Federal Register Vol. 81, No.216,
Federal Register Volume 81, Issue 216 (November 8, 2016)
Federal Register Volume 81, Issue 216 (November 8, 2016)
| Page Range | 78497-78700 | |
| FR Document |
Document Created: 2016-01-05 01:46:09
Document Modified: 2016-01-05 01:46:09
| Page and Subject | |
|---|---|
| 81 FR 78697 - Advancing the Goals of the Power Africa Initiative to Expand Access to Electricity in Sub- Saharan Africa Through the Establishment of the President's Power Africa Working Group | |
| 81 FR 78671 - Sunshine Act Meeting-November 30, 2016 Public Hearing | |
| 81 FR 78682 - Sunshine Act Meeting Notice | |
| 81 FR 78678 - Sunshine Act Meeting | |
| 81 FR 78610 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 78590 - National Advisory Council for Environmental Policy and Technology: Assumable Waters Subcommittee; Notice of Public Meetings | |
| 81 FR 78509 - Fluxapyroxad; Pesticide Tolerances | |
| 81 FR 78634 - Certain Quartz Slabs and Portions Thereof; Commission Determination Not To Review Initial Determinations Terminating the Investigation as to All Respondents; Termination of the Investigation | |
| 81 FR 78570 - Collection of Information; Proposed Extension of Approval; Comment Request-Publicly Available Consumer Product Safety Information Database | |
| 81 FR 78507 - Special Local Regulation; Saint Andrew Bay; Panama City, FL | |
| 81 FR 78613 - Approval of Inspectorate America Corporation, as a Commercial Gauger | |
| 81 FR 78613 - Accreditation and Approval of King Laboratories, Inc., as a Commercial Gauger and Laboratory | |
| 81 FR 78623 - Intent To Request Approval From OMB of One New Public Collection of Information: Certification of Identity Form (TSA Form 415) | |
| 81 FR 78591 - Adequacy Status of the Dallas-Fort Worth, Texas Attainment Demonstration 8-Hour Ozone Motor Vehicle Emission Budgets for Transportation Conformity Purposes | |
| 81 FR 78632 - Certain Height-Adjustable Desk Platforms and Components Thereof; Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation Based on a Settlement Agreement; Termination of the Investigation | |
| 81 FR 78683 - RTCA Program Management Committee Meeting | |
| 81 FR 78686 - Advisory Committee: National Academic Affiliations Council Notice of Meeting | |
| 81 FR 78642 - George W. Bush Presidential Library; Disposal of Presidential Records | |
| 81 FR 78631 - Ammonium Sulfate From China; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations | |
| 81 FR 78659 - Purdue University; Purdue University Research Reactor | |
| 81 FR 78594 - Information Collection; Preaward Survey Forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408) | |
| 81 FR 78576 - Manual for Courts-Martial; Publication of Supplementary Materials | |
| 81 FR 78658 - Duke Energy Florida, LLC; Levy Nuclear Plant Units 1 and 2 | |
| 81 FR 78671 - Information Collection Request Submission for OMB Review; Correction | |
| 81 FR 78589 - Agency Information Collection Activities; Comment Request; Implementation of Title I/II-A Program Initiatives | |
| 81 FR 78568 - Atlantic Highly Migratory Species; Advisory Panel | |
| 81 FR 78628 - Notice of Realty Action: Classification of Lands for Recreation and Public Purposes Act Lease for the Vulture Mountains Cooperative Recreation Management Area in Maricopa County, Arizona | |
| 81 FR 78566 - Notice of Request for Approval of an Information Collection; Importation of Fresh Citrus Fruit From Uruguay, Including Citrus Hybrids and Fortunella spp., Into the Continental United States | |
| 81 FR 78596 - Senior Executive Service Performance Review Board Membership | |
| 81 FR 78598 - Submission for OMB Review; Comment Request | |
| 81 FR 78565 - Office of Human Resources Management; 5 U.S.C. 4314(c)(4); Performance Review Board Membership | |
| 81 FR 78567 - Availability of an Environmental Assessment for the Biological Control of Giant Reed | |
| 81 FR 78499 - Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling | |
| 81 FR 78567 - Withdrawal of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback Moths | |
| 81 FR 78607 - Ninth Annual Sentinel Initiative; Public Workshop | |
| 81 FR 78603 - Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 78606 - Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
| 81 FR 78605 - Non-Inferiority Clinical Trials To Establish Effectiveness; Guidance for Industry; Availability | |
| 81 FR 78526 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); Draft Guidance for Industry; Availability | |
| 81 FR 78574 - Performance Review Board Membership | |
| 81 FR 78575 - Board of Visitors, United States Military Academy | |
| 81 FR 78596 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast | |
| 81 FR 78682 - 30-Day Notice of Intent To Seek Extension of Approval: Class I Railroad Annual Report | |
| 81 FR 78629 - Information Collection Request; Visitor Perceptions of Climate Change in National Parks | |
| 81 FR 78601 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Evaluation of the State Health Insurance Assistance Program (SHIP) | |
| 81 FR 78599 - Agency Information Collection Activities; Proposed Collection; Public Comment Request; Senior Medicare Patrol (SMP) Program National Beneficiary Survey | |
| 81 FR 78528 - Novus International, Inc.; Filing of Food Additive Petition (Animal Use) | |
| 81 FR 78635 - Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Domestic Violence and Housing Technical Assistance Consortium Safe Housing Needs Assessment | |
| 81 FR 78624 - Draft Safe Harbor Agreement and Receipt of Application for an Enhancement of Survival Permit for the Kamehameha Schools; Keauhou and Kilauea Forest Lands, Hawaii Island, Hawaii | |
| 81 FR 78684 - Tribal Transportation Self-Governance Program; Negotiated Rulemaking Meetings | |
| 81 FR 78599 - Proposed Information Collection Activity; Comment Request | |
| 81 FR 78630 - Notice of Temporary Concession Contract for Marina Operation, Food and Beverage, Retail and Campground Services in Fire Island National Seashore, New York | |
| 81 FR 78630 - Sole-Source Concession Contract for Lake Mead National Recreation Area | |
| 81 FR 78590 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Foreign Schools Eligibility Criteria Apply To Participate in Title IV HEA Programs | |
| 81 FR 78602 - Intent To Review a Study Data Standardization Plan Template; Notice of Availability; Establishment of a Public Docket; Request for Comments | |
| 81 FR 78500 - Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets | |
| 81 FR 78670 - Statistical Terminology and Notation for Special Nuclear Materials Control and Accountability | |
| 81 FR 78565 - Submission for OMB Review; Comment Request | |
| 81 FR 78685 - Agency Information Collection Activity Under OMB Review (Application for Supplemental Service Disabled Veterans Insurance) | |
| 81 FR 78673 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Pilot Period for the Supplemental Competitive Liquidity Provider Program | |
| 81 FR 78675 - Self-Regulatory Organizations; NASDAQ PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Exchange Rule 1079 Concerning the Process of Initiating a FLEX Transaction and Determining the Best Bid or Offer | |
| 81 FR 78677 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change To Revise the ICC Risk Management Model Description Document and the ICC Risk Management Framework | |
| 81 FR 78684 - Pipeline Safety: Voluntary Information-Sharing System Working Group Nominations | |
| 81 FR 78636 - Section 512 Study: Request for Additional Comments | |
| 81 FR 78591 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 78592 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 78539 - Wireless Emergency Alerts; Amendments to the Commission's Rules Regarding the Emergency Alert System | |
| 81 FR 78634 - Certain Food Supplements and Vitamins, Including Ocular Antioxidants and Components Thereof and Products Containing the Same; Institution of Investigation | |
| 81 FR 78632 - Frozen Warmwater Shrimp From Brazil, China, India, Thailand, and Vietnam; Scheduling of Full Five-Year Reviews | |
| 81 FR 78672 - Product Change-First-Class Package Service Negotiated Service Agreement | |
| 81 FR 78672 - Product Change-Priority Mail Negotiated Service Agreement | |
| 81 FR 78642 - Notice of Proposed Information Collection Request: Community Catalyst: The Role of Libraries and Museums in Community Transformation (Community Catalyst)-A National Leadership Grants Special Initiative | |
| 81 FR 78608 - Agency Information Collection Activities: Proposed Collection: Public Comment Request; The Advanced Education Nursing Traineeship (AENT) Program Specific Data Collection Forms | |
| 81 FR 78610 - National Human Genome Research Institute; Notice of Meetings | |
| 81 FR 78609 - Proposed Collection; 60-Day Comment Request; NCI Genomic Data Commons (GDC) Data Submission Request Form (National Cancer Institute) | |
| 81 FR 78671 - OMB No. 3206-0218, Death Benefit Payment Rollover Election, Form No. RI 94-7 | |
| 81 FR 78595 - Submission for OMB Review; Privacy Training | |
| 81 FR 78497 - Career and Career-Conditional Employment | |
| 81 FR 78679 - Florida Disaster Number FL-00120 | |
| 81 FR 78679 - North Carolina Disaster Number NC-00081 | |
| 81 FR 78679 - Wisconsin Disaster #WI-00055 | |
| 81 FR 78680 - Georgia Disaster Number GA-00082 | |
| 81 FR 78679 - Iowa Disaster #IA-00069 | |
| 81 FR 78560 - Co-Management of Subsistence Use of Polar Bears by Alaska Natives; Conservation of the Alaska-Chukotka Polar Bear Population | |
| 81 FR 78601 - Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities | |
| 81 FR 78643 - Astronomy and Astrophysics Advisory Committee; Notice of Meeting | |
| 81 FR 78597 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 78593 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 78680 - Privacy Act of 1974, as Amended; Computer Matching Program (SSA/Law Enforcement Agency (Source Jurisdiction))-Match Number 5001 | |
| 81 FR 78529 - Promulgation of State Implementation Plan Revisions; Infrastructure Requirements for the 2008 Lead, 2008 Ozone, 2010 NO2 | |
| 81 FR 78643 - Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 81 FR 78514 - Changes to the Coastal Zone Management Act Program Change Procedures | |
| 81 FR 78691 - Clean Air Act Redesignation Substitute for the Houston-Galveston-Brazoria 1997 8-Hour Ozone Nonattainment Area; Texas | |
| 81 FR 78688 - Clean Air Act Redesignation Substitute for the Dallas-Fort Worth 1-Hour Ozone and 1997 8-Hour Ozone Nonattainment Areas; Texas | |
| 81 FR 78619 - Privacy Act of 1974; Department of Homeland Security United States Citizenship and Immigration Services-004 Systematic Alien Verification for Entitlements Program System of Records | |
| 81 FR 78614 - Privacy Act of 1974; Department of Homeland Security United States Citizenship and Immigration Services-005 Intercountry Adoptions Security System of Records | |
| 81 FR 78661 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information and Safeguards Information |
Issue
Animal and Plant Health Inspection Service
National Oceanic and Atmospheric Administration
Army Department
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Transportation Security Administration
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
National Park Service
Copyright Office, Library of Congress
Institute of Museum and Library Services
Federal Aviation Administration
Federal Highway Administration
Pipeline and Hazardous Materials Safety 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.
U.S. Office of Personnel Management.
Final rule.
The U.S. Office of Personnel Management (OPM) is issuing a final rule on creditable service for career tenure. The final regulation removes the requirement for creditable service to be
Effective December 8, 2016.
Cathy Thornton by telephone at (202) 418-4321; by TTY at (202) 418-3134; by fax at (202) 606-4430; or by email to
On January 6, 2014, the Office of Personnel Management (OPM) proposed regulations at 79 FR 610 to revise part 315, title 5, Code of Federal Regulations (CFR), to change the criteria for career tenure in the Federal competitive service. The current regulations require an employee to serve a 3-year period of
This final rule removes “substantially continuous” from the requirement for career tenure. Under this final rule, an individual may attain career tenure after completing at least 3 years of
This final rule also makes conforming changes to section 315.201(b) and removes references to outdated and obsolete appointing authorities.
OPM received 12 sets of comments in response to the proposed rule. Eleven individuals and one professional organization provided comments. All 11 individuals supported the proposed changes. A discussion of the comments follows.
One individual suggested the final rule apply to term appointments. OPM is not adopting this suggestion because term appointments are not career or career-conditional appointments and thus do not count towards career tenure. However, creditable service for these purposes may include service on certain overseas limited term appointments under 5 CFR part 301, in accordance with section 315.201(b)(1)(i), and certain term appointments served in accordance with 315.201(b)(3)(iv).
Another individual asked how this rule will impact persons employed as overseas family members. For these purposes creditable service may begin, but not end, with an overseas limited appointment of indefinite duration or an overseas limited term appointment under 5 CFR part 301 in accordance with § 315.201(b)(1)(i).
Another commenter suggested that the final rule allow time under excepted service appointments to count as creditable service towards the attainment of career tenure. OPM is not adopting this suggestion. Generally speaking, career tenure is acquired through service on a permanent appointment in the competitive service that provides or leads to competitive status. Excepted service appointments, in general, do not lead to or provide competitive status. However, for these purposes creditable service may begin with an excepted service appointment that leads to non-competitive conversion to the competitive service. Readers can find a list of qualifying excepted service appointments in 5 CFR 315.201(b).
One commenter asked that OPM consider similar rules for purposes of annual leave accrual. OPM is not adopting this suggestion because it is the beyond the scope of the proposed rule.
The professional organization provided a comment pertaining to suicide prevention, which was beyond the scope of the proposed rule.
OPM is adopting the proposed rule as final without any changes.
This rule has been reviewed by the Office of Management and Budget in accordance with E.O. 12866.
I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would apply only to Federal agencies and employees.
The information collection requirements contained in this proposed rule are currently approved by the Office of Management and Budget under 3206-A120. This regulation does not modify this approved collection.
Government employees.
Accordingly, OPM amends 5 CFR part 315 as follows:
5 U.S.C. 1302, 3301, and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp. p. 218, unless otherwise noted; and E.O. 13562. Secs. 315.601 and 315.609 also issued under 22 U.S.C. 3651 and 3652. Secs. 315.602 and 315.604 also issued under 5 U.S.C. 1104. Sec. 315.603 also issued under 5 U.S.C. 8151. Sec. 315.605 also issued under E.O. 12034, 3 CFR, 1978 Comp. p. 111. Sec. 315.606 also issued under E.O. 11219, 3 CFR, 1964-1965 Comp. p. 303. Sec. 315.607 also issued under 22 U.S.C. 2506. Sec. 315.608 also issued under E.O. 12721, 3 CFR, 1990 Comp. p. 293. Sec. 315.610 also issued under 5 U.S.C. 3304(c).
(a)
(b)
(1)
(i) Nontemporary appointment in the competitive service: For this purpose, nontemporary appointment includes a career-conditional appointment. The 3 years may also begin, but not end, with status quo employment under subpart G of part 316 of this chapter, an overseas limited appointment of indefinite duration, or an overseas limited term appointment under part 301 of this chapter. The 3 years also may have begun with permanent employment under now obsolete appointing authorities such as probational, war service indefinite, emergency indefinite, nontemporary appointment from a civil service register to a position in the excepted service before January 23, 1955, temporary appointment pending establishment of a register (also known as TAPER authority), nontemporary appointment to a position in the District of Columbia Government before January 23, 1955, and appointment based on Public Law 83-121. Determinations of whether an obsolete authority provides the basis for creditable service may be obtained from OPM;
(ii) Nontemporary appointment to an excepted position, provided the employee's excepted position was brought into the competitive service and, on that basis, the employee acquired competitive status or was converted to a career-conditional appointment;
(iii) Nontemporary appointment to a nonappropriated fund (NAF) position in or under the Department of Defense or in or under the U.S. Coast Guard, Department of Homeland Security, provided the employee's NAF position was brought into the competitive service and, on that basis, the employee acquired competitive status or was converted to a career or career-conditional appointment;
(iv) Nontemporary excepted or nonappropriated fund appointment, Foreign Service appointment, or appointment in the Canal Zone Merit System, provided the employee is appointed to a competitive service position under the terms of an interchange agreement with another merit system under § 6.7 of this chapter, under Executive Order 11219 as amended by Executive Order 12292, or under Executive Order 11171;
(v) The date of appointment to a position on the White House Staff or in the immediate office of the President or Vice President, provided the service has been continuous and the individual was appointed to a competitive service position under § 315.602 of this chapter;
(vi) The date of nontemporary excepted appointment under § 213.3202(b) of this chapter (the former Student Career Experience Program) as in effect immediately before July 10, 2012, the effective date of the regulations removing that paragraph, provided the student's appointment was converted to a career or career-conditional appointment under Executive Order 12015 or under Executive Order 13562, with or without an intervening term appointment, and without a break in service of one day;
(vii) The date of veterans recruitment appointment (VRA), provided the appointment is converted to a career or career-conditional appointment under § 315.705 of this chapter, or the person is appointed from a civil service register without a break in service while serving under a VRA;
(viii) The date of nontemporary appointment to the Postal Career Service or the Postal Regulatory Commission after July 1, 1971, provided the individual is appointed to a career or career-conditional appointment under 39 U.S.C. 1006;
(ix) The date of nontemporary appointment under Schedule A, § 213.3102(u) of this chapter, of a person with an intellectual disability, severe physical disability, or a psychiatric disability, provided the employee's appointment is converted to a career or career-conditional appointment under § 315.709;
(x) The date of appointment in the Presidential Management Fellows Program under the provisions of Executive Order 13318, provided the employee's appointment was converted without a break in service to a career or career-conditional appointment under § 315.708 as in effect immediately before July 10, 2012, the effective date of the regulations that removed and reserved that section, or under Executive Order 13562;
(xi) The starting date of active service as an administrative enrollee in the United States Merchant Marine Academy;
(xii) Appointment as a career intern under Schedule B, § 213.3202(o) of this chapter, provided the employee's appointment was converted to a career or career-conditional appointment under § 315.712 as in effect immediately before July 10, 2012, the effective date of the regulations that removed and reserved that section;
(xiii) The date of appointment as a Pathways Participant in the Internship Program under Schedule D, § 213.3402(a) of this chapter, provided the employee's appointment is converted to a career or career-conditional appointment under § 315.713(a), with or without an intervening term appointment, and without a break in service of one day;
(xiv) The date of appointment as a Pathways Participant in the Recent Graduates Program under Schedule D, § 213.3402(b) of this chapter, provided the employee's appointment is converted to a career or career-conditional appointment under § 315.713(b), with or without an intervening term appointment, and without a break in service of one day;
(xv) The date of appointment as a Pathways Participant in the Presidential Management Fellows Program under Schedule D, § 213.3402(c) of this chapter, provided the employee's appointment is converted to a career or career-conditional appointment under § 315.713(c), with or without an intervening term appointment, and without a break in service of one day; and
(xvi) Employment with the District of Columbia Government after January 1, 1980 (the date the District implemented an independent merit personnel system not tied to the Federal system), provided the person was a District employee on December 31, 1979, was converted to the District system on January 1, 1980, and is employed by nontemporary appointment in the competitive service.
(2)
(3)
(i)
(B) Intermittent service on or after July 1, 1962, is counted as 1 day for each day an employee is in pay status, regardless of the number of hours for which the employee is actually paid on a given day. Agencies should consult the “260-Day Work Year Chart” in OPM's
(ii)
(A) Credit the first 30 calendar days of each period of nonpay status on the rolls during full-time employment, or during part-time employment on or after July 1, 1962. On this same basis, a seasonal employee receives credit for the first 30 calendar days of each period of nonduty/nonpay status. Nonpay status in excess of 30 days is not creditable.
(B) Credit periods of nonpay status and time off the rolls incident to entry into and return from military service and return from defense transfer, provided the person is reemployed in Federal service during the period of his or her statutory or regulatory restoration or reemployment rights.
(C) Credit periods of nonpay status and time off the rolls incident to transfer to and return from an international organization, provided the person is reemployed in Federal service under subpart C of part 352 of this chapter.
(D) Credit periods of nonpay status during which an employee was eligible to receive continuation of pay or injury compensation from the Office of Workers' Compensation Programs. Also credit periods of time off the rolls during which an employee was eligible to receive injury compensation from the Office of Workers' Compensation Programs, provided the person is reemployed under part 353 of this chapter.
(E) Credit up to 30 calendar days for time off the rolls that follows separation by reduction in force of employees who are eligible for entry on the reemployment priority list under subpart B of part 330 of this chapter, provided the person is reemployed in Federal service during the period of his or her reemployment priority.
(F) Credit up to 30 calendar days for time off the rolls that follow involuntary separation without personal cause of employees who are eligible for a noncompetitive appointment based on an interchange agreement with another merit system under § 6.7 of this chapter, provided the person is employed in the competitive service under the agreement during the period of his or her eligibility.
(G) Credit periods of nonpay status incident to an assignment to a State, local, or Indian tribal government, institution of higher education, or other eligible organization provided the employee returns to a creditable appointment pursuant to an agreement established under subchapter VI of chapter 33, title 5, U.S.C., and part 334 of this chapter.
(iii)
(iv)
(A) In the excepted service of the Federal executive branch, including employment in nonappropriated fund positions in or under any Federal agency;
(B) Under temporary, term, or other nonpermanent employment in the Federal competitive service;
(C) In the Senior Executive Service;
(D) In the Federal legislative branch;
(E) In the Federal judicial branch;
(F) In the armed forces;
(G) In the District of Columbia Government through December 31, 1979. For an employee on the District rolls on December 31, 1979, who converted on January 1, 1980, to the District independent personnel system, credit is also given for service between January 1, 1980, and September 25, 1980. Otherwise, service in the District of Columbia Government on or after January 1, 1980, is not creditable as intervening service; and
(H) Performed overseas by family members, as defined by § 315.608 of this chapter.
Animal and Plant Health Inspection Service, USDA.
Final rule; technical amendment.
In a final rule published in the
Effective November 8, 2016.
Dr. Donna Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road, Unit 148, Riverdale, MD 20737; (301) 851-2352.
In a final rule
Animal biologics, Exports, Imports, Labeling, packaging and containers, Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR part 112 as follows:
21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
(a) * * *
(12) An indications statement to read, “This product has been shown to be effective for the vaccination of healthy (insert name of species) __ weeks of age or older against __.”
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act (PHS Act). We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA).
This rule is effective January 9, 2017.
For access to the docket to read background documents or comments received, go to
Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD, 20993-0002, 240-402-0978.
This rule establishes new regulations implementing section 505(q) of the FD&C Act (21 U.S.C. 355(q)) as enacted by FDAAA (Pub. L. 110-85) and amended by FDASIA (Pub. L. 112-144). Section 505(q) of the FD&C Act governs the manner in which FDA handles certain citizen petitions and PSAs that ask the Agency to take any form of action related to an ANDA, a 505(b)(2) application, or an application submitted under section 351(k) of the PHS Act (351(k) application) (42 U.S.C. 262(k)). Section 505(q) of the FD&C Act specifies that FDA must not delay approval of a pending application because of any request to take any form of action relating to the application, unless the request is in writing and in a citizen petition or a PSA, and the Agency determines, upon reviewing the petition, that a delay is necessary to protect the public health. Section 505(q) of the FD&C Act also requires that all submitters of a petition (or PSA) include with their submission a verbatim certification statement specifying the date on which the information relied on in the petition first became known. Similarly, section 505(q) of the FD&C Act requires that the submitters of a supplement or a comment to a petition include with their submission a verbatim verification statement specifying the date on which the information relied on in their submission first became known. By enacting section 505(q) of the FD&C Act, Congress indicated a desire to ensure that petitions not be used to improperly delay approval of ANDAs, 505(b)(2) applications, or 351(k) applications. This rule clarifies the requirements of section 505(q) of the FD&C Act.
This rule amends FDA's regulations on general administrative procedures in part 10 (21 CFR part 10).
In § 10.31, paragraph (a) states that § 10.31 applies to all citizen petitions and PSAs that request that the Agency take any action that could, if taken, delay approval of an ANDA, a 505(b)(2) application, or a 351(k) application (
The rule also codifies the certification and verification requirements of section 505(q) of the FD&C Act. Section 10.31(c) clarifies that the Agency will consider a certification deficient if every word in the petitioner's certification does not match every word of the certification provided in section 505(q)(1)(H) of the FD&C Act. Likewise, § 10.31(d) clarifies that the Agency will consider the verification deficient if every word in the petitioner's or commenter's verification does not match every word of the verification provided in section 505(q)(1)(I) of the FD&C Act. However, because we believe section 505(q)(1)(I) of the FD&C Act contains a technical error when it specifies the word “petition” in the last sentence of the verification, we will accept either the word “petition” or “document” in the last sentence of the petitioner's or commenter's verification.
The rule also amends §§ 10.30 and 10.35. Section 10.30(e)(5) states that FDA intends to respond to a petition subject to section 505(q) of the FD&C Act within 150 days after the date on which the petition is received. This amendment incorporates a statutory change enacted by FDASIA. In addition, § 10.35(i) clarifies that a petitioner requesting a stay of action may supplement, amend, or withdraw a PSA, similar to the provision for citizen petitions in current § 10.30(g). Finally, §§ 10.30(e)(3) and 10.35(e) are amended to reflect that the Commissioner of Food and Drugs (the Commissioner) may dismiss a petition if changes in law, facts, or circumstances since the date on which the petition was submitted render the petition moot.
We estimate one-time costs to industry from this rule at about $613,800. We estimate annual costs at about $1,700. These costs equate to an estimated total annualized cost of about $89,100 at a 7 percent discount rate over 10 years and about $73,700 at a 3 percent discount rate over 10 years. The total annualized costs include the administrative cost to review the rule ($87,400) plus the cost for the additional effort preparing certifications for petitions and verifications for both responses to petitions and supplements to petitions ($1,700).
By providing additional clarity on the statutory requirements, we expect the rule will slightly reduce the number of deficient 505(q) petitions, leading to lower administrative costs for both industry and FDA.
In the
Over the years, FDA has received numerous petitions asking the Agency not to approve a particular ANDA or 505(b)(2) application (or classes of these applications concerning a particular drug product or active ingredient) unless certain criteria set forth in the petition are met. In many cases, the petitions have raised scientific and/or legal issues relating to the standards for approval of an application. Examples include petitions suggesting a particular method for demonstrating the bioequivalence of a proposed generic product to the reference listed drug (RLD) and petitions maintaining that a proposed generic product does not contain the same active ingredient as the RLD. When submitted early, such as when we are making decisions about the bioequivalence requirements for a generic drug product or before we have received the first ANDA, 505(b)(2) application, or 351(k) application for a drug or biological product, a petition may contain information that can contribute towards our evaluation of an application. However, when petitions are submitted late in the review process for challenged applications and do not raise valid scientific and/or legal issues, they may have the effect of improperly delaying the approval of an application. By enacting section 505(q) of the FD&C Act, Congress indicated a desire to ensure that petitions not be used to improperly delay approval of ANDAs, 505(b)(2) applications, or 351(k) applications.
Section 505(q)(1)(A) of the FD&C Act specifies that FDA must not delay approval of a pending ANDA, a 505(b)(2) application, or a 351(k) application because of any request to take any form of action relating to the application, unless the request is in writing and in a citizen petition submitted under § 10.30 or a PSA submitted under § 10.35, and the Agency determines, upon reviewing the petition, that a delay is necessary to protect the public health. In section 505(q)(5) of the FD&C Act the term
Section 505(q)(1)(B) of the FD&C Act states in this context that if FDA determines that a delay of approval of an ANDA, a 505(b)(2) application, or a 351(k) application is necessary to protect the public health, FDA is required to provide to the applicant not later than 30 days after making the determination (1) notification that the determination has been made; (2) if applicable, any clarification or additional data that the applicant should submit to the petition docket to allow FDA to review the petition promptly; and (3) a brief summary of the specific substantive issues raised in the petition that form the basis of FDA's determination. At FDA's discretion, the information is to be conveyed either in writing or in a meeting with the applicant. The information conveyed in the notification is to be considered part of the application and is subject to the disclosure requirements applicable to information in the application.
Section 505(q)(1)(F) of the FD&C Act governs the timeframe for final Agency action on a petition. Under this provision, FDA must take final Agency action on a petition not later than 150
Section 505(q) of the FD&C Act also includes certification and verification requirements for certain documents. Under section 505(q)(1)(H) of the FD&C Act, FDA may not consider a petition for review unless the petition is in writing and is signed and contains a certification that is specified in that section. Section 505(q)(1)(H) of the FD&C Act sets forth the exact words to be used in the certification. In addition, FDA may not accept for review any supplemental information or comments on a petition unless the submission is in writing and is signed and contains a specific verification. Section 505(q)(1)(I) of the FD&C Act sets forth the exact words to be used in the verification.
Section 505(q)(2) of the FD&C Act governs judicial review of final Agency action on a petition subject to section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA will be considered to have taken final Agency action on a petition if FDA makes a final decision within the meaning of § 10.45(d) during the 150-day period, or the 150-day period expires without FDA having made a final decision. Under section 505(q)(2)(B) of the FD&C Act, if a civil action is filed against the Secretary with respect to any issues raised in the petition before final Agency action, a court shall dismiss the action without prejudice for failure to exhaust administrative remedies. Section 505(q)(2) of the FD&C Act, however, does not apply to a petition containing requests relating to a 351(k) application.
In this rulemaking, the Agency finalizes the provisions outlined in the January 2012 proposed rule. In addition, the final rule incorporates changes enacted by FDASIA and responds to comments made to the proposed rule. FDA also is making editorial and organizational changes to clarify provisions. The final rule amends part 10 of FDA regulations on general administrative procedures. The amendment adds § 10.31, which includes the following provisions:
• Section10.31(a) states that § 10.31 will encompass all citizen petitions and PSAs that request that the Agency take any action that could, if taken, delay approval of an ANDA, a 505(b)(2) application, or a 351(k) application (
• Section 10.31(b) clarifies the date of submission for petitions submitted under § 10.31.
• Section 10.31(c) and (d) codify the certification and verification requirements of section 505(q)(1)(H) and (I) of the FD&C Act. Section 10.31(c) clarifies that the Agency will consider a certification deficient if every word in the petitioner's certification does not match every word of the certification provided in section 505(q)(1)(H) of the FD&C Act. Likewise, § 10.31(d) clarifies that the Agency will consider the verification deficient if every word in the petitioner's or commenter's verification does not match every word of the verification provided in section 505(q)(1)(I) of the FD&C Act. As discussed in section II.B.4 of the preamble to the proposed rule, we are making one minor editorial change to the language of the verification set out in the statute. We are changing “I verify under penalty of perjury that the foregoing is true and correct as of the date of this
The final rule amends §§ 10.20, 10.30, and 10.35 as follows:
• Adds § 10.30(e)(5) to incorporate a statutory change enacted by FDASIA. New § 10.30(e)(5) states that FDA intends to respond to a petition subject to section 505(q) of the FD&C Act within 150 days after the date on which the petition is received.
• Revises § 10.30(e)(2) to conform with the addition of § 10.30(e)(5).
• Makes minor revisions to §§ 10.20 and 10.30 to conform to the addition of § 10.31.
• With respect to § 10.35, administrative stay of action, makes revisions to conform with the implementation of section 505(q) of the FD&C Act. The final rule also adds new § 10.35(i) to clarify that a petitioner requesting a stay of action may supplement, amend, or withdraw a PSA, similar to the provision for citizen petitions in current § 10.30(g).
In addition to implementing the provisions in section 505(q) of the FD&C Act, the final rule makes minor technical changes by revising §§ 10.30(e)(3) and 10.35(e) to allow the Commissioner to dismiss a petition if changes in law, facts, or circumstances since the date on which the petition was submitted render the petition moot.
The final rule reflects revisions to the proposed rule in response to the enactment of FDASIA. Section 1135 of FDASIA amended section 505(q) of the FD&C Act in several ways. First, it shortened from 180 days to 150 days FDA's deadline for responding to petitions subject to section 505(q) of the FD&C Act. Second, it expanded the scope of section 505(q) of the FD&C Act to include certain petitions related to 351(k) applications. Lastly, FDASIA also added section 505(q)(4)(B) of the FD&C Act, which excludes such petitions from section 505(q)(2).
Accordingly, the final rule includes the following changes to the proposed rule:
• Adds § 10.30(e)(5) and revises § 10.30(e)(2) to reflect FDA's 150-day deadline for responding to petitions subject to section 505(q) of the FD&C Act.
• Revises § 10.31(a)(1) to reflect the applicability of section 505(q) of the FD&C Act to 351(k) applications.
These changes conform the final rule to reflect amendments to section 505(q) of the FD&C Act enacted by FDASIA that became law after publication of the proposed rule.
We received one submission containing several comments from the Pharmaceutical Research and Manufacturers of America (PhRMA). These comments primarily focused on the scope of proposed § 10.31 and the certification and verification requirements. PhRMA also raised several issues we deemed outside the scope of the proposed rule. In the discussion that follows, we address the comments.
We describe and respond to the comments in sections III.B through III.E. We have numbered each comment to help distinguish between different comments. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which comments were received.
(Comment 1) We received a comment from PhRMA concerning the scope of the rule. PhRMA stated that, in some instances, the rule would require unnecessary certifications for petitions outside the scope of section 505(q) of the FD&C Act that could cause confusion among petitioners, commentators, and the courts regarding which rules to apply to any given petition. PhRMA claimed the proposed rule could compromise a petitioner's fundamental right to know which statutory requirements and timelines FDA will apply to the petition. Accordingly, PhRMA requested that FDA revise the proposed rule to limit the rule's application to cases in which there is evidence that a relevant ANDA or 505(b)(2) application is pending before FDA.
(Response 1) We decline to make this revision. Normally, the existence of a pending application is not made public by FDA. (See
(Comment 2) PhRMA expressed specific concerns regarding the certification and verification requirements of the rule. First, PhRMA requested that the discretionary language found in the preamble to the proposed rule,
(Response 2) We recognize that a petition, supplement, or comment could be based on more than one type of information or multiple pieces of information. Section 505(q) of the FD&C Act requires that the petitioner provide in the certification the date on or about which information first became known to the petitioner. We interpret section 505(q) of the FD&C Act to require an on or about date for each piece of information that is relied upon in the petition. Section II.B.7 of the preamble to the proposed rule provides an example illustrating how a petition may list different types of information. A petition, supplement, or comment will meet the certification/verification requirement if it contains a date followed by a short description of the information. This requirement is essential to carrying out the legislative intent of Congress and does not impose an unreasonable burden on petitioners. Because of the fact-based nature of a petition, it is impracticable for FDA to specifically define or categorize all types of information that may be relied upon by a petitioner. A petitioner or commenter can, however, reasonably be expected to identify the main categories of information on which the petition, supplement, or comment relies and to provide dates for such categories. Indeed, this interpretation of the certification has worked well to date. The failure to certify or verify a “became known” date for any item of information contained in a petition would preclude the petitioner from relying on that information when seeking judicial review since section 505(q)(1)(H) and (I) of the FD&C Act requires that FDA not consider and/or accept for review any petition or information that fails to meet the certification and verification requirements.
(Comment 3) PhRMA expressed concern that the rule could be read as retroactively imposing requirements on petitions filed after September 26, 2007, but before the effective date of the final rule. Based on its concern, PhRMA requested that FDA revise the rule to clarify that § 10.31 will not apply to any petition that was pending at FDA before the final rule's effective date, to any supplement to such a petition, or to any comments on such a petition.
(Response 3) FDA's guidance for industry “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” (Ref. 1), describes FDA's current thinking on the applicability of section 505(q) to petitions submitted after September 27, 2007. As that guidance notes, section 505(q) of the FD&C Act applies to all petitions that are submitted on or after September 27, 2007 (or July 9, 2012, if the subject matter of the petition relates to the approval of a 351(k) application). To the extent the final rule imposes any additional requirements, those requirements will apply only to those petitions submitted on or after the effective date of the final rule.
(Comment 4) PhRMA requested that FDA include or otherwise establish a
(Response 4) We decline to implement such a mechanism for notifying petitioners. As PhRMA pointed out, section 505(q) of the FD&C Act does not require such a notification. The only notification provision in section 505(q) of the FD&C Act is found in section 505(q)(1)(B), which requires FDA to inform an ANDA applicant, a section 505(b)(2) applicant, or a 351(k) applicant that a delay in approval is necessary to protect the public health. Moreover, such a notification mechanism would be burdensome for the Agency and could inadvertently inform the public of pending ANDAs, 505(b)(2) applications, or 351(k) applications.
(Comment 5) PhRMA requested that FDA issue a regulation establishing (or clarifying) the administrative consequence of a decision to approve an ANDA or a 505(b)(2) application prior to making a final decision on a related 505(q) petition (
(Response 5) We believe the statute clearly defines what constitutes an exhaustion of administrative remedies with regard to section 505(q) petitions. Section 505(q)(2) of the FD&C Act governs judicial review of final Agency action on certain petitions filed under section 505(q). Under section 505(q)(2)(A) of the FD&C Act, FDA is considered to have taken final Agency action on a petition if either: (1) FDA makes a final decision within the meaning of § 10.45(d) during the 150-day period or (2) the 150-day period expires without FDA making a final decision. Section 505(q)(2) of the FD&C Act is silent as to the effect of approving an ANDA or a 505(b)(2) application prior to FDA's action on a petition. In our view, the language of section 505(q)(2) of the FD&C Act is clear and decouples a final action on a petition from a decision on an underlying ANDA or 505(b)(2) application. (We note that petitions addressing issues concerning 351(k) applications are excluded from the scope of section 505(q)(2) of the FD&C Act). Therefore, a decision on an ANDA or a 505(b)(2) application that occurs prior to the issuance of a petition response will not constitute final Agency action on the petition.
(Comment 6) PhRMA requested that FDA issue a regulation establishing (or clarifying) that a delay in approval of an ANDA or a 505(b)(2) application can extend beyond the 180-day (now 150-day) review period for a petition.
(Response 6) We decline to issue a regulation establishing or clarifying that a delay in approval of an ANDA or a 505(b)(2) application can exceed the 150-day review period for petitions. Because of the uncertainty in predicting the time it will take to resolve a particular issue, establishing an expectation on the possible length of a delay would be neither practical nor feasible. We believe that based on the language of section 505(q) of the FD&C Act, no clarification is necessary.
(Comment 7) Finally, PhRMA requested that FDA abandon its practice of not providing a substantive response to every section 505(q) petition regardless of the review status of a pending ANDA or 505(b)(2) application.
(Response 7) This issue is outside the scope of this rulemaking. FDA's current thinking on this issue is outlined in section III.E of its guidance for industry “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” (Ref. 1), and we do not believe further elaboration is necessary.
This rule amends §§ 10.20, 10.30, and 10.35, and adds § 10.31 in a manner consistent with the Agency's current understanding and application of these provisions. FDA is implementing certain provisions of FDAAA and FDASIA that govern petitions subject to section 505(q) of the FD&C Act. FDA has authority to issue regulations for the efficient administration of these provisions under section 701(a) of the FD&C Act (21 U.S.C. 371(a)).
FDA has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule (Ref. 2). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the annualized compliance costs to industry members, including small entities, is estimated to be slightly above $100, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
We estimate one-time costs to industry from this final rule at about $626,300. We estimate annual costs at about $1,800. These costs equate to an estimated total annualized cost of about $91,000 at a 7 percent discount rate over 10 years and about $75,200 at a 3 percent discount rate over 10 years. The total annualized costs include the administrative cost to review the rule ($89,200) plus the cost for the additional effort preparing certifications for petitions and verifications for both responses to petitions and supplements to petitions ($1,800).
The final rule contains several clarifications to the language provided in FDAAA and small additions to the statute's provisions. It reinforces the need for exact wording of both the certification and verification statements for petitions, supplements to petitions, and responses to petitions. Furthermore,
The Economic Analysis of Impacts of the final rule, performed in accordance with Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act, is available at
This final rule contains no new information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (the PRA). The final rule refers to previously approved collections of information found in FDA regulations. The collections of information in §§ 10.30 and 10.35 have been approved under OMB control number 0910-0191. The collections of information in § 10.31 have been approved under OMB control number 0910-0679. The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The certification and verification statements required under § 10.31(c) and (d) are “public disclosure[s] of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public . . . ,” (5 CFR 1320.3(c)(2)) and therefore not subject to OMB review.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects 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. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
The following references are on display in the Division of Dockets Management (see
Administrative practice and procedure, News media.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 10 is amended as follows:
5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.
(e) Except as provided in § 10.31(b), all submissions to the Division of Dockets Management will be considered as submitted on the date they are postmarked or, if delivered in person during regular business hours, on the date on which they are delivered, unless a provision in this part, an applicable
The additions and revisions read as follows:
(b) A petition (including any attachments) must be submitted in accordance with § 10.20 and, if applicable, § 10.31. The certification requirement in this section does not apply to petitions subject to the certification requirement of § 10.31. The petition must also be submitted in accordance with the following paragraphs, as applicable:
(c) A petition that appears to meet the requirements of paragraph (b)(3) of this section, § 10.20, and, if applicable, § 10.31, will be filed by the Division of Dockets Management, stamped with the date of filing, and assigned a unique docket number. * * *
(d) * * * The comments are to specify the docket number of the petition and include, if applicable, the verification under § 10.31, and may support or oppose the petition in whole or in part. * * *
(e) * * *
(2) Except as provided in paragraphs (e)(4) and (5) of this section, the Commissioner shall furnish a response to each petitioner within 180 days of receipt of the petition. * * *
(iii) Dismiss the petition if at any time the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition moot; or
(3) * * * If, at any time, the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition
(5) The Commissioner intends to furnish a response to each petitioner within 150 days of receipt of a petition subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act.
(a)
(1) The petition requests that the Commissioner take any form of action that could, if taken, delay approval of an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, a new drug application submitted through the pathway described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic Act, or a biologics license application submitted under section 351(k) of the Public Health Service Act.
(2) The petition is submitted on or after September 27, 2007.
(3) The petition is submitted in writing and under § 10.30 (for citizen petitions) or § 10.35 (for petitions for stay of action).
(b)
(c)
(2) The certification in paragraph (c)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the certification must contain each estimated relevant date. The information associated with a particular date must be identified.
(d)
(2) The verification in paragraph (d)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the verification must contain each estimated relevant date. The information associated with a particular date must be identified.
(b) * * * A request for stay must be submitted in accordance with § 10.20 and in the following form (except that a request for stay subject to § 10.31 must also include the certification provided in § 10.31(c)) no later than 30 days after the date of the decision involved. * * *
(e) * * * If, at any time, the Commissioner determines that changes in law, facts, or circumstances since the date on which the petition was submitted have rendered the petition moot, the Commissioner may dismiss the petition. * * *
(i) A petitioner may supplement, amend, or withdraw a petition for stay of action in writing without Agency approval and without prejudice to resubmission at any time until the Commissioner rules on the petition, provided the resubmission is made in accordance with paragraph (b) of this section, unless the petition for stay of action has been referred for a hearing under parts 12, 13, 14, or 15 of this chapter. After a ruling or referral, a petition for stay of action may be supplemented, amended, or withdrawn only with the approval of the Commissioner. The Commissioner may approve withdrawal with or without prejudice against resubmission of the petition for stay of action.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary special local regulation on Saint Andrew Bay extending the entire width of the channel from mile marker 285.0 to mile marker 289.0 on the Gulf Intracoastal Waterway in Panama City, FL. The special local regulation is needed to protect the persons participating in the Boat Parade of Lights marine event. This rulemaking restricts transit into, through and within the regulated area unless specifically authorized by the Captain of the Port Mobile.
This rule is effective from 4 p.m. until 10 p.m. on December 10, 2016.
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 LT Fannie L. Wilks, Sector Mobile, Waterways Management Division, U.S. Coast Guard; telephone 251-441-5940, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. At this time, it would be impracticable to complete the full notice and comment process because this special local regulation must be established on December 10, 2016.
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The Captain of the Port Mobile (COTP) has determined that potential hazards associated with the regatta event on December 10, 2016 will be a safety concern for anyone within the area of the Gulf Intracoastal Waterway between mile marker 285.0 and mile marker 289.0. This rule is needed to protect participants, spectators, and other persons and vessels during the regatta on navigable waters.
This rule establishes a special local regulation on December 10, 2016, which will be enforced between the hours of 4 p.m. and 10 p.m. The special local regulation takes place on the Gulf Intracoastal Waterway between mile marker 285.0 and mile marker 289.0, extending the entire width of the navigable channel. A similar special local regulation is currently in the Code of Federal Regulations under 33 CFR 100.801, Table 7, number 15 as occurring “1 Day; Saturday following Thanksgiving.” However, for the 2016 occurrence, the event sponsors changed the date of the event to December 10, 2016. The duration of the regulation is intended to protect participants, spectators, and other persons and vessels before, during, and after the regatta. No vessel or person will be permitted to enter, transit within or through, or exit the regulated area without obtaining permission from the COTP or a designated representative. Spectator vessels desiring to enter, transit through or within, or exit the regulated area may request permission to do so from the Patrol Commander. When permitted to transit the area vessels must follow restrictions within the regulated area as directed by the Coast Guard, and must operate at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
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 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 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
This regulatory action determination is based on the size, location, duration, and time-of-year of the regulation. The special local regulation will take place on a four-mile stretch of navigable waterway, during a short duration of four hours on the Gulf Intracoastal Waterway from mile marker 285.0 to 289.0 on December 10, 2016, which is a time of year experiencing lower than normal traffic. Moreover, the Coast Guard will issue Broadcast Notices to Mariners via VHF-FM marine channel 16 about the regulation so that waterway users may plan accordingly for transits during this restriction. The rule also allows vessels to seek permission from the COTP Mobile or a designated representative to enter the regulated area.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this 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 regulated area 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 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and 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. If you believe this 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 rule will not result in such an 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.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a special local regulation lasting for four hours on the Gulf Intracoastal Waterway between mile marker 285.0 and mile marker 289.0. It is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Marine safety, Navigation (water), Reporting and recordkeeping requirements, and Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state, or local law enforcement and sponsor provided vessels assigned or approved by the Captain of the Port (COTP) Mobile to patrol the regulated area.
(3) Spectator vessels desiring to transit the regulated area may do so only with prior approval of the Patrol Commander and when so directed by that officer will be operated at a minimum safe navigation speed in a manner which will not endanger participants in the regulated area or any other vessels.
(4) No spectator vessel shall anchor, block, loiter, or impede the through transit of participants or official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
(5) The patrol commander may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
(6) Any spectator vessel may anchor outside the regulated area, but may not anchor in, block, or loiter in a navigable channel. Spectator vessels may be moored to a waterfront facility within the regulated area in such a way that they shall not interfere with the progress of the event. Such mooring must be complete at least 30 minutes prior to the establishment of the regulated area and remain moored through the duration of the event.
(7) The Patrol Commander may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(8) The Patrol Commander will terminate enforcement of the special local regulations at the conclusion of the event.
(d)
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of fluxapyroxad in or on banana, coffee green bean, mango, and papaya. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), to ensure that residues on these commodities when imported into the United States would be in compliance with the FFDCA.
This regulation is effective November 8, 2016. Objections and requests for hearings must be received on or before January 9, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0380, is available at
Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0380 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fluxapyroxad including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluxapyroxad follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
The Agency recently published a tolerance rulemaking for fluxapyroxad. See
1.
i.
Such effects were identified for fluxapyroxad. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2003-2008 food consumption data NHANES/WWEIA. Tolerance level residues adjusted to account for the metabolites of concern (M700F008) and 100% crop treated assumptions were used for all plant commodities.
ii.
iii.
iv.
2.
Based on the Pesticide Root Zone Model Ground Water (PRZM/GW), the estimated drinking water concentrations (EDWCs) of fluxapyroxad for acute exposures are 127 ppb parts per billion (ppb) for surface water and 203 ppb for ground water. The EDWCs for chronic exposures for non-cancer assessments are 127 ppb for surface water and 188 ppb for ground water. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 203 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 188 ppb was used to assess the contribution to drinking water.
3.
There is no residential exposure associated with the proposed uses of fluxapyroxad in this action; however, there are existing turf uses that were previously assessed for fluxapyroxad. Although the Agency had conducted a residential exposure assessment for previous fluxapyroxad actions, the Agency completed an updated turf assessment to reflect an update in the single maximum application rate from 2.47 lb active ingredient (ai)/gallon to 0.005 lb ai/gallon. The present assessment assumed the following exposure scenarios:
•
•
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
EPA has not found fluxapyroxad to share a common mechanism of toxicity with any other substances, and fluxapyroxad does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that fluxapyroxad does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
1.
2.
3.
i. The toxicity database for fluxapyroxad is complete.
ii. There is no indication that fluxapyroxad is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Although an acute neurotoxicity study showed decreased rearing and motor activity, this occurred on the day of dosing only in the absence of histopathological effects or alterations in brain weights. This indicated that any neurotoxic effects of fluxapyroxad are likely to be transient and reversible due to alterations in neuropharmacology and not from neuronal damage. The Agency has low concern for neurotoxic effects of fluxapyroxad at any life stage.
iii. Based on the developmental and reproductive toxicity studies discussed in Unit III.C.2., there are no residual uncertainties with regard to prenatal and/or postnatal toxicity.
iv. There are no residual uncertainties identified in the exposure databases. The residue database is adequate. The dietary risk assessment is conservative and will not underestimate dietary exposure to fluxapyroxad. There are existing turf uses that were previously assessed and approved for fluxapyroxad. The assessment will not underestimate residential exposure via
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
There are no residential use patterns associated with the proposed uses in this action; however, there are residential exposure from existing turf uses that were previously assessed for fluxapyroxad. As a result, aggregate risk is represented by chronic dietary (food and water) and residential exposure. As reflected is these assessments, there are no risk concerns.
3.
4.
5.
6.
There is a suitable residue analytical method available for enforcement of fluxapyroxad tolerances for plants (BASF Methods L0137/01) which has been radio validated and has undergone successful validation by an independent laboratory. There are liquid chromatography with tandem mass spectrometry (LC/MS/MS) method and monitors two ion transitions. The Limit of Quantitation (LOQ) for BASF method L0137/01 is 0.01 ppm for various matrices.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for fluxapyroxad.
Therefore, tolerances are established without a U.S. registration for residues of fluxapyroxad in or on banana at 3.0 parts per million (ppm); coffee green bean at 0.2 ppm; mango at 0.7 ppm; and papaya at 0.6 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Office for Coastal Management, National Ocean Service, National Oceanic Atmospheric Administration (NOAA), Department of Commerce (Commerce).
Proposed rule; request for comments.
The National Oceanic and Atmospheric Administration (NOAA) wants to provide states and NOAA with a more efficient process for making changes to state coastal management programs (“management programs”). NOAA proposes to revise the Coastal Zone Management Act (CZMA) program change regulations and associated guidance (Program Change Guidance (July 1996) and Addendum (November 2013)) within our regulations. Under the CZMA, a coastal state may not implement any amendment, modification, or other change as part of its approved management program unless the amendment, modification, or other change is approved by the Secretary of Commerce under this subsection. Once NOAA approves the incorporation of a change into a management program, any new or amended management program enforceable policies are applied to federal actions through the CZMA federal consistency provision. This proposed rule addresses the issues raised in NOAA's Advanced Notice of Proposed Rulemaking, 73 FR 29093 (May 20, 2008) (ANPR) to: Provide a more efficient process for states and NOAA to make changes to state management programs; remove unnecessary requirements in the current regulations; establish program change documentation that all states would adhere to; continue to ensure that federal agencies and the public have an opportunity to comment to NOAA on a state's proposed change to its management program; and comply with the requirements of the CZMA and other applicable federal law. The proposed rule also addresses comments submitted on the ANPR.
Comments on this notice must be received by January 9, 2017.
You may submit comments on this proposed rule, identified by NOAA-NOS-2016-0137, by either of the following methods:
•
•
Mr. Kerry Kehoe, Federal Consistency Specialist, Office for Coastal Management, NOAA, at 240-533-0782 or
Unless otherwise specified, the term “NOAA” refers to the Office for Coastal Management, within NOAA's National Ocean Service. The Office for Coastal Management formed in 2014 through the merger of the Office of Ocean and Coastal Resource Management and the Coastal Services Center.
The CZMA (16 U.S.C. 1451-1466) was enacted on October 27, 1972, to encourage coastal states, Great Lake states, and United States territories and commonwealths (collectively referred to as “coastal states” or “states”) to be proactive in managing the uses and resources of the coastal zone for their benefit and the benefit of the Nation. The CZMA recognizes a national interest in the uses and resources of the coastal zone and in the importance of balancing the competing uses of coastal resources. The CZMA established the National Coastal Zone Management Program, a voluntary program for states. If a state decides to participate in the program it must develop and implement a comprehensive management program pursuant to federal requirements.
An important component of the National Coastal Zone Management Program is that state management programs are developed with the full participation of state and local agencies, industry, the public, other interested groups and federal agencies.
1. Uses Subject to Management (Subpart B);
2. Special Management Areas (Subpart C);
3. Boundaries (Subpart D);
4. Authorities and Organization (Subpart E); and
5. Coordination, Public Involvement and National Interest (Subpart F).
NOAA approval is required for the establishment of a state management program. Once approved, changes to one or more of the program management areas listed above, including new or revised enforceable policies, must be submitted to NOAA for approval through the program change process.
Program changes are important for several reasons: The CZMA requires states to submit changes to their programs to NOAA for review and approval (16 U.S.C. 1455(e)); state programs are not static—laws and issues change, requiring continual operation of the CZMA state-federal partnership; and the CZMA “federal consistency” provisions require that federal actions that have reasonably foreseeable coastal effects be consistent with the enforceable policies of federally-approved management programs. The state-federal partnership is a cornerstone of the CZMA. The primacy of state decisions under the CZMA and compliance with the CZMA federal consistency provision is balanced with adequate consideration of the national interest in CZMA objectives; the opportunity for federal agency input into the content of state management programs; NOAA evaluation of management programs and NOAA review and approval of changes to management programs.
In establishing and maintaining their federally-approved management programs, states must consider national interest objectives of the CZMA in addition to state and local interests. The national interest objectives of the CZMA include:
• Effective management, beneficial use, protection and development of the coastal zone (16 U.S.C. 1451(a));
• important ecological, cultural, historic and esthetic values of the coastal zone are essential to the well-being of all citizens (16 U.S.C. 1451(d));
• anticipating and planning for the effects of climate change (16 U.S.C. 1451(l));
• managing coastal development to minimize the loss of life and property caused by improper development and coastal storms (16 U.S.C. 1452(2)(B)); and
• giving priority consideration to coastal-dependent uses and orderly processes for siting major facilities related to national defense, energy, fisheries, recreation, and ports and transportation (16 U.S.C. 1452(2)(D)).
Some of the important issues NOAA must consider when evaluating program changes include whether the change would: (1) Affect CZMA national interest objectives; (2) attempt to regulate federal agencies, lands or waters, or areas outside state jurisdiction; (3) be preempted by federal law; (4) discriminate against particular coastal users or federal agencies; (5) include policies that are enforceable under state law; and (6) raise issues under the National Environmental Policy Act (NEPA), Endangered Species Act (ESA), Marine Mammal Protection Act (MMPA), National Historic Preservation Act (NHPA), Magnuson Stevens Fisheries Conservation and Management Act (MSFCMA) or other federal laws.
NOAA review and approval of program changes is also important because the CZMA provides for federal agency and public participation in the content of a state's management program. NOAA can only approve management programs and changes to management programs after federal agencies and the public have an opportunity to comment on the content of the program change. Within the context of the CZMA federal consistency provisions, an enforceable policy is a state policy that has been incorporated into a state's federally-approved management program, is legally binding under state law (
Program changes are also important because the CZMA federal consistency provision applies only if the federal action has reasonably foreseeable coastal effects and a state has applicable policies approved by NOAA that are legally enforceable under state law. It is therefore important for states to submit to NOAA for approval timely updates to state management program enforceable policies.
The current program change regulations, 15 CFR part 923, subpart H, have been in place since the late 1970s. The CZMA was revised in 1990, in part, to place greater emphasis on state management program enforceable policies. This has led to an increase in the number of program changes submitted to NOAA and the workload for state and federal staff. States and NOAA have, therefore, recognized the need to clarify the program change procedures and to provide a more administratively efficient submission and review process. In 1996, NOAA made minor revisions to the regulations and also issued program change guidance that further described program change requirements. In 2013, NOAA issued an addendum to the 1996 program change guidance for added clarification. Over the years, states and NOAA have, at times, found the regulations difficult to interpret. For example, there has been confusion about determining: When a program change is “routine” versus an “amendment;” when a program change is “substantial;” what level of state analysis is required; what level of detail is needed for a policy to be enforceable; and what can be approved as an enforceable policy.
NOAA's objectives in revising the program change regulations are to:
1. Establish a clear, efficient and transparent process for program change review;
2. Describe approval criteria and how these apply;
3. Use terminology from the CZMA, including time lines and extensions;
4. Eliminate the distinction between “routine program changes (RPCs)” and “amendments.” This would remove the program change analysis currently done by states to determine if a change is substantial, and therefore an amendment, and instead require states to describe the nature of the program change and indicate whether the state believes the program change would impact CZMA program approvability areas, national interest objectives, or compliance with other federal laws. The distinction between RPCs and amendments, and the substantiality analyses by states are administrative and paperwork burdens with little or no benefit;
5. Continue to determine on a case-by-case basis the appropriate level of NEPA
6. Encourage states to use underline/strikeout documents for program change submissions to show changes to previously approved policies;
7. Create a program change form that all states would use to submit changes to NOAA, easing state and NOAA paperwork burdens, promoting more consistent submissions and NOAA analyses, and expediting NOAA's review;
8. Use a NOAA “Program Change Web site” through which NOAA would electronically post program changes and public comments received, and notify federal agencies and the public of the status of program changes; and
9. Require states to post program change public notices on the state's management program Web site.
In addition, the current regulations at 15 CFR part 923, subpart H, include “termination of approved management programs.” However, sanctions to and termination of management programs are described in detail in Subpart L—Review of Performance. Therefore, the proposed changes to subpart H would no longer include termination of approved management programs.
Comments were submitted on the ANPR by the Coastal States Organization (CSO), the U.S. Navy, the San Francisco Bay Conservation and Development Commission (BCDC) and the states of Delaware and Oregon. Most of the comments received on the ANPR supported NOAA's objectives and some comments offered suggestions for how some of these objectives might be achieved. NOAA presented eight points in the ANPR to help focus comments. These eight points and the comments submitted to NOAA are discussed below.
1. Establishing a clearer and more efficient and transparent process for program change review.
For minor changes to enforceable policies, local plans, etc., a simplified approach could be an annual report to NOAA using a NOAA form/checklist that would describe the change, scope of the change and impacts to enforceable policies (Oregon).
For changes to local enforceable policies such as comprehensive plan provisions, land use regulations and maps, Oregon suggests two alternatives:
Alternative A—NOAA would allow a state to determine that a change in local enforceable policies is consistent with the underlying enforceable policies of state statute or rule that were previously approved by NOAA. A state would submit an annual summary of local amendments that are consistent with underlying state enforceable policies, along with the dates of approval by the state management program of the changes; or,
Alternative B—NOAA and each state would enter into a Memorandum of Understanding that specifies the conditions under which a state would submit changes to local statutes and administrative rules and regulations, and local enforceable policies.
The Navy made various recommendations:
1. Develop specific and reasonable timelines that allow sufficient time for review, and set timelines for related issues such as extensions, preliminary approvals, and requesting mediation;
2. The public should be provided immediate notice of proposed and final program changes;
3. Impose a new requirement for states to assist with notification of the public and federal agencies that may wish to review proposed changes; and
4. Use modern information technology by providing that posting the proposed changes on the Internet, when combined with an email notification roster (listserv), serves as official notification. Create Web sites that include the state's proposed text, NOAA decisions and NEPA documents and links to state management programs.
In response to the Navy, NOAA believes that all of the Navy's recommendations have been met in the proposed rule regarding use of both state and NOAA Web sites and listservs to provide notice of and access to program changes and NOAA's decisions as well as relevant timeframes and decision dates that are dictated primarily by statute.
2. Describing clearer approval/disapproval criteria and how these apply.
The only applicable criteria should be that (1) the program continues to meet the standards set forth in section 306 of the CZMA, and (2) that the revised program does not place an unacceptable burden on a federal agency operating in the coastal zone (CSO, Oregon).
Allow state policies to refer to state and allowable federal codes and regulations without including the full text of those authorities (Delaware).
NOAA also disagrees that states should be able to impose standards “by reference” when those referenced standards have not been subjected to the program change process, NOAA review and opportunity for federal agency and public comment.
3. Using the simpler statutory language, including time lines, extensions, and preliminary approval.
4. Keeping the “routine” concept to streamline the process for truly routine changes, but do away with “routine program changes (RPCs)” and “amendments” and replace with just “program changes.”
The Navy welcomes NOAA's initiative towards improving the transparency and ease of the coastal zone management program change review and approval process. The Navy supports NOAA's suggestion that truly routine program changes be identified and their handling streamlined. However, the Navy supports a separate process for amendments (substantial changes) so that affected federal agencies can comment on the proposals. The Navy stated that NOAA should review the types of changes that have been approved over recent years and develop a list of examples deemed to be routine, and NOAA should use the list to prepare descriptive criteria for routine changes.
NOAA believes it has met the Navy's objectives without needing to use the current distinction between routine program changes and amendments. As explained elsewhere in the proposed rule, this distinction is unnecessary and the history of program changes shows that most changes are routine. Moreover, under the proposed program change regulations, NOAA will provide access to program change materials, send notices to federal agencies, and provide an opportunity for federal agencies to comment on all program changes. At the same time, administrative burdens on states and NOAA will be lessened.
NOAA's proposed removal of the distinction between routine changes and amendments is based on NOAA's review of almost one thousand changes to management programs over the past thirty-five years. The vast majority of these changes were modifications to existing parts of NOAA approved management programs. In only a few instances did NOAA prepare an Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) and even rarer an Environmental Impact Statement (EIS). The determining factors in the few instances when NOAA prepared an EA or EIS, were the magnitude of the change proposed by a state, usually involving a major new component to the management program or a major change in focus to the existing management program. Most of these also involved controversial positions by the state.
From 1977 to March 2016, there have been approximately 862 changes to management programs approved by NOAA. Less than 2.5 percent, about twenty, were amendments; approximately 842 were RPCs. Seventy-five percent of the amendments (about fifteen) were before 1990 and many of these were for the addition of energy facility siting plans required by an amendment to the CZMA. For five of the amendments NOAA prepared an EIS (1998, 1991, 1997, 2004 and 2004) and two of these included informal ESA consultation. For fourteen of the amendments NOAA prepared an EA and FONSI. Of the approximately 842 RPCs, NOAA prepared an EA and FONSI for two of them.
State CZMA management programs are comprehensive programs that, when they are being developed, undergo extensive review by states, NOAA, federal agencies and the public, including environmental review and an EIS under NEPA. In most instances changes to management programs have added further details to the previously approved management program and have not presented issues not considered during initial program approval and subsequent program changes. Under NOAA's current program change regulations and guidance these would be routine program changes (RPCs) and not substantial changes, or amendments. NOAA intends to eliminate the distinction between RPCs and amendments and just have “program changes.”
5. Removing the “substantial” evaluations currently done by states and replacing such evaluations with a description of what the change is to the program. Further evaluations (by states or NOAA) would be for specific CZMA, NEPA, ESA, NHPA, etc., purposes,
Much of the difficulty in the current procedure for compiling and submitting program changes stems from the requirement for a detailed comparison of old and new versions of state laws, state rules and regulations, and local comprehensive plans and ordinances. While this side-by-side comparison may have some utility, it turns out to have little or no practical value to either NOAA or the state, and has become a barrier to making federal consistency determinations that reflect current conditions (Oregon).
For substantial changes, NOAA should also provide a
6. Establishing use of NEPA categorical exclusions.
The Navy recommended that NOAA consider, pursuant to 15 CFR 930.33(a)(3), developing a list of universal de minimis activities based on NEPA categorical exclusions and on existing federal activity de minimis lists that have been approved by state agencies, retaining the ability of states and federal agencies to mutually agree on additional de minimis activities. States could modify the universal de minimis lists by adding mitigating or compliance conditions. Such additions should be subject to the change review procedures.
In response to the Navy's novel approach to using the de minimis provision of NOAA's federal consistency regulations, NOAA does not believe it could impose such a list of de minimis activities. NOAA does, however, encourage federal agencies to propose de minimis activities and submit these to the coastal states for their concurrence under the federal consistency provision.
7. Submitting underline/strikeout documents showing changes to previously approved policies.
CSO found this to be an unnecessary and overly burdensome requirement. CSO stated that there may be instances where such a technique is employed to clearly explain a program change, but this is more appropriately an available tool, rather than a strict requirement.
The Navy suggested that NOAA require submission of underline/strikeout documents showing changes to previously approved documents.
8. Creating a program change checklist that states would submit to ease state and NOAA paperwork burdens and promote consistent submissions and NOAA analyses.
This section describes the general requirements for program changes. Paragraph (a) states that the term “program changes” includes all terms used in the statute, CZMA § 306(e), and identifies the Office for Coastal Management as the NOAA office that administers these regulations. Paragraph (b), derived from CZMA § 306(e), states that a coastal state may not implement a change as part of its management program until NOAA approves the program change. Similarly, a coastal state may not use a state or local government policy or requirement as an “enforceable policy” for purposes of federal consistency unless NOAA has approved the state or local policy or requirement as an “enforceable policy.” State or local government law not approved by NOAA as part of a state's management program remain legal requirements for state and local government purposes, but will not be part of a state's management program and, therefore, cannot be used for CZMA federal consistency purposes.
Paragraph (d) states that the term “enforceable policies” has the same definition as that included in NOAA's CZMA federal consistency regulations at 15 CFR 930.11(h). NOAA has added enforceable policy decision criteria in proposed § 923.84. These criteria have been included in NOAA guidance and information documents and have been part of long-standing NOAA implementation of program changes and enforceable policies.
Paragraph (e) notes that the submission of program changes may be required as a necessary action under NOAA's evaluation of management programs under CZMA § 312 and 15 CFR part 923, subpart L. Failure to comply with a necessary action to submit a program change can result in a suspension of CZMA grants pursuant to CZMA § 312 and the subpart L regulations.
This section sets forth various procedures for submitting program changes.
Paragraph (a). Program changes must be submitted by the Governor of a coastal state, the head of the single state agency designated under the management program to be the lead state agency for administering the CZMA, or the head of an office within the designated single state agency if the state has authorized that person to submit program changes.
NOAA would no longer require states to mail hard copies of program changes. Rather, all program changes would be submitted through the new Program Change Web site or through an alternative method, agreed to by the state and NOAA, if an electronic submission through the Web site is not possible.
All deadlines and timeframes would start on the first full business day after NOAA receives a program change (Day 1). For example, if a submission is received on a Thursday, Day one for timeline purposes would be Friday; if the day of receipt is Friday and Monday is a federal holiday, Day 1 would be Tuesday. All days, starting with Day 1, are included in the calculation of total time for a deadline, including weekends and federal holidays. States may request that the official start date occur at a later time; this is an administrative convenience NOAA has allowed states to use in the past to account for various state administrative purposes.
Paragraph (b). NOAA shall confirm receipt of all program changes and future deadlines. During NOAA's review of a program change, NOAA may request additional information that it needs to make its decision.
Paragraph (c). This paragraph sets forth the deadlines NOAA must follow in responding to state program change requests. The deadlines in paragraph (c) are the same as NOAA's current practice and clarify a discrepancy that exists in the current program change regulations and the CZMA. NOAA is required by the Act to respond within 30 calendar days of receipt of a program change request. The 30-day period starts on Day 1 (the first full business day after receipt of a program change request). If NOAA does not respond within the 30-day period, then NOAA's approval is presumed. NOAA may extend its review period up to 120 days after receipt of a program change request, if NOAA so notifies the state during the 30-day period. NOAA may continue to extend
Paragraph (d). This paragraph codifies the current practice of pre-submission consultation with NOAA to identify any potential approval issues prior to submitting a program change submission. States are encouraged to submit draft program changes to NOAA for informal review and to consult with NOAA, to the extent practicable, prior to state adoption of new or revised laws, policies and other provisions that the state intends to submit as a program change.
Paragraph (e). NOAA is simplifying the public notice and comment procedures for program changes. Given the reliance on electronic means of communication and the demise of hard copy notices in newspapers and other formats, all states would be required to post public notices on state management program's Web site and directly email or mail notices to applicable local and regional offices of relevant federal agencies, federal agency headquarter contacts, affected local governments and state agencies, and any individuals or groups requesting direct notice. NOAA's program change review period would not begin until such notice is provided. NOAA will also post the state notices on its Program Change Web site and directly notify via email federal agency headquarter contacts and any other individual or group requesting direct notice. The state's public notice would describe the program change, any new or modified enforceable policies, and indicate that any comments on the program change shall be submitted to NOAA. NOAA will post the program change and all NOAA decisions on its Web site and notify federal agency headquarter contacts and other individuals or groups requesting notification. NOAA may extend the public comment period.
Paragraph (f). This paragraph states that program changes to enforceable policies can only be applied for CZMA federal consistency review purposes on or after the date NOAA approves the changes. The effective date for the approved changes will be the date on NOAA's approval letter. NOAA will post its program change decision letters on its Program Change Web site. This section would also codify in regulation NOAA's long-standing position that a state enforceable policy cannot apply retroactively to previously proposed federal actions; proposed federal actions are only subject to the management program enforceable policies approved at the time the federal action is proposed under the various subparts of 15 CFR part 930. Applying newly approved program changes retroactively to proposed federal actions would be contrary to Congressional intent that federal consistency apply in an expeditious and timely manner, and could impose unfair requirements on applicants and federal agencies.
The changes described in § 923.82(b) are editorial or are minor in scope, both procedurally and substantively. These changes are not controversial and pose little or no impact on federal agencies or the public. Therefore, NOAA's review of changes under § 923.82(b) would be expedited.
Paragraphs (b)(1) through (4) describe program changes that are either editorial in nature or are minor in scope, both procedurally and substantively. Paragraph (b)(1) addresses editorial or non-substantive changes to state laws, regulations, enforceable policies, local government coastal programs or plans that contain enforceable policies, and other authorities. Paragraph (b)(2) covers changes to special area management plans that do not change a state's coastal zone boundary, enforceable policies or geographic location descriptions, and are not otherwise used by the state for federal consistency review. Paragraph (b)(3) covers most organizational changes where the primary structure and responsibilities of the management remain intact. NOAA will closely monitor organizational changes to ensure that major overhauls of a state's management program structure would not weaken a coastal program.
Paragraph (b)(4). Most program changes, even those that result in some substantive change to a management program, have historically been routine and non-controversial, and have not posed any approval issues or resulted in any comments from federal agencies or the public. NOAA's review of these types of program changes should be expedited so long as these minor substantive changes would only apply to revised enforceable policies, not wholly new enforceable policies, and the changes are consistent with the scope and application of the previously approved enforceable policy.
The types of program changes under § 923.82(c) are self-explanatory and include: any changes that are not covered under § 923.82(b) and would be used for federal consistency purposes (new or revised enforceable policies, changes to state lists of federal actions subject to federal consistency review, geographic location descriptions outside the coastal zone, necessary data and information); new or revised coastal uses; changes in the coastal zone boundary; program approval authorities; and special area management plans.
Paragraph (c)(4), recognizes that for some states with local coastal programs or plans, the state can respond to federal consistency reviews without having to refer to the local programs or plans. In such cases, while the local programs and plans are important implementing mechanisms for coastal management in the state, states do not need to submit updates to the local programs or plans if they do not contain enforceable policies for federal consistency purposes. This would remove the substantial administrative burden for states and NOAA to submit and review local coastal programs.
Paragraph (d) addresses changes to state Clean Air Act (CAA) and Clean Water Act (CWA) Pollution Control Requirements. CZMA § 307(f) states that CAA and CWA requirements established by the Federal Government or by any state or local government pursuant to the CWA and CAA shall be incorporated in state management programs and shall be the water pollution control and air pollution control requirements applicable to such management program. NOAA's long-standing interpretation of 307(f) has been that these CWA and CAA pollution control requirements are automatically enforceable policies of the state management programs and, therefore, states are not required to submit as program changes any changes to state CAA and CWA provisions.
Section 923.83 describes all the program change information a state would submit to NOAA. These requirements are self-explanatory. NOAA intends to transform each of these paragraphs into a form that would, to the greatest extent practicable, use check-boxes or “radio-buttons,” and require minimal text input. While the same form would be used for all program changes, there would be less information needed for those changes that fall under § 923.82(b).
Paragraph (a)(2)(vi) codifies NOAA interpretation and long-standing practice of the term “enforceable mechanism.” An enforceable mechanism is the state legal authority that makes a state policy enforceable under state law. In order to be an “enforceable policy,” CZMA § 304(6a) requires that the policies be legally binding under state law. NOAA has interpreted this to mean that the
States are encouraged to show the changes, additions and deletions to enforceable policies using an underline/strikeout format or other similar format. If a state uses an underline/strikeout format, the state should only show the changes from the version of the policy last approved by NOAA and the most current version that is being submitted to NOAA; a state does not need to show any changes to the policy that might have been made in between NOAA's last approval and the current version.
States are also encouraged to post comprehensive lists of the enforceable policies to the state's coastal management program Web site.
The decision criteria in this section are taken from the current Program Change Guidance (1996) and NOAA's Federal Consistency Overview document. NOAA has applied these criteria since at least 1996 when reviewing program change requests. These criteria are generally self-explanatory and states would use a program change form to be developed by NOAA to assess whether these criteria are satisfied. For enforceable policies under paragraph (b) of this section, a policy must contain a standard; if a provision of a state law or regulation merely directs a state agency to develop standards, then that provision would not be an enforceable policy as it does not contain a standard. An enforceable policy should contain terms such as “shall,” “must,” or other terms interpreted under state law that mandate some action or compliance. Paragraph (b) also clarifies that it does not always make sense to parse out the enforceable policies within a statute or regulation that also contain parts that are necessary details for applying enforceable policies even though not enforceable themselves. This includes definitions, procedures, and information requirements that are essential elements of interpreting the substantive standards and determining consistency with the standards. Therefore, in some cases NOAA may find that a statute or regulation in its entirety is enforceable.
Paragraph (b) also clarifies that enforceable policies must: Apply to areas and entities within state jurisdiction; not assert regulatory authority over federal agencies, lands or waters unless federal law authorizes such jurisdiction; not be preempted on their face by federal law; not attempt to incorporate by reference other state or local mandatory requirements not submitted to, reviewed, and approved by NOAA; not discriminate against a particular activity or entity; and not adversely affect the national interest in the CZMA objectives.
For example, if a state is concerned about having policies that would apply to offshore oil and gas activities, the state would need to develop policies that would apply to any activity or industry that would have similar coastal effects; the state could not single out offshore oil and gas unless there are specific activities or coastal effects that only apply to the offshore oil and gas industry. Likewise, if a state wants to promote marine renewable energy in its enforceable policies, it may do so, but could not at the same time prohibit other forms of energy development without sufficient justification. Blanket prohibitions are generally not approved by NOAA as part of a state's management program unless a state provides sufficient justification. NOAA will not approve proposed enforceable policies which can be applied in an arbitrary or in a discriminatory manner. An enforceable policy cannot prohibit an activity due to the nature of its effects,
Paragraph (c) codifies long-standing NOAA practice and guidance when previously NOAA-approved enforceable policies are no longer enforceable for purposes of federal consistency review. If an underlying enforceable mechanism,
Paragraph (d) describes NOAA criteria for states to amend their lists of federal actions subject to federal consistency review and to propose geographic location descriptions (GLDs) to review federal actions outside the coastal zone, either landward or seaward. This paragraph focuses on the need for a state to make an adequate justification based on reasonably foreseeable effects to the state's coastal uses or resources. For NOAA to find that an activity in a proposed GLD outside the coastal zone may have coastal effects, a state must show that the impact from an activity will have a reasonably foreseeable effect to coastal uses or resources of the state. A state's burden to demonstrate coastal effects means that a mere assertion that an activity in federal waters will have an impact is insufficient to make a finding of reasonably foreseeable coastal effects. Moreover, a state's effects analysis must provide more than general assertions of impacts or that resources or uses are “important,” or should be reviewed because of the proximity of an activity to state coastal uses or resources. A persuasive coastal effects analysis should identify:
1. The affected uses (
2. Where and in what densities the uses and resources are found.
3. How the state has a specific interest in the resource or use. Be specific in showing their connection to the coastal zone of the state (
4. Where the proposed activity overlaps with these resources, uses and values.
5. Impacts to the resources or uses from the proposed activity.
6. The causal connection to the proposed activity, including how any
7. Why any proposed mitigation may be inadequate.
8. Empirical data and information that supports the effects analysis and can be shown to be reliable; visualizes the affected area, resources and uses with maps; and shows values, trends and vulnerabilities.
This section describes compliance and consultations under other federal law such as ESA, NHPA, MSFCMA or MMPA. This has to do with the nature of NOAA's action in approving a program change, in that NOAA can approve or deny a program change, but cannot affect the state's ability to enact a law and implement it at the state level. NOAA's approval of any state or local provisions as enforceable policies of the state's management program means those provisions can be used during a state's CZMA federal consistency review.
In addition, it is important to understand the nature of NOAA's discretion for the review and approval of program changes when informally or formally consulting on Endangered Species Act, other federal consultations and addressing tribal concerns.
The CZMA is not a delegated program; there are not federal CZMA standards, there is not a federal coastal zone, and NOAA does not implement management programs. The CZMA is a voluntary program and if a state chooses to participate it develops a management program unique to each state, based on state laws and policies pursuant to general program requirements in the CZMA and NOAA's regulations.
Once NOAA approves a state's management program, NOAA cannot require a state to change its program. NOAA can, through periodic evaluations of a state's management program under CZMA § 312, establish necessary actions if NOAA finds a state is not adhering to its NOAA-approved program, but NOAA can only
If a state submits a program change, NOAA can approve or disapprove that program change. When NOAA reviews a program change, NOAA has a limited ability to require a state to make changes to state policies. If NOAA disapproves, this does not require a state to change state law. Therefore, there is no effect from NOAA's denial on the implementation of state law at the state (or local government) level. NOAA's denial means the disapproved state policy is not part of the state's NOAA approved management program and cannot be used for CZMA federal consistency purposes. NOAA cannot use a program change to require changes to other parts of a state's management program.
This program is subject to Executive Order 12372.
NOAA has concluded that this regulatory action is consistent with federalism principles, criteria, and requirements stated in Executive Order 13132. The proposed changes in the program change regulations are intended to facilitate federal agency coordination with coastal states, and ensure compliance with CZMA requirements. The CZMA and these revised implementing regulations promote the principles of federalism articulated in Executive Order 13132 by granting the states a qualified right to amend their federally-approved management programs to address activities that affect the land and water uses or natural resources of state coastal zones and to apply these amended management programs to federal actions through the CZMA federal consistency provision. CZMA § 307 and NOAA's implementing regulations (15 CFR part 930) balance responsibilities between federal agencies and state agencies whenever federal agencies propose activities, or applicants for a required federal license or permit propose to undertake activities, affecting state coastal uses or resources. Through the CZMA, federal agencies are required to carry out their activities in a manner that is consistent to the maximum extent practicable with federally-approved state management programs while licensees and permittees are to be fully consistent with the state programs. The CZMA and these implementing regulations, rather than preempting a state, provide a mechanism for it to object to federal actions that are not consistent with the state's management program. A state objection prevents the issuance of the federal permit or license, unless the Secretary of Commerce overrides the objection. Because the CZMA and these regulations promote the principles of federalism and enhance state authorities, no federalism assessment need be prepared.
This regulatory action is not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation for the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that the proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The term “small entity” includes small businesses, small organizations, and small governmental jurisdictions. The Regulatory Flexibility Act (RFA) defines a small jurisdiction as any government of a district with a population of less than 50,000.
The existing regulations do not have a significant economic impact on a substantial number of small entities and, thus, these clarifying changes will not result in any additional economic impact on affected entities. The proposed rule revises provisions of the program change regulations to provide for a more effective and efficient process for states to amend their management programs, NOAA to review the proposed changes, and for federal agencies and the public to comment. The program change regulations, and the proposed rule, primarily affect states; the proposed changes do not impose any requirements on small entities.
The existing regulations do not, and the proposed rule will not, if adopted, have a significant economic impact on a substantial number of small entities. Accordingly, an Initial Regulatory Flexibility Analysis was not prepared.
This proposed rule contains no additional collection-of-information requirement subject to review and approval by the Office of Management and Budget under the Paperwork Reduction Act; rather it changes the manner in which states provide information to NOAA and, in some
NOAA has concluded that this proposed regulatory action does not have the potential to pose significant impacts on the quality of the human environment. Further, NOAA has concluded that this proposed rule, if adopted, would not result in any changes to the human environment. Therefore, NOAA has concluded that, pursuant to sections 5.05 and 6.03c.3(i) of NAO 216-6, this proposed rulemaking does not have a significant impact on the human environment and is categorically excluded from the need to prepare an environmental assessment or environmental impact statement pursuant to the requirements of NEPA in accordance with NAO 216-6.
Administrative practice and procedure, Coastal zone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, NOAA proposes to revise 15 CFR part 923 as follows:
16 U.S.C. 1451
(a) This subpart establishes the criteria and procedures by which any proposed change to approved management programs shall be made. The term “program change” includes all terms used in section 306(e) of the Act, including amendment, modification or other program change. Draft program changes submitted to NOAA for informal review and comment are not subject to these requirements. Unless otherwise specified, the term “NOAA” refers to the Office for Coastal Management, within NOAA's National Ocean Service. (The Office for Coastal Management was formerly known as the Office of Ocean and Coastal Resource Management and the Coastal Services Center.)
(b) Pursuant to section 306(e) of the Act, a coastal state may not implement any change to a management program as part of its management program unless the state submits, and NOAA approves, the change for incorporation into the state's federally-approved management program. A state shall not use a state or local government policy or requirement as an “enforceable policy” under 16 U. S.C. 1453(6a) and § 930.11(h) of this subchapter for purposes of federal consistency under 16 U.S.C. 1456 and part 930 of this subchapter, unless NOAA has approved the incorporation of, and subsequent changes to, the state or local policy into the state's management program under this subpart. State or local government law not approved by NOAA as part of a state's management program remain legal requirements for state and local government purposes, but not for CZMA federal consistency purposes.
(c) For purposes of this subpart, program changes include changes to enforceable policies as well as changes to one or more of the following management program areas under part 923: Uses Subject to Management (Subpart B); Special Management Areas (Subpart C); Boundaries (Subpart D); Authorities and Organization (Subpart E); and Coordination, Public Involvement and National Interest (Subpart F).
(d) The phrase “enforceable policies” used in this subpart is described in 16 U.S.C. 1453(6a) and § 930.11(h) of this subchapter. Enforceable policies are the only policies states can use to determine whether a federal action is consistent with its management program under section 307, the Federal Consistency provision, of the Act (16 U.S.C. 1456 and part 930 of this subchapter).
(e) Suspension of grants. Pursuant to section 306(e)(1) of the Act and § 923.135 of this subchapter, NOAA may suspend all or part of any grant or cooperative agreement made under section 306 of the Act if the state has failed to submit a program change identified as a necessary action under section 312 of the Act and part 923, subpart L (Review of Performance) and pursuant to the requirements for NOAA to notify the Governor of a state under the enforcement provisions of § 923.135 of this subchapter.
(a) Pursuant to section 306(d)(6) of the Act and § 930.11(o) of this subchapter, all program changes shall be submitted to NOAA by: The Governor of a coastal state with an approved management program; the head of the single state agency designated under the management program to be the lead state agency for administering the CZMA; or the head of an office within the designated single state agency if the state has authorized that person to submit program changes. Program changes may be submitted to NOAA on a cyclical basis (
(1) One (1) copy shall be submitted electronically using the Program Change Form on NOAA's Program Change Web site and addressed to: Chief, Stewardship Division, Office for Coastal Management, NOAA, 1305 East-West Hwy., 10th Floor, Silver Spring, MD 20910.
(i) If a state is not able to electronically send all or part of a program change to NOAA through NOAA's Program Change Web site, the state and NOAA shall agree to an alternative method (
(2) All deadlines and timeframes under this subpart shall start on the first full business day after the day NOAA receives a program change (Day 1). For example, if a submission is received on a Thursday, day one of NOAA's review period would be Friday; if the day of receipt is Friday and Monday is a federal holiday, Day 1 would be Tuesday. All days, starting with Day 1, are included in the calculation of total time for a deadline, including weekends and federal holidays. A state may request that NOAA's review period begin on a specified date following receipt by NOAA.
(b) When NOAA receives a program change, NOAA shall notify the state (via email or letter) of the date the program change was received and NOAA's expected decision deadline. NOAA will also notify the state if NOAA determines the submission is incomplete. If NOAA
(c) NOAA shall respond to the state (via email or letter) within 30 calendar days after the date NOAA receives a program change. The 30 days starts on Day 1. If NOAA does not respond within the 30-day period, then NOAA's approval is presumed. NOAA may extend its review period up to 120 days after receipt of a program change request, if NOAA so notifies the state during the 30-day period. NOAA can extend beyond 120 days only as necessary to meet the requirements of the National Environmental Policy Act (NEPA) (42 U.S.C. 4321
(d) Pre-submission consultation. States shall, to the extent practicable, consult with NOAA prior to state adoption of new or revised state laws, policies, regulations, and other changes the state intends to submit to NOAA as a program change. States are encouraged to submit draft program changes to NOAA for informal review and comment prior to submitting a program change. If consulted, NOAA shall review draft submissions to identify issues that would need to be addressed in the formal submission.
(e) Public Notice and Comment.
(1) A state shall post a public notice of its program change on the state's management program Web site in a conspicuous manner, and email or mail the public notice to local and regional offices of relevant federal agencies, federal agency CZMA headquarter contacts identified on NOAA's federal consistency Web site, affected local governments and state agencies, and to individuals requesting direct notice. The state shall post its public notice prior to, or on the same date as, the date the state submits the electronic program change to NOAA. NOAA's program change review period shall not start until NOAA informs the state that it has received the program change. To meet the requirement for direct public notice (via email or mail), states are encouraged to maintain a coastal management listserv or mailing list. In addition to posting the public notice on the state's Web site and notifying the parties described above, states may, but are not required to, publish the notice in any state bulletin or newspaper.
(2) A state's public notice shall:
(i) Describe the nature of the program change;
(ii) If applicable, identify any new, modified or deleted enforceable policies of the management program;
(iii) Indicate that any comments on the content of the program change shall be submitted to NOAA through NOAA's Program Change Web site within 21 calendar days of the date NOAA's review period starts; and
(3) NOAA shall post all program changes on its Program Change Web site where any interested party may review or download materials. NOAA shall also post on its Program Change Web site deadlines, extensions and any comments received. For each program change posted on NOAA's Web site, NOAA shall notify the federal agency CZMA headquarter contacts (identified on NOAA's federal consistency Web site) via email. In addition, any party may request through the Program Change Web site that NOAA notify them via email when program changes are submitted by one or more state(s). NOAA's email shall also state that any party may submit comments to NOAA on a program change request within 21 calendar days from the date NOAA's review period starts.
(4) NOAA may, at its discretion, extend the public comment period or hold a public hearing. NOAA shall only consider holding a public hearing for a program change that would substantially change a management program and/or be controversial.
(5) NOAA shall post its program change decisions on its CZMA Program Change Web site and shall notify, by email, federal agency CZMA headquarter contacts and individuals requesting such notice. A state shall post NOAA's decision regarding a state's program change on the state agency's Web site.
(f) Application of approved program changes for federal consistency purposes under section 307 of the Act (16 U.S.C. 1456) and part 930 of this subchapter. Changes to a state's management program and enforceable policies shall be applicable for federal consistency purposes on the date NOAA approves the changes. The effective date for the approved changes will be the date on NOAA's approval letter. NOAA will post its program change decision letters on its Program Change Web site. Approved program changes shall not apply retroactively to state federal consistency reviews under part 930 of this subchapter, subparts C, D, E or F, for proposed federal actions where a federal agency (subpart C), applicant (subpart D), person (subpart E), or applicant agency (subpart F) had submitted to the management program a consistency determination or consistency certification prior to NOAA's approval, except as allowed by part 930 of this subchapter, unless the proposed federal action was finalized or authorized and there is a substantial change, amendment or renewal proposed for the federal action on or after the date of NOAA's approval of a program change, pursuant to the applicable subpart of part 930.
(a) As required by CZMA § 306(e)(3)(A), coastal states may not implement a change as part of its approved management program unless the change is approved by NOAA. In accordance with § 923.81 and § 923.83, states shall submit program changes to NOAA for approval using the Program Change Form on NOAA's Program Change Web site.
(b) The following types of program changes shall be approved by NOAA as long as they satisfy the decision criteria in § 923.84 and do not raise issues under any federal laws, as described in § 923.85:
(1) Editorial or non-substantive changes (
(2) Changes to special area management plans that do not change a state's coastal zone boundary, enforceable policies or geographic location descriptions, and are not otherwise used by the state for federal consistency review;
(3) Changes to the organization of a state's management program if the management program's structure and responsibilities will remain intact; and
(4) Changes to enforceable policies previously approved by NOAA that make minor substantive revisions consistent with the scope and application of the previously approved enforceable policy. If the proposed changes are not consistent with the scope and application of the previously approved enforceable policy, then NOAA shall more closely review the changes to ensure they satisfy the decision criteria.
(c) Any program change that is not described in paragraph (b) of this section shall be reviewed by NOAA to ensure the state's management program will remain approvable if the proposed
(1)
(2) Changes to enforceable policies, including modifications, additions and deletions;
(3) Changes to provisions that are not enforceable policies, but which a state may use to evaluate the scope or applicability of an enforceable policy (
(4) Changes to local government coastal management programs or plans if those local programs or plans contain enforceable policies that the state uses for federal consistency review. States are not required to submit program changes for local government coastal management programs or plans that do not contain enforceable policies for federal consistency review; and
(5) Changes or additions to the state's federal consistency list or geographic location descriptions (part 930 of this subchapter);
(6) Changes or additions to Necessary Data and Information (930.58 of this subchapter).
(d) Changes to state Clean Air Act (CAA) and Clean Water Act (CWA) Pollution Control Requirements. Pursuant to section 307(f) of the Act, requirements established by the CWA (33 U.S.C. 1251-1387) and the CAA (42 U.S.C. 7401-7671), or established by the Federal Government or by any state or local government pursuant to the CWA and CAA shall be incorporated in state management programs and shall be the water pollution control and air pollution control requirements applicable to such management program. Therefore, states are not required to submit as program changes any changes to state CAA and CWA provisions.
(a) All program changes submitted to NOAA shall be submitted in accordance with § 923.81. Using the Program Change Form, a state shall provide a brief description of the proposed program change(s) and a current version of the document(s) containing the program change (
(1) Changes to the five program approval areas. States shall indicate if the proposed program change(s) affect any of the five management program approval areas under this part:
(i) Uses Subject to Management (subpart B);
(ii) Special Management Areas (subpart C);
(iii) Boundaries (subpart D);
(iv) Authorities and Organization (subpart E); or
(v) Coordination, Public Involvement and National Interest (subpart F).
The state shall refer to its program approval findings and any other relevant documents and make a statement that, to the best of the state's knowledge, its management program would continue to satisfy these five areas if the proposed changes are approved by NOAA.
(2) Changes or additions to enforceable policies. States shall identify new, revised or deleted enforceable policies and describe the:
(i) Title of the policy or statutory section, if applicable;
(ii) If previously approved by NOAA, whether the proposed policy revisions are consistent with the scope and application of the previously approved version;
(iii) State legal citation for the policy (do not use public law numbers);
(iv) Date the policy was last updated by the state;
(v) Date the policy was last approved by NOAA; and
(vi) State enforceable mechanism that makes the policy enforceable under state law. The phrase “enforceable mechanism” means a state authority that makes an enforceable policy legally binding under state law, as described in this subpart and § 930.11(h) of this subchapter. Examples of an enforceable mechanism include state statutes, regulations, permitting programs, local government ordinances or court decisions. If an enforceable mechanism is changed so that an enforceable policy is no longer legally binding under state law, then the enforceable policy shall be submitted as a program change with a new underlying state enforceable mechanism; otherwise the policy is no longer enforceable for purposes of state CZMA federal consistency reviews under part 930 of this subchapter.
(3) Changes or additions to the state's federal consistency list or geographic location descriptions.
(i) For each new or revised listed federal action, states shall describe the:
(A) type of federal action;
(B) specific federal statutory authority;
(C) responsible federal agency; and
(D) reasonably foreseeable effects to the uses and resources of the state's coastal zone (§ 923.84(d) of this part).
(ii) For each new or revised geographic location description, states shall describe the:
(A) geographic location description, using specific geographic boundaries;
(B) listed federal actions to be included within a geographic location description; and
(C) reasonably foreseeable effects to the uses and resources of the state's coastal zone.
(iii) Exception for state and federal agreements made as part of a regional ocean plan prepared by a Regional Planning Body under the National Ocean Policy Executive Order 13547 (75 FR 43022 (July 22, 2010)). Geographic location descriptions and changes to state lists of federal license or permit activities that describe general concurrences for minor federal license or permit activities resulting from state and federal agency agreements as part of a Regional Planning Body's regional ocean plan, and agreed to by NOAA through the Regional Planning Body process, shall be part of a state's management program once the Regional Planning Body's regional ocean plan is approved by the Regional Planning Body and certified by the National Ocean Council. No further submission to NOAA shall be required; the requirements of § 930.53 of this subchapter and this part for notification to federal agencies and the public shall be met by the Regional Planning Body process.
(4) Changes to Necessary Data and Information. States shall describe any changes or additions to Necessary Data and Information approved by NOAA in accordance with § 930.58 of this subchapter and explain why such information is necessary in order for the state to commence its federal consistency review period.
(5) NOAA's decision criteria. The state shall indicate that the program change meets each of NOAA's decision criteria in § 923.84.
(6) Impacts relating to other federal laws. The state shall describe whether and how the program change will impact the following:
(i) Resources or interests of any federally-recognized American Indian or Alaska Native tribal government.
(ii) Threatened or endangered species listed under the federal Endangered Species Act (ESA);
(iii) Historic properties designated under the National Historic Preservation Act (NHPA);
(iv) Essential fish habitat designated under the Magnuson Stevens Fishery Conservation and Management Act (MSFCMA);
(v) Marine mammals managed under the Marine Mammal Protection Act (MMPA); and
(vi) Other resources managed under other federal statutes.
(7) The state shall identify the state's Web site where the public notices for the notification and submission requests are, or will be, located and where, if applicable, state documents related to the request may be viewed.
(8) The state shall submit to NOAA any substantive correspondence between the state and federal agencies (not including NOAA's Office for Coastal Management) concerning the development of the changes that are the subject of the program change request.
(9) The state shall indicate if the program change was developed pursuant to section 309 of the Act (16 U.S.C. 1456b—Coastal zone enhancement grants) and, if so, shall state the strategy title and years the strategy was carried out.
(10) The state shall indicate if the program change was developed as a necessary action pursuant to section 312 of the Act (16 U.S.C. 1458—Review of performance) and, if so, shall briefly describe the necessary action.
(a) NOAA shall review all program changes on a case-by-case basis. NOAA shall determine whether a management program, if changed, would continue to satisfy the applicable program approval criteria of CZMA § 306(d) and subparts B through F of this part and the requirements of this subpart (subpart H).
(b) Enforceable policies. In order for NOAA to approve the incorporation of a new or revised enforceable policy into a state's management program, the policy shall:
(1) Be legally binding under state law;
(2) Contain standards of sufficient specificity to guide public and private uses. A policy is not enforceable if it merely directs a state agency to develop regulations or standards.
(i) Definitions, procedures and information requirements are essential elements of determining compliance with regulatory and permit standards. As such, a state law or regulation that contains numerous standards, definitions, procedures, and information requirements may be considered enforceable in its entirety after consultation with NOAA. If NOAA determines that a law or regulation may be considered enforceable in its entirety, a state does not have to identify non-enforceable parts of the law or regulation.
(3) Apply only to areas and/or entities under state jurisdiction;
(4) Not refer to or otherwise purport to apply to federal agencies, federal lands or federal waters. The Act does not authorize states to establish regulatory standards for federal agencies or for federal lands or waters. A state policy that would regulate or otherwise establish standards for federal agencies or federal lands or waters shall not meet the Act's definition of “enforceable policy” (
(5) Not, on its face, be preempted by federal law. If a state policy seeks to regulate an activity where state regulation is preempted by federal law, the policy is not legally binding under state law and shall not be an enforceable policy under 16 U.S.C. 1453(6a). Policies previously approved by NOAA as enforceable policies shall no longer be enforceable if federal law enacted after NOAA's approval subsequently preempts the state policy;
(6) Not incorporate by reference other state or local requirements that are not identified, described and evaluated as part of the program change request. Any state or local requirements incorporated by reference shall not be applicable for federal consistency review purposes unless separately approved by NOAA as enforceable policies;
(7) Not discriminate against a particular type of activity or entity. Enforceable policies shall be applied to all relevant public and private entities that would have similar coastal effects. Enforceable policies may be specific to a particular type of activity or entity if NOAA agrees that a state has demonstrated that the activity or entity present unique circumstances; or
(8) Not adversely affect the national interest in the CZMA objectives described in 16 U.S.C. 1451 and 1452.
(c) Effect of Prior Program Change Approvals. If enforceable policies previously approved by NOAA become obsolete or non-enforceable through application of subsequently enacted state or federal law, such policies will no longer be enforceable for purposes of CZMA federal consistency review. For example, a state law change may repeal a previous policy or may change the policy in a manner that changes the scope and application of the policy. In such cases, the previously approved enforceable policy is no longer applicable under state law and the new or revised policy is not applicable for federal consistency purposes until that policy has been submitted by the state as a program change and approved by NOAA. A previously approved enforceable policy may also become non-enforceable and no longer legally binding under state law if subsequent federal law preempts state regulation of a particular activity.
(d) Changes to a management program's federal consistency list or a new or revised geographic location description under part 930 of this subchapter, subparts C, D, E, F or I. For changes to a management program's list of federal actions or a new or revised geographic location description, the state's effects analysis shall be based on information that would allow NOAA to find that the listed activity, either within the state's coastal zone or within a geographic location described outside the state's coastal zone, would have reasonably foreseeable effects on the uses or resources of the state's coastal zone. A state's analysis asserting impacts to uses or resources outside of the coastal zone shall not, by itself, demonstrate a coastal effect; rather, the state shall describe a causal connection of how an impact outside the coastal zone could result in a coastal effect. A state's effects analysis shall not be based on unsupported conclusions, speculation or the mere existence of coastal uses or resources within a geographic location. A state's coastal effects analysis shall, to the extent practicable, identify:
(1) The affected uses (
(2) Where and in what densities the uses and resources are found.
(3) How the state has a specific interest in the resource or use. Be specific in showing their connection to the coastal zone of the state (
(4) Where the proposed activity overlaps with these resources, uses and values.
(5) Impacts to the resources or uses from the proposed activity.
(6) The causal connection to the proposed activity, including how the impacts from the activity results in reasonably foreseeable effects on the state's coastal uses or resources.
(7) Why any proposed mitigation may be inadequate.
(8) Empirical data and information that supports the effects analysis and: can be shown to be reliable; visualizes the affected area, resources and uses with maps; and shows values, trends and vulnerabilities.
(a) NOAA shall determine on a case-by-case basis whether each program change requires NOAA to take additional actions under any other federal requirement described below.
(1) If a state's program change will affect the resources or interests of any federally-recognized American Indian or Alaska Native tribal government (tribe), NOAA shall contact the affected tribe(s) and determine if Government-to-Government consultation is desired under Executive Order 13175 (Nov. 6, 2000).
(2) If, for the purposes of ESA, NHPA, MSFCMA or MMPA compliance, NOAA determines that a state's program change will have effects on listed threatened or endangered species, historic properties, essential fish habitat or marine mammals, then NOAA shall determine if consultation is needed with the applicable federal agency under the ESA, NHPA, MSFCMA and MMPA.
(3) When NOAA determines whether to consult under other federal statutes or tribal executive orders, NOAA's ability to require changes to a state's proposed program change are limited by the following:
(i) Once NOAA approves a state's management program, NOAA cannot require a state to change its program. NOAA can, through periodic evaluations of a state's management program under section 312 of the Act, establish necessary actions if NOAA finds a state is not adhering to its NOAA-approved program, but NOAA can only recommend that a state change its program to create a different state standard or to address emerging issues; and
(ii) NOAA can approve or disapprove a program change request. When NOAA reviews a program change, NOAA has a limited ability to require a state to make changes to state policies. If NOAA disapproves a program change request, this does not require a state to change state law. Therefore, there is no effect from NOAA's denial on the implementation of state law at the state (or local government) level. NOAA's denial means the disapproved state policy is not part of the state's NOAA-approved management program and cannot be used for CZMA federal consistency purposes. NOAA cannot use a program change to require changes to other parts of a state's management program.
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” This draft guidance contains 15 sections of a multisection guidance intended to provide updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 6, 2017.
You may submit comments as follows:
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 Division of Dockets Management, 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
Submit written requests for single copies of the draft guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487.
We are announcing the availability of a draft guidance for industry entitled “Questions and Answers Regarding Food Facility Registration (Seventh Edition): Guidance for Industry.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
On October 10, 2003, FDA issued an interim final rule (68 FR 58893) to implement amendments to the FD&C Act made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Pub. L. 107-188). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA by December 12, 2003. Section 102 of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended section 415 of the FD&C Act to, among other things, require facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States to submit additional registration information to FDA. Section 102 of FSMA also directed FDA to amend the definition of “retail food establishment” in 21 CFR 1.227. On July 14, 2016, FDA issued a final rule (Registration Final Rule) to amend and update FDA's registration regulation and implement the FSMA revisions (81 FR 45912; July 14, 2016).
This draft guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act. The first edition of the guidance was issued as Level 2 guidance consistent with our good guidance practices regulation (21 CFR 10.115) and was made available on FDA's Web site on December 4, 2003. The second, third, fourth, and fifth editions of the guidance were issued as Level 1 guidance documents under 21 CFR 10.115 and were made available on FDA's Web site on January 12, 2004; February 17, 2004; August 6, 2004; and December 17, 2012, respectively. The sixth edition of the guidance was issued as Level 1 guidance and included one additional question and answer relating to a proposed amendment to the “farm” definition in 21 CFR 1.227 (see 79 FR 58523; September 29, 2014). Since publication of the sixth edition of the guidance, we have issued the Registration Final Rule. In addition, we have issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food final rule (Preventive Controls for Human Food Final Rule) (80 FR 55908; September 17, 2015) that, among other things, revised the definition of “farm” in 21 CFR 1.227. We have also issued the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule (Preventive Controls for Animal Food Final Rule) (80 FR 56169; September 17, 2015). We are issuing a seventh edition of the guidance to add information relating to the Registration Final Rule and the revised “farm” definition, as well as to address questions received from stakeholders since publication of the sixth edition. We are reserving two sections in the draft guidance and will issue a revised draft guidance at a later date that includes those reserved sections. The sections that we are announcing are as follows:
• Section A. Who Must Register?
• Section D: When Must You Register or Renew Your Registration?
• Section E: How and Where Do You Register or Renew Your Registration?
• Section F: What Information is Required in the Registration?
• Section G: What Optional Items are Included in the Registration?
• Section H: How and When Do You Update Your Facility's Registration Information?
• Section I: How and When Do You Cancel Your Facility's Registration Information?
• Section J: What Other Registration Requirements Apply?
• Section K: What are the Consequences of Failing to Register, Renew, Update, or Cancel Your Registration?
• Section L: What Does Assignment of a Registration Number Mean?
• Section M: Is Food Registration Information Available to the Public?
• Section N: Waiver Request
• Section O: General Registration Questions
• Section P: Suspension of Registration
• Section Q: Compliance Dates
We intend to announce the availability for public comment of the remaining sections of the draft guidance in a revised draft guidance.
This edition of the draft guidance also revises information in existing questions and answers, removes some questions and answers, and makes editorial changes (
Persons with access to the Internet may obtain the draft guidance at either
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of
Food and Drug Administration, HHS.
Notice of petition.
The Food and Drug Administration (FDA) is announcing that Novus International, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of poly (2-vinylpyridine-co-styrene) as a nutrient protectant for methionine hydroxy analog in animal food for beef cattle, dairy cattle, and replacement dairy heifers. Additionally, the petition proposes that the food additive regulations be amended to provide for the safe use of ethyl cellulose as a binder for methionine hydroxy analog to be incorporated into animal food.
Submit either electronic or written comments on the petitioner's environmental assessment by December 8, 2016.
You may submit comments as follows:
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 Division of Dockets Management, 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 comment 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
Carissa Doody, Center for Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6283,
Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2295) has been filed by Novus International, Inc., 20 Research Park Dr., Saint Charles, MO 63304. The petition proposes to amend part 573 (21 CFR part 573)
The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see
Environmental Protection Agency.
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve elements of State Implementation Plan (SIP) revisions from the State of Wyoming to demonstrate the State meets infrastructure requirements of the Clean Air Act (Act or CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for ozone on March 12, 2008, lead (Pb) on October 15, 2008, nitrogen dioxide (NO
Written comments must be received on or before December 8, 2016.
Submit your comments, identified by Docket ID No. EPA-R08-OAR-2012-0933 at
Abby Fulton, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6563,
1.
2.
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions and organize your comments;
• Explain why you agree or disagree;
• Suggest alternatives and substitute language for your requested changes;
• Describe any assumptions and provide any technical information and/or data that you used;
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced;
• Provide specific examples to illustrate your concerns, and suggest alternatives;
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats; and,
• Make sure to submit your comments by the comment period deadline identified.
On March 12, 2008, the EPA promulgated a new NAAQS for ozone, revising the levels of the primary and secondary eight-hour ozone standards from 0.08 parts per million (ppm) to 0.075 ppm (73 FR 16436, March 27, 2008). Subsequently, on October 15, 2008, the EPA revised the level of the primary and secondary Pb NAAQS from 1.5 micrograms per cubic meter (μg/m
Under sections 110(a)(1) and (2) of the CAA, states are required to submit infrastructure SIPs to ensure their SIPs provide for implementation, maintenance and enforcement of the NAAQS. These submissions must contain any revisions needed for meeting the applicable SIP requirements of section 110(a)(2), or certifications that their existing SIPs for PM
The EPA is acting upon the SIP submissions from Wyoming that address the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2008 ozone, 2008 Pb, 2010 NO
The EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, the EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA; “regional haze SIP” submissions required by the EPA rule to address the visibility protection requirements of CAA section 169A; and nonattainment new source review (NSR) permit program submissions to address the permit requirements of CAA, title I, part D.
Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.
Examples of some of these ambiguities and the context in which the EPA interprets the ambiguous portions of section 110(a)(1) and 110(a)(2) are discussed at length in our notice of proposed rulemaking: Promulgation of State Implementation Plan Revisions; Infrastructure Requirements for the 1997 and 2006 PM
With respect to certain other issues, the EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction (SSM) that may be contrary to the CAA and the EPA's policies addressing such excess emissions; (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by the EPA; and (iii) existing provisions for Prevention of Significant Deterioration (PSD) programs that may be inconsistent with current requirements of the EPA's “Final NSR Improvement Rule,” 67 FR 80186, Dec. 31, 2002, as amended by 72 FR 32526, June 13, 2007 (“NSR Reform”).
CAA section 110(a)(1) provides the procedural and timing requirements for SIP submissions after a new or revised NAAQS is promulgated. Section 110(a)(2) lists specific elements the SIP must contain or satisfy. These infrastructure elements include requirements such as modeling, monitoring and emissions inventories, which are designed to assure attainment and maintenance of the NAAQS. The elements that are the subject of this action are listed below.
• 110(a)(2)(A): Emission limits and other control measures.
• 110(a)(2)(B): Ambient air quality monitoring/data system.
• 110(a)(2)(C): Program for enforcement of control measures.
• 110(a)(2)(D): Interstate transport.
• 110(a)(2)(E): Adequate resources and authority, conflict of interest, and oversight of local governments and regional agencies.
• 110(a)(2)(F): Stationary source monitoring and reporting.
• 110(a)(2)(G): Emergency powers.
• 110(a)(2)(H): Future SIP revisions.
• 110(a)(2)(J): Consultation with government officials; public notification; and PSD and visibility protection.
• 110(a)(2)(K): Air quality modeling/data.
• 110(a)(2)(L): Permitting fees.
• 110(a)(2)(M): Consultation/participation by affected local entities.
A detailed discussion of each of these elements is contained in the next section.
Two elements identified in section 110(a)(2) are not governed by the three-year submission deadline of section 110(a)(1) and are therefore not addressed in this action. These elements relate to part D of Title I of the CAA, and submissions to satisfy them are not due within three years after promulgation of a new or revised NAAQS, but rather are
The Wyoming Department of Environmental Quality (Department or WDEQ) submitted certification of Wyoming's infrastructure SIP for the 2008 Pb NAAQS on October 12, 2011; 2008 ozone NAAQS on February 6, 2014; 2010 NO
1.
The State's submissions for the 2008 Pb, 2008 ozone 2010 NO
First, this infrastructure element does not require the submittal of regulations or emission limitations developed specifically for attaining the 2008 Pb, 2008 ozone 2010 NO
Second, as previously discussed, the EPA is not proposing to approve or disapprove any existing state rules with regard to director's discretion or variance provisions. A number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109, Nov. 24, 1987), and the agency plans to take action in the future to address such state regulations. In the meantime, the EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.
Finally, in this action, the EPA is also not proposing to approve or disapprove any existing state provision with regard to excess emissions during SSM of operations at a facility. A number of states have SSM provisions which are contrary to the CAA and existing EPA guidance
Therefore, the EPA is proposing to approve Wyoming's infrastructure SIP for the 2008 Pb, 2008 ozone 2010 NO
2.
The State's submissions cite five non-regulatory documents (
We find that Wyoming's SIP and practices are adequate for the ambient air quality monitoring and data system requirements and therefore propose to approve the infrastructure SIP for the
3.
To generally meet the requirements of section 110(a)(2)(C), the State is required to have SIP-approved PSD, nonattainment NSR, and minor NSR permitting programs that are adequate to implement the 2008 Pb, 2010 NO
Wyoming's Rule (02) II, Legal Authority, which the EPA approved into Wyoming's SIP,
With respect to Elements (C) and (J), the EPA interprets the CAA to require each state to make an infrastructure SIP submission for a new or revised NAAQS demonstrating that the air agency has a complete PSD permitting program meeting the current requirements for all regulated NSR pollutants. The requirements of Element D(i)(II) prong 3 may also be satisfied by demonstrating the air agency has a complete PSD permitting program that applies to all regulated NSR pollutants. Wyoming has shown that it currently has a PSD program in place that covers all regulated NSR pollutants, including greenhouse gases (GHGs).
On July 25, 2011 (76 FR 44265), we approved a revision to the Wyoming PSD program that addressed the PSD requirements of the Phase 2 Ozone Implementation Rule promulgated on November 29, 2005 (70 FR 71612). As a result, the approved Wyoming PSD program meets the current requirements for ozone.
With respect to GHGs, on June 23, 2014, the United States Supreme Court addressed the application of PSD permitting requirements to GHG emissions.
In accordance with the Supreme Court decision, on April 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) in
The EPA is planning to take additional steps to revise the federal PSD rules in light of the Supreme Court and subsequent D.C. Circuit opinion. Some states have begun to revise their existing SIP-approved PSD programs in light of these court decisions, and some states may prefer not to initiate this process until they have more information about the planned revisions to the EPA's PSD regulations. The EPA is not expecting states to have revised their PSD programs in anticipation of the EPA's planned actions to revise its PSD program rules in response to the court decisions.
At present, the EPA has determined that Wyoming's SIP is sufficient to satisfy Elements (C), (D)(i)(II) prong 3 and (J) with respect to GHGs. This is because the PSD permitting program previously approved by the EPA into the SIP continues to require that PSD permits issued to “anyway sources” contain limitations on GHG emissions based on the application of BACT. The EPA most recently approved revisions to Wyoming's PSD program on December 6, 2013 (78 FR 73445). The approved Wyoming PSD permitting program still contains some provisions regarding Step 2 sources that are no longer necessary in light of the Supreme Court decision and D.C. Circuit's amended judgment. Nevertheless, the presence of these provisions in the previously-approved plan does not render the infrastructure SIP submission inadequate to satisfy Elements (C), (D)(i)(II) prong 3 and (J). The SIP contains the PSD requirements for applying the BACT requirement to greenhouse gas emissions from “anyway sources” that are necessary at this time. The application of those requirements is not impeded by the presence of other previously-approved provisions regarding the permitting of Step 2 sources. Accordingly, the Supreme Court decision and subsequent D.C. Circuit judgment do not prevent the EPA's approval of Wyoming's infrastructure SIP as to the requirements of Elements (C), (D)(i)(II) prong 3, and (J).
Finally, we evaluate the PSD program with respect to current requirements for PM
On January 4, 2013, the U.S. Court of Appeals, in
The 2008 Implementation Rule addressed by
The court's decision with respect to the nonattainment NSR requirements promulgated by the 2008 Implementation Rule also does not affect the EPA's action on the present infrastructure action. The EPA interprets the Act to exclude nonattainment area requirements, including requirements associated with a nonattainment NSR program, from infrastructure SIP submissions due three years after adoption or revision of a NAAQS. Instead, these elements are typically referred to as nonattainment SIP or attainment plan elements, which would be due by the dates statutorily prescribed under subpart 2 through 5 under part D, extending as far as 10 years following designations for some elements.
The second PSD requirement for PM
Therefore, the EPA is proposing to approve Wyoming's infrastructure SIP for the 2008 Pb, 2008 ozone, 2010 NO
The State has a SIP-approved minor NSR program, adopted under section 110(a)(2)(C) of the Act. The minor NSR program is found in Chapter 6, Section 2 of the WAQSR. The EPA previously approved Wyoming's minor NSR program into the SIP (at that time as Chapter 1, Section 21), and has subsequently approved revisions to the program, and at those times there were no objections to the provisions of this program. (See, for example, 47 FR 5892, February 9, 1982). Since then, the State and the EPA have relied on the State's existing minor NSR program to assure that new and modified sources not captured by the major NSR permitting program do not interfere with attainment and maintenance of the NAAQS.
The EPA is proposing to approve Wyoming's infrastructure SIP for the 2008 Pb, 2010 NO
4.
With regard to the PSD portion of CAA section 110(a)(2)(D)(i)(II), this requirement may be met by a state's confirmation in an infrastructure SIP submission that new major sources and major modifications in the state are subject to a comprehensive EPA-approved PSD permitting program in the SIP that applies to all regulated NSR pollutants and that satisfies the requirements of the EPA's PSD implementation rules.
In-state sources not subject to PSD for a particular NAAQS because they are in
The EPA is proposing to approve the infrastructure SIP submission with regard to the requirements of prong 3 of section 110(a)(2)(D)(i)(II) for the 2008 Pb, 2010 NO
5.
As required by 40 CFR 51.166(q)(2)(iv), Wyoming's SIP-approved PSD program requires major new or modified sources to provide notice to states whose air quality may be impacted by the emissions of sources subject to PSD.
Wyoming has no pending obligations under sections 126(c) or 115(b) of the CAA; therefore, its SIP currently meets the requirements of those sections. In summary, the SIP meets the requirements of CAA section 110(a)(2)(D)(ii), and the EPA is therefore proposing approval of this element for the 2008 Pb, 2008 ozone, 2010 NO
6.
The provisions contained in Articles 1 and 2 of the Wyoming Environmental Quality Act (WEQA) (Chapter 11, Title 35 of the Wyoming Statutes) give the State adequate authority to carry out its SIP obligations with respect to the 2008 Pb, 2008 ozone, 2010 NO
With respect to funding, the State receives sections 103 and 105 grant funds through its Performance Partnership Grant along with required state matching funds to provide funding necessary to carry out Wyoming's SIP requirements.
Wyoming's Performance Partnership Agreement (available within the docket) with the EPA documents resources needed to carry out agreed upon environmental program goals, measures, and commitments, including developing and implementing appropriate SIPs for all areas of the State. Annually, states update these grant commitments based on current SIP requirements, air quality planning, and applicable requirements related to the NAAQS. Wyoming satisfactorily met all commitments agreed to in the Air Planning Agreement for fiscal year 2015. Furthermore, WAQSR Chapter 6, Section 2(a)(v), Permit for construction, modification, and operation, requires the owner and operator of each new major source or major modification to pay a fee sufficient to cover the cost of reviewing and acting on permit applications. Collectively, these rules and commitments provide evidence that the Wyoming DEQ has adequate personnel (
With respect to section 110(a)(2)(E)(iii), the State does not rely upon any other local or regional government, agency or instrumentality for implementation of the SIP. Therefore, we propose to approve Wyoming's SIP as meeting the requirements of section 110(a)(2)(E)(i) and (E)(iii) for the 2008 Pb, 2008 ozone, 2010 NO
Section 110(a)(2)(E)(ii) requires each state's SIP to contain provisions that comply with the requirements of section 128 of the CAA. Section 128 contains two explicit requirements: (i) That “any board or body which approves permits or enforcement orders under [the CAA] shall have at least a majority of members who represent the public interest and do not derive any significant portion of their income from persons subject to permits or enforcement orders” under the CAA; and (ii) that “any potential conflicts of interest by members of such board or body or the head of an executive agency with similar powers be adequately disclosed.”
In our December 6, 2013 (78 FR 73445) action, we disapproved Wyoming's March 26, 2008 and August 19, 2011 infrastructure SIP submissions for the 1997 and 2006 PM
On May 31, 2016, the EPA received a submission from the State of Wyoming to address the requirements of section 128 by adopting revisions to Chapter 1, Section 16 of the Wyoming Department of Environmental Quality General Rules of Practice and Procedure. The Wyoming Environmental Quality Council approved these revisions on March 2, 2016. A copy of the submission, which includes as revisions, the addition of Section 16, Air Quality Division, State Implementation Plan, to Chapter 1, is available within this docket. These rules address board composition and conflict of interest requirements of section 128(a)(1) and (2). We propose to approve this new rule language as meeting the requirements of section 128 for the reasons explained in more detail below. Because this revision meets the requirements of section 128, we also propose to approve the State's infrastructure SIP submissions for element 110(a)(2)(E)(ii). The State submitted the provisions to meet section 128 separately, but section 128 is not
We are proposing to approve the State's May 31, 2016 SIP submission as meeting the requirements of section 128 because we believe that it complies with the statutory requirements and is consistent with the EPA's guidance recommendations concerning section 128. In 1978, the EPA issued a guidance memorandum recommending ways states could meet the requirements of section 128, including suggested interpretations of certain key terms in section 128.
In implementing section 128, the EPA has identified a number of key considerations relevant to evaluation of a SIP submission. The EPA has identified these considerations in the 1978 guidance and in subsequent rulemaking actions on SIP submissions relevant to section 128, whether as SIP revisions for this specific purpose or as an element of broader actions on infrastructure SIP submissions for one or more NAAQS.
Each state must meet the requirements of section 128 through provisions that the EPA approves into the state's SIP and are thus made federally enforceable. Section 128 explicitly mandates that each SIP “shall contain requirements” that satisfy subsections 128(a)(1) and 128(a)(2). A mere narrative description of state statutes or rules, or of a state's current or past practice in constituting a board or body and in disclosing potential conflicts of interest, is not a requirement contained in the SIP and does not satisfy the plain text of section 128.
Subsection 128(a)(1) applies only to states that have a board or body that is composed of multiple individuals and that, among its duties, approves permits or enforcement orders under the CAA. It does not apply in states that have no such multi-member board or body that performs these functions, and where instead a single head of an agency or other similar official approves permits or enforcement orders under the CAA. This flows from the text of section 128, for two reasons. First, as subsection 128(a)(1) refers to a majority of members of the board or body in the plural, we think it reasonable to read subsection 128(a)(1) as not creating any requirements for an individual with sole authority for approving permits or enforcement orders under the CAA. Second, subsection 128(a)(2) explicitly applies to the head of an executive agency with “similar powers” to a board or body that approves permits or enforcement orders under the CAA, while subsection 128(a)(1) omits any reference to heads of executive agencies. We infer that subsection 128(a)(1) should not apply to heads of executive agencies who approve permits or enforcement orders. States with no multi-member board or body that performs these functions, and instead have a single head of an agency or other similar official who approves CAA permits or enforcement orders, can satisfy the requirements of CAA 128(a)(1) with a negative declaration to that effect.
Subsection 128(a)(2) applies to all states, regardless of whether the state has a multi-member board or body that approves permits or enforcement orders under the CAA. Although the title of section 128 is “State boards,” the language of subsection 128(a)(2) explicitly applies where the head of an executive agency, rather than a board or body, approves permits or enforcement orders. In instances where the head of an executive agency delegates his or her power to approve permits or enforcement orders, or where statutory authority to approve permits or enforcement orders is nominally vested in another state official, the requirement to adequately disclose potential conflicts of interest still applies. In other words, the EPA interprets section 128(a)(2) to apply to all states, regardless of whether a state board or body approves permits or enforcement orders under the CAA or whether a head of a state agency (or his/her delegates) performs these duties. Thus, all state SIPs must contain provisions that require adequate disclosure of potential conflicts of interest in order to meet the requirements of subsection 128(a)(2). The question of which entities or parties must be subject to such disclosure requirements must be evaluated by states and the EPA in light of the specific facts and circumstances of each state's regulatory structure.
A state may satisfy the requirements of section 128 by submitting for adoption into the SIP a provision of state law that closely tracks or mirrors the language of the applicable provisions of section 128. A state may take this approach in two ways. First, the state may adopt the language of subsections 128(a)(1) and 128(a)(2) verbatim. Under this approach, the state will be able to meet the continuing requirements of section 128 without any additional, future SIP revisions, even if the state adds or removes authority, either at the state or local level, to individual or to boards or bodies to approve permits or enforcement orders under the CAA so long as the state continues to meet section 128 requirements.
Second, the state may modify the language of subsections 128(a)(1) (if applicable) and 128(a)(2) to name the particular board, body, or individual official with approval authority. In this case, if the state subsequently modifies that authority, the state may have to submit a corresponding SIP revision to meet the continuing requirements of section 128. If the state chooses to not mirror the language of section 128, the state may adopt state statutes and/or regulations that functionally impose the same requirements as those of section 128, including definitions for key terms such as those recommended in the EPA's 1978 guidance. While either of these approaches would meet the minimum requirements of section 128, the statute also explicitly authorizes states to adopt more stringent requirements, for example, to impose additional requirements for recusal of board members from decisions, above and beyond the explicit board composition requirements. Although such recusal alone does not meet the requirements of section 128, states have the authority to require such recusal over and above the explicit requirements of section 128. These approaches give states flexibility in implementing section 128, while still ensuring consistency with the statute.
As previously explained, the EPA interprets subsection 128(a)(1) to apply only to states that have a board or body with multiple members that, among its duties, approves permits or enforcement orders under the Act. Wyoming's Environmental Quality Act establishes the Environmental Quality Council (EQC or Council), a separate agency of state government. See Wyoming Statutes 35-11-111(a). The members of the Council are appointed by the Governor. Among the duties of the Council are conducting hearings in any case contesting the administration or enforcement of any law, rule, regulation, standard or order issued or administered by DEQ or by any division of DEQ.
Given the duties and authorities of the Council, the Council appears to be a “board or body which approves permits or enforcement orders” under the CAA.
The State's May 31, 2016 submittal includes requirements that Council members “disclose any potential conflicts of interest in a public meeting of the Council as required by the Clean Air Act, Section 128(a)(2).” Thus, Wyoming's submittal addresses disclosure of potential conflicts of interest from Council members that approve permits and enforcement orders under the Act. We therefore propose to approve this submission as satisfying the requirements of subsection 128(a)(2).
In summary, the EPA proposes to approve Wyoming's May 31, 2016 submittal into the SIP to meet the requirements of section 128 of the Act. We also propose to approve Wyoming's infrastructure SIP with respect to the requirements of Section 110(a)(2)(E)(ii) for 2008 Pb, 2008 ozone
7.
Wyoming's SIP approved monitoring provision cited by Wyoming in its certifications (WAQSR Chapter 6, Section 2, Permit requirements for construction, modification, and operation), pertains to its program of periodic emissions testing and plant inspections of stationary sources, and related testing requirements and protocols (including periodic reporting) to assure compliance with emissions limits. Additionally, WAQSR Chapter 7, Section 2 (Continuous monitoring requirements for existing sources), requires certain sources to install and maintain continuous emission monitors to assure compliance with emission limitations.
Furthermore, Wyoming is required to submit emissions data to the EPA for purposes of the National Emissions Inventory (NEI). The NEI is the EPA's central repository for air emissions data. The EPA published the Air Emissions Reporting Rule (AERR) on December 5, 2008, which modified the requirements for collecting and reporting air emissions data (73 FR 76539). The AERR shortened the time states had to report emissions data from 17 to 12 months, giving states one calendar-year to submit emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through the EPA's online Emissions Inventory System. States report emissions data for the six criteria pollutants and their associated precursors—nitrogen oxides, sulfur dioxide, ammonia, lead, carbon monoxide, particulate matter and volatile organic compounds. Many states also voluntarily report emissions of hazardous air pollutants. Wyoming made its latest update to the NEI in May 2016. The EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the Web site
Based on the analysis above, we propose to approve the Wyoming SIP as meeting the requirements of CAA section 110(a)(2)(F) for the 2008 Pb, 2008 ozone
8.
Under CAA section 303, the EPA Administrator has authority to bring suit to immediately restrain an air pollution source that presents an “imminent and substantial endangerment to public health or welfare, or the environment.”
Wyoming's SIP certifications with regard to the section 110(a)(2)(G) emergency order requirements cite EPA approved provisions (WAQSR Chapter 12, Section 2, Air pollution emergency episodes) which establish a basis for the Division to issue notices to the public relating to levels of air pollution from “alerts,” “warnings,” and “emergencies” to prevent “a substantial threat to the health of persons” if “such [pollution] levels are sustained or exceeded” in places that are attaining or have attained such pollution levels. WAQSR Chapter 12, Section 2(a) allows for the broad application of this provision to “air pollutants” beyond PM
Furthermore, as stated in Wyoming's 2012 PM
While no single Wyoming statute mirrors the authorities of CAA section 303, we propose to find that the combination of WEQA and WAQSR provisions previously discussed provide for authority comparable to section 303. Section 303 authorizes the Administrator to immediately bring suit to restrain and issue emergency orders when necessary, and to take prompt administrative action against any person causing or contributing to air pollution that presents an imminent and substantial endangerment to public health or welfare, or the environment. Therefore, we propose that Wyoming's SIP submittals sufficiently meet the requirements of CAA 110(a)(2)(G) because they demonstrate that Wyoming has authority comparable to CAA section 303.
States must also have adequate contingency plans adopted into their SIP to implement the air agency's emergency episode authority (as previously discussed). This can be done by submitting a plan that meets the applicable requirements of 40 CFR part 51, subpart H for the relevant NAAQS if the NAAQS is covered by those regulations. The EPA approved Wyoming's Emergency Episode Plan on February 9, 1982 at 47 FR 5892. We find that Wyoming's Emergency Episode Plan and air pollution emergency rules (WAQSR Chapter 12, Section 2, Air pollution emergency episodes) include PM
As noted in the 2011 Memo “based on [the] EPA's experience to date with the Pb NAAQS and designating Pb nonattainment areas, [the] EPA expects that an emergency episode associated with Pb emissions would be unlikely and, if it were to occur, would be the result of a malfunction or other emergency situation at a relatively large source of Pb” (page 14).
Based on the above analysis, we propose approval of Wyoming's SIP as meeting the requirements of CAA section 110(a)(2)(G) for the 2008 Pb, 2008 ozone, and 2010 NO
9.
The general provisions in Article 1 of the WEQA (Article 1, Chapter 11, Title 35 of the Wyoming Statutes) and the particular provision in Article 2, section 35-11-202 of the Wyoming Statutes, gives the Director sufficient authority to meet the requirements of CAA section 110(a)(2)(H). Therefore, we propose to approve Wyoming's SIP as meeting the requirements of CAA section 110(a)(2)(H).
10.
In its certifications, the State cites one non-regulatory document relative to consultation with government officials (
Wyoming's SIP regulations for its PSD program were first federally-approved and made part of the SIP on September 6, 1979 (44 FR 51977). The EPA has further evaluated the State's SIP-approved PSD program in section VI.3 which discusses element 110(a)(2)(C) of this proposed action. As explained in that section, we propose to approve Wyoming's infrastructure SIPs for the 2008 Pb, 2010 NO
Finally, with regard to the applicable requirements for visibility protection, the EPA recognizes states are subject to visibility and regional haze program requirements under part C of the Act. In the event of the establishment of a new NAAQS, however, the visibility and regional haze program requirements under part C do not change. Thus, we find that there are no applicable visibility requirements under section 110(a)(2)(J) when a new NAAQS becomes effective.
Based on the above analysis, we propose to approve the Wyoming SIP as meeting the requirements of CAA section 110(a)(2)(J) for the 2008 Pb, 2008 ozone
11.
Wyoming's PSD program requires that estimates of ambient air concentrations be based on applicable air quality models specified in appendix W of 40 CFR part 51, and that modification or substitution of a model specified in appendix W must be approved by the Administrator (see WAQSR Chapter 6, Section 2(b)(iv)). Additionally, WAQSR Chapter 6, Section 2(f)(iv) authorizes the AQD Administrator to impose any reasonable conditions upon an approval to construct, modify or operate, including modeling “. . . to determine the effect which emissions from a source may have, or is having, on air quality in any area which may be affected by emissions from such source.” Furthermore, the WEQA 35-11-1101(b) and Wyoming's PPA provide Wyoming with the authority to submit air quality modeling date to the Administrator.
Therefore, we propose to approve the Wyoming SIP as meeting CAA section 110(a)(2)(K) for the 2008 Pb, 2008 ozone
12.
WAQSR Chapter 6, Section 2, paragraph (o) and WEQA sections 35-11-211(a), Fees, require applicants of construction permits to pay the costs for DEQ to review and act on the permit applications. We also note that fees collected under Wyoming's approved title V permit program (64 FR 8523, Feb, 22, 1990) are sufficient to implement and enforce the program (
13.
The non-regulatory document, Intergovernmental Cooperation, cited in Wyoming's submittals meets the requirements of CAA section 110(a)(2)(M). We propose to approve Wyoming's SIP as meeting these requirements for the 2008 Pb, 2008 ozone, 2010 NO
In this action, the EPA is proposing to approve infrastructure elements for the 2008 Pb, 2008 ozone, 2010 NO
A comprehensive summary of infrastructure elements, and additions to the Wyoming DEQ Rules of Practice and Procedures organized by the EPA's proposed rule action are provided in Table 1 and Table 2.
In this rulemaking, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the Wyoming Department of Environmental Quality General Rules of Practice and Procedure, Chapter 1, General Provisions, Section 16, Air Program State Implementation Plan Chapter 1, General Provisions, Section 16, Air Program State Implementation Plan pertaining to state board requirements VI.6. b.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves some state law as meeting federal requirements and disapproves other state law because it does not meet federal requirements; this proposed action does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, Oct. 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, Aug. 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 the 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, Feb. 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the 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).
Environmental protection, Air pollution control, Carbon monoxide, Greenhouse gases, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Federal Communications Commission.
Proposed rule.
This document proposes revisions to Wireless Emergency Alert (WEA) rules to improve WEA, leveraging advancements in technology to improve WEA's multimedia, multilingual and geo-targeting capabilities, as well as lessons learned from alert originators' experience since WEA was initially deployed. This document also proposes steps to improve the availability of information about WEA, both to empower consumers to make informed choices about the emergency information that they will receive, as well as to promote transparency for emergency management agencies and other WEA stakeholders. By this action, the Commission affords interested parties an opportunity to participate more fully in WEA, and to enhance the utility of WEA as an alerting tool.
Comments are due on or before December 8, 2016 and reply comments are due on or before January 9, 2017.
You may submit comments, identified by PS Docket No. 15-91, P.S. Docket No. 15-94, FCC 16-127, by any of the following methods:
•
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
James Wiley, Attorney Advisor, Public Safety and Homeland Security Bureau, at (202) 418-1678, or by email at
This is a summary of the Commission's Further Notice of Proposed Rulemaking in PS Docket No. 15-91, No. 15-94, FCC 16-127, released on September 29, 2016. The document is available for download at
This Further Notice of Proposed Rulemaking seeks comment on potential new or revised proposed information collection requirements. If the Commission adopts any new or revised final information collection requirements when the final rules are adopted, the Commission will publish a notice in the
1. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), we have prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this
2. With this
3. Specifically, with respect to ensuring the provision of effective WEA Alert Messages, we propose to establish clear definitions and requirements for CMS Providers participating in WEA in whole and in part. We ensure the provision of effective WEA Alert Messages by removing language from our rules that may contribute to emergency management agencies' uncertainty about WEA's quality of service. We require Participating CMS Providers to offer subscribers a method of accessing pending Alert Messages. We propose to require that earthquake-related alerts be delivered to the public in fewer than three seconds. We also seek comment on how to leverage the improvements to WEA that we adopt today to continue to improve WEA's value during disaster relief efforts. With respect to incorporating future technical advancements into WEA, we seek comment on and propose of a number of technological innovations that could expand WEA's multimedia, multilingual and geo-targeting capabilities, including innovations on 5G networks. With respect to developing consumer education tools, we propose to promote more informed consumer choice through improvements to the point-of-sale notifications for Participating CMS Providers' mobile devices, and to the WEA interface. Finally, we propose to improve WEA transparency through requiring Participating CMS Providers to disclose their performance along three key metrics, latency, geo-targeting, and reliability, and we seek comment on whether additional alert logging could be instrumental in allowing them to collect relevant data.
4. This
5. The proposed action in this
6. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term
7.
8.
9.
10. On January 26, 2001, the Commission completed the auction of 422 C and F Block Broadband PCS licenses in Auction No. 35. Of the 35 winning bidders in that auction, 29 claimed small business status. Subsequent events concerning Auction 35, including judicial and agency determinations, resulted in a total of 163 C and F Block licenses being available for grant. On February 15, 2005, the Commission completed an auction of 242 C-, D-, E-, and F-Block licenses in Auction No. 58. Of the 24 winning bidders in that auction, 16 claimed small business status and won 156 licenses. On May 21, 2007, the Commission completed an auction of 33 licenses in the A, C, and F Blocks in Auction No. 71. Of the 12 winning bidders in that auction, five claimed small business status and won 18 licenses. On August 20, 2008, the Commission completed the auction of 20 C-, D-, E-, and F-Block Broadband PCS licenses in Auction No. 78. Of the eight winning bidders for Broadband PCS licenses in that auction, six claimed small business status and won 14 licenses.
11.
12.
13.
14.
15. In 2007, the Commission reexamined its rules governing the 700 MHz band in the
16.
17.
18.
19. In 2009, the Commission conducted Auction 86, the sale of 78 licenses in the BRS areas. The Commission offered three levels of bidding credits: (i) A bidder with attributed average annual gross revenues that exceed $15 million and do not exceed $40 million for the preceding three years (small business) received a 15 percent discount on its winning bid; (ii) a bidder with attributed average annual gross revenues that exceed $3 million and do not exceed $15 million for the preceding three years (very small business) received a 25 percent discount on its winning bid; and (iii) a bidder with attributed average annual gross revenues that do not exceed $3 million for the preceding three years (entrepreneur) received a 35 percent discount on its winning bid. Auction 86 concluded in 2009 with the sale of 61 licenses. Of the ten winning bidders, two bidders that claimed small business status won 4 licenses; one bidder that claimed very small business status won three licenses; and two bidders that claimed entrepreneur status won six licenses.
20. In addition, the SBA's Cable Television Distribution Services small business size standard is applicable to EBS. There are presently 2,436 EBS licensees. All but 100 of these licenses are held by educational institutions. Educational institutions are included in this analysis as small entities. Thus, we
21.
22.
23.
24.
25. In addition, an element of the definition of “small business” is that the entity not be dominant in its field of operation. We are unable at this time to define or quantify the criteria that would establish whether a specific television station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply do not exclude any television station from the definition of a small business on this basis and are therefore over-inclusive to that extent. Also as noted, an additional element of the definition of “small business” is that the entity must be independently owned and operated. We note that it is difficult at times to assess these criteria in the context of media entities and our estimates of small businesses to which they apply may be over-inclusive to this extent. There are also 2,117 low power television stations (LPTV). Given the nature of this service, we will presume that all LPTV licensees qualify as small entities under the above SBA small business size standard.
26. The Commission has, under SBA regulations, estimated the number of licensed NCE television stations to be 380. We note, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. Our estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from
27. This
28. We propose to require Participating CMS Providers, to gather, analyze and report on system performance metrics such as the geo-targeting, latency, and availability and reliability. We propose to require Participating CMS Providers to offer potential subscribers notice at the point of sale that more accurately reflects the extent to which they will offer WEA. We seek comment on whether Participating CMS Providers should be required to update their election to participate in WEA. We seek comment on the costs of compliance.
29. The RFA requires an agency to describe any significant alternatives that it has considered in developing its approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
30. As noted in paragraph 1 above, this
31. With respect to ensuring the provision of effective WEA Alert Messages, we seek comment on whether there are any particular considerations that we should take into account when defining the nature of a Participating CMS Provider's participation in WEA due to the electing entity's size. We also seek comment on whether non-nationwide Participating CMS Providers require the regulatory flexibility implicated by certain provisions of Sections 10.330 and 10.500, and if so, whether we should retain the flexibility that the current language of those rules may provide only as applicable to them. With respect to incorporating technical advancements to improve WEA, we seek comment on whether support for additional languages would be unduly burdensome for non-nationwide Participating CMS Providers, and if so, whether there are steps that we can take to accommodate these entities to make compliance more feasible. We also seek comment on whether alternative geo-targeting standards would be appropriate for non-nationwide Participating CMS Providers. With respect to developing consumer education tools, we seek comment on whether we should give special consideration to non-nationwide entities if we were to require Participating CMS Providers to offer a consistent menu of opt-out choices, and on whether non-nationwide Participating CMS Providers should be required to make more lenient disclosures at the point of sale. Finally, with respect to improving WEA transparency, we propose the use of performance, rather than design standards to collect information relevant to our analysis of WEA's system integrity. We also seek comment on whether it would be appropriate to adopt an alternative, less frequent reporting requirement for non-nationwide Participating CMS Providers, and on whether such Participating CMS Providers should also be allowed to collect less granular data on system performance in order to reduce any cost burdens entailed by these proposed recordkeeping and reporting requirements.
32. None.
33. We propose to adopt definitions for participation in WEA “in whole” and “in part” based on the attestations that CMS Providers are required to offer in their election letters, and on the notifications that CMS Providers offer potential subscribers at the point of sale. Specifically, we propose to define CMS Providers participating in WEA “in whole” as CMS Providers that have agreed to transmit WEA Alert Messages in a manner consistent with the technical standards, protocols, procedures, and other technical requirements implemented by the Commission in the entirety of their geographic service area and to all mobile devices on their network. Similarly, we propose to define CMS Providers participating in WEA “in part” as CMS Providers that have agreed to transmit WEA Alert Messages in a manner consistent with the technical standards, protocols, procedures, and other technical requirements implemented by the Commission in some, if not all of their geographic service area, and to some, if not all of the mobile devices on their network. We seek comment on these proposed definitions for CMS Provider participation in WEA. What are the technical prerequisites to offering WEA in a geographic area where a commercial mobile service is available? What factors lead Participating CMS Providers to offer WEA in a geographic area smaller than the area in which they offer commercial mobile service, or to fewer than all mobile devices on their network?
34. We also seek comment on our proposal to incorporate the extent to which CMS Providers offer WEA on mobile devices on their networks into our definitions of participation in whole and in part. Bluegrass Cellular states that “participation in whole has no bearing on the number or percentage of devices on the network that are WEA capable.” If this were the case, however, could a CMS Provider that offers WEA on only one mobile device qualify as participating in whole? Would this be consistent with a common-sense interpretation of “in whole” participation, or with our requirement that only CMS Providers participating in part must disclose at the point of sale
35. If participation in WEA in whole entails offering WEA on all mobile devices on the network, we seek comment on how “mobile devices” should be defined. For purposes of WEA, Section 10.10(j) defines “mobile devices” as “[t]he subscriber equipment generally offered by CMS providers that supports the distribution of WEA Alert Messages.” This definition would encompass any mobile device connected to a Participating CMS Providers' network that is capable of receiving WEA Alert Messages, including but not limited to LTE-enabled and future generation tablet computers, and phablets. The record shows, however, that there is significant variation among Participating CMS Providers with respect to mobile devices on their networks that support WEA capability. For example, the Department of Homeland Security's
36. In addition to defining participation in WEA in whole and in part with reference to the extent to which Participating CMS Providers offer WEA in the entirety of their geographic service area and to all mobile devices operating on their networks, we seek comment on whether these definitions should include the extent to which Participating CMS Providers make WEA available using all available network technologies. To what extent should Participating CMS Providers' attestation that they will “support the development and deployment of technology for the `C' interface, the CMS Provider Gateway, the CMS Provider infrastructure, and mobile devices with WEA functionality” be read as a commitment to support WEA using all available network technologies? To what extent do Participating CMS Providers currently use available technologies, such as Wi-Fi and small cells, in support of their WEA deployments? To the extent that Participating CMS Providers do not leverage all available technologies to further their participation in WEA, we seek comment on any factors that have contributed to this decision. We seek comment on any additional technologies already commercially deployed in CMS networks that could be leveraged in support of WEA, and on any additional functionalities that they may enable.
37. We seek comment on whether, in the event we adopt new definitions for participation in WEA, it would be appropriate to require CMS Providers to refresh and renew their election to participate in WEA. Further, notwithstanding whether we ultimately adopt new definitions for WEA participation, have the nature of CMS networks (having evolved from 2 and 3G to 4G technologies) and the requirements of Part 10 changed sufficiently since WEA's deployment to merit a renewed election? How frequently, if at all, should Participating CMS Providers be required to update their election in order to provide the Commission and the public with an up-to-date account of their WEA service offerings? Alternatively, should the occurrence of a certain event or events trigger a Participating CMS Provider's obligation to renew their election? If so, what specific event or events should give rise to a requirement for a Participating CMS Provider to renew their election? We seek comment on steps that we can take to mitigate any burden that disclosure of this information may present for Participating CMS Providers, and especially non-nationwide Participating CMS (
38. We anticipate that adopting these definitions for the modes of Participation in WEA would improve long-term participation in WEA while incenting achievement of evolving WEA objectives, consistent with Participating CMS Providers technology refresh cycle. We seek comment on this analysis. What steps can we take to encourage Participating CMS Providers to increase their engagement with WEA voluntarily? Further, we seek comment on whether clearly delineated modes of participation in WEA, taken together with a renewed election requirement, would facilitate emergency management agencies' response planning efforts by evincing the extent to which WEA is available in local communities. To what extent could information about each Participating CMS Provider's WEA service offerings by geographic area, device, and technology facilitate community reliance on WEA as an emergency management tool? What steps can we take to make this information as useful as possible to emergency management agencies while limiting burdens on Participating CMS Providers? Are there alternative approaches that we could consider in order to accomplish our objective of incenting increased engagement with WEA by Participating CMS Providers and emergency management agencies?
39. We propose to amend Sections 10.330 and 10.500 to delete parallel statements that “WEA mobile device functionality is dependent on the capabilities of a Participating CMS Provider's delivery technologies” and that “[i]nfrastructure functions are dependent upon the capabilities of the delivery technologies implemented by a Participating CMS Provider.” Since the time these provisions were adopted, Participating CMS Providers have overwhelmingly elected to utilize cell broadcast technology in fulfillment of their WEA election. Participating CMS Providers' infrastructure has proven to be universally capable of the basic functionalities described by Section 10.330 and 10.500. Accordingly, we believe these provisions are no longer necessary. Moreover, removing these provisions from our Part 10 rules would likely clarify for emergency management agencies considering whether to become authorized as WEA alert initiators that the alerting service WEA offers is capable of providing these critical functions, especially when taken together with the performance reporting and alert logging requirements
40. We seek comment on whether Providers CMS Providers, and particularly non-nationwide CMS Providers (small, rural or regional Participating CMS Providers), continue to require the flexibility that this language may provide. There is no record about why these caveats remain necessary given changes in technology over the four years since WEA's deployment. Does the flexibility that this language may provide enable CMS Providers to participate in WEA that otherwise would be unable to do so? We invite comment from any Participating CMS Provider that would no longer be able to participate in WEA in whole or in part were we to remove this language from Sections 10.330 and 10.500. Such commenters should specify the manner in which their WEA service would be unable to comply with the requirements of Sections 10.330 and 10.500 were we to remove the prefatory language from those Sections, while still being capable of providing the WEA service described elsewhere in Part 10. Similarly, would removing this language make any WEA-capable mobile devices incapable of continuing to support WEA? If so, why? We seek comment on whether, if we retain this language at all, it should be modified to apply only to non-nationwide Participating CMS Providers.
41. We propose to amend Section 10.500 to state that WEA-capable mobile devices must preserve Alert Messages in an easily accessible format and location until the Alert Message expires. We seek comment on this proposal. We seek comment on the various approaches that Participating CMS Providers currently take to Alert Message preservation, and on any best practices that have emerged in this area. We seek comment on whether we should standardize the manner in which Participating CMS Providers preserve Alert Messages, informed by relevant best practices.
42. We seek comment on the extent to which Participating CMS Providers currently offer users the ability to access Alert Messages after they have been viewed and dismissed. Is Blackberry, Android and Windows' practice of providing access to dismissed Alert Messages in an “inbox” or in “message history” consistent among all devices and providers? Section 10.420 specifies “Expiration Time” as a required CAP element in WEA Alert Messages. Is it feasible to use this CAP element as a basis for identifying the time at which an Alert Message should be discarded? If WEA Alert Messages are retained past this expiration time, Denver OEMHS expresses concern that users will view expired Alert Messages and assume that they are current, causing confusion and panic. Where Alert Messages are preserved for user review, for how long are they preserved? If Alert Messages continue to be preserved after the underlying emergency condition has expired, are expired Alert Messages clearly marked as such to prevent user confusion? To what extent do Participating CMS Providers' existing practices achieve our goal of providing subscribers with a straightforward method of accessing Alert Messages until they expire?
43. Based on the comments, we believe that having continued access to WEA Alert Messages, including information regarding protective measures the public can take to protect life and property, could promote superior public safety outcomes. NYCEM and APCO have already suggested several use cases in which public response outcomes could be improved through easy access to active Alert Messages, such as to review details about shelter locations and commodity distribution points, and to recall complex information presented in longer WEA Alert Messages. Further, FEMA states that requiring appropriate alert preservation “would reduce user confusion, make training easier, and would require only one educational campaign if preservation was consistent across platforms.” FEMA further states that requiring appropriate alert preservation “could alleviate some milling behavior, as some will search for alerts on the internet once dismissed to find the content.” We seek comment on these analyses, as well as on additional use cases in which access to pending Alert Messages could have public safety benefits.
44. As we discussed in the
45. We propose to require Participating CMS Providers to deliver earthquake-related Alert Messages to the public in fewer than three seconds, measured from the time an earthquake-related Alert Message is created to when it is delivered and displayed at the mobile device. We seek comment on the parameters for WEA to deliver earthquake alerts in less than three seconds, including any operational or regulatory changes that may be necessary in order to achieve this objective. We seek comment on the appropriate points by which to measure the applicable delivery timeframe. Should the applicable timeframe be measured from the time the alert originator issues the earthquake alert to the time it arrives at the end user device? In order to meet our end-to-end latency objective while respecting the limitations of Participating CMS Provider infrastructure, should the delivery delay from the IPAWS Alert Gateway to the end user be limited to two seconds? If Alert Messages are not received by all WEA-capable mobile devices in the target area simultaneously, how should we determine whether earthquake alerts are being delivered on time to meet our proposed requirement? We seek comment on these proposals, as well as any potential alternatives. We also seek
46. In order to help eliminate any delays that could unnecessarily affect the delivery of an earthquake alert, we seek comment on whether we should require prioritization of earthquake-related Alert Messages at the CMS Provider Alert Gateway by processing them “upon receipt,” before any non-Presidential Alert that may also be queued for transmission. We expect that prioritization at the CMS Provider Alert Gateway would remove the possibility of any queuing delay that may occur due to simultaneous arrival of multiple alerts. We seek comment on the extent to which prioritizing earthquake alerts at the Alert Gateway would reduce their end-to-end latency in instances where the Alert Gateway is processing more than one Alert Message at a time, as well as in other instances. We also seek comment on whether it would be appropriate to prioritize earthquake alerts in transit over other Alert Messages or control channel activity if giving them elevated priority at the Participating CMS Provider Alert Gateway would not sufficiently reduce delivery latency for them to arrive on time to save lives. We note that WEA Alert Message segments are transmitted by the Radio Access Network (RAN) every 80ms to 5.12 seconds. Could standardizing the transmission periodicity of WEA message segments reduce end-to-end alert delivery latency for all WEA Alert Messages? What are the advantages and disadvantages of shorter WEA transmission periods? Can they be changed dynamically? We seek comment on the extent to which giving earthquake alerts priority at the Alert Gateway, in transit, and through other means could enable earthquake-related Alert Messages to be delivered to the public in fewer than three seconds. Even if prioritization of earthquake alerts at the Alert Gateway, by itself, would not be sufficient, should we require such prioritization as an intermediate step towards this goal? We also seek comment on whether any other types of events merit higher priority treatment because of their extreme time sensitivity (
47. We seek comment on any technical issues that prioritizing earthquake alerts in transit might present for Participating CMS Providers, and on when this standard could feasibly be achieved. In the alternative, we seek comment on whether a different Alert Message latency requirement would strike a more appropriate balance between the costs of prioritization and the benefits of earthquake early warning. With respect to AT&T's perspective that changing the way that Alert Messages are prioritized would require a “re-design of the entire system,” we seek comment on what, if any aspects of the WEA system would need to be redesigned in order to allow earthquake alerts to be delivered to the public in fewer than three seconds. Why, if at all, would changing the way that the Participating CMS Provider Alert Gateway prioritizes WEA Alert Messages affect any aspect of the WEA system other than the Participating CMS Provider Alert Gateway itself? From a technical standpoint, how is it currently possible to prioritize Presidential Alerts but not other types of Alert Messages? We anticipate that changing the manner in which this Gateway handles earthquake alerts would necessitate revisions to Gateway software, and relevant standards. We seek comment on this analysis. Can the Participating CMS Provider Alert Gateway's standards and software be updated to allow it to distinguish earthquake alerts from other Imminent Threat Alerts, for example, by reference to the its CAP “event code” parameter? If not, what steps should we take to allow for earthquake-related alerts to be treated differently from other Imminent Threat Alerts? We anticipate that reducing the end-to-end latency for earthquake alerts will facilitate the use of WEA during such incidents, providing a unique mechanism in the United States for warning the public about earthquakes before the damaging tremors occur. We observe that Japan's Earthquake and Tsunami Warning System (ETWS) is currently the only earthquake early warning service in the world that integrates mass earthquake-related communications with cellular networks. We anticipate that making WEA an effective platform for early earthquake warnings could, in combination with other earthquake mitigation efforts, help to mitigate the $4.4 billion dollars in earthquake-related losses FEMA estimates that the United States suffers annually, by saving lives and preventing and mitigating injuries, thereby reducing income loss and by helping to mitigate damage to infrastructure by alerting members of the public who are in a position to take preparatory actions to prevent damage in the event of an earthquake. We seek comment on this analysis, including to on the extent to which such prioritization would mitigate earthquake-related losses and on the costs of any related upgrades to WEA to permit such prioritization.
48. Commenters address several potential uses for WEA as a secondary messaging service,
49. In light of the foregoing, we seek comment on the potential for WEA to serve as a secondary messaging tool for emergency managers, specifically during disaster relief efforts. Specifically, we seek comment on how to enhance WEA's support for many-back-to-one communication to facilitate emergency managers' response planning efforts, and on whether WEA can be made a more useful tool during and after emergencies by facilitating its ability to interface other authoritative sources of information. Are there existing needs or gaps in the public communications tools currently available to emergency managers for use during disaster relief efforts that WEA can fill? What, if any, critical capacities does WEA lack that could inhibit its utility for post-disaster communications?
50. We seek comment on improvements to WEA that we should consider in order to ensure that it is optimized for this use, including by enabling WEA to be used as a tool for queueing the collection of targeted community feedback during disaster recovery efforts, to measure evacuation effectiveness, and during active shooter scenarios, as recommended by CSRIC V. We seek comment on whether using WEA in this manner could assist emergency management agencies' resource-need pairing during emergencies, and on any additional use cases where “many-to-one” feedback could improve emergency response. We seek comment from technology vendors who have developed innovative solutions to aggregating and analyzing public response on the potential for implementation of those technologies in the emergency management context. We seek comment on whether best practices based in data science literacy are available to facilitate emergency managers' skillful use of targeted community feedback, and if not, on whether we should direct the Public Safety and Homeland Security Bureau to convene a panel of experts to produce recommendations for this purpose, as recommended by CSRIC V. We also seek comment on the extent to which WEA can be used to funnel milling behavior towards other authoritative sources of information, such as radio or television, that may be better fit to provide critical information to the public in certain circumstances. Would such an approach make WEA more useful to emergency managers in disaster relief situations?
51. As noted above, we are committed to allowing the public to realize the benefits of multimedia content in WEA, and we propose that an appropriate path to achieve this goal would be to require support for certain multimedia content, including thumbnail-sized images and hazard symbols, in Public Safety Messages on 4G LTE and future networks. We recognize that Participating CMS Providers have concerns about message delivery latency and network congestion that may result from including multimedia in WEA Alert Messages. Further, we acknowledge the record indicates that further standards development is necessary to support multimedia capabilities in WEA. As we discuss in further detail below, we believe these issues can be addressed given an appropriate regulatory framework and timeframe for compliance. Accordingly, we seek to develop the record on data constraints and technical parameters that should be associated with developing and implementing this functionality, and on a reasonable timeframe within which to require Participating CMS Providers to support it. Pursuant to the approach we propose to adopt, emergency management agencies could use Public Safety Messages to transmit thumbnail-sized images of evacuation routes in connection with Imminent Threat Alerts, an image of the face of a missing child after an AMBER Alert, or specific instructions for protective action to the access and functional needs community through the use of hazard symbols. We invite commenters to offer additional use cases where this functionality could help meet the public's need for actionable, multimedia-enabled content during emergencies.
52. With respect to the potential for alert delivery latency, we observe that, according to the
53. We seek comment on any appropriate technical constraints that should apply to the multimedia content that Participating CMS Providers would be required to support. We anticipate that constraints on the permissible size of multimedia data files would also help Participating CMS Providers to manage network loading. The
54. With respect to the integration of support for hazard symbols into WEA's core functionality, CSRIC IV and CSRIC V recommend further study. The
55. With respect to concerns in the record regarding the possibility for increased network load, we propose to allow Participating CMS Providers to use network congestion mitigation strategies to feasibly and timely deliver multimedia-enabled Public Safety Messages. For example, we seek comment on whether staggering transmission of multimedia message segments could facilitate delivery of this content to subscribers, while mitigating potential network congestion concerns. Would it make sense to constrain any requirement to support multimedia to devices operating on 4G LTE and future networks? We seek comment on best practices that emergency management agencies could implement with respect to multimedia messaging if the transmission of such content implicated greater delay than text-only Alert Messages, and if Alert Messages that contained multimedia content could not be received by members of their communities on legacy networks or that are using legacy devices that no longer accept software updates. Recognizing the limitations of cell broadcast technology, to what extent would a requirement to support thumbnail-sized images and hazard symbols spur Participating CMS Providers to integrate new technologies into their WEA systems that could improve their ability to support the low-latency transmission of high-quality multimedia content? For example, commenters agree that Multimedia Broadcast Multicast Service (eMBMS) would permit the broadcast of “large amounts of data, including multimedia content.” We seek comment on the technical steps that would be required to integrate technology that supports the transmission of multimedia content into WEA.
56. Allowing multimedia content in WEA Alert Messages would have tremendous public safety benefits. NYCEM, FEMA and TDI, for example, believe that allowing multimedia content in WEA Alert Messages would significantly contribute to Alert Message comprehension, particularly for individuals with disabilities, and FEMA adds that the use of graphical symbols could improve Alert Message interpretation by individuals with limited English proficiency. NCMEC states that multimedia content would “greatly enhance the immediate usefulness of AMBER Alerts.” San Joaquin County OES adds that multimedia content in WEA Alert Messages would hasten protective action taking and reduce milling. We seek comment on these analyses, as well as on any additional public safety benefits that multimedia messaging may enable. Even though Chester County EMA and The Weather Company suggest the inclusion of multimedia would be unnecessary in light of the availability of embedded references and “third party apps and television that users normally use,” we find that unique benefits could result from including multimedia content in Alert Messages, especially as Participating CMS Providers' ability to support this functionality evolves along with advancements in technology. For example, WEA Public Safety Messages could be used to push an authoritative interactive map to every community member with a WEA-capable mobile device that shows the recipient's location relative to evacuation routes, shelter locations or resource distribution points. For communities struggling to recover from natural disasters, for example, this functionality would hold tremendous public safety value above and apart from multimedia-enabled emergency information available through other sources that in any case may not be as readily available as a consumer's mobile device. We also seek comment on whether those benefits would be particularly acute when implemented in an authoritative alerting services such as WEA that the public receives by default.
57. We observe that, according to commenters, expanding the language capabilities of WEA has potential to yield particular benefits for those with limited English proficiency. The record suggests, however, that the technical issues that prevented Participating CMS Providers from supporting multilingual Alert Messages when WEA was first deployed continue to limit their ability to support Alert Messages in languages other than English and Spanish. While FEMA states that IPAWS and CAP have the capacity to support Alert Messages in languages other than English and Spanish, additional languages are not currently supported in Participating CMS Provider networks. According to Participating CMS Providers, significant standards-setting work and potentially support for new character sets would be required in order to enable them to support WEA Alert Messages in languages other than English and Spanish. Further, AT&T and Verizon observe that each additional WEA Alert Message language option will require Participating CMS Providers to transmit an additional Alert Message, which could threaten network capacity and risk alert delivery delays. In light of these ongoing issues and additional data, we agree with T-Mobile that “[t]he Commission should promote further study of the technical impact of multilingual WEA messages so that such messages can be incorporated into the WEA system in the future without creating unintended, adverse impacts.”
58. Only 79 percent of individuals living in the United States that are 5-years old or older speak only English at home. According to the
59. We seek comment on the potential benefits of requiring Participating CMS Providers to support Alert Messages in languages other than English and Spanish. To what extent would emergency management agencies initiate Alert Messages in languages in addition to English and Spanish were Participating CMS Providers required to support them? To what extent would CMS Provider support for additional languages incent emergency management agencies to further develop their capabilities in initiating Alert Messages in those languages where relevant to their respective communities? What, if any, additional steps can we take to support emergency management agencies' efforts to develop multilingual alerting capabilities? We expect that emergency management agencies already integrate individuals who don't speak English very well into their communities' emergency response plans, and we seek comment on whether increasing emergency management agencies' multilingual alerting capability could help to further
60. If we were to adopt rules to deepen WEA's language capabilities, we seek comment on whether we should prioritize support for those languages predominantly spoken in communities where, according to Census data, 50 percent or fewer speak English “very well” (
61. We seek comment on whether supporting Alert Messages written in ideographic languages, such as Vietnamese, Chinese and Korean, would pose unique challenges for WEA stakeholders, including Participating CMS Providers and emergency mangers. We note that WEA messages use GSM 7-bit encoding, and that the 3GPP standard for cell broadcast allows switching to the basic Unicode (UCS-2) character set, which includes all living languages, in order to provide support for modern, ideographic languages such as Kanji. Do Participating CMS Providers' WEA infrastructure and WEA-capable mobile devices support this functionality? If not, what steps would be necessary to incorporate Unicode into WEA? We also seek comment on whether emergency management agencies would face particular difficulties in initiating Alert Messages in ideographic languages. Does alert origination software currently support initiating Alert Messages in ideographic languages? If not, what steps would be required in order to upgrade this software? Are there additional standards, protocols and system updates that would be required to enable alerting in Vietnamese, Chinese and Korean in particular? Further, we seek comment on whether WEA Alert Messages can be made available in American Sign Language (ASL) for subscribers that are deaf or hard of hearing. How would the provision of WEA Alert Messages in ASL allow for better accessibility to those who are ASL-fluent?
62. In addition to any potential changes to the WEA character set that may be required, we seek comment on any necessary preconditions to supporting additional languages in WEA in general, and to supporting Korean, Vietnamese or Chinese Alert Messages in particular. We also seek comment on whether support for additional languages would be burdensome for non-nationwide (
63. While our geo-targeting requirement, as amended above, will improve WEA geo-targeting by facilitating the delivery of Alert Messages to a more granular polygon level, the limitations of cell broadcast-based geo-targeting may result in continued over-alerting. According to CSRIC IV, the “ideal case” from an alert originator perspective would be where “all WEA-enabled mobile devices in the geographic area affected by an emergency event would receive the WEA Alert Message broadcast, and no mobile devices outside the defined alert area would receive those particular WEA Alert Message broadcasts.” “However,” CSRIC IV reports, “this ideal case cannot be realized using currently deployed cell broadcast alone.” CSRIC V recommends that the Commission collaborate with WEA stakeholders to develop standards and implement systems that support enhanced, device-based geo-targeting. CSRIC V recommends that the Commission set a goal that Participating CMS Providers geo-target Alert Messages in a manner that includes “100% of the targeted devices within the specified alert area with not more than .10 mile overshoot,” and states that WEA stakeholders, including Participating CMS Providers, “have committed to working to close the gap between current capabilities and aspirational goals.”
64. As we emphasize above, more granular geo-targeting remains a critical need for both consumers and emergency managers. Accordingly, we propose to require Participating CMS Providers to match the target area specified by alert originators. We anticipate that this may require Participating CMS Providers to leveraging the location sense of WEA-capable mobile devices on their networks. In the following paragraphs, we seek comment on how we should define “matching” the target area for purposes of any such requirement, as well as on steps that alert initiators and Participating CMS Providers can take to minimize alert delivery latency and maximize the amount of data available for other Alert Message content. We also seek comment on the readiness of innovations that could allow alert initiators to geo-target more flexibly, and to smaller areas.
65. As an initial matter, should a Participating CMS Provider be considered to have “matched” the targeted area for the purpose of this requirement if, as recommended by CSRIC V, 100 percent of devices within the targeted area receive the Alert Message with not more than 0.1 mile overshoot? In the alternative, if providers are leveraging the same technology in the WEA context that is being used to provide indoor location, would it make sense to harmonize our geo-targeting accuracy requirement for WEA with our wireless E911 indoor location accuracy requirements? If not, why not? Further, would an alternative accuracy requirement be appropriate for non-nationwide Participating CMS Providers? We seek comment on any alternative approaches to defining “matching” for the purposes of assessing compliance with our proposed requirement. In circumstances where Participating CMS Providers are unable to match the target area, we propose that they should be required to provide their best approximation of the target area, as we require in the
66. The record indicates that it will be technically feasible for Participating CMS Providers to comply with our requirement that they geo-target Alert Messages to an area that matches the target area, given appropriate time for the development of relevant standards and network modifications. We expect that Participating CMS Providers will be able to geo-fence their transmission of Alert Messages by transmitting target area coordinates to 100 percent of mobile devices in the target area, erring on the side of over-inclusion where
67. We seek comment on the extent to which polygon compression techniques and alert originator best practices could maximize the amount of data that remains for Alert Message content if Alert Message coordinates are transmitted along with content to WEA-capable mobile devices. ATIS concludes that each coordinate pair would require data equivalent to that needed to display thirteen characters using current methods. However, researchers have examined methods of compressing coordinate data to consume between 9.7 percent and 23.6 percent of this data. We seek comment on feasible methods of leveraging polygon compression techniques in WEA. Should such techniques be used to set a maximum on the amount of data that can be consumed by polygon coordinates? Further, we seek comment on appropriate best practices for the number of decimal places to which a coordinate should be specified in order to conserve Alert Message space for text. CSRIC V recommends that alert originators determine the granularity of alert areas using vertices with two to five decimal places, depending on the nature of the hazard. CSRIC V finds that this would allow alert originators to target Alert Messages to with precision from 1.1 km to 1.1 meters. We seek comment on this recommendation and analysis. We note that, under current standards, a valid polygon consists of one-hundred coordinate pairs or fewer. Would rules or best practices be appropriate to determine the maximum number of coordinate pairs that should be included in an Alert Message? We seek comment on any additional technical challenges that Participating CMS Providers may face in complying with a more accurate geo-targeting standard, and on feasible methods of overcoming them.
68. While we believe that a device-based approach is most likely to enable Participating CMS Providers to match the target area, we seek comment on whether continued focus on network-based approaches could enable Participating CMS Providers to meet this accuracy requirement. For example, could geo-targeting be improved by leveraging the relatively smaller coverage areas of network-based technologies, such as small cell technology, distributed antenna systems (DAS), Wi-Fi access points, beacons, commercial location-based services (cLBS), institutional and enterprise location systems, or smart building technology? We observe that these network-based technologies are widely deployed across the United States, and particularly in urban areas. Are CMS Provider networks configured to be able to send a WEA Alert Message over the control channel to these network-based technologies? What steps would be necessary to enable these technologies to assist in geo-targeting? Since the radio frequency propagation areas of these technologies are significantly smaller than the propagation areas for large cell sites, do they hold potential to improve geo-targeting? If not, why not? We also seek comment on the reliability of network-based technologies relative to the larger transmission facilities Participating CMS Providers traditionally use for WEA cell broadcast. Would relying on these technologies as a path forward to further improving geo-targeting leave the system vulnerable to becoming far less accurate when its accuracy is needed most, including during Imminent Threat Alerts?
69. Finally, we seek comment on whether additional, incremental improvements to geo-targeting could be achieved through standards updates that could allow Participating CMS Providers to support “nesting polygons.” Nesting polygons describe overlapping geographic areas where one polygon is situated, or “nests,” at least in part, within the boundaries of another, larger polygon. We seek comment on the extent to which existing network technologies can be leveraged to support nesting polygons, provided that relevant standards are updated to support them. We anticipate that a scenario where nesting polygons could be useful would be where one WEA Alert Message is appropriate for broadcast in the area where an incident, such as a chemical spill, has occurred (
70. We reason that achieving a geo-targeting standard whereby Participating CMS Providers can match the target area specified by an alert originator, either through device- or network-based techniques, would have tremendous benefits for public safety, and would eliminate the current dangers of poor geo-targeting that deter many emergency managers from becoming authorized as WEA alert originators. As discussed above, alert originators continue to demand more accurate geo-targeting from WEA before they will rely on it for emergency messaging in situations where it could be dangerous for individuals in areas adjacent to the target area to receive instructions intended only for individuals within the target area. Further, each incremental improvement that Participating CMS Providers can make to geo-targeting incrementally reduces alert fatigue, and increases the public's trust in WEA as an alerting platform, thereby reducing milling and, potentially, network congestion. We seek comment on this reasoning. Finally, we note that the
71. As we noted in our
72. While we understand that specific WEA capabilities for 5G networks and devices are not yet developed, we believe it is appropriate to seek comment on those capabilities now in light of the importance of designing these networks and devices with WEA capabilities in the early stages of development and throughout their development process. We disagree with CTIA that “it is premature at this time to address specific WEA capabilities that 5G might enable.” Participating CMS Providers are already examining how best to integrate 5G technologies into their networks and industry stakeholders are currently working to shape the strategic development of the 5G ecosystem. We observe that Verizon is expected to begin 5G field trials in the next few months, and most experts predict that 5G will be widely available as soon as 2020. Further, the record suggests that technological upgrades can be costly and time-consuming, and we reason that including WEA alerts and warnings in 5G from the beginning can reduce total costs for Participating CMS Providers and hasten the deployment of improvements to WEA that could benefit the public. We therefore seek to initiate a dialogue that will foster a better understanding of how Participating CMS Providers intend to incorporate WEA capabilities into their 5G offerings, as well as to identify areas where we can help provide regulatory clarity, where needed, that can drive design and investment. For example, AT&T opines that “[w]ith the standards for 5G now under development, it is important to have agreement that 360 characters is the maximum length for 4G and future services.”
73. In light of the foregoing, we seek comment on how to best incorporate alerts and warnings into the development of 5G technologies, and on how 5G technologies may enable further enhancements to WEA. What additional measures could the Commission take to facilitate the incorporation of WEA capabilities into 5G as these networks and devices are being designed? We seek comment on what, if any, steps the Commission should take to continue to ensure that WEA evolves along with advancements in technology in the 5G environment. What standards need to be developed or what other mechanisms need to be in place to ensure that WEA will be incorporated, and what actions are providers undertaking already? Elsewhere in this
74. In the
[[CMS provider]] has chosen to offer wireless emergency alerts within portions of its service area, as defined by the terms and conditions of its service agreement, on wireless emergency alert capable devices. There is no additional charge for these wireless emergency alerts.
Wireless emergency alerts may not be available on all devices or in the entire service area, or if a subscriber is outside of the [[CMS provider]] service area. For details on the availability of this service and wireless emergency alert capable devices, please ask a sales representative, or go to [[CMS provider's URL]].
75. Similarly, CMS Providers electing not to transmit WEA Alert Messages are required to offer, at a minimum, the following point-of-sale notification, “[[CMS provider]] presently does not transmit wireless emergency alerts.” We noted that our decision allowed, but did not require the disclosure of additional information regarding the technical
76. We propose to require CMS Providers to disclose sufficient information at the point of sale to allow customers to make an informed decision about whether they would consistently receive WEA Alert Messages if they were to become a subscriber. To what extent do CMS Providers voluntarily provide additional information at the point of sale regarding the nature of their WEA participation beyond any disclosure required by our rules? Is our existing requirement, which requires CMS Providers participating in part to inform consumers at the point of sale that WEA “may not be available on all devices or in the entire service area,” sufficient to inform potential subscribers of whether they will receive a potentially life-saving alert through the Participating CMS Provider's network? If this point-of-sale notification is insufficient to support educated consumer choice among providers, what additional information would help to inform this choice and allow market forces to more aptly influence further improvements to WEA?
77. If we base our proposed definitions of modes of participation in WEA on the devices a Participating CMS Provider makes WEA capable, the extent to which WEA is offered in their geographic service area, and the technologies they commit to use in support of their WEA service, would it be reasonable to require corresponding adjustments to consumer disclosures? We propose that, as a baseline, CMS Providers should provide information regarding the extent to which they offer WEA (in what geographic areas, and on what devices) at the point of sale. Would this information be sufficient to promote informed consumer choice? Should we also require CMS Providers to disclose at the point of sale the specific network technologies that they commit to use in offering WEA? We seek comment on the extent to which knowledge of the specific technologies that competing CMS Providers will use to support WEA would promote more informed consumer choice between CMS Providers. Should this disclosure also include the extent to which the Participating CMS providers' networks are able to offer full 360-character Alert Messages? Would it be sufficient for Participating CMS Providers to provide potential subscribers with a link to a Web site describing their WEA capability at the point of sale, and would this approach help Participating CMS Providers to control costs associated with this proposal? With respect to CMS Providers who elect not to participate in WEA, should they be required to make any additional disclosures at the point of sale to ensure that consumers are aware that they will not be able to receive any potentially life-saving alerts through service with this carrier? We seek comment on the potential benefits and costs that might be associated with additional point-of-sale disclosures.
78. Section 602(b)(2) of the WARN Act provides that “any commercial mobile service licensee electing to transmit emergency alerts may offer subscribers the capability of preventing the subscriber's device from receiving such alerts, or classes of such alerts, other than an alert issued by the President.” Section 10.500 of the Commission's rules requires Participating CMS Providers' WEA-capable mobile devices to maintain consumers' opt-out preferences and display alerts to the consumer consistent with those selections. Pursuant to Section 10.280, a Participating CMS Provider may provide their subscribers with the option to opt out of Imminent Threat and AMBER Alerts, and must present the consumer “with a clear indication of what each option means, and provide examples of the types of messages the customer may not receive as a result of opting out.” The Commission adopted these requirements in the
79. Apple states that “enabling users to opt out of certain alerts at particular times or under specified conditions (such as when Do Not Disturb mode is turned on) would likely increase end-user participation.” Microsoft agrees that consumers should have control over what types of alerts are received, and when. NWS observes that opt-out choices are currently presented in an inconsistent manner across devices and operating systems, and recommends standardizing the presentation of opt-out choices. On the other hand, ATIS expresses concern that “adding complexity to the opt-out options may actually increase the number of subscribers choosing to opt-out of WEA,” and Blackberry urges us to leave opt out functionality such as “scheduling” and “time of day” features to device manufacturers' discretion. CSRIC V recommends that Commission collaborate with WEA stakeholders to create a set of “minimum specifications for an enhanced, secured and trusted, standards-based, CMSP-controlled WEA mobile device based application . . . in order to ensure high level support.”
80. We propose to require Participating CMS Providers to implement changes to the WEA application that would provide the public with more granular options regarding whether they receive WEA Alert Messages. In essence, Participating CMS Providers should provide consumers with tools that allow them to receive the alerts that they want to receive, in the manner they wish to receive them, and during the times they wish to receive them.
81. First, we propose to amend Section 10.280(b) to require that Participating CMS Providers offer their subscribers more informed choices among the Alert Message classifications that they wish to receive. We seek comment on the approaches that Participating CMS Providers currently take to “provide their subscribers will a clear indication of what each [Alert Message] option means,” and on specific improvements that they could make to the WEA application to enable consumers to make more informed choices among the different types of WEA Alert Messages they will receive. As demonstrated in Appendix F, some Participating CMS Providers offer their subscribers the option to choose whether to receive “Extreme” and “Severe” Alert Messages, as well as AMBER Alerts. Are these options sufficiently clear to empower consumers to make informed choices among Alert Messages? Would it be more clear if the options that Participating CMS Providers offered their subscribers tracked our alert message classifications (
82. We also propose to require that Participating CMS Providers enhance their subscribers' ability to personalize how they receive the Alert Messages of their choosing. In the
83. In the alternative, we seek comment on whether to require all Participating CMS Providers to adopt a standardized opt-out menu, as recommended by NWS, and in a manner consistent with CSRIC V's recommendation.
84. The Commission's Part 10 WEA rules do not establish a procedure for Participating CMS Providers to report the results of any required tests to alert originators or to government entities. As such, there is no available method for analyzing the success of C-interface, Required Monthly, or State/Local WEA Tests. In the
85. Hyper-Reach and the majority of public safety commenters support requiring Participating CMS Providers to report the extent of alert delivery latency, the accuracy of geo-targeting, and the availability and reliability of their WEA network because it would improve transparency and understanding of IPAWS/WEA among emergency managers, and because this transparency, in turn, could increase WEA adoption by non-participating emergency managers. CSRIC V states, for example, that “confidence in WEA among [Alert Originators] is dampened by perceived unpredictability of WEA geo-targeting,” and building confidence “will require a means by which they can know that the polygon provided is what is actually delivered at the towers for distribution.” Accordingly, CSRIC V recommends that ATIS and CTIA study methods of passively collecting and sharing data on the accuracy of geo-targeting with emergency management agencies. As demonstrated in Appendix G, NYCEM already independently generates performance reports on WEA geo-targeting, latency and reliability from actual Alert Messages issued in New York City. These tests demonstrate that some mobile devices in the target area do not receive WEA Alert Messages that are intended for them, and that some mobile devices do not receive Alert Messages intended for them until almost an hour after they are initially transmitted. APCO and Pinellas County EM urge the Commission to adopt reporting requirements specific enough to result in the production of uniform reports to emergency management agencies. While AT&T would support a requirement for Participating CMS Providers to report the results of RMTs, Sprint states that the kind of information we proposed to gather through test reporting (
86. We propose to amend Section 10.350 to require Participating CMS Providers to submit annual reports to the Commission that demonstrate the following system performance metrics for their nationwide WEA deployment (Annual WEA Performance Reports).
•
•
•
We seek comment on these reporting elements and on the assessment methodologies Participating CMS Providers could use to produce Annual WEA Performance Reports below.
87. First, we seek comment on whether an annual requirement would achieve the right frequency of reporting. We reason that WEA performance data recorded over a period of one year would be sufficient to provide a statistically significant sample of data to inform Annual WEA Performance Reports. We seek comment on this rationale. We note that the record reflects concern that reporting requirements will “result in an increased burden for carriers participating in the service on a voluntary basis,” as well as concern that there is currently no method available to alert originators to verify system availability and reliability except anecdotally. Does our proposed approach strike the appropriate balance between these concerns? If not, we invite commenters to recommend alternative periodicities within which such reports should be required.
88. In the alternative, would a single performance report to become due on a date certain, rather than an annual requirement, suffice to inform emergency managers and the public about WEA's capabilities? What types of changes, if any, would be substantive enough to warrant additional reporting beyond the initial report? For example, as Participating CMS Providers make material upgrades to their networks to incorporate new or updated technologies (
89. We seek comment on the methodology by which Participating CMS Providers may develop Annual WEA Performance Reports. We anticipate that State/Local WEA Tests would be an effective method of collecting annual report data since they are test messages that may be used by state and local emergency managers to evaluate system readiness, and are required to be processed consistent with our Alert Message requirements. We seek comment on this analysis. Would a different classification of WEA Alert Message be more appropriate for use to collect performance data, be more likely to produce results that are representative of Alert Message delivery under actual emergency conditions, or be less burdensome to implement? For example, AT&T states that Participating CMS Providers' reporting obligations should be limited to RMTs. We observe that Section 10.350 does not require Participating CMS Providers to deliver RMTs to mobile devices, and allows RMTs to be distributed “within 24 hours of receipt by the CMS Provider Gateway unless pre-empted by actual alert traffic or unable due to an unforeseen condition.” Given these limitations, we seek comment on the value of RMTs as the basis for collecting Annual WEA Performance Report data. For example, could it be less burdensome and comparably effective for Participating CMS Providers to collect geo-targeting data from cell sites to which RMTs are delivered, as opposed to from mobile devices to which State/Local WEA Tests are delivered? To what extent could an analysis of the radio frequency propagation characteristics of the particular constellation of cell sites and cell sectors chosen to geo-target an RMT be used as an accurate proxy for the geographic area to which an Alert Message with the same target area would actually be delivered? Further, we seek comment on whether RMTs could provide meaningful data about alert delivery latency, given that Participating CMS Providers are allowed to delay up to 24 hours before retransmitting them. For example, would it be less burdensome and comparably effective to allow Participating CMS Providers to schedule performance analyses during times when network usage is light? Would it be feasible and desirable to “pause the timer” on any applicable latency measurement at the CMS Provider Alert Gateway until such a time within 24 hours as becomes convenient to distribute the test message? Would such an approach undermine the representativeness of the latency data collected because actual Alert Messages are not held for any period of time in order to await more ideal network conditions?
90. We seek comment on the specific data that Participating CMS Providers would be required to gather in order to complete statistically significant reports on the accuracy of WEA geo-targeting, the extent of alert delivery latency, and system availability and reliability. Would determining the accuracy of geo-targeting require either a measurement of the contours of the geographic area within which WEA-capable mobile devices receive the message, or an estimation of the radio frequency propagation contours of the cell broadcast facilities selected to geo-target the Alert Message? Would it require comparing the target area to the alert area? Would an average deviation from the target area be an adequate measure of the accuracy of geo-targeting, or would emergency managers benefit from a report on the specific percentage of instances in which a Participating CMS Provider is able to meet our geo-targeting standard? Further, we seek comment on whether there are WEA geo-targeting scenarios that pose particular challenges to Participating CMS Providers. If so, should Participating CMS Providers be required to collect, analyze and report on geo-targeting under those specific circumstances? In any case, should Participating CMS Providers be required to collect, analyze and report on their ability to geo-target Alert Messages to geocodes, circles, and polygons of varying complexities, and in varying geographic morphologies? How many samples of each type would be necessary to produce a statistically significant report on the accuracy of a Participating CMS Providers' WEA geo-targeting capability nationwide?
91. Further, we seek comment on the specific data points that Participating CMS Providers would be required to gather in order to measure alert delivery latency. Would it be satisfactory to simply measure the amount of time that elapses from the moment that an alert originator presses “send” using their alert origination software to the moment that the Alert Message is displayed on
92. Similarly, we seek comment on the specific data points that Participating CMS Providers would be required to collect in order to satisfactorily measure the regularity of system availability and reliability. Would the alert logging requirement that we adopt today suffice to determine the WEA system's rate of success at delivering Alert Messages? Where do errors with Alert Message transmission tend to occur? If at junctures other than the C-interface, does this militate for the collection of system availability data at each interface in the alert distribution chain in addition to the CMS Provider Alert Gateway? If less than 100 percent of WEA-capable mobile devices in the target area receive a WEA message intended for them, would this implicate shortcomings in system availability or reliability? If so, should Participating CMS Providers also be required to collect data on the percentage of WEA-capable mobile devices for which an Alert Message is intended that actually receive it, and to report this data to the Commission as a fundamental aspect of system availability and performance? Would this more nuanced approach be necessary in order to allow Participating CMS Providers to diagnose and correct any issues in alert distribution that may arise, and to promote sufficient transparency to facilitate Commission action in the public interest? Would an average measure of the rate of system availability be sufficient to grow emergency managers' confidence that the system will work as intended when needed, or do emergency managers require more granular data? Would it be necessary for Participating CMS Providers to log and report the CMAC attributes of each Alert Message at each of the C-E interfaces in order to establish whether the WEA system is able to deliver Alert Messages with “five nines” of reliability (
93. We seek comment on whether emergency managers need any additional information beyond the accuracy of geo-targeting, the extent of alert delivery latency, and the regularity of system availability and reliability in order to understand the strengths and weaknesses of WEA as an alert origination tool. What, if any, additional data could Participating CMS Providers collect without incurring additional cost burdens, if we were to require them to collect each of the aforementioned data points? In the alternative, we seek comment on whether, and if so, to what extent making alert logs available upon emergency management agencies' request could satisfy their need for this information. Further, in addition to the possibility of requiring performance reports less frequently from non-nationwide Participating CMS Providers, we seek comment on whether such Participating CMS Providers should also be allowed to collect less granular data on system performance in order to reduce any cost burdens entailed by these proposed recordkeeping and reporting requirements.
94. We seek comment on whether we should defer to Participating CMS Providers regarding how they collect annual report data. Does such an approach provide Participating CMS Providers with increased flexibility that will reduce the burdens of these recordkeeping and reporting requirements? Would this approach only be appropriate for non-nationwide Participating CMS Providers? We seek comment on whether one effective and efficient method of generating national data for annual submission to the Commission might be through the use of a representative sample of the different real world environments in which the WEA system would be used (
95. In the alternative, we seek comment on whether our State/Local WEA Testing model provides a framework to emergency managers that is sufficient to enable them to collect localized geo-targeting, latency, and system availability data without requiring additional involvement from Participating CMS Providers. We observe that, even in the absence of State/Local WEA Tests, NYCEM deployed a network of volunteers using mobile device offered by an assortment of Participating CMS Providers to collect data on WEA geo-targeting and latency in New York City. We applaud NYCEM for their voluntary effort to improve awareness about WEA system performance. We seek comment on whether such tests demonstrate that it would be feasible for any emergency management agency that wishes to gather performance statistics about WEA to do so for themselves. We seek comment on whether NYCEM's tests were able to produce statistically significant results, and if not, we seek comment on whether emergency managers would be willing to voluntarily collaborate and share test results with one another such that their findings could be aggregated into a statistically significant sample size.
96. We propose to treat Annual WEA Performance Reports submitted to the Commission as presumptively confidential, as we have reports in the E911, Emergency Alert System (EAS), and Network Outage Reporting System (NORS) contexts. Similarly, we propose to require that Participating CMS Providers grant emergency management agencies' requests for locality-specific versions of these performance metrics if and only if the requesting entity agrees to provide confidentiality protection at least equal to that provided by FOIA. Would the production of the proposed performance metrics require Participating CMS Providers to disclose information that they consider to be proprietary? Would offering such aspects of Annual WEA Performance Reports presumptively confidential treatment and only requiring that that
97. We anticipate that requiring Annual WEA Performance Reports would be likely to benefit emergency managers and the public. For example, we agree with Jefferson Parish EM that performance reports would help to improve system transparency with respect to “how long it took for the alert to reach the public,” whether there was “under alerting or overlap of the alerts,” and how often there are network conditions in which “Emergency Managers . . . could not send alerts.” We also agree with NYCEM that “[a]s with any other mission-critical system, mobile service providers should be required to capture and report system errors” in order to improve the system's security posture. Further, FEMA and other commenting emergency management agencies agree that reporting geo-targeting, latency and system availability and reliability data could provide a compelling demonstration of WEA's capacity to deliver timely, geo-targeted Alert Messages to specific areas and localities on a national scale, which could potentially increase WEA adoption by non-participating emergency managers who are “reluctant to activate WEA” without demonstrations of “coverage and delivery latency within their jurisdiction.” We seek comment on this assessment. We also seek comment on whether the greater transparency promoted by Annual WEA Performance Reports would better support alert originator and emergency operations center response planning. At the same time, we anticipate that regular performance reporting requirements may also be useful to us in our efforts to bring to light and address potential areas for improvement in the WEA system nationwide. Regardless, we seek comment on whether increases in system transparency created by Annual WEA Performance Reports would be likely to improve our ability to act in the public interest to remediate any issues that the reports may reveal. We seek comment on our analysis of these potential benefits, and on any other benefits that Annual WEA Performance Reports may provide.
98. As discussed above, we require Participating CMS Providers to log their receipt of Alert Messages at their Alert Gateway and to appropriately maintain those records for review. We now seek comment on whether and, if so, how to create a uniform format for alert logging, and on how the collection of more detailed system integrity data could be integrated into Annual WEA Performance Reports. We seek comment on the extent to which emergency managers would benefit from standardization of the format of Participating CMS Providers' alert logs. Emergency managers confirm that there is value in log keeping by Participating CMS Providers, but CMS Providers confirm there is significant variation among them with respect to log keeping. Absent standardization of alert logging capabilities, would emergency managers be forced to contend with this variation in a manner that may significantly decrease the value of alert logs? Does this support the value proposition of a uniform standard consistently applied to Participating CMS Providers' log keeping? Would the creation of a uniform format require the modification of standards relevant to Alert Gateway functionality? Would updates to Alert Gateway software also be required?
99. We also seek comment on whether the logging requirements we adopt today should extend beyond the CMS Provider Alert Gateway to the RAN and to WEA-capable mobile devices in furtherance of our goal of improving WEA transparency. We anticipate that alert logging beyond the Alert Gateway will continue to improve the transparency of the WEA system, will contribute to emergency managers' confidence that the system will work as intended when needed, and will improve our ability to detect and remediate any latent issues. We seek comment on this analysis. Will requiring Participating CMS Providers to log error reports and the CMAC attributes of Alert Messages at the CMS Provider Alert Gateway, as we do today, be sufficient to safeguard the integrity of WEA? If not, would it be advisable to require that Participating CMS Providers log this information at each of the C-E interfaces? We also seek comment on whether data other than, or in addition to error reports and CMAC attributes can be utilized as indicia of system integrity. Do Participating CMS Providers currently safeguard WEA system integrity through mechanisms other than, or in addition to alert logging? Further, we seek comment on whether requiring Participating CMS Providers to log data relevant to the accuracy of geo-targeting, the extent of alert delivery latency, and the system availability and reliability could contribute to the collection of data for Annual WEA Performance Reports? For example, if we were to require Participating CMS Providers to log alert receipt and transmission time stamps at each of the C-E interfaces, would that data contribute to their ability to report on specific sources of alert delivery latency?
100. The rules we propose in this
101. We propose a 30-month compliance timeframe for each proposed rule where compliance would be expected to require updates to standards and system specifications, as well as software updates for various components of the WEA system. These proposals include requiring Participating CMS Providers make changes to the WEA interface to promote informed consumer choice, requiring them to expedite delivery of earthquake-related Alert Messages, requiring them to provide a method of accessing pending Alert Messages, requiring support for multimedia content in Public Safety Messages, and requiring them to track and report on critical system performance metrics. We seek comment on this approach and analysis. In the
102. With respect to our proposal to require Participating CMS Providers to produce and share critical system performance metrics, we anticipate that compliance would require updates to software and standards, as well as the coordinated efforts of professionals employed by Participating CMS Providers in order to design and implement appropriate data collection and sharing mechanisms. We seek comment on this reasoning. We seek comment whether compliance with this proposal would require updates to software and standards akin to those required by rules we adopt in the
103. We propose to require Participating CMS Providers to match the target area specified by alert originators within 42 months of the rules' publication in the
104. We propose to require compliance with our proposed point-of-sale notification requirements, and with our new definitions of the modes of participation in WEA insofar as they necessitate a renewed obligation to file election letters within 120 days of the rule's publication in the
105. We propose to require compliance with our WEA infrastructure functionality proposal within 30 days of the rules' publication in the
106. We also seek comment on reasonable timeframes in which to expect Participating CMS Providers to be able to reach the other policy objectives that we discuss above, including developing a uniform standard for alert log formatting and developing additional alert logging capabilities throughout the WEA system and deepening WEA's language support capabilities. With respect to alert logging, we seek comment on whether one year would be sufficient for industry to complete a standard to describe a uniform alert log format that will facilitate comparison of Participating CMS Providers' WEA services, as we concluded would be appropriate for standards necessitated by rules we adopt in the
107. We seek comment on a reasonable timeframe within which to require Participating CMS Providers to support transmission of Alert Messages in languages in addition to English and Spanish. Could standards appropriate to support additional languages in WEA, including ideographic languages, be completed or otherwise integrated into WEA within one year, consistent with our reasoning about the time that it takes to complete standards in the
108. Finally, we seek comment on a reasonable implementation timeframe for our proposal to prioritize earthquake-related Alert Messages at the Participating CMS Provider Alert Gateway. Would Participating CMS Providers be able to implement this change on the same 30-month timeframe that we allow for other proposals anticipated to necessitate changes to software and standards? Could any changes to the prioritization of earthquake-related Alert Messages in transit be completed within the same timeframe? If not, what additional considerations should we take into account in our analysis of what changes in Alert Message prioritization in transit will require? We seek to implement each of our proposed rules in as swift of a timeframe as possible, while ensuring that our proposed rules do not pose undue burdens for Participating CMS Providers, recognizing the current state and technology. We invite commenters to offer into the record any additional considerations relevant to compliance with our proposed rules.
109. Accordingly,
110.
Fish and Wildlife Service, Interior.
Advance notice of proposed rulemaking; solicitation of comments.
The U.S. Fish and Wildlife Service (Service) is authorized to issue regulations to facilitate the implementation of the sustainable harvest management obligations under the
We will accept comments received or postmarked by the end of the day on January 9, 2017.
•
•
Hilary Cooley, Polar Bear Project Leader, U.S. Fish and Wildlife Service, Marine Mammals Management Office, 1011 East Tudor Road, Anchorage, Alaska 99503; by telephone (907) 786-3800; or by facsimile (907) 786-3816. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at (800) 877-8339.
One of the purposes of this advance notice of proposed rulemaking (ANPR) is to solicit public comments on developing and administering a co-management framework to manage the subsistence use of polar bears in Alaska. This effort would include implementation of the sustainable harvest management obligations of the
As previously mentioned, the U.S.-Russia Agreement is implemented in the United States through title V of the MMPA. Congress passed the MMPA in 1972 to prevent marine mammal species and population stocks from declining beyond the point at which they ceased to be significant functioning elements in the ecosystems of which they are a part. The MMPA prohibits, with certain exceptions and exemptions, the take of marine mammals. Prior to enactment of title V of the MMPA and ratification of the U.S.-Russia Agreement, section 101(b) of the MMPA governed the take of polar bears from the Alaska-Chukotka population, providing a general exemption for the taking of all marine mammals by any Indian, Aleut, or Eskimo who lives in Alaska and who dwells on the coast of the North Pacific Ocean or the Arctic Ocean if such taking is for subsistence purposes or for the purpose of creating and selling authentic native articles of handicraft and clothing, provided that the taking is not accomplished in a wasteful manner. Under MMPA section 101(b), if the Secretary determines any species or stock of marine mammal subject to taking by Indians, Aleuts, or Eskimos is depleted, the taking may be regulated.
The MMPA also recognizes the intrinsic role that marine mammals have played and continue to play in the subsistence, cultural, and economic lives of Alaska Natives. The Service, in turn, recognizes the important role that Alaska Natives can play in the conservation of marine mammals such as the polar bear. Amendments to the MMPA in 1994 acknowledged this role by authorizing the Service to enter into cooperative agreements with Alaska Natives for the conservation and co-management of subsistence use of marine mammals (16 U.S.C. 1388).
Upon enactment of title V of the MMPA and ratification of the U.S.-Russia Agreement in 2007, the MMPA's Alaskan Native exemption under section 101(b) no longer applied with respect to take from the Alaska-Chukotka population of polar bears (16 U.S.C. 1423g). The U.S.-Russia Agreement and title V of the MMPA continues to allow consumptive use of polar bears for subsistence purposes or the creation of authentic native handicrafts and clothing by Alaskan natives, but subjects that use to a number of restrictions, including those adopted by the U.S.-Russia Polar Bear Commission (Commission), the bilateral authority established under the U.S.-Russia Agreement.
The 2007 amendments to the MMPA also identified the Alaska Nanuuq Commission (ANC), and any successor entity, as the Alaska Native entity that represents all villages in the State of Alaska that engage in the annual subsistence taking of polar bears from the Alaska-Chukotka population. The ANC was established in 1995 to represent the interests of subsistence users and polar bear hunters on issues relating to the subsistence harvest of polar bears in Alaska. The 2007 amendments to the MMPA allow for the Service to share authority for the management of the taking of polar bears from the Alaska-Chukotka population for subsistence purposes with the ANC, or a successor entity, provided certain criteria are met, including: Entering into a cooperative agreement with the Secretary of the Interior (Secretary) under section 119 for the conservation of bears; meaningfully monitoring compliance with title V and the U.S.-Russia Agreement by Alaska Native people; and administering a co-management program for polar bears in accordance with title V and the U.S.-Russia Agreement.
In 2008, the Service listed polar bears as a threatened species worldwide under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
In addition to the national legislation just discussed, polar bear management in the United States is guided by multi- and bilateral agreements. In 1973 the Governments of Canada, Denmark (on behalf of Greenland), Norway, the Soviet Union, and the United States entered into the
In 1988, the Inuvialuit-Inupiat Polar Bear Management Agreement in the Southern Beaufort Sea was signed by the Inuvialuit Game Council and the North Slope Borough Fish and Game Committee (I-I Agreement). The I-I Agreement noted that the Inupiat of the United States and the Inuvialuit of Canada have traditionally harvested a portion of polar bears from the same population in the southern Beaufort Sea and recognized that the maintenance of a sustained harvest for traditional users in perpetuity requires that the number of polar bears taken annually not exceed the productivity of the population. Objectives of the I-I Agreement include maintaining a healthy viable population of polar bears in the southern Beaufort Sea and managing polar bears on a sustained-yield basis in accordance with all the best information available. The I-I Agreement provides protection to denning bears and family groups and establishes a process for determining an annual sustainable harvest.
In 2000, the Government of the United States and the Government of the Russian Federation signed the U.S.-Russia Agreement. The U.S.-Russia Agreement pledges cooperation with the goal of ensuring the conservation of the Alaska-Chukotka polar bear population (ACPBP), conservation of its habitat, and the regulation of its use for subsistence purposes by native people. It prohibits the taking of polar bears from this population inconsistent with the terms of the U.S.-Russia Agreement or the Range States Agreement.
The U.S.-Russia Agreement entered into force on September 23, 2007. The U.S.-Russia Agreement, among other things, provides legal protections for the ACPBP, found in the Chukchi-Northern Bering Sea. The U.S.-Russia Agreement is implemented in the United States through title V of the MMPA and builds upon those protections provided to polar bears through the 1973 Range States Agreement. The U.S.-Russia Agreement establishes a common legal, scientific, and administrative framework specifically for the conservation and management of the ACPBP shared between the United States and the Russian Federation. During the negotiation of the U.S.-Russia Agreement, it was recognized that continued availability of bears from the ACPBP for subsistence hunting in Alaska depended upon a coordinated management regime between the two countries. The negotiators, including those representing Alaskan Natives, determined that the best path forward was to replace the general subsistence take exemption contained in section 101(b) of the MMPA with the U.S.-Russia Agreement, which pledges coordinated management with the Russian Federation and provides for an equal role in management for government representatives and Native people in both Alaska and Russia.
Importantly, article 8 of the U.S.-Russia Agreement establishes the Commission, which is tasked with coordinating measures for the conservation and study of the ACPBP. The Commission includes a U.S. section and a Russian section, with each national section comprising two members; for the United States, there is one representative of the Federal Government and one representative of the Alaska Native interest. Under the U.S.-Russia Agreement, each section has one vote, and all decisions of the Commission may be made only with the approval of both sections. Consequently, the U.S. Native representative has an integral role in Commission actions and must be knowledgeable of, or have expertise in, polar bears. To date, although not required under title V of the MMPA, the U.S. Native Commissioner has been associated with the ANC, the recognized co-management entity, and through that entity, the Commissioner received input to help form positions with the U.S. Federal Commissioner.
As identified above, the Federal Government has responsibility for the management and conservation of polar
From 1997 to 2016, the Service has maintained cooperative agreements with the ANC. Through these cooperative agreements, the Service has worked to better understand the needs and interests of Alaska Native subsistence hunters and to exchange information on polar bears and their habitat. Since 2007, the Service's cooperative agreements with the ANC have focused on accomplishing polar bear conservation and implementing the U.S.-Russia Agreement.
The cooperative agreements between the Service and the ANC included a commitment to hold an annual meeting of the ANC. Commissioners from each of the 15 primary polar bear harvesting villages were appointed by their respective tribal governments to serve on the ANC Board. The cooperative agreements also included a requirement for coordination between the ANC Chairman and the ANC Commissioners to ensure: (1) That all Commissioners were fully informed of the taking limitation that will be implemented for the ACPBP; (2) that community concerns about conservation, management, and subsistence use of polar bears were shared with the ANC executive leadership with copies to the Service; and (3) that Commissioners attended local tribal government meetings, including those with the ANC leadership and Service employees, to present information on the polar bear harvest and other information about polar bear management and conservation and provide relevant reports from these meetings to the ANC executive leadership with copies to the Service.
Consistent with these agreements, the ANC was requested to assist in monitoring polar bear harvest in the local community by providing information to the hunters and community on progress of the harvest and, when appropriate, helping to ensure that Marking, Tagging, and Reporting Program (MTRP) taggers completed their tagging and reporting requirements. The MTRP, established pursuant to section 109(i) of the MMPA, requires hunters to present polar bear hides and skulls within 30 days of harvesting for tagging. The MTRP involves a network in 105 communities throughout Alaska and includes approximately 170 individuals hired as taggers. The ANC also committed to develop and implement steps to obtain authority from the tribal village governments to implement and enforce the annual taking limit under the U.S.-Russia Agreement and to develop a harvest monitoring system that included: Allocation procedures; reporting, tracking, and enforcement mechanisms; notification measures for providing real-time information on progress of harvest; and outreach and education materials.
At the second annual meeting of the Commission, which took place June 7-10, 2010, in Anchorage, Alaska (75 FR 65507, October 25, 2010), the Commissioners adopted an annual limit of polar bears that may be removed from the ACPBP of no more than 58 bears per year, of which no more than 19 may be females, to be divided evenly between the two nations. The Commission determined that all forms of human-caused removal of individuals from the ACPBP will be incorporated in this annual taking limit. The Commission, at each of its subsequent annual meetings held in 2011, 2012, 2013, 2014, and 2015, has maintained this take limit to ensure the continued harvest of polar bears remains sustainable (81 FR 3153, January 20, 2016). In 2012, the Commission adopted a multiyear quota system establishing a 5-year harvest level allowing annual adjustments to increase or decrease the taking limit depending on the harvest in the preceding year(s).
It is important to recognize that the subsistence harvest of polar bears is the primary way animals are removed from the population, but not the only way that humans take polar bears; all forms of removal are incorporated in the annual taking limit adopted by the Commission. For example, pursuant to article 6 of the U.S.-Russia Agreement, polar bears from the ACPBP may be taken when human life is threatened. Article 6 also authorizes the take of polar bears for scientific research and for the purpose of rescuing or rehabilitating injured polar bears, consistent with the Range States Agreement. Thus, in the course of the U.S. subsistence harvest season, which currently consists of the entire calendar year, the annual taking limit will need to be adjusted to account for subsistence harvest and other forms of removal, should they occur.
Of equal importance for Alaska Native polar bear hunters to understand is that the Commission adopted an annual taking limit in which no more than one-third of the overall limit may be female. Therefore, in the implementation of the annual taking limit, neither the limit on the total number of polar bears that may be removed from the population, nor the limit on the number of females that may be removed, can be exceeded.
The Service recognizes that federally enforced harvest limitations or closures for Alaska Native polar bear subsistence hunters have never been in place, and, therefore, we believe that the effectiveness of such measures is predicated on consultations and a collaborative co-management relationship with Alaska Natives and Tribal Governments. Such consultation is not only a crucial element of success, but also part of our responsibilities under the MMPA, and:
• The President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951);
• Executive Order 13175;
• Department of the Interior Secretarial Order 3225 of January 19, 2001 [Endangered Species Act and Subsistence Uses in Alaska (Supplement to Secretarial Order 3206)];
• Department of the Interior Secretarial Order 3317 of December 1, 2011 (Tribal Consultation and Policy);
• Department of the Interior Memorandum of January 18, 2001 (Alaska Government-to-Government Policy);
• the Department of the Interior's manual at 512 DM 2; and
• the Native American Policy of the U.S. Fish and Wildlife Service, January 20, 2016 (in the Service Manual at 510 FW 1).
In addition to working through and with our co-management partner, the ANC, the Service has conducted government-to-government consultations with tribal governments and held many informational meetings in villages and at other relevant forums and conferences. During these meetings, we have heard varying levels of awareness and satisfaction with the way the above duties assigned and agreed to by the ANC were implemented.
We have heard from Alaska Native tribal governments and stakeholders
The ANC has been working towards developing details of a co-management plan for polar bears taken from the ACPBP. However, the Service has recently determined that we will not be able to continue to provide financial support for the ANC's operations, and it is thus unlikely that the ANC will be able to continue to serve as the representative of Alaska Native people for polar bear subsistence use, as defined in title V of the MMPA, as well as for Alaska Native polar bear hunters taking bears from the Southern Beaufort Sea population. We continue to believe that the activities included in previous agreements with the ANC are important, and we are interested in feedback as well as suggestions for improved delivery methods to increase effectiveness.
The Service is seeking a co-management partner, as a successor entity to the ANC, that will provide the Commission with relevant information about the Chukchi Sea population in its deliberative process and serve as a co-management partner with the Service for managing the ACPBP in accordance with the U.S.-Russia Agreement. We also seek a partner to represent Alaska Native polar bear subsistence hunters who harvest polar bears from the Southern Beaufort Sea population, a population that is not regulated under the U.S.-Russia Agreement and title V of the MMPA. We are interested in Alaska Native input on the formation of a new co-management partner who is able to:
(1) Involve subsistence users in conservation and management of polar bears in Alaska, including the creation of effective two-way communication;
(2) Collect and exchange local observations on polar bears for the development of sound management practices for polar bears in Alaska;
(3) Develop a regional harvest management system in accordance with title V of the MMPA and the U.S.-Russia Agreement, including promulgation of local ordinances or regulations that restrict the taking of polar bears for subsistence purposes, allocation of a quota to Alaska Native subsistence hunters, monitoring Alaska Native subsistence harvest of polar bears, and, if necessary, enforcement by the co-management partner that complements Federal regulations; and
(4) Develop a polar bear co-management structure, which requires obtaining delegated governmental authority to represent, at a minimum, the 15 tribal governments in the State of Alaska that engage in the annual subsistence taking of polar bears from the Alaska-Chukotka population and the Southern Beaufort Sea population.
Thus, the appropriate Alaska Native Organization (ANO) would play an important role in informing positions of the United States at the Commission meetings. A committed and engaged partner is particularly important at this time given the commitments to implement the U.S.-Russia Agreement.
As noted above, we are also soliciting preliminary ideas about the content of regulations to facilitate implementation of harvest regulations for polar bears in the Alaska-Chukotka population. In order to ensure the annual taking limit established by the Commission is not exceeded, we believe it is necessary and appropriate to require more timely reporting, and we also need to ensure that hunters have effective notice of current information regarding the number and sex of bears that have been harvested relative to the annual taking limit. Therefore, we are seeking ideas and insights on: (1) The most effective ways to keep hunters informed of the number of bears available to harvest during the course of a season and when the annual taking limit has been met; and (2) the quickest and easiest ways for hunters to report their harvest.
We request comments and suggestions and encourage the submission of new ideas, materials, and recommendations from: The public; Alaska Native tribal governments, corporations, and organizations; environmental organizations; local, State, and Federal agencies; and any other interested party. Please ensure that the comments pertain only to the issues presented in this ANPR. You must submit your comments and supporting materials by one of the methods listed in
We are interested in hearing from leaders and members of the Alaskan Native community, hunters, and tribal governments. We also welcome comments and information from Native Corporations, the State of Alaska, other governmental agencies, nongovernmental organizations, and members of the public. To be most useful, and most likely to inform decisions, comments should be specific, be substantive, explain the reasoning behind the comment, and address the issues outlined in this ANPR.
For the purposes of this ANPR, we are seeking input on the development and implementation of a co-management framework to manage subsistence use of polar bears in Alaska, including the sustainable harvest management obligations of the U.S.-Russia Agreement as implemented under title V of the MMPA. We are also soliciting preliminary ideas about the content of regulations to facilitate implementation of harvest regulations for polar bears in the Alaska-Chukotka population. Because establishment and implementation of a co-management framework would not alter existing international obligations or national laws and regulations affecting polar bear management, including the U.S.-Russia Agreement, we are not seeking comments on those topics.
We are seeking comments on: (1) The appropriate activities and functions to be carried out by a co-management partner; (2) candidate organizations or entities to serve in the capacity of a co-management partner; (3) recommendations for improving the process for obtaining the input and engagement of Alaskan Natives in polar bear conservation and management; (4) recommendations for improving the exchange of information between the Federal Government and Alaskan Natives on polar bear conservation and management; and (5) methods and measures for effective implementation of polar bear harvest management, consistent with the obligations of the U.S.-Russia Agreement.
We are particularly interested in receiving comments on the following questions relating to the establishment and maintenance of a cooperative agreement with an ANO for polar bear conservation and management and the promulgation of regulations to monitor and manage the harvest of polar bears from the Alaska-Chukotka population:
1. Should the Service enter into a cooperative agreement with a new ANO for polar bear conservation and management?
2. What functions and roles should a polar bear co-management entity perform?
3. How should a polar bear co-management entity be formed?
4. Are there existing organizations or entities that are capable of and interested in serving in the role of the polar bear co-management entity?
5. What methods are most effective for the exchange of information between the Federal Government and Alaskan Natives?
6. Should harvest regulations for polar bears in the Alaska-Chukotka population be promulgated only at the Federal level or issued by the polar bear co-management entity and then adopted in Federal regulations?
7. What is the appropriate timing for reporting of harvested bears?
8. What is the most effective method for reporting of harvested bears in a timely manner?
For all of the reasons identified above, the Service is interested in identifying a co-management partner in the immediate future so that we can ensure the effective engagement of Alaskan Natives in the many ongoing and time-critical polar bear management and conservation actions. It is our goal to have a co-management partner in place in 2017 so that they can proceed with securing the necessary authorizations from tribal governments and, assuming that option is preferred, establish a program of locally enforceable ordinances for polar bear harvest from the ACPBP. Further, as discussed above, the U.S.-Russia Agreement is in effect, including the annual taking limit established by the Commission, and we have an obligation to take actions necessary for its implementation. Thus, one management option being considered by the Service is, in the absence of ordinances adopted by the ANC or its successor by which Federal regulations would be based, to proceed with promulgation of regulations at only the Federal level.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden 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 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 regarding this information collection received by December 8, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Office of Human Resources Management, Departmental Management, USDA.
Notice of Performance Review Board Appointments.
This notice announces the members of the Senior Executive Service and Senior Level and Scientific or Professional Performance Review Boards (PRB), as required by 5 U.S.C. 4314(c)(4). Agriculture has six PRBs: the Office of the Secretary; Departmental Management and Staff Offices; Marketing and Regulatory Programs and Food Safety; Farm and Foreign Agricultural Services; Food, Nutrition and Consumer Services; and Rural Development; Natural Resources and Environment; and Research, Education and Economics. Each PRB is comprised of a Chairperson and a mix of career and noncareer senior executives that meet annually to review and evaluate performance appraisal documents and provide a written recommendation to the Secretary for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.
Roberta Jeanquart, Director, Office of Human Resources Management, telephone: (202) 260-8718, or Patricia Moore, Director, Executive Resources Management Division, telephone: (202) 720-8629.
Effective October 6, 2016.
In accordance with 5 U.S.C. 4314(c)(4), the USDA PRB members are named below:
Bumbary-Langston, Inga P.; Cordova, Elvis; Moore, Patricia L.; Oden, Bianca M.; and Shorter, Malcom.
Abebe, Yeshimebet M.A.; Alboum, Jonathan; Dean, Telora T.; Holladay, Jon M.; Johansson, Robert C.; Leonard, Joe E.; Prieto, Jeffrey M.; and Young, Michael L.
Almanza, Alfred V.; Coale, Dana H.; Keith, Susan; Mitchell, Lawrence W.; Ricci, Carrie F.; and Shea, Anthony K.
Beyerhelm, Christopher P.; Christensen, Thomas W.; Glendenning, Roger W.; Quick, Bryce R.; Jackson, Yvette S.; Salerno, Lillian E.; and Wilson, Kathryn T.
Bonnie, Robert F.; Berns-Melhus, Kim M.; Rodriguez-Franco, Carlos; and Hamer Jr., Hubert.
Bartuska, Ann M.; Bohman, Mary E.; Hamer Jr., Hubert; Jacobs-Young, Chavonda J.; Ramaswamy, Sonny; and Smith, David W.
Animal and Plant Health Inspection Service, USDA.
Approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request approval of an information collection associated with the regulations for the importation of fresh citrus fruit from Uruguay, including
We will consider all comments that we receive on or before January 9, 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
For information on the regulations for the importation of fresh citrus fruit from Uruguay into the continental United States, contact Dr. Nicole Russo, Director, Imports, Regulations, and Manuals, PHP, PPQ, APHIS, 4700 River Road Unit 156, Riverdale, MD 20737; (301) 851-2159. For copies of more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Section 319.56-59 of the regulations provides the requirements for the importation of fresh citrus fruit from Uruguay, including
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the 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, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
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.
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that we are withdrawing an environmental assessment that was prepared by the Animal and Plant Health Inspection Service relative to a permitted environmental release of diamondback moths which have been genetically engineered for repressible female lethality and to express red fluorescence as a marker. While we reached a finding of no significant impact (FONSI) in connection with this action and posted that FONSI on our Web site, the public was not notified of the FONSI via publication of an associated notice in the
Mrs. Chessa Huff-Woodard, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1236; (301) 851-3943.
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered (GE) organisms and products are considered “regulated articles.” A permit must be obtained or a notification acknowledged before a regulated article may be released into the environment. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release into the environment of a regulated article.
Subsequent to a permit application from Cornell University (APHIS Permit Number 13-297-102r) seeking the permitted field release of three strains of GE diamondback moth (DBM),
We solicited comments on the EA for 30 days ending September 29, 2014. We received 287 comments by that date. The comments were from industry organizations, environmental and consumer advocacy groups, researchers, and private citizens.
Based upon analysis described in the EA and a thorough review of the comments we received, APHIS determined that release of the GE DBMs would not have a significant impact on the quality of the human environment. This finding of no significant impact (FONSI) was posted on the APHIS Web site.
In November 2014, APHIS issued Permit Number 13-297-102r, which allowed for open field release of the GE DBMs. No open field releases took place under this permit. In July 2015, the initial permit was amended to add caged releases to the list of allowable actions (APHIS Permit Number 13-297-102r-a1). Caged releases pursuant to the amended permit occurred between July 2015 and March 11, 2016, when the permit was withdrawn.
Although, as mentioned previously, we posted the FONSI on our Web site, we failed to formally advise the public of our FONSI regarding the release of GE DBMs via publication of a second notice in the
On March 16, 2016, APHIS received a permit application from Cornell University (APHIS Permit Number 16-076-101r) seeking the permitted field release of GE DBMs in both open and caged releases. We are currently preparing an EA for this new application and will publish notices associated with the EA and FONSI (if one is reached) in the
Animal and Plant Health Inspection Service, USDA.
Notice of availability and request for comments.
We are advising the public that the Animal and Plant Health Inspection Service has prepared a draft environmental assessment relative to the control of giant reed (
We will consider all comments that we receive on or before December 8, 2016.
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. Colin D. Stewart, Assistant Director, Pests, Pathogens, and Biocontrol Permits Permitting and Compliance Coordination, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2327, email:
Giant reed (
APHIS' review and analysis of the proposed action are documented in detail in a draft environmental assessment (EA) entitled “Field release of the European leaf sheath mining midge,
The EA may be viewed on 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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; solicitation of nominations.
NMFS solicits nominations for the Atlantic Highly Migratory Species (HMS) Advisory Panel (AP). NMFS consults with and considers the comments and views of the HMS AP when preparing and implementing Fishery Management Plans (FMPs) or FMP amendments for Atlantic tunas, swordfish, sharks, and billfish. Nominations are being sought to fill approximately one-third (11) of the seats on the HMS AP for a 3-year appointment. Individuals with definable interests in the recreational and commercial fishing and related industries, environmental community, academia, and non-governmental organizations are considered for membership on the HMS AP.
Nominations must be received on or before December 8, 2016.
You may submit nominations and requests for the Advisory Panel Statement of Organization, Practices, and Procedures by any of the following methods:
•
•
Peter Cooper at (301) 427-8503.
The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
Nomination packages should include:
1. The name of the nominee and a description of his/her interest in HMS or HMS fisheries, or in particular species of sharks, swordfish, tunas, or billfish;
2. Contact information, including mailing address, phone, and email of the nominee;
3. A statement of background and/or qualifications;
4. A written commitment that the nominee shall actively participate in good faith, and consistent with ethics obligations, in the meetings and tasks of the HMS AP; and
5. A list of outreach resources that the nominee has at his/her disposal to communicate HMS issues to various interest groups.
Qualification for membership includes one or more of the following:
Member tenure will be for 3 years (36 months), with approximately one-third of the members' terms expiring on December 31 of each year. Nominations are sought for terms beginning January 2017 and expiring December 2019.
Nominations for the HMS AP will be accepted to allow representation from commercial and recreational fishing interests, academic/scientific interests, and the environmental/non-governmental organization community, who are knowledgeable about Atlantic HMS and/or Atlantic HMS fisheries. Current representation on the HMS AP, as shown in Table 1, consists of 12 members representing commercial interests, 12 members representing recreational interests, 4 members representing environmental interests, 4 academic representatives, and the International Commission for the Conservation of Atlantic Tunas (ICCAT) Advisory Committee Chairperson. Each HMS AP member serves a 3-year term with approximately one-third of the total number of seats (33) expiring on December 31 of each year. NMFS seeks to fill 3 commercial, 5 recreational, and 2 environmental organization vacancies by December 31, 2016. NMFS will seek to fill vacancies based primarily on maintaining the current representation from each of the sectors. NMFS also considers species expertise and representation from the fishing regions (Northeast, Mid-Atlantic, Southeast, Gulf of Mexico, and Caribbean) to ensure the diversity and balance of the AP. Table 1 includes the current representation on the HMS AP by sector, region, and species with terms that are expiring identified in bold. It is not meant to indicate that NMFS will only consider persons who have expertise in the species or fishing regions that are listed. Rather, NMFS will aim toward having as diverse and balanced an AP as possible.
The intent is to have a group that, as a whole, reflects an appropriate and equitable balance and mix of interests given the responsibilities of the HMS AP.
Five additional members on the HMS AP include one member representing each of the following Councils: New England Fishery Management Council, the Mid-Atlantic Fishery Management Council, the South Atlantic Fishery Management Council, the Gulf of Mexico Fishery Management Council, and the Caribbean Fishery Management Council. The HMS AP also includes 22 ex-officio participants: 20 representatives of the coastal states and two representatives of the interstate commissions (the Atlantic States Marine Fisheries Commission and the Gulf States Marine Fisheries Commission).
NMFS will provide the necessary administrative support, including technical assistance, for the HMS AP. However, NMFS will not compensate participants with monetary support of any kind. Depending on availability of funds, members may be reimbursed for travel costs related to the HMS AP meetings.
Meetings of the HMS AP will be held as frequently as necessary but are routinely held twice each year—once in the spring, and once in the fall. The meetings may be held in conjunction with public hearings.
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995 (PRA), the Consumer Product Safety Commission (CPSC or Commission) requests comments on a proposed extension of approval of a collection of information for the Publicly Available Consumer Product Safety Information Database. The Commission will consider all comments received in response to this notice before requesting an extension of approval of this collection of information from the Office of Management and Budget (OMB).
Submit written or electronic comments on the collection of information by December 8, 2016.
OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or emailed to
For further information contact: Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to:
In the
Section 212 of the CPSIA added section 6A to the Consumer Product Safety Act (CPSA), which requires the Commission to establish and maintain a publicly available, searchable database on the safety of consumer products and other products or substances regulated by the Commission. Among other things, section 6A of the CPSA requires the Commission to collect reports of harm from the public for potential publication in the publicly available Database, and to collect and publish comments about reports of harm from manufacturers. As explained in the August 19, 2016
We estimate the burden of this collection of information as follows:
Based on the data set forth in Tables 1 and 2 above, the annual reporting cost is estimated to be $719,381. This estimate is based on the sum of two estimated total figures for reports of harm and manufacturer submissions. The estimated number of respondents and responses are based on the actual responses received in FY 2015. We assume that the number of responses and respondents will be similar in future years.
To estimate the costs for submitting reports of harm, we multiplied the estimated total burden hours associated with reports of harm (1,358 hours + 441 hours + 1,735 hours = 3,534 hours) by an estimated total compensation for all workers in private industry of $32.06 per hour,
To estimate the burden associated with submitting a general comment through the business portal regarding a report of harm, we averaged the burden provided by each company within each group and then calculated a weighted average from the three groups, weighting each group by the proportion of comments received from that group. We found that the average time to submit a general comment regarding a report of harm is 117 minutes based on the data in Table 3 (((15 minutes + 45 minutes + 30 minutes + 15 minutes)/4 companies)*.31 + ((105 minutes + 45 minutes + 150 minutes + 15 minutes)/4 companies)*.39 + ((240 minutes + 60 minutes + 480 minutes)/3 companies)*.30 = 117 minutes).
Registered businesses generally submit comments through our Web site. Unregistered businesses submit comments by mail, email, or fax. We estimate that for unregistered businesses, submitting comments takes a little longer because we often must ask the businesses to amend their submissions to include the required certifications. Thus, we estimated that on average, comments submitted by mail, email, or fax take 30 minutes longer than those submitted through our Web site (117 minutes + 30 minutes = 147 minutes).
The submission of a claim of materially inaccurate information is a relatively rare event for all respondents. Accordingly, we averaged all responses together. Eight of the businesses contacted had submitted claims of materially inaccurate information. We found that the average time to submit a claim that a report of harm contains a material inaccuracy is 165 minutes ((30 minutes + 90 minutes + 45 minutes + 90 minutes + 60 minutes + 660 minutes + 45 minutes + 300 minutes)/8 companies = 165 minutes).
Registered businesses generally submit claims through the business portal. Unregistered businesses submit claims by mail, email, or fax. We estimate that submitting claims by mail, email, or fax takes a little longer because we often must ask the businesses to amend their submission to include the required certifications. Thus, we estimated that on average, claims submitted by mail, email, or fax take 30 minutes longer than those submitted through our Web site (165 minutes + 30 minutes = 195 minutes).
The submission of a claim of confidential information is a relatively rare event for all respondents; accordingly, we averaged all responses together. Five of the businesses contacted had submitted claims of confidential information. We found that the average time to submit a claim that a report of harm contains confidential information is 42 minutes ((45 minutes + 15 minutes + 60 minutes + 30 minutes + 60 minutes)/5 companies = 42 minutes).
Registered businesses generally submit confidential information claims through the business portal. Unregistered businesses submit confidential information claims by mail, email, or fax. We estimate that submitting claims in this way takes a little longer because we often must ask the businesses to amend their submission to include the required certifications. Thus, we estimate that a confidential information claim submitted by mail, email, or fax would take 30 minutes longer than those submitted through our Web site (42 minutes + 30 minutes = 72 minutes).
For voluntary brand identification, we estimate that a response would take 10 minutes on average. Most responses consist only of the brand name and a product description. In many cases a business will submit multiple entries in a brief period of time and, based on the date and time stamps on these records, an entry often takes less than two minutes. CPSC staff enters the same data in a similar form based on our own research, and that experience was also factored into our estimate.
For small batch manufacturer identification, we estimate that a response would take 10 minutes on average. The form consists of three check boxes and the information should be readily accessible to the respondent.
The responses summarized in Table 2 are generally submitted by manufacturers. To avoid underestimating the cost associated with the collection of this data, we assigned the higher hourly wage associated with a manager or professional in goods-producing industries to these tasks. To estimate the cost of manufacturer submissions we multiplied the estimated total burden hours in Table 2 (8,826 hours) by an estimated total compensation for a manager or professional in goods-producing industries of $68.67 per hour,
Therefore, the total estimated annual cost to respondents is $719,381 ($113,300 burden for reports of harm + $606,081 burden for manufacturer submissions = $719,381).
We estimate the annualized cost to the CPSC to be $954,531. This figure is based on the costs for four categories of work for the Database: Reports of Harm, Materially Inaccurate Information Claims, Manufacturer Comments, and Small Batch Identification. Each category is described below. No government cost is associated with Voluntary Brand Identification because this information is entered directly into the Database by the manufacturer with no processing required by the government. The information assists the government in directing reports of harm to the correct manufacturer. We did not attempt to calculate separately the government cost for claims of confidential information because the number of claims is so small. The time to process these claims is included with claims of materially inaccurate information.
The Reports of Harm category also includes sending consent requests for reports when necessary, processing that consent when received, determining whether a product is out of CPSC's jurisdiction, and confirming that pictures and attachments do not have any personally identifiable information. The Reports category also entails
We estimate the annualized cost to the CPSC of $954,531 by adding the four categories of work related to the Database summarized in Tables 4 through 7 (Reports of Harm ($809,243) + MII Claims ($67,975) + Manufacturer Comments ($11,835) + Small Batch Identification ($65,478) = $954,531).
This information collection renewal request based on an estimated 12,360 burden hours per year for the Database is a decrease of 7,485 hours since this collection of information was last approved by OMB in 2013. The decrease in burden is due primarily to the fact that the number of incoming reports of harm has decreased, and the number of claims based on those reports has decreased as well. While comments did not decline significantly, they did shift to the more efficient online submissions. We note a large increase in small batch manufacturer activity, which has been rising steadily for years. However, this increase was not large enough to offset the decreases in other areas.
Department of the Army, DoD.
Notice.
Notice is given of the names of members of a Performance Review Board for the Department of the Army.
Barbara Smith, Civilian Senior Leader Management Office, 111 Army Pentagon, Washington, DC 20310-0111.
Section 4314(c)(1) through (5) of Title 5, U.S.C., requires each agency to establish, in accordance with regulations, one or more Senior Executive Service performance review boards. The boards shall review and evaluate the initial appraisal of senior executives' performance by supervisors and make recommendations to the appointing authority or rating official relative to the performance of these executives.
The Department of the Army Performance Review Board will be composed of a subset of the following individuals:
1. Ms. Lisha Adams, Executive Deputy to the Commanding General, U.S. Army Materiel Command.
2. LTG Joseph Anderson, Deputy Chief of Staff, G-3/5/7, Department of the Army.
3. LTG Robert P. Ashley Jr., Deputy Chief of Staff, G-2, Department of the Army.
4. Mr. Stephen D. Austin, Assistant Chief of the Army Reserve, Office of the Chief Army Reserve.
5. LTG Gwendolyn Bingham, Assistant Chief of Staff for Installation Management, Department of the Army.
6. Dr. Joseph L. Corriveau, Director, Edgewood Chemical Biological Center, U.S. Army Edgewood Chemical Biological Center, U.S. Army Research, Development and Engineering Command.
7. Mr. James C. Dalton, Director of Civil Works, U.S. Army Corps of Engineers.
8. Ms. Gwendolyn R. DeFilippi, Director, Civilian Senior Leader Management Office, Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
9. Ms. Steffanie B. Easter, Principal Deputy Assistant Secretary of the Army for Acquisition, Policy and Logistics, Office of the Assistant Secretary of the Army (Acquisition, Logistics, and Technology).
10. Ms. Sue A. Engelhardt, Director of Human Resources, U.S. Army Corps of Engineers.
11. Mr. Randall L. Exley, The Auditor General, U.S. Army, Office of the Auditor General.
12. Mr. Richard Fong, Senior Research Scientist (Warheads Technology), U.S. Army Armament Research, Development, and Engineering Center (ARDEC), U.S. Army Research, Development and Engineering Command.
13. Ms. Susan J. Goodyear, Deputy Chief of Staff for Resource Management, U.S. Army Materiel Command.
14. Mr. Patrick K. Hallinan, Executive Director of the Army National Cemeteries Program, Department of the Army.
15. Mr. Stuart A. Hazlett, Director of Contracting, U.S. Army Corps of Engineers.
16. Ms. Ellen M. Helmerson, Deputy Chief of Staff, G-8, U.S. Army Training and Doctrine Command.
17. Mr. David Jimenez, Assistant to the Deputy Under Secretary of the Army/Director of Test and Evaluation.
18. MG Donald E. Jackson, Jr., Deputy Commanding General for Civil and Emergncy Operations, U.S. Army Corps of Engineers.
19. MG Daniel I. Karbler, Commanding General, U.S. Army Test and Evaluation Command.
20. Ms. Krystyna M. A. Kolesar, Deputy Director, Program Analysis & Evaluation Directorate, Office of the Deputy Chief of Staff, G-8.
21. Mr. Mark R. Lewis, Executive Advisor to the Adminstrative Assistant to the Secretary of the Army, Office of the Administrative Assistant.
22. LTG Kevin W. Mangum, Deputy Commanding General/Chief of Staff, U.S. Army Training and Doctrine Command.
23. Mr. David Markowitz, Assistant Deputy Chief of Staff, G-8, Deputy Chief of Staff, G-8.
24. Mr. Joseph M. McDade, Principal Deputy General Counsel of the Air Force.
25. Ms. Kathleen S. Miller, Assistant Deputy Chief of Staff for Operations (G-3/5/7), Office of the Deputy Chief of Staff, G-3/5/7.
26. Mr. William F. Moore, Assistant Deputy Chief of Staff, G-4, Office of the Deputy Chief of Staff, G-4.
27. Mr. Levator Norsworthy Jr., Deputy General Counsel(Acquisition)/Senior Deputy General Counsel, Office of the General Counsel.
28. Mr. Gerald B. O'Keefe, Administrative Assistant to the Secretary of the Army, Office of the Administrative Assistant to the Secretary of the Army.
29. Mr. Philip R. Park, Principal Deputy General Counsel, Office of the General Counsel.
30. LTG Gustave F. Perna, Commanding General, U.S. Army Materiel Command.
31. Mr. Dean E. Pfoltzer, Principal Director, Policy and Resources/Chief Financial Officer, Office of the Chief Information Officer/G-6.
32. Mr. David W. Pittman, Deputy Director, Engineer Research and Development Center, U.S. Army Corps of Engineers.
33. Mr. Vic S. Ramdass, Director for Partnering USSOUTHCOM, U.S. Southern Command.
34. Ms. Diane M. Randon, Deputy Assistant Chief of Staff for Installation Management, Office of the Assistant Chief of Staff for Installation Management.
35. Mr. Jeffrey N. Rapp, Assistant Deputy Chief of Staff, G-2 Office of the Deputy Chief of Staff, G-2.
36. Dr. Jaques Reifman, Senior Research Scientist (Advanced Medical Technology), U.S. Army Medical Research Materiel Command.
37. Mr. J. Randall Robinson, Principal Deputy to the Assistant Secretary of the Army (Installations, Energy and
38. Mr. Craig R. Schmauder, Deputy General Counsel (Installation, Environment and Civil Works), Office of the General Counsel.
39. Mr. Karl F. Schneider, Deputy Chief Management Officer, Office of the Under Secretary of the Army.
40. LTG Todd T. Semonite, Commanding General, U.S. Army Corps of Engineers.
41. Ms. Monica Shephard, Vice Director for Joint Force Development, J7.
42. MG James E. Simpson, Commanding General, U.S. Army Contracting Command.
43. Ms. Caral E. Spangler, Principal Deputy Assistant Secretary of the Army (Financial Management and Comptroller). Office of the Assistant Secretary of the Army (Financial Management & Comptroller).
44. Honorable Robert M. Speer, Assistant Secretary of the Army (Financial Management & Comptroller), Office of the Assistant Secretary of the Army (Financial Management & Comptroller).
45. Ms. Patricia P. Stokes, Senior Security Advisor, U.S. Department of the Army, Office of the Deputy Chief of Staff, G-2.
46. Honorable Debra S. Wada, Assistant Secretary of the Army (Manpower and Reserve Affairs), Office of the Assistant Secretary of the Army (Manpower and Reserve Affairs).
47. Mr. Davis S. Welch, Deputy Director and Senior Advisor for Army Budget, Office of the Assistant Secretary of the Army (Financial Management & Comptroller).
48. MG Darell K. Williams, Commanding General, U.S. Army Combined Arms Support Command, U.S. Army Training and Doctrine Command.
49. LTG Michael E. Williamson, Deputy Assistant Secretary of the Army (Acquisition, Logistics and Technology), Office of the Assistant Secretary of the Army (Acquisition, Logistics and Technology).
50. LTG Larry D. Wyche, Deputy Commanding General, U.S. Army Material Command.
Department of the Army, DoD.
Notice of committee meeting.
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. § 552b, as amended), and 41 CFR § 102-3.150, the Department of Defense announces that the following Federal advisory committee meeting will take place.
The meeting will be held on Wednesday, November 30, 2016, Time 1:30-4:30 p.m. Members of the public wishing to attend the meeting will be need to show photo identification in order to gain access to the meeting location. All participants are subject to security screening.
The meeting will be held in Room 1301, Agricultural Committee Hearing Room, Longworth House Office Building, New Jersey and Independence Avenues SE., Washington, DC.
Mrs. Deadra K. Ghostlaw, the Designated Federal Officer for the committee, in writing at: Secretary of the General Staff, ATTN: Deadra K. Ghostlaw, 646 Swift Road, West Point, NY 10996; by email at:
The committee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. § 552b, as amended), and 41 CFR § 102-3.150. The USMA BoV provides independent advice and recommendations to the President of the United States on matters related to morale, discipline, curriculum, instruction, physical equipment, fiscal affairs, academic methods, and any other matters relating to the Academy that the Board decides to consider.
Pursuant to 41 CFR § 102-3.140d, the committee is not obligated to allow a member of the public to speak or otherwise address the committee during the meeting. However, the committee Designated Federal Official and Chairperson may choose to invite certain submitters to present their comments verbally during the open portion of this meeting or at a future meeting. The Designated Federal Officer, in consultation with the committee Chairperson, may allot a specific amount of time for submitters to present their comments verbally.
Joint Service Committee on Military Justice (JSC), Department of Defense.
Publication of Discussion and Analysis (Supplementary Materials) accompanying the Manual for Courts-Martial, United States (2012 ed.) (MCM).
The JSC hereby publishes Supplementary Materials accompanying the MCM as amended by Executive Orders 13643, 13669, 13696, 13730, and 13740. These changes have not been coordinated within the Department of Defense under DoD Directive 5500.1, “Preparation, Processing and Coordinating Legislation, Executive Orders, Proclamations, Views Letters and Testimony,” June 15, 2007, and do not constitute the official position of the Department of Defense, the Military Departments, or any other Government agency. These Supplementary Materials have been approved by the JSC and the General Counsel of the Department of Defense, and shall be applied in conjunction with the rule with which they are associated. The Discussions are effective insofar as the Rules they supplement are effective, but may not be applied earlier than the date of publication in the
These Supplementary Materials are effective as of November 8, 2016.
Major Harlye S. Carlton, USMC, (703) 963-9299 or
The amendments to the Discussion and Analysis of the MCM are as follows:
(a) Article 120 is amended to read as follows:
(b) Article 120b is inserted to read as follows:
(c) Article 120c is inserted to read as follows:
(d) The following Note is inserted after Article 120c to read as follows:
“[
(e) Article 125 is amended to read as follows:
(f) Article 134 abusing public animal is amended to read as follows:
(g) Article 134 Assault with intent to commit voluntary manslaughter, robbery, sodomy, arson, or burglary is amended to read as follows:
(h) Article 134 Indecent conduct is inserted to read as follows:
(i) The Notes are amended by adding note
“
This chart was compiled for convenience purposes only and is not the ultimate authority for specific lesser included offenses. Lesser offenses are those which are necessarily included in the offense charged.
Attempts to commit an offense may constitute a lesser included offense and are not listed.
(a) The Discussion immediately following paragraph 4 is amended to read as follows:
“The Department of Defense, in conjunction with the Department of Homeland Security, has published supplementary materials to accompany the Manual for Courts-Martial. These materials consist of a Discussion (accompanying the Preamble, the Rules for Courts-Martial, the Military Rules of Evidence, and the Punitive Articles), an Analysis, and various appendices. These supplementary materials do not constitute the official views of the Department of Defense, the Department of Homeland Security, the Department of Justice, the military departments, the United States Court of Appeals for the Armed Forces, or any other authority of the Government of the United States, and they do not constitute rules.
The 1995 amendment to paragraph 4 of the Preamble eliminated the practice of identifying the Manual for Courts-Martial, United States, by a particular year. Historically the Manual had been published in its entirety sporadically (
Amendments made to the Manual can be researched in the relevant Executive Order as referenced in Appendix 25. Although the Executive Orders were removed from Appendix 25 of the Manual in 2012 to reduce printing requirements, they can be accessed online.
(a) The Discussion immediately following R.C.M. 307(c)(3) is amended by deleting the first two Notes.
(b) The Discussion immediately following R.C.M. 307(c)(3) is amended by inserting the words “For Article 134 offenses, also refer to paragraph 60c(6) in Part IV.” after the words “How to draft specifications.”
(c) The Discussion immediately following R.C.M. 307(c)(3) is amended by deleting the Note directly following the words “(G)
(d) Part (G)(i) in the Discussion immediately following R.C.M. 307(c)(3) is amended to read as follows:
“(i)
(e) Part (G)(v) in the Discussion immediately following R.C.M. 307(c)(3) is inserted to read as follows:
“(v)
(f) The note immediately following R.C.M. 307(c)(4) is deleted and Discussion is inserted to read as follows:
“The prohibition against unreasonable multiplication of charges addresses those features of military law that increase the potential for overreaching in the exercise of prosecutorial discretion. It is based on reasonableness, and has no foundation in Constitutional rights. To determine if charges are unreasonably multiplied, see R.C.M. 906(b)(12). Because prosecutors are free to charge in the alternative, it may be reasonable to charge two or more offenses that arise from one transaction if sufficient doubt exists as to the facts or the law. In no case should both an offense and a lesser included offense thereof be separately charged. See also Part IV, paragraph 3, and R.C.M. 601(e)(2) concerning referral of several offenses.”
(g) The Discussion immediately following R.C.M. 701(e) is amended by
“Counsel must remain cognizant of professional responsibility rules regarding communicating with represented persons.”
(h) The Discussion immediately following R.C.M. 809(a) is amended to read as follows:
“Article 48 makes punishable “direct” contempt, as well as “indirect” or “constructive” contempt. “Direct” contempt is that which is committed in the presence of the court-martial or its immediate proximity. “Presence” includes those places outside the courtroom itself, such as waiting areas, deliberation rooms, and other places set aside for the use of the court-martial while it is in session. “Indirect” or “constructive” contempt is non-compliance with lawful writs, processes, orders, rules, decrees, or commands of the court-martial. A “direct” or “indirect” contempt may be actually seen or heard by the court-martial, in which case it may be punished summarily.
The words “any person,” as used in Article 48, include all persons, whether or not subject to military law, except the military judge and foreign nationals outside the territorial limits of the United States who are not subject to the code. The military judge may order the offender removed whether or not contempt proceedings are held. It may be appropriate to warn a person whose conduct is improper that persistence in a course of behavior may result in removal or punishment for contempt.
Each finding of contempt may be separately punished.
A person subject to the code who commits contempt may be tried by court-martial or otherwise disciplined under Article 134 for such misconduct in addition to or instead of punishment for contempt.
(i) The Discussion immediately following R.C.M. 906(b)(5) is amended to read as follows:
“Each specification may state only one offense. R.C.M. 307(c)(4). A duplicitous specification is one which alleges two or more separate offenses. Lesser included offenses (
(j) The Discussion immediately following R.C.M. 906(b)(12) is amended to read as follows:
“Unreasonable multiplication of charges as applied to findings and sentence is a limitation on the military's discretion to charge separate offenses and does not have a foundation in the Constitution. The concept is based on reasonableness and the prohibition against prosecutorial overreaching. In contrast, multiplicity is grounded in the Double Jeopardy Clause of the Fifth Amendment. It prevents an accused from being twice punished for one offense if it is contrary to the intent of Congress.
The following non-exhaustive factors should be considered when determining whether two or more offenses are unreasonably multiplied: whether the specifications are aimed at distinctly separate criminal acts; whether they represent or exaggerate the accused's criminality; whether they unreasonably increase his or her exposure to punishment; and whether they suggest prosecutorial abuse of discretion in drafting of the specifications. Because prosecutors are permitted to charge in the alternative based on exigencies of proof, a ruling on this motion ordinarily should be deferred until after findings are entered.”
(k) The Discussion immediately following R.C.M. 907(b)(3) is amended to read as follows:
“Multiplicity is a legal concept, arising from the Double Jeopardy Clause of the Fifth Amendment, which provides that no person shall be put in jeopardy twice for the same offense. Absent legislative intent to the contrary, an accused cannot be convicted and punished for violations of two or more statutes if those violations arise from a single act. Where Congress intended to impose multiple punishments for the same act, imposition of such sentence does not violate the Constitution.
Multiplicity differs from unreasonable multiplication of charges. If two offenses are not multiplicious, they nonetheless may constitute an unreasonable multiplication of charges as applied to findings or sentence.
To determine if two charges are multiplicious, the practitioner should first determine whether they are based on separate acts. If so, the charges are not multiplicious because separate acts may be charged and punished separately. If the charges are based upon a single act, the practitioner should next determine if Congress intended to impose multiple convictions and punishments for the same act. When there is no overt expression of congressional intent in the relevant statutes, such intent may be inferred based on the elements of the charged statutes and their relationship to each other or other principles of statutory interpretation. If each statute contains an element not contained in the other, it may be inferred that Congress intended they be charged and punished separately. Likewise, if each statute contains the same elements, it may be inferred that Congress did not intend they be charged and punished separately. A lesser included offense will always be multiplicious if charged separately, but offenses do not have to be lesser included to be multiplicious.
Ordinarily, a specification should not be dismissed for multiplicity before trial. The less serious of any multiplicious specifications shall be dismissed after findings have been reached. Due consideration must be given, however, to possible post-trial or
(l) The Discussion immediately following R.C.M. 910(a)(1) is amended to read as follows:
“
A plea of guilty to a lesser included offense does not bar the prosecution from proceeding on the offense as charged.
A plea of guilty does not prevent the introduction of evidence, either in support of the factual basis for the plea, or, after findings are entered, in aggravation.
(m) The Discussion immediately following R.C.M. 916(j)(2) is amended to read as follows:
“Examples of ignorance or mistake which need only exist in fact include: ignorance of the fact that the person assaulted was an officer; belief that property allegedly stolen belonged to the accused; belief that a controlled substance was really sugar.
Examples of ignorance or mistake which must be reasonable as well as actual include: belief that the accused charged with unauthorized absence had permission to go; belief that the accused had a medical “profile” excusing shaving as otherwise required by regulation. Some offenses require special standards of conduct (
Examples of offenses in which the accused's intent or knowledge is immaterial include: Any rape of a child, or any sexual assault or sexual abuse of a child when the child is under 12 years old. However, such ignorance or mistake may be relevant in extenuation and mitigation.
See subsection (l)(1) of this rule concerning ignorance or mistake of law.”
(n) The Discussion immediately following R.C.M. 918(a)(1) is amended to read as follows:
“
If A and B are joint accused and A is convicted but B is acquitted of an offense charged, A should be found guilty by excepting the name of B from the specification as well as any other words indicating the offense was a joint one.
(o) The note immediately following R.C.M. 1003(c)(1)(C) is deleted, and the following is added immediately following the last paragraph of the Discussion:
“Multiplicity is addressed in R.C.M. 907(b)(3)(B). Unreasonable multiplication of charges is addressed in R.C.M. 906(b)(12).”
(a) The Discussion immediately following paragraph 3.b.(1)(c) is amended to read as follows:
“The “elements test” is the proper method for determining lesser included offenses.
(b) The following Discussion is added immediately after paragraph 3.b.(5):
“Practitioners must consider lesser included offenses on a case-by-case basis.
(c) The following Discussion is added immediately after paragraph 60.b:
“The terminal element is merely the expression of one of the clauses under Article 134. See paragraph c below for an explanation of the clauses and rules for drafting specifications. More than one clause may be alleged and proven; however, proof of only one clause will satisfy the terminal element. For clause 3 offenses, the military judge may judicially notice whether an offense is capital.
(d) The following Discussion is added immediately after paragraph 60.c.(6)(a):
“Clauses 1 and 2 are theories of liability that must be expressly alleged in a specification so that the accused will be given notice as to which clause or clauses to defend against. The words “to the prejudice of good order and discipline in the armed forces” encompass both paragraph c.(2)(a), prejudice to good order and discipline, and paragraph c.(2)(b), breach of custom of the Service. A generic sample specification is provided below:
If clauses 1 and 2 are alleged together in the terminal element, the word “and” should be used to separate them. Any clause not proven beyond a reasonable doubt should be excepted from the specification at findings.
(e) The following replaces the paragraph below “Discussion” following paragraph 60.c.(6)(b):
“The words “an offense not capital” are sufficient to provide notice to the accused that a clause 3 offense has been charged and are meant to include all crimes and offenses not capital. A generic sample specification for clause 3 offenses is provided below:
In addition to alleging each element of the federal statute, practitioners should consider including, when appropriate and necessary, words of criminality (
(a) R.C.M. 306, the last paragraph beginning with “
“
(b) R.C.M. 307(c)(3), after the paragraph beginning with the words, “2012 Amendment,” and prior to the line beginning with the words, “The sources of the lettered subsection” add the following:
“
(c) R.C.M. 307(c)(3)(A), after the paragraph beginning with the words “
(d) R.C.M. 307(c)(3)(G), after the paragraph beginning with the words “
“
(e) R.C.M. 307(c)(3)(G)(i), insert the following language as a new paragraph after the existing paragraph:
“
(f) R.C.M. 307(c)(3)(G)(v), insert the following language:
“
(g) R.C.M. 307(c)(4), after the paragraph beginning with the words “
“
Nothing in the rule or the discussion section should be construed to imply that it would be overreaching for a prosecutor to bring several charges against an accused for what essentially amounts to one transaction if there is a valid legal reason to do so. For example, prosecutors may charge two offenses for exigencies of proof, which is a long accepted practice in military law.
The language in the discussion section of the 2012 edition of the Manual referring to
(h) R.C.M. 701(e), after the paragraph beginning with the words, “
“
(i) R.C.M. 906(b)(12), delete the paragraph beginning with the words the “2012 Amendment,” and insert in its place:
“
Multiplicity and unreasonable multiplication of charges are two distinct concepts. Unreasonable multiplication of charges as applied to findings and sentence is a limitation on the prosecution's discretion to charge separate offenses. Unreasonable multiplication of charges does not have a foundation in the Constitution but is instead based on the concept of reasonableness and is a prohibition against prosecutorial overreaching. In contrast, multiplicity is based on the Double Jeopardy Clause of the Fifth Amendment and prevents an accused from being twice punished for one offense if it is contrary to the intent of Congress. A charge may be found not to be multiplicious but at the same time it may be dismissed because of unreasonable multiplication.
Use of the term “multiplicity (or multiplicious) for sentencing” is inappropriate. If a charge is multiplicious, meaning that it violates the Constitutional prohibition against Double Jeopardy, it necessarily results in dismissal of the multiplied offenses, therefore obviating any issue on sentencing with respect to that charge.
Subparagraphs (i) and (ii) were added to the rule. They clarify the distinction between unreasonable multiplication of charges as applied to findings and to sentence. Although these concepts have existed for years (
The discussion sections were added to address concerns that CAAF voiced in dicta in
For more information on multiplicity and how it relates to unreasonable multiplication of charges, see Michael J. Breslin & LeEllen Coacher,
The language in the discussion section of the 2012 edition of the Manual referring to the
(j) R.C.M. 907(b)(3)(B), insert the following language as a new paragraph after the existing paragraph:
“
The discussion of multiplicity is derived from the Supreme Court's holding in
Two offenses that arise from the same transaction may not be multiplicious, even if each does not require proof of an element not required to prove the other, if the intent of Congress was that an accused could be convicted of and punished for both offenses arising out of the same act. The
The language in the discussion section of the 2012 edition of the Manual referring to the
(k) R.C.M. 916(b), insert the following language immediately following the paragraph beginning with the words “
“
(l) R.C.M. 916(j), insert the following language immediately following the
“
Paragraph (j)(3) was deleted. The rule reflects changes to Article 120. The Court of Appeals for the Armed Forces ruled that the statutory burden shift to the accused in the 2007 version of Article 120 was unconstitutional and the subsequent burden shift to the government to disprove consent beyond a reasonable doubt once the accused had raised the affirmative defense of consent by a preponderance of the evidence resulted in a legal impossibility.
(m) R.C.M. 920(e)(5)(D), insert the following language immediately following the paragraph beginning with the words “
“
(n) R.C.M. 1003(c)(1)(C), delete the paragraph beginning with the words the “2012 Amendment” and insert in its place:
“
Additionally, the committee decided to move the discussion of the factors in
The language in the discussion section of the 2012 edition of the Manual referring to the
(o) R.C.M. 1004(c)(7)(B), insert the following language immediately following the paragraph beginning with the words “
“
(p) R.C.M. 1004(c)(8), insert the following language immediately following the paragraph beginning with the words “
“
(a) Paragraph 3.b.(4), Article 79, Lesser included offenses,
“
Article 134 offenses generally will not be lesser included offenses of enumerated offenses in Articles 80-133.
(b) Paragraph 43.a, Article 118, Murder, is amended by adding the following language:
“
(c) Paragraph 45, Article 120, Rape and sexual assault generally, the first paragraph of the analysis beginning with the word “
“
(d) Paragraph 45, Article 120, Rape and sexual assault generally, is amended by deleting subparagraphs b, c, d, e, and f.
(e) Paragraph 45, Article 120b, Rape and sexual assault of a child, is amended by inserting “b” after “45”.
(f) Paragraph 45b, Article 120b, Rape and sexual assault of a child, is amended by deleting subparagraphs b, c, d, e, and f.
(g) Paragraph 45c, Article 120c, Other sexual misconduct, is amended by deleting subparagraphs b, c, d, e, and f.
(h) Paragraph 51, Article 125, Sodomy, is amended by changing the title to “Forcible Sodomy” and adding the following language at the beginning:
“
(i) Paragraph 60.c.(6)(a) is amended to read as follows:
“
The President ended the historical practice of allowing the terminal element to be inferred from Article 134 specifications, s
Although a single terminal element is required, there are three theories of liability that would satisfy the terminal element: a disorder or neglect to the prejudice of good order and discipline (under clause 1); conduct of a nature to bring discredit upon the armed forces (under clause 2); or a crime or offense not capital (under clause 3). The three clauses are “distinct and separate.”
When charging both clauses 1 and 2, practitioners are encouraged to use the word “and” to separate the theories in one specification, rather than using the word “or” to separate the theories. Practitioners may also allege two separate specifications. At findings, the Trial Counsel or Military Judge must make certain that the record is clear as to whether the trier of fact found that clause 1, clause 2, or both clauses were proven beyond a reasonable doubt. Using the word “and” to separate clauses 1 and 2 in the terminal element allows the trier of fact to except the unproven clause from the specification. This approach forces intellectual rigor in analyzing each clause as distinct and separate. Nothing in this analysis should be read to suggest that a specification connecting the two theories with the disjunctive “or” necessarily fails to give the accused reasonable notice of the charge against him.
(j) Paragraph 60.c.(6)(b) is amended by deleting the paragraph beginning with the words “
“
(k) Paragraph 62.c.(2) is amended to read as follows:
“(2) When determining whether adulterous acts constitute the offense of adultery under Article 134, commanders should consider the listed factors. The offense of adultery is intended to prohibit extramarital sexual behavior that directly affects the discipline of the armed forces, respect for the chain of command, or maintenance of unit cohesion. The intent of this provision is to limit the crime of adultery to those situations where the negative impact to the unit is real rather than theorized. This provision should not be interpreted to criminalize sexual practices between two adults with full and mutual consent from each other, but rather, to punish the collateral negative effects of extramarital sexual activity when there exists a genuine nexus between that activity and the efficiency and effectiveness of the armed forces.
While each commander has discretion to dispose of offenses by members of the command, wholly private and consensual sexual conduct between adults is generally not punishable under this paragraph. The right to engage in such conduct, however, is tempered in a military context by the mission of the military, the need for cohesive teams, and the need for obedience to orders. Cases involving fraternization or other unprofessional relationships may be more appropriately charged under Article 92 or Article 134—Fraternization. Cases involving abuse of authority by officers may be more appropriately charged under Article 133.
Rule for Courts-Martial 306(b) advises commanders to dispose of alleged offenses at the lowest appropriate level. As the R.C.M. 306(b) discussion states, many factors must be taken into consideration and balanced, including, to the extent practicable, the nature of the offense, any mitigating or extenuating circumstances, any recommendations made by subordinate commanders, the interests of justice, military exigencies, and the effect of the decision on the military member and the command. The goal should be a disposition that is warranted, appropriate, and fair. In the case of officers, also consult the explanation to paragraph 59 of Part IV in deciding how to dispose of an allegation of adultery.”
(l) Paragraph 90 is amended to read as follows:
“
Institute of Education Sciences (IES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.
Interested persons are invited to submit comments on or before January 9, 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 Erica Johnson, 202-245-7676.
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.
The purpose of this follow-up data collection is to provide policy makers with detailed information on the core policies promoted by Title I and Title II-A being implemented at the state and district levels, and the resources and supports they provide to schools and teachers. The timing of the data collection is critical to provide information prior to the full implementation of the Every Student Succeeds Act (ESSA) in the 2017-18 school year. Although other research studies cover similar topics on recent federal education policy, the breadth of research questions and the depth of responses from all states and a nationally representative sample of 570 school districts sets the Title I/II study apart from other studies.
This study will rely on information collected from existing sources, for which there are no respondents or burden, and on a set of revised state and district surveys, based on the 2014 data collection, in order to address the study's research questions. Extant data sources include (a) the National Assessment of Educational Progress (NAEP) and (b) EDFacts data.
The revised surveys of states and school districts will begin in April 2017. All respondents will have the opportunity to complete an electronic (
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before December 8, 2016.
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 Beth Grebeldinger, 202-377-4018.
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.
Environmental Protection Agency (EPA).
Notice of federal advisory subcommittee meetings.
Consistent with the Federal Advisory Committee Act, Public Law 92463, EPA is giving notice of an upcoming public meeting of the Assumable Waters Subcommittee convened under the National Advisory Council for Environmental Policy and Technology (NACEPT). The Assumable Waters Subcommittee will provide advice and recommendations as to how the EPA can best clarify assumable waters for dredge and fill permit programs pursuant to Clean Water Act section 404(g)(1). The EPA is undertaking this effort to support states and tribes that wish to assume the program. Similar to the parent NACEPT, the subcommittee represents a diversity of interests from academia, industry, non-governmental organizations, and local, State, and tribal governments.
Meeting agendas and materials will be posted at
The Assumable Waters Subcommittee will hold a public meeting on:
• December 9th, from 12:30 p.m. to 3:30 p.m. EDT, at this Web site:
• This is virtual meeting which can be accessed at this Web site:
Jacob B. Strickler, Acting Designated Federal Officer, via email at:
Requests to make oral comments or to provide written comments to the Assumable Waters Subcommittee should be sent to Jacob B. Strickler via email at:
Environmental Protection Agency (EPA).
Notice of adequacy.
The Environmental Protection Agency (EPA) is notifying the public that it has found that the motor vehicle emissions budgets (MVEBs) in the Dallas-Fort Worth, Texas (DFW) Attainment Demonstration (AD) State Implementation Plan (SIP) revision for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS), submitted on August 5, 2016 by the Texas Commission on Environmental Quality (TCEQ) are adequate for transportation conformity purposes. As a result of EPA's finding, the DFW area must use these budgets for future conformity determinations.
These budgets are effective November 23, 2016.
The essential information in this notice will be available at EPA's conformity Website:
Throughout this document “we,” “us,” and “our” refers to EPA. The word “budget(s)” refers to the mobile source emissions budget for volatile organic compounds (VOCs) and the mobile source emissions budget for nitrogen oxides (NO
On August 5, 2016, we received a SIP revision from the TCEQ. This revision consisted of an AD SIP for the DFW 2008 8-hour ozone NAAQS nonattainment area. This submission established MVEBs for the DFW 2008 ozone nonattainment area for the year 2017. The MVEB is the amount of emissions allowed in the SIP for on-road motor vehicles; it establishes an emissions ceiling for the DFW area regional transportation network, used to develop the 2017 on-road motor vehicle emissions projections contained in the AD SIP. The MVEBs are provided in Table 1:
On September 7, 2016, EPA posted the revised DFW area MVEBs on EPA's Web site for the purpose of soliciting public comments, as part of the adequacy process. The comment period closed on October 6, 2016, and we received no comments.
Today's notice is simply an announcement of a finding that EPA has already made. EPA Region 6 sent a letter to TCEQ on October 17, 2016, finding that the MVEBs in the DFW AD SIP, submitted on August 5, 2016 are adequate and must be used for transportation conformity determinations in the DFW area. This finding has also been announced on EPA's conformity Web site:
Transportation conformity is required by section 176(c) of the Clean Air Act. EPA's conformity rule, 40 Code of Federal Regulations (CFR) part 93, requires that transportation plans, programs and projects conform to state air quality implementation plans and establishes the criteria and procedures for determining whether or not they do so. Conformity to a SIP means that transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards.
The criteria by which EPA determines whether a SIP's MVEB is adequate for transportation conformity purposes are outlined in 40 CFR 93.118(e)(4). We have also described the process for determining the adequacy of submitted SIP budgets in our July 1, 2004, final rulemaking entitled, “Transportation Conformity Rule Amendments for the New 8-hour Ozone and PM
Within 24 months from the effective date of this notice, the DFW-area transportation partners, such as the North Central Texas Council of Governments, will need to demonstrate conformity to the new MVEBs if the demonstration has not already been made, pursuant to 40 CFR 93.104(e). See 73 FR 4419 (January 24, 2008).
42 U.S.C. 7401
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid 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 Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before January 9, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams, (202) 418-2918.
In addition, the Commission has adopted provisions that permit respondents subject to the information collection requirement for Shared Service Agreements to redact confidential or proprietary information from their disclosures.
This collection is being revised to reflect the burden associated with the Shared Service Agreement disclosure requirements adopted in the
This information collection requirement will provide the Commission and the public with more comprehensive information about the prevalence and content of Shared Service Agreements between television stations, which will improve the Commission's and the public's ability to assess the potential impact of these agreements on the Commission's rules and policies.
The information collection requirements contained under 47 CFR 73.1212, 73.3527, 73.1943 and 76.1701 are still a part of the information collection and remain unchanged since last approved by OMB.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the
Written PRA comments should be submitted on or before January 9, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
These recordkeeping and reporting requirements have potential to increase emergency managers' confidence that WEA will work as intended when needed. This increased confidence in system availability will encourage emergency managers that do not currently use WEA to become authorized. These reporting and recordkeeping requirements also help to ensure a fundamental component of system integrity. Alert logs are necessary to establish a baseline for system integrity against which future iterations of WEA can be evaluated. Without records that can be used to describe the quality of system integrity, and the most common causes of message transmission failure, it will be difficult to evaluate how any changes to WEA that we may adopt subsequent to this
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 November 22, 2016.
1.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning preaward survey forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408).
Submit comments on or before January 9, 2017.
Submit comments identified by Information Collection 9000-0011, Preaward Survey Forms, (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408) by any of the following methods:
•
•
Ms. Cecelia L. Davis, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, 202-219-0202 or email
To protect the Government's interest and to ensure timely delivery of items of the requisite quality, contracting officers, prior to award, must make an affirmative determination that the prospective contractor is responsible,
There are no Governmentwide systems for collecting the number of preaward surveys completed in a fiscal year as preaward surveys are only required in limited circumstances where information for the prospective contractor cannot be obtained by the contracting officer to make an affirmative statement of responsibility. Further, if the contemplated contract will have a fixed price at or below the $150,000 simplified acquisition threshold (SAT) or will involve the acquisition of commercial items (see Part 12); the contracting officer should not request a preaward survey unless circumstances justify its cost.
Using parameters identified above a Federal Procurement Data System (FPDS) ad hoc report was completed identifying that in Fiscal Year (FY) 2015 an estimated total of 24,791 contracts were awarded Governmentwide that were over the SAT, and for which commercial acquisition procedures were not used. Of that number, it is estimated that preaward surveys were completed for 15 percent, or 3,719 of the 24,791 contracts that were awarded. Of the six Standard Forms (1403, 1404, 1405, 1406, 1407, and 1408), we estimated that Standard Form 1403 is used most frequently because it is a general form and accounts for 30 percent or 1,116 times, Standard Forms 1404 and 1407 account for 15 percent or 558 times, Standard Form 1408 accounts for 20 percent or 744 times, and Standard Forms 1405 and 1406 account 10 percent or 372 times.
After consultation with subject matter experts, it was determined that the time required to prepare and complete the Standard Forms is estimated at 24 hours per response. Because preaward survey data is generally used for multiple contracts awarded within a 12 month period, it is estimated that only one (1) response would be reported annually per respondent per form.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control Number 9000-0011, Preaward Survey Forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408), in all correspondence.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for comments regarding a new OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request for approval of an information collection requirement regarding privacy training. A notice was published in the
Submit comments on or before December 8, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
• Regulations.gov:
•
Mr. Charles Gray, Procurement Analyst, Office of Governmentwide Acquisition Policy, at telephone 703-795-6328 or via email to
The Privacy Act of 1974, (5 U.S.C. 552a) prescribes fair information practices for the collection, maintenance, use, and dissemination of personal information by Federal agencies. Consistent with the provisions of the Privacy Act of 1974, OMB Circular A-130, “Managing Information as a Strategic Resource,” and other OMB memoranda, this rule specifically addresses the recordkeeping and reporting associated with FAR clause 52.224-XX, “Privacy Training.” The clause is used in solicitations and contracts whenever contract performance requires the employees of the contractor (or the employees of subcontractors) to have access to personally identifiable information (PII), including access to a system of records on individuals or entails the design, development, maintenance, or the operation of a system of records on individuals. The recordkeeping effort involves maintenance of training completion documentation by contractors; the reporting covers submission of the training completion documentation to the contracting officer upon request. It is anticipated that the Government would request this documentation only rarely.
DoD, GSA, and NASA provided notification of the applicability of the Paperwork Reduction Act and requested approval for a new information collection requirement as part of FAR Case 2010-013, published at 76 FR 63896, on October 14, 2011. Two respondents commented on the annual burden estimate.
Please cite OMB Control No. 9000-0182, Privacy Training, in all correspondence.
Gulf Coast Ecosystem Restoration Council.
Notice of Performance Review Board appointments.
This notice announces the members of the Senior Executive Service Performance Review Board (PRB) for the Gulf Coast Ecosystem Restoration Council as required by 5 U.S.C. 4314(c)(4). The PRB is comprised of a Chairperson and a mix of career Federal senior executives and State members from the Council. The PRB meets annually to review and evaluate performance appraisal documents and provides a written recommendation to the Secretary for final approval of each executive's performance rating, performance-based pay adjustment, and performance award.
Effective October 6, 2016.
Justin Ehrenwerth, Executive Director, GCERC, telephone: (504) 444-3265.
In accordance with 5 U.S.C. 4314(c)(4), the persons named below have been selected to serve on the PRB:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of rescheduled public webcast.
The HHS/CDC's Division of Select Agents and Toxins (DSAT) and the U.S. Department of Agriculture's Animal and Plant Health Inspection Service, Agriculture Select Agent Services (AgSAS) are jointly charged with the regulation of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance and information related to the Federal Select Agent Program for interested individuals.
The webcast, which was originally scheduled for Wednesday, November 9, 2016 is rescheduled to Wednesday, February 8, 2017 from 12 p.m. to 4 p.m. EST. All who wish to join the webcast should register by February 6, 2017. The registration is available on this Web site:
The webcast will be broadcast from CDC, 1600 Clifton Road, Atlanta, GA 30329. This will only be produced as a webcast; therefore, no accommodations will be provided for in-person participation.
The public webcast—originally scheduled for Wednesday, November 9, 2016 and rescheduled to Wednesday, February 8, 2017—is an opportunity for the affected community (
Representatives from the Federal Select Agent Program will be present during the webcast to address questions and concerns from the web participants.
Participants that have already registered for the November date will not need to re-submit registration requests for the new date. Those individuals that have not registered and want to participate in the webcast should complete their registration online by February 6, 2017. The registration is available on this Web site:
Centers for Medicare & Medicaid Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by January 9, 2017.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
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. The term “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
1.
The National Study uses a mixed-method approach to examine 25 waiver jurisdictions (including 23 states, the District of Columbia and one tribal government) with Terms and Conditions approved in Federal Fiscal years 2012, 2013, and 2014. Proposed data collection methods are two topically-focused telephone surveys: (a) A telephone survey of waiver jurisdiction representatives and evaluators who are focused on measuring well-being, and (b) a second telephone survey of waiver jurisdiction representatives and evaluators that is focused on understanding practice and systems-level changes within child welfare service systems. Also proposed is a Web-based survey of waiver jurisdiction representatives and evaluators that will look more broadly at the implementation of waiver demonstrations and corresponding changes in child welfare policy, practice, and financing. Two sampling survey forms are being proposed to collect the necessary contact information for respondents to the Web-based survey and the telephone survey focused on understanding practice and systems-level changes within child welfare service systems. Data collected through these instruments will be used by the Children's Bureau to gain an understanding of the jurisdictions' collective experience with implementing their demonstrations.
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW.; Washington, DC 20202; Attn: ACF Reports Clearance Officer. Email address:
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by December 8, 2016.
Submit written comments on the collection of information by fax 202-395-5806 or by email to
Katherine Glendening by phone: 202-795-7350 or email:
In compliance with section 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance.
A notice was published in the
The SMP survey will be conducted over a three-year period beginning in Fiscal Year 2017 (FY 2017). Sites in each of the 50 states, the District of Columbia, and the territories of Guam and Puerto Rico will be surveyed once during the three-year period. Results from the surveys will be used to understand satisfaction among individuals who attend SMP education sessions, as well as how the program can be improved to provide better service to its target population. Eighteen (18) unique states/territories will be surveyed in FY17, with each state or territory expected to generate 75 unique responses, for a total of 1,350 individual responses in Year 1. This process will then be replicated in Year 2 (FY18), with a different group of 18 states and territories being surveyed. In Year 3 (FY19), the final 17 states/territories will be surveyed. By the end of FY19, SMP will obtain 3,975 completed surveys to measure satisfaction at the national level (53 states/territories × 75 responses per state/territory). SMP will use the following factors to draw a representative sample of education session attendees:
• Randomly select 18 states and territories to be surveyed in Years 1 and 2 and 17 states/territories in Year 3, with the states/territories stratified by the average number of education session attendees per month.
• Survey a specific site no more than once.
• Sample from at least five presenters in each state/territory.
• Survey no fewer than five events and no more than 20 events in each state/territory.
• Survey no more than two events per month in each state/territory.
To generate a sample with a 95% confidence level at the national level, a minimum of 384 responses will be required, which is based on over 450,000 education session attendees in 2014. SMP anticipates collecting 75 completed surveys per state/territory, for a total collection of 3,975 completed surveys. This larger collection will enable ACL to make state-to-state comparisons, which is an important feature of this survey. Specifically, state-to-state comparisons will allow ACL to identify which states/territories are providing the best services to their beneficiaries, and what best practices can be shared across states/territories. The larger collection will also provide each state/territory with sufficient information to take local action to improve service within budgetary constraints.
The proposed survey instrument may be viewed on the ACL Web site:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The average annual burden associated with these activities is summarized below:
Administration for Community Living, HHS.
Notice.
Wednesday, November 30, 2016 from 9:00 a.m. to 5:00 p.m.; and Thursday, December 1, 2016 from 9:00 a.m. to 3:00 p.m.
These meetings will be open to the general public.
These meetings will be held in U.S. Department of Health and Human Services/Hubert H. Humphrey Building located at 200 Independence Avenue SW., Conference Room 505A, Washington, DC 20201. Individuals who would like to participate via conference call may do so by dialing toll-free #: 888-677-5620, when prompted enter pass code: 1697798. Individuals whose full participation in the meeting will require special accommodations (
The Committee Members will discuss preparation of the PCPID 2017 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report. They will also receive presentations from selected experts in the field of Intellectual and Developmental Disabilities.
For further information, please contact Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW., Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email:
The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies.
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Comments must be received by December 8, 2016.
Submit written comments on the collection of information by fax 202.395.5806 or by email to
Katherine Glendening by phone: 202-795-7350 or email:
In compliance with section 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance.
The State Health Insurance Assistance Program (SHIP) was created under Section 4360 of the Omnibus Budget Reconciliation Act (OBRA) of 1990 (P.L. 101-508). SHIP was created to provide grant funding to states/territories, who in turn provide “. . . information, counseling, and assistance . . . to individuals who are eligible to receive benefits under title XVIII of the Social Security Act” (Medicare). SHIP grants help Medicare beneficiaries and their families to obtain information about topics, such as Medicare enrollment (Parts A and B), Medicare Advantage plans (Part C), prescription drug coverage (Part D), Medicare Savings Programs (MSPs), supplemental insurance policies (Medigap), Medicaid issues, and other health insurance issues. The survey will gauge individuals' satisfaction with the services provided by SHIP counselors. While the SHIP program currently tracks the number of contacts the program makes with individual citizens, as well as descriptive information about counseling sessions such as topic, location, and beneficiary demographics, the program does not track outcome measurements, including customer satisfaction.
A notice was published in the
The SHIP survey will be conducted over a three-year period beginning in Fiscal Year 2017 (FY 2017), with sites in each of the 50 states, the District of Columbia and the territories of Guam, Puerto Rico and the U.S. Virgin Islands being surveyed once during the three-year period. Results from the surveys
• Review counseling sessions at two points each year:
○ One week in the spring (outside of the annual Medicare Open Enrollment Period)
○ One week in the fall (during the annual Medicare Open Enrollment Period)
• Focus only on non-redundant individuals (
• Randomly select 18 states and territories to be surveyed each year, with the states/territories stratified by data collection method* and the size of the Medicare-eligible population.
* Data collection method refers to how each state/territory collects and enters its records of counseling sessions. The majority of states/territories (29 of 54) directly enter counseling records into SHIP's National Performance Reporting (NPR) system, but the remaining states/territories upload data in batches at the end of each month. To ensure that the batch upload states/territories will be able to pull weekly samples twice per year, we will limit these states/territories to Years 2 and 3 of the survey administration period, thereby allowing for technical assistance to these states/territories if necessary.
To generate a sample with a 95% confidence level at the national level 384 responses will be required (n = 3,000,000 counseling sessions in 2015). SHIP anticipates collecting 75 completed surveys per state/territory, for a total collection of 4,050 completed surveys over the 3-year period. This larger collection will enable ACL to make state-to-state comparisons, which is an important feature of this survey. Specifically, state-to-state comparisons will allow ACL to identify which states/territories are providing the best services to their beneficiaries, and what best practices can be shared across states/territories. The larger collection will also provide each state/territory with sufficient information to take local action to improve service within budgetary constraints.
The proposed survey instrument may be viewed on the Web site:
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The average annual burden associated with these activities is summarized below:
Food and Drug Administration, HHS.
Notice of availability; request for comments.
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of FDA's ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues, a PhUSE working group developed the PhUSE SDSP template. The purpose of this review is to evaluate the template and determine whether FDA will recommend its use either as is, or in a modified form, for regulatory submissions of study data. FDA is seeking public comment on the use of the PhUSE SDSP template for regulatory submissions.
Although you can comment on the PhUSE SDSP template at any time, to ensure that the Agency considers your comments in this review, please submit either electronic or written comments by January 9, 2017.
You may submit comments as follows:
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 Division of Dockets Management, 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
Crystal Allard, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 1518, Silver Spring, MD 20993-0002, 301-796-8856,
FDA is a participating member of PhUSE, an independent, non-profit consortium of academic, regulatory, non-profit, and private sector entities. PhUSE provides a global platform for the discussion of topics encompassing the work of biostatisticians, data managers, statistical programmers, and e-clinical information technology professionals, with the mission of providing an open, transparent, and collaborative forum to address computational science issues. As part of this collaboration, PhUSE working groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. You can learn more about PhUSE working groups at
In December 2014, FDA published the Study Data Technical Conformance Guide (the “Guide,” available at
FDA now intends to review the PhUSE SDSP template, a deliverable of the working group effort described previously in this document, with the potential result that FDA could recommend the use of the template in its current form, or in a modified form, for use in the regulatory submission of study data in conformance with the Guide. FDA invites public comment on all matters regarding the use of the PhUSE SDSP template.
The PhUSE SDSP template is available at:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff.” This guidance document is intended to assist medical device manufacturers meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
You may submit comments as follows:
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 Division of Dockets Management, 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
An electronic copy of the guidance document is available for download from the Internet. See the
Isaac Chang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993-0002, 301-796-2789.
Medical device reporting under section 519(a) of the Federal Food Drug, and Cosmetic Act (21 U.S.C. 360i(a)) provides a mechanism that allows FDA and device manufacturers, user facilities, and importer of medical devices to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving your medical devices. The goal is to detect and correct problems in a timely manner. This guidance updates FDA's policy and clarifies FDA's interpretations of the regulatory requirements under part 803 (21 CFR part 803) and includes a section on common reporting errors.
The draft of this guidance was made available in the
This document supersedes the draft entitled, “Medical Device Reporting for Manufacturers; Guidance for Industry and Food and Drug Administration Staff,” dated July 9, 2013, and the previous guidance on this topic, “Medical Device Reporting for Manufacturers,” issued March 1997.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on medical device reporting. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; the collections of information in part 803, regarding medical device reporting, have been approved under OMB control number 0910-0437; the collections of information in 21 CFR part 806, regarding corrections and removals, have been approved under OMB control number 0910-0359; the collections of information in 21 CFR part 807, subpart E, regarding premarket notification,
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Non-Inferiority Clinical Trials to Establish Effectiveness.” This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of non-inferiority (NI) study designs to provide evidence of the effectiveness of a drug or biologic. The guidance gives advice on when NI studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the NI margin, and how to test the NI hypothesis.
Submit either electronic or written comments on Agency guidances at any time.
You may submit comments as follows:
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 Division of Dockets Management, 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
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Scott Goldie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire
FDA is announcing the availability of a guidance for industry entitled “Non-Inferiority Clinical Trials to Establish Effectiveness.” This guidance consists of four parts. The first part is a general discussion of regulatory, study design, scientific, and statistical issues associated with the use of NI studies to establish the effectiveness of a drug or biologic. The second part focuses on some of these issues in more detail, notably the statistical approaches used to determine the NI margin and to test for non-inferiority. The third part addresses commonly asked questions about NI studies. The fourth part includes four examples of successful and unsuccessful efforts to define NI margins and test for non-inferiority.
This guidance finalizes the draft guidance for industry, “Non-Inferiority Clinical Trials,” published in 2010. In addition, it supersedes the guidance for industry, “Antibacterial Drug Products: Use of Noninferiority Trials to Support Approval,” also published in 2010, which will be withdrawn.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on NI clinical trials to establish effectiveness. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, is the subject of NDA 019152 held by Pfizer Inc. CALAN SR is indicated for the treatment of hypertension, to lower blood pressure. CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, is currently listed in the “Discontinued Drug Product List” section of the Orange Book.
Heritage Pharma Labs, Inc., submitted a citizen petition dated August 31, 2016 (Docket No. FDA-2016-P-2674), under 21 CFR 10.30, requesting that the Agency determine whether CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list CALAN SR (verapamil hydrochloride) extended-release oral
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Ninth Annual Sentinel Initiative Public Workshop.” Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. Topics will include an update on the state of FDA's Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016. In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. This workshop will also engage stakeholders to discuss current and emerging Sentinel Initiative projects.
The public workshop will be held on February 2, 2017, from 9 a.m. to 4:30 p.m., Eastern Standard Time (EST). Submit either electronic or written comments by March 2, 2017.
You may submit comments as follows:
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 Division of Dockets Management, 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
Carlos Bell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4343, Silver Spring, MD 20993-0002, 301-796-3714, FAX: 301-796-9832, email:
If you need special accommodations due to a disability, please contact Joanna Higgison at the Duke-Margolis Center for Health Policy (phone: 908-432-4872, email:
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995), HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
Comments on this ICR should be received no later than January 9, 2017.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
HRSA provides advanced education nursing grants to educational institutions to increase the numbers of advanced education nurses through the ANEW Program. The ANEW Program is authorized by Title VIII, Section 811(a)(2) of the Public Health Service Act, (42 U.S.C. 296j(a)(2)), as amended by Section 5308 of the Patient Protection and Affordable Care Act of 2010, Public Law 111-148. This renewal with revision request includes the Project Abstract, Program Narrative, Attachments, and Tables. The proposed ANEW tables are very similar to the previous AENT tables and include information on program participants such as the projected number of enrollees/trainees receiving traineeship support, projected number of graduates receiving traineeship support for the previous fiscal year, the types of programs they are enrolling into and/or from which enrollees/trainees are graduating, and the distribution of primary care nurse practitioners, primary care clinical nurse specialists, and nurse-midwives who plan to practice in rural and underserved settings. To reduce the reporting burden for applicants, HRSA simplified the tables to focus on the types of providers and practice settings that are included in the statute to determine whether applicants qualify for the preference or special consideration in making awards for this program.
Eligible state government entities include the 50 states, the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, American Samoa, the U.S. Virgin Islands, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
National Institutes of Health.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Louis M. Staudt, MD, Ph.D., Director, Center for Cancer Genomics, National Cancer Institute, Building 10 Room 5A02, 10 Center Drive, Bethesda MD 20814 or call non-toll-free number 301-402-1892 or Email your request, including your address to:
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimizes the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 50 hours.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of meetings of the National Advisory Council for Human Genome Research.
The meetings will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
In compliance with Section 3506(c)(2)(A) of the Paperwork
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; 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.
The Substance Abuse and Mental Health Services Administration/Center for Substance Abuse Prevention (SAMHSA/CSAP) is requesting a revision from the Office of Management and Budget (OMB) of the information collection regarding the Assessment of the Communities Talk: Town Hall Meetings to Prevent Underage Drinking. The current data collection has approval under OMB No. 0930-0288, Assessment of the Town Hall Meetings on Underage Drinking Prevention, which expires on January 31, 2017. Revisions were made to the two existing data collection instruments: The Organizer Survey and the Participant Form (English and Spanish versions). SAMHSA is requesting to add a new data collection instrument titled the Organizer Survey—6 month Follow-up, in which hosts of the Communities Talk events will opt in to provide information on any actions that were taken as result of the Communities Talk event.
Under the current approval, the Organizer Survey consists of 30 items. Under this revision, the Organizer Survey includes 20 items about the Communities Talk event. The following table provides a summary of the proposed changes to the instrument.
Three new questions were added pertaining to what influenced the decision to host an event (new q5), perception of how important UAD and its consequences is to the community (new q14), and agreement with mobilization actions statements (new q16).
The revisions were necessary to better align the data gathered to the short-term and long-term outcomes of the Communities Talk for event hosts, specifically—
• Increase utility of training.
• Increase utility of technical assistance.
• Increase national conversations about UAD.
• Increase youth involvement in UAD.
• Increase community mobilization for UAD prevention.
• Increase organization capacity for prevention.
• Increase use of evidence-based approaches to UAD prevention.
Changes were also made to the Participant Form. Under the current approval, the Participant Form consists of 14 items. Under this revision, the Participant Form includes 17 items about the Communities Talk event. The following table provides a summary of the proposed changes to the instrument, in English and Spanish.
Three new questions were added surrounding how often respondents are involved in UAD prevention in the community (new q9), likelihood will become more involved in UAD prevention in the community (new q10), and agreement with mobilization actions statements (new q12).
The revisions were necessary to better align the data gathered to the short-term and long-term outcomes of the Communities Talk, specifically—
• Increase knowledge of UAD prevention.
• Increase intentions to share information on UAD prevention.
• Increase national conversations about UAD.
• Increase youth involvement in UAD.
• Increase community mobilization for UAD prevention.
CBOs that opt in to be contacted 6 months after completing the Organizer Survey for SAMHSA to follow up on any actions that were taken as a result of the Communities Talk event in their community will be provided with the Organizer Survey—6 month Follow-up. This survey will allow SAMHSA to measure progress towards the short- and long-term outcomes of the Communities Talk, specifically—
• Increase utility of training.
• Increase utility of technical assistance.
• Increase national conversations about UAD.
• Increase youth involvement in UAD prevention.
• Increase community mobilization for UAD prevention.
• Increase capacity for prevention organizers.
• Increase use of evidence-based approaches to UAD prevention.
The Organizer Survey—6 month Follow-up consists of 13 items and captures information on—
• Where the Communities Talk event was held;
• Awareness of UAD activities that have taken place as a result of the event;
• Community mobilization and collaboration efforts;
• Perception of the importance of UAD and its consequences to the community; and
• Increase in youth involvement in UAD prevention activities in the community.
SAMHSA supports nationwide Communities Talk events every other year. Collecting data on each round of Communities Talk events, and using this information to inform policy and measure impact, supports SAMHSA's strategic initiative number 1: Prevention of substance use and mental illness. A specific goal under this initiative is to prevent or reduce the consequences of UAD and adult problem drinking; a specific objective is to establish the prevention of UAD as a priority issue for states, territories, tribal entities, colleges and universities, and communities.
SAMHSA will use the information collected to document the implementation efforts of this nationwide initiative, determine if the federally sponsored Communities Talk events lead to additional activities within the community that are aimed at preventing and reducing UAD, identify what these activities may possibly include, and help plan for future rounds of Communities Talk events. SAMHSA intends to post online a summary document of each round of Communities Talk events and present findings at national conferences attended by CBOs that have hosted these events and might host future events. Similarly, SAMHSA plans to share findings with the Interagency Coordinating Committee on the Prevention of Underage Drinking. Agencies within this committee encourage their grantees to participate as the event hosts.
Additionally, the information collected will support performance measurement for SAMHSA programs under the Government Performance Results Act (GPRA).
SAMHSA/CSAP will use a web-based method to collect data through the Organizer Survey and Organizer Survey—6 month Follow-up, and a paper-and-pencil approach to collect data through the Participant Form. The web-based application will comply with the requirements of Section 508 of the Rehabilitation Act to permit accessibility to people with disabilities.
Every 2 years, the Organizer Survey will be completed by an estimated 500 Communities Talk event organizers and will require only one response per respondent. It will take an average of 10 minutes (0.167 hours) to review the instructions and complete the survey. Similarly, the Organizer Survey—6 month Follow-up will be completed by an estimated 500 Communities Talk event organizers and will require only one response per respondent. It will take an average of 15 minutes (0.25 hours) to review the instructions and complete the survey. This burden estimate is based on comments from three 2016 Communities Talk even hosts who reviewed the survey and
The Participant Form will be completed by an average of 30 participants per sampled community-based organization (n = 400) and will require only one response per respondent. It will take an average of 5 minutes (0.083 hours) to review the instructions and complete the form.
Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857,
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of Inspectorate America Corporation as a commercial gauger.
Notice is hereby given, pursuant to CBP regulations, that Inspectorate America Corporation has been approved to gauge petroleum and certain petroleum products for customs purposes for the next three years as of February 17, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.13, that Inspectorate America Corporation, 2184 Jefferson Highway, Lutcher, LA 70071, has been approved to gauge petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.13. Inspectorate America Corporation is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of King Laboratories, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that King Laboratories, Inc., has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of July 12, 2016.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that King Laboratories, Inc., 1515 West Hillsborough Ave., Tampa, FL 33603, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. King Laboratories, Inc., is approved for the following gauging procedures for petroleum and certain
King Laboratories, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
Department of Homeland Security, Privacy Office.
Notice of Privacy Act system of records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current DHS system of records titled, “DHS/United States Citizenship and Immigration Services (USCIS)-005 Intercountry Adoptions Security” system of records. DHS/USCIS collects, uses, and maintains Intercountry Adoptions Security records on prospective adoptive parents and other individuals associated with an intercountry adoption-related application or petition.
DHS/USCIS is updating this system of records to: Clarify the information technology used to process intercountry adoption-based applications and petitions; update the categories of individuals in the system; clarify the categories of records in the system; update the legal authorities for the intercountry adoption immigration process from countries that are party to the Hague Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption (Hague Adoption Convention) and from non-Hague Adoption Convention (orphan) countries; reflect an increased retention period for intercountry adoption records; include all sources of records for adoption-based forms used in the Hague Adoption Convention process and non-Hague (orphan) process; and add Routine Use R, which permits the disclosure of information to the Department of Health and Human Services. Additionally, this notice includes non-substantive changes to simplify the formatting and text of the previously published notice.
This updated system will be included in the Department of Homeland Security's inventory of record systems.
Submit comments on or before December 8, 2016. This updated system will be effective December 8, 2016.
You may submit comments, identified by docket number DHS-2016-0071 by one of the following methods:
•
•
•
For general questions, please contact: Donald K. Hawkins, (202) 272-8000, Privacy Officer, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW., Washington, DC 20529. For privacy questions, please contact: Jonathan R. Cantor, (202) 343-1717, Acting Chief Privacy Officer, Privacy Office, Department of Homeland Security, Washington, DC 20528.
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the DHS/USCIS proposes to update and reissue a current DHS system of records titled, “DHS/USCIS-005 Intercountry Adoptions Security” system of records.
DHS/USCIS oversees certain intercountry adoption-related requests from U.S. citizens seeking to adopt a child from a foreign country and bring that child to the United States to permanently live with them. The intercountry adoption process is a cooperative effort between USCIS and the Department of State (DOS). USCIS plays a vital role in the intercountry adoption process by determining the suitability and eligibility of a prospective adoptive parent to adopt, and by determining the eligibility of a child to immigrate as an immediate relative of a U.S. citizen under 8 U.S.C. 1101(b)(1)(F) or (G). USCIS receives and adjudicates both domestic and internationally-filed applications and
USCIS uses two information technology (IT) systems to process intercounty adoption filings, depending on whether the intercounty adoption application was filed domestically or internationally. The USCIS National Benefits Center (NBC) processes all Hague and domestically-filed orphan intercountry adoption filings. USCIS uses the National Benefits Center's Adoption Case Management System (ACMS) within the National Processing Workflow Repository (NPWR) as the case management system for domestically filed intercountry adoption-based applications and petitions from receipt of the application or petition to final adjudication. USCIS uses the Case and Activity Management for International Operations (CAMINO) system to process applications and petitions filed internationally with USCIS international offices. Previously, USCIS used the Secure Information Management Service (SIMS) to track and review intercountry adoption cases. SIMS, however, did not fully meet the case tracking requirements of the intercountry adoption process. USCIS decommissioned SIMS after the launch of these systems.
USCIS is updating this system of records to: (1) Identify the Adoptions Case Management System (ACMS) and Case and Activity Management for International Operations (CAMINO) as the information technology systems used to process intercountry adoption-based applications and petitions; (2) update the categories of individuals in the system to include other individuals whose presence in the residence of the prospective adoptive parent(s) (known as the Adult Household Member) as relevant to determine suitability; (3) clarify the categories of record in the system; (4) update the legal authorities for the intercountry adoption immigration process to include the Intercountry Adoption Universal Accreditation Act of 2012 (UAA) (Pub. L. 112-276), which went into effect on July 14, 2014; (5) reflect a reduced retention period from 75 years to 25 and 15 years for internationally and domestically, respectively, filed intercountry adoption applications and petitions; (6) update the sources of records to include Hague petition and application forms (
Consistent with DHS's information-sharing mission, information stored in the DHS/USCIS-005 Intercountry Adoptions Security may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, when appropriate, information may be shared with appropriate Federal, State, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice unless disclosure is otherwise prohibited under the confidentiality statutes, regulations, or policies applicable to that information.
This updated system will be included in DHS's inventory of record systems.
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
Below is the description of the DHS/USCIS-005 Intercountry Adoptions Security System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS)-005
DHS/USCIS-005 Intercountry Adoptions Security
Unclassified, Sensitive.
Intercountry adoption records are maintained in the ACMS or CAMINO IT systems and associated electronic and paper files located at the USCIS NBC, service centers, and domestic and international field offices.
Categories of individuals covered by this system include:
(1) All individuals, including the applicant or petitioner (and spouse, if married), seeking an intercountry adoption through the Hague Adoption Convention process or non-Hague orphan process;
(2) All individuals who meet the definition of an adult member of the household;
(3) Any other individual whose presence in the applicant's or petitioner's residence is relevant to the suitability of the prospective adoptive parent(s) suitability to adopt;
(4) Representatives, including attorneys, adoption service providers, and form preparers, of the prospective adoptive parent(s);
(5) Children being adopted; and
(6) Birth mothers, fathers, or custodians of adopted children.
• Full Name;
• Alias(es);
• Gender;
• Physical and mailing address;
• Address abroad;
• Email address;
• Telephone number;
• Physical Description (
• Biometric (
• Date of birth;
• Country of birth;
• City of birth;
• State or Province of birth;
• Citizenship status;
• Naturalization history;
• Certificate of Citizenship or Certificate of Naturalization Number;
• Residence status;
• Marital history and status;
• Spouse's immigration status;
• USCIS Online Account Number;
• Social Security number (SSN);
• A-Number;
• USCIS Receipt/Case Number;
• Passport number;
• Country of adoption;
• Adoption filing history;
• Payments made and anticipated future payments in relation to the adoption;
• Criminal history;
• Photographs;
• Accommodations/Disabilities;
• Home study;
• Medical and Social History (
• Financial Information (
• Supporting Documentation as necessary (
• Proof of Citizenship (
• Proof of Marriage and termination of previous marriages;
• Criminal and National Security Background Check Results;
• Case Decision; and
• Signature.
• Full Name;
• Alias(es);
• Gender;
• Mailing address;
• Email address;
• Telephone number;
• Date of birth;
• County of birth;
• State or Province of birth;
• City, Town, or Village of Birth;
• A-Number;
• SSN;
• Passport number;
• Relationship to Prospective adoptive parent(s);
• Photographs;
• Physical Description (
• Biometric (
• Criminal and National Security background check results;
• Accommodations/Disabilities;
• Signature; and
• Email Address.
• Full Name at Birth;
• Full Name at Present;
• Alias;
• Date of birth;
• Gender;
• Country of birth
• City/Town/Village of Birth;
• Place of habitual residency;
• Present legal custodian;
• Present address;
• Address where the beneficiary will reside;
• Parental history and custody information (
• Date of adoption;
• Country/Place of adoption;
• Physical or mental afflictions;
• Accommodations/disabilities;
• A-Number;
• Passport number;
• Relationship to prospective adoptive parent, if any;
• Article 16 Report, which is an official report from countries that are party to the Hague Adoption Convention, on a child's psychological, social, medical history, and reasons the child is in need of an adoptive placement;
• Supporting Documentation as Necessary (
• Case decision.
• Name;
• Date of birth;
• Relationship to adopted child(ren) (
• Supporting documentation (identity information, death certificates, DNA test results, description of how the child beneficiary was abandoned or released for adoption, consent to adoption, adoption documentation, etc.).
• Name;
• Organization name;
• Mailing address;
• Phone and Fax numbers;
• Email address;
• Accreditation or Approval status; and
• Signature.
• Full name;
• Organization or Business name;
• Business State ID number;
• Employer Tax Identification Number;
• Physical and Mailing addresses;
• Email address;
• Phone and fax numbers;
• Relationship to benefit requestor; and
• Signature.
• Name;
• Law firm/Recognized organization name;
• Physical and Mailing addresses;
• Phone and fax numbers;
• Email address;
• USCIS Online Account Number;
• Attorney Bar Card Number or equivalent;
• Bar Membership;
• Accreditation date;
• Source of Accreditation;
• Board of Immigration Appeals Representative Accreditation;
• Expiration date;
• Law Practice Restriction Explanation; and
• Signature.
The legal authorities for intercountry adoption from Hague Adoption Convention countries include the Hague Adoption Convention, the Intercountry Adoption Act of 2000, 8 U.S.C. 1101(b)(1)(G) (INA 101(b)(1)(G)), and 8 CFR 204.300-204.314. The legal authorities for intercountry adoption for non-Hague Adoption Convention countries include the Intercountry Adoption Universal Accreditation Act of 2012, Consolidated Appropriations Act of 2014 sec. 7083, 8 U.S.C. 1101(b)(1)(F) (INA 101(b)(1)(F)), and 8 CFR 204.3.
USCIS collects information on prospective adoptive parents and other associated individuals in order to assess the suitability and eligibility of the prospective adoptive parent(s) to adopt. USCIS also collects information
Except as permitted by the Privacy Act, 5 U.S.C. 552a and applicable routine uses, USCIS may not disclose or give access to any information or record relating to any applicant, petitioner, spouse (if married), or adult member of the household to any individual or entity other than that person, including an accredited agency, approved person, exempted provider, supervised provider, or other adoption service provider, absent written consent, as provided by the Privacy Act, 5 U.S.C. 552a.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3). Even when a valid routine use permits disclosure of information from this system of records to a third party, in some cases such disclosure may not be permissible because of confidentiality laws and policies that limit the sharing of information regarding individuals applying for certain immigration benefits. These confidentiality provisions may be subject to certain exceptions which would allow for disclosure, such as in the case of a criminal or civil investigation.
A. To the Department of Justice (DOJ), including Offices of the U.S. Attorneys, or other federal agencies conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. DHS or any component thereof;
2. Any employee or former employee of DHS in his/her official capacity;
3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or
4. The United States or any agency thereof.
B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
E. To appropriate agencies, entities, and persons when:
1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and
3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.
G. To an appropriate federal, state, local, tribal, territorial, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation, enforcing, or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
H. To clerks and judges of courts exercising naturalization jurisdiction to enable such courts to determine eligibility for naturalization and grounds for revocation of naturalization.
I. To DOS in the processing of visas, applications, or petitions for benefits under the INA, and all other immigration and nationality laws including treaties and reciprocal agreements.
J. To an attorney or representative (as defined in 8 CFR 1.2) who is acting on behalf of an individual covered by this system of records.
K. To appropriate federal, state, tribal, and local government law enforcement and regulatory agencies, foreign governments, and international organizations for example the Department of Defense, the DOS, the Department of the Treasury, the United Nations, and INTERPOL and individuals and organizations during the course of an investigation by DHS or the processing of a matter under DHS's jurisdiction, or during a proceeding within the purview of the immigration and nationality laws, when necessary to elicit information required by DHS to carry out its functions and statutory mandates.
L. To an appropriate federal, state, tribal, local, or foreign government agency or organization, or international organization, lawfully engaged in collecting law enforcement intelligence, whether civil or criminal, or charged with investigating, prosecuting, enforcing, or implementing civil or criminal laws, related rules, regulations or orders, to enable these entities to carry out their law enforcement responsibilities, including the collection of law enforcement intelligence, and the disclosure is appropriate to the proper performance of the official duties of the person making the disclosure.
M. To an appropriate federal, state, local, tribal, territorial, foreign, or international agency, if the information is relevant and necessary to a requesting agencies decision concerning the hiring or retention of an individual, or issuance of a security clearance, license, contract, grant, or other benefit, or if the information is relevant and necessary to a DHS decision concerning the hiring or retention of an employee, the issuance of a security clearance, the reporting of an investigation of an employee, the letting of a contract, or the issuance of
N. To a federal, state, or local government agency, or employer seeking to verify or ascertain the citizenship or immigration status of any individual within the jurisdiction of the agency or employer for any purpose authorized by law.
O. To the Social Security Administration (SSA) for the purpose of issuing a Social Security number and card to an alien who has made a request for a Social Security number as part of the immigration process and in accordance with any related agreements in effect between the SSA, DHS, and the DOS entered into pursuant to 20 CFR 422.103(b) (3); 422.103(c); and 422.106(a), or other relevant laws and regulations.
P. To federal and foreign government intelligence or counterterrorism agencies or components when DHS becomes aware of an indication of a threat or potential threat to national or international security, or when the information is needed to assist in anti-terrorism efforts and disclosure is appropriate to the proper performance of the official duties of the person making the disclosure.
Q. To officials of other federal, state, and local government agencies and adoption agencies and social workers to elicit information required for making a final determination of the prospective adoptive parent's ability to care for a beneficiary or the beneficiary's immigration eligibility.
R. To the Department of Health and Human Services to obtain information about children who are under its legal custody and/or protection.
S. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
None.
DHS/USCIS stores records in this system electronically or on paper in secure facilities in a locked drawer or behind a locked door. The records may be stored on magnetic disc, tape, cloud services, and digital media.
Records may be retrieved by an individual's name, date of birth, address, A-Number, Receipt Number, SSN, or a combination thereof.
DHS/USCIS safeguards records according to applicable rules and policies, including all applicable DHS automated systems security and access policies. DHS/USCIS has imposed strict controls imposed to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
DHS/USCIS stores the physical documents (paper forms) and supplemental documentation in the Alien File and processes applications and petitions in the respective DHS/USCIS case management system. Physical applications and supplemental documentation is stored in the Alien File. The A-File records are permanent whether hard copy or electronic. USCIS transfers the A-Files to the custody of NARA 100 years after the individual's date of birth.
Electronic benefits information is archived and disposed of in accordance with NARA-approved retention schedule for the respective USCIS case management systems (CAMINO and ACMS):
• Electronic data pertaining to intercountry applications and petitions filed internationally are electronically stored in CAMINO. NARA approved the CAMINO retention schedule [N1-566-12-06] on April 17, 2013. CAMINO retains records 25 years from the last completed action.
• Electronic data pertaining to intercountry applications and petitions filed domestically are stored in ACMS. USCIS is working with NARA to develop a retention and disposal schedule for data contained within ACMS. USCIS proposal for retention and disposal of these records is to store and retain adoption related records for 15 years, during which time the records will be archived. The 15 year retention period is derived from the length of time USCIS may interact with a customer.
Assistant Center Director, Adoptions, National Benefits Center, Overland Park, KS 66213; and Director, Refugee, Asylum, and International Operations Directorate, 20 Massachusetts Avenue NW., Washington, DC 20529.
Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the National Records Center (NRC) FOIA/PA Office, P.O. Box 648010, Lee's Summit, MO 64064-8010. The NRC can be found at
When seeking records about yourself from this system of records or any other Departmental system of records, your request must conform with the Privacy Act regulations set forth in 6 CFR part 5. You must first verify your identity, meaning that you must provide your full name, current address, and date and place of birth. You must sign your request, and your signature must either be notarized or submitted under 28 U.S.C. 1746, a law that permits statements to be made under penalty of perjury as a substitute for notarization. While no specific form is required, you may obtain forms for this purpose from the Chief Privacy Officer and Chief Freedom of Information Act Officer,
• Explain why you believe the Department would have information on you;
• Identify which component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records.
If your request is seeking records pertaining to another living individual, you must include a statement from that
Without the above information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
See “Notification procedure” above.
See “Notification procedure” above.
Information contained in this system of records is primarily supplied by prospective adoptive parents and adult members of the household on forms associated with either the Hague Adoption Convention process or the orphan intercountry adoption process. These application and petition forms include:
• Form I-600, Petition to Classify Orphan as an Immediate Relative
• Form I-600A, Application for Advance Processing of Orphan Petition
• Form I-600A/Form I-600, Supplement 1 (Listing of Adult Member of the Household)
• Form I-800, Petition to Classify Convention Adoptee as an Immediate Relative
• Form I-800A, Application for Determination of Suitability to Adopt a Child from Convention Country
• Form I-800A Supplement 1 (Listing of Adult Member of the Household)
• Form I-800A Supplement 2 (Consent to Disclose Information)
• Form I-800A Supplement 3 (Request for Action on Approved Form I-800A)
Information contained in this system of records is also obtained through representatives of prospective adoptive parents and other organizations involved in an intercountry adoption case including information from the child's country of origin; the home study prepared by an authorized home study preparer submitted to USCIS in furtherance of the intercountry adoption immigration process; interviews performed by authorized USCIS and DOS personnel of individuals seeking to adopt; and data obtained from other DHS and non-DHS federal agency's systems and databases, including the Federal Bureau of Investigation, DOS, and U.S. Customs and Border Protection.
Specifically, Intercountry Adoptions Security stores and uses information from the following USCIS, DHS, and other federal agency systems of records:
• DHS/USCIS/ICE/CBP-001 Alien File, Index, and National File Tracking System of Records, 78 FR 69864 (November 21, 2013);
• DHS/USCIS-002 Background Check Service, 72 FR 31082 (June 5, 2007);
• DHS/USCIS-003 Biometric Storage System, 72 FR 17172 (April 6, 2007);
• DHS/USCIS-006 Fraud Detection and National Security Records (FDNS) 77 FR 47411 (August 8, 2012);
• DHS/USCIS-007 Benefit Information System, 81 FR 72069, (October 19, 2016)
• DHS/CBP-011 U.S. Customs and Border Protection TECS, 73 FR 77778 (December 19, 2008);
• DHS/CBP-021 Arrival and Departure Information System (ADIS), 80 FR 72081 (November 18, 2015);
• DHS/NPPD-004 DHS Automated Biometric Identification System (IDENT), 72 FR 31080 (June 5, 2007);
• JUSTICE/FBI-002 The FBI Central Records System, 72 FR 3410 (January 25, 2007);
• JUSTICE/FBI-009 Fingerprint Identification Records System (FIRS), 72 FR 3410 (January 25, 2007);
• STATE-05 Overseas Citizens Services Records, 73 FR 24343 (May 2, 2008);
• STATE-26 Passport Records, 76 FR 34966 (July 6, 2011); and
• STATE-39 Visa Records, 77 FR 65245 (October 25, 2012).
None.
Department of Homeland Security, Privacy Office.
Notice of Privacy Act System of Records.
In accordance with the Privacy Act of 1974, the Department of Homeland Security (DHS) proposes to update and reissue a current DHS system of records titled, “DHS/United States Citizenship and Immigration Services (USCIS)-004 Systematic Alien Verification for Entitlements (SAVE) Program” system of records. DHS/USCIS collects, uses, and maintains the SAVE Program records on noncitizen applicants for public benefits, licenses, grants, governmental credentials, or other statutorily authorized purposes.
DHS/USCIS is updating this system of records to: (1) Update the category of individuals to include sponsors listed on the Form I-864
This updated system will be included in the Department of Homeland Security's inventory of record systems.
Submit comments on or before December 8, 2016. This updated system will be effective December 8, 2016.
You may submit comments, identified by docket number DHS-2016-0076 by one of the following methods:
•
•
•
For general questions, please contact:
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/USCIS proposes to update and reissue a current DHS system of records titled, “DHS/U.S. Citizenship and Immigration Services (USCIS)-004, Systematic Alien Verification for Entitlement (SAVE) Program System of Records.”
The SAVE Program is a primarily web-based service designed to assist Federal, State, tribal, and local government agencies, benefit-issuing agencies, private entities, institutions, and licensing bureaus authorized by law in determining immigration status for granting benefits, licenses, and other lawful purposes. Benefits may include Social Security benefits, public health care, food stamps, conducting background investigations, armed forces recruitment, REAL ID compliance, or any other statutorily authorized purpose. The SAVE Program does not provide determinations regarding an applicant's eligibility for a specific benefit or license; only the benefit granting agency can make that determination. The SAVE Program does not receive the customer agency's final determination of benefit eligibility.
USCIS is updating this Privacy Act System of Records Notice for the SAVE Program to (1) update the category of individuals covered by this SORN, to include sponsors listed on the Form I-864,
Consistent with DHS's information sharing mission, information stored in the DHS/USCIS-004 Systematic Alien Verification for Entitlement (SAVE) Program may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/USCIS may share information with appropriate Federal, State, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.
This updated system will be included in DHS's inventory of record systems.
The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.
Below is the description of the DHS/USCIS-004 Systematic Alien Verification for Entitlements (SAVE) System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.
Department of Homeland Security (DHS)/U.S. Citizenship and Immigration Services (USCIS)-004
DHS/USCIS-004 Systematic Alien Verification for Entitlements (SAVE) Program
Unclassified, For Official Use Only.
Records are maintained at USCIS Headquarters in Washington, DC, DHS/USCIS domestic and international field offices, and at the DHS Stennis Data Center (DC1).
Categories of individuals covered by this system include both U.S. citizens and non-U.S. citizens covered by provisions of the Immigration and Nationality Act of the United States, including individuals who have been lawfully admitted to the United States, individuals who have been granted or derived U.S. citizenship, and individuals who have applied for other immigration benefits pursuant to 8 U.S.C. 1103
• Full Name;
• Date of birth;
• Country of birth;
• A-Number;
• SSN (in very limited circumstances using the Form G-845,
• Receipt number;
• Admission number (I-94 number);
• Customer Agency Case number;
• Agency DUNS number;
• Visa number;
• DHS Document type;
• DHS Document Expiration date;
• Government-issued identification (
○ Document type;
○ Country of issuance (COI);
○ Document number;
○ Expiration date; and
○ Benefit requested (
• Copies of original immigration documents; and
• U.S. Immigration and Custom Enforcement (ICE) Student and Exchange Visitor Identification System (SEVIS) ID.
• Case Verification; and
• SAVE program response.
• Agency name;
• Address;
• Names of Point(s) of Contact;
• Contact telephone number;
• Fax number;
• Email address;
• User ID; and
• Type of benefit(s) the agency issues (
• Full Name;
• Date of birth;
• Country of birth;
• A-Number;
• SSN;
• Photograph;
• Government-issued identification (
○ Document type;
○ Country of issuance (COI);
○ Document number; and
○ Expiration date.
• Visa number;
• Form numbers (
• Other unique identifying numbers (
• Entry/Departure date;
• Port of entry;
• Alien Status Change date;
• Naturalization date;
• Date admitted until, country of citizenship;
• Document Grant date;
• Document Receipt number;
• Codes (
• Beneficiary information (
• Petitioner information (
• Sponsor information (
• Spouse information (
• Children information (
• Employer information (
• Alert(s);
• Case summary comments;
• Case category;
• Date of encounter;
• Encounter information;
• Custody actions and decisions;
• Case actions and decisions;
• Bonds;
• Photograph;
• Asylum applicant receipt date;
• Airline and flight number;
• Country of residence;
• City (
• Date visa issued;
• Address in United States;
• Nationality;
• Decision memoranda; Investigatory reports and materials compiled for the purpose of enforcing immigration laws;
• Exhibits;
• Transcripts; and
• Other case-related papers concerning aliens, alleged aliens, or lawful permanent residents brought into the administrative adjudication process.
Authority for having a system for verification of immigration status is found in Immigration Reform and Control Act (IRCA), Public Law 99-603, 100 Stat. 3359 (1986); Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA), Public Law 104-193, 110 Stat. 2105 (1996); Title IV, Subtitle A, of Illegal Immigration Reform and Immigrant Responsibility Act (IIRIRA), Public Law 104-208, 110 Stat. 3009 (1997); the REAL ID Act of 2005, Public Law 109-13, 119 Stat. 231 (2005); Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (Mar. 23, 2010), as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, 124 Stat. 1029 (Mar. 30, 2010); and the FAA Extension, Safety and Security Act of 2016, Public Law 114-190, 130 Stat. 615 (July 15, 2016).
The purpose of this system is to provide a fee-based service that assists federal, state, tribal, or local government agencies, or contractors acting on the agency's behalf, private entities and agencies and licensing bureaus for any legally mandated purpose in accordance with an authorizing statute to confirm immigration and naturalized and derived citizen status information, to the extent that such disclosure is necessary to enable these agencies and entities to make decisions related to (1) determining eligibility for a federal, state, or local public benefit; (2) issuing a license or grant; (3) issuing a government credential; (4) conducting a background investigation; or (5) any other lawful purpose.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, all or a portion of the records or information contained in this system may be disclosed outside DHS as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the U.S. Department of Justice (DOJ), including Offices of the United States Attorneys, or other federal agency conducting litigation or in proceedings before any court, adjudicative, or administrative body, when it is relevant or necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. DHS or any component thereof;
2. Any employee or former employee of DHS in his/her official capacity;
3. Any employee or former employee of DHS in his/her individual capacity when DOJ or DHS has agreed to represent the employee; or
4. The United States or any agency thereof.
B. To a congressional office from the record of an individual in response to an inquiry from that congressional office made at the request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or General Services Administration pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
D. To an agency or organization for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
E. To appropriate agencies, entities, and persons when:
1. DHS suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised;
2. DHS has determined that as a result of the suspected or confirmed compromise, there is a risk of identity theft or fraud, harm to economic or property interests, harm to an individual, or harm to the security or integrity of this system or other systems or programs (whether maintained by DHS or another agency or entity) that rely upon the compromised information; and
3. The disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with DHS's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
F. To contractors and their agents, grantees, experts, consultants, and others performing or working on a contract, service, grant, cooperative agreement, or other assignment for DHS, when necessary to accomplish an agency function related to this system of records. Individuals provided information under this routine use are subject to the same Privacy Act requirements and limitations on disclosure as are applicable to DHS officers and employees.
G. To an appropriate federal, state, local, tribal, territorial, international, or foreign law enforcement agency or other appropriate authority charged with investigating or prosecuting a violation, enforcing, or implementing a law, rule, regulation, or order, when a record, either on its face or in conjunction with other information, indicates a violation or potential violation of law, which includes criminal, civil, or regulatory violations and such disclosure is proper and consistent with the official duties of the person making the disclosure.
H. To approved federal, state, and local government agencies for any legally mandated purpose in accordance with their authorizing statute or law and when an approved Memorandum of Agreement or Computer Matching Agreement (CMA) is in place between DHS and the entity.
I. To airport operators to determine the eligibility of individuals seeking unescorted access to any Security Identification Display Area of an airport, as required by the FAA Extension, Safety, and Security Act of 2016.
J. To the news media and the public, with the approval of the Chief Privacy Officer in consultation with counsel, when there exists a legitimate public interest in the disclosure of the information, when disclosure is necessary to preserve confidence in the integrity of DHS, or when disclosure is necessary to demonstrate the accountability of DHS officers, employees, or individuals covered by the system, except to the extent the Chief Privacy Officer determines that release of the specific information in the context of a particular case would constitute an unwarranted invasion of personal privacy.
None.
USCIS stores records in this system electronically or on paper in secure facilities in a locked drawer behind a locked door. The records may be stored on magnetic disc, tape, and digital media.
USCIS retrieves records by name of applicant or other unique identifier to include (but not limited to): Verification Number, A-Number, I-94 Number, SSN, Passport number and Country of Issuance (COI), Visa number, SEVIS Identification, or by the submitting agency name.
USCIS safeguards records in this system according to applicable rules and policies, including all applicable DHS automated systems security and access policies. USCIS has imposed strict controls to minimize the risk of compromising the information that is being stored. Access to the computer system containing the records in this system is limited to those individuals who have a need to know the information for the performance of their official duties and who have appropriate clearances or permissions.
The retention and disposal schedule, N1-566-08-7, has been approved by the National Archives and Records Administration. Records collected in the process of enrolling in SAVE and in verifying citizenship or immigration status are stored and retained in SAVE for ten (10) years from the date of the completion of verification, unless the records are part of an ongoing investigation in which case they will be retained until completion of the investigation. This period is based on the statute of limitations for most types of misuse or fraud possible using SAVE (under 18 U.S.C. 3291, the statute of limitations for false statements or misuse regarding passports, citizenship, or naturalization documents).
The DHS system manager is the Chief, Verification Division, U.S. Citizenship and Immigration Services, Department of Homeland Security, 131 M Street NE., Suite 200, Mail Stop 200, Washington, DC 20529.
Individuals seeking notification of and access to any record contained in this system of records, or seeking to contest its content, may submit a request in writing to the National Records Center, Freedom of Information Act (FOIA)/Privacy Act (PA) Office, P.O. Box 648010, Lee's Summit, MO 64064-8010. Specific FOIA information can be found at
• Explain why you believe the Department would have information on you;
• Identify which component(s) of the Department you believe may have the information about you;
• Specify when you believe the records would have been created; and
• Provide any other information that will help the FOIA staff determine which DHS component agency may have responsive records;
• If your request is seeking records pertaining to another living individual, you must include a statement from that individual certifying his/her agreement for you to access his/her records.
Without the above information, the component(s) may not be able to conduct an effective search, and your request may be denied due to lack of specificity or lack of compliance with applicable regulations.
See “Notification procedure” above.
See “Notification procedure” above.
Records are obtained from several sources to include:
(A) Agencies and entities seeking to determine immigration or naturalized or derived citizenship status;
(B) Individuals seeking public licenses, benefits, or credentials;
(C) Other DHS components assisting with enrollment and system maintenance processes;
(D) Information collected from the federal databases listed below:
• Arrival/Departure Information System (ADIS);
• Central Index System (CIS);
• Computer-Linked Application Information Management System 3 & 4 (CLAIMS 3 & CLAIMS 4);
• Customer Profile Management System (CPMS);
• Customs and Border Protection's (CBP) TECS;
• CBP Automatic Tracking System-Passenger (ATS-P);
• Electronic Immigration System (ELIS);
• Enforcement Integrated Database (EID);
• Enforcement Alien Removal Module (EARM);
• Enterprise Service Bus Person Centric Query Service (ESB PCQS);
• Enterprise Citizenship and Immigration Services Centralized Operational Repository (eCISCOR);
• Enterprise Document Management System (EDMS);
• Marriage Fraud Amendment System (MFAS);
• Microfilm Digitization Application System (MiDAS);
• National File Tracking System (NFTS);
• Refugees, Asylum, and Parole System (RAPS);
• DOJ's Immigration Review Information Exchange System (IRIES);
• Student and Exchange Visitor Identification System (SEVIS);
• Immigration status (
• Department of State the Consular Consolidated Database (DOS-CCD).
(E) Information created by the Systematic Alien Verification for Entitlements (SAVE) program.
This system may receive records from another system exempted in that source system under 5 U.S.C. 552a(j)(2). DHS will claim the same exemptions for those records that are claimed for the systems of records from which they originated.
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 an individual traveler providing his or her name and address and information about verifying identity documents that have been issued to the traveler but are not present with him or her at an airport security screening checkpoint.
Send your comments by January 9, 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.
TSA requires individuals to provide an acceptable verifying identity document in order to proceed through security screening, enter the sterile area of the airport, or board a commercial aircraft. Under 49 CFR 1560.3, acceptable verifying identity documents include federally-issued documents, such as U.S. passports and U.S. passport cards, passports issued by foreign governments, and state-issued driver's licenses and identification cards. The complete list of acceptable verifying identity documents is available at
Secure driver's licenses and identification documents are a vital component of the Department of Homeland Security's (DHS's) national security strategy. In particular, preventing terrorists from obtaining state-issued identification documents is critical to securing the United States against terrorism. The 9/11 Commission noted “[f]or terrorists, travel documents are as important as weapons” and recommended that the Federal
The REAL ID Act of 2005 (REAL ID Act)
To implement the REAL ID Act, TSA may accept state-issued verifying identity documents only if they have been issued by a state that is in compliance with the minimum security requirements and standards set forth in the Act, or if the state has received an extension from DHS. In accordance with DHS policy, TSA will begin implementing the REAL ID Act at airport security screening checkpoints on January 22, 2018. Starting on that day, TSA will not accept state-issued driver's licenses and other state-issued identification cards from states that are not compliant with REAL ID Act requirements unless DHS has granted the state a temporary extension to achieve compliance.
Concurrently with implementation of the REAL ID Act, TSA is updating the identity verification process for travelers who arrive at an airport security checkpoint without an acceptable verifying identity document. This process involves a traveler providing his or her name and address and answering questions to confirm his or her identity. If the traveler's identity is confirmed, he or she will be allowed to enter the screening checkpoint. Travelers using this process for identity verification may be subject to additional security screening. A traveler will not be permitted to fly if his or her identity cannot be confirmed. A traveler also will not be permitted to fly if he or she declines to cooperate with the identity verification process.
To initiate the identity verification process, a traveler without an acceptable verifying identity document must complete a Certification of Identity (COI) form (TSA Form 415). The current TSA Form 415 requests the traveler's name and address. After completing the form, the traveler is connected with TSA's Identity Verification Call Center (IVCC). The IVCC searches various commercial and government databases using the name and address on the TSA Form 415 as key search criteria to find other identifying information about the traveler. The IVCC then asks the traveler a series of questions based on information found in the databases to verify the individual's identity.
To ensure that the identity verification process described above does not become a means for travelers to circumvent implementation of the REAL ID Act, TSA is updating the process so that it is generally only available to travelers who certify that they—
• Reside in or have been issued a driver's license or state identification card by a state that is compliant with the REAL ID Act or a state that has been granted an extension by DHS; or
• Have been issued another verifying identity document that TSA accepts.
To enable travelers to make this certification, TSA is revising Form 415. The revised TSA Form 415 requests a traveler's name and address and asks for the following additional information:
(1) Whether the traveler has been issued a driver's license or state identification card.
(2) If yes, the state that issued the document.
(3) Whether the traveler has been issued an acceptable verifying identity document other than a state-issued driver's license or identification card.
TSA will use the information provided on revised TSA Form 415 to generate questions intended to verify the identity of a traveler who arrives at a security-screening checkpoint without an acceptable verifying identity document. A failure to collect this information would result in TSA being unable to verify the identity of travelers without an acceptable verifying identity document and these travelers being unable to proceed through the security checkpoint and board a commercial aircraft.
The most likely respondents to this proposed information request are travelers who arrive at an airport security checkpoint without an acceptable verifying identity document because they lost or forgot their driver's license or other state-issued identification card. Other likely respondents are travelers who had their verifying identity document stolen and travelers carrying a form of identification that they incorrectly believed to be acceptable. TSA estimates that approximately 191,214 passengers will complete the TSA Form 415 annually. TSA estimates each form will take approximately three minutes to complete. This collection would result in an annual reporting burden of 9,561 hours.
Fish and Wildlife Service, Interior.
Notice of availability; request for comments.
We, the U.S. Fish and Wildlife Service (Service), have received an application from Kamehameha Schools (KS), a private charitable education trust, for an enhancement of survival permit (permit) under the Endangered Species Act of 1973, as amended (ESA). The permit application includes a draft Safe Harbor Agreement (SHA) between KS, the Service, and the Hawaii Department of Land and Natural Resources (DLNR). Kamehameha Schools is proposing to conduct proactive conservation activities to promote the survival and recovery of 32 federally endangered species and one species currently proposed for listing (“covered species”) across the Keauhou
To ensure consideration, please send your written comments by December 8, 2016.
To request further information or submit written comments, please use one of the following methods, and note that your information request or comments are in reference to the Kamehameha Schools—Keauhou and Kilauea Forest Lands SHA, draft EAS, and the proposed issuance of the Permit:
•
•
•
•
•
Ms. Michelle Bogardus (Maui Nui and Hawaii Island Team Manager) or Ms. Donna Ball (Hawaii Island Fish and Wildlife Biologist), U.S. Fish and Wildlife Service (see
Under a SHA, participating landowners undertake management activities on their property to enhance, restore, or maintain habitat conditions for species listed under the ESA (16 U.S.C. 1531
The SHA and its associated permit allow the property owner to alter or modify the enrolled property back to agreed-upon pre-permit baseline conditions at the end of the term of the permit, even if such alteration or modification results in the incidental take of a listed species. The baseline conditions must reflect the known biological and habitat characteristics that support existing levels of use of the enrolled property by species covered in the SHA. The authorization to take listed species is contingent on the property owner complying with obligations in the SHA and the terms and conditions of the permit. The SHA's net conservation benefits must be sufficient to contribute, either directly or indirectly, to the recovery of the covered listed species. Enrolled landowners may make lawful use of the enrolled property during the term of the permit and may incidentally take the listed species named on the permit in accordance with the terms and conditions of the permit.
Permit application requirements and issuance criteria for enhancement of survival permits for SHAs are found in the Code of Federal Regulations (CFR) at 50 CFR 17.22(c). The Service's Safe Harbor Policy (64 FR 32717, June 17, 1999) and the Safe Harbor Regulations (68 FR 53320, September 10, 2003; and 69 FR 24084, May 3, 2004) are available at
The Service has received a permit application from KS to authorize incidental take of the covered species with implementation of the SHA. The permit application includes a draft SHA between KS, the Service, and Hawaii DLNR. The conservation objective of the SHA is to promote recovery of the following Federal- and State-endangered birds: the Hawaii Creeper (
Of the covered species, all but one of the wildlife species currently occur on the property. The Alala is currently extirpated in the wild, but survives through an intensive captive breeding program and partnership between the San Diego Zoo, the Service, and Hawaii DLNR. The Alala will be reintroduced to the wild in November 2016 on State-owned lands adjacent to Keauhou and Kilauea Forest. It is likely that released Alala will disburse beyond the release site and enter the enrolled property under the SHA. Of the covered plant species, eight currently occur on the enrolled property. The remaining covered plant species are known to have historically occurred in the region, and may become re-established on the enrolled property through habitat enhancement and restoration activities described in the SHA, or may be outplanted on the enrolled property over the term of the SHA and permit.
The land area covered by the SHA and permit (“enrolled property”) encompasses 32,280 acres on the southeastern slope of Mauna Loa on the island of Hawaii. The enrolled property is bounded by Federal lands to the west and south (Hawaii Volcanoes National Park), State lands to the east (Puu Makaala Natural Area Reserve) and north (Mauna Loa Forest Reserve), and State-leased lands to the north (Kipuka Ainahou Nene Sanctuary). Kamehameha Schools' management and stewardship practices have contributed to preserving some of the last remaining intact native forests in Hawaii. Keauhou Forest and Kilauea Forest support native habitat for numerous endangered species. A portion of the enrolled property, Kilauea Forest, has been largely unaltered and has long been recognized for its native bird populations. The area within the Keauhou boundary was formerly altered by ranching and logging operations. Currently no cattle ranching operations exist, and both Keauhou and Kilauea are managed to preserve and restore the native forests via ungulate removal, reforestation, and out-plantings of native and rare species. In addition to native forest restoration activities, portions of Keauhou (but not Kilauea) will include forest management practices for the purposes of sustainably harvesting native hardwoods. These efforts implemented by KS are expected to result in a further increase in biodiversity in the region. In addition, KS continues to provide educational opportunities to promote the conservation of healthy native ecosystems.
Covered activities associated with the SHA include: (1) Removal of invasive predators; (2) habitat restoration and native plant community outplantings; (3) koa silviculture; (4) ungulate fence installation/maintenance and ungulate control; (5) invasive weed control; (6) fire threat management; (7) response efforts for Rapid Ohia Death; and (8) other activities on the enrolled property that are not likely to result in take of the covered species due to the incorporation of take avoidance and minimization measures. All of the covered activities are associated with enhancement of the native forest, and will result in a net benefit to each of the covered species. If issued, the permit would authorize incidental take of the covered species that may occur as a result of the covered activities. Incidental take associated
Kamehameha Schools is simultaneously applying to the Hawaii DLNR for an Incidental Take License (ITL) under the Hawaii Endangered Species Law (Hawaii Revised Statutes § 195D). The draft SHA serves as the basis for permit and ITL decisions by the Service and the Hawaii DLNR, respectively. Kamehameha Schools worked closely with the Service and DLNR to develop the SHA.
The Service proposes to enter into the SHA and to issue a permit to KS authorizing incidental take of the covered species caused by covered activities, if permit issuance criteria are met. Both the SHA and the permit would have a term of 50 years.
Due to the difficulty in monitoring individuals of some of the covered species, occupied habitat has been used to establish baseline conditions for the Hawaiian forest birds, the Hawaiian hawk, and Hawaiian hoary bat. The baseline for the Hawaiian forest birds, including the Akiapolaau, Hawaii Creeper, Hawaii Akepa, and Iiwi, is represented by the extent of their current occupied habitat, determined to be forest habitat with a tree cover of closed canopy, open canopy, scattered trees and very scattered trees for a total of 4,162 acres. The baseline for the Hawaiian Hawk and Hawaiian hoary bat is defined as 18,517 acres of open or closed canopy tree cover across the enrolled property, of which a majority is native dominated koa and ohia trees.
The baseline determination for the Nene is based on weekly surveys conducted by Hawaii DLNR on the enrolled property and surrounding lands. While Nene occasionally transit the property, there are no breeding Nene on the enrolled property; therefore the baseline is set at zero individuals. Alala are currently extirpated from the wild so none occur on the enrolled property. Therefore, the baseline for the Alala under the SHA is set at zero individuals.
Baseline conditions for each of the listed plant species are based on comprehensive surveys that occurred on the enrolled property in 2007 (Table 3). Eight listed plant species are currently known to exist on the enrolled property.
Seventeen of the plant covered species are not currently known to be present on the enrolled property. These plants were determined to either have the potential to spread naturally onto the enrolled property or be reintroduced by KS in the future. The baseline for these plants is zero.
Under the SHA, the conservation benefits for the covered species are expected to be realized through implementation of all of the covered activities including: (1) Removal of invasive predators; (2) habitat restoration and native plant community outplantings; (3) koa silviculture; (4) ungulate fence installation/maintenance and ungulate control; (5) invasive weed control; (6) fire threat management; (7) response efforts for Rapid Ohia Death; and (8) other activities. Additionally, KS will execute a right of access for Alala monitoring and predator control. The SHA will also connect a variety of high-quality National Park and State-owned protected lands, which will promote an increase of forest connectivity, covered species populations and their distributions.
Kamehameha Schools will be required to monitor the covered species and baseline conditions according to schedule outlined in the SHA. Some covered species surveys have been conducted by partners of KS in the past; these partners may continue to assist KS in meeting their monitoring obligations under the SHA and permit.
Incidental take of the forest birds (the Akiapolaau, Hawaii Creeper, Hawaii Akepa, and the Iiwi) may occur in the form of harm or harassment from noise, visual disturbance, or removal of trees in a portion of the property from koa silviculture activities and weed control. Weed control is likely to result in low levels of take of the Hawaiian hawk and the nene in the form of harassment. Habitat restoration, installation of new fences, and weed control activities may result in the loss or destruction of individuals of covered plant species (outplants, propagules), with the exception of three special-concern species (
The Service anticipates that the SHA will result in the following benefits to the covered species: (1) Establishment of new populations and/or habitat where they do not currently exist; (2) an increase in the current range of wild populations; (3) opportunities to increase genetic diversity of the species; (4) a reduction of forest fragmentation and an increase in habitat connectivity through habitat restoration, enhancement, and creation efforts; (5) an increase in habitat connectivity by creating a habitat “bridge” between large protected areas; and (6) protection and maintenance of current levels of occupied nesting and foraging habitats. For these reasons, the cumulative impact of this SHA and the activities it covers, which would be facilitated by the allowable incidental take, is likely to provide a net conservation benefit to the covered species.
For the reasons discussed above, the conservation measures implemented under this SHA are likely to enhance, create, and conserve habitat for the long-term recovery of the covered species. Through this SHA, KS will provide a large expanse of suitable habitat that is fenced and free from ungulates for the
The management activities to be implemented pursuant to the SHA directly support recovery actions and conservation objectives outlined in conservation and recovery plans for the covered species (USFWS 1984a, USFWS 1984b, USFWS 1996, USFWS 1998a, USFWS 1998b, USFWS 1998c, USFWS 2004, USFWS 2006, USFWS 2009, Hawaii DLNR 2015, and Fraiola and Rubenstein 2007) including: Protection, management, restoration, and conservation of suitable and known occupied habitat; ungulate control; alien species control; and re-establishment of connectivity of currently fragmented habitats.
A decision by the Service to enter into the proposed SHA and to issue the proposed permit are Federal actions that trigger the need for compliance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
You may submit your comments and materials by one of the methods listed in the
(1) Whether the implementation of the proposed SHA would provide a net conservation benefit to the covered species;
(2) Other conservation measures that would lead to a net-conservation benefit for the covered species;
(3) The length of the proposed term of the permit;
(4) The direct, indirect, and cumulative effects that implementation of the SHA could have on the human environment;
(5) Other plans, projects, or information that might be relevant to evaluating the effects of this proposed action; and
(6) Information regarding the adequacy of the proposed SHA pursuant to the requirement for permits at 50 CFR parts 13 and 17.
All comments and materials we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personally identifiable information in your comments, you should be aware that your entire comment—including your personally identifiable information—may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public review, we cannot guarantee that we will be able to do so. 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. Comments and materials we receive, as well as supporting documentation we use in preparing the EAS, will be available for public inspection by appointment, during normal business hours, at our Pacific Islands Field Office (see
We will evaluate the permit application, associated documents, and public comments in reaching a final decision on whether the permit application and the EAS meet the requirements of section 10(a) of the ESA (16 U.S.C. 1531
We provide this notice pursuant to: Section 10(c) of the ESA (16 U.S.C. 1531
Bureau of Land Management, Interior.
Notice of realty action.
The Bureau of Land Management (BLM) has examined and found suitable for classification for lease to the Maricopa County Parks and Recreation Department (MCPRD) under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended (43 U.S.C. 869
Interested parties may submit written comments regarding the proposed classification and lease of public lands on or before December 23, 2016.
Comments concerning this notice should be addressed to Rem Hawes, Field Manager, BLM Hassayampa Field Office, 21605 North 7th Ave., Phoenix, AZ 85027.
Hillary Conner, Realty Specialist, at the above address; phone 623-580-5649; or by email at
The following described public lands in Maricopa County, Arizona, are being considered for an R&PP lease.
The areas described contain approximately 1,046 acres, more or less. The MCPRD proposes to use the above described lands for a variety of recreation facilities to be associated with the Vulture Mountains Cooperative Recreation Management Area. This is a cooperatively managed area between the BLM and MCPRD for public lands located south of Wickenburg, Arizona. Related improvements for the proposed lease include picnic and camping facilities, restrooms, trailheads, developed day use facilities, and parking.
Issuance of a lease is in conformance with the Bradshaw Harquahala Resource Management Plan, approved April 2010, through land use authorization decision LR-24, and is in the public's interest. The lands are not needed for any other Federal purpose and the lease will be analyzed in a site-specific environmental analysis.
Upon publication in the
The lease, when issued, will be subject to the provisions of the R&PP Act and will contain the following terms, conditions, and reservations:
1. Provisions of the R&PP Act and all applicable regulations of the Secretary of the Interior.
2. All minerals shall be reserved to the United States, together with the right to prospect for, mine and remove such deposits from the same under applicable law and such regulations as the Secretary of the Interior may prescribe.
3. All valid existing rights.
4. An appropriate indemnification clause protecting the United States from claims arising out of the lessee's use, occupancy, or operation of the property. It will also contain any other terms and conditions deemed necessary and appropriate by the Authorized Officer.
5. The lessee shall comply with and shall not violate any of the terms or provisions of Title VI of the Civil Rights Act of 1964 (78 Stat. 241), and requirements of the regulations, as modified or amended, of the Secretary of the Interior issued pursuant thereto (43 CFR part 17) for the period that the lands leased herein are used for the purpose for which the grant was made pursuant to the act cited above, or for another purpose involving the provision of similar services or benefits.
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 available to the public at any time. While you can ask in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
43 CFR 2741.5.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB Control Number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB.
To ensure that your comments on this ICR are considered, OMB must receive them on or before December 8, 2016.
Please direct all written comments on this ICR directly to the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior, to
Larry Perez, Communications Coordinator, Climate Change Response Program, National Park Service, 1201 Oakridge Drive, Fort Collins, CO 80525 (mail); or
The information gathered in this collection will be used to assess the efficacy of current and hypothetical park climate change messaging in cultivating both a sense of concern and inspiration to act among visitors. The information will be used primarily by NPS administrators, program managers, interpretive specialists, and educators. Results from the collection will be shared broadly across the NPS for application in the development, design, and delivery of climate change communications products.
A Notice was published in the
We again invite comments concerning this information collection on:
• Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful;
• The accuracy of the agency's estimate of the burden of the proposed collection of information;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. 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.
National Park Service, Interior.
Notice.
The National Park Service intends to award a temporary concession contract to a qualified person for the conduct of certain visitor services within Fire Island National Seashore for a term not to exceed 1 year. The visitor services include marina operation, food and beverage, retail and campground.
Judy Bassett, Northeast Regional Concession Chief, Northeast Region, 200 Chestnut Street, Philadelphia, PA 19106; Telephone (215) 597-4903, by email at
The National Park Service intends to award the temporary concession contract, TC-FIIS007-17, to a qualified person (as defined in 36 CFR 51.3) that is currently operating under the existing contract. If the National Park Service is unable to reach acceptable terms, however, it may find another qualified person for the award of the temporary concession contract. The National Park Service has determined that a temporary concession contract not to exceed 1 year is necessary in order to avoid interruption of visitor services, and has taken all reasonable and appropriate steps to consider alternatives to avoid an interruption of visitor services.
This action is issued pursuant to 36 CFR 51.24(a). This is not a request for proposals.
National Park Service, Interior.
Notice of proposed award of sole-source concession contract for Lake Mead National Recreation Area.
Public notice is hereby given that the National Park Service proposes to award a sole-source concession contract for the conduct of certain visitor services within Lake Mead National Recreation Area (Lake Mead NRA) for a term not to exceed five (5) years. The visitor services include the provision of wireless Internet access within remote but developed areas of Lake Mead NRA.
The term of the sole-source concession contract will commence (if awarded) no earlier than sixty (60) days from the publication of this notice.
The Director of the National Park Service (NPS) may award a concession contract non-competitively upon a determination that extraordinary circumstances exist under which compelling and equitable considerations require the award of the concession contract to a particular qualified person in the public interest (36 CFR 51.25). Contracts that are awarded non-competitively pursuant to 36 CFR 51.25 are commonly referred to as “sole-source” contracts.
The NPS has determined that BladeBeam, Inc. is a “qualified person” as defined by 36 CFR 51.3, and has determined that compelling and equitable considerations exist because of the difficulty of providing wireless Internet in the remote but developed areas of Lake Mead NRA, and because BladeBeam, Inc. is willing to make a significant investment with no guaranteed return.
The NPS has determined that a sole-source concession contract is in the public interest because it is the authorization most likely to allow a pilot test of providing wireless Internet services in remote but developed areas of Lake Mead NRA.
This is not a request for proposals. The NPS is seeking approval from the Principal Deputy Assistant Secretary for Fish and Wildlife and Parks contemporaneously.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-562 and 731-TA-1329 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of ammonium sulfate from China, provided for in subheading 3102.21.00 of the Harmonized Tariff Schedule of the United States. The Department of Commerce has preliminarily determined that such imports are subsidized.
Effective October 24, 2016.
Jordan Harriman (202-205-2610), 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 this phase of the investigations, hearing procedures, 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 and C (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigations must be served on all other parties to the investigations (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 investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.21 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 8) granting a joint motion to terminate the investigation based on a settlement agreement.
Lucy Grace D. Noyola, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-3438. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on April 25, 2016, based on a complaint filed by Varidesk LLC of Coppell, Texas (“Complainant”). 81 FR 24128, 24128-29 (Apr. 25, 2016). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain height-adjustable desk platforms and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 9,113,703 and 9,277,809.
On October 12, 2016, Complainant and Respondents filed a joint motion to terminate the investigation based on a settlement agreement.
On October 14, 2016, the presiding administrative law judge (“ALJ”) issued an ID (Order No. 8) granting the motion. The ALJ found the requirements of Commission Rule 210.21(b)(1) were met. The ALJ also found that termination of the investigation was not contrary to the public interest, and that termination was in the public interest and will conserve public and private resources. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of full reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation
Keysha Martinez (202-205-2136), 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).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.
In accordance with sections 201.16(c) and 207.3 of the Commission's 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.
The Commission has determined that these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C.1675(c)(5)(B).
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.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review (1) an October 12, 2016, initial determination (“Order 20”) granting an unopposed joint motion to terminate the investigation as to one respondent based on a settlement agreement and (2) an October 13, 2016, initial determination (“Order 21”) terminating the investigation as to the last respondent based on complainant's withdrawal of certain allegations in the complaint. This investigation is terminated.
Ron Traud, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-3427. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on May 16, 2016, based on a complaint filed by Cambria Company LLC (“Cambria”) of Belle Plaine, Minnesota. 81 FR 30342 (May 16, 2016). The complaint alleges violations of Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain quartz slabs and portions thereof by reason of infringement of the claims of U.S. Patent Nos. D737,058; D712,670; D713,154; D737,576; D737,577; and D738,630.
On September 14, 2016, the presiding administrative law judge (“ALJ”) issued an initial determination terminating the investigation as to U.S. Patent No. D737,058. Order 15. On October 13, 2016, the Commission determined not to review that initial determination. Notice of Commission Determination Not to Review an ID Terminating the Investigation as to U.S. Design Patent No. D737,058.
On September 28, 2016, Cambria and Wilsonart jointly moved to terminate the investigation as to Wilsonart based on a settlement agreement. OUII filed a response supporting the motion. Dorado did not oppose the motion. On October 12, 2016, the ALJ issued Order 20, an initial determination granting the motion. The ALJ found that the joint motion complied with the Commission's rules for termination and that consideration of the public interest factors pursuant to 19 CFR 210.50(b)(2) did not prevent termination as to Wilsonart. No party filed a petition seeking review of that initial determination.
On October 6, 2016, Cambria moved to terminate the investigation as to Dorado based on Cambria's withdrawal of certain allegations in the complaint. OUII filed a response supporting the motion. OUII Resp. at 1. Dorado did not oppose the motion. Dorado Resp. at 1. On October 13, 2016, the ALJ issued Order 21, an initial determination granting the motion. No party filed a petition seeking review of that initial determination.
The Commission has determined not to review Orders 20 or 21. This investigation is terminated.
The authority for the Commission's determination is contained in Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on October 6, 2016, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Kemin Industries, Inc. of Des Moines, Iowa and Kemin Foods, L.C. of Des Moines, Iowa. An amended complaint was filed on October 26, 2016. The complaint, as amended, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain food supplements and vitamins, including ocular antioxidants and components thereof and products containing the same by reason of infringement of certain clams of U.S. Patent No. 8,815,955 (“the ’955 patent”) and U.S. Patent No. 9,226,940 (“the ’940 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained 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
The Office of the Secretary, U.S. International Trade Commission, telephone (202) 205-2000.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2016).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain food supplements and vitamins, including ocular antioxidants and components thereof and products containing the same by reason of infringement of one or more of claims 1-13 of the ’955 patent and claims 1-13 of the ’940 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainants are: Kemin Industries, Inc., 2100 Maury Street, Des Moines, IA 50317, Kemin Foods, L.C., 2100 Maury Street, Des Moines, IA 50317.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: OmniActive Health Technologies, Phoenix House, T-8, A Wing, 462 Senapati Bapat Marg, Lower Perel, Mumbai—400 013, India, OmniActive Health Technologies, Inc., 67 East Park Place, Suite 500, Morristown, NJ 07960.
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
The Office of Unfair Import Investigations will not be named as a party to this investigation.
Responses to the complaint, as amended, and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice, Office on Violence Against Women (OVW) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until January 9, 2017.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at 202-514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1) 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,
(1)
(2)
(3)
(4)
Domestic violence is a major cause of homelessness, particularly for families with children. Among those families currently experiencing homelessness, more than 80 percent had previously experienced domestic violence. According to the U.S. Conference of Mayors, in 2008, 28% of families were homeless because of domestic violence
The Safe Housing Needs Assessment will be used to determine the training and technical assistance needs of organizations providing safe housing for domestic violence victims and their families.
The Safe Housing Needs Assessment will gather input from community service providers, coalitions and continuums of care. This assessment is the first of its kind aimed at simultaneously reaching the domestic and sexual violence field, as well as the homeless and housing field. The assessment seeks to gather information on topics ranging from the extent to which both fields coordinate to provide safety and access to services for domestic and sexual violence survivors within the homeless system, to ways in which programs are implementing innovative models to promote long-term housing stability for survivors and their families. Additionally, this assessment seeks to identify specific barriers preventing collaboration across these fields, as well as promising practices. The results will help the Consortium provide organizations and communities with the tools, strategies and support necessary to improve coordination between domestic violence/sexual assault service providers and homeless and housing service providers, so that survivors and their children can ultimately avoid homelessness and live free from abuse.
(5)
(6)
U.S. Copyright Office, Library of Congress.
Notice of inquiry.
The U.S. Copyright Office seeks further comments on the impact and effectiveness of the Digital Millennium Copyright Act (“DMCA”) safe harbor provisions. This request provides an opportunity for interested parties to reply or expand upon issues raised in written comments submitted on or before April 1, 2016, and during the public roundtables held May 2-3, 2016 in New York, and May 12-13, 2016 in San Francisco. The Copyright Office also invites parties to submit empirical research studies assessing issues related to the operation of the safe harbor provisions on a quantitative or qualitative basis.
Written responses to the questions outlined below must be received no later than 11:59 p.m. Eastern Time on February 6, 2017. Empirical research studies providing quantitative or qualitative data relevant to the subject matter of this study must be received no later than 11:59 p.m. Eastern Time on March 8, 2017.
For reasons of government efficiency, the Copyright Office is using the
Cindy Abramson, Assistant General Counsel, by email at
In order to evaluate key parts of the copyright law as it pertains to the digital copyright marketplace, the U.S. Copyright Office is conducting a study to evaluate the impact and effectiveness of the DMCA safe harbor provisions contained in 17 U.S.C. 512. To aid its work in this area, the Office published an initial Notice of Inquiry on December 31, 2015 (“First Notice”), seeking written comments to 30 questions covering eight categories of topics. These included questions about the general efficacy of the DMCA provisions enacted in 1998, as well as the practical costs, and burdens, of the current DMCA environment.
In May 2016, the Copyright Office convened roundtables in New York and San Francisco, each for a two day period. The roundtables provided participants with the opportunity to share their views on the topics identified in the First Notice, as well as any other issues relating to the operation of the DMCA safe harbors.
Based on the initial round of written submissions and the results of the roundtable discussions, the Copyright Office believes a number of themes merit additional consideration. Many of these relate to questions of balance,
One of the key themes that emerged from the first round of public comments and the roundtable discussions was the diversity of the current Internet ecosystem and the importance of factoring such diversity into any policymaking in the online space. Participants noted that there is a wide variety of experiences and views even within particular stakeholder groups.
For example, study participants pointed out that differences in the characteristics of content creators result in different experiences with the operation of the DMCA safe harbors.
Likewise, a heterogeneous picture of ISPs emerged from the first round of comments and the public roundtables, with large deviations in terms of functions, size, resources, and business models, as well as the volume of DMCA takedown notices received on an annual basis. While some of the larger platforms
In addition, several study participants highlighted the importance of taking into consideration the needs of individual Internet users when developing recommendations for possible changes to the DMCA safe
While some study participants asserted that the section 512 safe harbors are currently operating effectively and as Congress intended, a number of participants identified various shortcomings and barriers for content creators, ISPs, and individual Internet users. These differing views were especially stark when comparing the experiences of content creators (large and small) with the experiences of online service providers.
ISPs, civic organizations, and content creators also expressed differing views regarding the extent to which false or abusive notices are a problem under the current system, and the effectiveness of the counter-notice process for ensuring access to legitimate content. Several ISPs and civic groups pointed to abusive notices as one of the primary shortcomings of the safe harbor regime. They pointed to the length of time required to have material replaced after a counter-notice,
Both content creators and ISPs identified shortcomings in their abilities to efficiently process notices under the current system. ISPs identified the difficulty of receiving notices through multiple channels (
In contrast, many content creators identified ISP-specific web forms as a barrier to effective use of the notice-and-takedown process, increasing the amount of time required to have the same material taken down across multiple platforms.
Study participants noted similar barriers that discourage users from submitting counter-notices, even in response to what some consider to be erroneous or fraudulent takedown notices. The identified barriers included a similar lack of standardization for filing counter-notices, a lack of education regarding the counter-notice process, privacy concerns, and the threat of potential legal proceedings.
In addition to noting practical barriers that may make utilization of the safe harbor system difficult, several commenters pointed to court opinions that they argue have decreased the effectiveness of the statutory scheme created by Congress. These developments include judicial interpretations of the actual and red flag knowledge standards, the right and ability to control and financial benefit tests, section 512's references to “representative lists,” and section 512's requirement that ISPs implement a repeat infringer policy. Some content creators and others expressed concern that the first three developments, taken together, have systematically changed the application of section 512, tipping it in favor of ISPs,
One other debate between content creators and ISPs relates to the fact that section 512 sets forth a variety of differing safe harbor requirements for ISPs depending upon the function they are performing (
Study participants have suggested a number of potential solutions to the issues raised above, though it should be understood that these solutions stem only from the subset of stakeholders who suggest or acknowledge in the first instance that the current regime requires or could benefit from changes. These solutions included both non-legislative solutions (such as education, the use of technology, or voluntary and standard technical measures) and legislative fixes (either through changes to section 512 itself or passage of legislation to address issues not directly addressed by section 512).
The non-legislative solution that appeared to have the broadest approval was the idea of creating governmental and private-sector educational materials on copyright and section 512. Participants recommended the creation of targeted educational materials for all participants in the Internet ecosystem, including content creators,
A number of study participants noted that technology can help address some of the inefficiencies of the current notice-and-takedown process. Some participants cited increased efficiencies to be had from both automated notices and takedowns, as well as other technological tools.
Another potential non-legislative solution that was suggested was the development and adoption of industry-wide, or sub-industry-specific, voluntary measures
Another potential solution proposed by some of the participants was legislative action to improve the section 512 safe harbor system, either by amending the statute itself, or adopting ancillary legislative reform proposals. The most frequently discussed potential legislative change was adoption of a notice-and-stay-down requirement.
The Copyright Office is also seeking comments on three additional topics: judicial opinions that were not covered by the initial round of public comments, the disposition of Internet safe harbors under foreign copyright laws, and empirical research into the effectiveness, impact, and utilization of the current section 512 safe harbors.
The Copyright Office is interested in hearing from the public about judicial decisions issued since the first round of public comments closed in April 2016, and how they may impact the workings of one or more aspects of the section 512 safe harbors. These include, in particular, recent decisions from the Eastern District of Virginia and the Second Circuit. In
Similarly, while some of the initial written responses and roundtable discussions touched upon Internet safe harbor regimes outside the United States,
Finally, the Copyright Office is asking for the submission of additional analyses and empirical data related to the effectiveness, impact, and utilization of the current section 512 safe harbors. While several participants referenced a trio of recent studies performed by researchers at the University of California, Berkeley School of Law, others noted that a nucleus of authoritative studies and evidence is still lacking, overall.
The Copyright Office seeks further public input in the form of written comments responsive to this Notice and the issues discussed above, as well as the submission of studies and empirical data relevant to the subject matter of this study. Parties may also take this opportunity to respond to positions or data raised in the first round of comments and/or at the roundtables.
1. As noted above, there is great diversity among the categories of content creators and ISPs who comprise the Internet ecosystem. How should any improvements in the DMCA safe harbor system account for these differences? For example, should any potential new measures, such as filtering or stay-down, relate to the size of the ISP or volume of online material hosted by it? If so, how? Should efforts to improve the accuracy of notices and counter-notices take into account differences between individual senders and automated systems? If so, how?
2. Several commenters noted the importance of taking into account the perspectives and interests of individual Internet users when considering any changes to the operation of the DMCA safe harbors. Are there specific issues for which it is particularly important to consult with or take into account the perspective of individual users and the general public? What are their interests, and how should these interests be factored into the operation of section 512?
3. Participants expressed widely divergent views on the overall effectiveness of the DMCA safe harbor system. How should the divergence in views be considered by policy makers? Is there a neutral way to measure how effective the DMCA safe harbor regime has been in achieving Congress' twin goals of supporting the growth of the Internet while addressing the problem of online piracy?
4. Several public comments and roundtable participants noted practical barriers to effective use of the notice-and-takedown and counter-notice processes, such as differences in the web forms used by ISPs to receive notices or adoption by ISPs of additional requirements not imposed under the DMCA (
5. A number of study participants identified the timelines under the DMCA as a potential area in need of reform. Some commenters expressed the view that the process for restoring access to material that was the subject of a takedown notice takes too long, noting that the material for which a counter-notice is sent can ultimately be inaccessible for weeks or months before access is restored. Other commenters expressed the view that the timeframe for restoring access to content is too short, and that ten days is not enough time for a copyright holder to prepare and file litigation following receipt of a counter-notice. Are changes to the section 512 timeline needed? If so, what timeframes for each stage of the process would best facilitate the dual goals of encouraging online speech while protecting copyright holders from widespread online piracy?
6. Participants also noted disincentives to filing both notices and counter-notices, such as safety and privacy concerns, intimidating language, or potential legal costs. How do these concerns affect use of the notice-and-takedown and counter-notice processes, and how can these disincentives best be addressed?
7. Some participants recommended that the penalties under section 512 for filing false or abusive notices or counter-notices be strengthened. How could such penalties be strengthened? Would the benefits of such a change outweigh the risk of dissuading notices or counter-notices that might be socially beneficial?
8. For ISPs acting as conduits under section 512(a), what notice or finding should be necessary to trigger a repeat infringer policy? Are there policy or other reasons for adopting different requirements for repeat infringer policies when an ISP is acting as a conduit, rather than engaging in caching, hosting, or indexing functions?
9. Many participants supported increasing education about copyright law generally, and/or the DMCA safe harbor system specifically, as a non-legislative way to improve the functioning of section 512. What types of educational resources would improve the functioning of section 512? What steps should the U.S. Copyright Office take in this area? Is there any role for legislation?
10. How can the adoption of additional voluntary measures be encouraged or incentivized? What role, if any, should government play in the development and implementation of future voluntary measures?
11. Several study participants pointed out that, since passage of the DMCA, no standard technical measures have been adopted pursuant to section 512(i). Should industry-wide or sub-industry-specific standard technical measures be adopted? If so, is there a role for government to help encourage the adoption of standard technical measures? Is legislative or other change required?
12. Several study participants have proposed some version of a notice-and-stay-down system. Is such a system advisable? Please describe in specific detail how such a system should operate, and include potential legislative language, if appropriate. If it is not advisable, what particular problems would such a system impose? Are there ways to mitigate or avoid those problems? What implications, if any, would such as system have for future online innovation and content creation?
13. What other specific legislative provisions or amendments could improve the overall functioning of the DMCA safe harbor regime? Please be specific, including proposed statutory language as appropriate.
14. Several study participants mentioned concerns regarding certain case law interpretations of the existing provisions of section 512. Additionally, two new judicial decisions have come out since the first round of public comments was submitted in April 2016. What is the impact, if any, of these decisions on the effectiveness of section 512? If you believe it would be appropriate to address or clarify existing provisions of section 512, what would be the best ways to address such provisions (
15. What approaches have jurisdictions outside the United States taken to address the question of ISP liability and the problem of copyright infringement on the Internet? To what extent have these approaches worked well, or created problems for consumers, content creators, ISPs, or other stakeholders?
16. Please identify any other pertinent issues that the Copyright Office may
Many commenters expressed a desire for more comprehensive empirical data regarding the functioning and effects of the DMCA safe harbor system. The Copyright Office is providing an extended deadline for submissions of empirical research on any of the topics discussed in this Notice, or other topics that are likely to provide useful data to assess and/or improve the operation of section 512.
National Archives and Records Administration (NARA).
Notice of proposed disposal of Presidential records; request for public comment.
The National Archives and Records Administration (NARA) has identified certain Presidential records from the George W. Bush Presidential Library as appropriate for disposal under the provisions of 44 U.S.C. 2203(f)(3). This notice describes our reasons for determining that these records do not warrant retaining any longer.
This notice does not constitute a final agency action, as described in 44 U.S.C. 2203(f)(3), and we will not dispose of any Presidential records following this notice. After reviewing any comments we receive during this 45-day notice and comment period, we will make a decision on the records. If we decide to dispose of them, we will issue a second, 60-day advance notice, which constitutes a final agency action.
Comments are due by December 23, 2016.
Submit written comments by mail to Director, Presidential Libraries; National Archives and Records Administration (LP), Suite 2200; 8601 Adelphi Road; College Park, MD 20740-6001, or by fax to 301.837.3199.
Susan K. Donius at 301.837.3250.
We propose the following materials for disposal because we have determined that they lack continuing administrative, historical, information, or evidentiary value.
The items identified include (full list below) ephemera located within the Staff Member Office Files and White House Office of Records Management Subject/Alpha Files of the George W. Bush Presidential Library:
Institute of Museum and Library Services, National Foundation for the Arts and the Humanities.
Notice, request for comments, collection of information.
The Institute of Museum and Library Service (“IMLS”) as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This pre-clearance consultation program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The purpose of this Notice is to solicit comments concerning The Role of Libraries and Museums in Community Transformation (Community Catalyst)—A National Leadership Grants Special Initiative.
A copy of the proposed information collection request can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the
The IMLS is particularly interested in comments which:
• 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,
For a copy of the documents contact: Dr. Marvin Carr, Senior Advisor, STEM and Community Engagement, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW., Suite 4000, Washington, DC 20024. Dr. Carr can be reached by telephone: 202-653-4752; fax: 202-653-4603; email:
The Institute of Museum and Library Services is the primary source of federal support for the Nation's 123,000 libraries and 35,000 museums. The Institute's mission is to inspire libraries and museums to advance innovation, learning and civic engagement. We provide leadership through research, policy development, and grant making. IMLS provides a variety of grant programs to assist the Nation's museums and libraries in improving their operations and enhancing their services to the public. (20 U.S.C. 9101
To administer The Role of Libraries and Museums in Community Transformation (Community Catalyst)—A National Leadership Grants Special Initiative. National Leadership Grants for Libraries (NLG-Libraries) and National Leadership Grants for Museums (NLG-Museums), under which this special initiative falls, support projects that address challenges faced by the library and museum fields and that have the potential to advance practice in those fields. Successful projects will generate results such as new tools, research findings, models, services, practices, or alliances that can be widely used, adapted, scaled, or replicated to extend the benefits of federal investment. This special joint NLG-Libraries and NLG-Museums initiative invites proposals for development and testing of approaches to deepen and sustain the collaborative work that libraries and museums engage in with their communities. Funded projects will create a foundation for enhanced collective impact in communities, especially working with those from diverse economic, social, and cultural backgrounds and will involve key partners such as community service organizations, government entities, and/or funders.
This funding opportunity may include grants and/or cooperative agreements. We will seek proposals that use approaches grounded in community innovation labs; such processes help to build understanding and develop options when complex social problems affect many stakeholders. They are effective where no one entity is accountable for solving the problem, no one solution is sufficient for solving the problem, and current solutions are insufficient. Labs draw on diverse perspectives about a problem to make sense of an issue and focus on rapid experimentation to surface and adapt solutions to problems. By bringing together stakeholders with a collective blend of knowledge and experience with various aspects of local place and social wellbeing, these individuals and organizations can co-create, and test solutions together in ways that they could not have done on their own. Participants will seek to help their local community collaborate across sectors, question old assumptions, develop deep understandings of local system dynamics, explore solutions that leverage existing community assets and yield innovative responses, and rehearse potential strategies for change that include drawing upon museums and libraries.
This process will help to advance our understanding of what is currently occurring in a community and where there are different leverage points to effect change. The desired goal is to help catalyze civic revitalization with the active involvement of key community assets, museums and libraries.
Stephanie Burwell, Chief Information Officer, Office of the Chief Information Officer, Institute of Museum and Library Services, 955 L'Enfant Plaza North SW., Suite 4000, Washington, DC 20024-2135. Mrs. Burwell can be reached by Telephone: 202-653-4684, Fax: 202-653-4625, or by email at
In accordance with the Federal Advisory Committee Act (Pub., L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Astronomy and Astrophysics Advisory Committee (#13883).
National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230, Stafford I, Room 1235.
Open.
Dr. Christopher Davis, Program Director, Division of Astronomical Sciences, Suite 1045, National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Telephone: 703-292-4910.
To provide advice and recommendations to the National Science Foundation (NSF), the National Aeronautics and Space Administration (NASA) and the U.S. Department of Energy (DOE) on issues within the field of astronomy and astrophysics that are of mutual interest and concern to the agencies.
To hear presentations of current programming by representatives from NSF, NASA, DOE and other agencies relevant to astronomy and astrophysics; to discuss current and potential areas of cooperation between the agencies; to formulate recommendations for continued and new areas of cooperation and mechanisms for achieving them.
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
This biweekly notice includes all notices of amendments issued, or proposed to be issued, from October 8, 2016, to October 24, 2016. The last biweekly notice was published on October 25, 2016.
Comments must be filed by December 8, 2016. A request for a hearing must be filed by January 9, 2017.
You may submit comments by any of the following methods:
•
•
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-2016-0226, 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-2016-0226, 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 will post 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 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 a petition 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, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. 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, a petition shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (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 proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest. The petition must also set forth the specific contentions which the petitioner seeks to have litigated at 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 shall 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 those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall 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 these requirements 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, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions consistent with the NRC's regulations, policies, and procedures.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day 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).
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 decide 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 held 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 any 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 by January 9, 2017. 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. A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding may, in 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 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, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene (hereinafter “petition”), and documents filed by interested governmental entities participating 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. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
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
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a petition. Submissions should be in Portable Document Format (PDF). Additional guidance on PDF submissions 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 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, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document 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
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with to respect 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. Do the proposed changes involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed amendment would modify the KPS renewed facility operating license and Technical Specification (TS) by deleting the portions of the license and TS that are no longer applicable to a facility with no spent nuclear fuel stored in the spent fuel pool, while modifying the remaining portions to correspond to all nuclear fuel stored within an Independent Spent Fuel Storage Installation (ISFSI). This amendment becomes effective upon removal of all spent nuclear fuel from the KPS spent fuel pool and its transfer to dry cask storage within an ISFSI.
The definition of safety-related structures, systems, and components (SSCs) in 10 CFR 50.2 states that safety-related SSCs are those relied on to remain functional during and following design basis events to assure:
1. The integrity of the reactor coolant boundary;
2. The capability to shutdown the reactor and maintain it in a safe shutdown condition; or
3. The capability to prevent or mitigate the consequences of accidents which could result in potential offsite exposures comparable to the applicable guideline exposures set forth in 10 CFR 50.43(a)(1) or 100.11.
The first two criteria (integrity of the reactor coolant pressure boundary and safe shutdown of the reactor) are not applicable to a plant in a permanently defueled condition. The third criterion is related to preventing or mitigating the consequences of accidents that could result in potential offsite exposures exceeding limits. However, after all nuclear spent fuel assemblies have been transferred to dry cask storage within an ISFSI, none of the SSCs at KPS are required to be relied on for accident mitigation. Therefore, none of the SSCs at KPS meet the definition of a safety-related SSC stated in 10 CFR 50.2. The proposed deletion of
Section 14 of the KPS Updated Safety Analysis Report (USAR) described the design basis accidents related to the spent fuel pool. These postulated accidents are predicated on spent fuel being stored in the spent fuel pool. With the removal of the spent fuel from the spent fuel pool, there are no remaining spent fuel assemblies to be monitored and there are no credible accidents that require the actions of a Certified Fuel Handler, Shift Manager, or a Non-certified Operator to prevent occurrence or mitigate the consequences of an accident.
The proposed changes do not have an adverse impact on the remaining decommissioning activities or any of their postulated consequences.
The proposed changes related to the relocation of certain administrative requirements do not affect operating procedures or administrative controls that have the function of preventing or mitigating any accidents applicable to the safe management of irradiated fuel or decommissioning of the facility.
Therefore, the proposed amendment does not involve a significant increase in the consequences of a previously evaluated accident.
2. Do the proposed changes create the possibility of a new or different kind of accident from any accident previously evaluated?
Response: No.
The proposed changes eliminate the operational requirements and certain design requirements associated with the storage of the spent fuel in the spent fuel pool, and relocate certain administrative controls to the Quality Assurance Program Description.
After the removal of the spent fuel from the spent fuel pool and transfer to the ISFSI, there are no spent fuel assemblies that remain in the spent fuel pool. Coupled with a prohibition against storage of fuel in the spent fuel pool, the potential for fuel related accidents is removed. The proposed changes do not introduce any new failure modes.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Do the proposed changes involve a significant reduction in the margin of safety?
Response: No.
The removal of all spent nuclear fuel from the spent fuel pool into storage in casks within an ISFSI, coupled with a prohibition against future storage of fuel within the spent fuel pool, removes the potential for fuel related accidents.
The design basis and accident assumptions within the KPS USAR and the TS relating to safe management and safety of spent fuel in the spent fuel pool are no longer applicable. The proposed changes do not affect remaining plant operations, systems, or components supporting decommissioning activities.
The requirements for systems, structures, and components (SSCs) that have been deleted from the KPS TS are not credited in the existing accident analysis for any applicable postulated accident; and as such, do not contribute to the margin of safety associated with the accident analysis.
Therefore, the proposed changes do 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?
Response: No.
The proposed change revises TS Chapter 6, “Administrative Controls,” Section 6.5, “Programs” by eliminating the “Inservice Testing Program” specification. Most requirements in the IST Program are removed, as they are duplicative of requirements in the ASME OM Code [American Society of Mechanical Engineers Code for Operation and Maintenance of Nuclear Power Plants], as clarified by Code Case OMN-20, “Inservice Test Frequency.” The remaining requirements in the Section 6.5.8, IST Program are eliminated [. . .]. A new defined term, “Inservice Testing Program,” is added to the TS, which references the requirements of 10 CFR 50.55a(f).
Performance of inservice testing is not an initiator to any accident previously evaluated. As a result, the probability of occurrence of an accident is not significantly affected by the proposed change. Inservice test frequencies under Code Case OMN-20 are equivalent to the current testing period allowed by the TS with the exception that testing frequencies greater than 2 years may be extended by up to 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to mitigate any accident previously evaluated as the components are required to be operable during the testing period extension. Performance of inservice tests utilizing the allowances in OMN-20 will not significantly affect the reliability of the tested components. As a result, the availability of the affected components, as well as their ability to mitigate the consequences of accidents previously evaluated, is not affected.
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?
Response: No.
The proposed change does not alter the design or configuration of the plant. The proposed change does not involve a physical alteration of the plant; no new or different kind of equipment will be installed. The proposed change does not alter the types of inservice testing performed. In most cases, the frequency of inservice testing is unchanged. However, the frequency of testing would not result in a new or different kind of accident from any previously evaluated since the testing methods are not altered.
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 change involve a significant reduction in a margin of safety?
Response: No.
The proposed change eliminates some requirements from the TS in lieu of
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?
Response: No.
The proposed change would allow the use of Optimized ZIRLO
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?
Response: No.
Use of Optimized ZIRLO
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
The proposed change will not involve a significant reduction in the margin of safety. 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 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?
Response: No.
The proposed change revises TS Chapter 5, “Administrative Controls,” Section 5.5, “Programs and Manuals,” or equivalent, by deleting the “lnservice Testing Program” specification. A new defined term, “INSERVICE TESTING PROGRAM,” is added to the TS, which references the requirements of 10 CFR 50.55a(f), “Inservice testing requirements.” The regulations in 10 CFR 50.55a(f) require that specified pumps and valves meet the inservice test requirements in the American Society of Mechanical Engineers (ASME) Code for Operation and Maintenance of Nuclear Power Plants (ASME OM Code) and addenda. Most requirements currently in the TS lnservice Testing Program are duplicative of requirements in the ASME OM Code and addenda, as modified by NRC-approved alternatives or reliefs. The proposed change primarily affects the required frequency for performing ASME OM Code required tests for pumps and valves which are covered by the Inservice Testing Program. The proposed change would allow a longer interval between some tests and require a shorter interval between other tests; the effect of the change to specific test intervals depends on the plant-specific licensing basis.
Performance of inservice testing is not an initiator to any accident previously evaluated. As a result, the probability of occurrence of an accident is not significantly affected by the proposed change. Changing the required test frequency of pumps and valves will not affect the ability of the components to mitigate any accident previously evaluated, as the components are required to be operable. If components required by the TSs are found to be inoperable, the TSs specify the actions required to ensure safe operation of the facility, and these actions are not altered by the proposed change. Performance of inservice tests in accordance with the ASME OM Code, as modified by NRC-approved alternatives or reliefs, will not significantly affect the reliability of the tested components. As a result, the availability of the affected components, as well as their ability to mitigate the consequences of accidents previously evaluated, is not significantly affected.
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?
Response: No.
The proposed change does not alter the design or configuration of the plant. The proposed change does not involve a physical alteration of the plant; no new or different kind of equipment will be installed. The proposed change does not alter the types of inservice testing performed. Changes to the frequency of testing would not result in a new or different kind of accident from any previously evaluated since the testing methods are not altered. 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?
Response: No.
The proposed change eliminates some requirements from the TSs in lieu of requirements in the ASME OM Code, as modified by NRC-approved alternatives or reliefs. Compliance with the ASME OM Code is required by 10 CFR 50.55a. Changes to the required test frequency will not affect the ability of the components to respond to an accident, as the components are required to be operable. The proposed change also eliminates a provision which allowed, under certain circumstances, the licensee to delay declaring equipment inoperable due to a missed surveillance. This change will not have a significant effect on plant operation or safety, as the licensee will still be required by TSs to assess component operability. If components required by the TSs are found to be inoperable, the TSs specify the actions required to ensure safe operation of the facility, and these actions are not altered by the proposed change. The proposed change also eliminates a statement that nothing in the ASME OM Code should be construed to supersede the requirements of any TS. Elimination of the statement will not have a significant effect on plant operation or safety. Therefore, the proposed change does not involve a significant reduction in a margin of safety.
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?
Response: No.
The proposed change revises TS Chapter 5, “Administrative Controls,” Section 5.5, “Programs and Manuals,” by eliminating the “Inservice Testing Program” specification. Most requirements in the Inservice Testing Program are removed, as they are duplicative of requirements in the ASME OM Code, as clarified by Code Case OMN-20, “Inservice Test Frequency.” The remaining requirements in the Section 5.5 IST Program
Performance of inservice testing is not an initiator to any accident previously evaluated. As a result, the probability of occurrence of an accident is not significantly affected by the proposed change. Inservice test frequencies under Code Case OMN-20 are equivalent to the current testing period allowed by the TS with the exception that testing frequencies greater than 2 years may be extended by up to 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to mitigate any accident previously evaluated as the components are required to be operable during the testing period extension. Performance of inservice tests utilizing the allowances in OMN-20 will not significantly affect the reliability of the tested components. As a result, the availability of the affected components, as well as their ability to mitigate the consequences of accidents previously evaluated, is not affected.
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?
Response: No.
The proposed change does not alter the design or configuration of the plant. The proposed change does not involve a physical alteration of the plant; no new or different kind of equipment will be installed. The proposed change does not alter the types of inservice testing performed. In most cases, the frequency of inservice testing is unchanged. However, the frequency of testing would not result in a new or different kind of accident from any previously evaluated since the testing methods are not altered.
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 change involve a significant reduction in a margin of safety?
Response: No.
The proposed change eliminates some requirements from the TS in lieu of requirements in the ASME Code, as modified by use of Code Case OMN-20. Compliance with the ASME Code is required by 10 CFR 50.55a. The proposed change also allows inservice tests with frequencies greater than 2 years to be extended by 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to respond to an accident as the components are required to be operable during the testing period extension. The proposed change will eliminate the existing TS SR 3.0.3 allowance to defer performance of missed inservice tests up to the duration of the specified testing frequency, and instead will require an assessment of the missed test on equipment operability. This assessment will consider the effect on a margin of safety (equipment operability). Should the component be inoperable, the Technical Specifications provide actions to ensure that the margin of safety is protected. The proposed change also eliminates a statement that nothing in the ASME Code should be construed to supersede the requirements of any TS. [. . .] However, elimination of the statement will have no effect on plant operation or 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?
Response: No.
The proposed changes to the FCS RERP do not impact the function of plant structures, systems, or components (SSCs). The proposed changes do not affect accident initiators or precursors, nor does it alter design assumptions. The proposed changes do not prevent the ability of the on-shift staff and ERO to perform their intended functions to mitigate the consequences of any accident or event that will be credible in the permanently defueled condition. The proposed changes only remove positions that will no longer be credited in the FCS RERP.
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?
Response: No.
The proposed changes reduce the number of on-shift and ERO positions commensurate with the hazards associated with a permanently shut down and defueled facility. The proposed changes do not involve installation of new equipment or modification of existing equipment, so that no new equipment failure modes are introduced. Also, the proposed changes do not result in a change to the way that the equipment or facility is operated so that no new accident initiators are created.
Therefore, the proposed amendment 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?
Response: No.
Margin of safety is associated with confidence in the ability of the fission product barriers (
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?
Response: No.
The proposed changes only impact administrative requirements associated with staff qualification, staff titles, personnel staffing levels, and clarification of systems used during decommissioning. The proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated because: (1) The proposed amendment does not represent a change to any system design, (2) the proposed amendment does not alter, degrade, or prevent action described or assumed in any accident in the USAR [updated safety analysis report] from being performed, (3) the proposed amendment does not alter any assumptions previously made in evaluating radiological consequences, and [(4)] the proposed amendment does not affect the integrity of any fission product barrier. No safety related equipment is affected by the proposed change.
Therefore, the proposed changes do 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?
Response: No.
The proposed changes do not alter the physical design, safety limits, or safety analysis assumptions associated with the operation of the plant. Hence, the proposed changes do not introduce any new accident initiators, nor do these changes reduce or adversely affect the capabilities of any plant structure or system in the performance of their safety function.
Therefore, the proposed changes 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?
Response: No.
The proposed changes do not alter the manner in which safety limits or limiting safety system settings are determined. The safety analysis acceptance criteria are not affected by these proposed changes. Further, the proposed changes do not change the design function of any equipment assumed to operate in the event of an accident.
Therefore, the proposed changes do 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?
Response: No.
The proposed change revises TS Chapter 6, “Administrative Controls,” Section 6.8, “Procedures and Programs,” by eliminating the “Inservice Testing Program” specification. Most requirements in the Inservice Testing Program are removed, as they are duplicative of requirements in the ASME OM Code, as clarified by Code Case OMN-20, “Inservice Test Frequency.” The remaining requirements in the Section 6.8 IST [Inservice Testing] Program are eliminated [. . .]. A new defined term, “Inservice Testing Program,” is added to the TS, which references the requirements of 10 CFR 50.55a(f).
Performance of inservice testing is not an initiator to any accident previously evaluated. As a result, the probability of occurrence of an accident is not significantly affected by the proposed change. Inservice test frequencies under Code Case OMN-20 are equivalent to the current testing period allowed by the TS with the exception that testing frequencies greater than 2 years may be extended by up to 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be suitable for performance of the required testing. The testing frequency extension will not affect the ability of the components to mitigate any accident previously evaluated as the components are required to be operable during the testing period extension. Performance of inservice tests utilizing the allowances in OMN-20 will not significantly affect the reliability of the tested components. As a result, the availability of the affected components, as well as their ability to mitigate the consequences of accidents previously evaluated, is not affected.
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?
Response: No.
The proposed change does not alter the design or configuration of the plant. The proposed change does not involve a physical alteration of the plant; no new or different kind of equipment will be installed. The proposed change does not alter the types of inservice testing performed. In most cases, the frequency of inservice testing is unchanged. However, the frequency of testing would not result in a new or different kind of accident from any previously evaluated since the testing methods are not altered.
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 change involve a significant reduction in a margin of safety?
Response: No.
The proposed change eliminates some requirements from the TS in lieu of requirements in the ASME Code, as modified by use of Code Case OMN-20. Compliance with the ASME Code is required by 10 CFR 50.55a. The proposed change also allows inservice tests with frequencies greater than 2 years to be extended by 6 months to facilitate test scheduling and consideration of plant operating conditions that may not be
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?
Response: No.
The in-containment refueling water storage tank (IRWST) provides flooding of the refueling cavity for normal refueling. The tank also serves as a heat sink during Passive Residual Heat Removal (PRHR) Heat Exchanger (HX) operation and in the event of a loss-of-coolant-accident (LOCA) provides injection in support of long-term RCS cooling. This activity adds normally closed covers to the IRWST vents and overflow weirs to prevent debris from entering the tank, prevent over-pressurization and accommodate volume and mass increases in the tank. The vent and overflow weir covers open upon differential pressures between the IRWST and containment.
The rod drive MG sets provide the power to the control rod drive mechanisms through the reactor trip switchgear. This activity revises the equipment description and equipment tag associated with the risk-significant control relays which open to de-energize the rod drive MG sets and permit rods to drop.
The proposed changes to add the IRWST vent and overflow weir covers and to change the description of the equipment and equipment tag related to the rod drive MG sets does not inhibit the SSCs from performing their safety-related function. The design bases of the IRWST vents and overflow weirs are not modified as a result of the addition of the covers to the vents and overflow weirs and the change to the control cabinet relay description and equipment tag. This proposed amendment does not have an adverse impact on the response to anticipated transients or postulated accident conditions because the functions of the SSCs are not changed. Required IRWST venting is not affected for any accident conditions. Required DAS functions are not affected for any accident conditions. Safety-related structure, system, component (SSC) or function is not adversely affected by this change. The changes to include the IRWST covers and to change the control cabinet relay description and tag number do not involve an interface with any SSC accident initiator or initiating sequence of events, and thus, the probabilities of the accidents evaluated in the 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. Probabilistic Risk Assessment (PRA) modeling and analyses associated with the SSCs are not impacted by this change.
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?
Response: No.
The proposed changes to the design of the IRWST vent and overflow weir covers do not adversely affect any safety-related equipment, and do not add any new interfaces to safety-related SSCs. No system or design function or equipment qualification is affected by these changes. The changes do not introduce a new failure mode, malfunction or sequence of events that could affect plant safety or safety-related equipment as the simplistic design of the cover louvers and hinged flappers are not considered unique designs. No new credible failure modes are introduced by the addition of the covers.
The proposed changes to the description and equipment tag associated with the risk-significant control relays for the rod drive MG sets do not adversely affect any safety-related equipment, and do not add any new interfaces to safety-related SSCs. No system or design function or equipment qualification is affected by these changes. The changes do not introduce a new failure mode, malfunction or sequence of events that could affect plant safety or safety-related equipment because the design function of the control relays, control cabinets, or rod drive MG sets is not changed.
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?
Response: No.
The proposed changes maintain compliance with the applicable Codes and Standards, thereby maintaining the margin of safety associated with these SSCs. The proposed changes do not alter any applicable design codes, code compliance, design function, or safety analysis. Consequently, no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by the proposed change, thus the margin of safety is not reduced. Because no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by these changes, no margin of safety is reduced.
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?
Response: No.
The proposed changes to revise the completion date for License Condition 2.C(9)b for WBN Unit 1 and License Condition 2.C(3) for WBN Unit 2 regarding the completion of permanent modifications to the Fort Loudoun Dam from February 1, 2017, to June 30, 2018, do not affect the structures, systems, or components (SSCs) of the plant, affect plant operations, or any design function or an analysis that verifies the capability of an SSC to perform a design function. No change is being made to any of the previously evaluated accidents in the WBN Updated Final Safety Analysis Report (UFSAR).
The proposed changes do not (1) require physical changes to plant SSCs; (2) prevent the safety function of any safety-related system, structure, or component during a design basis event; (3) alter, degrade, or prevent action described or assumed in any accident described in the WBN UFSAR from being performed because the safety-related SSCs are not modified; (4) alter any assumptions previously made in evaluating radiological consequences; or (5) affect the integrity of any fission product barrier.
Therefore, the proposed change does not involve a significant increase in the probability or consequence 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?
Response: No.
The proposed changes do not introduce any new accident causal mechanisms, because no physical changes are being made to the plant, nor do they affect any plant systems that are potential accident initiators.
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?
Response: No.
The margin of safety associated with the acceptance criteria of any accident is unchanged. The proposed changes will have no effect on the availability, operability, or performance of safety-related systems and components.
The proposed change will not adversely affect the operation of plant equipment or the function of equipment assumed in the accident analysis.
The proposed amendment does not involve changes to any safety analyses assumptions, safety limits, or limiting safety system settings. The changes do not adversely affect plant-operating margins or the reliability of equipment credited in the safety analyses.
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.
The following notices were previously published as separate individual notices. The notice content was the same as above. They were published as individual notices either because time did not allow the Commission to wait for this biweekly notice or because the action involved exigent circumstances. They are repeated here because the biweekly notice lists all amendments issued or proposed to be issued involving no significant hazards consideration.
For details, see the individual notice in the
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
Relocating the requirement to immediately suspend irradiated fuel movement from the determination of inoperability to the expiration of the AOT is consistent with the Westinghouse Standard Technical Specifications (STS) for an inoperable CREVS train and thereby establishes a commensurate level of safety. This change does not impact the functioning of the fuel handling system and so does not significantly increase the probability of a fuel handling accident. The removal of the kitchen and lavatory area exhaust damper requirements aligns the licensing basis with the current design and enhances the reliability of the CRE. The CREVS is not an initiator of an accident. Hence, neither of the proposed changes increase the probability of an accident previously evaluated.
The proposed changes do not impair the CREVS' capability to provide a protected environment from which operators can control the Units for all postulated events in the presence of a single failure. For an inoperable CRE boundary in any plant MODE, the suspension of fuel movement for
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?
Response: No.
Relocating the requirement to immediately suspend irradiated fuel movement until expiration of the AOT is consistent with the Westinghouse STS and hence does not introduce a new type of accident than previously evaluated or change the methods governing normal plant operation. Aligning the Control Room kitchen and lavatory ventilation exhaust pathway licensing bases with their current design does not introduce new failure modes for existing equipment or result in any new limiting single failure modes. The proposed changes do not challenge the performance or integrity of any safety-related system.
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?
Response: No.
The proposed changes align the current CREVS TS ACTION(s) with the Westinghouse STS and the licensing bases for the Control Room kitchen and lavatory ventilation exhaust pathways with their current design. As such, the proposed changes do not involve changes to any safety analyses assumptions, safety limits, or limiting safety system settings nor do they adversely impact plant operating margins or the reliability of equipment credited in the safety analyses.
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 October 12, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 11, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 7, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 14, 2016.
To increase the margin to the maximum reactor pressure vessel (RPV) acceptance criteria for certain anticipated transient without scram (ATWS) transients, the SRs for the allowable value (AV) for the ATWS recirculation pump trip (ATWS-RPT) on high RPV steam dome pressure are modified (SR 3.3.4.1.4.b). The ATWS-RPT AV for DNPS, Unit Nos. 2 and 3, is lowered to less than or equal to 1,198 pounds per square inch gauge (psig). The ATWS-RPT AV for QCNPS, Unit Nos. 1 and 2, is lowered to less than or equal to 1,195 psig.
The Commission's related evaluation of the amendments is contained in a Safety evaluation dated October 20, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 17, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 20, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 17, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 17, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 13, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated October 13, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 17, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated August 25, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated October 17, 2016.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Combined licenses and record of decision; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued combined license numbers NPF-99 and NPF-100 to Duke Energy Florida, LLC (DEF) for Levy Nuclear Plant Units 1 and 2 (LNP Units 1 and 2). In addition, the NRC has prepared a Summary Record of Decision (ROD) that supports the NRC's decision to issue combined license numbers NPF-99 and NPF-100.
Combined license numbers NPF-99 and NPF-100 became effective on October 26, 2016.
Please refer to Docket ID NRC-2008-0558 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:
•
•
•
Donald Habib, telephone: 301- 415-1035, email:
Under section 2.106 of title 10 of the
Accordingly, the combined licenses were issued on October 26, 2016, and became effective immediately.
The NRC has prepared a Final Safety Evaluation Report (FSER) and Final Environmental Impact Statement (FEIS) that document the information reviewed and the NRC's conclusion. The Commission has also issued its Memorandum and Order documenting its final decision on the uncontested hearing held on July 28, 2016, which serves as the ROD in this proceeding. The NRC also prepared a document summarizing the ROD to accompany its actions on the combined license application; this Summary ROD incorporates by reference materials contained in the FEIS. The FSER, FEIS, Summary ROD, and accompanying documentation included in the combined license package, as well as the Commission's hearing decision and ROD, are available online in the ADAMS Public Document collection at
The ADAMS accession numbers for the documents related to this notice are listed below.
The documents identified in the following table are available to interested persons through the ADAMS Public Documents collection. A copy of the combined license application is also available for public inspection at the NRC's PDR and at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License renewal; issuance.
The U.S. Nuclear Regulatory Commission (NRC) issued a renewal of Facility Operating License No. R-87, held by the Purdue University (the licensee) for the continued operation of its Purdue University Research Reactor (PUR-1 or the reactor) for an additional 20 years.
The operating license renewal for Facility Operating License No. R-87 is effective on October 31, 2016.
Please refer to Docket ID NRC-2011-0186 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:
•
•
•
Cindy K. Montgomery, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3398; email:
The NRC has issued renewed Facility Operating License No. R-87, held by the licensee, which authorizes continued operation of the Purdue University Research Reactor, located on the campus of Purdue University, in the city of West Lafayette, Tippecanoe County, Indiana. The PUR-1 is a heterogeneous pool-type, nuclear research reactor that uses Materials Testing Reactor plate type fuel. The PUR-1 is licensed to operate at a steady-state power level of 12 kilowatts thermal (kW(t)). The renewed Facility Operating License No. R-87 will expire 20 years from its date of issuance.
The renewed facility operating license 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 regulations in chapter I of title 10 of the
The NRC staff prepared a safety evaluation report for the renewal of Facility Operating License No. R-87 and concluded, based on that evaluation, that the licensee can continue to operate the facility without endangering the health and safety of the public. The NRC staff also prepared an environmental asessment and finding of no significant impact for the renewal of the facility operating license, noticed in the
The documents identified in the following table are available to interested persons as indicated.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License amendment request; opportunity to comment, request a hearing, and petition for leave to intervene; order.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of four amendment requests. The amendment requests are for Crystal River Unit 3 Nuclear Generating Plant; Diablo Canyon Nuclear Power Plant, Unit Nos. 1 and 2; Vogtle Electric Generating Plant, Units 3 and 4; and Browns Ferry Nuclear Plant, Units 1, 2, and 3. For each amendment request, the NRC proposes to determine that they involve no significant hazards consideration. Because each amendment request contains sensitive unclassified non-safeguards information (SUNSI) and/or safeguards information (SGI), an order imposes procedures to obtain access to SUNSI and SGI for contention preparation.
Comments must be filed by December 8, 2016. A request for a hearing must be filed by January 9, 2017. Any potential party as defined in § 2.4 of title 10 of the
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
C. Kay Goldstein, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-1506, email:
Please refer to Docket ID NRC-2016-0218, 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-2016-0218, 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 will post 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 into ADAMS.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the NRC is publishing this 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 notice includes notices of amendments containing SUNSI and/or SGI.
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, this means that operation of the facility in accordance with the proposed amendment would not (1) involve a significant increase in the probability or consequences of an accident previously
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 a notice of issuance 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 a petition 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, which is available at the NRC's PDR, located at One White Flint North, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852. 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, a petition shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (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 proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest. The petition must also set forth the specific contentions which the petitioner seeks to have litigated at 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 shall 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 those specific sources and documents of which the petitioner is aware and on which the petitioner intends to rely to establish those facts or expert opinion to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall 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 these requirements 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, and have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that person's admitted contentions, including the opportunity to present evidence and request permission to cross-examine witnesses, consistent with the NRC's regulations, policies, and procedures.
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Requests for hearing, petitions for leave to intervene, and motions for leave to file new or amended contentions that are filed after the 60-day 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).
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 decide 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 held 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 any 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 by January 9, 2017. 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. A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may also have the opportunity to participate under 10 CFR 2.315(c).
If a hearing is granted, any person who does not wish, or is not qualified, to become a party to the proceeding
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene (hereinafter “petition”), and documents filed by interested governmental entities participating 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. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
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
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a petition. Submissions should be in Portable Document Format (PDF). Additional guidance on PDF submissions 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 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 a document 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
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with respect to these license amendment applications, see the applications for amendment which are available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
No.
The proposed PLAN and deletion of the cyber security plan will become effective after all the spent nuclear fuel has been removed from the Spent Fuel Pools (SFP) and there are no requirements to return spent fuel to the SFP. The only current design basis accident is the Fuel Handling Accident (FHA), once the fuel is removed from the pool and placed on the ISFSI pad, the FHA will no longer be credible.
The proposed amendment has no effect on plant systems, structures, and components (SSCs) and no effect on the capability of any plant SSC to perform its design function. The proposed amendment would not increase the likelihood of the malfunction of any plant SSC. Therefore, the proposed amendment does not involve a significant increase in the probability or consequences of a previously evaluated accident.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
No.
The proposed amendment does not involve significant physical alteration of the plant. Minor modifications are associated with this proposed amendment (
3. Does the proposed amendment involve a significant reduction in a margin of safety?
No.
Plant safety margins are established through limiting conditions for operation and safety analysis described in the FSAR. Because the 10 CFR part 50 license for CR-3 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 occurrence of postulated accidents associated with reactor operation is no longer credible. The proposed amendment does not involve a change in the plant's design, configuration, or operation. The modifications associated with this proposed amendment does not affect plant safety or design margins. 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.
The license amendment request was originally noticed in the
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
This license amendment does not physically impact any system, structure, or component (SSC) that is a potential initiator of an accident. Therefore, implementation of AST, the AST assumptions and inputs, the proposed TS changes, and newχ/Q [atmospheric dispersion factors] values have no impact on the probability for initiation of any design basis accident. Once the occurrence of an accident has been postulated, the new accident source term and χ/Q values are inputs to analyses that
Reactor coolant specific activity, testing criteria of charcoal filters, and the accident induced primary-to-secondary system leakage performance criterion are not initiators for any accident previously evaluated. The proposed change to require the 48-inch containment purge valves to be sealed closed during operating MODES 1, 2, 3, and 4 is not an accident initiator for any accident previously evaluated. The change in the classification of a portion of the 40-inch Containment Penetration Area Ventilation line is also not an accident initiator for any accident previously evaluated. Thus, the proposed TS changes and AST implementation will not increase the probability of an accident.
The change to the decay time prior to fuel movement is not an accident initiator. Decay time is used to determine the source term for the dose consequence calculation following a potential FHA [fuel handling accident] and has no effect on the probability of the accident. Likewise, the change to the Control Room radiation monitors setpoint cannot cause an accident and the operation of containment spray during the recirculation phase is used for mitigation of a LOCA [loss-of-coolant accident], and thus not an accident initiator.
As a result, there are no proposed changes to the parameters or conditions that could contribute to the initiation of an accident previously evaluated in Chapter 15 of the Updated Final Safety Analysis Report (UFSAR). As such, the AST cannot affect the probability of an accident previously evaluated.
Regarding accident consequences, equipment and components affected by the proposed changes are mitigative in nature and relied upon once the accident has been postulated. The license amendment implements a new calculation methodology for determining accident consequences and does not adversely affect any plant component or system that is credited to mitigate fuel damage. Subsequently, no conditions have been created that could significantly increase the consequences of any accidents previously evaluated.
Requiring that the 48-inch containment purge supply and exhaust valves be sealed closed during operating MODES 1, 2, 3, and 4 eliminates a potential path for radiological release following events that result in radioactive material releases to the containment, thus reducing potential consequences of the event. The auxiliary building ventilation system allowable methyl iodide penetration limit is being changed, which results in more stringent testing requirements, and thus higher filter efficiencies for reducing potential releases.
Changes to the operation of the containment spray system to require operation during the recirculation mode are also mitigative in nature. While the plant design basis has always included the ability to implement containment spray during recirculation, this license amendment now requires operation of containment spray in the recirculation mode for dose mitigation. DCPP [Unit Nos. 1 and 2 are] designed and licensed to operate using containment spray in the recirculation mode. As such, operation of containment spray in the recirculation mode has already been analyzed, evaluated, and is currently controlled by Emergency Operating Procedures. Usage of recirculation spray reduces the consequence of the postulated event. Likewise, the additional shielding to the Control Room and the addition of a HEPA [high-efficiency particulate air] filter to the TSC [Technical Support Center] ventilation system reduces the consequences of the postulated event to the Control Room and TSC personnel. Lowering the limit for DEX [Dose Equivalent XE-133] lowers potential releases. By reclassifying a portion of the 40-inch Containment Penetration Area Ventilation line to PG&E Design Class I, this line will be seismically qualified, thus assuring that post-LOCA release points are the same as those used for determining χ/Q values.
The change to the decay time from 100 hours to 72 hours prior to fuel movement is an input to the FHA. Although less decay will result in higher released activity, the results of the FHA dose consequence analysis remain within the dose acceptance criteria of the event. Also, the radiation levels to an operator from a raised fuel assembly may increase due to a lower decay time, however, any exposure will continue to be maintained under 10 CFR 20 limits by the plant Radiation Protection Program.
Plant-specific radiological analyses have been performed using the AST methodology, assumption and inputs, as well as new χ/Q values. The results of the dose consequences analyses demonstrate that the regulatory acceptance criteria are met for each analyzed event. Implementing the AST involves no facility equipment, procedure, or process changes that could significantly affect the radioactive material actually released during an event. Subsequently, no conditions have been created that could significantly increase the consequences of any of the events being evaluated.
Based on the above discussion, the proposed changes do 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 accident from any accident previously evaluated?
Response: No.
This license amendment does not alter or place any SSC in a configuration outside its design or analysis limits and does not create any new accident scenarios.
The AST methodology is not an accident initiator, as it is a method used to estimate resulting postulated design basis accident doses. The proposed TS changes reflect the plant configuration that supports implementation of the new methodology and supports reduction in dose consequences. DCPP is designed and licensed to operate using containment spray in the recirculation mode. This change will not affect any operational aspect of the system or any other system, thus no new modes of operation are introduced by the proposed change.
The function of the radiation monitors has not changed; only the setpoint has changed as a result of an assessment of all potential release pathways. The continued operation of containment spray and the radiation monitor setpoint change do not create any new failure modes, alter the nature of events postulated in the UFSAR, nor introduce any unique precursor mechanism.
Requiring the 48-inch containment purge valves to be sealed closed during operating MODES 1, 2, 3, and 4 does not introduce any new accident precursor. This change only eliminates a potential release path for radionuclides following a LOCA.
The proposed TS testing criteria for the auxiliary building ventilation system charcoal filters cannot create an accident, but results in requiring more efficient filtration of potentially released iodine. The proposed changes to the DEX activity limit, the TS terminology, and the decay time of the fuel before movement are also unrelated to accident initiators.
The only physical changes to the plant being made in support of AST is the addition of Control Room shielding in an area previously modified, the addition of a HEPA filter at the intake of the TSC normal ventilation system, and the upgrade to the damper actuators, pressure switches, and damper solenoid valves to support reclassifying a portion of the Containment Penetration Area Ventilation line to PG&E Design Class I. Both Control Room shielding and HEPA filtration are mitigative in nature and do not have any impact on plant operation or system response following an accident. The Control Room modification for adding the shielding will meet applicable loading limits, so the addition of the shielding cannot initiate a failure. Upgrading damper actuators, pressure switches, and damper solenoid valves involve replacing existing components with components that are PG&E Design Class I. Therefore, the addition of shielding, a HEPA filter, and upgrading components cannot create a new or different kind of accident.
Since the function of the SSCs has not changed for AST implementation, no new failure modes are created by this proposed change. The AST change itself does not have the capability to initiate accidents.
Therefore, the proposed change does not create the possibility of a new or different type of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
Response: No.
Implementing the AST is relevant only to calculated dose consequences of potential design basis accidents evaluated in Chapter 15 of the UFSAR. The changes proposed in this license amendment involve the use of a new analysis methodology and related regulatory acceptance criteria. New atmospheric dispersion factors, which are based on site specific meteorological data, were calculated in accordance with regulatory guidelines. The proposed TS, TS Bases, and UFSAR changes reflect the plant configuration that will support implementation of the new methodology and result in operation in accordance with regulatory guidelines that support the revisions to the radiological analyses of the
The change to the minimum decay time prior to fuel movement results in higher fission product releases after a FHA. However, the results of the FHA dose consequence analysis remain within the dose acceptance criteria of the event.
The proposed changes continue to ensure that the dose consequences of design basis accidents at the exclusion area, low population zone boundaries, in the TSC, and in the Control Room are within the corresponding acceptance criteria presented in RG 1.183 and 10 CFR 50.67. The margin of safety for the radiological consequences of these accidents is provided by meeting the applicable regulatory limits, which are set at or below the 10 CFR 50.67 limits. An acceptable margin of safety is inherent in these limits.
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 requests involve no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of partial joint penetration (PJP) welds joining weldable couplers to stainless steel embedment plates as being able to perform their design function in lieu of satisfying the AISC N690-1994, Section Q1.26.2.2, Section Q1.26.2.3, and Section Q1.26.3 requirements for non-destructive examination (NDE) on 10 percent weld populations, reexamination, and repair, respectively. The proposed change does 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 change has no adverse effect on the design function of the mechanical couplers or the SSCs to which the mechanical couplers are welded. The probabilities of the accidents evaluated in the Updated Final Safety Analysis Report (UFSAR) are not affected.
The change does not impact the support, design, or operation of mechanical and fluid systems. The change does not impact the support, design, or operation of any safety-related structures. There is no change to plant systems or the response of systems to postulated accident conditions. There is no change to the predicted radioactive releases due to normal operation or postulated accident conditions. 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 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?
Response: No.
The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of PJP welds joining weldable couplers to stainless steel embedment plates as being able to perform their design function in lieu of satisfying the AISC N690-1994, Section Q1.26.2.2, Section Q1.26.2.3, and Section Q1.26.3 requirements for non-destructive examination on 10 percent weld populations, reexamination, and repair, respectively. The proposed change 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 change does not adversely affect the design function of the mechanical couplers, the structures in which the couplers are used, or 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 non-safety-related equipment. 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?
Response: No.
The proposed change describes how evaluation of coupler strength, and by extension, weld strength and quality are used to demonstrate the capacity of the PJP welds joining weldable couplers to stainless steel embedment plates as being able to perform their design function in lieu of satisfying the AISC N690-1994, Section Q1.26.2.2, Section Q1.26.2.3, and Section Q1.26.3 requirements for non-destructive examination on 10 percent weld populations, reexamination, and repair, respectively. The proposed change satisfies the same design functions as stated in the UFSAR. This change does not adversely affect compliance with any design 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 change.
Because no safety analysis or design basis acceptance limit/criterion is challenged or exceeded by this change, no significant 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.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
Response: No.
The proposed change revises the CSP Milestone 8 implementation date. This 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 is an extension to the completion date of implementation Milestone 8, that in itself 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 have 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?
Response: No.
The proposed change revises the CSP Implementation Schedule. This proposed change to extend the completion date of implementation Milestone 8 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. This change also 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?
Response: No.
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 extends the CSP Implementation Schedule. Because there is no change to these established safety margins as 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.
A. This Order contains instructions regarding how potential parties to this proceeding may request access to documents containing sensitive unclassified information (including Sensitive Unclassified Non-Safeguards Information (SUNSI) and Safeguards Information (SGI)). Requirements for access to SGI are primarily set forth in 10 CFR parts 2 and 73. Nothing in this Order is intended to conflict with the SGI regulations.
B. Within 10 days after publication of this notice of hearing and opportunity to petition for leave to intervene, any potential party who believes access to SUNSI or SGI is necessary to respond to this notice may request access to SUNSI or SGI. A “potential party” is any person who intends to participate as a party by demonstrating standing and filing an admissible contention under 10 CFR 2.309. Requests for access to SUNSI or SGI submitted later than 10 days after publication will not be considered absent a showing of good cause for the late filing, addressing why the request could not have been filed earlier.
C. The requestor shall submit a letter requesting permission to access SUNSI, SGI, or both to the Office of the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, and provide a copy to the Associate General Counsel for Hearings, Enforcement and Administration, Office of the General Counsel, Washington, DC 20555-0001. The expedited delivery or courier mail address for both offices is: U.S. Nuclear Regulatory Commission, 11555 Rockville Pike, Rockville, Maryland 20852. The email address for the Office of the Secretary and the Office of the General Counsel are
(1) A description of the licensing action with a citation to this
(2) The name and address of the potential party and a description of the potential party's particularized interest that could be harmed by the action identified in C.(1);
(3) If the request is for SUNSI, the identity of the individual or entity requesting access to SUNSI and the requestor's basis for the need for the information in order to meaningfully participate in this adjudicatory proceeding. In particular, the request must explain why publicly-available versions of the information requested would not be sufficient to provide the basis and specificity for a proffered contention; and
(4) If the request is for SGI, the identity of each individual who would have access to SGI if the request is granted, including the identity of any expert, consultant, or assistant who will aid the requestor in evaluating the SGI. In addition, the request must contain the following information:
(a) A statement that explains each individual's “need to know” the SGI, as required by 10 CFR 73.2 and 10 CFR 73.22(b)(1). Consistent with the definition of “need to know” as stated in 10 CFR 73.2, the statement must explain:
(i) Specifically why the requestor believes that the information is necessary to enable the requestor to proffer and/or adjudicate a specific contention in this proceeding;
(ii) The technical competence (demonstrable knowledge, skill, training or education) of the requestor to effectively utilize the requested SGI to provide the basis and specificity for a proffered contention. The technical competence of a potential party or its counsel may be shown by reliance on a qualified expert, consultant, or assistant who satisfies these criteria.
(b) A completed Form SF-85, “Questionnaire for Non-Sensitive Positions” for each individual who would have access to SGI. The completed Form SF-85 will be used by the Office of Administration to conduct the background check required for access to SGI, as required by 10 CFR part 2, subpart G and 10 CFR 73.22(b)(2), to determine the requestor's trustworthiness and reliability. For security reasons, Form SF-85 can only be submitted electronically through the electronic questionnaire for investigations processing (e-QIP) Web site, a secure Web site that is owned and operated by the Office of Personnel Management. To obtain online access to the form, the requestor should contact the NRC's Office of Administration at 301-415-3710.
(c) A completed Form FD-258 (fingerprint card), signed in original ink, and submitted in accordance with 10 CFR 73.57(d). Copies of Form FD-258 may be obtained by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by calling 1-630-829-9565, or by email to
(d) A check or money order payable in the amount of $333.00
(e) If the requestor or any individual who will have access to SGI believes they belong to one or more of the categories of individuals that are exempt from the criminal history records check and background check requirements in 10 CFR 73.59, the requestor should also provide a statement identifying which exemption the requestor is invoking and explaining the requestor's basis for believing that the exemption applies. While processing the request, the Office of Administration, Personnel Security Branch, will make final determination whether the claimed exemption applies. Alternatively, the requestor may contact the Office of Administration for an evaluation of their exemption status prior to submitting their request. Persons who are exempt from the background check are not required to complete the SF-85 or Form FD-258; however, all other requirements for access to SGI, including the need to know, are still applicable.
Copies of documents and materials required by paragraphs C.(4)(b), (c), and (d) of this Order must be sent to the following address: U.S. Nuclear Regulatory Commission, ATTN: Personnel Security Branch, Mail Stop TWFN-03-B46M, 11555 Rockville Pike, Rockville, MD 20852.
These documents and materials should
D. To avoid delays in processing requests for access to SGI, the requestor should review all submitted materials for completeness and accuracy (including legibility) before submitting them to the NRC. The NRC will return incomplete packages to the sender without processing.
E. Based on an evaluation of the information submitted under paragraphs C.(3) or C.(4) above, as applicable, the NRC staff will determine within 10 days of receipt of the request whether:
(1) There is a reasonable basis to believe the petitioner is likely to establish standing to participate in this NRC proceeding; and
(2) The requestor has established a legitimate need for access to SUNSI or need to know the SGI requested.
F. For requests for access to SUNSI, if the NRC staff determines that the requestor satisfies both E.(1) and E.(2) above, the NRC staff will notify the requestor in writing that access to SUNSI has been granted. The written notification will contain instructions on how the requestor may obtain copies of the requested documents, and any other conditions that may apply to access to those documents. These conditions may include, but are not limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order setting forth terms and conditions to prevent the unauthorized or inadvertent disclosure of SUNSI by each individual who will be granted access to SUNSI.
G. For requests for access to SGI, if the NRC staff determines that the requestor has satisfied both E.(1) and E.(2) above, the Office of Administration will then determine, based upon completion of the background check, whether the proposed recipient is trustworthy and reliable, as required for access to SGI by 10 CFR 73.22(b). If the Office of Administration determines that the individual or individuals are trustworthy and reliable, the NRC will promptly notify the requestor in writing. The notification will provide the names of approved individuals as well as the conditions under which the SGI will be provided. Those conditions may include, but not be limited to, the signing of a Non-Disclosure Agreement or Affidavit, or Protective Order
H. Release and Storage of SGI. Prior to providing SGI to the requestor, the NRC staff will conduct (as necessary) an inspection to confirm that the recipient's information protection system is sufficient to satisfy the requirements of 10 CFR 73.22. Alternatively, recipients may opt to view SGI at an approved SGI storage location rather than establish their own SGI protection program to meet SGI protection requirements.
I. Filing of Contentions. Any contentions in these proceedings that are based upon the information received as a result of the request made for SUNSI or SGI must be filed by the requestor no later than 25 days after the requestor is granted access to that
J. Review of Denials of Access.
(1) If the request for access to SUNSI or SGI is denied by the NRC staff either after a determination on standing and requisite need, or after a determination on trustworthiness and reliability, the NRC staff shall immediately notify the requestor in writing, briefly stating the reason or reasons for the denial.
(2) Before the Office of Administration makes an adverse determination regarding the proposed recipient(s) trustworthiness and reliability for access to SGI, the Office of Administration, in accordance with 10 CFR 2.705(c)(3)(iii), must provide the proposed recipient(s) any records that were considered in the trustworthiness and reliability determination, including those required to be provided under 10 CFR 73.57(e)(1), so that the proposed recipient(s) have an opportunity to correct or explain the record.
(3) The requestor may challenge the NRC staff's adverse determination with respect to access to SUNSI by filing a challenge within 5 days of receipt of that determination with: (a) The presiding officer designated in this proceeding; (b) if no presiding officer has been appointed, the Chief Administrative Judge, or if he or she is unavailable, another administrative judge, or an Administrative Law Judge with jurisdiction pursuant to 10 CFR 2.318(a); or (c) if another officer has been designated to rule on information access issues, with that officer.
(4) The requestor may challenge the NRC staff's or Office of Administration's adverse determination with respect to access to SGI by filing a request for review in accordance with 10 CFR 2.705(c)(3)(iv). Further appeals of decisions under this paragraph must be made pursuant to 10 CFR 2.311.
K. Review of Grants of Access. A party other than the requestor may challenge an NRC staff determination granting access to SUNSI or SGI whose release would harm that party's interest independent of the proceeding. Such a challenge must be filed with the Chief Administrative Judge within 5 days of the notification by the NRC staff of its grant of access.
If challenges to the NRC staff determinations are filed, these procedures give way to the normal process for litigating disputes concerning access to information. The availability of interlocutory review by the Commission of orders ruling on such NRC staff determinations (whether granting or denying access) is governed by 10 CFR 2.311.
L. The Commission expects that the NRC staff and presiding officers (and any other reviewing officers) will consider and resolve requests for access to SUNSI or SGI, and motions for protective orders, in a timely fashion in order to minimize any unnecessary delays in identifying those petitioners who have standing and who have propounded contentions meeting the specificity and basis requirements in 10 CFR part 2. The attachment to this Order summarizes the general target schedule for processing and resolving requests under these procedures.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; withdrawal.
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 5.3, “Statistical Terminology and Notation for Special Nuclear Materials Control and Accountability,” that was issued in 1973. This document is being withdrawn in part because regulatory guidance is not needed for common statistical terminology and notation information that is commonly used in the field of statistics. Further, RG 5.3 provided guidance on the term “limits of error” as defined in the NRC's regulations. This term is no longer a defined regulatory term and is no longer used by the NRC except in certain transaction reports. Also, RG 5.3 endorsed a 1972 American National Standards Institute (ANSI) standard that was later withdrawn. Therefore, the NRC finds that RG 5.3 is obsolete.
The effective date of the withdrawal of RG 5.3, “Statistical Terminology and Notation for Special Nuclear Materials Control and Accountability” is November 8, 2016.
Please refer to Docket ID NRC-2016-0228 when contacting the NRC about the availability of information regarding this document. You may obtain publically-available information related to this document, using the following methods:
•
•
•
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Glenn Tuttle, Office of Nuclear Materials Safety and Safeguards, telephone: 301-415-7230, email:
The NRC staff issued RG 5.3 in February 1973 to provide guidance on material control and accounting (MC&A) requirements that were then set forth in section 70.51 of Title 10 of the
Regulatory Guide 5.3 provided guidance on the statistical terminology and notation used in ANSI N15.5-1972, and such information is now found in any elementary statistics textbook. A specific regulatory guide on common statistical terminology and notation is therefore no longer needed. In addition, ANSI N15.5-1972 has been withdrawn by ANSI in coordination with the
Further, any other statistical terms that require explanation or clarification are now included in the 10 CFR 74.4 set of MC&A definitions, and regulatory guidance related to MC&A definitions is included in NUREG-1065, “Acceptable Standard Format and Content for the Fundamental Nuclear Material Control (FNMC) Plan Required for Low-Enriched Uranium Facilities,” (ADAMS Accession No. ML031340288) and NUREG/CR-5734, “Recommendations to the NRC on Acceptable Standard Format and Content for the Fundamental Nuclear Material Control (FNMC) Plan Required for Low-Enriched Uranium Enrichment Facilities” (ADAMS Accession No. ML15120A354). Additional general statistical information is provided in NUREG/CR-4604, “Statistical Methods for Nuclear Materials Management” (ADAMS Accession No. ML103430339).
Because RG 5.3 is no longer needed, the NRC is withdrawing RG 5.3. Withdrawal of a regulatory guide means that the guide no longer provides useful information or has been superseded by other guidance, technological innovations, congressional actions, changes in NRC regulations, or other events. The withdrawal of RG 5.3 does not alter any prior or existing NRC licensing approval or the acceptability of licensee commitments to RG 5.3. Although RG 5.3 is withdrawn, current licensees may continue to use it, and withdrawal does not affect any existing licenses or agreements. However, RG 5.3 should not be used in future requests or applications for NRC licensing actions.
For the Nuclear Regulatory Commission.
2 p.m.,Wednesday, November 30, 2016.
Offices of the Corporation, Twelfth Floor Board Room, 1100 New York Avenue NW., Washington, DC.
Hearing open to the public at 2 p.m.
Public Hearing in conjunction with each meeting of OPIC's Board of Directors, to afford an opportunity for any person to present views regarding the activities of the Corporation.
Individuals wishing to address the hearing orally must provide advance notice to OPIC's Corporate Secretary no later than 5 p.m. Wednesday, November 23, 2016. The notice must include the individual's name, title, organization, address, and telephone number, and a concise summary of the subject matter to be presented.
Oral presentations may not exceed ten (10) minutes. The time for individual presentations may be reduced proportionately, if necessary, to afford all participants who have submitted a timely request an opportunity to be heard.
Participants wishing to submit a written statement for the record must submit a copy of such statement to OPIC's Corporate Secretary no later than 5 p.m. Wednesday, November 23, 2016. Such statement must be typewritten, double spaced, and may not exceed twenty-five (25) pages.
Upon receipt of the required notice, OPIC will prepare an agenda, which will be available at the hearing, that identifies speakers, the subject on which each participant will speak, and the time allotted for each presentation.
A written summary of the hearing will be compiled, and such summary will be made available, upon written request to OPIC's Corporate Secretary, at the cost of reproduction.
Written summaries of the projects to be presented at the December 8, 2016, Board meeting will be posted on OPIC's Web site.
Information on the hearing may be obtained from Catherine F. I. Andrade at (202) 336-8768, via facsimile at (202) 408-0297, or via email at
Peace Corps.
Action/correction.
The Peace Corps published a document in the
Denora Miller, 202-692-1236.
In the
U.S. Office of Personnel Management (OPM).
30-Day notice and request for comments.
The Retirement Services within OPM offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) OMB No. 3206-0218, Death Benefit Payment Rollover Election, Form No. RI 94-7. As required by the Paperwork Reduction Act of 1995 as amended by the Clinger-Cohen Act, OPM is soliciting comments for this collection. The information collection was previously published in the
Comments are encouraged and will be accepted until December 8, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent by email to
A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent by email to
Form RI 94-7 provides Federal Employees Retirement System (FERS) surviving spouses and former spouses with the means to elect payment of FERS rollover-eligible benefits directly or to an Individual Retirement Arrangement (IRA), eligible employer plan or Thrift Savings Plan (TSP) account. The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of OPM, including whether the information will have practical utility;
2. Evaluate the accuracy of OPM'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,
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 2, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 2, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 2, 2016, it filed with the Postal Regulatory Commission a
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to extend the pilot period for the Exchange's Supplemental Competitive Liquidity Provider Program (the “Program”), which is currently set to expire on October 28, 2016, to expire on November 4, 2016.
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
On August 30, 2011, the Exchange received approval of rules applicable to the qualification, listing and delisting of securities of issuers on the Exchange.
The Program was approved by the Commission on a pilot basis running one-year from the date of implementation.
The Exchange established the Program in order to enhance liquidity on the Exchange in certain ETPs listed on the Exchange (and thereby enhance the Exchange's ability to compete as a listing venue) by providing a mechanism by which ETP CLPs compete for part of a daily quoting incentive on the basis of providing the most aggressive quotes with the greatest amount of size. Such competition has the ability to reduce spreads, facilitate the price discovery process, and reduce costs for investors trading in such securities, thereby promoting capital formation and helping the Exchange to compete as a listing venue. As such, the Exchange believes that it is appropriate to extend the current operation of the Program. Through this filing, the Exchange seeks to extend the current pilot period of the Program until November 4, 2016.
The Exchange believes that its proposal is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6(b) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change extends an established pilot program, thus allowing the Program to enhance competition in both the listings market and in competition for market makers. The Program will continue to promote competition in the listings market by providing issuers with a vehicle for paying the Exchange additional fees in exchange for incentivizing tighter spreads and deeper liquidity in listed securities and allow the Exchange to continue to compete with similar programs at Nasdaq Stock Market LLC
The Exchange also believes that extending the pilot program will allow the Program to continue to enhance competition among market participants by creating incentives for market makers to compete to make better quality markets. By continuing to require that market makers both meet the quoting requirements and also compete for the daily financial incentives, the quality of quotes on the Exchange will continue to improve. This, in turn, will attract more liquidity to the Exchange and further improve the quality of trading in exchange-listed securities participating in the Program, which will also act to bolster the Exchange's listing business.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (A) Significantly affect the protection of investors or the public interest; (B) impose any significant burden on competition; and (C) by its terms, become operative for 30 days from the date on which it was filed or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative before 30 days from the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
The Exchange has asked the Commission to waive the 30-day operative delay. The Exchange asserts that waiver of the operative delay will allow the Exchange to extend the Program prior to its expiration on October 28, 2016, which will ensure that the Program continues to operate uninterrupted while the Exchange and the Commission continue to analyze data regarding the Program. The Commission notes that this filing's proposal to extend the Program for only one week is based on the Exchange's representation that the one-week period will allow the Exchange time to update its Web site and submit to the Commission monthly data reports related to the Program as described in the CLP Approval Order going back to July 2015, and that, upon the completion of the update and submission, the Exchange will file a longer-term extension to the Program.
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: (1) Necessary or appropriate in the public interest; (2) for the protection of investors; or (3) otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Exchange Rule 1079, FLEX Index, Equity, and Currency Options, at Section (b), Procedure for Quoting and Trading FLEX Options.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend section (b), Procedure for Quoting and Trading FLEX Options, of Rule 1079. Specifically, the Exchange proposes to amend subsection (1), Requesting Quotations, by largely reversing the changes it made to that subsection in a 2013 proposed rule change (the “2013 Amendments”).
FLEX option transactions on the Exchange are governed by Rule 1079. Under Rule 1079(b) a Requesting Member may obtain quotes and execute trades in certain non-listed FLEX options at the specialist post of the non-FLEX option on the Exchange. The Requesting Member is a Phlx member, qualified to trade FLEX options pursuant to paragraph (c) of Rule 1079, who initiates a FLEX Request For Quotes (“RFQ”) pursuant to Rule 1079(b).
Pursuant to the 2013 Amendments, the Exchange revised a number of its FLEX rules, which it stated were intended to be similar to those of NYSE MKT LLC (“
Prior to the 2013 Amendments, Rule 1079(b)(1) permitted a Requesting Member to initiate an RFQ
Because most Exchange specialists no longer have a presence on the Exchange's trading floor, and are therefore unable to trade FLEX options, and because Exchange specialists (remote or otherwise) may have no interest in being an assigned FLEX Specialist in any event, the Exchange proposes to revert to Rule 1079(b)(1) largely as it read prior to the 2013 Amendments. That language did not require the participation of a FLEX Specialist to initiate a FLEX trade. As revised, the rule will once again permit FLEX transactions to be initiated without the participation of a specialist so long as all other requirements of Rule
The Exchange did not intend for the 2013 Amendments to expand the role of a FLEX Specialist beyond the provisions of Rule 1079(b)(1) that the Exchange is now proposing to roll back to their wording prior to the 2013 Amendments. Because the Exchange did not intend for the 2013 Amendments to expand the role of a FLEX Specialist in any case, the current proposed change to roll Rule 1079(b)(1) back to its wording prior to the 2013 Amendments will have no collateral consequences for the FLEX trading process under the rest of Rule 1079's provisions. In particular, the Exchange notes that the BBO (the best bid, offer or both, as applicable, entered in response to an RFQ) can be determined by the Requesting Member, without the assistance or intervention of a FLEX Specialist, consistent with the original 1998 Approval Order.
In practice, initially due to oversight by Exchange staff, the Exchange has not required the participation of an assigned FLEX Specialist as provided for in the 2013 Amendments but has instead continued to permit FLEX trading to occur without an assigned FLEX Specialist, just as FLEX trading has been conducted since the original 1998 Approval Order. Further, the negative practical effects of the superfluous FLEX Specialist participation requirement appear to have been inadequately considered by the Exchange when the requirement was initially adopted in the 2013 Amendments as a very small part of a more extensive set of amendments to Rule 1079 dealing with unrelated matters.
Finally, the Exchange proposes to amend the introductory language to Rule 1079, which provides that a Requesting Member shall obtain quotes and execute trades in certain non-listed FLEX options at the specialist post of the non-FLEX option on the Exchange. The Exchange proposes to delete the reference to the “specialist” post, which is a term no longer commonly used at the Exchange. Rather, the area where an option is traded is now simply referred to as a post.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe that amendments proposed herein will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act inasmuch as they simply reinstate previous Exchange rule language which had been approved by the Commission, and remove an outdated reference to the specialist post.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) of the Act
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
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.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. 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-Phlx-2016-107 and should be submitted on or before November 29, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 15, 2016, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
ICC proposes revising the ICC Risk Management Framework to incorporate certain risk model enhancements related to its single name CDS liquidity charge methodology. ICC also proposes minor clarifying edits to the ICC Risk Management Model Description document and the ICC Risk Management Framework. These revisions do not require any changes to the ICC Clearing Rules.
Specifically, ICC proposes to introduce minimum instrument liquidity requirements independent of instrument maturities. ICC's current approach features instrument liquidity requirements that decay with time to maturity for fixed credit spread levels. The proposed approach introduces minimum liquidity requirements for individual instruments, independent of time to maturity for the considered instruments. ICC believes the proposal thus establishes minimum liquidity charges that do not decay over time as maturity is approached. The revised calculation for single name CDS liquidity charges at the instrument level will incorporate a price-based bid-offer width (“BOW”) floor component, which ICC asserts will provide stability of requirements, as well as a dynamic spread-based BOW component, which ICC asserts will reflect the additional risk associated with distressed market conditions. The values of such price-based BOW and spread-based BOW will be fixed factors, which will be subject to at least monthly reviews and updates by ICC Risk Management Department with consultation with the Risk Committee.
ICC also proposes enhancements to the liquidity charge calculation at the risk factor level. ICC's current risk factor level liquidity requirements are based on forward CDS spread levels. Under the revised calculation, liquidity charges at the risk factor level will be computed by first calculating the liquidity requirements for each individual instrument position in the portfolio, and then summing all instrument liquidity requirements for positions with the same directionality,
Additionally, to facilitate replication of the enhanced liquidity charge calculations, ICC will provide end-of-day data for instruments in which clients have open positions, allowing for additional transparency and easier replication for clients who wish to estimate liquidity charges for hypothetical and current positions.
ICC also proposes updating liquidity scaling factors to reflect the methodology enhancements. There is no price based component under the current methodology. To reflect the introduction of a price based component, the liquidity scaling factors will be decomposed and adjusted in order to maintain the same overall composition with both price and spread based components.
ICC has also proposed minor clarifying edits to the ICC Risk Management Framework and the ICC Risk Management Model Description document. ICC will add language to the Overview section of the Risk Management Framework to identify which ICC documents provide additional details regarding ICC's risk management approach. ICC will add language to the Governance and Organization section of the Risk Management Framework to note that the reporting line of ICC's Chief Risk Officer to the Chairperson of the ICC Risk Committee, who is also a non-executive manager on the Board, allows the Chief Risk Officer to bring any issues or concerns directly to the Board without intermediation by other ICC personnel. ICC will also make edits to the Governance and Organization section of the Risk Management Framework to revise the list of documents reviewed by the Risk Committee on at least an annual basis to include the ICC End-of-Day Price Discovery Policies and Procedures and the ICC Operational Risk Management Framework. Finally, ICC will add minor clarifying details to the technical calculation descriptions set forth in the ICC Risk Management Model Description document, specifically in the Recovery Rate Sensitivity Risk Analysis, Interest Rate Sensitivity Risk Analysis, Spread Risk Analysis, and Guaranty Fund Size Estimation sections.
Section 19(b)(2)(C) of the Act
The Commission finds that the proposed rule change is consistent with the requirements of Section 17A of the Act
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act and in particular with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
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, November 10, 2016, 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 her designee, has certified that, in her 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 matter at the closed meeting.
Chair White, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matter of the closed meeting will be:
Institution and settlement of administrative proceedings; 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.
U.S. Small Business Administration.
Amendment 10.
This is an amendment of the Presidential declaration of a major disaster for the State of North Carolina (FEMA-4285-DR), dated 10/10/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance,, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of North Carolina, dated 10/10/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All counties contiguous to the above listed county have previously been declared.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Florida (FEMA-4283-DR), dated 10/24/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of FLORIDA, dated 10/24/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration
Notice
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Iowa (FEMA-4289-DR), dated 10/31/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416
Notice is hereby given that as a result of the President's major disaster declaration on 10/31/2016, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14956B and for economic injury is 14957B.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of WISCONSIN dated 10/31/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14947 6 and for economic injury is 14948 0.
The States which received an EIDL Declaration # are Wisconsin, Iowa, Minnesota.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of GEORGIA (FEMA-4284-DR), dated 10/20/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Georgia, dated 10/20/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
Social Security Administration (SSA).
Notice of a renewal of an existing computer matching program that will expire on April 9, 2017.
In accordance with the provisions of the Privacy Act, as amended, this notice announces a renewal of an existing computer matching program that we are currently conducting with Source Jurisdiction.
We will file a report of the subject matching program with the Committee on Homeland Security and Governmental Affairs of the Senate; the Committee on Oversight and Government Reform of the House of Representatives; and the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). The matching program will be effective as indicated below.
Interested parties may comment on this notice by either telefaxing to (410) 966-0869 or writing to the Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 617 Altmeyer Building, 6401 Security Boulevard, Baltimore, MD 21235-6401. All comments received will be available for public inspection at this address.
The Acting Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, as shown above.
The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L.) 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the conditions under which computer matching involving the Federal government could be performed and adding certain protections for persons applying for, and receiving, Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such persons.
The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, State, or local government records. It requires Federal agencies involved in computer matching programs to:
(1) Negotiate written agreements with the other agency or agencies participating in the matching programs;
(2) Obtain approval of the matching agreement by the Data Integrity Boards of the participating Federal agencies;
(3) Publish notice of the computer matching program in the
(4) Furnish detailed reports about matching programs to Congress and OMB;
(5) Notify applicants and beneficiaries that their records are subject to matching; and
(6) Verify match findings before reducing, suspending, terminating, or denying a person's benefits or payments.
We have taken action to ensure that all of our computer matching programs comply with the requirements of the Privacy Act, as amended.
Notice of Computer Matching Program, SSA with the Law Enforcement Agency (Source Jurisdiction)
SSA and Source Jurisdiction.
The purpose of this matching program is to establish the terms, conditions, and safeguards under which we will conduct a computer matching program with Source Jurisdiction in accordance with the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 (5 U.S.C. 552a), and the regulations and guidance promulgated thereunder, to identify individuals in the Source Jurisdiction who are (1) fleeing fugitive felons, parole violators, or probation violators, as defined by the Social Security Act (Act) and in accordance with the Martinez Settlement and the Clark Court Order, as defined below; and who are also (2) Supplemental Security Income (SSI) recipients, Retirement, Survivors and Disability Insurance (RSDI) beneficiaries, Special Veterans Benefit (SVB) beneficiaries, or representative payees for SSI recipients, RSDI beneficiaries, or SVB beneficiaries.
Sections 1611(e)(4)(A), 202(x)(l)(A)(iv) and (v), and 804(a)(2) and (3) of the Act (42 U.S.C. 1382(e)(4)(A), 402(x)(l)(A)(iv) and (v), and 1004(a)(2) and (3)) prohibit the payment of SSI, RSDI, or SVB benefits to an SSI recipient, RSDI beneficiary, or SVB beneficiary for any month during which such individual flees to avoid prosecution, or custody or confinement after conviction, under the applicable laws of the jurisdiction from which the person flees, for a crime or attempt to commit a crime considered to be a felony under the laws of said jurisdiction. These sections of the Act also prohibit payment of SSI, RSDI, or SVB benefits to a recipient/beneficiary in jurisdictions that do not define such crimes as felonies, but as crimes punishable by death or imprisonment for a term exceeding 1 year (regardless of the actual sentence imposed), and to an individual who violates a condition of probation or parole imposed under Federal or state law. As a result of a settlement of a nationwide class action in
The legal authority for our disclosure of information to the Source Jurisdiction is: Sections 1106(a), 1611(e)(5), 1631(a)(2)(B)(xiv), 202(x)(3)(C), 205(j)(2)(B)(iii) and 807(b)(3) of the Act; the Privacy Act of 1974, as amended by the Computer Matching and Privacy Protection Act of 1988 (5 U.S.C. 552a(b)(3)); and our disclosure regulations promulgated at 20 CFR 401.150. The settlement terms in
The Source Jurisdiction will identify individuals who are fleeing fugitive felons, probation violators, or parole violators in its records originating from various databases. The Source Jurisdiction will prepare and disclose its records electronically (
The Source Jurisdiction will provide specific data elements for individuals as specified in Attachment A. Our Data Elements Matched: SSR/SVB and MBR: Individual's SSN and payment status; Master Files of SSN Holders and SSN Applications: Individual's name, date of birth, SSN, and gender; Master Representative Payee File: Individual's SSN and status as a representative payee.
The purpose of using the Alphident file under this agreement is to locate an individual's SSN by name search. We will use the Alphident file when the Source Jurisdiction either fails to provide an SSN or provides an incorrect SSN for the named individual. The Alphident file allows us to locate the SSN by utilizing electronic data systems currently available. We match the name and date of birth data received from the Source Jurisdiction against the Alphident file. If both sets of data match only one record in our file, we assume that the SSN associated with the matched name and date of birth belongs to the person named by the Source Jurisdiction. We then treat the individual whose SSN was generated through the Alphident search in the same manner as those individuals whose SSNs provided by the Source Jurisdiction matched our records. If the name of an individual matches with a single SSN in our records, we assume that the SSN associated with the matching record belongs to the individual in the Source Jurisdiction's records, even if the date of birth does not match. We then considers this a matched item.
The effective date of this matching program is April 10, 2017, provided that the following notice periods have lapsed: 30 days after publication of this notice in the
Surface Transportation Board.
Notice and request for comments.
As required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-21 (PRA), the Surface Transportation Board (STB or Board) gives notice of its intent to seek approval from the Office of Management and Budget (OMB) for an extension of the collection of Class I Railroad Annual Reports, described below. The Board previously published a notice about this collection in the
Comments on this information collection should be submitted by December 8, 2016.
Written comments should be identified as “Paperwork Reduction Act Comments, Surface Transportation Board: Class I Railroad Annual Report.” These comments should be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Chandana L. Achanta, Surface Transportation Board Desk Officer, by email at
For further information regarding this collection, contact Pedro Ramirez at (202) 245-0333 or at
Comments are requested concerning: (1) The accuracy of the Board's burden estimates; (2) ways to enhance the quality, utility, and clarity of the information collected; (3) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate; and (4) whether the collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility. Submitted comments will be summarized and included in the Board's request for OMB approval.
Under the PRA, a federal agency that conducts or sponsors a collection of information must display a currently valid OMB control number. A collection of information, which is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c), includes agency requirements that persons submit reports, keep records, or provide information to the agency, third parties, or the public. Under 44 U.S.C. 3506(c)(2)(A), federal agencies are required to provide, prior to an agency's submitting a collection to OMB for approval, a 60-day notice and comment period through publication in the
Information from certain schedules contained in these reports is compiled and published on the Board's Web site,
The TVA Board of Directors will hold a public meeting on November 10, 2016, at the Union County Schools Fine Arts Center, 926 Panther Overlook, Blairsville, Georgia. The public may comment on any agenda item or subject at a public listening session which begins at 8:30 a.m. (ET). Following the end of the public listening session, the meeting will be called to order to
For more information: Please call TVA Media Relations at (865) 632-6000, Knoxville, Tennessee. People who plan to attend the meeting and have special needs should call (865) 632-6000. Anyone who wishes to comment on any of the agenda in writing may send their comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville, Tennessee 37902.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
RTCA Program Management Committee Meeting.
The FAA is issuing this notice to advise the public of a meeting of RTCA Program Management Committee Meeting.
The meeting will be held December 15, 2016 08:30 a.m.-04:30 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW., Suite 910, Washington, DC 20036.
Karan Hofmann at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the RTCA Program Management Committee. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman,
Federal Highway Administration, DOT.
Notice of meetings.
This document announces meetings four and five of the Tribal Transportation Self-Governance Program (TTSPG) Negotiated Rulemaking Committee.
Robert W. Sparrow, Designated Federal Official, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone: (202) 366-9483 or at
These meetings will be open to the public. Time has been set aside during each day of the meetings for members of the public to contribute to the discussion and provide oral comments.
Members of the public may submit written comments on the topics to be considered during the meetings no less than 2 business days before each of the above scheduled meetings, to Federal Docket Management System (FDMS) Docket Number FHWA-2016-0002. If you submit a comment, please include the docket number for this notice (FHWA-2016-0002). You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. The FHWA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FHWA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing.
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. The DOT posts these comments, without edit, including any personal information the commenter provides, to
Decisions with respect to future meeting dates and locations will be made at each meeting and from time to time thereafter. Notices of all future meetings will be shown on the FHWA TTSGP Web site at
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Request for member nominations; voluntary information-sharing system working group.
PHMSA is seeking nominations for individuals to serve as members for three-year terms on the Voluntary Information-Sharing System (VIS) Working Group. This is a newly created working group established in accordance with section 10 of the Protecting our Infrastructure of Pipelines and Enhancing Safety (PIPES) Act of 2016 (Pub. L. 114-183), the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., App. 2, as amended), and 41 CFR 102-3.50(a). The Secretary of Transportation (Secretary) must convene a working group by December 19, 2016 to consider the development of a voluntary information-sharing system to encourage collaborative efforts to improve inspection information feedback and information sharing with the purpose of improving gas transmission and hazardous liquid pipeline facility integrity risk analysis. PHMSA intends to comply with section 10 of the PIPES Act of 2016 by convening a working group by December 19, 2016.
Nominations must be received on or before November 28, 2016.
All nomination material should be emailed to the Advisory Committee Program Manager Cheryl Whetsel at
Cheryl Whetsel at 202-366-4431 or
The VIS Working Group will consider and provide recommendations to the Secretary as specifically outlined in section 10 of the PIPES Act of 2016:
(a) The need for, and the identification of, a system to ensure that dig verification data are shared with in-line inspection operators to the extent consistent with the need to maintain proprietary and security-sensitive data in a confidential manner to improve pipeline safety and inspection technology;
(b) Ways to encourage the exchange of pipeline inspection information and the development of advanced pipeline inspection technologies and enhanced risk analysis;
(c) Opportunities to share data, including dig verification data between operators of pipeline facilities and in-line inspector vendors to expand knowledge of the advantages and disadvantages of the different types of in-line inspection technology and methodologies;
(d) Options to create a secure system that protects proprietary data while encouraging the exchange of pipeline inspection information and the development of advanced pipeline inspection technologies and enhanced risk analysis;
(e) Means and best practices for the protection of safety- and security-sensitive information and proprietary information; and
(f) Regulatory, funding, and legal barriers to sharing the information described in paragraphs (a) through (d).
The VIS Working Group will consist of no more than 30 members appointed by the Secretary, including representatives from:
(a) PHMSA;
(b) Industry stakeholders, including:
• Operators of pipeline facilities,
• Inspection technology, coating, and cathodic protection vendors, and
• Pipeline inspection organizations;
(c) Safety advocacy groups;
(d) Research institutions;
(e) State public utility commissions or State officials responsible for pipeline safety oversight;
(f) State pipeline safety inspectors;
(g) Labor representatives; and
(h) Other entities, as determined appropriate by the Secretary.
• Each member serves a three-year term unless the member becomes unable to serve, resigns, ceases to be qualified to serve, is removed by the Secretary, or if the VIS Working Group fulfills its purpose before the term ends. The Secretary may reappoint a member to serve additional terms.
• All Group members must be able to attend approximately four meetings each year in Washington, DC, other designated locations, or by teleconference.
• Members serve without compensation although travel expenses, including per diem, may be reimbursed for those performing committee duties away from their homes and regular places of business.
• A member appointed for his or her individual views or advice must be appointed as a Special Government Employee (SGE). Other members will serve as Representatives or Regular Government Employees. SGEs are subject to certain Federal conflict of interest laws.
Any interested person may nominate one or more qualified individuals for membership on the VIS Working Group. Self-nominations are also accepted. The PHMSA Administrator, on behalf of the Secretary, is seeking individuals with diverse experiences and expertise in research and development, academia, human factors, large scale data management, standards for data exchanges, secure information sharing, risk management and risk analysis, natural gas or hazardous liquid pipeline safety, in-line inspection, pipeline anomaly assessment and remediation, pipeline inspection technology, software system development, integrity management, or other related experience.
• Nominations must include a current, complete résumé including business address and home address, telephone number, email address, education, professional or business experience, present occupation, and membership on other working groups or advisory committees, past or present.
• Nominations must include a short biography identifying each nominee's qualifications and expertise.
• Nominations for non-industry positions on the VIS Working Group should highlight relevant experience on panels that dealt with transportation safety, information-sharing systems, technology development, data management, software development, or detail their interest in the subject matter that will be considered by the committee.
• Nominations must acknowledge that the nominee is aware of the nomination unless self-nominated.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Comments must be submitted on or before December 8, 2016.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-5870 or email
By direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2 that a meeting of the National Academic Affiliations Council will be held November 29, 2016—November 30, 2016 in the VA Boston Healthcare System's Barsamian Auditorium, Room 3C-108-1, 1400 VFW Parkway, West Roxbury, MA 02132. The November 29, 2016 session will begin at 9:00 a.m. and end at 4:30 p.m. The November 30, 2016 session will begin at 9 a.m. and adjourn at 11:45 a.m. The meeting is open to the public, except when the Council is conducting tours of the VA facility. Tours of VA facilities are closed to the public, to protect Veterans' privacy and personal information, in accordance with 5 U.S.C. 552b(c)(6).
The purpose of the Council is to advise the Secretary on matters affecting partnerships between VA and its academic affiliates.
On November 29, 2016, the Council will receive updates on VA's educational portfolio and patient aligned care team (PACT) concept. Following these presentations, the Council will convene in a closed session, as it tours the VA Boston Healthcare System's West Roxbury campus. The Council will reconvene in open session to host a town hall style event focused on PACT implementation. The town hall meeting will begin at 11:15 a.m. and end promptly at 12:15 p.m. Additional agenda items include a discussion on VA's efforts to implement innovative academic relationships and collaboration, an overview of the VA National Nursing Academy, and a presentation on the Northeast Region VA Nursing Alliance. On November 30, 2016, the Council will receive an update on the graduate medical education expansion initiative authorized under Public Law 113-146 and host a faculty development showcase sponsored by the VA Boston Healthcare System. The Council will receive public comments from 4:15 p.m. to 4:30 p.m. on November 29, 2016 and again from 11:30 a.m. to 11:45 a.m. on November 30, 2016.
Interested persons may attend and present oral statements to the Council. A sign-in sheet for those who want to give comments will be available at the meeting. Individuals who speak are invited to submit a 1-2 page summary of their comments at the time of the meeting for inclusion in the official meeting record. Oral presentations will be limited to five minutes or less, depending on the number of participants. Interested parties may also provide written comments for review by the Council prior to the meeting or at any time, by email to,
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a redesignation substitute and making finding of attainment for both the revoked 1-hour and the revoked 1997 8-hour ozone National Ambient Air Quality Standards (NAAQS) for the Dallas-Fort Worth ozone nonattainment areas (DFW area).
This rule is effective on December 8, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2015-0721. All documents in the docket are listed on the
Tracie Donaldson, 214-665-6633,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our May 25, 2016 proposal (81 FR 33161). In that document we proposed to approve a redesignation substitute and make a finding of attainment for both the 1-hour and the 1997 8-hour ozone NAAQS for the Dallas-Fort Worth 1-hour and 1997 8-hour ozone nonattainment areas (DFW areas). The redesignation substitute demonstration indicates that the area has attained the revoked 1-hour and the revoked 1997 8-hour ozone NAAQS due to permanent and enforceable emission reductions and that it will maintain those NAAQS for ten years from the date of the EPA's approval of this demonstration. Final approval of the redesignation substitute results in the area no longer being subject to any remaining applicable anti-backsliding requirements, including nonattainment new source review associated with the revoked NAAQS. In general, final approval of the redesignation substitute allows Texas to seek to revise the Texas State Implementation Plan (SIP) for the area to remove anti-backsliding measures from the active portion of its SIP if it can demonstrate, pursuant to CAA section 110(1), that such revision would not interfere with attainment or maintenance of any applicable NAAQS, or any other requirement of the CAA. Because the EPA believes Texas does not need to revise its SIP to alter certain provisions for NNSR effective in the DFW area, the offset and threshold requirements applicable in the DFW area for NNSR will be automatically altered upon finalization of the redesignation substitute.
We received comments on the proposal from three commenters. Our response to the comments is below.
The EPA agrees that approval of the redesignation substitute will result in the DFW area no longer being subject to the regulatory anti-backsliding requirements for the 1997 ozone standard established pursuant to the principles of CAA section 172(e). However if an anti-backsliding provision is in the Texas SIP and needs to be changed to reflect the change in this area's status, such change is subject to the SIP revision process, which in turn is subject to review under CAA sections 110 and 193, if applicable. To date, Texas has not submitted a SIP revision concerning any anti-backsliding provisions for the EPA's consideration.
The EPA acknowledges that this rule has been challenged in the D.C. Circuit by the commenter. However, the rule has not been stayed pending resolution of the litigation, and as such, it is appropriate to continue to implement the 2008 ozone SIP Requirements Rule during the pendency of the litigation.
The EPA believes the redesignation substitute is an appropriate mechanism because it serves as a successor to a redesignation to attainment, for which these areas would have been eligible if the EPA had not revoked the 1-hour and 1997 ozone standards. For a more detailed description of why the EPA has determined the DFW area has met the redesignation criteria for the revoked 1997 ozone standard, see 81 FR 33161 for the proposal and Technical Support Document. Upon approval of a redesignation substitute, a state may request to revise its SIP to shift regulatory anti-backsliding requirements contained in the active portion of the SIP to the contingency measures portion of the SIP, subject to a showing of consistency with the general anti-backsliding checks in CAA sections 110(l) and 193 (if applicable). The EPA approval of the redesignation substitute has the same effect on these areas' nonattainment regulatory anti-backsliding requirements as would a redesignation to attainment for the revoked standard. The EPA believes that, under any view of anti-backsliding for a revoked standard, it should not mean imposing requirements greater than those that would apply if the standard had not been revoked.
An approvable redesignation substitute must include more than a determination of attainment of the prior NAAQS, and show that it addresses redesignation criteria for that NAAQS. Moreover, the state remains subject to ongoing requirements to meet the new more stringent 2008 ozone standard in that area. In this context, the EPA believes finalizing of this action is appropriate—it recognizes and supports Texas's progress in having attained the prior standards in the DFW area due to permanent and enforceable emissions reductions, and reinforces continued attainment by demonstrating that the DFW area can maintain the revoked standard. See 80 FR 12264, 12305.
We find that Texas has successfully demonstrated it has met the requirements for approval of a redesignation substitute for the revoked 1-hour and the revoked 1997 8-hour ozone NAAQS for the DFW area. We are approving the redesignation substitute for the DFW area based on our determination that the demonstration provided by the State of Texas shows that the DFW area has attained the revoked 1-hour and the revoked 1997 8-hour ozone NAAQS due to permanent and enforceable emission reductions, and that it will maintain these NAAQS for ten years from the date of the EPA's approval of this demonstration. As we no longer redesignate nonattainment areas to attainment for the revoked 1-hour and the revoked 1997 8-hour ozone NAAQS, approval of the demonstration serves as a redesignation substitute under the EPA's implementing regulations. As a result of this action, Texas is no longer required to adopt any additional applicable 1-hour and 1997 8-hour ozone NAAQS requirements for the area which have not already been approved into the SIP (40 CFR 51.1105(b)(1)). It also allows the state to request that the EPA approve the shifting of planning and control requirements implemented pursuant to the 1-hour and the 1997 8-hour ozone NAAQS from the active portion of the SIP to the contingency measures portion of the SIP, upon a showing of consistency with CAA sections 110(l) and 193 (if applicable) (40 CFR 51.1105(b)(2)).
Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves a demonstration provided by the State of Texas and finds that the DFW area is no longer subject to the regulatory anti-backsliding requirements under the principles of CAA section 172(e) for the revoked 1-hour ozone and the revoked 1997 8-hour ozone NAAQS; and imposes no additional requirements. Accordingly, I certify that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
The rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 9, 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. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Volatile organic compounds.
Environmental protection, Air pollution control.
42 U.S.C. 7401
40 CFR parts 52 and 81 are amended as follows:
42 U.S.C. 7401
(m)
42 U.S.C. 7401,
The revisions and additions read as follows:
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a redesignation substitute and making a finding of attainment for the revoked 1997 8-hour ozone National Ambient Air Quality Standard (NAAQS) for the Houston-Galveston-Brazoria ozone nonattainment area (HGB area).
This rule is effective on December 8, 2016.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2015-0609. All documents in the docket are listed on the
Tracie Donaldson, 214-665-6633,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our May 25, 2016 proposal (81 FR 33166). In that document we proposed to approve a redesignation substitute and make a finding of attainment for the 1997 8-hour ozone NAAQS for the Houston-Galveston-Brazoria ozone nonattainment area (HGB area). The redesignation substitute demonstration indicates that the area has attained the revoked 1997 8-hour ozone NAAQS due to permanent and enforceable emission reductions and that it will maintain that NAAQS for ten years from the date of the EPA's approval of this demonstration. Final approval of the redesignation substitute results in the area no longer being subject to any remaining applicable anti-backsliding requirements, including nonattainment new source review, associated with the revoked NAAQS. In general, final approval of the redesignation substitute allows Texas to seek to revise the Texas SIP for the area to remove anti-backsliding measures from the active portion of its SIP if it can demonstrate, pursuant to CAA section 110(1), that such revision would not interfere with attainment or maintenance of any applicable NAAQS, or any other requirement of the CAA. Because the EPA believes Texas does not need to revise its SIP to alter certain provisions for NNSR effective in the HGB area, the offset and threshold requirements applicable in the HGB area for NNSR will be automatically altered upon finalization of the redesignation substitute.
We previously approved a HGB area redesignation substitute for the revoked 1-hour ozone standard (80 FR 63429). In this action, we are also finalizing a non-substantive technical correction to 40 CFR 81.344 to reflect this approval.
We received comments on the proposal from five commenters. Our response to the comments are below.
The EPA agrees that approval of the redesignation substitute will result in the HGB area no longer being subject to the regulatory anti-backsliding requirements for the 1997 ozone standard established pursuant to the principles of CAA section 172(e). However, if an anti-backsliding provision is in the Texas SIP and needs to be changed to reflect the change in this area's status, such change is subject to the SIP revision process, which in turn is subject to review under CAA sections 110 and 193, if applicable. To date, Texas has not submitted a SIP revision concerning any anti-backsliding provisions for the EPA's consideration.
The EPA acknowledges that this rule has been challenged in the D.C. Circuit by the commenter. However, the rule has not been stayed pending resolution of the litigation, and as such, it is appropriate to continue to implement the 2008 ozone SIP Requirements Rule during the pendency of the litigation.
The EPA believes the redesignation substitute is an appropriate mechanism because it serves as a successor to a redesignation to attainment, for which these areas would have been eligible if the EPA had not revoked the 1-hour and 1997 ozone standards. For a more detailed description of why the EPA has determined the HGB area has met the redesignation criteria for the revoked 1997 ozone standard, see 81 FR 33166 for the proposal and Technical Support Document. Upon approval of a redesignation substitute, a state may request to revise its SIP to shift regulatory anti-backsliding requirements contained in the active portion of the SIP to the contingency measures portion of the SIP, subject to a showing of consistency with the general anti-backsliding checks in CAA sections 110(l) and 193 (if applicable). The EPA approval of the redesignation substitute has the same effect on these areas' nonattainment regulatory anti-backsliding requirements as would a redesignation to attainment for the revoked standard. The EPA believes that, under any view of anti-backsliding for a revoked standard, it should not mean imposing requirements greater than those that would apply if the standard had not been revoked.
An approvable redesignation substitute must include more than a determination of attainment of the prior NAAQS, and show that it addresses redesignation criteria for that NAAQS. Moreover, the state remains subject to ongoing requirements to meet the new more stringent 2008 ozone standard in that area. In this context, the EPA believes finalizing this action is appropriate—it recognizes and supports Texas's progress in having attained the
We find that Texas has successfully demonstrated it has met the requirements for approval of a redesignation substitute for the revoked 1997 8-hour ozone NAAQS for the HGB area. We are approving the redesignation substitute for the HGB area based on our determination that the demonstration provided by the State of Texas shows that the HGB area has attained the revoked 1997 8-hour ozone NAAQS due to permanent and enforceable emission reductions, and that it will maintain that NAAQS for ten years from the date of the EPA's approval of this demonstration. As we no longer redesignate nonattainment areas to attainment for the revoked 1997 8-hour ozone NAAQS, approval of the demonstration serves as a redesignation substitute under the EPA's implementing regulations. As a result of this action, Texas is no longer required to adopt any additional applicable 1997 8-hour ozone NAAQS requirements for the area which have not already been approved into the SIP (40 CFR 51.1105(b)(1)). It also allows the state to request that the EPA approve the shifting of planning and control requirements implemented pursuant to the 1997 ozone NAAQS from the active portion of the SIP to the contingency measures portion of the SIP, upon a showing of consistency with CAA sections 110(l) and 193 (if applicable) (40 CFR 51.1105(b)(2)).
We are also finalizing a non-substantive technical correction to 40 CFR 81.344 (Section 107 Attainment Status Designations for Texas) to reflect our previous approval of a HGB area redesignation substitute demonstration for the revoked 1-hour ozone standard.
Under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves a demonstration provided by the State of Texas and finds that the HGB area is no longer subject to the regulatory anti-backsliding requirements under the principles of CAA section 172(e) for the revoked 1997 8-hour ozone NAAQS; and imposes no additional requirements. Accordingly, I certify that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
The rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. The EPA has determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment.
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 9, 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)]
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Volatile organic compounds.
Environmental protection, Air pollution control.
42 U.S.C. 7401
40 CFR parts 52 and 81 are amended as follows:
42 U.S.C. 7401
(n)
42 U.S.C. 7401,
The revisions and additions read as follows:
(b) The Working Group shall consist of representatives of the following executive branch departments and agencies (Participating Agencies):
(c) The Working Group may consult with non-United States Government entities that participate in Power Africa as bilateral, multilateral, private sector partners and nongovernmental organizations to provide input and advice to the United States Government, as appropriate, regarding the implementation of Power Africa.
(d) The Working Group may establish sub-groups consisting exclusively of Working Group members or their designees, as appropriate, such as one for each of the three pillars of the Power Africa Roadmap: (1) megawatts, (2) connections, and (3) unlocking energy sector potential.
(e) The Working Group shall be supported by the Office of the Coordinator for Power Africa within USAID.
(a) Ensure efficient and effective coordination of energy access activities in Sub-Saharan Africa among Participating Agencies.
(b) Identify, prioritize, and evaluate potential Power Africa projects, regulatory and policy reforms, and programmatic focus areas, including maximizing deployment of and access to renewable energy.
(c) Identify country and project specific obstacles to the development of the electricity sector, including financial and technical assistance needs
(d) Enhance coordination among Participating Agencies to maximize the efficiency and effectiveness of United States Government development assistance and other development finance tools as related to Power Africa priorities.
(e) Facilitate information sharing and coordination of partnerships between Participating Agencies and African governments, the private sector, development partners, and bilateral and multilateral partners to help advance Power Africa's goals.
(f) Identify appropriate courses of action to liaise with host governments to advance regulatory and policy reforms, as well as energy transactions, related to Power Africa.
(g) Identify best practices for Participating Agencies to coordinate their engagement with development partners, including bilateral donors, development finance institutions, and multilateral development banks on energy access issues, to ensure that Power Africa's tools are deployed in a way that is complementary to and leverages the impact of United States Government resources.
(h) Meet with private sector partners, as appropriate, to review Power Africa projects and activities, and to solicit input regarding technical, policy, financial or political, obstacles that partners are encountering in the energy sector across Sub-Saharan Africa.
(i) Meet with bilateral and multilateral development partners, as appropriate, to coordinate country-specific and regional energy access policy agendas, coordinate deployment of financial resources and technical expertise to identify and accelerate Power Africa projects and activities, and review project pipelines.
(j) Monitor and periodically evaluate Power Africa projects and activities to measure the effectiveness of United States Government assistance and other development finance tools in achieving Power Africa's electricity generation and access goals, and to share lessons learned. These evaluations may recommend reforms to facilitate support for future projects and activities, and to increase the Working Group's effectiveness.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
| 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 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR