that are selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable stand-alone projects that can be completed with the amount awarded.
The FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection. The FTA does not provide pre-award authority for discretionary funds until projects are selected and even then, there are Federal requirements that must be met before costs are incurred. Funds under this NOFO cannot be used to reimburse applicants for otherwise eligible expenses incurred prior to FTA award of a Grant Agreement until FTA has issued pre-award authority for selected projects through a notification in the
If selected, awardees will apply for a grant through FTA's Transit Award Management System (TrAMS). Recipients of Bus and Bus Infrastructure Program funding in urban areas are subject to the grant requirements of section 5307 Urbanized Area Formula Grant program, including those of FTA Circular 9030.1E. Recipients of Bus and Bus Infrastructure Program funding in rural areas are subject to the grant requirements of section 5311 Formula Grants for Rural Areas Program, including those of FTA Circular 9040.1G. All recipients must follow the Grants Management Requirements of FTA Circular 5010.1E, and the labor protections of 49 U.S.C. 5333(b). All discretionary grants, regardless of award amount, will be subject to the congressional notification and release process. Technical assistance regarding these requirements is available from each FTA regional office.
The FTA requires that all capital procurements meet FTA's Buy America requirements, which require that all iron, steel, or manufactured products be produced in the U.S. These requirements help create and protect manufacturing jobs in the U.S. The Bus Infrastructure Program will have a significant economic impact toward meeting the objectives of the Buy America law. The FAST Act amended the Buy America requirements to provide for a phased increase in the domestic content for rolling stock. For FY 2016 and FY 2017, the cost of components and subcomponents produced in the United States must be more than 60 percent of the cost of all components. For FY 2018 and FY 2019, the cost of components and subcomponents produced in the United States must be more than 65 percent of the cost of all components. For FY 2020 and beyond, the cost of components and subcomponents produced in the United States must be more than 70 percent of the cost of all components. There is no change to the requirement that final assembly of rolling stock must occur in the United States. FTA issued final guidance on the implementation of the phased increase in domestic content on September 1, 2016. Any proposal that will require a waiver must identify the items for which a waiver will be sought in the application.
FTA requires that its recipients receiving planning, capital and/or operating assistance that will award prime contracts exceeding $250,000 in FTA funds in a Federal fiscal year comply with the Disadvantaged Business Enterprise (DBE) program regulations at 49 CFR part 26. Applicants should expect to include any funds awarded, excluding those to be used for vehicle procurements, in setting their overall DBE goal. Note, however, that projects including vehicle procurements remain subject to the DBE program regulations. The rule requires that, prior to bidding on any FTA-assisted vehicle procurement, entities that manufacture vehicles, perform post-production alterations or retrofitting must submit a DBE Program plan and goal methodology to FTA. Further, to the extent that a vehicle remanufacturer is responding to a solicitation for new or remanufactured vehicles with a vehicle to which the remanufacturer has provided post-production alterations or retro-fitting (
FTA will then issue a transit vehicle manufacturer (TVM) concurrence/certification letter. Grant recipients must verify each entity's compliance with these requirements before accepting its bid. A list of compliant, certified TVMs is posted on FTA's Web page at
FTA encourages proposers to notify the appropriate State Departments of Transportation and MPOs in areas likely to be served by the project funds made available under this program. Selected projects must be incorporated into the long-range plans and transportation improvement programs of states and metropolitan areas before they are eligible for FTA funding.
The applicant assures that it will comply with all applicable federal statutes, regulations, executive orders, directives, FTA circulars, and other federal administrative requirements in carrying out any project supported by the FTA grant. The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The applicant agrees that the most recent Federal requirements will apply to the project, unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before receiving a grant if it does not have current certifications on file.
Post-award reporting requirements include the electronic submission of Federal Financial Reports and Milestone Reports in FTA's electronic grants management system.
This program is not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.” FTA will consider applications for funding only from eligible recipients for eligible projects listed in Section C. Complete applications must be submitted through GRANTS.GOV by 11:59 p.m. EDT on August 25, 2017. For issues with GRANTS.GOV please contact GRANTS.GOV by phone at 1-800-518-4726 or by email at
For further information concerning this notice please contact the Bus Infrastructure Program manager, Mark Bathrick, via email at
Notice.
The Department of Veterans Affairs (VA) is seeking nominations of qualified candidates to be considered for membership on the National Research Advisory Council (Council). The Council provides advice to the Secretary of Veterans Affairs (Secretary) and the Under Secretary for Health (USH), and makes recommendations on the nature and scope of research and development sponsored and/or conducted by the Veterans Health Administration (VHA) to include: (1) The policies and projects of the Office of Research and Development (ORD); (2) the focus of research on the high priority health care needs of Veterans; (3) the balance of basic, applied, and outcomes research; (4) the scientific merit review process; (5) the appropriate mechanisms by which ORD can leverage its resources to enhance the research financial base; (6) the rapid response to changing health care needs, while maintaining the stability of the research infrastructure; and (7) the protection of human subjects of research.
Nominations for membership on the Council must be received no later than 5:00 p.m. EST on August 15, 2017. Packages received after this time will not be considered for the current membership cycle.
All nominations should be mailed to Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., (10P9), Washington, DC 20420, emailed (recommended) to
Melissa Cooper, Designated Federal Officer, Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue NW., (10P), Washington, DC 20420, Telephone (202) 461-6044. (This is not a toll free number.) A copy of the Council's charter and list of the current membership can be obtained by contacting Mrs. Cooper or by accessing the Web site:
The Council advises the Secretary and the USH on all matters related to the research and development program, and conducts analyses and develops reports or other materials as necessary. In order to avoid duplication of effort, the Council is encouraged to review deliberations of other committees or entities, and may incorporate or otherwise use the results of deliberations of such entities. As a part of its function, the Council may accept for consideration suggestions for research and development from Congress, VA and non-VA scientists, Veterans and their representatives, and the general public.
The Council meets at least four times annually, which may include a site visit to a VA field location. In accordance with Federal Travel Regulation, members will receive travel expense reimbursement and per diem for any
The Committee was established by the directive of the Secretary, in accordance with the provisions of the Federal Advisory Committee Act, as amended, 5 U.S.C. App. 2.
Appropriate categories of primary expertise that may be represented include:
a. Basic biomedical research;
b. rehabilitation research and development;
c. health services research and development;
d. clinical research;
e. geriatric care;
f. primary care;
g. special Veterans population health issues;
h. occupational and environmental health research;
i. mental health and behavioral research; and
j. surgery.
In addition, the Council will have at least one Veteran as a member to ensure an important perspective on the health problems of Veterans.
The Secretary will appoint members for overlapping 2-year terms of service and may reappoint members for one additional term. The Secretary will appoint the Chair for a term of not more than 3 years and may reappoint the Chair for one additional term. Several members may be regular government employees, but the majority of the Council's membership will be special government employees.
Requirements for Nomination Submission:
Nominations should be typed in 12 point font (one nomination per nominator). Nomination package should include:
(1) A letter of nomination that clearly states the name and affiliation of the nominee, the basis for the nomination (
(2) A statement from the nominee indicating that he/she is a U.S. citizen and is willing to serve as a member of the Committee;
(3) A statement from the nominee that that he/she appears to have no conflict of interest that would preclude membership;
(4) The nominee's contact information, including name, mailing address, telephone numbers, and email address;
(5) A current resume or curriculum vitae (CV); and
(6) A cover letter.
The cover letter must summarize the nominee's interest in serving on the Council and contributions she/he can make to the work of the Council, his/her current engagement in relevant Veterans service activities, and his/her the military branch affiliation and timeframe of military service (if applicable). Finally, please include in the cover letter the nominee's complete contact information (name, address, email address, and phone number); and a statement confirming that she/he is not a Federally-registered lobbyist. The resume/CV should show professional work experience, publications, academic affiliations, and Veterans service involvement, and highlight any service related to issues considered by the National Research Advisory Council. Note that VA will conduct an ethics review for each selected nominee.
Self-nominations will be accepted. Any letters of nomination from organizations or other individuals should accompany the package when it is submitted. Non-Veterans are also eligible for nomination.
Additional information regarding this issue can be found at
The Department makes every effort to ensure that the membership of VA Federal advisory Committees is fairly balanced in terms of points of view represented and the committee's capabilities. Every effort is made to ensure that a broad representation of geographic areas, gender, racial and ethnic minority groups, and the disabled are given consideration for membership. Appointment to this Committee shall be made without discrimination because of a person's race, color, religion, sex (including gender identity, transgender status, sexual orientation, and pregnancy), national origin, age, disability, or genetic information. Other considerations to promote a balanced membership may include: Longevity of military service, significant deployment and research experience, ability to handle complex issues, experience running complex organizations, special qualifications, and competence to effectively advise on VA research and development issues.
Department of Veterans Affairs.
Notice with request for comments.
This notice announces that the roster of employees on the Disciplinary Appeals Board Panel is available for review and comment. Employees, employee organizations, and other interested parties shall be provided, without charge, a list of the names of employees on the Panel upon request and may submit comments concerning the suitability for service on the Panel of any employee whose name is on the list.
Names that appear on the Panel may be selected to serve on a Board or as a grievance examiner after August 17, 2017.
Requests for the list of names of employees on the Panel and written comments may be directed to: Secretary of Veterans Affairs, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420. Requests and comments may also be faxed to (202) 495-5200.
Larry Ables, Employee Relations & Performance Management Service, Office of Human Resources Management, Department of Veterans Affairs, 810 Vermont Avenue NW., Mailstop 051, Washington, DC 20420. Mr. Ables may be reached at (202) 461-6172.
Section 203 of the Department of Veterans Affairs Health Care Personnel Act of 1991 (Pub. L. 102-40), dated May 7, 1991, revised the disciplinary grievance and appeal procedures for employees appointed under 38 U.S.C. 7401(1). It also required the periodic designation of employees of the Department who are qualified to serve on Disciplinary Appeals Boards. These employees constitute the Disciplinary Appeals Board Panel from which Board members in a case are appointed. Public Law
Nuclear Regulatory Commission.
Final rule.
The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to incorporate by reference recent editions and addenda to the American Society of Mechanical Engineers (ASME) Codes for nuclear power plants and a standard for quality assurance. The NRC is also incorporating by reference six ASME Code Cases. This action is in accordance with the NRC's policy to periodically update the regulations to incorporate by reference new editions and addenda of the ASME Codes and is intended to maintain the safety of nuclear power plants and to make NRC activities more effective and efficient.
This final rule is effective on August 17, 2017. The incorporation by reference of certain publications listed in the regulation is approved by the Director of the Federal Register as of August 17, 2017.
Please refer to Docket ID NRC-2011-0088 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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•
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Daniel I. Doyle, Office of Nuclear Reactor Regulation, telephone: 301-415-3748, email:
The NRC is amending its regulations to incorporate by reference recent editions and addenda to the ASME Codes for nuclear power plants and an ASME standard for quality assurance. The NRC is also incorporating by reference six ASME Code Cases.
This final rule is the latest in a series of rulemakings to amend the NRC's regulations to incorporate by reference revised and updated ASME Codes for nuclear power plants. The ASME is a voluntary consensus standards body, and the ASME Codes are voluntary consensus standards. The ASME periodically revises and updates its codes for nuclear power plants by issuing new editions and addenda. The NRC's use of the ASME Codes is consistent with applicable requirements of the National Technology Transfer and Advancement Act (NTTAA). This rulemaking is in accordance with the NRC's policy to update the regulations to incorporate by reference those new editions and addenda. The incorporation by reference of the new editions and addenda will maintain the safety of nuclear power plants, make NRC activities more effective and efficient, and allow nuclear power plant licensees and applicants to take advantage of the latest ASME Codes. Additional discussion of voluntary consensus standards and the NRC's compliance with the NTTAA is set forth in Section XIV of this document, “Voluntary Consensus Standards.”
Major provisions of this final rule include:
• Incorporation by reference of ASME Codes into the NRC's regulations and delineation of the NRC's requirements for the use of these codes, including conditions.
• Incorporation by reference of various versions of quality assurance standard NQA-1 into NRC regulations and approval for their use.
• Incorporation by reference of six ASME Code Cases.
The NRC prepared a regulatory analysis (ADAMS Accession No. ML16130A522) to identify the costs and benefits associated with this final rule. The regulatory analysis prepared for this rulemaking was used to determine if the rule is cost-effective, overall, and to help the NRC evaluate potentially costly conditions placed on specific provisions of the ASME Codes and Code Cases which are the subject of this rulemaking. Therefore, the regulatory analysis focuses on the marginal difference in benefits and costs for each provision of this final rule relative to the “no action” baseline alternative. The regulatory analysis identified costs and benefits in a quantitative fashion as well as in a qualitative fashion. An uncertainty analysis was performed to evaluate the effects of uncertainties in the quantitative estimation of both costs and benefits, and this analysis showed the rule alternative is cost effective with over 99 percent certainty. The standard deviation of the cost estimate net benefit is $4.1 million.
Table 1 summarizes the costs and benefits for the alternative of proceeding with the final rule (Alternative 2) and shows that the final rule is quantitatively cost-beneficial with a net benefit of $14.7 million to both the industry and the NRC when compared to the regulatory baseline (Alternative 1). The regulatory analysis shows that implementing the final rule is quantitatively cost-effective and an efficient use of NRC and Industry resources. Uncertainty analysis shows a standard deviation of $4.08 million, resulting in a net benefit range of $8.19 million to $21.6 million. Because the
There are several benefits associated with this final rule. The new motor-operated valve (MOV) provisions in this final rule result in over $25 million in averted costs (7-percent net present value) due to the removal of quarterly testing requirements and replacing those requirements with less frequent diagnostic and biannual testing requirements. Additionally, the provisions in this final rule will result in averted costs to the NRC and the industry from relief requests for the code cases in this final rule, in particular the ASME OMN-20 Code Case Time Period Extension provision, in excess of $5.1 million (7-percent net present value).
Qualitative factors which were considered include regulatory stability and predictability, regulatory efficiency, and consistency with the NTTAA. Table 50 in the regulatory analysis includes a discussion of the costs and benefits that were considered qualitatively. Considering non-quantified costs and benefits, the regulatory analysis shows that the rulemaking is justified because the number and significance of the non-quantified benefits outweigh the non-quantified costs. Certainly, if the qualitative benefits (including the safety benefit, regulatory efficiency, and other nonquantified benefits) are considered together with the quantified benefits, then the benefits would outweigh the identified quantitative and qualitative impacts. Therefore, integrating both quantified and non-quantified costs and benefits, the benefits of the final rule outweigh the identified quantitative and qualitative impacts attributable to the final rule.
The ASME develops and publishes the ASME
It has been the NRC's practice to establish requirements for the design, construction, operation, ISI examination, and IST of nuclear power plants by approving the use of editions and addenda of the ASME Codes in § 50.55a of title 10 of the
The ASME Codes are consensus standards developed by participants with broad and varied interests, including the NRC and licensees of nuclear power plants. The ASME's adoption of new editions of, and addenda to, the ASME Codes does not mean that there is unanimity on every provision in the ASME Codes. There may be disagreement among the technical experts, including NRC representatives, on the ASME Code committees and subcommittees, regarding the acceptability or desirability of a particular Code provision included in an ASME-approved Code edition or addenda. If the NRC believes that there is a significant technical or regulatory concern with a provision in an ASME-approved Code edition or addenda being considered for incorporation by reference, then the NRC will condition the use of that provision when it incorporates by reference that ASME Code edition or addenda. In some cases, the condition increases the level of safety afforded by the ASME Code provision or addresses a regulatory issue not considered by the ASME. In other instances, where research data or experience has shown that certain Code provisions are unnecessarily conservative, the condition may provide that the Code provision need not be complied with in some or all respects. The NRC's conditions are included in § 50.55a, typically in paragraph (b) of that regulation. In a Staff Requirements Memorandum (SRM) dated September 10, 1999, the Commission indicated that NRC rulemakings adopting (incorporating by reference) a voluntary consensus standard must identify and justify each part of the standard that is not adopted. For this rulemaking, the provisions of the 2009 Addenda, 2010 Edition, 2011 Addenda, and 2013 Edition of Section III, Division 1; and the 2009 Addenda, 2010 Edition, 2011 Addenda, and 2013 Edition of Section XI, Division 1, of the ASME BPV Code; and the 2009 Edition, 2011 Addenda, and 2012 Edition of the OM Code that the NRC is not adopting, or partially adopting, are identified in the Discussion, Regulatory Analysis, and Backfitting and Issue Finality sections of this document. The provisions of those specific editions and addenda and Code Cases that are the subject of this rulemaking that the NRC finds to be conditionally acceptable, together with the applicable conditions, are also identified in the Discussion, Regulatory Analysis, and Backfitting and Issue Finality sections of this document.
The ASME Codes are voluntary consensus standards, and the NRC's incorporation by reference of these Codes is consistent with applicable requirements of the NTTAA. Additional discussion on NRC's compliance with the NTTAA is set forth in Section XIV
This final rule reflects the NRC's redesignation of paragraphs within § 50.55a set forth in a final rule dated November 5, 2014 (79 FR 65776), as corrected on December 11, 2014 (79 FR 73461). The re-designation of paragraphs was needed to address the Office of the Federal Register's requirements in 1 CFR part 51 for incorporation by reference. For additional information on the November 2014 final rule, please consult the statement of considerations (preamble) for that final rule.
The NRC regulations incorporate by reference ASME Codes for nuclear power plants. The ASME periodically revises and updates its codes for nuclear power plants. This final rule is the latest in a series of rulemakings to amend the NRC's regulations to incorporate by reference revised and updated ASME Codes for nuclear power plants. The proposed rule which led to this final rule was published on September 18, 2015 (80 FR 56820). This rulemaking is intended to maintain the safety of nuclear power plants and make NRC activities more effective and efficient.
The NRC follows a three-step process to determine acceptability of new provisions in new editions and addenda to the Codes and the need for conditions on the uses of these Codes. This process was employed in the review of the Codes that are the subject of this rule. First, the NRC staff actively participates with other ASME committee members with full involvement in discussions and technical debates in the development of new and revised Codes. This includes a technical justification of each new or revised Code. Second, the NRC committee representatives discuss the Codes and technical justifications with other cognizant NRC staff to ensure an adequate technical review. Third, the NRC position on each Code is reviewed and approved by NRC management as part of the rule amending § 50.55a to incorporate by reference new editions and addenda of the ASME Codes and conditions on their use. This regulatory process, when considered together with the ASME's own process for developing and approving the ASME Codes, provides reasonable assurance that the NRC approves for use only those new and revised Code edition and addenda, with conditions as necessary, that provide reasonable assurance of adequate protection to public health and safety, and that do not have significant adverse impacts on the environment.
The NRC is amending its regulations to incorporate by reference:
• The 2009 Addenda, 2010 Edition, 2011 Addenda, and 2013 Edition of the ASME BPV Code, Section III, Division 1 and Section XI, Division 1, with conditions on their use.
• The 2009 Edition, the 2011 Addenda, and the 2012 Edition of Division 1 of the OM Code, with conditions on their use.
• ASME Standard NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications,” including several editions and addenda to NQA-1 from previous years with slightly varying titles as identified in § 50.55a(a)(1)(v). More specifically, the NRC is incorporating by reference the 1983 Edition through the 1994 Edition, the 2008 Edition, and the 2009-1a Addenda to the 2008 Edition of ASME NQA-1, with conditions on their use.
• ASME BPV Code Case N-513-3, “Evaluation Criteria for Temporary Acceptance of Flaws in Moderate Energy Class 2 or 3 Piping Section XI, Division 1,” Mandatory Appendix I, “Relations for
• ASME BPV Code Case N-729-4, “Alternative Examination Requirements for PWR Reactor Vessel Upper Heads With Nozzles Having Pressure-Retaining Partial-Penetration Welds Section XI, Division 1,” ASME approval date: June 22, 2012, with conditions on its use.
• ASME BPV Code Case N-770-2, “Alternative Examination Requirements and Acceptance Standards for Class 1 PWR Piping and Vessel Nozzle Butt Welds Fabricated with UNS N06082 or UNS W86182 Weld Filler Material With or Without Application of Listed Mitigation Activities, Section XI, Division 1,” ASME approval date: June 9, 2011, with conditions on its use.
• ASME BPV Code Case N-824, “Ultrasonic Examination of Cast Austenitic Piping Welds From the Outside Surface Section XI, Division 1,” ASME approval date: October 16, 2012.
• ASME BPV Code Case N-852, “Application of the ASME NPT Stamp, Section III, Division 1; Section III, Division 2; Section III, Division 3; Section III, Division 5,” Approval Date: February 9, 2015.
• OM Code Case OMN-20, “Inservice Test Frequency.”
The current regulations in § 50.55a(a)(1)(ii) incorporate by reference ASME BPV Code, Section XI, 1970 Edition through the 1976 Winter Addenda; and the 1977 Edition (Division 1) through the 2008 Addenda (Division 1), subject to the existing conditions in § 50.55a(b)(2)(i) through (xxix). This amendment revises § 50.55a(a)(1)(ii) to incorporate by reference the 2009 Addenda (Division 1) through the 2013 Edition (Division 1) of the ASME BPV Code, Section XI. It also clarifies the wording and adds, removes, or revises some of the conditions as explained in this document.
The NRC is revising § 50.55a(a)(1)(iv) to incorporate by reference the 2009 Edition, 2011 Addenda, and 2012 Edition of Division 1 of the OM Code. Based on this revision, the NRC regulations will incorporate by reference in § 50.55a the 1995 Edition through the 2012 Edition of the OM Code.
The NRC reviewed changes to the Codes in the editions and addenda of the Codes identified in this rulemaking, and published a proposed rule in the
There is not a separate heading for ASME quality assurance standard NQA-1 because there are three separate discussions of NQA-1—one under the heading for ASME BPV Code, Section III, one under the heading for ASME BPV Code, Section XI, and one under the heading for OM Code—because there are three conditions related to NQA-1, one in each of those areas (§ 50.55a(b)(1)(iv) for Section III, § 50.55a(b)(2)(x) for Section XI, and § 50.55a(b)(3)(i) for the OM Code). In addition, administrative and editorial changes to various paragraphs of § 50.55a are being adopted for accuracy, clarity, consistency, and general
Four of the six ASME Code Cases being incorporated by reference in this rulemaking (N-729-4, N-770-2, N-824, and OMN-20) are discussed in Section II.D of this document, “ASME Code Cases.” A fifth ASME Code Case, N-852, is discussed in Section II.A, “ASME BPV Code, Section III,” because the NRC's approval of that Code Case relates to a provision of Section III, which is addressed in § 50.55a(b)(1)(ix). The sixth ASME Code Case, N-513-3, is discussed in Section II.B, “ASME BPV Code, Section XI,” because the NRC's approval of that Code Case relates to a provision of Section XI, which is addressed in § 50.55a(b)(2)(xxxiv).
The NRC is clarifying that Section III Nonmandatory Appendices are not incorporated by reference. This language was originally added in a final rule published on June 21, 2011 (76 FR 36232); however, it was omitted from the final rule published on November 5, 2014 (79 FR 65776). The NRC is correcting the omission by inserting the parenthetical clause “(excluding Nonmandatory Appendices)” in § 50.55a(a)(1)(i).
The NRC is identifying prohibited subparagraphs and notes for each ASME BPV Code edition and addenda in tabular form as opposed to the narrative form of the existing regulation. No substantive change to the requirements is intended by this revision. The NRC believes that presenting the information in tabular form will increase the clarity and understandability of the regulation.
The existing condition in § 50.55a(b)(1)(ii) prohibits, for welds with leg sizes less than 1.09 t
As an editorial matter, this final rule identifies the prohibited ASME BPV Code provisions as “notes,” which is the term used by the ASME, rather than “footnotes.” The NRC is using the terminology used by the ASME for clarity.
The NRC is approving for use the version of NQA-1 referenced in the 2010 Edition, 2011 Addenda, and 2013 Edition of the ASME BPV Code, Section III, Subsection NCA, Article 7000, which this rule is also incorporating by reference. This allows applicants and licensees to use the 2008 Edition and the 2009-1a Addenda of NQA-1 when using the 2010 and later editions and addenda of Section III.
In the 2010 Edition of ASME BPV Code, Section III, Subsection NCA, Article NCA-4000, “Quality Assurance,” was updated to require N-Type Certificate Holders to comply with the requirements of Part 1 of the 2008 Edition and the 2009-1a Addenda of ASME Standard NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications,” as modified and supplemented in NCA-4120(b) and NCA-4134. In addition, NCA-4110(b) was revised to remove the reference to a specific edition and addenda of ASME NQA-1, and Table NCA-7100-2, “Standards and Specifications Referenced in Division 1,” was updated to require the 2008 Edition and 2009-1a Addenda of NQA-1 when using the 2010 Edition of Section III. In light of these changes, the NRC reviewed the 2008 Edition and the 2009-1a Addenda of NQA-1 and compared it to previously approved versions of NQA-1 and found that there were no significant differences. In addition, the NRC reviewed the changes to Subsection NCA that reference the 2008 Edition and 2009-1a Addenda of NQA-1, compared them to previously approved versions of Subsection NCA, and found that there were no significant differences. Therefore, the NRC has concluded that these editions and addenda of NQA-1 are acceptable for use.
The NRC is revising § 50.55a(b)(1)(iv) to clarify that an applicant's or licensee's commitments addressing those areas where NQA-1 either does not address a requirement in appendix B to 10 CFR part 50, “Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,” or is less stringent than the comparable appendix B requirement govern the applicant's or licensee's Section III activities. The clarification is consistent with § 50.55a(b)(2)(x) and (b)(3)(i). The NQA-1 provides the ASME's method for establishing and implementing a quality assurance (QA) program for the design and construction of nuclear power plants and fuel reprocessing plants. However, NQA-1, as modified and supplemented in NCA-4120(b) and NCA-4134, does not address some of the requirements of appendix B to 10 CFR part 50. In some cases, the provisions of NQA-1 are less stringent than the comparable appendix B requirements. Therefore, in order to meet the requirements of appendix B, an applicant's or licensee's QA program description must contain commitments addressing those provisions of appendix B which are not covered by NQA-1, as well as provisions that supplement or replace the NQA-1 provisions where the appendix B requirement is more stringent.
Finally, the NRC is removing the reference in § 50.55a(b)(1)(iv) to versions of NQA-1 older than the 1994 Edition because the NRC did not receive any adverse comments from any applicant or licensee about removing versions of NQA-1 older than the 1994 Edition from the regulation. The NRC received only one comment regarding NQA-1. The comment expressed support for incorporation by reference of NQA-1 and did not respond to the NRC's request for comment regarding the removal of references to older versions of NQA-1.
The NRC is revising § 50.55a(b)(1)(vii) so that the existing condition prohibiting the use of paragraph NB-7742(a)(2) of the 2006 Addenda through the 2007 Edition, up to and including the 2008 Addenda, is extended to include the editions and addenda up to the 2013 Edition, which are the subject of this rulemaking.
The NRC is adding § 50.55a(b)(1)(viii) to allow licensees to use either the ASME BPV Code Symbol Stamps of editions and addenda earlier than the 2011 Addenda to the 2010 Edition of the ASME BPV Code or the ASME Certification Marks with the appropriate
The ASME BPV Code requires, in certain instances, that components be stamped. The stamp signifies that the component has been designed, fabricated, examined and tested, as specified in the ASME BPV Code. The stamp also signifies that the required ASME BPV Code data report forms have been completed, and the authorized inspector has inspected the item and authorized the application of the ASME BPV Code Symbol Stamp.
The ASME has instituted changes in the BPV Code to consolidate the different ASME BPV Code Symbol Stamps into a common ASME Certification Mark. This action was implemented in the 2011 Addenda to the 2010 Edition of the ASME BPV Code. As of the end of 2012, ASME no longer utilizes the ASME BPV Code Symbol Stamp. Licensees, however, may not have updated to the edition or addenda that identifies the use of the ASME Certification Mark. Nevertheless, licensees are legally required to implement the ASME BPV Code Edition and Addenda identified as their current code of record. As ASME components are procured, these components may be received with the ASME Certification Mark, while the licensee's current code of record may require the component to have the ASME BPV Code Symbol Stamp. Installation of a component under such circumstances would not be in compliance with the regulations that the licensees are required to meet.
Both the ASME Certification Mark and the ASME BPV Code Symbol Stamp are official ASME methods of certifying compliance with the Code. Although these ASME Certification Marks differ slightly in appearance, they serve the same purpose of certifying code compliance by the ASME Certificate Holder and continue to provide for the same level of quality assurance for the application of the ASME Certification Mark as was required for the application of the ASME BPV Code Symbol Stamp. The new ASME Certification Mark represents a small, non-safety significant modification of ASME's trademark. As such, it does not change the technical requirements of the Code. The ASME has confirmed that the Certification Mark with designator is equivalent to the corresponding BPV Code Symbol Stamp. Based on statements made by ASME in a letter dated August 17, 2012, the NRC has concluded that the ASME BPV Code Symbol Stamps and ASME Certification Mark with code-specific designators are equivalent with respect to their certification of compliance with the BPV Code. The NRC discussed this issue in Regulatory Issue Summary 2013-07, “NRC Staff Position on the Use of American Society of Mechanical Engineers Certification Mark,” dated May 28, 2013.
The NRC is adding § 50.55a(b)(1)(ix) to allow licensees to use the NPT Code Symbol Stamp with the letters arranged horizontally as specified in ASME BPV Code Case N-852 for the service life of a component that had the NPT Code Symbol Stamp applied during the time period from January 1, 2005, through December 31, 2015.
Public comments on the use of the NPT Code Symbol requested that the NRC accept the NPT Code Symbol Stamp having the NPT letters arranged horizontally as an acceptable NPT Stamp to certify Code compliance for fabricated items that have already been stamped prior to receiving a replacement NPT Code Symbol Stamp from the ASME. The comments requested that the NRC include acceptance of Code Case N-852 in this final rule for this purpose. Within the context of its Code rules, ASME asserts that the NPT Code Symbol Stamp having the NPT letters arranged horizontally, although differing slightly in appearance from the NPT Code Symbol Stamp as illustrated in Section III, Table NCA-8100-1 of the ASME BPV Code, 2010 Edition and earlier editions and addenda, serves the same purpose of certifying Code compliance by the ASME NPT Certificate Holder with confirmation by the Authorized Nuclear Inspector and provides the same level of quality assurance. In addition, ASME indicated that on or after January 1, 2016, the ASME will no longer authorize use of the NPT Code Symbol Stamp having the NPT letters arranged horizontally. Accordingly, on or after January 1, 2016, fabricated items will only be stamped with the NPT Code Symbol Stamp as illustrated in Section III, Table NCA-8100-1 of the ASME BPV Code, 2010 Edition and earlier editions and addenda.
The NRC agrees in general with this comment, in which the ASME asserts that the ASME NPT Code Symbol Stamp with the letters arranged horizontally to be equivalent to the “N over PT” ASME NPT Code Symbol Stamp. Therefore, using either Code Symbol Stamp serves the same purpose of certifying code compliance by the ASME Certificate Holder with confirmation by the Authorized Nuclear Inspector and provides the same level of quality assurance. The NRC also notes that the same administrative and technical requirements in the ASME Code still apply whether an ASME NPT Code Symbol Stamp with the letters arranged horizontally or an “N over PT” ASME NPT Code Symbol Stamp is applied. However, since this NPT Code Symbol Stamp having the NPT letters arranged horizontally will only be applied onto fabricated components from the time period of January 1, 2005, through December 31, 2015, the time period for when this NPT Code Symbol Stamp was applied to the component should be limited to these dates to prevent inadvertent fraudulent material. Therefore, the NRC agrees that the ASME BPV Code Case N-852 is acceptable for the service life of the component that had the NPT Code Symbol stamp applied from the time period of January 1, 2005, through December 31, 2015. In response to this comment, the NRC added § 50.55a(b)(1)(ix) to include a statement that licensees may use the NPT Code Symbol Stamp with the letters arranged horizontally as specified in ASME BPV Code Case N-852 for the service life of a component that had the NPT Code Symbol Stamp applied during the time period from January 1, 2005, through December 31, 2015. The NRC is incorporating by reference ASME BPV Code Case N-852 in § 50.55a(a)(1)(iii)(F) because it is referenced in § 50.55a(b)(1)(ix).
Although the proposed rule did not include this Code Case, the NRC has determined that the incorporation by reference of this Code Case at the final rule stage is a logical outgrowth of the proposed rule. The NRC's intent to ensure that § 50.55a identify all ASME-approved methods for labelling Code components is apparent from the statement of considerations for the proposed rule. See 80 FR 56820 (September 18, 2015) at 56823-56824. The NRC did not entirely achieve that purpose, and this resulted in public comments seeking approval of this Code Case, which supports the proposition that the public had a reasonable opportunity to either propose the correction, with conditions as the commenter believes are necessary or desirable, or to indicate why the (anticipated) correction should not be made. Therefore, the NRC concludes that it may incorporate by reference ASME BPV Code Case N-852.
In the proposed rule, the NRC proposed a revision to § 50.55a(a)(1)(ii) that would have clarified that Section XI Nonmandatory Appendix U of the 2013 Edition of ASME BPV Code, Section XI was not incorporated by reference and therefore not approved for use. After considering public comments, the NRC has determined that it will not exclude Appendix U from the incorporation by reference because it is the integration of ASME BPV Code Cases N-513-3, “Evaluation Criteria for Temporary Acceptance of Flaws in Moderate Energy Class 2 or 3 Piping Section XI, Division 1,” and N-705, “Evaluation Criteria for Temporary Acceptance of Degradation in Moderate Energy Class 2 or 3 Vessels and Tanks Section XI, Division 1,” into Section XI. The NRC has approved Code Cases N-513-3 and N-705 in RG 1.147. However, as described in the discussion for § 50.55a(b)(2)(xxxiv) in Section II.B, “ASME BPV Code Section XI,” the NRC has found it necessary to adopt two new conditions to the use of Nonmandatory Appendix U.
The NRC is adopting two conditions in the language of § 50.55a(a)(1)(ii)(C)(
The NRC is revising § 50.55a(b)(2)(vi) to expressly state that licensees that implemented the expedited examination of containment during the 5-year period from September 9, 1996, to September 9, 2001, may use either the 1992 Edition with the 1992 Addenda or the 1995 Edition with the 1996 Addenda of Subsection IWE and Subsection IWL, as conditioned by the requirements in paragraphs (b)(2)(viii) and (ix), when implementing the initial 120-month inspection interval for the containment ISI requirements of this section.
The expedited examination involved the completion of the first set of examinations of the first or initial 120-month containment inspection interval. It is noted that all of the operating reactors in the previously stated class would have gone past their initial 120-month inspection interval by 2011. The change removes the possibility of misinterpretation of the provision as requiring plants that do not fall in the previously stated class, such as reactors licensed after September 9, 2001, to use the 1992 Edition with 1992 Addenda or the 1995 Edition with 1996 Addenda of Subsection IWE and Subsection IWL, Section XI for implementing the initial 120-month inspection interval of the containment ISI program. Applicants and licensees that do not fall in the previously stated class must use Code editions and addenda in accordance with § 50.55a(g)(4)(i) and (ii), respectively, for the initial and successive 120-month containment ISI intervals.
The NRC is revising § 50.55a(b)(2)(viii) by removing the condition for using the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL requiring compliance with § 50.55a(b)(2)(viii)(E). To support the removal of the condition, the NRC is adding new requirements governing the performance and documentation of concrete containment examinations in § 50.55a(b)(2)(viii)(H) and (I), which are discussed separately in the next two headings.
Section 50.55a(b)(2)(viii)(E) is one of several conditions that apply to the inservice examination of concrete containments using Subsection IWL of various editions and addenda of the ASME BPV Code, Section XI, incorporated by reference in § 50.55a(a)(1)(ii). The NRC is removing the condition in § 50.55a(b)(2)(viii)(E) when applying the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL because its intent has been incorporated into the Code in the new provision IWL-2512, “Inaccessible Areas.”
The NRC is adding § 50.55a(b)(2)(viii)(H) to specify the information that must be provided in the ISI Summary Report required by IWA-6000, when inaccessible concrete surfaces are evaluated under the new Code provision IWL-2512. This new condition replaces the existing condition in § 50.55a(b)(2)(viii)(E), when using the 2007 Edition with the 2009 Addenda through the 2013 Edition of Subsection IWL.
The existing condition in § 50.55a(b)(2)(viii)(E) of the current rule requires that, for Class CC applications, the licensee shall evaluate the acceptability of inaccessible areas when conditions exist in accessible areas that could indicate the presence of or result in degradation to such inaccessible areas, and provide the evaluation information required by § 50.55a(b)(2)(viii)(E)(
In the 2009 Addenda Subsection IWL, the ASME revised existing provisions IWL-1220 and IWL-2510 and added the new provision IWL-2512 intended to incorporate the condition in § 50.55a(b)(2)(viii)(E) into Subsection IWL. The IWL-2510, “Surface Examination,” was restructured into new paragraphs in IWL-2511, “Accessible Areas,” with almost the same provisions as the previous IWL-2510 and IWL-2512, “Inaccessible Areas,” to be specific to examinations required for accessible areas, and differentiate between those and the new requirements for inaccessible areas. The inaccessible areas addressed by the new IWL-2512 are: (1) Concrete surfaces obstructed by adjacent structures, parts or appurtenances (
The revised IWL-2511(a) has a new requirement that states that, “If the Responsible Engineer determines that observed suspect conditions indicate the presence of, or could result in, degradation of inaccessible areas, the requirements of IWL-2512(a) shall be met.” The new IWL-2512(a) requires the “Responsible Engineer” to evaluate suspect conditions and specify the type and extent of examinations, if any, required to be performed on inaccessible surface areas described in the previous paragraph. The acceptability of the evaluated inaccessible area would be determined either based on the evaluation or based on the additional examinations, if determined to be required. The new IWL-2512(b) further requires a periodic technical evaluation of below-grade inaccessible areas of concrete to be performed to determine and manage its susceptibility to degradation regardless of whether suspect conditions exist in accessible areas that would warrant an evaluation of inaccessible areas based on the condition in § 50.55a(b)(2)(viii)(E). Therefore, the revised IWL-2511(a) and new IWL-2512 code provisions address the evaluation and acceptability of inaccessible areas consistent with the existing condition in § 50.55a(b)(2)(viii)(E), with one exception. The exception is that the new IWL-2512 provision does not explicitly require the information specified in § 50.55a(b)(2)(viii)(E)(
For these reasons, the NRC is identifying the information that must be provided in the ISI Summary Report required by IWA-6000 when inaccessible concrete surfaces are evaluated under the new code provision IWL-2512. This new condition replaces the existing condition in § 50.55a(b)(2)(viii)(E) when using the 2007 Edition with the 2009 Addenda through the 2013 Edition of Subsection IWL. The information required by the new condition must be provided when inaccessible concrete areas are evaluated per IWL-2512(a) for degradation based on suspect conditions found in accessible areas, as well as when periodic technical evaluations of inaccessible below-grade concrete areas required by IWL-2512(b) are performed.
The NRC is adding § 50.55a(b)(2)(viii)(I) to place a condition on the periodic technical evaluation requirements in the new IWL-2512(b), for consistency with NUREG-1801, Revision 2, “Generic Aging Lessons Learned (GALL) Report,” with regard to aging management of below-grade containment concrete surfaces. The new IWL-2512(b) provision is applicable to inaccessible below-grade concrete surfaces exposed to foundation soil, backfill, or groundwater. This condition would apply only during the period of extended operation of a renewed license under 10 CFR part 54, when using IWL-2512(b) of the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL.
In the 2009 Addenda of Subsection IWL, the ASME added new Code provisions, IWL-2512(b) and (c) as well as a new line item L1.13 in Table IWL-2500-1, intended to specifically address aging management concerns with potentially unidentified degradation of inaccessible below-grade containment concrete areas and to be responsive to actions outlined in the GALL Report related to aging management of inaccessible below-grade concrete surfaces. It is noted that these new Code provisions are an enhancement to the requirement of the existing condition in § 50.55a(b)(2)(viii)(E) to specifically address aging management of inaccessible below-grade containment concrete areas and is generally acceptable to the NRC.
The new IWL-2512(b) provides requirements for systematically performing a periodic technical evaluation of concrete surfaces exposed to foundation soil, backfill, or groundwater to determine susceptibility of the concrete to deterioration that could affect its ability to perform its intended design function under conditions anticipated through the service life of the structure. It requires the technical evaluation to be performed and documented at periodic intervals not to exceed 10 years regardless of whether conditions exist in accessible areas that would warrant an evaluation of inaccessible areas by the existing condition in § 50.55a(b)(2)(viii)(E), which the NRC finds reasonable for the initial 40-year operating license period. The new IWL-2512(b) further provides the specific elements, including aging mechanisms considered, that the technical evaluation should include, as well as the definition of an aggressive below-grade environment. The new IWL-2512(c) requires that the evaluation results of IWL-2512(b) be used to define and document the condition monitoring program, if determined to be required, including required examinations and frequencies, to be implemented for the management of degradation and aging effects of the below-grade concrete surface areas. If it is determined that additional examinations are required, these examinations of inaccessible below-grade areas will be implemented in accordance with new line item L1.13 in Table IWL-2500-1 under Examination Category L-A, Concrete, with acceptance criteria based on IWL-3210. It should be noted that a technical evaluation approach, such as in IWL-2512(b), could be used, and is generally used, to determine acceptability of a below-grade inaccessible area to satisfy the condition in § 50.55a(b)(2)(viii)(E).
The technical evaluation requirements in IWL-2512(b) assist in determining the susceptibility to degradation and manage aging effects of inaccessible below-grade concrete surfaces, before the loss of intended function. The requirements are based on, and are generally consistent with, the guidance in the GALL Report, with the following two exceptions. The first exception is that IWL-2512(b) requires the technical evaluation to determine the susceptibility of the concrete to degradation and the ability to perform the intended design function through its service life at periodic intervals not to exceed 10 years. The aging management programs (AMPs) for safety-related structures (
Based on these reasons, the NRC is adding § 50.55a(b)(2)(viii)(I) to place a condition on the periodic technical evaluation requirements in IWL-2512(b) for consistency with the GALL Report, when addressing the two exceptions previously described with respect to aging management of inaccessible below-grade concrete components of the
The NRC is extending the applicability of the existing conditions in § 50.55a(b)(2)(ix)(A)(
The NRC reviewed the Code changes in Subsection IWE of the 2009 Addenda through the 2013 Edition of ASME BPV Code, Section XI, and noted that all of the changes were editorial or administrative with the intent to improve the clarity of the existing requirements or correct errors by errata. There were no changes to Subsection IWE in the Code editions and addenda that are the subject of this rulemaking that the NRC believes would require new regulatory conditions to ensure safety, nor do the changes to Subsection IWE address the NRC's reasons for adopting the conditions on the use of Subsection IWE. Accordingly, the NRC is extending the applicability of the existing conditions (by adding the words “edition and” to § 50.55a(b)(2)(ix) as discussed) without any change to the provisions of the conditions.
The NRC is approving for use the version of NQA-1 referenced in the 2009 Addenda, 2010 Edition, 2011 Addenda, and the 2013 Edition of the ASME BPV Code, Section XI, Table IWA 1600-1, “Referenced Standards and Specifications,” which this rule is also incorporating by reference. This allows, but does not require, licensees to use the 1994 Edition or the 2008 Edition and the 2009-1a Addenda of NQA-1 when using the 2009 Addenda and later editions and addenda of Section XI.
In the 2013 Edition of ASME BPV Code, Section XI, Table IWA 1600-1 was updated to allow licensees to use the 1994 Edition or the 2008 Edition with the 2009-1a Addenda of NQA-1 when using the 2013 Edition of Section XI. In the 2010 Edition of ASME BPV Code, Section XI, IWA-1400, “Owner's Responsibilities,” Subparagraph (n)(2) was updated to reference the NQA-1 Part I, Basic Requirements and Supplementary Requirements for Nuclear Facilities. In the 2009 Addenda of the 2007 Edition of ASME BPV Code, Section XI, Table IWA-1600-1, “Referenced Standards and Specifications,” was updated to allow licensees to use the 1994 Edition of NQA-1. The NRC reviewed the 2008 Edition and the 2009-1a Addenda of NQA-1 and compared it to previously approved versions of NQA-1 and found that there were no significant differences. Therefore, the NRC has concluded that these editions and addenda of NQA-1 are acceptable for use.
The NRC is amending § 50.55a(b)(2)(x) to clarify that a licensee's commitments addressing those areas where NQA-1 either does not address a requirements in appendix B to 10 CFR part 50 or is less stringent than the comparable appendix B requirement govern the licensee's Section XI activities. The clarification is consistent with § 50.55a(b)(1)(iv) and (b)(3)(i). The ASME's method for establishing and implementing a QA program for the design and construction of nuclear power plants and fuel reprocessing plants is described in NQA-1. However, NQA-1 does not address some of the requirements of appendix B to 10 CFR part 50. In some cases, the provisions of NQA-1 are less stringent than the comparable appendix B requirements. Therefore, in order to meet the requirements of appendix B, a licensee's QA program description must contain commitments addressing those provisions of appendix B which are not covered by NQA-1, as well as provisions that supplement or replace the NQA-1 provisions where the appendix B requirement is more stringent.
Finally, the NRC is removing the reference in § 50.55a(b)(2)(x) to versions of NQA-1 older than the 1994 Edition because the NRC did not receive any adverse comments from any applicant or licensee regarding concerns about removing versions of NQA-1 older than the 1994 Edition from the regulation. The NRC received only one comment regarding NQA-1. The comment expressed support for incorporation by reference of NQA-1 and did not respond to the NRC's request for comment regarding the removal of references to older versions of NQA-1.
The NRC is revising § 50.55a(b)(2)(xii) to allow underwater welding on irradiated materials in accordance with IWA-4660, “Underwater Welding,” of Section XI, 1997 Addenda through the latest edition and addenda incorporated by reference in § 50.55a(a)(1)(ii). The conditions for which underwater welding would be permitted without prior NRC approval are based on technical factors, such as neutron fluence and, for certain material classes, helium concentration.
The existing condition in § 50.55a(b)(2)(xii) does not allow underwater welding on irradiated materials by prohibiting the use of IWA-4660, “Underwater Welding,” of Section XI, 1997 Addenda through the latest edition and addenda incorporated by reference in § 50.55a(a)(1)(ii) on materials that are irradiated; however, there are two problems with the restriction in § 50.55a(b)(2)(xii). First, the neutron fluence threshold above which a material is considered to be irradiated is not defined in § 50.55a(b)(2)(xii). Second, studies such as those documented in Boiling Water Reactor Vessel and Internals Project (BWRVIP) Report 1003020 (BWRVIP-97) have shown that reactor internals can tolerate some neutron irradiation without suffering damage to weldability, as long as the helium concentration in the material does not exceed a certain threshold. The NRC completed its Safety Evaluation of BWRVIP-97 in May 2008 and concluded that implementation of the guidelines in the BWRVIP-97 report, with some modifications as documented in the
The most recent editions of the ASME BPV Code state in Article IWA-4660 that underwater welding may not be performed on irradiated materials other than P-No. 8 materials containing less than 0.1 atomic parts per million (appm) measured or calculated helium content generated through irradiation. Some editions and addenda of the ASME BPV Code prior to 2010 state in Article IWA-4660 that underwater welding may only be performed in applications not predicted to exceed a thermal neutron fluence of 1 × 10
Current ASME BPV Code and Code Case requirements for welding on irradiated materials, other than the underwater welding requirements specified in IWA-4660, are inconsistent. Thresholds for weldability may be stated in terms of fast neutron fluence, thermal neutron fluence, or helium concentration. In some cases, thresholds are not defined and the Code or Code Case simply states that consideration must be given to irradiation effects when welding. The NRC believes that thresholds for welding on irradiated materials should be based on the current understanding of irradiation damage, as supported by technical studies (such as BWRVIP-97) which have been evaluated by the NRC. In addition, the NRC believes that these thresholds should be consistently applied for all Code and Code Case applications.
During the public comment period for this rulemaking, a representative of ASME recommended that § 50.55a(b)(2)(xii) be revised such that it applies only to those editions and addenda earlier than the 2010 Edition. The effect of such a revision would be to allow welding on P-No. 8 materials containing less than 0.1 appm measured or calculated helium content generated through irradiation. However, this proposed revision would not be consistent with other ASME BPV Code or Code Case requirements for welding on irradiated materials, and this proposed revision does not address standards for welding on material classes other than P-No. 8. Instead the NRC is adopting conditions that would apply to all materials and which can be consistently applied for all Code and Code Case applications. The first condition, § 50.55a(b)(2)(xii)(A), is based on fast neutron fluence and applies to ferritic materials. The second condition, § 50.55a(b)(2)(xii)(B), is based on helium content and/or thermal fluence and applies to austenitic materials. For P-No. 8 austenitic materials, the evaluation of BWRVIP-97 supports a weldability threshold based on helium content and thermal fluence. For austenitic materials other than P-No. 8, there are insufficient data to support a weldability threshold based on helium content, and, therefore, the NRC is adopting a weldability threshold based on thermal fluence only.
The conditions for which underwater welding are permitted, as stated in the revision of § 50.55a(b)(2)(xii), were determined, in part, based on technical discussions in a Category 2 public meeting with industry representatives held on January 19, 2016. The NRC later presented the new conditions at a public meeting held on March 2, 2016. There were no comments on this change from the attendees at the March 2, 2016, public meeting. Summaries of the January 19 and March 2, 2016, public meetings are available in ADAMS under Accession Nos. ML16050A383 and ML16069A408, respectively.
The NRC is adding § 50.55a(b)(2)(xviii)(D) to prohibit applicants and licensees from using the ultrasonic examination nondestructive examination (NDE) personnel certification requirements in Section XI, Appendix VII and Subarticle VIII-2200 of the 2011 Addenda and 2013 Edition of the ASME BPV Code. Paragraph (b)(2)(xviii) currently includes conditions on the certification of NDE personnel. In addition, the new paragraph will require applicants and licensees to use the 2010 Edition, Table VII-4110-1 training hour requirements for Levels I, II, and III ultrasonic examination personnel, and the 2010 Edition, Subarticle VIII-2200 of Appendix VIII prerequisites for personnel requirements. In the 2011 Addenda and 2013 Edition, the ASME BPV Code added an accelerated Appendix VII training process for certification of ultrasonic examination personnel based on training and prior experience, and separated the Appendix VII training requirements from the Appendix VIII qualification requirements. These new ASME BPV Code provisions will provide personnel in training with less experience and exposure to representative flaws in representative materials and configurations common to operating nuclear power plants, and they would permit personnel with prior non-nuclear ultrasonic examination experience to qualify for examinations in nuclear power plants without exposure to the variety of defects, examination conditions, components, and regulations common to operating nuclear power plants.
The impact of reduced training and nuclear power plant familiarization is unknown. The ASME BPV Code supplants training hours and field experience without a technical basis, minimum defined training criteria, process details, or standardization. For these reasons, the NRC is prohibiting the use of Appendix VII and Subarticle VIII-2200 of the 2011 Addenda and 2013 Edition. The NRC is requiring applicants and licensees using the 2011 Addenda and 2013 Edition to use the prerequisites for ultrasonic examination personnel certifications in Table VII-4110-1 and Subarticle VIII-2200, Appendix VIII in the 2010 Edition.
The NRC is revising § 50.55a(b)(2)(xxi)(A) to modify the standard for visual magnification resolution sensitivity and contrast for visual examinations performed on Examination Category B-D components instead of ultrasonic examinations, making the rule conform with ASME BPV Code, Section XI requirements for VT-1 examinations. The character recognition rules are used in ASME BPV Code, Section XI, Table IWA-2211-1 for VT-1 tests, and are the standard tests used for resolution and contrast checks of the VT-1 equipment. This revision essentially removed a requirement that was an addition to ASME BPV Code that required 1-mil wires to be used in licensees' Sensitivity, Resolution, and Contrast Standard targets. In 2004, the NRC published NUREG/CR-6860, “An Assessment of Visual Testing,” showing that a linear target, such as a wire, is not an effective method for testing the resolution of a video camera system. In addition, Boiling Water Reactor Vessel and Internals Project Report 105696 (BWRVIP-03) was changed to eliminate a
Simple line detection can be a poor performance standard, allowing detection of a highly blurred image. This does not emulate sharpness quality recognition for evaluation of weld discontinuities. The 750 μm (30 mil) and the even smaller 25 μm (1 mil) widths should not be used as performance standards because they do not determine image sharpness. This technique only measures the “visible minimum” for long linear indications, and does not measure a system's resolution or recognition limits. If the wire, or printed line, has a strong enough contrast against the background, then a linear feature well below the resolution of a system can be detected.
The NRC is revising § 50.55a(b)(2)(xxiii) to clarify that this condition, prohibiting the ASME BPV Code provisions allowing elimination of mechanical processing of thermally cut surfaces under certain circumstances, only applies to the 2001 Edition through the 2009 Addenda.
In the proposed rule, the NRC proposed adding § 50.55a(b)(2)(xxx), with a condition regarding steam generator preservice examinations. The NRC received requests for clarification of the proposed condition, including elaboration on the kind of preservice examination that should be performed. The NRC agrees with the need for this clarification; however, during the development of the final rule, the NRC determined that additional time was needed to evaluate this proposed condition. Therefore, to ensure that this rulemaking is concluded as timely as possible, the NRC is not including this condition in this final rule and will address the need for a condition in a future rulemaking. The NRC has concluded that omitting this condition does not present a health or safety concern because licensees are currently performing appropriate steam generator preservice inspections under existing programs.
The NRC is adding § 50.55a(b)(2)(xxxi) to require the use of Nonmandatory Appendix W when using a mechanical clamping device on an ASME BPV Code Class piping system. This condition, in part, clearly prohibits the use of mechanical clamping devices on small item Class 1 piping and portions of piping systems that form the containment boundary. This condition also maintains the previously required design and testing requirements for the implementation of mechanical clamping devices on ASME BPV Code Class piping systems.
In the 2010 Edition of the ASME BPV Code, a change was made to include mechanical clamping devices under the small items exclusion rules of IWA-4131. Currently in the 2007 Edition/2008 Addenda of Section XI under IWA-4133, “Mechanical Clamping Devices Used as Piping Pressure Boundary,” mechanical clamping devices may be used only if they meet the requirements of Mandatory Appendix IX of Section XI of the ASME BPV Code. Article IX-1000 (c) of Appendix IX prohibits the use of mechanical clamping devices on (1) Class 1 piping and (2) portions of a piping system that form the containment boundary.
In the 2010 Edition, IWA-4133 was modified to allow use of IWA-4131.1(c) for the installation of mechanical clamping devices. This change allowed the use of small items exclusion rules in the installation of mechanical clamping devices. Subparagraph IWA-4131.1(c) was added such that mechanical clamping devices installed on items classified as “small items” under IWA-4131, including Class 1 piping and portions of a piping system that form the containment boundary, would be allowed without a repair/replacement plan, pressure testing, services of an Authorized Inspection Agency, and completion of the NIS-2 form. The NRC, in accordance with the previously approved IWA-4133 of the 2007 Edition/2008 Addenda of the ASME BPV Code, does not believe that the ASME has provided a sufficient technical basis to support the use of mechanical clamping devices on Class 1 piping or portions of a piping system that form the containment boundary as a permanent repair. Furthermore, the NRC finds that the ASME has not provided any basis for the small item exemption allowing the installation of mechanical clamps on these components. In the 2011 Addenda of the ASME BPV Code, IWA-4131.1(c) was relocated to IWA-4131.1(d). To add clarity to the condition, the NRC has included statements such that the implementation of these paragraphs is now prohibited.
In the 2013 Edition, Mandatory Appendix IX of Section XI of the ASME BPV Code was changed to Nonmandatory Appendix W of Section XI of the ASME BPV Code. The NRC found insufficient basis to make this change, removing the mandatory requirements for the use of mechanical clamping devices on ASME BPV Code Class piping systems. By taking this action, the ASME BPV Code now allows mechanical clamping devices to be installed in various methods through interpretations of the ASME BPV Code that do not maintain the requirements for design and testing of the formerly mandatory Appendix IX. Therefore, to clarify the requirement for the implementation of mechanical clamps in ASME BPV Code Class systems, the NRC requires the use of Appendix W of Section XI when using mechanical clamping devices, and prohibits the use of mechanical clamping devices on small item Class 1 piping and portions of a piping system that form the containment boundary, as would otherwise be permitted under IWA-4131.1(c) in the 2010 Edition and IWA-4131.1(d) in the 2011 Addenda through 2013 Edition.
The NRC is adding § 50.55a(b)(2)(xxxii) to require licensees using the 2010 Edition and later editions and addenda of Section XI to continue to submit Summary Reports as required in IWA-6240 of the 2009 Addenda.
Prior to the 2010 Edition, Section XI required the preservice summary report to be submitted prior to the date of placement of the unit into commercial service, and the inservice summary report to be submitted within 90 calendar days of the completion of each refueling outage. In the 2010 Edition, IWA-6240 was revised to state, “Summary reports shall be submitted to the enforcement and regulatory authorities having jurisdiction at the plant site, if required by these authorities.” This change in the 2010 Edition could lead to confusion as to whether or not the summary reports need to be submitted to the NRC, as well as the time for submitting the reports, if they were required. The NRC concludes that summary reports must continue to be submitted to the NRC in a timely manner because they provide valuable information regarding examinations performed, conditions noted, corrective actions taken, and the implementation status of preservice inspection and ISI programs. Therefore, the NRC is adding § 50.55a(b)(2)(xxxii) to ensure that preservice and inservice summary reports will continue to be submitted within the timeframes currently
The NRC is adding § 50.55a(b)(2)(xxxiii) to prohibit the use of Appendix G, Paragraph G-2216, in the 2011 Addenda and later editions and addenda of the ASME BPV Code, Section XI. The 2011 Addenda of the ASME BPV Code included, for the first time, a risk-informed methodology to compute allowable pressure as a function of inlet temperature for reactor heat-up and cool-down at rates not to exceed 100 degrees F/hr (56 degrees C/hr). This methodology was developed based upon probabilistic fracture mechanics (PFM) evaluations that investigated the likelihood of reactor pressure vessel (RPV) failure based on specific heat-up and cool-down scenarios.
During the ASME's consideration of this change, the NRC staff noted that additional requirements would need to be placed on the use of this alternative. For example, the NRC staff indicated that it would be important for a licensee who wishes to utilize such a risk-informed methodology for determining plant-specific pressure-temperature limits to ensure that the material condition of its facility is consistent with assumptions made in the PFM evaluations that supported the development of the methodology. One aspect of this would be evaluating plant-specific ISI data to determine whether the facility's RPV flaw distribution was consistent with the flaw distribution assumed in the supporting PFM evaluations. This consideration is consistent with a similar requirement established by the NRC in § 50.61a, “Alternative Fracture Toughness Requirements for Protection against Pressurized Thermal Shock Events.” The PFM methodology that supports § 50.61a is very similar to that which was used to support ASME BPV Code, Section XI, Appendix G, Paragraph G-2216. These concerns with the Paragraph G-2216 methodology for computing allowable pressure as a function of inlet temperature for reactor heat-up and cooldown were not addressed by the ASME. Accordingly, the NRC is prohibiting the use of Paragraph G-2216 in Appendix G of the 2010 Edition. The continued use of the deterministic methodology of Section XI, Appendix G to generate Pressure-Temperature (P-T) limits remains acceptable.
The NRC is adding § 50.55a(b)(2)(xxxiv) to require that two conditions, (A) and (B), be satisfied when using Nonmandatory Appendix U of the 2013 Edition of the ASME BPV Code, Section XI. In the proposed rule, the NRC had proposed to exclude Nonmandatory Appendix U from the incorporation by reference and therefore not approve it for use. After considering public comments, the NRC has incorporated by reference Appendix U in this final rule because it integrates ASME BPV Code Cases N-513-3, “Evaluation Criteria for Temporary Acceptance of Flaws in Moderate Energy Class 2 or 3 Piping Section XI, Division 1,” and N-705, “Evaluation Criteria for Temporary Acceptance of Degradation in Moderate Energy Class 2 or 3 Vessels and Tanks Section XI, Division 1,” into Section XI. The NRC has approved the use of ASME BPV Code Cases N-513-3 and N-705 in RG 1.147, which allows licensees to use these code cases without prior permission from the NRC.
The first condition on the use of Appendix U is set forth in § 50.55a(b)(2)(xxxiv)(A) of this final rule and requires that an ASME BPV Code repair or replacement activity temporarily deferred under the provisions of Nonmandatory Appendix U to the 2013 Edition of the ASME BPV Code, Section XI, must be performed during the next scheduled outage. This condition is consistent with the NRC's condition on the use of ASME BPV Code Case N-513-3 in RG 1.147, Revision 17. Appendix U defines that the evaluation period is the operational time for which the temporary acceptance criteria are satisfied but not exceeding 26 months from the initial discovery of the condition. Original versions of ASME BPV Code Case N-513 stated, in part, that certain flaws may be acceptable without performing a repair/replacement activity for a limited time, not to exceed the time to the next scheduled outage. The NRC staff found that the acceptance of ASME BPV Code Case N-513 was based on allowing continued plant operation with a monitored and evaluated low safety significant degraded condition for a limited time until plant shutdown. By allowing use of this Appendix, this option is allowed rather than requiring an unnecessary plant shutdown to repair the degradation. However, the NRC believes once the plant is shut down, the degraded piping must be repaired.
The second condition on the use of Appendix U is set forth in § 50.55a(b)(2)(xxxiv)(B) of this final rule. This paragraph requires the use of the mandatory appendix in ASME BPV Code Case N-513-3 in lieu of the appendix referenced in paragraph U-S1-4.2.1(c) of Appendix U (which was inadvertently omitted from Appendix U). The NRC is incorporating by reference the mandatory appendix in ASME BPV Code Case N-513-3 in § 50.55a(a)(1)(iii)(A) because it is referenced in § 50.55a(b)(2)(xxxiv)(B).
A proposed condition on Disposition of Flaws in Class 3 Components, which was located in § 50.55a(b)(2)(xxxiv) of the proposed rule, is not included in this final rule based on public comments that the error has been corrected by ASME in published erratum.
The NRC is adding § 50.55a(b)(2)(xxxv) to specify that when licensees use the 2013 Edition of the ASME BPV Code, Section XI, Appendix A, Paragraph A-4200, if T
Nonmandatory Appendix A provides a procedure based on linear elastic fracture mechanics (LEFM) for determining the acceptability of flaws that have been detected during inservice inspections that exceed the allowable flaw indication standards of IWB-3500. Sub-article A-4200 provides a procedure for determining fracture toughness of the material used in the LEFM analysis. The NRC staff's concern is related to the proposed insertion regarding an alternative based on the use of the Master Curve methodology to determine the nil-ductility transition reference temperature RT
While use of RT
With this condition, users of Appendix A can avoid using an erroneous fracture toughness K
The NRC is adding § 50.55a(b)(2)(xxxvi) to require licensees using ASME BPV Code, Section XI, 2013 Edition, Appendix A, Paragraph A-4400, to obtain NRC approval under § 50.55a(z) before using irradiated T
Sub-article A-4400 provides guidance for considering irradiation effects on materials. The NRC staff's concern is related to use of RT
Permission of measurement of RT
The NRC is adding new paragraphs (g)(2)(i), (ii), and (iii) and revising current paragraphs (g) introductory text, (g)(2), (g)(3) introductory text, and (g)(3)(i), (ii), and (v) to distinguish the requirements for accessibility and preservice examination from those for inservice inspection in § 50.55a(g). In addition, consistent with other paragraphs of this section, headings are added to the subordinate paragraphs of (g) in order to enhance readability of the regulation. No substantive change to the requirements are intended by these revisions.
The NRC is revising § 50.55a(b)(3) to clarify that Subsections ISTA, ISTB, ISTC, ISTD, ISTE, and ISTF; Mandatory Appendices I, II, III, and V; and Nonmandatory Appendices A through H and J through M of the OM Code are each incorporated by reference into § 50.55a. The NRC is also clarifying that the OM Code Nonmandatory Appendices incorporated by reference into § 50.55a are approved for use, but are not mandated. The Nonmandatory Appendices may be used by applicants and licensees of nuclear power plants, subject to the conditions in § 50.55a(b)(3).
The NRC is revising § 50.55a(b)(3)(i) to allow use of the 1994 Edition, 2008 Edition, and the 2009-1a Addenda of NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications.” The NRC reviewed these editions and addenda, compared them to the previously approved versions of NQA-1, and found that there were no significant differences.
The NRC is removing the reference in § 50.55a(b)(3)(i) to versions of NQA-1 older than the 1994 Edition, inasmuch as these versions do not appear to be in use at any nuclear power plant. The NRC did not receive any adverse comments from any applicant or licensee regarding concerns about removing versions of NQA-1 older than the 1994 Edition from the regulation. The NRC received one comment regarding NQA-1, supporting incorporation by reference of NQA-1 but not responding to the NRC's request for comment regarding the removal of references to older versions of NQA-1. Accordingly, the NRC concludes that removal of NQA-1 versions older than the 1994 Edition will not have any adverse effect on licensees, and the final rule removes these older versions from § 50.55a(b)(3)(i).
The NRC is revising § 50.55a(b)(3)(ii) to reflect the new Appendix III, “Preservice and Inservice Testing of Active Electric Motor Operated Valve Assemblies in Light-Water Reactor Power Plants,” of the OM Code, 2009 Edition, 2011 Addenda, and 2012 Edition. Appendix III of the OM Code establishes provisions for periodic verification of the design-basis capability of MOVs within the scope of the IST program. Appendix III of the OM Code reflects the incorporation of OM Code Cases OMN-1, “Alternative Rules for Preservice and Inservice Testing of Active Electric Motor-Operated Valve Assemblies in Light-Water Reactor Power Plants,” and OMN-11, “Risk-Informed Testing for Motor-Operated Valves.” The NRC is adding four new conditions on the use of Mandatory Appendix III in new § 50.55a(b)(3)(ii)(A), (B), (C), and (D) to address periodic verification of MOV design-basis capability. These new conditions are discussed in the next four sections.
In the proposed rule, the NRC specified in § 50.55a(b)(3)(ii)(A) that licensees evaluate the adequacy of the diagnostic test interval for each MOV and adjust the interval as necessary, but not later than 5 years or three refueling outages (whichever is longer) from initial implementation of OM Code,
In response to public comments, the NRC revised § 50.55a(b)(3)(ii)(A) to clarify its intent for licensees to evaluate the test interval within 5 years or three refueling outages (whichever is longer) following implementation of Appendix III to the OM Code, rather than implying that every MOV must be tested within 5 years or three refueling outages of the initial implementation of Appendix III. For example, the condition allows grouping of MOVs to share test information in the evaluation of the MOV periodic verification intervals within 5 years or three refueling outages (whichever is longer) of the implementation of OM Code, Appendix III. Therefore, § 50.55a(b)(3)(ii)(A) of this final rule states that licensees shall evaluate the adequacy of the diagnostic test intervals established for MOVs within the scope of OM Code, Mandatory Appendix III, not later than 5 years or three refueling outages (whichever is longer) from initial implementation of OM Code, Appendix III.
The NRC is adding § 50.55a(b)(3)(ii)(B) to require that when using Mandatory Appendix III, licensees ensure that the potential increase in core damage frequency (CDF) and large early release frequency (LERF) associated with the extension is acceptably small when extending exercise test intervals for high risk MOVs beyond a quarterly frequency. As discussed in a final rule published September 22, 1999 (64 FR 51386), with respect to the use of OM Code Case OMN-1, the NRC considers it important for licensees to have sufficient information from the specific MOV, or similar MOVs, to demonstrate that exercising on a refueling outage frequency does not significantly affect component performance. The information may be obtained by grouping similar MOVs and establishing periodic exercising intervals of MOVs in the group over the refueling interval.
Section 50.55a(b)(3)(ii)(B) requires that the increase in the overall plant CDF and LERF resulting from the extension be acceptably small. As presented in RG 1.174, “An Approach for Using Probabilistic Risk Assessment [PRA] in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis,” the NRC considers acceptably small changes to be relative and to depend on the current plant CDF and LERF. For plants with total baseline CDF of 10
The NRC is adding § 50.55a(b)(3)(ii)(C) to require, when applying Mandatory Appendix III, that licensees categorize MOVs according to their safety significance using the methodology described in OM Code Case OMN-3, “Requirements for Safety Significance Categorization of Components Using Risk Insights for Inservice Testing of LWR Power Plants,” subject to the conditions discussed in RG 1.192, or using an MOV risk ranking methodology accepted by the NRC on a plant-specific or industry-wide basis in accordance with the conditions in the applicable safety evaluation. Paragraph III-3720 in Appendix III to the OM Code states that when applying risk insights, each MOV shall be evaluated and categorized using a documented risk ranking methodology. Further, Appendix III only addresses risk ranking methodologies that include two risk categories. In light of the potential extension of quarterly test intervals for high risk MOVs and the relaxation of IST activities for low risk MOVs based on risk insights, the NRC has determined that the rule should specify that plant-specific or industry-wide risk ranking methodologies must have been accepted by the NRC through RG 1.192 (which accepts OM Code Case OMN-3 with the specified conditions) or the issuance of safety evaluations. As noted in the response to public comments, the intent of this condition is to indicate that when applying Appendix III to the OM Code, licensees may use either a two-risk category approach (high or low) or a three-risk category approach (high, medium, and low), provided the risk ranking method has been accepted by the NRC.
The NRC is adding § 50.55a(b)(3)(ii)(D) to require that when a licensee applies Paragraph III-3600, “MOV Exercising Requirements,” of Appendix III to the OM Code, the licensee verify that the stroke time of the MOV satisfies the assumptions in the plant's safety analyses. Previous editions and addenda of the OM Code specified that the licensee must perform quarterly MOV stroke time measurements that could be used to verify that the MOV stroke time satisfies the assumptions in the safety analyses consistent with plant TS. The need for verification of the MOV stroke time during periodic exercising is consistent with the NRC's lessons learned from the implementation of OM Code Case OMN-1. However, Paragraph III-3600 of Appendix III of the versions of the OM Code that will be incorporated by reference in this rulemaking no longer require the verification of MOV stroke time during periodic exercising. For this reason, the NRC is adopting this new condition, which will effectively retain the need to verify that the MOV stroke time during periodic exercising satisfies the assumptions in the plant's safety analyses.
Based on the discussion during the public webinar on March 2, 2016, the NRC revised the condition to clarify that it applies to MOVs referenced in the plant TS. In particular, the NRC revised the condition to indicate that when a licensee applies Paragraph III-3600 of Appendix III to the OM Code, the licensee shall verify that the stroke time of MOVs specified in plant technical specifications satisfies the assumptions in the plant's safety analyses.
The NRC is adding § 50.55a(b)(3)(iii) to apply specific conditions for IST programs applicable to licensees of new nuclear power plants in addition to the provisions of the OM Code as incorporated by reference with conditions in § 50.55a. Licensees of “new reactors” are, as identified in the paragraph: (1) Holders of operating
Commission Papers SECY-90-016, “Evolutionary Light Water Reactor (LWR) Certification Issues and Their Relationship to Current Regulatory Requirements;” SECY-93-087, “Policy, Technical, and Licensing Issues Pertaining to Evolutionary and Advanced Light-Water Reactor (ALWR) Designs;” SECY-94-084, “Policy and Technical Issues Associated with the Regulatory Treatment of Non-Safety Systems (RTNSS) in Passive Plant Designs;” and SECY-95-132, “Policy and Technical Issues Associated with the Regulatory Treatment of Non-Safety Systems (RTNSS) in Passive Plant Designs (SECY-94-084),” discuss IST programs for new reactors licensed under 10 CFR part 52.
In recognition of new reactor designs and lessons learned from nuclear power plant operating experience, the ASME is updating the OM Code to incorporate improved IST provisions for components used in nuclear power plants that were issued (or will be issued) construction permits, or COLs, on or following January 1, 2000 (defined in the OM Code as post-2000 plants). The first phase of the ASME effort incorporated IST provisions that specify full flow pump testing and other clarifications for post-2000 plants in the OM Code beginning with the 2011 Addenda. The second phase of the ASME effort incorporated preservice and inservice inspection and surveillance provisions for pyrotechnic-actuated (squib) valves in the 2012 Edition of the OM Code. The ASME is considering further modifications to the OM Code to address additional lessons learned from valve operating experience and new reactor issues. As described in the following paragraphs, § 50.55a(b)(3)(iii) will include four specific conditions which are discussed in the following paragraphs.
The NRC is adding § 50.55a(b)(3)(iii)(A) to require that licensees within the scope of § 50.55a(b)(3)(iii) periodically verify the capability of power-operated valves (POVs) to perform their design-basis safety functions. While Appendix III to the OM Code addresses this requirement for MOVs with the conditions specified in § 50.55a, applicable applicants and licensees will need to develop programs to periodically verify the design-basis capability of other POVs. The NRC's Regulatory Issue Summary 2000-03, “Resolution of Generic Issue 158: Performance of Safety-Related Power-Operated Valves Under Design Basis Conditions,” provides attributes for a successful long-term periodic verification program for POVs by incorporating lessons learned from MOV performance at operating nuclear power plants and research programs. Implementation of Appendix III to the OM Code as accepted in § 50.55a(b)(3)(ii) satisfies § 50.55a(b)(3)(iii)(A) for MOVs.
Section 50.55a(b)(3)(iii)(A) is consistent with the Commission policy for new reactors summarized in an NRC Staff Memorandum, “Consolidation of SECY-94-084 and SECY-95-132,” dated July 24, 1995, that (a) the design capability of safety-related POVs should be demonstrated by a qualification test prior to installation; (b) prior to initial startup, POV capability under design-basis differential pressure and flow should be verified by a pre-operational test; and (c) during the operational phase, POV capability under design-basis differential pressure and flow should be verified periodically through a program similar to that developed for MOVs in Generic Letter 89-10, “Safety-Related Motor-Operated Valve Testing and Surveillance,” dated June 28, 1989.
The condition in § 50.55a(b)(3)(iii)(A) specifies with the same level of detail as the condition in § 50.55a(b)(3)(ii) that nuclear power plant licensees must establish a program to ensure the continued capability of MOVs in performing their design-basis safety functions. When establishing the MOV periodic verification condition, the NRC provided guidance in the final rule published September 22, 1999 (64 FR 51370), for licensees to develop acceptable programs that would satisfy the MOV periodic verification condition. Similarly, the NRC staff is providing guidance herein for new reactor applicants and licensees to develop acceptable programs to periodically verify the capability of POVs to perform their design-basis safety functions.
In NUREG-2124, “Final Safety Evaluation Report [FSER] Related to the Combined Licenses for Vogtle Electric Generating Plant, Units 3 and 4,” the NRC staff found the provisions established by the COL applicant for Vogtle Units 3 and 4 in its Final Safety Analysis Report (FSAR), Revision 5, Section 3.9.6.2.2, “Valve Testing,” to periodically verify the capability of POVs (such as air-operated valves (AOVs), solenoid-operated valves (SOVs), and hydraulic-operated valves (HOVs)) to perform their design-basis safety functions to be acceptable. In particular, the Vogtle Units 3 and 4 FSAR specifies that:
Power-operated valves other than active MOVs are exercised quarterly in accordance with OM ISTC, unless justification is provided in the inservice testing program for testing these valves at other than Code mandated frequencies. Although the design basis capability of power-operated valves is verified as part of the design and qualification process, power-operated valves that perform an active safety function are tested again after installation in the plant, as required, to ensure valve setup is acceptable to perform their required functions, consistent with valve qualification. These tests, which are typically performed under static (no flow or pressure) conditions, also document the “baseline” performance of the valves to support maintenance and trending programs. During the testing, critical parameters needed to ensure proper valve setup are measured. Depending on the valve and actuator type, these parameters may include seat load, running torque or thrust, valve travel, actuator spring rate, bench set and regulator supply pressure. Uncertainties associated with performance of these tests and use of the test results (including those associated with measurement equipment and potential degradation mechanisms) are addressed appropriately. Uncertainties may be considered in the specification of acceptable valve setup parameters or in the interpretation of the test results (or a combination of both). Uncertainties affecting both valve function and structural limits are addressed. Additional testing is performed as part of the air-operated valve (AOV) program, which includes the key elements for an AOV Program as identified in the JOG AOV program document, Joint Owners Group Air Operated Valve Program Document, Revision 1, December 13, 2000 (References 203 and 204) [JOG AOV Program Document, Revision 1, December 13, 2000 (ADAMS Accession No. ML010950310), and NRC comment letter dated October 8, 1999, to Nuclear Energy Institute (ADAMS Accession No. ML020360077)]. The AOV program incorporates the attributes for a successful power-operated valve long-term periodic verification program, as discussed in Regulatory Issue Summary 2000-03, Resolution of Generic Safety Issue 158: Performance of Safety-Related Power-Operated Valves Under Design Basis
For example, key lessons learned addressed in the AOV program include:
• Valves are categorized according to their safety significance and risk ranking.
• Setpoints for AOVs are defined based on current vendor information or valve qualification diagnostic testing, such that the valve is capable of performing its design-basis function(s).
• Periodic static testing is performed, at a minimum on high risk (high safety significance) valves, to identify potential degradation, unless those valves are periodically cycled during normal plant operation, under conditions that meet or exceed the worst case operating conditions within the licensing basis of the plant for the valve, which would provide adequate periodic demonstration of AOV capability. If required based on valve qualification or operating experience, periodic dynamic testing is performed to re-verify the capability of the valve to perform its required functions.
• Sufficient diagnostics are used to collect relevant data (
• Test frequency is specified, and is evaluated each refueling outage based on data trends as a result of testing. Frequency for periodic testing is in accordance with References 203 and 204, with a minimum of 5 years (or 3 refueling cycles) of data collected and evaluated before extending test intervals.
• Post-maintenance procedures include appropriate instructions and criteria to ensure baseline testing is re-performed as necessary when maintenance on the valve, repair or replacement, have the potential to affect valve functional performance.
• Guidance is included to address lessons learned from other valve programs specific to the AOV program.
• Documentation from AOV testing, including maintenance records and records from the corrective action program are retained and periodically evaluated as a part of the AOV program.
The attributes of the AOV testing program described above, to the extent that they apply to and can be implemented on other safety-related power-operated valves, such as electro-hydraulic operated valves, are applied to those other power-operated valves.” (Vogtle Electric Generating Plant, Units 3 and 4, Updated Final Safety Analysis Report (UFSAR), Section 3.9.6, “Inservice Testing of Pumps and Valves”)
Applicable applicants and licensees may follow the method described in the Vogtle Units 3 and 4 FSAR in satisfying § 50.55a(b)(3)(iii)(A), or may establish a different method, subject to evaluation by the NRC during the licensing process or inspections.
The NRC is adding § 50.55a(b)(3)(iii)(B) to require that licensees within the scope of § 50.55a(b)(3)(iii) perform bi-directional testing of check valves within the IST program where practicable. Nuclear power plant operating experience has revealed that testing check valves in only the flow direction can result in significant degradation, such as a missing valve disc, not being identified by the test. Nonmandatory Appendix M, “Design Guidance for Nuclear Power Plant Systems and Component Testing,” to OM Code, 2011 Addenda and 2012 Edition, includes guidance for the design of new reactors to enable bi-directional testing of check valves. New reactor designs will provide the capability for licensees of new nuclear power plants to perform bi-directional testing of check valves within the IST program. Bi-directional testing of check valves in new reactors, as required by § 50.55a(b)(3)(iii)(B), could be accomplished by valve-specific testing or condition monitoring activities in accordance with Appendix II to the OM Code as accepted in § 50.55a. The NRC is specifying this provision for bi-directional testing of check valves for new reactors in § 50.55a(b)(3)(iii)(B) to emphasize that new reactors should include the capability for bi-directional testing of check valves as part of their initial design.
In the proposed rule, the NRC proposed adding § 50.55a(b)(3)(iii)(C) to require that licensees subject to § 50.55a(b)(3)(iii) monitor flow-induced vibration (FIV) from hydrodynamic loads and acoustic resonance during preservice testing and inservice testing to identify potential adverse flow effects that might impact components within the scope of the IST program.
Nuclear power plant operating experience has revealed the potential for adverse flow effects from vibration caused by hydrodynamic loads and acoustic resonance on components in the reactor coolant, steam, and feedwater systems. Therefore, the licensee will be required to address potential adverse flow effects on safety-related pumps, valves, and dynamic restraints within the IST program in the reactor coolant, steam, and feedwater systems from hydraulic loading and acoustic resonance during plant operation. In response to public comments, the NRC revised § 50.55a(b)(3)(iii)(C) to clarify its intent that FIV monitoring of components may be conducted during preservice testing or inservice testing. This requirement will confirm that piping, components, restraints, and supports have been designed and installed to withstand the dynamic effects of steady-state FIV and anticipated operational transient conditions. As part of preservice testing activities, the initial test program may be used to verify that safety-related piping and components are properly installed and supported such that vibrations caused by steady-state or dynamic effects do not result in excessive stress or fatigue in safety-related plant systems.
In the Vogtle Units 3 and 4 FSER, the NRC staff found the provisions established by the COL applicant for Vogtle Units 3 and 4 in its FSAR, Revision 5, Section 3.9, “Mechanical Systems and Components,” Section 14.2.9, “Preoperational Test Descriptions,” and Section 14.2.10, “Startup Test Procedures,” with incorporation by reference of corresponding sections of the AP1000 Design Control Document (DCD), to monitor FIV from hydrodynamic loads and acoustic resonance during preservice testing or inservice testing to be acceptable. In particular, the NRC staff stated in the Vogtle Units 3 and 4 FSER:
AP1000 DCD Tier 2, Section 3.9.2, “Dynamic Testing and Analysis,” describes tests to confirm that piping, components, restraints, and supports have been designed to withstand the dynamic effects of steady-state FIV and anticipated operational transient conditions. Section 14.2.9.1.7, “Expansion, Vibration and Dynamic Effects Testing,” in AP1000 DCD Tier 2, Chapter 14, “Initial Test Program,” states that the purpose of the expansion, vibration and dynamic effects testing is to verify that safety-related, high energy piping and components are properly installed and supported such that, in addition to other factors, vibrations caused by steady-state or dynamic effects do not result in excessive stress or fatigue to safety-related plant systems. Nuclear power plant operating experience has revealed the potential for adverse flow effects from vibration caused by hydrodynamic loads and acoustic resonance on reactor coolant, steam, and feedwater systems. . . . In its response, SNC [Vogtle Units 3 and 4 COL applicant] stated that it intended to use the overall Initial Test Program to demonstrate that the plant has been constructed as designed and the systems perform consistent with design requirements. SNC referenced the provisions in the AP1000 DCD for vibration monitoring and testing to be implemented at VEGP. For example, the applicant notes that AP1000 DCD Tier 2, Section 3.9.2.1, “Piping Vibration, Thermal Expansion and Dynamic Effects,” specifies that the preoperational test
As clarified in the final rule in response to public comments, a licensee may monitor components for adverse FIV effects during preservice testing or IST activities.
Applicable applicants and licensees may either apply the methods described in the Vogtle Units 3 and 4 FSAR in satisfying § 50.55a(b)(3)(iii)(C) or develop their own plant-specific methods to satisfy § 50.55a(b)(3)(iii)(C) for NRC review during the licensing process.
The NRC is adding § 50.55a(b)(3)(iii)(D) to require that licensees within the scope of § 50.55a(b)(3)(iii) establish a program to assess the operational readiness of pumps, valves, and dynamic restraints within the scope of the Regulatory Treatment of Non-Safety Systems (RTNSS) for applicable reactor designs. As of the time of this final rule, these are designs which have been certified in a design certification rule under 10 CFR part 52. In SECY-94-084 and SECY-95-132, the Commission discusses RTNSS policy and technical issues associated with passive plant designs. Some new nuclear power plants have advanced light-water reactor (ALWR) designs that use passive safety systems that rely on natural forces, such as density differences, gravity, and stored energy to supply safety injection water and to provide reactor core and containment cooling. Active systems in passive ALWR designs are categorized as non-safety systems with limited exceptions. Active systems in passive ALWR designs provide the first line of defense to reduce challenges to the passive systems in the event of a transient at the nuclear power plant. Active systems that provide a defense-in-depth function in passive ALWR designs need not meet all of the acceptance criteria for safety-related systems. However, there should be a high level of confidence that these active systems will be available and reliable when needed. The combined activities to provide confidence in the capability of these active systems in passive ALWR designs to perform their functions important to safety are referred to as the RTNSS program. In the NRC Staff Memorandum, “Consolidation of SECY-94-084 and SECY-95-132,” dated July 24, 1995, the NRC staff provided a consolidated list of the approved policy and technical positions associated with RTNSS equipment in passive plant designs discussed in SECY-94-084 and SECY-95-132. This new paragraph specifies the need for licensees to assess the operational readiness of RTNSS pumps, valves, and dynamic restraints.
The July 24, 1995, staff memorandum summarizes the Commission policy positions related to inservice testing of RTNSS pumps and valves as follows:
The staff also concluded that additional inservice testing requirements may be necessary for certain pumps and valves in passive plant designs. The unique passive plant design relies significantly on passive safety systems, but also depends on non-safety systems (which are traditionally safety-related systems in current light-water reactors) to prevent challenges to passive systems. Therefore, the reliable performance of individual components is a very significant factor in enhancing the safety of passive plant design. The staff recommends that the following provisions be applied to passive ALWR plants to ensure reliable component performance.
1. Important non-safety-related components are not required to meet criteria similar to safety-grade criteria. However, the non-safety-related piping systems with functions that have been identified as being important by the RTNSS process should be designed to accommodate testing of pumps and valves to assure that the components meet their intended functions. Specific positions on the inservice testing requirements for those components will be determined as a part of the staff's review of plant-specific implementation of the regulatory treatment of non-safety systems for passive reactor designs.
2. . . . The vendors for advanced passive reactors, for which the final designs are not complete, have sufficient time to include provisions in their piping system designs to allow testing at power. Quarterly testing is the base testing frequency in the Code and the original intent of the Code. Furthermore, the COL holder may need to test more frequently than during cold shutdowns or at every refueling outage to ensure that the reliable performance of components is commensurate with the importance of the safety functions to be performed and with system reliability goals. Therefore, to the extent practicable, the passive ALWR piping systems should be designed to accommodate the applicable Code requirements for the quarterly testing of valves. However, design configuration changes to accommodate Code-required quarterly testing should be done only if the benefits of the test outweigh the potential risk.
3. The passive system designs should incorporate provisions (1) to permit all critical check valves to be tested for performance, to the extent practicable, in both forward- and reverse-flow directions, although the demonstration of a non-safety direction test need not be as rigorous as the corresponding safety direction test, and (2) to verify the movement of each check valve's obturator during inservice testing by observing a direct instrumentation indication of the valve position such as a position indicator or by using nonintrusive test methods.
4. . . . Similarly, to the extent practicable, the design of non-safety-related piping systems with functions under design-basis condition that have been identified as being important by the RTNSS process should incorporate provisions to periodically test power-operated valves in the system during operations to assure that the valves meet their intended functions under design-basis conditions.
5. . . . Mispositioning may occur through actions taken locally (manual or electrical), at a motor control center, or in the control room, and includes deliberate changes of valve position to perform surveillance testing. The staff will determine if and the extent to which this concept should be applied to MOVs in important non-safety-related systems when the staff reviews the implementation of the regulatory treatment of non-safety systems.” (NRC Staff Memorandum, “Consolidation of SECY-94-084 and SECY-95-132,” July 24, 1995, pages 26-28).
Consistent with the Commission policy for RTNSS equipment, § 50.55a(b)(3)(iii)(D) specifies that new reactor licensees shall assess the operational readiness of pumps, valves, and dynamic restraints within the RTNSS scope. This regulatory requirement will allow licensees flexibility in developing programs to assess operational readiness of RTNSS components that satisfy the Commission policy. Guidance on the implementation of the Commission policy for RTNSS equipment is set forth in NRC Inspection Procedure 73758, “Part 52, Functional Design and Qualification, and Preservice and Inservice Testing Programs for Pumps, Valves and
The NRC is revising § 50.55a(b)(3)(iv) to address Appendix II, “Check Valve Condition Monitoring Program,” provided in the 2003 Addenda through the 2012 Edition of the OM Code. In the proposed rule, the NRC proposed a condition in § 50.55a(b)(3)(iv) to provide assurance that the valve or group of valves is capable of performing its intended function(s) over the entire interval. Public comments indicated that the proposed condition could be misinterpreted. Therefore, the NRC revised the proposed condition to clarify that the implementation of Appendix II must include periodic sampling of the check valves over the maximum interval allowed by Appendix II for the check valve condition monitoring program. A new table was added to the paragraph to specify the maximum intervals between check valve condition monitoring activities when applying interval extensions.
The conditions currently specified for the use of Appendix II, 1995 Edition with the 1996 and 1997 Addenda, and 1998 Edition through the 2002 Addenda, of the OM Code remain unchanged by this final rule.
The NRC is adding a new condition, § 50.55a(b)(3)(vii), to prohibit the use of Subsection ISTB, “Inservice Testing of Pumps in Light-Water Reactor Nuclear Power Plants,” in the 2011 Addenda of the OM Code. In the 2011 Addenda to the OM Code, the upper end of the “Acceptable Range” and the “Required Action Range” for flow and differential or discharge pressure for comprehensive pump testing in Subsection ISTB was raised to higher values. The NRC staff on the OM Code committee accepted the proposed increase of the upper end of the “Acceptable Range” and “Required Action Range” with the planned addition of a requirement for a pump periodic verification test program in the OM Code. However, the 2011 Addenda to the OM Code did not include the requirement for a pump periodic verification test program. Since then, the 2012 Edition of the OM Code has incorporated Mandatory Appendix V, “Pump Periodic Verification Test Program,” which supports the changes to the acceptable and required action ranges for comprehensive pump testing in Subsection ISTB. Therefore, the new § 50.55a(b)(3)(vii) prohibits the use of Subsection ISTB in the 2011 Addenda of the OM Code. Licensees will be allowed to apply Subsection ISTB with the revised acceptable and required action ranges in the 2012 Edition of the OM Code as incorporated by reference in § 50.55a.
The NRC is adding § 50.55a(b)(3)(viii) to specify that licensees who wish to implement Subsection ISTE, “Risk-Informed Inservice Testing of Components in Light-Water Reactor Nuclear Power Plants,” of the OM Code, 2009 Edition, 2011 Addenda, and 2012 Edition, must request and obtain NRC approval in accordance with § 50.55a(z) to apply Subsection ISTE on a plant-specific basis as a risk-informed alternative to the applicable IST requirements in the OM Code.
In the 2009 Edition of the OM Code, the ASME included new Subsection ISTE that describes a voluntary risk-informed approach in developing an IST program for pumps and valves at nuclear power plants. If a licensee chooses to implement this risk-informed IST approach, Subsection ISTE indicates that all requirements in Subsection ISTA, “General Requirements,” Subsection ISTB, and Subsection ISTC, “Inservice Testing of Valves in Light-Water Reactor Nuclear Power Plants,” of the OM Code continue to apply, except those identified in Subsection ISTE. The ASME selected risk-informed guidance from OM Code Cases OMN-1, OMN-3, OMN-4, “Requirements for Risk Insights for Inservice Testing of Check Valves at LWR Power Plants,” OMN-7, “Alternative Requirements for Pump Testing,” OMN-11, and OMN-12, “Alternative Requirements for Inservice Testing Using Risk Insights for Pneumatically and Hydraulically Operated Valve Assemblies in Light-Water Reactor Power Plants,” in preparing Subsection ISTE of the OM Code.
During development of Subsection ISTE, the NRC staff participating on the OM Code committees indicated that the conditions specified in RG 1.192 for the use of the applicable OM Code Cases need to be considered when evaluating the acceptability of the implementation of Subsection ISTE. In addition, the NRC staff noted that several aspects of Subsection ISTE will need to be addressed on a case-by-case basis when determining the acceptability of its implementation. Therefore, the new condition in § 50.55a(b)(3)(viii) requires that licensees who wish to implement Subsection ISTE of the OM Code must request approval from the NRC to apply Subsection ISTE on a plant-specific basis as a risk-informed alternative to the applicable IST requirements in the OM Code.
Nuclear power plant applicants for construction permits under 10 CFR part 50, or combined licenses for construction and operation under 10 CFR part 52, may describe their proposed implementation of the risk-informed IST approach specified in Subsection ISTE of the OM Code for NRC review in their applications.
The NRC is adding a condition on the use of Subsection ISTF in § 50.55a(b)(3)(ix). First, the condition states that Subsection ISTF, 2011 Addenda, is prohibited for use. Second, the condition specifies that licensees applying Subsection ISTF, “Inservice Testing of Pumps in Light-Water Reactor Nuclear Power Plants—Post-2000 Plants,” in the 2012 Edition of the OM Code shall satisfy the requirements of Mandatory Appendix V, “Pump Periodic Verification Test Program,” of the OM Code, 2012 Edition.
As previously discussed regarding the new condition in § 50.55a(b)(3)(vii), the upper end of the “Acceptable Range” and the “Required Action Range” for flow and differential or discharge pressure for comprehensive pump testing in Subsection ISTB in the OM Code was raised to higher values in combination with the incorporation of Mandatory Appendix V, “Pump Periodic Verification Test Program.” However, the 2011 Addenda of the OM Code does not include Appendix V. In addition, Subsection ISTF in the 2011 Addenda and 2012 Edition of the OM Code does not include a requirement for a pump periodic verification test program. Therefore, the new condition in § 50.55a(b)(3)(ix) requires that the provisions of Appendix V be applied when implementing Subsection ISTF of the 2012 Edition of the OM Code to support the application of the upper end of the Acceptable Range and the Required Action Range for flow and differential or discharge pressure for inservice pump testing in Subsection ISTF.
The NRC is adding § 50.55a(b)(3)(xi) to emphasize the provisions in OM Code, 2012 Edition, Subsection ISTC-3700, “Position Verification Testing,” to verify that valve obturator position is accurately indicated. Subsection ISTC-3700 of the OM Code requires that
The NRC initially emphasized the ASME OM Code requirement for valve position indication in 1995 in the original issuance of NUREG-1482, “Guidelines for Inservice Testing at Nuclear Power Plants,” paragraph 4.2.5. The NRC's position is further elaborated in NUREG-1482 (Revision 2), “Guidelines for Inservice Testing at Nuclear Power Plants: Inservice Testing of Pumps and Valves and Inservice Examination and Testing of Dynamic Restraints (Snubbers) at Nuclear Power Plants,” paragraph 4.2.7. As discussed in NUREG-1482 (Revision 2), ISTC-3700 allows flexibility to licensees in verifying that operation of valves with remote position indicators is accurately indicated. For example, NUREG-1482 refers to various methods to verify valve operation, such as nonintrusive techniques, flow initiation or absence of flow, leak testing, and pressure testing. The extent of verification necessary for valve operation to satisfy ISTC-3700 will depend on the type of valve, the sophistication of the diagnostic equipment used in testing the valve, possible failure modes of the valve, and the operating history of the valve and similar valve types. To satisfy ISTC-3700, the licensee is responsible for developing and implementing a method to provide reasonable assurance that valve operation is accurately indicated.
The NRC is requiring this condition for the implementation of the 2012 Edition of the OM Code for the 120-month IST interval in order to allow additional time for licensees to comply with this condition.
The NRC is revising the introductory text of § 50.55a(f) to indicate that systems and components must meet the requirements for “preservice and inservice testing” in the applicable ASME Codes and that both activities are referred to as “inservice testing” in the remainder of paragraph (f). The change clarifies that the OM Code includes provisions for preservice testing of components as part of its overall provisions for IST programs. No expansion of IST program scope was intended by this clarification.
In the proposed rule, the NRC included references to the OM Code in § 50.55a(f)(3)(iii)(A), Class 1 Pumps and Valves: First Provision; § 50.55a(f)(3)(iii)(B), Class 1 Pumps and Valves: Second Provision; § 50.55a(f)(3)(iv)(A), Class 2 and 3 Pumps and Valves: First Provision; and § 50.55a(f)(3)(iv)(B): Second Provision; to align the regulatory language with the current ASME OM Code used for IST programs. Because § 50.55a(f)(3)(iii) and (iv) specifically reference Class 1, 2, or 3 pumps and valves, the proposed changes to these paragraphs referencing the OM Code are unnecessary and have not been adopted in this final rule.
The NRC is revising § 50.55a(f)(4) to clarify that this paragraph is applicable to pumps and valves that are within the scope of the OM Code. This revision aligns the scope of pumps and valves for inservice testing with the scope defined in the OM Code.
Public comments on the alignment of the IST program scope in § 50.55a(f)(4) indicated that the nuclear industry is addressing the requirements in 10 CFR part 50, appendices A and B, to establish an IST program for safety-related pumps and valves that are not classified as ASME BPV Code Class 1, 2, or 3 components through either the OM Code provisions or augmented IST programs. For example, one public commenter indicated that generally, augmented IST programs are designed to meet the OM Code where practicable, but relief requests are not required when alternate testing is necessary. The NRC regulations in § 50.55a address the concept of augmented IST programs for pumps and valves at nuclear power plants. For example, § 50.55a(f)(6)(ii), “Augmented IST requirements,” indicates that the licensee may follow an augmented IST program for pumps and valves for which the NRC deems that added assurance of operational readiness is necessary. The NRC finds that an augmented IST program as addressed in § 50.55a(f)(6)(ii) is acceptable for safety-related pumps and valves that are not classified as ASME BPV Code Class 1, 2, or 3 components.
Public commenters were concerned that the alignment of the scope of the OM Code and § 50.55a would cause a potential paperwork burden for the submittal of relief or alternative requests for safety-related pumps and valves that are not classified as ASME BPV Code Class 1, 2, or 3 components. In response to these comments, the NRC included a provision in § 50.55a(f)(4) that the IST requirements for pumps and valves that are within the scope of the OM Code but are not classified as ASME BPV Code Class 1, Class 2, or Class 3 may be satisfied as an augmented IST program in accordance with § 50.55a(f)(6)(ii) without requesting relief under § 50.55a(f)(5) or alternatives under § 50.55a(z). This use of an augmented IST program may be acceptable provided the basis for deviations from the OM Code, as incorporated by reference in this section, demonstrates an acceptable level of quality and safety, or that implementing the Code provisions would result in hardship or unusual difficulty without a compensating increase in the level of quality and safety, where documented and available for NRC review. This additional provision avoids the potential paperwork burden for the submittal of relief or alternative requests by allowing the licensee to maintain the documentation demonstrating an acceptable level of quality and safety on site for NRC review, as appropriate. The
The NRC recognizes that updating an Appendix VIII program is a complex and time-consuming process. The NRC also recognizes that licensees would face the possibility of needing to maintain multiple Appendix VIII programs if units were to update their ISI programs on different dates. Maintaining certifications to multiple Appendix VIII programs would be very complicated, while not improving the effectiveness of the programs. Based on public comments, and to assist licensees in updating and coordinating their ISI programs, the NRC is adding two options to the regulations. First, the NRC is revising § 50.55a(g)(4)(i) and (ii) to clarify that a licensee whose ISI interval commences during the 12- to 18-month period after the approval date of this final rule, may delay the update of their Appendix VIII program by up to 18 months after the approval date of this final rule. This will provide licensees with enough time to incorporate the changes for the new Appendix VIII program. Second, the NRC is adding the option for licensees to update their ISI program to use the latest edition and addenda of Appendix VIII incorporated by reference in § 50.55a(a)(1) at any time in the licensee's ten-year interval. Licensees can normally update their ISI programs using all or portions of newer versions of ASME BPV Code Section XI under § 50.55a(g)(4)(iv), subject to NRC review and approval. While some requests to use portions of ASME BPV Code Section XI require a detailed review by the NRC, a licensee asking to use the entire latest incorporated-by-reference version of Appendix VIII would certainly be approved by the NRC staff in this process. This provision will, therefore, allow licensees to use the latest incorporated version of Appendix VIII, as long as it is coupled with the same edition and addenda of Appendix I, without the NRC review and approval process. This will allow licensees to coordinate their ISI programs and use the latest approved version of Appendix VIII without the delay imposed by submitting a relief request under § 50.55a (g)(4)(iv).
The NRC is removing the revision number of the three RGs currently approved by the Office of the Federal Register for incorporation by reference throughout the substantive provisions of § 50.55a addressing the ASME Code Cases,
The NRC is revising § 50.55a(a)(1)(iii) to maintain the ASME Code Cases in alphanumeric order.
The discussions under the following headings address four of the six ASME Code Cases being incorporated by reference in this rulemaking (N-729-4, N-770-2, N-824, and OMN-20). A fifth ASME Code Case, N-852, is discussed in Section II.A, “ASME BPV Code, Section III,” because the NRC's approval of that Code Case relates to a provision of Section III, which is addressed in § 50.55a(b)(1)(ix). The sixth ASME Code Case, N-513-3, is discussed in Section II.B, “ASME BPV Code, Section XI,” because the NRC's approval of that Code Case relates to a provision of Section XI, which is addressed in § 50.55a(b)(2)(xxxiv).
On September 10, 2008, the NRC issued a final rule to update § 50.55a to the 2004 Edition of the ASME BPV Code (73 FR 52730). As part of the final rule, § 50.55a(g)(6)(ii)(D) implemented an augmented ISI program for the examination of pressurized water reactor RPV upper head penetration nozzles and associated partial penetration welds. The program required the implementation of ASME BPV Code Case N-729-1, with certain conditions.
The application of ASME BPV Code Case N-729-1 was necessary because the inspections required by the 2004 Edition of the ASME BPV Code, Section XI were not written to address degradation of the RPV upper head penetration nozzles and associated welds by primary water stress corrosion cracking (PWSCC). The safety consequences of inadequate inspections can be significant. The NRC's determination that the ASME BPV Code required inspections are inadequate is based upon operating experience and analysis. The absence of an effective inspection regime could, over time, result in unacceptable circumferential cracking, or the degradation of the RPV upper head or other reactor coolant system components by leakage assisted corrosion. These degradation mechanisms increase the probability of a loss-of-coolant accident.
Examination frequencies and methods for RPV upper head penetration nozzles and welds are provided in ASME BPV Code Case N-729-1. The use of code cases is voluntary, so these provisions were developed, in part, with the expectation that the NRC would incorporate the code case by reference into the CFR. Therefore, the NRC adopted rule language in § 50.55a(g)(6)(ii)(D) requiring implementation of ASME BPV Code Case N-729-1, with conditions, in order to enhance the examination requirements in the ASME BPV Code, Section XI for RPV upper head penetration nozzles and welds. The examinations conducted in accordance with ASME BPV Code Case N-729-1 provide reasonable assurance that ASME BPV Code allowable limits will not be exceeded and that PWSCC will not lead to failure of the RPV upper head penetration nozzles or welds. However, the NRC concluded that certain conditions were needed in implementing the examinations in ASME BPV Code Case N-729-1. These conditions are set forth in § 50.55a(g)(6)(ii)(D).
On June 22, 2012, the ASME approved the fourth revision of ASME BPV Code Case N-729 (N-729-4). This revision changed certain requirements based on a consensus review of inspection techniques and frequencies. These changes were deemed necessary by the ASME to supersede the previous requirements under N-729-1 to establish an effective long-term inspection program for the RPV upper head penetration nozzles and associated welds in pressurized water reactors. The
The NRC is updating the requirements of § 50.55a(g)(6)(ii)(D) to require licensees to implement ASME BPV Code Case N-729-4, with conditions. One existing condition on ASME BPV Code Case N-729-1 has been modified, four existing conditions are being deleted in this final rule, one existing condition is being redesignated without substantive change, and two new conditions—in § 50.55a(g)(6)(ii)(D)(
The NRC is revising § 50.55a(g)(6)(ii)(D)(
The NRC is removing the existing conditions in § 50.55a(g)(6)(ii)(D)(
The NRC is adopting a new condition in § 50.55a(g)(6)(ii)(D)(
In 2006, one of the 21 “cold head” plants identified two indications within a penetration nozzle and the associated partial penetration weld. Then, between 2006 and 2013, five of the 21 “cold head” plants identified multiple indications within fifteen different penetration nozzles and the associated partial penetration welds. None of these indications caused leakage, and volumetric examination of the penetration nozzles showed that no flaws in the nozzle material had grown through-wall; however, this increasing trend creates a reasonable safety concern.
Recent operational experience has shown that the volumetric inspection of penetration nozzles, at the current inspection frequency, is adequate to identify indications in the nozzle material prior to leakage; however, volumetric examinations cannot be performed on the partial penetration welds. Therefore, given the additional cracking identified at cold leg temperatures, the NRC staff has concerns about the adequacy of the partial penetration weld examinations.
Leakage from a partial penetration weld into the annulus between the nozzle and head material can cause corrosion of the low alloy steel head. While initially limited in leak rate, due to limited surface area of the weld being in contact with the annulus region, corrosion of the vessel head material can expose more of the weld surface to the annulus, allowing a greater leak rate. Since an indication in the weld cannot be identified by a volumetric inspection, a postulated crack through the weld, just about to cause leakage, could exist as a plant performed its last volumetric and/or bare metal visual examination of the upper head material. This gives the crack years to breach the surface and leak prior to the next scheduled visual examination.
Only a surface examination of the wetted surface of the partial penetration weld can reliably detect flaws in the weld. Unfortunately, this examination cannot size the flaws in the weld, and, if performed manually, requires significant radiological dose to examine all of the partial penetration welds on the upper head. As such, the available techniques are only able to detect a flaw after it has caused leakage. These techniques are a bare metal visual examination or a volumetric leak path assessment performed on the frequency of the volumetric examination.
Volumetric leak path examinations are only done during outages when a volumetric examination of the nozzle is performed. Therefore, under the current requirements allowed by Note 4 of ASME BPV Code Case N-729-4, leakage from a crack in the weld of a “cold head” plant could start and continue to grow for the 5 years between the required bare metal visual examinations to detect leakage through the partial penetration weld.
Given the additional cracking identified at cold leg temperatures of upper head penetration nozzles and associated welds, the NRC finds limited basis to continue to categorize these “cold head” plants as having a low susceptibility to crack initiation. The NRC is increasing the frequency of the bare metal visual examinations of “cold heads” to identify potential leakage as soon as reasonably possible due to the volumetric examination limitations. Therefore, the NRC is conditioning Note 4 of ASME BPV Code Case N-729-4 to require a bare metal visual exam during each outage in which a volumetric exam is not performed. The NRC also will allow “cold head” plants to extend their bare metal visual inspection frequency from once each refueling outage, as stated in Table 1 of N-729-1, to once every 5 years, but only if the licensee performed a wetted surface examination of all of the partial penetration welds during the previous volumetric examination. Applying the conditioned bare metal visual inspection frequency or a volumetric examination each outage will allow licensees to identify any potential leakage through the partial penetration welds prior to significant degradation of the low alloy steel head material, thereby providing reasonable assurance of the structural integrity of the reactor coolant pressure boundary.
These issues, including the operational experience, the fact that volumetric examination is not available to interrogate the partial penetration welds, and potential regulatory options, were discussed publicly at multiple ASME BPV Code meetings, at the annual Materials Programs Technical Information Exchange public meeting
The NRC is adopting a new condition in § 50.55a(g)(6)(ii)(D)(
Recently, the ASME BPV Code Committee approved an interpretation of the language in Paragraph -3132(b), which implied that any size rounded indication is acceptable unless there is relevant indication of nozzle leakage, even those greater than
Therefore, in order to ensure compliance with the previous and ongoing requirement, the NRC is revising condition § 50.55a(g)(6)(ii)(D)(
On June 21, 2011 (76 FR 36232), the NRC issued a final rule, which included § 50.55a(g)(6)(ii)(F) that requires the implementation of ASME BPV Code Case N-770-1, “Alternative Examination Requirements and Acceptance Standards for Class 1 PWR Piping and Vessel Nozzle Butt Welds Fabricated with UNS N06082 or UNS N86182 Weld Filler Material With or Without Application of Listed Mitigation Activities,” with certain conditions.
On June 9, 2011, the ASME approved the second revision of ASME BPV Code Case N-770 (N-770-2). The major changes from N-770-1 to N-770-2 included establishing new ASME BPV Code Case, Table 1, inspection item classifications for optimized weld overlays and allowing alternatives when complete inspection coverage cannot be met. Minor changes were also made to address editorial issues, to correct figures, or to add clarity. The NRC found that the updates and improvements in N-770-2 are sufficient to update § 50.55a(g)(6)(ii)(F).
The NRC, therefore, is updating the requirements of § 50.55a(g)(6)(ii)(F) to require licensees to implement ASME BPV Code Case N-770-2, with conditions. The NRC conditions have been modified to address the changes in ASME BPV Code Case N-770-2 and to ensure that this regulatory framework will provide adequate protection of public health and safety. The following sections discuss each of the NRC's changes to the conditions on ASME BPV Code Case N-770-2. As discussed earlier, this final rule incorporates by reference ASME BPV Code Case N-770-2 into § 50.55a(a)(1)(iii)(D).
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is revising § 50.55a(g)(6)(ii)(F)(
Uncracked welds mitigated with optimized weld overlays were re-categorized by ASME BPV Code Case N-770-2 from Inspection Item D to Inspection Item C-2; however, the initial inspection requirement was not incorporated into the Code Case for Inspection Item C-2. The NRC has determined that uncracked welds mitigated with an optimized weld overlay must have an initial inservice examination no sooner than the third refueling outage and no later than 10 years following the application of the weld overlay to identify unacceptable crack growth. Optimized weld overlays establish compressive stress on the inner half thickness of the weld, but the outer half thickness may also be under tensile stress. The requirement for an initial inservice examination no sooner than the third refueling outage and no later than 10 years following the application of the weld overlay is based on the design of optimized weld overlays, which require the outer quarter thickness of the susceptible material to provide structural integrity for the weld. Therefore, the NRC is continuing adoption of the condition, which requires the initial inservice examination of uncracked welds mitigated by optimized weld overlay (
The NRC is revising § 50.55a(g)(6)(ii)(F)(
Previously, under N-770-1, the initial inservice examination of these welds was not allowed to be deferred. Allowing deferral of the initial inservice examination in accordance with N-770-2 could, in certain circumstances, allow the initial inservice examination to be performed up to 20 years after installation. Therefore, the NRC is adopting a condition which would preclude the deferral of the initial inservice examination of uncracked welds mitigated by optimized weld overlays.
The NRC is revising § 50.55a(g)(6)(ii)(F)(
The NRC is adding § 50.55a(g)(6)(ii)(F)(
The development of a sufficient number of mockups would be required to establish an Appendix VIII program for examination of ASME BPV Code Class 1 piping and vessel nozzle butt welds through cast stainless steel materials. The NRC recognizes that significant time and resources are required to create mockups and to allow for qualification of equipment, procedures and personnel. Therefore, the NRC is requiring licensees to use these Appendix VIII qualifications no later than their first scheduled weld examinations involving cast stainless steel materials occurring after January 1, 2022.
The NRC is adding § 50.55a(g)(6)(ii)(F)(
The material of concern is the weld material susceptible to PWSCC adjoining the cast stainless steel material. Appendix VIII qualified procedures are available to perform the inspection of the susceptible weld material, but they are not qualified to inspect the cast stainless steel materials. Therefore, the NRC is adopting a condition changing the inspection volume for stress-improved dissimilar metal welds with cast stainless steel from the ASME BPV Code Section XI requirements to “the maximum extent practical including 100 percent of the susceptible material volume.” This will
The NRC is adding § 50.55a(g)(6)(ii)(F)(13) to require the encoding of ultrasonic volumetric examinations of Inspection Items A-1, A-2, B, E, F-2, J, and K in Table 1 of N-770-2. A human performance gap has been found between some ultrasonic testing procedures, as demonstrated during ASME BPV Code, Section XI, Appendix VIII qualification versus as applied in the field.
The human factors that contributed to the licensee-performed examinations which failed to identify significant flaws at North Anna Power Station, Unit 1 in 2012 (Licensee Event Report 50-338/2012-001-00) and at Diablo Canyon Nuclear Power Plant in 2013 (Relief Request REP-1 U2, Revision 2) can be avoided by the use of encoded ultrasonic examinations. Encoded ultrasonic examinations electronically store both the positional and ultrasonic information from the inspections. Encoded examinations allow for the inspector to evaluate the data and search for indications outside of a time limited environment to assure that the inspection was conducted properly and to allow for sufficient time to analyze the data. Additionally, the encoded examination would allow for an independent review of the data by other inspectors or an independent third party. Finally, the encoded examination could be compared to previous and/or future encoded examinations to determine if flaws are present and flaw growth rates. Therefore, the NRC is adopting a condition requiring the use of encoding for ultrasonic volumetric examinations of non-mitigated or cracked mitigated dissimilar metal butt welds in the reactor coolant pressure boundary which are within the scope of ASME BPV Code Case N-770-2.
The NRC is adding § 50.55a(b)(2)(xxxvii) to allow licensees to use the provisions of ASME BPV Code Case N-824, “Ultrasonic Examination of Cast Austenitic Piping Welds From the Outside Surface Section XI, Division 1,” subject to four conditions in § 50.55a(b)(2)(xxxvii)(A) through (D), when implementing inservice examinations in accordance with the ASME BPV Code, Section XI requirements.
During the construction of nuclear power plants, it was recognized that the grain structure of cast austenitic stainless steel (CASS) could prevent effective ultrasonic inspections of piping welds where one or both sides of the welds were constructed of CASS. The high strength and toughness of CASS (prior to thermal embrittlement) made it desirable as a building material despite this known inspection issue. This choice of construction materials has rendered many pressure boundary components without a means to reliably inspect them volumetrically. While there is no operational experience of a CASS component failing, as part of the reactor pressure boundary, inservice volumetric inspection of these components is necessary to provide reasonable assurance of their structural integrity.
The current regulatory requirements for the examination of CASS, provided in § 50.55a, do not provide sufficient guidance to assure that the CASS components are being inspected adequately. To illustrate that ASME BPV Code does not provide adequate guidance, ASME BPV Code, Section XI, Appendix III, Supplement 1 states, “Cast materials may preclude meaningful examinations because of geometry and attenuation variables.” For this reason, over the past several decades, licensees have been unable to perform effective inspections of welds joining CASS components. To allow for continued operation of their plants, licensees submitted hundreds of requests for relief from the ASME BPV Code requirements for inservice inspection of CASS components to the NRC, resulting in a significant regulatory burden.
The recent advances in inspection technology are driving renewed work at ASME BPV Code meetings to produce Section XI, Appendix VIII, Supplement 9 to resolve the CASS inspection issue, but it will be years before these code updates will be published, as well as additional time to qualify and approve procedures for use in the field. Until then, licensees would still use the requirements of ASME BPV Code Section XI, Appendix III, Supplement 1, which states that inspection of CASS materials meeting the ASME BPV Code requirements may not be meaningful. Consequently, less effective examinations would continue to be used in the field, and more relief requests would be generated between now and the implementation of Supplement 9.
The NRC commissioned a research program to determine the effectiveness of the new technologies for inspections of CASS components in an effort to resolve some of the known inspection issues. The result of this work is published in NUREG/CR-6933, “Assessment of Crack Detection in Heavy-Walled Cast Stainless Steel Piping Welds Using Advanced Low-Frequency Ultrasonic Methods”, March 2007, and NUREG/CR-7122, “An Evaluation of Ultrasonic Phased Array Testing for Cast Austenitic Stainless Steel Pressurizer Surge Line Piping Welds,” March 2012. Based on the improvements in ultrasonic inspection technology and techniques for CASS components, the ASME approved BPV Code Case N-824 (N-824) on October 16, 2012, which describes how to develop a procedure capable of meaningfully inspecting welds in CASS components.
Effective examinations of CASS components require the use of lower frequencies and larger transducers than are typically used for ultrasonic inspections of piping welds and would require licensees to modify their inspection procedures. The NRC recognizes that requiring the use of spatial encoding will limit the full implementation of ASME BPV Code Case N-824, as spatial encoding is not practical for many weld configurations.
At this time, the use of ASME BPV Code Case N-824, as conditioned, is the most effective known method for adequately examining welds with one or more CASS components. With the use of ASME BPV Code Case N-824, as conditioned, licensees will be able to take full credit for completion of the § 50.55a required inservice volumetric inspection of welds involving CASS components. The implementation of ASME BPV Code Case N-824, as conditioned, will have the dual effect of improving the rigor of required volumetric inspections and reducing the number of uninspectable Class 1 and Class 2 pressure retaining welds.
The NRC concludes that incorporation of ASME BPV Code Case N-824, subject to the four conditions in § 50.55a(b)(2)(xxxvii)(A) through (D), will significantly improve the flaw detection capability of ultrasonic inspection of CASS components until Supplement 9 is implemented, thereby providing reasonable assurance of leak tightness and structural integrity. Additionally, it will reduce the regulatory burden on licensees and allow licensees to submit fewer relief requests for welds in CASS materials. The four conditions on the use of ASME BPV Code Case N-824,
The NRC, based upon NUREG/CR-6933 and NUREG/CR-7122, has determined that inspections of CASS materials are very challenging, and sufficient technical basis exists to condition the code case to bring the code case into agreement with the NUREG/CR reports. The NUREG/CR reports also show that CASS materials produce high levels of coherent noise. The noise signals can be confusing and mask flaw indications. Use of encoded inspection data allows the inspector to mitigate this problem through the ability to electronically manipulate the data, which allows for discrimination between coherent noise and flaw indications. The NRC found that encoding CASS inspection data provides significant detection benefits. Therefore, the NRC is adding a condition in § 50.55a(b)(2)(xxxvii)(A) to require the use of encoded data when utilizing N-824 for the examination of CASS components.
The use of dual element phased-array search units showed the most promise in obtaining meaningful responses from flaws. For this reason, the NRC is adding a condition in § 50.55a(b)(2)(xxxvii)(B) to require the use of dual, transmit-receive, refracted longitudinal wave, multi-element phased array search units when utilizing N-824 for the examination of CASS components.
The optimum inspection frequencies for examining CASS components of various thicknesses are described in NUREG/CR-6933 and NUREG/CR-7122. For this reason, the NRC is adding a condition in § 50.55a(b)(2)(xxxvii)(C) to require that ultrasonic examinations performed to implement ASME BPV Code Case N-824 on piping greater than 1.6 inches (41 mm) thick shall use a phased array search unit with a center frequency of 500 kHz with a tolerance of + /− 20 percent.
NUREG/CR-6933 shows that the grain structure of CASS can reduce the effectiveness of some inspection angles. For this reason, the NRC is adding a condition in § 50.55a(b)(2)(xxxvii)(D) to require that ultrasonic examinations performed to implement ASME BPV Code Case N-824 shall use a phased array search unit which produces angles including, but not limited to, 30 to 55 degrees with a maximum increment of 5 degrees.
The NRC is adding § 50.55a(b)(3)(x) to allow licensees to implement OM Code Case OMN-20, “Inservice Test Frequency,” in the OM Code, 2012 Edition, for the editions and addenda of the OM Code that are listed in § 50.55a(a)(1)(iv) as being approved for incorporation by reference. As a conforming change, § 50.55a(a)(1)(iii)(G) is being added to incorporate by reference OM Code Case OMN-20 into § 50.55a.
Surveillance Requirement (SR) 3.0.3 from TS 5.5.6, “Inservice Testing Program,” allows licensees to apply a delay period before declaring the SR for TS equipment “not met” when the licensee inadvertently exceeds or misses the time limit for performing TS surveillance. Licensees have been applying SR 3.0.3 to inservice tests. The NRC has determined that licensees cannot use TS 5.5.6 to apply SR 3.0.3 to inservice tests under § 50.55a(f) that are not associated with a TS surveillance. To invoke SR 3.0.3, the licensee shall first discover that a TS surveillance was not performed at its specified frequency. Therefore, the delay period that SR 3.0.3 provides does not apply to non-TS support components tested under § 50.55a(f). The OM Code does not provide for any inservice test frequency reductions or extensions. In order to provide inservice test frequency reductions or extensions that can no longer be provided by SR 3.0.3 from TS 5.5.6, the ASME has developed OM Code Case OMN-20. The NRC has reviewed OM Code Case OMN-20 and has found it acceptable for use. The NRC determined that OM Code Case OMN-20 may be safely used for all licensees using editions and addenda of the OM Code that are listed in § 50.55a(a)(1)(iv). The NRC will include OM Code Case OMN-20 in the next revision of RG 1.192, at which time a conforming change will be made to delete both this paragraph and § 50.55a(a)(1)(iii)(G).
The proposed rule was published on September 18, 2015, for a 75-day comment period (80 FR 56820). The public comment period closed on December 2, 2015.
After the close of the public comment period, the NRC held a public meeting on March 2, 2016, to discuss the proposed rule, to answer questions on specific provisions of the proposed rule, and to discuss public comments received on the proposed rule in order to enhance the NRC's understanding of the comments. The public meeting summary is available in ADAMS under Accession No. ML16069A408.
The NRC received 27 letters and emails in response to the opportunity for public comment on the proposed rule. These comment submissions were submitted by the following commenters (listed in order of receipt):
In general, the comments:
• Suggested revising or rewording conditions to make them clearer.
• Supported incorporation of Code Cases N-729-4, N-770-2, N-824, or OMN-20 into § 50.55a.
• Supported the proposed changes to add or remove conditions.
• Opposed proposed conditions.
• Supplied additional information for NRC consideration.
• Proposed rewriting or renumbering of paragraphs.
• Asked questions or requested information from the NRC.
Due to the large number of comments received and the length of the NRC's responses, this document summarizes the NRC's response to comments in areas of particular interest to stakeholders that prompted the NRC to make changes in this final rule from what was proposed. A discussion of all comments and complete NRC responses are presented in a separate document, “2017 Final Rule (10 CFR 50.55a) American Society of Mechanical Engineers Codes and Code Cases: Analysis of Public Comments,” (ADAMS Accession No. ML16130A531).
Public commenters were concerned that the NRC was proposing to exclude incorporating by reference Nonmandatory Appendix U because Nonmandatory Appendix U is the incorporation of the provisions of ASME BPV Code Cases N-513-3 and N-705, without any technical changes, into the Section XI Code. The NRC agrees with this comment, in that ASME BPV Code Cases N-513-3 and N-705 have been approved in RG 1.147. Based on these comments, the NRC has removed the proposed exclusion of Nonmandatory Appendix U from this final rule. However, the NRC has found it necessary to apply two new conditions in § 50.55a(b)(2)(xxxiv)(A) and (B) to Nonmandatory Appendix U. The first condition provides regulatory consistency with the approval of the code cases in RG 1.147. The second condition requires the use of an Appendix from ASME BPV Code Case N-513-3 that was unintentionally omitted from Appendix U. The NRC discussed these changes at the March 2, 2016, public meeting, and the NRC considered the public feedback from that meeting when developing this final rule.
Public commenters were concerned that the proposed rule continued to prohibit the use of underwater welding in § 50.55a(b)(2)(xii), when changes were made to address this condition in the 2010 Edition of Section XI. The NRC agrees that the condition should be modified to address the changes in the Code. After consideration of the public comments, the NRC noted other inconsistencies for addressing welding on irradiated materials that appear in the Code and in some Code Cases. Section 50.55a(b)(2)(xii) of this final rule reflects a change to include two conditions that provide consistency for welding of irradiated materials. The NRC discussed these changes at the March 2, 2016, public meeting, and the NRC considered the public feedback from that meeting when developing this final rule.
Public commenters were concerned that the wording of the proposed condition in § 50.55a(b)(2)(xxxi) was unclear and that citing the specific paragraphs of Section XI to which the NRC is taking exception would be clearer. The NRC agrees. To clarify the requirement for the implementation of mechanical clamps, the condition was changed to require the use of Appendix W of Section XI when using mechanical clamps. Additionally, use of IWA-4131.1(c) of the 2010 Edition of Section XI and IWA-4131.1(d) of the 2011 Addenda of the 2010 Edition and later versions of Section XI is prohibited. Identifying these specific subparagraphs was deemed necessary, as they may have caused confusion with the intended purpose of the original proposed condition in maintaining the previous regulatory requirements for mechanical clamping devices. Section 50.55a(b)(2)(xxxi) of this final rule reflects this change.
Public commenters had concerns with conditions proposed on ASME BPV Code Case N-824, “Ultrasonic Examination of Cast Austenitic Piping Welds From the Outside Surface Section XI, Division 1,” in § 50.55a(b)(2)(xxxvii)(A) through (E). There were concerns that the conditions would limit the use of Code Case N-824 and that some conditions did not have a sufficient technical basis. The NRC partially agreed with the comments requesting the removal and modification of some conditions in § 50.55a(b)(2)(xxxvii) restricting the frequencies and angles usable on some cast austenitic welds. Based on the public comments, one condition was removed entirely and two others were modified. Section 50.55a(b)(2)(xxxvii)(A) through (D) of this final rule contain the modified and reduced conditions on the use of ASME BPV Code Case N-824. The NRC discussed these changes at the March 2, 2016, public meeting, and the NRC considered the public feedback from that meeting when developing this final rule.
Public commenters raised concerns regarding the proposed condition in § 50.55a(b)(3)(xi) to emphasize the OM Code provisions in Subsection ISTC-3700, “Position Verification Testing,” to verify that valve operation is accurately indicated. Public commenters indicated that because of the significance of implementing the condition, some licensees might need time to revise or create procedures to govern the implementation of this condition. Public commenters also suggested that the condition be limited to active valves. The NRC partially agrees and partially disagrees with these comments. The NRC agrees that additional time to implement the condition regarding valve position verification is appropriate. Therefore, the NRC has revised the condition to indicate that it will be effective with implementation of the 2012 Edition of the OM Code. The NRC staff does not agree with the suggestion to limit the condition to active valves because the OM Code requires that passive valves undergo periodic verification of position indication.
The NRC is removing the revision number of the three RGs currently approved by the Office of the Federal Register for incorporation by reference throughout the substantive provisions of § 50.55a addressing the ASME Code Cases,
The NRC is revising the incorporation by reference language to update the
The NRC is revising § 50.55a(a)(1)(i) to clarify that Section III Nonmandatory Appendices of the listed editions and addenda are excluded from the incorporation by reference. The exclusion was originally added in a final rule published on June 21, 2011 (76 FR 36232); however, it was erroneously omitted from the final rule published on November 5, 2014 (79 FR 65776). The NRC is correcting the omission in this final rule by inserting “(excluding Nonmandatory Appendices)” in § 50.55a(a)(1)(i). The NRC is relocating the definition of the term “BPV Code,” which is used throughout the section, from § 50.55a(b) to § 50.55a(a)(1)(i).
The NRC is revising § 50.55a(a)(1)(i)(E) to add ASME BPV Code, Section III 2009 Addenda, 2010 Edition, 2011 Addenda, and 2013 Edition.
The NRC is revising § 50.55a(a)(1)(ii) to include two minor editorial changes: to replace “Boiler and Pressure Vessel Code” with “BPV Code” and to replace “limited to” with “limited by.”
The NRC is revising § 50.55a(a)(1)(ii)(C)(
The NRC is revising § 50.55a(a)(1)(iii)(A) to include information for a new standard that is being incorporated by reference, entitled, “ASME BPV Code Case N-513-3 Mandatory Appendix I.”
The NRC is revising § 50.55a(a)(1)(iii)(B) to maintain alphanumeric order for the ASME Code Cases listed in § 50.55a(a)(1)(iii). ASME BPV Code Case N-722-1 was previously approved for incorporation by reference.
The NRC is revising § 50.55a(a)(1)(iii)(C) to add the title “ASME BPV Code Case N-729-4,” and include information for the standard that is being incorporated by reference.
The NRC is adding § 50.55a(a)(1)(iii)(D) to add the title “ASME BPV Code Case N-770-2,” and include information for the standard that is being incorporated by reference.
The NRC is adding § 50.55a(a)(1)(iii)(E) to include information for a new standard that is being incorporated by reference, entitled, “ASME BPV Code Case N-824.”
The NRC is adding § 50.55a(a)(1)(iii)(F) to include information for a new standard that is being incorporated by reference, entitled, “ASME BPV Code Case N-852.”
The NRC is adding § 50.55a(a)(1)(iii)(G) to include information for a new standard that is being incorporated by reference, entitled, “ASME OM Code Case OMN-20.”
The NRC is revising § 50.55a(a)(1)(iv) to correct the title of the OM Code and to relocate the definition of the term “OM Code,” which is used throughout the section, from § 50.55a(b) to § 50.55a(a)(1)(iv).
The NRC is adding new § 50.55a(a)(1)(iv)(B) to include ASME OM Code 2009 Edition and 2011 Addenda.
The NRC is adding new § 50.55a(a)(1)(iv)(C) to include ASME OM Code 2012 Edition.
The NRC is adding new § 50.55a(a)(1)(v) to include information regarding NQA-1 standards and add the title “ASME Quality Assurance Requirements” for ASME NQA-1 Code as part of NRC titling convention.
The NRC is revising § 50.55a(b) to correct the title of the ASME OM Code.
The NRC is revising § 50.55a(b)(1) to reflect the latest edition incorporated by reference, the 2013 Edition.
The NRC is revising § 50.55a(b)(1)(ii) to clarify rule language and add Table I, which clarifies prohibited Section III provisions for welds with leg size less than 1.09 t
The NRC is revising § 50.55a(b)(1)(iv) to clarify that it allows, but does not require, applicants and licensees to use the 2008 Edition through the 2009-1a Addenda of NQA-1 when applying the 2010 Edition and later editions of the ASME BPV Code, Section III, up to the 2013 Edition. Applicants and licensees are required to meet appendix B of 10 CFR part 50, and NQA-1 is one way of meeting portions of appendix B. An applicant or licensee may select any version of NQA-1 that has been approved for use in § 50.55a, but they must also use the administrative, quality, and technical provisions contained in the version of NCA-4000 referencing that Edition or Addenda of
NQA-1 provides a method for establishing and implementing a QA program for the design and construction of nuclear power plants and fuel reprocessing plants; however, NQA-1, as modified and supplemented by NCA-4000, does not meet all of the requirements of appendix B to 10 CFR part 50.
Section 50.55a(b)(1)(iv) clarifies that applicants and licensees using NQA-1 are also required to meet appendix B to 10 CFR part 50 and the commitments contained in their QA program descriptions. To meet the requirements of appendix B, when using NQA-1 during the design and construction phase, applicants and licensees must address, in their quality program description, those areas where NQA-1 is insufficient to meet appendix B. Additional guidance and regulatory positions on how to meet appendix B when using NQA-1 are provided in RG 1.28, “Quality Assurance Program Criteria (Design and Construction).”
The NRC is revising § 50.55a(b)(1)(vii) to reflect the editions and addenda of the ASME BPV Code incorporated by reference in this rulemaking.
The NRC is adding § 50.55a(b)(1)(viii) to allow licensees to use either the ASME BPV Code Symbol Stamp or ASME Certification Mark with the appropriate certification designator and class designator as specified in the 2013 Edition through the latest edition and addenda incorporated by reference in § 50.55a.
The NRC is adding § 50.55a(b)(1)(ix) to allow licensees to use the NPT Code Symbol Stamp with the letters arranged horizontally as specified in ASME BPV Code Case N-852 for the service life of a component that had the NPT Code Symbol Stamp applied during the time period from January 1, 2005, through December 31, 2015.
The NRC is revising § 50.55a(b)(2) to reflect the editions and addenda of the ASME BPV Code incorporated by reference in this rulemaking.
The NRC is revising § 50.55a(b)(2)(vi) to clarify that the provision applies only to the class of licensees of operating reactors that were required by previous versions of § 50.55a to develop and implement a containment ISI program in accordance with Subsection IWE and Subsection IWL, and complete an expedited examination of containment during the 5-year period from September 9, 1996 to September 9, 2001.
The NRC is revising § 50.55a(b)(2)(viii) by removing the condition for using the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL requiring compliance with § 50.55a(b)(2)(viii)(E). To support the removal of the condition, the NRC is adding new requirements governing the performance and documentation of concrete containment examinations in § 50.55a(b)(2)(viii)(H) and (I), which are discussed separately in the next two headings.
The NRC is adding § 50.55a(b)(2)(viii)(H) to require licensees to provide the applicable information specified in paragraphs (b)(2)(viii)(E)(
The NRC is adding § 50.55a(b)(2)(viii)(I) to provide a new condition requiring the technical evaluation required by IWL-2512(b) of the 2009 Addenda up to and including the 2013 Edition of inaccessible below-grade concrete surfaces exposed to foundation soil, backfill, or groundwater be performed at periodic intervals not to exceed 5 years. In addition, the licensee must examine representative samples of the exposed portions of the below-grade concrete, when such below-grade concrete is excavated for any reason. The condition applies only to holders of renewed licenses under 10 CFR part 54 during the period of extended operation (
The NRC is revising § 50.55a(b)(2)(ix) to continue to apply the existing conditions in § 50.55a(b)(2)(ix)(A)(
The NRC is revising the rule text in § 50.55a(b)(2)(ix)(D) to improve clarity. Section 50.55a(b)(2)(ix)(D) introductory text and (b)(2)(ix)(D)(1) are combined. The information required to be included in the ISI Summary report is now all on the same paragraph level. No substantive change to the requirements is intended by this revision.
The NRC is revising § 50.55a(b)(2)(x) to clarify that it allows, but does not require, licensees to use the 1994 Edition or the 2008 Edition through the 2009-1a Addenda of NQA-1 when applying the 2009 Addenda and later editions and addenda of the ASME BPV Code, Section XI, up to the 2013 Edition. Licensees are required to meet appendix B of 10 CFR part 50, and NQA-1 is one way of meeting portions of appendix B. A licensee may select any version of NQA-1 that has been approved for use in § 50.55a.
NQA-1 provides a method for establishing and implementing a QA program for the design and construction of nuclear power plants and fuel reprocessing plants; however, NQA-1 does not meet all of the requirements of appendix B to 10 CFR part 50. Section 50.55a(b)(2)(x) clarifies that licensees using NQA-1 are also required to meet appendix B to 10 CFR part 50 and the commitments contained in their QA program descriptions. To meet the
The NRC is revising § 50.55a(b)(2)(xii) to allow underwater welding on irradiated materials in accordance with IWA-4660 under certain conditions. Licensees are allowed to perform welding on irradiated materials if certain neutron fluence criteria and, for certain material classes, helium concentration criteria are not exceeded. If these criteria are exceeded, the licensee is prohibited from performing welding on irradiated materials unless the licensee obtains NRC approval in accordance with § 50.55a(z).
The NRC is adding § 50.55a(b)(2)(xviii)(D) to provide a new condition prohibiting the use of Appendix VII and Subarticle VIII-2200 of the 2011 Addenda and 2013 Edition of Section XI of the ASME BPV Code. Licensees are required to implement Appendix VII and Subarticle VIII-2200 of the 2010 Edition of Section XI.
The NRC is revising § 50.55a(b)(2)(xxi)(A) to modify the standard for visual magnification resolution sensitivity and contrast for visual examinations performed on Examination Category B-D components instead of ultrasonic examinations. A visual examination with magnification that has a resolution sensitivity to resolve 0.044 inch (1.1 mm) lower case characters without an ascender or descender (
The NRC is revising § 50.55a(b)(2)(xxiii) to modify the applicability of the condition. The condition will only apply to the 2001 Edition through the 2009 Addenda IWA-4461.4, which was revised in the 2010 Edition to remove paragraph IWA-4461.4.2, which permitted an application specific evaluation of thermally cut surfaces in lieu of a thermal metal removal process qualification.
The NRC is adding § 50.55a(b)(2)(xxxi) to provide a new condition maintaining the requirement to use Appendix IX, now renumbered as Appendix W, when installing a mechanical clamping device on an ASME BPV Code Class piping system. Additionally, the condition prohibits the use of mechanical clamping devices in accordance with the changes made to IWA-4131.1(c) in the 2010 Edition and IWA-4131.1(d) in the 2011 Addenda through 2013 Edition on small item Class 1 piping and portions of a piping system that form the containment boundary.
The NRC is adding § 50.55a(b)(2)(xxxii) to provide a new condition requiring licensees using the 2010 Edition or later editions and addenda of Section XI to follow the requirements of IWA-6240 of the 2009 Addenda of Section XI for the submittal of Preservice and Inservice Summary Reports. The condition also describes the timing of the submission of the Summary Reports by referencing the specific Section XI paragraph IWA-6240(b) in the regulation.
The NRC is adding § 50.55a(b)(2)(xxxiii) to provide a new condition to prohibit the use of Appendix G, Paragraph G-2216, in the 2011 Addenda and later editions and addenda of the ASME BPV Code, Section XI.
The NRC is adding § 50.55a(b)(2)(xxxiv)(A) and (B) to require that two conditions be satisfied when using Nonmandatory Appendix U of the 2013 Edition of the ASME BPV Code, Section XI. Paragraph (b)(2)(xxxiv)(A) requires that an ASME BPV Code repair or replacement activity temporarily deferred under the provisions of Nonmandatory Appendix U to the 2013 Edition of the ASME BPV Code, Section XI, shall be performed during the next scheduled refueling outage. Paragraph (b)(2)(xxxiv)(B) requires the use of the mandatory appendix in ASME BPV Code Case N-513-3, in lieu of the appendix referenced in paragraph U-S1-4.2.1(c) of Appendix U, which was inadvertently omitted from Appendix U.
The NRC is adding § 50.55a(b)(2)(xxxv) to provide a new condition to specify that when licensees use ASME BPV Code, Section XI, 2013 Edition, Appendix A, paragraph A-4200, if T
The NRC is adding § 50.55a(b)(2)(xxxvi) to provide a new condition requiring licensees using ASME BPV Code, Section XI, 2013 Edition, Appendix A, paragraph A-4400, to obtain NRC approval under § 50.55a(z) before using irradiated T
The NRC is adding § 50.55a(b)(2)(xxxvii) to provide a new provision that allows licensees to implement ASME BPV Code Case N-824, “Ultrasonic Examination of Cast Austenitic Piping Welds From the Outside Surface Section XI, Division 1,” subject to four conditions in paragraphs (b)(2)(xxxvii)(A) through (D). Each of these paragraphs are discussed in the following headings.
The NRC is adding § 50.55a(b)(2)(xxxvii)(A) to add a new condition that requires ultrasonic examinations performed to implement ASME BPV Code Case N-824 to be spatially encoded.
The NRC is adding § 50.55a(b)(2)(xxxvii)(B) to add a new condition that requires that ultrasonic examinations performed to implement ASME BPV Code Case N-824 shall use dual, transmit-receive, refracted longitudinal wave, multi-element phased array search units instead of the requirements of Paragraph 1(c)(1)(-a) of N-824.
The NRC is adding § 50.55a(b)(2)(xxxvii)(C) to add a new condition that requires that ultrasonic examinations performed to implement ASME BPV Code Case N-824 on piping greater than 1.6 inches (41 mm) thick shall use a phased array search unit with a center frequency of 500 kHz with a tolerance of + /− 20 percent instead of the requirements of Paragraph 1(c)(1)(-c)(-2).
The NRC is adding § 50.55a(b)(2)(xxxvii)(D) to add a new condition that requires that ultrasonic examinations performed to implement ASME BPV Code Case N-824 shall use a phased array search unit which produces angles including, but not limited to, 30 to 55 degrees with a maximum increment of 5 degrees instead of the requirements of Paragraph 1(c)(1)(-d).
The NRC is revising § 50.55a(b)(3) to clarify that Subsections ISTA, ISTB, ISTC, ISTD, ISTE, and ISTF; Mandatory Appendices I, II, III, and V; and Nonmandatory Appendices A through H and J through M of the OM Code are each incorporated by reference into § 50.55a. The NRC is also clarifying that the OM Code Nonmandatory Appendices incorporated by reference into § 50.55a are approved for use, but are not mandated. The Nonmandatory Appendices may be used by applicants and licensees of nuclear power plants, subject to the conditions in § 50.55a(b)(3).
The NRC is revising § 50.55a(b)(3)(i) to allow licensees to use the 1994 Edition, 2008 Edition, and 2009-1a Addenda of NQA-1 when using the 1995 Edition through the 2012 Edition of the OM Code. Licensees are required to meet appendix B to 10 CFR part 50, and NQA-1 is one way of meeting portions of appendix B.
NQA-1 provides a method for establishing and implementing a QA program for the design and construction of nuclear power plants and fuel reprocessing plants; however, NQA-1 does not meet all of the requirements of appendix B to 10 CFR part 50. Section 50.55a(b)(3)(i) clarifies that licensees using NQA-1 are also required to meet appendix B to 10 CFR part 50 and the commitments contained in their QA program descriptions. To meet the requirements of appendix B, licensees must address, in their quality program description, those areas where NQA-1 is insufficient to meet appendix B. Additional guidance and regulatory positions on how to meet appendix B when using NQA-1 are provided in RG 1.28.
The NRC is revising § 50.55a(b)(3)(ii) to set forth four conditions on the use of mandatory Appendix III, “Preservice and Inservice Testing of Active Electric Motor Operated Valve Assemblies in Light-Water Reactor Power Plants,” in the OM Code, 2009 Edition, 2011 Addenda, and 2012 Edition. The four conditions, which are set forth in paragraphs (b)(3)(ii)(A) through (D), are discussed in the next four headings.
The NRC is adding § 50.55a(b)(3)(ii)(A) to require that licensees evaluate the adequacy of the diagnostic test intervals established for MOVs within the scope of OM Code, Appendix III, not later than 5 years or three refueling outages (whichever is longer) from initial implementation of OM Code, Appendix III.
The NRC is adding § 50.55a(b)(3)(ii)(B) to require that licensees ensure that the potential increase in CDF and LERF associated with the extension is acceptably small when extending exercise test intervals for high risk MOVs beyond a quarterly frequency. As specified in RG 1.192, when extending exercise test intervals for high risk MOVs beyond a quarterly frequency, licensees must ensure that the potential increase in CDF and risk associated with the extension is small and consistent with the intent of the Commission's Safety Goal Policy Statement. As discussed earlier in Section II, the NRC provides guidance in RG 1.174 that acceptably small changes are relative and depend on the current plant CDF and LERF. For plants with total baseline CDF of 10
The NRC is adding § 50.55a(b)(3)(ii)(C) to require, when applying Appendix III to the OM Code, that licensees categorize MOVs according to their safety significance using the methodology described in OM Code Case OMN-3 subject to the conditions discussed in RG 1.192, or using an MOV risk ranking methodology accepted by the NRC on a plant-specific or industry-wide basis in accordance with the conditions in the applicable safety evaluation.
The NRC is adding § 50.55a(b)(3)(ii)(D) to require, when applying Paragraph III-3600, “MOV Exercising Requirements,” of Appendix III to the OM Code, licensees shall verify that the stroke time of MOVs specified in plant technical specifications satisfies the assumptions in the plant's safety analyses.
The NRC is adding § 50.55a(b)(3)(iii) to specify that, in addition to complying with the provisions in the OM Code as required with the conditions specified in § 50.55a(b)(3), holders of operating licenses for nuclear power reactors that received construction permits under this part on or after the date 12 months after August 17, 2017, and holders of COLs issued under 10 CFR part 52, whose initial fuel loading occurs on or after the date 12 months after August 17, 2017, shall also comply with four condition on power-operated valves, check valves, flow-induced vibration, and operational readiness of high-risk non-safety systems, to the extent applicable. These four conditions, which are set forth in
The NRC is adding § 50.55a(b)(3)(iii)(A) to require that licensees subject to § 50.55a(b)(3)(iii) periodically verify the capability of power-operated valves (POVs) to perform their design-basis safety functions.
The NRC is adding § 50.55a(b)(3)(iii)(B) to require that licensees subject to § 50.55a(b)(3)(iii) perform bi-directional testing of check valves within the IST program where practicable.
The NRC is adding § 50.55a(b)(3)(iii)(C) to require that licensees subject to § 50.55a(b)(3)(iii) monitor flow-induced vibration (FIV) from hydrodynamic loads and acoustic resonance during preservice testing or inservice testing to identify potential adverse flow effects that might impact components within the scope of the IST program.
The NRC is adding § 50.55a(b)(3)(iii)(D) to require that licensees subject to § 50.55a(b)(3)(iii) establish a program to assess the operational readiness of pumps, valves, and dynamic restraints within the scope of the Regulatory Treatment of Non-Safety Systems for applicable reactor designs. As of the time of this final rule, these are designs which have been certified in a design certification rule under 10 CFR part 52. This final rule refers to these RTNSS components using the term, “high risk non-safety systems.”
As noted by the public commenters, ASME is preparing guidance for new reactor licensees to use in developing programs for the treatment of RTNSS equipment. The NRC staff is participating on the OM Code committees to assist in developing guidance for the treatment of RTNSS equipment that is consistent with Commission policy. Guidance on the implementation of the Commission policy for RTNSS equipment is set forth in NRC Inspection Procedure 73758, “Part 52, Functional Design and Qualification, and Preservice and Inservice Testing Programs for Pumps, Valves and Dynamic Restraints,” dated April 19, 2013.
The NRC is revising § 50.55a(b)(3)(iv) to extend the existing conditions on the use of Appendix II to the new Editions and Addenda which are the subject of this rulemaking. These conditions are that: (i) Trending and evaluation shall support the determination that the valve or group of valves is capable of performing its intended function(s) over the entire interval; and (ii) at least one of the Appendix II condition monitoring activities for a valve group shall be performed on each valve of the group at approximate equal intervals not to exceed the maximum interval shown in the following table:
The conditions currently specified for the use of Appendix II, 1995 Edition with the 1996 and 1997 Addenda, and 1998 Edition through the 2002 Addenda, of the OM Code remain the same in this final rule.
The NRC is adding § 50.55a(b)(3)(vii) to prohibit the use of Subsection ISTB in the 2011 Addenda to the OM Code.
The NRC is adding § 50.55a(b)(3)(viii) to specify that licensees who wish to implement Subsection ISTE, “Risk-Informed Inservice Testing of Components in Light-Water Reactor Nuclear Power Plants,” of the OM Code, 2009 Edition, 2011 Addenda, and 2012 Edition, must first request and obtain NRC approval in accordance with § 50.55a(z) to apply Subsection ISTE on a plant-specific basis as a risk-informed alternative to the applicable IST requirements in the OM Code.
The NRC will evaluate § 50.55a(z) requests for approval to implement Subsection ISTE in accordance with the following considerations. These considerations are consistent with the guidance provided in RG 1.174.
Subsection ISTE-1100, “Applicability,” establishes the component safety categorization methodology and process for dividing the population of pumps and valves, as identified in the IST Program Plan, into high safety significant component (HSSC) and low safety significant component (LSSC) categories. When establishing a risk-informed IST program, the licensee should address a wide range of components important to safety at the nuclear power plant that includes both safety-related and nonsafety-related components. These components might extend beyond the scope of the OM Code.
The licensee should specify, in its request for authorization to implement a risk-informed IST program, the methodology to be applied in risk ranking its components. ISTE-4000, “Specific Component Categorization Requirements,” incorporates OM Code Case OMN-3 for the categorization of pumps and valves in developing a risk-informed IST program. The OMN-3 Code Case methodology for risk ranking uses two categories of safety
The licensee should categorize components according to their safety significance based on the methodology described in Subsection ISTE with the applicable conditions on the use of OM Code Case OMN-3 specified in RG 1.192, or use other risk ranking methodologies accepted by the NRC on a plant-specific or industry-wide basis with applicable conditions specified by the NRC for their acceptance. The licensee should address the seven conditions in RG 1.192 for the use of OM Code Case OMN-3, as appropriate, in developing the risk-informed IST program described in Subsection ISTE. With respect to the provisions in Subsection ISTE, these conditions are:
(a) The implementation of ISTE-1100 should include within the scope of a licensee's risk-informed IST program non-ASME OM Code pumps and valves categorized as HSSCs that might not currently be included in the IST program at the nuclear power plant.
(b) The decision criteria discussed in ISTE-4410, “Decision Criteria,” and Nonmandatory Appendix L, “Acceptance Guidelines,” of the OM Code for evaluating the acceptability of aggregate risk effects (
(c) The implementation of ISTE-4440, “Defense in Depth,” should be consistent with the guidance contained in Section 2.2.1, “Defense-in-Depth Evaluation,” and Section 2.2.2, “Safety Margin Evaluation,” of RG 1.175, “An Approach for Plant-Specific, Risk-Informed Decisionmaking: Inservice Testing.”
(d) The implementation of ISTE-4500, “Inservice Testing Program,” and ISTE-6100, “Performance Monitoring,” should be consistent with the guidance contained in Section 3.2, “Program Implementation,” and Section 3.3, “Performance Monitoring,” of RG 1.175.
(e) The implementation of ISTE-3210, “Plant-Specific PRA,” should be consistent with the guidance that the Owner is responsible for demonstrating and justifying the technical adequacy of the PRA analyses used as the basis to perform component risk ranking and for estimating the aggregate risk impact. For example, RG 1.200, “An Approach for Determining the Technical Adequacy of Probabilistic Risk Assessment Results for Risk-Informed Activities,” and RG 1.201, “Guidelines for Categorizing Structures, Systems, and Components in Nuclear Power Plants According to their Safety Significance,” provide guidance for PRA technical adequacy and component risk ranking.
(f) The implementation of ISTE-4240, “Reconciliation,” should specify that the expert panel may not classify components that are ranked HSSC by the results of a qualitative or quantitative PRA evaluation (excluding the sensitivity studies) or the defense-in-depth assessment to LSSC.
(g) The implementation of ISTE-3220, “Living PRA,” should be consistent with the following: (i) To account for potential changes in failure rates and other changes that could affect the PRA, changes to the plant must be reviewed and, as appropriate, the PRA updated; (ii) when the PRA is updated, the categorization of structures, systems, and components must be reviewed and changed, if necessary, to remain consistent with the categorization process; and (iii) the review of the plant changes must be performed in a timely manner and must be performed once every two refueling outages, or as required by § 50.71(h)(2) for COL holders.
Subsection ISTE-5100, “Pumps,” incorporates OM Code Case OMN-7 for risk-informed testing of pumps categorized as LSSCs. Subsection ISTE-5100 allows the interval for Group A and Group B testing of LSSC pumps specified in Subsection ISTB of the OM Code to be extended from the current 3-month interval to intervals of 6 months or 2 years. Subsection ISTE-5100 eliminates the requirement in Subsection ISTB to perform comprehensive pump testing for LSSC pumps. Table ISTE-5121-1, “LSSC Pump Testing,” specifies that pump operation may be required more frequently than the specified test frequency (6 months) to meet vendor recommendations. Subsection ISTE-4500, “Inservice Testing Program,” specifies in ISTE-4510, “Maximum Testing Interval,” that the maximum testing interval shall be based on the more limiting of (a) the results of the aggregate risk, or (b) the performance history of the component. ISTE-5130, “Maximum Test Interval—Pre-2000 Plants,” specifies that the most limiting interval for LSSC pump testing shall be determined from ISTE-4510 and ISTE-5120, “Low Safety Significant Pump Testing.” The ASME developed the comprehensive pump test requirements in the OM Code to address weaknesses in the Code requirements to assess the operational readiness of pumps to perform their design-basis safety function. Therefore, the licensee should ensure that testing under Subsection ISTE will provide assurance of the operational readiness of pumps in each safety significant categorization to perform their design-basis safety function as described in RGs 1.174 and 1.175.
Subsection ISTE-5300, “Motor Operated Valve Assemblies,” provides a risk-informed IST approach instead of the IST requirements for MOVs in Mandatory Appendix III to the OM Code. The ASME prepared Appendix III to the OM Code to replace the requirement for quarterly stroke-time testing of MOVs with a program of periodic exercising and diagnostic testing to address lessons learned from nuclear power plant operating experience and industry and regulatory research programs for MOV performance. Subsection ISTC of the OM Code specifies the implementation of Appendix III for periodic exercising and diagnostic testing of MOVs to replace quarterly stroke-time testing previously required for MOVs. Appendix III incorporates provisions that allow a risk-informed IST approach for MOVs as described in OM Code Cases OMN-1 and OMN-11. Subsection ISTE-5300 is not consistent with the provisions for the risk-informed IST program for MOVs specified in Appendix III to the OM Code (and Code Cases OMN-1 and 11). Therefore, licensees who wish to implement Subsection ISTE should address the provisions in paragraph III-3700, “Risk-Informed MOV Inservice Testing,” of Appendix III to the OM Code as incorporated by reference in § 50.55a, with the applicable conditions, instead of ISTE-5300.
Subsection ISTE-5400, “Pneumatically and Hydraulically Operated Valves,” specifies that licensees test their AOVs and HOVs in accordance with Appendix IV to the OM Code. Subsection ISTE-5400 indicates that Appendix IV is in the course of preparation. The NRC staff will need to review Appendix IV prior to accepting its use as part of Subsection ISTE. Therefore, licensees who wish to implement Subsection ISTE should describe the planned IST provisions for AOVs and HOVs in its request for approval to implement Subsection ISTE.
Subsection ISTE does not include a requirement to implement the pump periodic verification test program specified in Mandatory Appendix V to the OM Code, 2012 Edition. Therefore, licensee should address the consideration of a pump periodic verification test program in its risk-informed IST program, proposed as part of the authorization request to implement Subsection ISTE.
The NRC is adding § 50.55a(b)(3)(ix) to specify that licensees applying Subsection ISTF, “Inservice Testing of Pumps in Light-Water Reactor Nuclear Power Plants—Post-2000 Plants,” in the 2012 Edition of the OM Code shall satisfy the requirements of Mandatory Appendix V, “Pump Periodic Verification Test Program,” of the OM Code, 2012 Edition. The paragraph also states that Subsection ISTF, 2011 Addenda, is not acceptable for use.
The NRC is adding § 50.55a(b)(3)(x) to allow licensees to implement OM Code Case OMN-20, “Inservice Test Frequency,” in the OM Code, 2012 Edition, for the editions and addenda of the OM Code that are listed in § 50.55a(a)(1)(iv).
The NRC is adding § 50.55a(b)(3)(xi) to emphasize the provisions in the OM Code, 2012 Edition, Subsection ISTC-3700, “Position Verification Testing,” to verify that valve obturator position is accurately indicated. The OM Code, Subsection ISTC-3700 requires valves with remote position indicators shall be observed locally at least once every 2 years to verify that valve operation is accurately indicated. Licensees will be required to implement the condition when adopting the 2012 Edition of the OM Code as their Code of Record for the applicable 120-month IST interval.
The NRC is revising the heading for § 50.55a(f) and clarifying that the OM Code includes provisions for preservice testing of components as part of its overall provisions for IST programs.
The NRC is revising § 50.55a(f)(4) to ensure that the paragraph is applicable to pumps and valves that are within the scope of the OM Code. The NRC is also including an additional provision in § 50.55a(f)(4) stating that the IST requirements for pumps and valves that are within the scope of the OM Code but are not classified as ASME BPV Code Class 1, Class 2, or Class 3 may be satisfied as an augmented IST program, in accordance with § 50.55a(f)(6)(ii), without requesting relief under § 50.55a(f)(5) or alternatives under § 50.55a(z). This use of an augmented IST program may be acceptable provided the basis for deviations from the OM Code, as incorporated by reference in this section, demonstrates an acceptable level of quality and safety, or that implementing the Code provisions would result in hardship or unusual difficulty without a compensating increase in the level of quality and safety, where documented and available for NRC review. These changes align the scope of pumps and valves for inservice testing with the scope defined in the OM Code without imposing an unnecessary paperwork burden on nuclear power plant licensees for the submittal of relief and alternative requests for pumps and valves within the scope of the OM Code but not classified as ASME BPV Code Class 1, Class 2, or Class 3 components.
The NRC is revising the heading in § 50.55a(g), adding new paragraphs (g)(2)(i), (ii), and (iii), and revising current paragraphs (g) introductory text, (g)(2), (g)(3) introductory text, and (g)(3)(i), (ii), and (v) to distinguish the requirements for accessibility, preservice examination, and inservice inspection. No substantive change to the requirements is intended by these revisions.
The NRC is revising § 50.55a(g)(4)(ii) to add an implementation period of 18-months for licensees whose ISI interval commences during the 12 through 18-month period after the publication of this final rule. The NRC is also revising § 50.55a(g)(4)(i) and (ii) to add a provision allowing licensees to adopt the latest version of Appendix VIII of the ASME BPV Code edition or addenda listed in § 50.55a(a)(1) at any time in the licensee's 120-month ISI interval.
The NRC is revising § 50.55a(g)(6)(ii)(D) to reflect the NRC's approval of ASME BPV Code Case N-729-4, which supersedes the NRC's earlier approval of ASME BPV Code Case N-729-1. The revisions include changes to the conditions governing the use of the Code Case to reflect the change from N-729-1 to N-729-4. The effect of these changes is to require licensees to implement an augmented ISI program for the examination of the pressurized water reactor RPV upper head penetrations. The following discussions provide a more detailed discussion of the revisions to § 50.55a(g)(6)(ii)(D).
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In December 2010, the NRC issued NUREG-1801, Revision 2, for applicants to use in preparing their license renewal applications. The GALL Report provides aging management programs (AMPs) that the NRC staff has concluded are sufficient for aging management in accordance with the license renewal rule, as required in § 54.21(a)(3). In addition, NUREG-1800, Revision 2, “Standard Review Plan for Review of License Renewal Applications for Nuclear Power Plants,” was issued in December 2010 to ensure the quality and uniformity of NRC staff reviews of license renewal applications and to present a well-defined basis on which the NRC staff evaluates the applicant's aging management programs and activities. In April 2011, the NRC issued NUREG-1950, “Disposition of Public Comments and Technical Bases for Changes in the License Renewal Guidance Documents NUREG-1801 and NUREG-1800,” which describes the technical bases for the changes in Revision 2 of the GALL Report and Revision 2 of the SRP for review of license renewal applications. Revision 2 of the GALL Report, in Sections XI.M1, XI.S1, XI.S2, and XI.S3, describes the evaluation and technical bases for determining the sufficiency of ASME BPV Code Subsections IWB, IWC, IWD, IWE, IWF, and IWL for managing aging during the period of extended operation. In addition, many other AMPs in the GALL Report rely, in part but to a lesser degree, on the requirements specified in the ASME BPV Code, Section XI. Revision 2 of the GALL Report also states that the 1995 Edition through the 2004 Edition of the ASME BPV Code, Section XI, Subsections IWB, IWC, IWD, IWE, IWF, and IWL, as modified and limited by § 50.55a, were found to be acceptable editions and addenda for complying with the requirements of § 54.21(a)(3), unless specifically noted in certain sections of the GALL Report. The GALL Report further states that the future
In a final rule issued on June 21, 2011 (76 FR 36232), subsequent to Revision 2 of the GALL Report, the NRC found that the 2004 Edition with the 2005 Addenda through the 2007 Edition with the 2008 Addenda of Section XI of the ASME BPV Code, Subsections IWB, IWC, IWD, IWE, IWF, and IWL, as subject to the conditions in § 50.55a, are acceptable for the AMPs in the GALL Report and the conclusions of the GALL Report remain valid with the augmentations specifically noted in the GALL Report.
As part of this rulemaking, the NRC evaluated whether those AMPs in Revision 2 of the GALL Report which rely upon Subsections IWB, IWC, IWD, IWE, IWF, and IWL of Section XI in the editions and addenda of the ASME BPV Code incorporated by reference into § 50.55a, continue to be acceptable if the AMP relies upon the versions of these Subsections in the 2007 Edition with the 2009 Addenda through the 2013 Edition. The NRC finds that the 2007 Edition with the 2009 Addenda through the 2013 Edition of Section XI of the ASME BPV Code, Subsections IWB, IWC, IWD, IWE, IWF, and IWL, as subject to the conditions of this rule, are acceptable for the AMPs in the GALL Report and the conclusions of the GALL Report remain valid with the augmentations specifically noted in the GALL Report. Accordingly, an applicant for license renewal may use, in its plant-specific license renewal application, Subsections IWB, IWC, IWD, IWE, IWF, and IWL of Section XI of the 2007 Edition with the 2009 Addenda through the 2013 Edition of the ASME BPV Code, as subject to the conditions in this rule, without additional justification.
Similarly, a licensee approved for license renewal that relied on the GALL AMPs may use Subsections IWB, IWC, IWD, IWE, IWF, and IWL of Section XI of the 2007 Edition with the 2009 Addenda through the 2013 Edition of the ASME BPV Code. However, a licensee must assess and follow applicable NRC requirements with regard to changes to its licensing basis. Some of the AMPs in the GALL Report recommend augmentation of certain Code requirements in order to ensure adequate aging management for license renewal. The technical and regulatory aspects of the AMPs for which augmentations are recommended also apply if the editions or addenda from the 2007 Edition with the 2009 Addenda through the 2013 Edition of Section XI of the ASME BPV Code are used to meet the requirements of § 54.21(a)(3). The NRC staff evaluated the changes in the 2007 Edition with the 2009 Addenda through the 2013 Edition of Section XI of the ASME BPV Code to determine if the augmentations described in the GALL Report remain necessary. The NRC staff's evaluation has concluded that the augmentations described in the GALL Report are necessary to ensure adequate aging management. For example, Table IWB-2500-1, in the 2007 Edition with the 2009 Addenda of ASME BPV Code, Section XI, Subsection IWB, requires surface examination of ASME BPV Code Class 1 branch pipe connection welds less than nominal pipe size (NPS) 4 under Examination Category B-J. However, the NRC staff finds that volumetric or opportunistic destructive examination, rather than surface examination, is necessary to adequately detect and manage the aging effect due to stress corrosion cracking or thermal, mechanical and vibratory loadings in the components for the period of extended operation. Therefore, GALL Report Section XI.M35, “One-Time Inspection of ASME BPV Code Class 1 Small-Bore Piping,” includes the augmentation of the requirements in ASME BPV Code, Section XI,
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule does not have a significant economic impact on a substantial number of small entities. This final rule affects only the licensing and operation of nuclear power plants. The companies that own these plants do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810).
The NRC has prepared a final regulatory analysis on this regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The regulatory analysis is available as indicated in the “Availability of Documents” section of this document.
The NRC's Backfit Rule in § 50.109 states that the NRC shall require the backfitting of a facility only when it finds the action to be justified under specific standards stated in the rule. Section 50.109(a)(1) defines backfitting as the modification of or addition to systems, structures, components, or design of a facility; the design approval or manufacturing license for a facility; or the procedures or organization required to design, construct, or operate a facility. Any of these modifications or additions may result from a new or amended provision in the NRC's rules or the imposition of a regulatory position interpreting the NRC's rules that is either new or different from a previously applicable NRC position after issuance of the construction permit or the operating license or the design approval.
Section 50.55a requires nuclear power plant licensees to:
• Construct ASME BPV Code Class 1, 2, and 3 components in accordance with the rules provided in Section III, Division 1, of the ASME BPV Code (“Section III”).
• Inspect Class 1, 2, 3, Class MC, and Class CC components in accordance with the rules provided in Section XI, Division 1, of the ASME BPV Code (“Section XI”).
• Test Class 1, 2, and 3 pumps, valves, and dynamic restraints (snubbers) in accordance with the rules provided in the OM Code.
This final rule is incorporating by reference the 2009 Addenda, 2010 Edition, 2011 Addenda, and the 2013 Edition of the ASME BPV Code, Section III, Division 1 and ASME BPV Code, Section XI, Division 1, including NQA-1 (with conditions on its use), as well as the 2009 Edition and 2011 Addenda and 2012 Edition of the OM Code and Code Cases N-770-2 and N-729-4.
The ASME BPV and OM Codes are national consensus standards developed by participants with broad and varied interests, in which all interested parties (including the NRC and utilities) participate. A consensus process involving a wide range of stakeholders is consistent with the NTTAA, inasmuch as the NRC has determined that there are sound regulatory reasons for establishing regulatory requirements for design, maintenance, ISI, and IST by rulemaking. The process also facilitates early stakeholder consideration of backfitting issues. Therefore, the NRC believes that the NRC need not address backfitting with respect to the NRC's general practice of incorporating by reference updated ASME Codes.
Incorporation by reference of more recent editions and addenda of Section III of the ASME BPV Code does not affect a plant that has received a construction permit or an operating license or a design that has been approved. This is because the edition and addenda to be used in constructing a plant are, under § 50.55a, determined based on the date of the construction permit, and are not changed thereafter, except voluntarily by the licensee. The incorporation by reference of more recent editions and addenda of Section III ordinarily applies only to applicants after the effective date of a final rule incorporating these new editions and addenda. Therefore, incorporation by reference of a more recent edition and addenda of Section III does not constitute “backfitting” as defined in § 50.109(a)(1).
Incorporation by reference of more recent editions and addenda of Section XI of the ASME BPV Code and the OM Code affects the ISI and IST programs of operating reactors. However, the Backfit Rule generally does not apply to incorporation by reference of later editions and addenda of the ASME BPV Code (Section XI) and OM Code. As previously mentioned, the NRC's longstanding regulatory practice has been to incorporate later versions of the ASME Codes into § 50.55a. Under § 50.55a, licensees shall revise their ISI and IST programs every 120 months to the latest edition and addenda of Section XI of the ASME BPV Code and the OM Code incorporated by reference into § 50.55a 12 months before the start of a new 120-month ISI and IST interval. Therefore, when the NRC approves and requires the use of a later version of the Code for ISI and IST, it is implementing this longstanding regulatory practice and requirement.
Other circumstances where the NRC does not apply the Backfit Rule to the approval and requirement to use later Code editions and addenda are as follows:
1. When the NRC takes exception to a later ASME BPV Code or OM Code provision but merely retains the current existing requirement, prohibits the use of the later Code provision, limits the use of the later Code provision, or supplements the provisions in a later Code. The Backfit Rule does not apply because the NRC is not imposing new requirements. However, the NRC explains any such exceptions to the Code in the statement of considerations and regulatory analysis for the rule.
2. When an NRC exception relaxes an existing ASME BPV Code or OM Code provision but does not prohibit a licensee from using the existing Code provision. The Backfit Rule does not apply because the NRC is not imposing new requirements.
3. The NRC's consideration of backfitting for modifications and limitations imposed during previous routine updates of § 50.55a have established a precedent for determining the kinds of modifications or limitations which should be considered backfitting, or require a backfit analysis (
The incorporation by reference and adoption of a requirement mandating the use of a later ASME BPV Code or OM Code may constitute backfitting in some circumstances. In these cases, the NRC would perform a backfit analysis or documented evaluation in accordance with § 50.109. These include the following:
1. When the NRC endorses a later provision of the ASME BPV Code or OM Code that takes a substantially different direction from the existing requirements, the action is treated as a backfit (
2. When the NRC requires implementation of a later ASME BPV Code or OM Code provision on an expedited basis, the action is treated as a backfit. This applies when implementation is required sooner than it would be required if the NRC simply endorsed the Code without any expedited language (
3. When the NRC takes an exception to an ASME BPV Code or OM Code provision and imposes a requirement that is substantially different from the existing requirement as well as substantially different from the later Code (
This section discusses the backfitting considerations for all the changes to § 50.55a that go beyond the minimum changes necessary and required to adopt the new ASME Code Addenda into § 50.55a.
1. Revise § 50.55a(b)(1)(ii), “Weld leg dimensions,” to clarify rule language and add Table I, which clarifies prohibited Section III provisions for welds with leg sizes less than 1.09 t
2. Revise § 50.55a(b)(1)(iv), “Quality assurance,” to require that when applying editions and addenda later than the 1989 Edition of Section III, the requirements of NQA-1, 1994 Edition, 2008 Edition, and the 2009-1a Addenda are acceptable for use, provided that the edition and addenda of NQA-1 specified in either NCA-4000 or NCA-7000 is used in conjunction with the administrative, quality, and technical provisions contained in the edition and addenda of Section III being used. This revision clarifies the current requirements, and is considered to be consistent with the meaning and intent of the current requirements, and therefore is not considered to result in a change in requirements. Therefore, this change is not a backfit.
3. Add a new condition as § 50.55a(b)(1)(viii), “Use of ASME Certification Marks,” to allow licensees to use either the ASME BPV Code Symbol Stamp or ASME Certification Mark with the appropriate certification designator and class designator as specified in the 2013 Edition through the latest edition and addenda incorporated by reference in § 50.55a. This condition does not result in a change in requirements previously approved in the Code and, therefore, is not a backfit.
1. Revise § 50.55a(b)(2)(vi), “Effective edition and addenda of Subsection IWE and Subsection IWL,” to clarify that the provision applies only to the class of licensees of operating reactors that were required by previous versions of § 50.55a to develop, implement a containment ISI program in accordance with Subsection IWE and Subsection IWL, and complete an expedited examination of containment during the 5-year period from September 9, 1996, to September 9, 2001. This revision clarifies the current requirements, is considered to be consistent with the meaning and intent of the current requirements, and is not considered to result in a change in requirements. Therefore, this change is not a backfit.
2. Revise § 50.55a(b)(2)(viii), “Concrete containment examinations,” so that when using the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL, the conditions in § 50.55a(b)(2)(viii)(E) do not apply, but the new conditions in § 50.55a(b)(2)(viii)(H) and (I) do apply. This revision does not require § 50.55a(b)(2)(viii)(E) to be used when following the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL because most of its requirements have been included in IWL-2512, “Inaccessible Areas.” Therefore, this change is not a backfit because the requirements have not changed. The revision to add the condition in § 50.55a(b)(2)(viii)(H) captures the reporting requirements of the current § 50.55a(b)(2)(viii)(E) which were not included in IWL-2512. Therefore, this change is not a backfit because the requirements have not changed. The revision to add the condition in § 50.55a(b)(2)(viii)(I) addresses a new code provision in IWL-2512(b) for evaluation of below-grade concrete surfaces during the period of extended operation of a renewed license. The condition assures consistency with the GALL Report, Revision 2, and applies to plants going forward using the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWL. The requirements remain unchanged from the recommendations in the GALL Report and, therefore, this change is not a backfit.
3. Revise § 50.55a(b)(2)(ix), “Metal containment examinations,” to extend the applicability of the existing conditions in § 50.55a(b)(2)(ix)(A)(2) and (b)(2)(ix)(B) and (J) to the 2007 Edition with 2009 Addenda through the 2013 Edition of Subsection IWE. This condition does not result in a change to current requirements, and is therefore not a backfit.
4. Revise § 50.55a(b)(2)(x), “Quality assurance,” to require that when applying the editions and addenda later than the 1989 Edition of ASME BPV Code, Section XI, the requirements of NQA-1, 1994 Edition, the 2008 Edition, and the 2009-1a Addenda specified in either IWA-1400 or Table IWA 1600-1, “Referenced Standards and Specifications,” of that edition and addenda of Section XI are acceptable for use, provided the licensee uses its appendix B to 10 CFR part 50 QA program in conjunction with Section XI requirements. This revision clarifies the current requirements, which the NRC considers to be consistent with the meaning and intent of the current requirements. Therefore, the NRC does not consider the clarification to be a change in requirements. Therefore, this change is not a backfit.
5. Revise § 50.55a(b)(2)(xii), “Underwater welding,” to allow underwater welding on irradiated materials under certain conditions. The revision eliminates the prohibition on welding on irradiated materials. Therefore, this change is not a backfit.
6. Add a new condition as § 50.55a(b)(2)(xviii)(D), “NDE personnel certification: Fourth provision,” to prohibit the use of Appendix VII and Subarticle VIII-2200 of the 2011 Addenda and 2013 Edition of Section XI of the ASME BPV Code. Licensees are required to implement Appendix VII
7. Revise § 50.55a(b)(2)(xxi)(A), “Table IWB-2500-1 examination requirements: First provision,” to modify the standard for visual magnification resolution sensitivity and contrast for visual examinations of Examination Category B-D components, making the rule conform with ASME BPV Code, Section XI requirements for VT-1 examinations. This revision removes a condition that was in addition to the ASME BPV Code requirements and does not impose a new requirement. Therefore, this change is not a backfit.
8. Add a new condition as § 50.55a(b)(2)(xxxi), “Mechanical clamping devices;” to prohibit the use of mechanical clamping devices in accordance with IWA-4131.1(c) in the 2010 Edition and IWA-4131.1(d) in the 2011 Addenda through 2013 Edition on small item Class 1 piping and portions of a piping system that forms the containment boundary. This condition does not constitute a change in NRC position and does not affect licensees because the use of the subject provisions is not currently allowed by § 50.55a. Therefore, the addition of this new condition is not a backfit.
9. Add a new condition as § 50.55a(b)(2)(xxxii), “Summary report submittal,” to clarify that licensees using the 2010 Edition or later editions and addenda of Section XI must continue to submit to the NRC the Preservice and Inservice Summary Reports required by IWA-6240 of the 2009 Addenda of Section XI. This condition does not result in a change in the NRC's requirements insomuch as these reports have been required in the 2009 Addenda of Section XI and all previous editions and addenda. Therefore, the addition of this new condition is not a backfit.
10. Add a new condition as § 50.55a(b)(2)(xxxiii), “Risk-Informed allowable pressure,” to prohibit the use of ASME BPV Code, Section XI, Appendix G, Paragraph G-2216. The use of Paragraph G-2216 is not currently allowed by § 50.55a. Therefore, the condition does not constitute a new or changed NRC position on the lack of acceptability of Paragraph G-2216. Therefore, the addition of this new condition is not a backfit.
11. Add a new condition as § 50.55a(b)(2)(xxxiv), “Nonmandatory Appendix U.” Paragraph (b)(2)(xxxiv)(A) requires that repair or replacement activities temporarily deferred under the provisions of Nonmandatory Appendix U shall be performed during the next scheduled refueling outage. This condition is imposed to ensure that repairs/replacements are performed on degraded components when a unit is shutdown for refueling. This change is consistent with the condition previously placed on ASME BPV Code Case N-513-3 and, therefore, does not impose a new requirement. This change is not a backfit. Paragraph (b)(2)(xxxiv)(B) requires that the mandatory appendix in ASME BPV Code Case N-513-3 be used in lieu of the appendix referenced in Paragraph U-S1-4.2.1(c) of Appendix U. This change is required because the appendix referenced in Appendix U was unintentionally omitted. This change is not a backfit.
12. Add a new condition as § 50.55a(b)(2)(xxxv), “Use of RT
13. Add a new condition as § 50.55a(b)(2)(xxxvi), “Fracture toughness of irradiated materials,” to require licensees using ASME BPV Code, Section XI 2013 Edition Nonmandatory Appendix A, Paragraph A-4400, to obtain NRC approval before using irradiated T
14. Add a new condition as § 50.55a(b)(2)(xxxvii), “ASME BPV Code Case N-824,” to allow the use of the code case as conditioned. Conditions on the use of ASME BPV Code Case N-824 do not constitute backfitting, inasmuch as the use of this code case is not required by the NRC but instead is an alternative which may be voluntarily used by the licensee (
1. Add a new condition as § 50.55a(b)(3)(ii)(A), “MOV diagnostic test interval,” to require that licensees evaluate the adequacy of the diagnostic test intervals established for MOVs within the scope of OM Code, Appendix III, not later than 5 years or three refueling outages (whichever is longer) from initial implementation of Appendix III of the OM Code. This condition represents an exception to a later OM Code provision but merely retains the current NRC condition on ASME OM Code Case OMN-1, and is therefore not a backfit because the NRC is not imposing a new requirement.
2. Add a new condition as § 50.55a(b)(3)(ii)(B), “MOV testing impact on risk,” to require that licensees ensure that the potential increase in core damage frequency and large early release frequency associated with the extension is acceptably small when extending exercise test intervals for high risk MOVs beyond a quarterly frequency. This condition represents an exception to a later OM Code provision but merely retains the current NRC condition on ASME OM Code Case OMN-1, and is therefore not a backfit because the NRC is not imposing a new requirement.
3. Add a new condition as § 50.55a(b)(3)(ii)(C), “MOV risk categorization,” to require, when applying Appendix III to the OM Code, that licensees categorize MOVs according to their safety significance using the methodology described in OM Code Case OMN-3 subject to the conditions discussed in RG 1.192, or using an MOV risk ranking methodology accepted by the NRC on a plant-specific or industry-wide basis in accordance with the conditions in the applicable safety evaluation. This condition represents an exception to a later OM Code provision but merely retains the current NRC condition on ASME OM Code Case OMN-1, and is therefore not a backfit because the NRC is not imposing a new requirement.
4. Add a new condition as § 50.55a(b)(3)(ii)(D), “MOV stroke time,” to require that, when applying Paragraph III-3600, “MOV Exercising Requirements,” of Appendix III to the OM Code, licensees shall verify that the stroke time of the MOVs specified in plant technical specifications satisfies the assumptions in the plant's safety analyses. This condition retains the MOV stroke time requirement for a smaller set of MOVs than was specified in previous editions and addenda of the
5. Add new conditions as § 50.55a(b)(3)(iii)(A) through (D), “New reactors,” to apply specific conditions for IST programs applicable to licensees of new nuclear power plants in addition to the provisions of the OM Code as incorporated by reference with conditions in § 50.55a. Licensees of “new reactors” are, as identified in the paragraph: (1) Holders of operating licenses for nuclear power reactors that received construction permits under this part on or after the date 12 months after August 17, 2017, and (2) holders of COLs issued under 10 CFR part 52, whose initial fuel loading occurs on or after the date 12 months after August 17, 2017. This implementation schedule for new reactors is consistent with the NRC regulations in § 50.55a(f)(4)(i). These conditions represent an exception to a later OM Code provision but merely retain a current NRC requirement, and are therefore not a backfit because the NRC is not imposing a new requirement.
6. Revise § 50.55a(b)(3)(iv), “Check valves (Appendix II),” to specify that Appendix II, “Check Valve Condition Monitoring Program,” of the OM Code, 2003 Addenda through the 2012 Edition, is acceptable for use with the following clarification: Trending and evaluation shall support the determination that the valve or group of valves is capable of performing its intended function(s) over the entire interval. At least one of the Appendix II condition monitoring activities for a valve group shall be performed on each valve of the group at approximate equal intervals not to exceed the maximum interval shown in the following table:
The regulation is being revised to extend the applicability of this existing NRC condition on the OM Code to the 2012 Edition of the OM Code and to update the clarification for the use of Appendix II. This does not represent a change in the NRC's position that the condition is needed with respect to the OM Code. Therefore, this condition is not a backfit.
7. Add a new condition as § 50.55a(b)(3)(vii), “Subsection ISTB,” to prohibit the use of Subsection ISTB in the 2011 Addenda to the OM Code because the complete set of planned Code modifications to support the changes to the comprehensive pump test acceptance criteria was not made in that addenda. This condition represents an exception to a later OM Code provision but merely limits the use of the later Code provision, and is therefore not a backfit because the NRC is not imposing a new requirement.
8. Add a new condition as § 50.55a(b)(3)(viii), “Subsection ISTE,” to allow licensees to implement Subsection ISTE, “Risk-Informed Inservice Testing of Components in Light-Water Reactor Nuclear Power Plants,” in the OM Code, 2009 Edition, 2011 Addenda and 2012 Edition, where the licensee has obtained authorization to implement Subsection ISTE as an alternative to the applicable IST requirements in the OM Code on a case-by-case basis in accordance with § 50.55a(z). This condition represents an exception to a later OM Code provision but merely limits the use of the later Code provision, and is therefore not a backfit because the NRC is not imposing a new requirement.
9. Add a new condition as § 50.55a(b)(3)(ix), “Subsection ISTF,” to specify that licensees applying Subsection ISTF, 2012 Edition, shall satisfy the requirements of Mandatory Appendix V, “Pump Periodic Verification Test Program,” of the OM Code, 2012 Edition. The condition also specifies that Subsection ISTF, 2011 Addenda, is not acceptable for use. This condition represents an exception to a later OM Code provision but merely limits the use of the later Code provision, and is therefore not a backfit because the NRC is not imposing a new requirement.
10. Add a new condition as § 50.55a(b)(3)(x), “ASME OM Code Case OMN-20,” to allow licensees to implement OM Code Case OMN-20, “Inservice Test Frequency,” in the OM Code, 2012 Edition. This condition allows voluntary action initiated by the licensee to use the code case and is, therefore, not a backfit.
11. Add a new condition as § 50.55a(b)(3)(xi), “Valve Position Indication,” to emphasize, when implementing OM Code (2012 Edition), Subsection ISTC-3700, “Position Verification Testing,” licensees shall implement the OM Code provisions to verify that valve operation is accurately indicated. This condition emphasizes the OM Code requirements for valve position indication and is not a change to those requirements. As such, this condition is not a backfit.
12. Revise § 50.55a(f), “Preservice and inservice testing requirements,” to clarify that the OM Code includes provisions for preservice testing of components as part of its overall provisions for IST programs. No expansion of IST program scope is intended by this clarification. This condition does not result in a change in requirements previously approved in the Code and is, therefore, not a backfit.
13. Revise § 50.55a(f)(4), “Inservice testing standards for operating plants,” to state that the paragraph is applicable to pumps and valves that are within the scope of the OM Code. Also, revise § 50.55a(f)(4) to state that the IST requirements for pumps and valves that are within the scope of the OM Code but are not classified as ASME BPV Code Class 1, Class 2, or Class 3 may be satisfied as an augmented IST program in accordance with § 50.55a(f)(6)(ii) without requesting relief under § 50.55a(f)(5) or alternatives under § 50.55a(z). This use of an augmented IST program may be acceptable provided the basis for deviations from the OM Code as incorporated by reference in this section demonstrates an acceptable level of quality and safety, or that implementing the Code provisions would result in hardship or
Revise § 50.55a(g)(6)(ii)(D), “Reactor vessel head inspections.”
On June 22, 2012, the ASME approved the fourth revision of ASME BPV Code Case N-729 (N-729-4). The NRC proposed to update the requirements of § 50.55a(g)(6)(ii)(D) to require licensees to implement ASME BPV Code Case N-729-4, with conditions. The ASME BPV Code Case N-729-4 contains similar requirements as N-729-1; however, N-729-4 also contains new requirements to address previous NRC conditions, including changes to inspection frequency and qualifications. The new NRC conditions on the use of ASME BPV Code Case N-729-4 address operational experience, clarification of implementation, and the use of alternatives to the code case.
The current regulatory requirements for the examination of pressurized water reactor upper RPV heads that use nickel-alloy materials are provided in § 50.55a(g)(6)(ii)(D). This section was first created by rulemaking, dated September 10, 2008 (73 FR 52730), to require licensees to implement ASME BPV Code Case N-729-1, with conditions, instead of the inspections previously required by the ASME BPV Code, Section XI. The action did constitute a backfit; however, the NRC concluded that imposition of ASME BPV Code Case N-729-1, as conditioned, constituted an adequate protection backfit.
The General Design Criteria (GDC) for nuclear power plants (appendix A to 10 CFR part 50) or, as appropriate, similar requirements in the licensing basis for a reactor facility, provide bases and requirements for NRC assessment of the potential for, and consequences of, degradation of the reactor coolant pressure boundary (RCPB). The applicable GDC include GDC 14 (Reactor Coolant Pressure Boundary), GDC 31 (Fracture Prevention of Reactor Coolant Pressure Boundary), and GDC 32 (Inspection of Reactor Coolant Pressure Boundary). General Design Criterion 14 specifies that the RCPB be designed, fabricated, erected, and tested so as to have an extremely low probability of abnormal leakage, of rapidly propagating failure, and of gross rupture. General Design Criterion 31 specifies that the probability of rapidly propagating fracture of the RCPB be minimized. General Design Criterion 32 specifies that components that are part of the RCPB have the capability of being periodically inspected to assess their structural and leak-tight integrity.
The NRC concludes that ASME BPV Code Case N-729-4, as conditioned, shall be mandatory in order to ensure that the requirements of the GDC are satisfied. Imposition of ASME BPV Code Case N-729-4, with conditions, ensures that the ASME BPV Code-allowable limits will not be exceeded, leakage will likely not occur, and potential flaws will be detected before they challenge the structural or leak-tight integrity of the RPV upper head within current nondestructive examination limitations. The NRC concludes that the regulatory framework for providing adequate protection of public health and safety is accomplished by the incorporation of ASME BPV Code Case N-729-4 into § 50.55a, as conditioned. All current licensees of U.S. pressurized water reactors will be required to implement ASME BPV Code Case N-729-4, as conditioned. The Code Case provisions on examination requirements for RPV upper heads are essentially the same as those established under ASME BPV Code Case N-729-1, as conditioned. One exception is the condition in § 50.55a(g)(6)(ii)(D)(
The NRC continues to find that inspections of RPV upper heads, their penetration nozzles, and associated partial penetration welds are necessary for adequate protection of public health and safety and that the requirements of ASME BPV Code Case N-729-4, as conditioned, represent an acceptable approach, developed, in part, by a voluntary consensus standards body for performing future inspections. The NRC concludes that approval of ASME BPV Code Case N-729-4, as conditioned, by incorporation by reference of the Code Case into § 50.55a, is necessary to ensure that the facility provides adequate protection to the health and safety of the public and constitutes a redefinition of the requirements necessary to provide reasonable assurance of adequate protection of public health and safety. Therefore, a backfit analysis need not be prepared for this portion of the rule in accordance with § 50.109(a)(4)(ii) and (iii).
Revise § 50.55a(g)(6)(ii)(F), “Examination requirements for Class 1 piping and nozzle dissimilar metal butt welds.”
On June 9, 2011, the ASME approved the second revision of ASME BPV Code Case N-770 (N-770-2). The NRC is updating the requirements of § 50.55a(g)(6)(ii)(F) to require licensees to implement ASME BPV Code Case N-770-2, with conditions. The ASME BPV Code Case N-770-2 contains similar baseline and ISI requirements for unmitigated nickel-alloy butt welds, and preservice and ISI requirements for mitigated butt welds as N-770-1. However, N-770-2 also contains new requirements for optimized weld overlays, a specific mitigation technique and volumetric inspection coverage. Further, the NRC conditions on the use of ASME BPV Code Case N-770-2 have been modified to address the changes in the code case, clarify inspection coverage requirements and require the development of inspection qualifications to allow complete weld inspection coverage in the future.
The current regulatory requirements for the examination of ASME Class 1 piping and nozzle dissimilar metal butt welds that use nickel-alloy materials is provided in § 50.55a(g)(6)(ii)(F). This section was first created by rulemaking, dated June 21, 2011 (76 FR 36232), to require licensees to implement ASME BPV Code Case N-770-1, with conditions. The NRC added § 50.55a(g)(6)(ii)(F) to require licensees to implement ASME BPV Code Case N-770-1, with conditions, instead of the inspections previously required by the ASME BPV Code, Section XI. The action did constitute a backfit; however, the NRC concluded that imposition of ASME BPV Code Case N-770-1, as conditioned, constituted an adequate protection backfit.
The GDC for nuclear power plants (appendix A to 10 CFR part 50) or, as appropriate, similar requirements in the licensing basis for a reactor facility, provide bases and requirements for NRC assessment of the potential for, and consequences of, degradation of the RCPB. The applicable GDC include GDC 14 (Reactor Coolant Pressure Boundary), GDC 31 (Fracture Prevention of Reactor Coolant Pressure Boundary) and GDC 32 (Inspection of Reactor Coolant Pressure
The NRC concludes that ASME BPV Code Case N-770-2, as conditioned, must be imposed in order to ensure that the requirements of the GDC are satisfied. Imposition of ASME BPV Code Case N-770-2, with conditions, ensures that the requirements of the GDC are met for all mitigation techniques currently in use for Alloy 82/182 butt welds because ASME BPV Code-allowable limits will not be exceeded, leakage would likely not occur and potential flaws will be detected before they challenge the structural or leak-tight integrity of piping welds. All current licensees of U.S. pressurized water reactors will be required to implement ASME BPV Code Case N-770-2, as conditioned. The Code Case provisions on examination requirements for ASME Class 1 piping and nozzle nickel-alloy dissimilar metal butt welds are somewhat different from those established under ASME BPV Code Case N-770-1, as conditioned, and will require a licensee to modify its procedures for inspection of ASME Class 1 nickel-alloy welds to meet these requirements. Accordingly, the NRC imposition of the ASME BPV Code Case N-770-2, as conditioned, may be deemed to be a modification of the procedures to operate a facility resulting from the imposition of the new regulation, and as such, this rulemaking provision may be considered backfitting under § 50.109(a)(1).
The NRC continues to find that ASME Class 1 nickel-alloy dissimilar metal weld inspections are necessary for adequate protection of public health and safety, and that the requirements of ASME BPV Code Case N-770-2, as conditioned, represent an acceptable approach developed by a voluntary consensus standards body for performing future ASME Class 1 nickel-alloy dissimilar metal weld inspections. The NRC concludes that approval of ASME BPV Code Case N-770-2, as conditioned, by incorporation by reference of the Code Case into § 50.55a, is necessary to ensure that the facility provides adequate protection to the health and safety of the public and constitutes a redefinition of the requirements necessary to provide reasonable assurance of adequate protection of public health and safety. Therefore, a backfit analysis need not be prepared for this portion of the rule in accordance with § 50.109(a)(4)(ii) and (iii).
The NRC finds that incorporation by reference into § 50.55a of the 2009 Addenda through 2013 Edition of Section III, Division 1, of the ASME BPV Code, subject to the identified conditions; the 2009 Addenda through 2013 Edition of Section XI, Division 1, of the ASME BPV Code, subject to the identified conditions; and the 2009 Edition through the 2012 Edition of the OM Code, subject to the identified conditions, does not constitute backfitting or represent an inconsistency with any issue finality provisions in 10 CFR part 52.
The NRC finds that the incorporation by reference of Code Cases N-824 and OMN-20 does not constitute backfitting or represent an inconsistency with any issue finality provisions in 10 CFR part 52.
The NRC finds that the inclusion of a new condition on Code Case N-729-4 and a new condition on Code Case N-770-2 constitutes backfitting necessary for adequate protection.
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).
This final rule is in accordance with the NRC's policy to incorporate by reference in § 50.55a new editions and addenda of the ASME BPV and OM Codes to provide updated rules for constructing and inspecting components and testing pumps, valves, and dynamic restraints (snubbers) in light-water nuclear power plants. The ASME Codes are national voluntary consensus standards and are required by the NTTAA to be used by government agencies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. The National Environmental Policy Act (NEPA) requires Federal agencies to study the impacts of their “major Federal actions significantly affecting the quality of the human environment,” and prepare detailed statements on the environmental impacts of the proposed action and alternatives to the proposed action (42 U.S.C. 4332(C); NEPA Sec. 102(C)).
The NRC has determined under NEPA, as amended, and the NRC's regulations in subpart A of 10 CFR part 51, that this rule is not a major Federal action significantly affecting the quality of the human environment and, therefore, an environmental impact statement is not required. The rulemaking does not significantly increase the probability or consequences of accidents, no changes are being made in the types of effluents that may be released off-site, and there is no significant increase in public radiation exposure. The NRC estimates the radiological dose to plant personnel performing the inspections required by ASME BPV Code Case N-770-2 would be about 3 rem per plant over a 10-year interval, and a one-time exposure for mitigating welds of about 30 rem per plant. The NRC estimates the radiological dose to plant personnel performing the inspections required by ASME BPV Code Case N-729-4 would be about 3 rem per plant over a 10-year interval and a one-time exposure for mitigating welds of about 30 rem per plant. As required by 10 CFR part 20, and in accordance with current plant procedures and radiation protection programs, plant radiation protection staff will continue monitoring dose rates and would make adjustments in shielding, access requirements, decontamination methods, and procedures as necessary to minimize the dose to workers. The increased occupational dose to individual workers stemming from the ASME BPV Code Case N-770-2 and N-729-4 inspections must be maintained within the limits of 10 CFR part 20 and as low as reasonably achievable. Therefore, the NRC concludes that the increase in occupational exposure would not be significant. This final rule does not involve non-radiological plant effluents and has no other environmental impacts. Therefore, no significant non-radiological impacts are associated with this action. The determination of this environmental assessment is that there will be no significant off-site impact to the public from this action.
This final rule amends collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because the rule will reduce the burden for existing information collections, the public burden for the information collections is expected to be decreased by 58.5 hours per response. This reduction includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the information collection.
The information collection is being conducted to document the plans for and the results of ISI and IST programs. The records are generally historical in nature and provide data on which future activities can be based. The practical utility of the information collection for the NRC is that appropriate records are available for auditing by NRC personnel to determine if ASME BPV and OM Code provisions for construction, inservice inspection, repairs, and inservice testing are being properly implemented in accordance with § 50.55a, or whether specific enforcement actions are necessary. Responses to this collection of information are generally mandatory under 10 CFR 50.55a.
You may submit comments on any aspect of the information collection(s), including suggestions for reducing the burden, by the following methods:
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The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting the collection displays a currently valid OMB control number.
This final rule is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, OMB has not found it to be a major rule as defined in the Congressional Review Act.
Section 12(d)(3) of the National Technology Transfer and Advancement Act of 1995, Public Law 104-113 (NTTAA), and implementing guidance in OMB Circular A-119 (February 10, 1998), requires each Federal government agency (should it decide that regulation is necessary) to use a voluntary consensus standard instead of developing a government-unique standard. An exception to using a voluntary consensus standard is allowed where the use of such a standard is inconsistent with applicable law or is otherwise impractical. The NTTAA requires Federal agencies to use industry consensus standards to the extent practical; it does not require Federal agencies to endorse a standard in its entirety. Neither the NTTAA nor OMB Circular A-119 prohibit an agency from adopting a voluntary consensus standard while taking exception to specific portions of the standard, if those provisions are deemed to be “inconsistent with applicable law or otherwise impractical.” Furthermore, taking specific exceptions furthers the Congressional intent of Federal reliance on voluntary consensus standards because it allows the adoption of substantial portions of consensus standards without the need to reject the standards in their entirety because of limited provisions which are not acceptable to the agency.
In this final rule, the NRC is continuing its existing practice of establishing requirements for the design, construction, operation, ISI (examination), and IST of nuclear power plants by approving the use of the latest editions and addenda of the ASME Codes in § 50.55a. The ASME Codes are voluntary consensus standards, developed by participants with broad and varied interests, in which all interested parties (including the NRC and licensees of nuclear power plants) participate. Therefore, the NRC's incorporation by reference of the ASME Codes is consistent with the overall objectives of the NTTAA and OMB Circular A-119.
In this final rule, the NRC is also continuing its existing practice of approving the use of ASME BPV and OM Code Cases, which are ASME-approved alternatives to compliance with various provisions of the ASME BPV and OM Codes. The ASME Code Cases are national consensus standards as defined in the NTTAA and OMB Circular A-119. The ASME Code Cases constitute voluntary consensus standards, in which all interested parties (including the NRC and licensees of nuclear power plants) participate. Therefore, the NRC's approval of the use of the ASME Code Cases in this final rule is consistent with the overall objectives of the NTTAA and OMB Circular A-119.
As discussed in Section II of this document, “Discussion,” the NRC is conditioning the use of certain provisions of the 2009 Addenda, 2010 Edition, 2011 Addenda, and 2013 Edition of the ASME BPV Code Section III, Division 1 and Section XI, Division 1. The NRC is also conditioning the use of certain provisions of the 2009 Edition, the 2011 Addenda, and the 2012 Edition of the OM Code, Division 1. This final rule also includes various versions of quality assurance standard NQA-1 and Code Cases N-729-4, N-770-2, N-824, OMN-20, N-513-3 Mandatory Appendix I, and N-852. In addition, this final rule does not adopt (“excludes”) certain provisions of the ASME Codes, as discussed in this statement of considerations and in the regulatory analysis for this rulemaking. The NRC staff's position is that this final rule complies with the NTTAA and OMB Circular A-119 despite these conditions and “exclusions.”
If the NRC did not conditionally accept ASME editions, addenda, and code cases, the NRC would disapprove these entirely. The effect would be that licensees and applicants would submit a larger number of requests for use of alternatives under § 50.55a(z), requests for relief under § 50.55a(f) and (g), or requests for exemptions under § 50.12 and/or § 52.7. These requests would likely include broad scope requests for approval to issue the full scope of the ASME Code editions and addenda which would otherwise be approved in this final rule (
The NRC did not identify any other voluntary consensus standards, developed by U.S. voluntary consensus standards bodies for use within the United States, which the NRC could incorporate by reference instead of the ASME Codes. The NRC also did not
In summary, this final rule satisfies the requirements of Section 12(d)(3) of the NTTAA and OMB Circular A-119.
The NRC is incorporating by reference recent editions and addenda to the ASME Codes for nuclear power plants and a standard for quality assurance. The NRC is also incorporating by reference six ASME Code Cases. As described in the “Background” and “Discussion” sections of this document, these materials provide rules for safety governing the design, fabrication, and inspection of nuclear power plant components.
The NRC is required by law to obtain approval for incorporation by reference from the Office of the Federal Register (OFR). The OFR's requirements for incorporation by reference are set forth in 1 CFR part 51. On November 7, 2014, the OFR adopted changes to its regulations governing incorporation by reference (79 FR 66267). The OFR regulations require an agency to include in a final rule a discussion of the ways that the materials the agency incorporates by reference are reasonably available to interested parties and how interested parties can obtain the materials. The discussion in this section complies with the requirement for final rules as set forth in § 51.5(b).
The NRC considers “interested parties” to include all potential NRC stakeholders, not only the individuals and entities regulated or otherwise subject to the NRC's regulatory oversight. These NRC stakeholders are not a homogenous group, so the considerations for determining “reasonable availability” vary by class of interested parties. The NRC identifies six classes of interested parties with regard to the material to be incorporated by reference in an NRC rule:
• Individuals and small entities regulated or otherwise subject to the NRC's regulatory oversight who are subject to the material to be incorporated by reference by rulemaking. This class also includes applicants and potential applicants for licenses and other NRC regulatory approvals. In this context, “small entities” has the same meaning as a “small entity” under § 2.810.
• Large entities otherwise subject to the NRC's regulatory oversight who are subject to the material to be incorporated by reference by rulemaking. This class also includes applicants and potential applicants for licenses and other NRC regulatory approvals. In this context, “large entities” are those which do not qualify as a “small entity” under § 2.810.
• Non-governmental organizations with institutional interests in the matters regulated by the NRC.
• Other Federal agencies, states, local governmental bodies (within the meaning of § 2.315(c)).
• Federally-recognized and State-recognized
• Members of the general public (
The NRC makes the materials to be incorporated by reference available for inspection to all interested parties, by appointment, at the NRC Technical Library, which is located at Two White Flint North, 11545 Rockville Pike, Rockville, Maryland 20852; telephone: 301-415-7000; email:
Interested parties may purchase a copy of the materials from ASME at Three Park Avenue, New York, NY 10016, or at the ASME Web site
For the class of interested parties constituting members of the general public who wish to gain access to the materials to be incorporated by reference in order to participate in the rulemaking, the NRC recognizes that the $9,000 cost may be so high that the materials could be regarded as not reasonably available for purposes of commenting on this rulemaking, despite the NRC's actions to make the materials available at the NRC's PDR.
Accordingly, the NRC sent a letter to the ASME on April 9, 2015, requesting that they consider enhancing public access to these materials during the public comment period. In an April 21, 2015, letter to the NRC, the ASME agreed to make the materials available online in a read-only electronic access format during the public comment period.
During the public comment period, the ASME made publicly-available the editions and addenda to the ASME Codes for nuclear power plants, the ASME standard for quality assurance, and the ASME Code Cases which the NRC proposed to incorporate by reference. The ASME made the materials publicly-available in read-only format at the ASME Web site
The materials are available to all interested parties in multiple ways and in a manner consistent with their interest in this rulemaking. Therefore, the NRC concludes that the materials the NRC is incorporating by reference in this rulemaking are reasonably available to all interested parties.
The NRC will not be issuing guidance for this rulemaking. The ASME BPV Code and OM Code provide direction for the performance of activities to satisfy the Code requirements for design, inservice inspection, and inservice testing of nuclear power plant SSCs. In addition, the NRC provides
Revision 2 of NUREG-1482, “Guidelines for Inservice Testing at Nuclear Power Plants,” provides guidance for the development and implementation of IST programs at nuclear power plants. With direction provided in the ASME BPV and OM Codes, and guidance in this
The NRC is making the documents identified in Table 2 available to interested persons through one or more of the following methods, as indicated. To access documents related to this action, see the
Administrative practice and procedure, Antitrust, Classified information, Criminal penalties, Education, Fire prevention, Fire protection, Incorporation by reference, Intergovernmental relations, Nuclear power plants and reactors, Penalties, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements, Whistleblowing.
For the reasons set forth in the preamble, and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR part 50.
Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.
The revisions and additions read as follows:
(a)
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(B) “Operation and Maintenance of Nuclear Power Plants, Division 1: Section IST Rules for Inservice Testing of Light-Water Reactor Power Plants:”
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(C) “Operation and Maintenance of Nuclear Power Plants, Division 1: OM Code: Section IST:”
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(B) ASME NQA-1, “Quality Assurance Requirements for Nuclear Facility Applications:”
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(A) The repair or replacement activities temporarily deferred under the provisions of Nonmandatory Appendix U must be performed during the next scheduled refueling outage.
(B) In lieu of the appendix referenced in paragraph U-S1-4.2.1(c) of Appendix U the mandatory appendix in ASME BPV Code Case N-513-3 must be used.
(xxxv)
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(A) Ultrasonic examinations must be spatially encoded.
(B) Instead of Paragraph 1(c)(1)(-a), licensees shall use dual, transmit-receive, refracted longitudinal wave, multi-element phased array search units.
(C) Instead of Paragraph 1(c)(1)(-c)(-2), licensees shall use a phased array search unit with a center frequency of 500 kHz with a tolerance of ± 20 percent.
(D) Instead of Paragraph 1(c)(1)(-d), the phased array search unit must produce angles including, but not limited to, 30 to 55 degrees with a maximum increment of 5 degrees.
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For the Nuclear Regulatory Commission.
| 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 |