Page Range | 57509-57692 | |
FR Document |
Page and Subject | |
---|---|
80 FR 57691 - National Voter Registration Day, 2015 | |
80 FR 57613 - Sunshine Act Meetings | |
80 FR 57644 - Regular Board of Directors Meeting; Sunshine Act | |
80 FR 57644 - Audit Committee Meeting; Sunshine Act | |
80 FR 57614 - Sunshine Act Meeting | |
80 FR 57569 - Sunshine Act Meeting | |
80 FR 57607 - Human Studies Review Board; Notification of a Public Meetings | |
80 FR 57571 - Commerce Data Advisory Council; Public Meeting | |
80 FR 57578 - Certain Cut-to-Length Carbon Steel Plate From the Russian Federation: Request for Comments | |
80 FR 57632 - Notice of Application for Withdrawal and Notification of Public Meetings; South Dakota and Wyoming | |
80 FR 57605 - Extension of Request for Scientific Views on the Draft Aquatic Life Ambient Water Quality Criterion for Selenium-Freshwater 2015 | |
80 FR 57637 - Renewal of Approved Information Collection | |
80 FR 57608 - Board of Scientific Counselors Homeland Security Subcommittee; Notification of Public Teleconference Meeting and Public Comment | |
80 FR 57617 - Health Insurance Marketplace, Medicare, Medicaid, and Children's Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE), October 7, 2015 | |
80 FR 57627 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
80 FR 57536 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA | |
80 FR 57629 - Notice of Issuance of Final Determination Concerning Certain Analytical-Grade Acetonitrile | |
80 FR 57581 - Proposed Information Collection; Comment Request; Coastal Zone Management Program Administration | |
80 FR 57597 - Commission to Review the Effectiveness of the National Energy Laboratories | |
80 FR 57598 - DOE/NSF Nuclear Science Advisory Committee; Notice of Open Meeting | |
80 FR 57526 - Protection System, Automatic Reclosing, and Sudden Pressure Relaying Maintenance Reliability Standard | |
80 FR 57549 - Relay Performance During Stable Power Swings Reliability Standard | |
80 FR 57598 - Environmental Management Site-Specific Advisory Board, Northern New Mexico | |
80 FR 57509 - Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards | |
80 FR 57649 - Imposition of Missile Proliferation Sanctions on Two North Korean Entities | |
80 FR 57650 - Imposition of Nonproliferation Measures on Two North Korean Entities | |
80 FR 57650 - 30-Day Notice of Proposed Information Collection: Exchange Alumni Virtual Program | |
80 FR 57649 - Determination Under Section 610 of the Foreign Assistance Act of 1961, as Amended | |
80 FR 57620 - Submission for OMB Review; Comment Request | |
80 FR 57650 - Determination Under Section 610 of the Foreign Assistance Act of 1961 | |
80 FR 57614 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
80 FR 57614 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
80 FR 57627 - Meeting of the Secretary's Advisory Committee on Human Research Protections | |
80 FR 57619 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
80 FR 57616 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
80 FR 57643 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act | |
80 FR 57644 - New Postal Product | |
80 FR 57567 - Notice of Intent To Grant Exclusive License | |
80 FR 57568 - Notice of Intent To Seek Approval To Collect Information | |
80 FR 57582 - Western Pacific Fishery Management Council; Public Meetings | |
80 FR 57596 - New England Fishery Management Council; Public Meeting | |
80 FR 57596 - Western Pacific Fishery Management Council; Public Meeting | |
80 FR 57643 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Flash/Cancellation/Transfer Notice (I-12) Approval of an Existing Collection in Use Without an OMB Control Number | |
80 FR 57572 - Order Relating to Aiman Ammar, Rashid Albuni, Engineering Construction & Contracting Co., Advanced Tech Solutions, and iT Wave FZCO | |
80 FR 57548 - Protection of Human Subjects | |
80 FR 57567 - Salmon-Challis National Forest; Idaho; Big Creek Geothermal Leasing Proposal | |
80 FR 57651 - Notice of Funding Availability for the Ladders of Opportunity Initiative: Pilot On-the-Job-Training Supportive Services Program | |
80 FR 57603 - City of Gonzales, Texas; Notice of Intent to File License Application, Filing of Pre-Application Document (PAD), Commencement of Pre-Filing Process, and Scoping; Request for Comments on the PAD and Scoping Document, and Identification of Issues and Associated Study Requests | |
80 FR 57601 - Pacific Gas and Electric Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
80 FR 57600 - South Carolina Electric and Gas Company; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
80 FR 57599 - Southeastern Power Administration; Notice of Filing | |
80 FR 57604 - Venture Global Calcasieu Pass, LLC; TransCameron Pipeline, LLC: Notice of Applications | |
80 FR 57599 - Combined Notice of Filings #2 | |
80 FR 57602 - Combined Notice of Filings #1 | |
80 FR 57597 - Meeting of the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College | |
80 FR 57644 - Astronomy and Astrophysics Advisory Committee; Notice of Meeting | |
80 FR 57570 - Submission for OMB Review; Comment Request | |
80 FR 57571 - Submission for OMB Review; Comment Request | |
80 FR 57656 - FY15 Discretionary Funding Opportunity: Low or No Emission Vehicle Deployment Program (LoNo) Program | |
80 FR 57584 - Taking of Marine Mammals Incidental to Specified Activities; San Francisco-Oakland Bay Bridge Pier E3 Demolition via Controlled Implosion | |
80 FR 57628 - Accreditation and Approval of Amspec Services, LLC, as a Commercial Gauger and Laboratory | |
80 FR 57621 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Payment Request Forms | |
80 FR 57621 - Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications | |
80 FR 57631 - Accreditation and Approval of Saybolt LP as a Commercial Gauger and Laboratory | |
80 FR 57568 - Information Collection Activity; Comment Request | |
80 FR 57580 - Alternative Personnel Management System at the National Institute of Standards and Technology | |
80 FR 57641 - Certain Silicon-on-Insulator Wafers; Notice of Institution of Investigation | |
80 FR 57642 - Certain Document Cameras and Software for use Therewith Notice of Institution of Investigation | |
80 FR 57614 - Carrot Neurotechnology, Inc.; Analysis of Proposed Consent Order To Aid Public Comment | |
80 FR 57531 - National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions | |
80 FR 57623 - Use of Investigational Tobacco Products; Draft Guidance for Industry and Investigators; Availability | |
80 FR 57645 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Make Permanent the Rules of the New Market Model Pilot, the Supplemental Liquidity Providers Pilot, and the Pilot Program Allowing “UTP Securities” To Be Traded on the Exchange Pursuant to a Grant of Unlisted Trading Privileges | |
80 FR 57645 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to Implementation of a Fee on Securities Lending and Repurchase Transactions With Respect to Shares of the CurrencyShares® Euro Trust and the CurrencyShares® Japanese Yen Trust | |
80 FR 57569 - Submission for OMB Review; Comment Request | |
80 FR 57633 - Notice of Availability of the Record of Decision and Approved Resource Management Plan Amendments for the Great Basin Region Greater Sage-Grouse Sub-Regions of Idaho and Southwestern Montana; Nevada and Northeastern California; Oregon; and Utah | |
80 FR 57635 - Notice of Proposed Withdrawal; Sagebrush Focal Areas; Idaho, Montana, Nevada, Oregon, Utah, and Wyoming and Notice of Intent To Prepare an Environmental Impact Statement | |
80 FR 57611 - Deletion of Consent Agenda Items From September 17, 2015; Open Meeting | |
80 FR 57613 - Information Collection Being Reviewed by the Federal Communications Commission | |
80 FR 57610 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
80 FR 57639 - Notice of Availability of the Record of Decision; and Approved Resource Management Plan Amendments for the Rocky Mountain Region Greater Sage-Grouse Sub-Regions of Lewistown, North Dakota, Northwest Colorado, and Wyoming; and Approved Resource Management Plans for Billings, Buffalo, Cody, HiLine, Miles City, Pompeys Pillar National Monument, South Dakota, and Worland | |
80 FR 57605 - Proposed Information Collection Request; Comment Request; Safe Drinking Water Act State Revolving Fund Program | |
80 FR 57609 - Delegation of Authority to the State of West Virginia To Implement and Enforce Additional or Revised National Emission Standards for Hazardous Air Pollutants and New Source Performance Standards | |
80 FR 57576 - Multilayered Wood Flooring From the People's Republic of China: Preliminary Results of the Changed Circumstances Review of Sino-Maple (JiangSu) Co., Ltd. | |
80 FR 57512 - Promulgation of NCUA Rules and Regulations | |
80 FR 57564 - Retrospective Regulatory Review-State Safety Plan Development and Reporting | |
80 FR 57661 - Request for Citizens Coinage Advisory Committee Membership Application | |
80 FR 57519 - Revocation of Jet Route J-513; North Central United States | |
80 FR 57540 - Approval and Promulgation of Implementation Plans; South Carolina; Infrastructure Requirements for the 2008 Lead National Ambient Air Quality Standards | |
80 FR 57537 - Approval and Promulgation of Implementation Plans; Georgia; Removal of Clean Fuel Fleet Program | |
80 FR 57538 - Approval and Promulgation of Implementation Plans; Florida Infrastructure Requirements for the 2008 Lead NAAQS | |
80 FR 57664 - Migratory Bird Hunting; Final Frameworks for Late-Season Migratory Bird Hunting Regulations | |
80 FR 57543 - Airworthiness Directives; Bombardier, Inc. Airplanes | |
80 FR 57517 - Amendment of Class C Airspace; Portland International Airport, OR | |
80 FR 57518 - Amendment of Class C Airspace; Burbank, CA | |
80 FR 57523 - Amendment of Class E Airspace; Douglas, WY | |
80 FR 57521 - Establishment of Class E Airspace, Delta, CO | |
80 FR 57524 - Establishment of Class E Airspace; Iron Mountain, MI | |
80 FR 57522 - Establishment of Class E Airspace; Newberry, MI | |
80 FR 57579 - Fresh Garlic From the People's Republic of China: Final Results of the Changed Circumstances Review | |
80 FR 57553 - Rules of General Application, Adjudication and Enforcement | |
80 FR 57545 - Airworthiness Directives; Dassault Aviation Airplanes |
Agricultural Research Service
Forest Service
National Agricultural Library
Rural Utilities Service
Economics and Statistics Administration
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Navy Department
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
Substance Abuse and Mental Health Services Administration
Coast Guard
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
Federal Aviation Administration
Federal Highway Administration
Federal Transit Administration
National Highway Traffic Safety Administration
United States Mint
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Department of Energy.
Final rule.
This rule finalizes the Department of Energy (DOE)'s part of the Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards joint interim rule which was issued December 19, 2014 and makes several technical corrections to DOE's portion of the interim final rule.
DOE is not making new policy with either the interim final rule or this final rule. All regulatory language included here is consistent with either the policies in the Uniform Guidance or DOE's existing policies and practices.
Ellen Colligan, Procurement Analyst, U.S. Department of Energy, Office of Acquisition Management, Contract and Financial Assistance Policy Division MA-611, Telephone: (202) 287-1776. Email:
The Department makes substantial use of financial assistance awards (grants and cooperative agreements) to meet its mission goals. To manage these awards, the Department added requirements specifying changes and additions to its Administrative Requirements for Grants and Cooperative Agreements.
On December 19, 2014, OMB published a rulemaking in the
DOE is finalizing this rule with technical corrections as detailed below.
DOE received no comments from members of the public in response to its section of the joint interim final rule. However, DOE has found areas where technical corrections are necessary. Corrections are included only where it has come to the attention of DOE that particular language in the final guidance did not match with DOE's intent and would result in an erroneous implementation of the guidance. The technical corrections include:
a. Adding the national interest exception from competition (consistent with the existing requirement in section 600.6(b)(8)). When carrying requirements forward from our current regulations, this section was inadvertently dropped from the regulations. We need this exception for instances where non-competitive awards are necessary to meet the national interest of the United States.
b. Clarifying that restricted eligibility needs to be approved one level above CO. In an attempt to clarify this section of the regulations when carrying the requirement forward to our new regulations, the approval level was omitted. We need to add this back since regulations as written do not require any higher level approval.
c. Adding section 910.127, Legal Authority and Effect which is consistent with 10 CFR 600.16. There is nothing in the new regulations to indicate what constitutes a legal award or exactly how the recipient acknowledges that they have agreed to the terms and conditions of the award. Therefore, we are carrying forward a section from our current regulations which clarifies this issue.
d. Clarifying sections 910.501 and 910.507 to update some references from “program-specific” to “compliance” audits. The major difference between program-specific audits and compliance audits is that program-specific audits require that the auditee prepare a financial statement and that the auditor perform an audit of the financial statements. The guidance provided in 2 CFR 910 corresponding to Compliance Audits by for-profit entities is consistent with prior DOE guidance. The requirements in 2 CFR 910 do not require an auditee to prepare financial statements and do not require an auditor to perform an audit of financial statements. Instead, the guidance in 2 CFR 910 specifies requirements to be met by the auditee and auditor that ensures the audit complies with Generally Accepted Government Auditing Standards (GAGAS), Federal statutes and regulations, and the terms and conditions of Federal award. The effect is that 2 CFR 910 does not “create new policy or requirements . . .” in accordance with OMB implementing guidance (consistent with the existing requirement in section 600.316). The corrections primarily replace the term “Program-Specific” Audit with the term “Compliance” Audit in order to eliminate potential confusion between the two types of audits.
e. Making a wording change to 910.502 to parallel a technical correction made by OMB December 19, 2014. Wording change is to say that “. . . determination of when a Federal award is expended
The regulatory action today has been determined not to be a “significant regulatory action” under Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (October 4, 1993). Accordingly, this rule is not subject to review under the Executive Order by the Office of Information and Regulatory Affairs within the Office of Management and Budget.
DOE has also reviewed the regulation pursuant to Executive Order 13563, issued on January 18, 2011 (76 FR 3281 (Jan. 21, 2011)). Executive Order 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, agencies are required by Executive Order 13563 to: (1) Propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity); (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
DOE emphasizes as well that Executive Order 13563 requires agencies to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible. In its guidance, the Office of Information and Regulatory Affairs has emphasized that such techniques may include identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes. DOE believes that today's NOPR is consistent with these principles, including the requirement that, to the extent permitted by law, agencies adopt a regulation only upon a reasoned determination that its benefits justify its costs and, in choosing among alternative regulatory approaches, those approaches maximize net benefits.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction.
With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law; these regulations meet the relevant standards of Executive Order 12988.
The Regulatory Flexibility Act (RFA) requires an agency that is issuing a final rule to provide a final regulatory flexibility analysis or to certify that the rule will not have a significant economic impact on a substantial number of small entities. OMB determined that the common interim final rule implements OMB final guidance issued on December 26, 2013, and will not have a significant economic impact beyond the impact of the December 2013 guidance.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Ch. 3506; 5 CFR 1320 Appendix A.1) (PRA), DOE reviewed the interim final rule and determined that there are no new collections of information contained therein. DOE's procurement reporting and recordkeeping burdens have been approved under OMB Control No. 1910-4100.
DOE has concluded that promulgation of this rule falls into a class of actions which would not individually or cumulatively have significant impact on the human environment, as determined by DOE's regulations (10 CFR part 1021, subpart D) implementing the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321
OMB determined that the joint interim final rule does not have any Federalism implications, as required by Executive Order 13132
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a budgetary impact statement before promulgating a rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires covered agencies to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. OMB has determined that this joint interim final rule will not result in expenditures by State, local, and tribal governments, or by the private sector, of $100 million or more in any one year. Accordingly, the Federal agencies participating in this joint interim final rule have not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use”, 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to the Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to promulgation of a Final Rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution and use. Today's rule is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.
The Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for agencies to review most disseminations of information to the public under implementing guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (February 22, 2002), and DOE's guidelines were published at 67 FR 62446 (October 7, 2002). DOE has reviewed today's notice under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
An agency may find good cause to exempt a rule from the requirement for a notice of rulemaking and the opportunity for public under the Administrative Procedure Act (APA) if the requirement is determined to be unnecessary, impracticable, or contrary to the public interest under
As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule prior to its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).
The Office of the Secretary of Energy has approved issuance of this rule.
Accounting, Administrative practice and procedure, Grant programs, Reporting and recordkeeping requirements.
Accordingly, the interim rule amending 2 CFR part 910 which was published at 79 FR 75867 on December 19, 2014, is adopted as a final rule with the following changes:
42 U.S.C. 7101,
The additions read as follows:
(b) * * *
(3) Approved, prior to award, by an approver at least one level above the Contracting Officer.
(c) * * *
(8) The responsible program Assistant Secretary, Deputy Administrator, or other official of equivalent authority has determined that making the award non-competitively is in the public interest. This authority cannot not be delegated.
(a) A DOE financial assistance award is valid only if it is in writing and is signed, either in writing or electronically, by a DOE Contracting Officer.
(b) Recipients are free to accept or reject the award. A request to draw down DOE funds constitutes the Recipient's acceptance of the terms and conditions of this Award.
(b)
(2) If a for-profit entity receives more than one award from DOE with a sum total of expenditures of $750,000 or more during the for-profit entity's fiscal year, but does not have any single award with expenditures of $750,000 or more; the entity must determine whether any or all of the awards have common compliance requirements (
The revision reads as follows:
National Credit Union Administration (NCUA).
Final rule and Interpretive Ruling and Policy Statement 15-1.
The NCUA Board (Board) is issuing a final rule to amend Interpretive Ruling and Policy Statement (IRPS) 87-2, as amended by IRPS 03-2 and 13-1. The amended IRPS increases the asset threshold used to define the term “small entity” under the Regulatory Flexibility Act (RFA) from $50 million to $100 million and, thereby, provides transparent consideration of regulatory relief for a greater number of credit unions in future rulemakings. The final rule and IRPS also makes a technical change to NCUA's regulations in connection with procedures for developing regulations.
This rule and IRPS are effective November 23, 2015.
Kevin Tuininga, Lead Liquidations Counsel, Office of General Counsel, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428 or telephone: (703) 518-6543.
The RFA, as amended, generally requires federal agencies to determine and consider the impact of proposed and final rules on small entities. Since adopting IRPS 13-1 in 2013, the Board has defined “small entity” in this context as a federally insured credit union (FICU) with less than $50 million in assets.
On February 19, 2015, the Board issued a proposed rulemaking and IRPS with a 60-day comment period.
Congress enacted the RFA in 1980, Public Law 96-354, and amended it with the Small Business Regulatory Enforcement Fairness Act of 1996.
For an IRFA, the procedural requirements include, among other things, “a description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply,” a description of reporting, recordkeeping, and other compliance burden, and an identification of any overlapping or conflicting federal rules.
The FRFA must meet requirements similar to that of the IRFA, but must also discuss and respond to public comments and describe “the steps the agency has taken to minimize the significant economic impact on small entities . . . , including a statement of factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other
The RFA establishes terms for various subgroups that fall within the meaning of “small entity,” including “small business,” “small organization,” and “small governmental jurisdiction.”
In 1981, the Board initially defined “small entity” in IRPS 81-4 as any FICU with less than $1 million in assets.
The public comment period for the proposed rule and IRPS ended on May 4, 2015. NCUA received 16 comment letters from commenters that included credit union trade associations, state credit union leagues, federal credit unions, and a federally insured, state-chartered credit union.
More than one-third of commenters either expressed some level of satisfaction with the $100 million threshold or did not directly advocate a specific threshold higher than $100 million. Two of these commenters observed that the proposed threshold “sufficiently captures small [FICUs] that have unique challenges and particular sensitivity to even the smallest regulatory requirement.” Another stated that the increase will benefit and account for the FICUs generally facing significant challenges based on the characteristics NCUA identified in the proposal. One commenter noted that increasing the RFA threshold to $100 million is consistent with NCUA's proposed definition of the term “complex” credit union for risk-based capital purposes. This commenter also stated that $100 million seemed appropriate in comparison to the RFA threshold used for banks. One commenter praised NCUA for proposing to increase the threshold to $100 million only two years after approving an increase from $10 million to $50 million. Multiple commenters, including some that expressed satisfaction with the proposed threshold, alluded to compelling reasons to set the threshold higher than $100 million, but did not directly advocate a specific number or discuss the reasons for doing so.
Approximately half of the commenters expressed concern about the proposed $100 million asset threshold and recommended a higher threshold for the final rule. Many from this group favored the $550 million threshold set by the Small Business Administration (SBA), citing one or more of the Federal Deposit Insurance Corporation, Office of the Comptroller of the Currency, and the Federal Reserve Board as examples of regulators that use the SBA asset threshold for purposes of the RFA. Some commenters also suggested a threshold of at least $250 million, as an alternative to $550 million. One commenter suggested that $175 million would also be more appropriate than $100 million, noting that the Consumer Financial Protection Bureau uses this threshold to assemble panels in complying with its obligations under the Small Business Regulatory Enforcement Fairness Act. Another commenter suggested $300 million as the appropriate asset threshold.
Two commenters posited that, if NCUA is willing to adopt a risk-based capital rule with requirements on par with banking regulators, it should be willing to bring its RFA threshold into parity as well. One commenter maintained that even FICUs with $250 million in assets are not dominant in their field and did not present greater risk to the Insurance Fund, particularly because the RFA does not mandate specific changes to existing regulations.
One commenter argued the RFA does not require use of a bright-line asset threshold, which risks “bifurcating the industry” when used to determine eligibility for regulatory relief. This commenter also expressed concern that some FICUs over $100 million in assets but with few employees and branches will not be taken into consideration when NCUA is studying the economic impact of rules on FICUs under the $100 million threshold. A few commenters that advocated an asset threshold higher than $100 million contended that NCUA should consider the definition of “small entity” in the context of the entire group of financial institutions against which FICUs compete, including banks.
At least eight commenters expressed concerns about the capacity of NCUA's Office of Small Credit Union Initiatives (OSCUI) to serve small credit unions under an increased asset threshold. Many of these commenters suggested that NCUA should separate the eligibility threshold OSCUI uses from the asset threshold set for RFA purposes, leaving the OSCUI threshold at $50 million or adjusting it to $75 million. If NCUA increases OSCUI's eligibility threshold,
Two commenters advocated, without elaboration, that NCUA adjust the threshold annually based on an index to capture a percentage of the smallest credit unions. One commenter asked for review every two years and another advocated an annual review. Anticipating additional future increases in the RFA threshold, one commenter suggested that NCUA increase efficiency and avoid more comment periods by effecting a larger increase in the final rule.
Several commenters commented generally on excessive regulatory burden, a lack of resources and employees to cope with the burden, and the continuing loss of small FICUs. One commenter asked that NCUA explain in the preamble to the final rule the circumstances under which it might make distinctions among small FICUs. Another commenter noted the RFA classification does not convey any immediate regulatory relief to FICUs in existing rules and recommended that NCUA revisit its current regulations to consider substituting the final rule's small entity threshold for existing size standards. This commenter also criticized the use of the term “small credit union” in both the Small Credit Union Exam Program and the RFA context, indicating that using the same term in reference to different thresholds could be confusing.
The Board has carefully considered all the public comments it received in response to the proposed rule and IRPS. The final rule and IRPS and the Board's response to the public comments are discussed below.
Based on the comment letters and economic analysis of FICUs in various asset ranges, the Board maintains $100 million is the most appropriate asset threshold for the final rule and IRPS. The proposed threshold received significant support in public comments, and the factors NCUA considered in the proposal continue to support $100 million as the most suitable threshold at this time. Increasing the RFA threshold to $100 million will account for FICUs that generally face more significant challenges than their larger peers based on their relatively small asset base, membership, and economies of scale.
Increasing the threshold to levels recommended by a minority of commenters would cover up to 93 percent of FICUs and risk dilution of the RFA's special consideration for the smallest FICUs.
Finally, the RFA threshold does not make larger FICUs ineligible for regulatory relief. The Board fully intends to continue to carefully consider the impact of all of its regulations on all FICUs.
Data gathered for the period between 2001 and 2014 reflects the competitive disadvantages across multiple industry metrics for FICUs below $100 million in assets, including the following:
• Deposit growth rates;
• asset growth rates; membership growth rates;
• loan origination growth rates;
• inflation-adjusted average loan amounts;
• ratio of operating costs to assets;
• merger and liquidation trends;
• average year-to-date loan amounts;
• non-interest expenses per dollar loaned;
• average assets per full-time employee; and
• average non-interest expense per annual loan originations.
Particularly, rates of deposit growth, rates of membership growth, rates of loan origination growth, and the ratio of operating costs to assets, each discussed more fully below, exemplify differentiations between FICUs both above and below the $100 million threshold.
Smaller FICUs have consistently demonstrated an inability to grow their deposit base at a rate that keeps pace with larger FICUs. This slower growth rate makes it difficult for smaller FICUs to cover fixed costs, which are increasing over time. FICUs with growing deposits and loans are able to spread out fixed costs and incrementally reduce operating costs.
In general, deposit growth rates drop off significantly for FICUs with less than $100 million in assets. FICUs with less than $100 million in assets as of the end of the year 2000 grew their deposits by an average of 3.9 percent annually over the next 14 years. In comparison, FICUs with greater than $100 million in assets as of the end of the year 2000 grew deposits at 7.1 percent annually, on average, over the same period. On an asset-weighted basis, the industry's average deposit growth rate from 2001 to 2014 was 6.8 percent per year.
FICUs with less than $100 million in assets also had significantly slower membership growth rates than larger FICUs. On average, FICUs with less than $100 million in assets as of the end of the year 2000 had their membership shrink by 0.5 percent annually over the next 14 years. In contrast, FICUs $100 million or more in assets as of the end of the year 2000 grew their membership by 2.3 percent annually over the same period. On an asset-weighted basis, the industry's membership growth rate was 1.8 percent per year from 2001 to 2014.
FICUs with less than $100 million in assets also had significantly slower growth in loan originations than larger FICUs. On average, FICUs with less than $100 million in assets as of the end of the year 2000 grew loan originations by 3.7 percent annually over the next 14 years. In contrast, FICUs with $100 million or more in assets as of the end of the year 2000 grew their loan originations by 9.6 percent annually over the same period. On an asset-weighted basis, the industry's loan origination growth was 6.6 percent per year from 2001 to 2014.
FICUs with less than $100 million in assets also had higher annual operating expenses per unit of assets and per dollar of loan originations compared to other asset groups. On average, FICUs with less than $100 million in assets as of the end of the year 2000 had annual operating expenses equal to 4.0 percent of assets over the next 14 years. FICUs with $100 million or more in assets as of the end of the year 2000 had annual operating expenses of 3.5 percent of assets over the same period.
The impact of these differences in operating expenses can be dramatic. Between 2001 and 2014, FICUs with less than $100 million in assets as of the end of the year 2000, had operating expenses, on average, equal to 18 cents for every dollar in loan originations.
The 55 basis point difference in operating expenses between FICUs above and below the $100 million asset threshold resulted in large and persistent differences in earnings between these FICUs. The earnings gap between FICUs above and below the threshold averaged 41 basis points over the 2001 to 2014 period. To put this in perspective, during that period, 25 percent of FICUs below the $100 million asset threshold had negative earnings. Only 2.8 percent of FICUs with $100 million or more in assets had negative earnings over the same period.
FICUs with persistently weak or negative earnings are more likely to go out of business via failure or merger. Despite representing 83 percent of all FICUs, FICUs with less than $100 million in assets experienced 93 percent of mergers and liquidations since 2004. The disappearance of these FICUs threatens to deprive the credit union industry of a critical constituency.
Although the number of mergers and failures for FICUs below $100 million is disproportionately high, these FICUs do not represent a correspondingly high risk exposure to the Insurance Fund. For FICUs with assets of $50 million to less than $100 million (those which this final rule and IRPS include in RFA coverage), losses have historically been relatively small. Nine FICUs between $50 million and $100 million in inflation-adjusted assets failed between the first quarter of 2001 and fourth quarter of 2014. Resulting losses totaled less than $56 million. In contrast, losses for FICUs between $100 million and $250 million were $379 million, more than six times that amount over the same period. FICUs between $100 million and $550 million accounted for $790 million in inflation-adjusted losses.
Rather than expanding the RFA threshold to $550 million or $250 million, which would include FICUs responsible for significantly more losses and risk, the Board believes the $100 million threshold represents a reasonable additional share for RFA coverage. FICUs with assets of $50 million to less than $100 million hold 4.5 percent of system assets, bringing the total system assets within RFA coverage to 10 percent. To the extent the increase to $100 million results in more FICU exemptions from rules governing safety and soundness, it will not present material risk to the Insurance Fund.
For additional background, the table below shows the differentiation of the characteristics between the final rule's $100 million threshold and the expanded RFA coverage thresholds that also received support from some commenters. Unless otherwise indicated, the table includes cumulative data from 2001 to 2014.
The Board's task under the RFA is to designate as “small” a subset of institutions to which its regulations apply, rather than comparing FICUs to the array of competing institutions that are not subject to NCUA's regulations.
Although a bright line asset threshold arguably bifurcates groups of FICUs for purposes of the RFA, it also avoids diluting the pool of FICUs for which the RFA requires special consideration. The Board believes a threshold significantly higher than $100 million would divert focus from the FICUs that are most in need of the RFA process. Further, the $100 million threshold does not preclude the Board from considering regulatory impacts on larger FICUs. The Board fully intends to continue reviewing the impact of all of its regulations on all FICUs.
The RFA requires a formal, published, analytical process during promulgation of a regulation whenever such regulation would impose significant economic burdens on a substantial number of small FICUs. It subjects this published consideration to the benefit of public comments. It does not, however, impose a substantive limit on the conclusions the Board may draw based on its analyses. On the contrary, the Board is still able to make distinctions in future rulemakings above or below the threshold designated in this final rule and IRPS. The Board can make these distinctions based on its RFA analysis and its broader consideration of regulatory impacts across all FICUs.
The Board's rule governing liquidity and contingency funding demonstrates this possibility by imposing differing compliance requirements on three asset tiers of FICUs.
As the liquidity rule also demonstrates, asset thresholds remain a principal comparative tool used to determine a FICU's relative size. As such, an asset threshold, rather than an employee- or branch-based demarcation, continues to be the most transparent and administratively feasible as a framework for its RFA analyses. An asset threshold is consistent with size standards that appear in the FCU Act and other NCUA regulations.
With respect to review, the Board continues to believe that the three-year period the proposed rule retained from 2013 provides a reasonable time within which to discern and interpret new trends in relevant data. Further, it is consistent with the longstanding review period NCUA uses for all its regulations. Rather than an annual or biannual adjustment, the three-year cycle avoids the uncertainty of continuous fluctuation that more frequent adjustments could create. Further, the scheduled opportunity to study trends and receive comments provides an advantage over automatically indexed adjustments.
As discussed in the proposal, the Board will separately consider whether to align thresholds in existing rules, such as those applying interest rate risk and liquidity requirements, with the RFA threshold. The NCUA's regular three-year review cycle provides appropriate opportunities for these considerations. Individual reviews will facilitate transparent considerations of unique risks and compliance burdens specific to those rules, rather than encouraging a one-size-fits-all approach.
By increasing the RFA threshold to $100 million in assets, the Board recognizes its role in ensuring additional scrutiny of regulatory costs for FICUs under that threshold. The increase requires the Board to engage in the RFA's public analytical process for the benefit of considerably more FICUs, whenever a regulation would impose significant economic burdens on a substantial number of them. Further, future rules are more likely to invoke an RFA analysis because of the greater number of FICUs for which the Board must consider substantial economic impacts.
The $100 million threshold will cause NCUA to give special consideration to an additional 733 small FICUs. The total number of FICUs covered by the RFA will increase to approximately 4,690. This represents 75.6 percent of FICUs, which hold 10 percent of FICU assets. When an IRFA or FRFA is triggered, these additional FICUs will have the benefit of an opportunity to comment on a transparent and published analysis of impacts and alternatives. For all of these FICUs, future regulations will be thoroughly evaluated to determine whether an exemption or other separate consideration should apply. The $100 million threshold ensures that regulatory relief will be consistently and robustly considered for significantly more FICUs.
This final rule and IRPS retains the three-year review cycle that the Board adopted in 2013. The review period gives FICUs a regular opportunity to provide input on the Board's RFA threshold. Finally, the rule references IRPS 15-1 in § 791.8(a) of NCUA's regulations governing regulatory procedures, replacing the reference to IRPS 13-1.
For any final rule it adopts, the RFA requires NCUA to prepare a FRFA that, among other things, describes the steps the agency has taken to minimize economic impact on small entities (currently defined by NCUA as FICUs with under $50 million in assets), unless the NCUA certifies that the final rule will not have a significant economic impact on a substantial number of small entities. In this case, the final rule and IRPS expands the number of FICUs defined as small entities under the RFA. It, therefore, will not have a significant economic impact on a substantial number of FICUs under $50 million in assets that are already covered by the RFA.
With respect to additional FICUs that will now be covered, the principal component of the final rule and IRPS will provide prospective relief in the form of special and more robust consideration of FICUs' ability to handle compliance burdens. This prospective relief is not yet quantifiable. Further, the final rule and IRPS can only reduce, rather than increase, compliance burdens for these FICUs and, therefore, will not raise costs in a manner that requires a FRFA. Accordingly, NCUA has determined and certifies that the final rule and IRPS will not have a significant economic impact on a substantial number of small entities. No FRFA is required.
The Paperwork Reduction Act of 1995 (PRA) applies to rulemakings in which an agency creates a new paperwork burden on regulated entities or modifies an existing burden.
Executive Order 13132 encourages independent regulatory agencies to consider the impact of their actions on state and local interests. NCUA, an independent regulatory agency as defined in 44 U.S.C. 3502(5), voluntarily complies with the executive order to adhere to fundamental federalism principles. This final rule and IRPS will not have 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. NCUA has determined that this final rule and IRPS does not constitute a policy that has federalism implications for purposes of the executive order.
NCUA has determined that this final rule and IRPS will not affect family well-being within the meaning of Section 654 of the Treasury and General Government Appropriations Act, 1999, Public Law 105-277, 112 Stat. 2681 (1998).
Administrative practice and procedure, Credit unions, Sunshine Act.
For the reasons discussed above, the Board amends IRPS 87-2 (as amended by IRPS 03-2 and IRPS 13-1) by revising the second sentence of paragraph 2 of Section II and replacing the last two sentences of paragraph 2 of Section II to read as follows:
2. * * * NCUA will designate federally insured credit unions with less than $100 million in assets as small entities. * * * Every three years, the NCUA Board will review and consider adjusting the asset threshold it uses to define small entities for purposes of analyzing whether a regulation will have a significant economic impact on a substantial number of small entities.
For the reasons discussed above, the Board amends 12 CFR part 791 as follows:
12 U.S.C. 1766, 1789 and 5 U.S.C 552b.
(a) NCUA's procedures for developing regulations are governed by the Administrative Procedure Act (5 U.S.C. 551
Federal Aviation Administration (FAA), DOT.
Final rule, technical amendment.
This action amends geographic coordinates of Portland International Airport, Portland, OR, under Class C airspace, due to recent surveys of the airport. This action also updates the name and geographic coordinates of satellite airports referenced in the Portland description. This action does not change the boundaries or operating requirements of the airspace.
Effective date 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points and subsequent amendments can be viewed online at
The order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jason Stahl, Airspace Policy and Regulations Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it updates the geographic coordinates of Portland International Airport, Portland, OR.
During a review of the airspace for Portland International Airport, Portland, OR, the FAA identified that the airport's geographic coordinates were incorrect. This action updates the geographic coordinates to coincide with the FAA's aeronautical database for the respective Class C airspace area. Additionally, this action updates the names and geographic coordinates of referenced airports within the Portland International Airport's Class C airspace description.
Class C airspace designations are published in paragraph 4000 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class C airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends Class C airspace at Portland International Airport, Portland, OR, by adjusting the geographic coordinates to reflect recent survey data. This rule also adjusts the Evergreen North-South Airpark, Vancouver, WA, formerly Evergreen Airport, and Pearson Field, Vancouver, WA, formerly Pearson Airpark.
This is an administrative change and does not affect the boundaries, altitudes, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 4,000 feet MSL within a 5-mile radius of Portland International Airport, excluding that airspace within a 1-mile radius of Evergreen North-South Airpark and that airspace from the 003° bearing from Evergreen North-South Airpark clockwise to the 105° bearing from Evergreen North-South Airpark, and excluding that airspace up to but not including 1,100 feet MSL in an area bounded by a line beginning at the point where the 019° bearing from Pearson Field intersects the 5-mile arc from Portland International Airport extending southeast to a point 1
Federal Aviation Administration (FAA), DOT.
Final rule, technical amendment.
This action amends the name and geographic coordinates of the Burbank-Glendale-Pasadena Airport at Burbank, CA. The Burbank-Glendale-Pasadena Airport has been renamed Bob Hope Airport and geographic coordinates are updated to reflect recent surveys of the airport.
Effective date 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jason Stahl, Airspace Policy and Regulations Group, Office of Airspace Services, Federal Aviation
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the air traffic service route structure in the north central United States to maintain the efficient flow of air traffic.
During a biennial review of the Burbank-Glendale-Pasadena Airport's airspace the FAA identified that the airport's name had been changed to Bob Hope Airport and the geographic coordinates were incorrect. This action updates the name and geographic coordinates to coincide with the FAA's aeronautical database for the respective Class C airspace area.
Class C airspace designations are published in paragraph 4000 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class C airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 amends the Class C airspace within which all aircraft operators are subject to operating rules and equipment requirements of Part 91 of the Federal Aviation Regulations (see 14 CFR 91.130). The name of the Burbank-Glendale-Pasadena Airport is changed to Bob Hope Airport and the geographic coordinates are updated. This rule is meant to insure pilots do not confuse instructions provided to them by Air Traffic Control.
This is an administrative change and does not affect the boundaries, altitudes, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) is unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 4,800 feet MSL within a 5-mile radius of Bob Hope Airport excluding that airspace below 3,000 feet MSL within a 1.8-mile radius of Whiteman Airport, and excluding that airspace below 3,500 feet MSL east of a direct line from a point 5 miles on the 004° bearing from the airport to a point 5 miles on the 090° bearing from the airport; and that airspace extending upward from 3,000 feet MSL to and including 4,800 feet MSL within a 10-mile radius of Bob Hope Airport from the 104° bearing clockwise to the 004° bearing from the airport excluding that airspace south of the north boundary of the Los Angeles, CA, Class B airspace area, and excluding that airspace beyond an 8-mile radius north and east of the 294° bearing, and excluding that airspace beyond 5 miles north and east of a line from a point 8 miles on the 343° bearing from the airport to a point 5 miles on the 004° bearing from the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action removes jet route J-513 in the north central United States. The FAA is taking this action to reflect and accommodate route changes made in Canadian airspace as part of Canada's Windsor-Toronto-Montreal (WTM) airspace redesign project.
Effective date 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA, Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Colby Abbott, Airspace Policy and Regulations Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the air traffic service route structure in the north central United States to maintain the efficient flow of air traffic.
In 1969, the FAA published in the
In 1970, the FAA published in the
In November 2014, Canada removed the portions of J-513 in Canadian airspace as part of their WTM airspace redesign program; however, corresponding action for the portion of J-513 in United States airspace was not accomplished by the FAA. This disconnect led to the charted depiction of J-513 being removed from the Instrument Flight Rules (IFR) high altitude enroute charts, but the legal description remained in FAA Order 7400.9 and the National Airspace System Repository (NASR).
Since the basis for which J-513 was originally established no longer exists, the FAA is removing the route from 14 CFR part 71 and FAA Order 7400.9. Subsequently, the FAA will remove the route from the NASR database.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
The FAA is amending Title 14 of the Code of Federal Regulations (14 CFR) part 71 by removing jet route J-513. This action responds to the route changes made in Canadian airspace as part of Canada's WTM airspace redesign project. This action removes a route that was put in place in accordance with a request from the Canadian Department of Transport, which traversed through Canadian and U.S. airspace. Canada has subsequently removed this route and the route no longer exists on aeronautical charts. Therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
Jet routes are published in paragraph 2004 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The jet route listed in this document will be subsequently removed in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a. This airspace action consists of modifying an airway and it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace extending upward from 700 feet above the surface at Blake Field Airport, Delta CO, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures developed for the airport. This action enhances the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA, 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Blake Field Airport, Delta CO.
On June 22, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Blake Field Airport, Delta, CO. Controlled airspace is established within a 3.8-mile radius of Blake Field Airport, with segments extending from the 4-mile radius to 7.5 miles northeast, and 12 miles southwest of the airport. Development of new RNAV (GPS) standard instrument approach procedures has made this action necessary for continued safety and management of IFR operations at the airport.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within 3.8-mile radius of Blake Field Airport, and that airspace 2.0 miles northwest and 2.5 miles southeast of the 227° bearing from the airport extending from the 3.8-mile radius to 12 miles southwest of the airport, and that airspace within a 4.0-mile radius of point in space coordinates at lat. 38°47′43″N., long. 107°58′46″ W., from a point where the 4.0-mile radius of the point in space intersects the 3.8 mile radius of the airport; thence clockwise along the 4.0-mile radius of the point in space to where the Blake Field Airport 48° bearing intersects the 4.0-mile radius; thence south to lat. 38°47′34″ N., long. 107°57′03″ W.; thence west to where the Blake Field Airport 79° bearing intersects the 3.8 mile radius of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at the Newberry VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME), Newberry, MI, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Minneapolis Air Route Traffic Control Center (ARTCC). This action enhances the safety and efficiency of aircraft operations within the National Airspace System (NAS). A minor change in the regulatory text is made to align the new Class E airspace with Minneapolis ARTCC's airspace.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Raul Garza, Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-868-2927.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106(f), describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at the Newberry VOR/DME, Newberry, MI.
On June 24, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 1,200 feet above the surface at the Newberry VOR/DME navigation aid, Newberry, MI, to contain aircraft while in IFR conditions under control of Minneapolis ARTCC by safely vectoring aircraft from en route airspace to terminal areas. Controlled airspace is needed for the safety and management of IFR operations within the confines of Minneapolis ARTCC airspace.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 1,200 feet above the surface within an area bounded by lat. 46°58′41″ N., long. 086°25′25″ W.; to lat. 45°44′17″ N., long. 086°27′14″ W.; to lat. 45°43′49″ N., long. 085°20′28″ W.; to lat. 46°29′24″ N., long. 084°50′43″ W.; to lat. 46°48′24″ N., long. 085°51′50″ W., to lat. 46°58′30″ N., long. 086°25′01″ W., thence to the point of beginning, excluding that airspace within Federal airways and within Canadian airspace.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace at Converse County Airport, Douglas, WY, to accommodate new Standard Instrument Approach Procedures (SIAPs) at Converse County Airport, and addresses an inaccuracy identified by FAA Airspace Policy and Support that V-19, which is no longer located in the area, is used in the legal description of the airspace. The geographic coordinates of the airport also are adjusted. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Converse County Airport, Douglas, WY.
On June 23, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E airspace extending upward from 700 feet above the surface at Converse County Airport, Douglas, WY. New Standard Instrument Approach Procedures are necessary for the safety and management of IFR operations at the airport. Class E airspace extending upward from 700 feet above the surface is modified to within a 4-mile radius of Converse County Airport, with a segment extending from the 4-mile radius to the 7-mile radius east to southwest of the airport, and a segment extending from the 4-mile radius to 7 miles northwest of the airport. The geographic coordinates of the airport are updated to coincide with the FAA's aeronautical database. The lateral boundary for that airspace extending from 1,200 feet above the surface is defined utilizing latitudinal and longitudinal reference points instead of Federal airway V-19, and does not change the lateral boundaries or operating requirements of the 1,200 foot airspace. This action enhances the safety and management of controlled airspace within the NAS.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 4-mile radius of Converse County Airport beginning at lat. 42°50′30″ N., long. 105°27′11″ W., clockwise along the 4-mile radius of the airport to the 065° bearing from the airport, and that airspace within a 7-mile radius of the airport from the 065° bearing from the airport clockwise to the 226° bearing, thence northeast to lat. 42°48′41″ N., long. 105°28′28″ W., and that airspace 1 mile either side of the 297° bearing from airport extending from the 4-mile radius to 7 miles northwest of the airport, thence to the point of beginning That airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 43°05′27″ N., long. 106°16′37″ W.; to lat. 43°35′23″ N., long. 104°30′02″ W.; to lat. 43°00′00″ N., long. 104°30′02″ W.; to lat. 43°00′00″ N., long. 104°03′16″ W.; to lat. 41°53′15″ N., long. 104°03′15″ W.; to lat. 41°51′54″ N., long. 105°17′18″ W.; thence to the point of beginning.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E airspace at the Iron Mountain VHF Omni-Directional Radio Range/Distance Measuring Equipment (VOR/DME), Iron Mountain, MI, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Minneapolis Air Route Traffic Control Center (ARTCC). This action enhances the safety and efficiency of aircraft operations within the National Airspace System (NAS). A minor change in the regulatory text is made to align the new Class E airspace with Minneapolis ARTCC's airspace.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Raul Garza, Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-868-2927.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 (f), describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at the Iron Mountain VOR/DME, Iron Mountain, MI.
On June 24, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace extending upward from 1,200 feet above the surface at the Iron Mountain VOR/DME navigation aid, Iron Mountain, MI, to contain aircraft while in IFR conditions under control of Minneapolis ARTCC by safely vectoring aircraft from en route airspace to terminal areas. Controlled airspace is needed for the safety and management of IFR operations within the confines of Minneapolis ARTCC airspace.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 1,200 feet above the surface within an area bounded by lat. 47°50′36″ N., long. 089°41′25″ W.; to lat. 47°54′30″ N., long. 088°46′30″ W.; thence clockwise via the arc of a 35-mile radius centered on the McKay TACAN to lat. 47°50′36″ N., long. 089°41′25″ W.; to lat. 47°05′00″ N., long. 087°00′00″ W.; to lat. 47°01′28″ N., long. 086°59′15″ W.; to lat. 46°53′22″ N., long. 088°21′39″ W.; to Iron Mountain VOR/DME; to Ironwood VORTAC; to lat. 46°51′42″ N., long. 090°20′18″ W.; thence to the point of beginning, excluding that airspace within Federal airways and within Canadian airspace.
Federal Energy Regulatory Commission, DOE.
Final rule.
Pursuant to the Federal Power Act, the Commission approves a revised Reliability Standard, PRC-005-4 (Protection System, Automatic Reclosing and Sudden Pressure Relaying Maintenance), developed and submitted by the North American Electric Reliability Corporation (NERC). In addition, the Commission approves one new definition and four revised definitions referenced in the proposed Reliability Standard, as well as the assigned violation risk factors and violation severity levels, and the associated implementation plan. Consistent with Order No. 758, the proposed Reliability Standard requires applicable entities to test and maintain certain sudden pressure relays as part of a protection system maintenance program.
This rule will become effective November 23, 2015.
1. Pursuant to section 215 of the Federal Power Act (FPA),
2. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval.
3. In 2007, the Commission approved an initial set of Reliability Standards submitted by NERC, including initial versions of four protection system and load-shedding-related maintenance standards: PRC-005-1, PRC-008-0, PRC-011-0, and PRC-017-0.
4. In February 2012, the Commission issued Order No. 758 in response to NERC's request for approval of its interpretation of Requirement R1 of the then-current version of the protection system maintenance standard, Reliability Standard PRC-005-1. In that order, the Commission accepted NERC's proposed interpretation of Requirement R1, which provided guidance on the types of protection system equipment to which the Reliability Standard did or did not apply. In reviewing NERC's interpretation, however, the Commission raised several concerns about potential gaps in the coverage of PRC-005-1, including a concern that the standard as written may not include all components that serve in some protective capacity.
5. On December 18, 2014, NERC submitted a petition seeking approval of proposed Reliability Standard PRC-005-4, which would add to the applicability of Reliability Standard PRC-005-3 those sudden pressure relays that NERC has identified as having a potential effect on the reliable operation of the Bulk-Power System.
6. NERC stated that sudden pressure relays are “designed to quickly detect faults on the Bulk-Power System transformer equipment that may remain undetected by other Protection Systems, and can operate to limit any potential damage on the equipment.”
7. NERC explained that, consistent with Order No. 758, NERC's System Protection and Control Subcommittee (SPCS) performed a technical study “to determine which devices that respond to non-electrical quantities should be addressed within PRC-005 identified devices.”
8. NERC also explained that the SPCS developed a Supplemental Report in response to comments and questions from the Commission staff about its initial recommendations. These comments and questions focused on whether PRC-005 should include turbine generator vibration monitors and circuit breaker arc extinguishing systems.
9. NERC stated that the standard drafting team that was tasked with developing the modifications to PRC-005 in response to Order No. 758 adopted the SPCS Report's recommendations, both as to the scope of additional relays included and as to the required minimum maintenance activities and maximum maintenance intervals for these relays.
10. NERC maintained in its petition that Reliability Standard PRC-005-4 will enhance reliability by extending the coverage of an applicable entity's protection system maintenance program to include sudden pressure relaying components. NERC further maintained that the proposed standard satisfies the Commission's concerns as raised in Order No. 758 “by including . . . sudden pressure relays that detect [a] fault on Bulk-Power System transformer equipment and trip in response to fault conditions, as recommended by the SPCS Report.”
11. NERC explained that Reliability Standard PRC-005-4 has been modified to include “Sudden Pressure Relaying” devices (newly-defined) as part of an applicable entity's protection system maintenance program.
12. NERC's proposed implementation plan for PRC-005-4 incorporates the phased-in implementation period approved for PRC-005-2, which has a twelve-year phase-in period, and adds compliance dates for the new requirements for applicable sudden pressure relays. NERC asked that PRC-005-4 become effective the first day of the first calendar quarter following Commission approval. Reliability Standard PRC-005-3 would be retired immediately prior to PRC-005-4 becoming effective.
13. NERC explained that the evidence retention period for PRC-005-4 is shorter than that required in the preceding versions of the standard, as it requires entities to maintain records for one maintenance cycle, rather than two cycles, if the interval of the maintenance activity is longer than the audit cycle. For maintenance activities where the interval is shorter than the audit cycle, documentation is to be retained for all maintenance activities since the previous audit.
14. Finally, NERC stated that the violation risk factors proposed in PRC-005-4 track those in previous versions of the standard, and that the violation severity levels have been revised to include the additional component (sudden pressure relays) in a manner consistent with the approach taken for PRC-005-3.
15. On April 22, 2015, the Commission issued a Notice of Proposed Rulemaking (NOPR) proposing to approve Reliability Standard PRC-005-4, along with the new definition of Sudden Pressure Relaying, the four revised definitions referenced in the standard, and the assigned violation risk factors and violation severity levels.
16. Comments on the NOPR were filed by NERC, the Edison Electric Institute (EEI), the National Rural Electric Cooperative Association (NRECA), Tennessee Valley Authority (TVA), Southern Company Services, Inc. (Southern Companies), and Eric S. Morris. Dominion Resources Services, Inc. filed a motion to intervene in this rulemaking, but did not file substantive comments. Ameren submitted late-filed comments on August 31, 2015.
17. Pursuant to section 215(d)(2) of the FPA, the Commission approves Reliability Standard PRC-005-4, as well as the new definition of Sudden Pressure Relaying, the four revised definitions referenced in the proposed standard, the assigned violation risk factors and violation severity levels, and the proposed implementation plan (as discussed further below). We find that Reliability Standard PRC-005-4 will enhance reliability by requiring the inclusion of certain sudden pressure relays utilized in a trip application as part of the protection system maintenance program, and by requiring entities to undertake minimum required maintenance activities at maximum defined maintenance intervals. Moreover, we note that all of the commenters that addressed the issue support approval of PRC-005-4, as well as the associated definitions and violation risk factors and violation severity levels.
18. Below we discuss the following matters: (1) continued assessment of reliability gaps associated with non-electrical sensing devices; and (2) alignment of implementation plans with other versions of PRC-005.
19. The Commission indicated in the NOPR that it continued to have some concern “that the misoperation of other types of non-electrical sensing relays or devices, such as pressure sensing devices associated with air blast or SF6 circuit breaker arc extinguishing systems, could affect the reliable operation of the Bulk-Power System.”
20. NERC agrees with the Commission's proposal to continue to work with Commission staff “to explore misoperations of particular types of non-electrical sensing relays or devices . . . to assess the impact of this equipment on the reliable operation of the Bulk-Power System.”
21. With respect to the Commission's expressed concern regarding density switches or sensors, EEI notes that the SPCS report found no operating experience in which misoperation of such a device contributed to a cascading event, and further found that “density switches typically respond to an abnormal equipment condition and take[] action to protect the equipment from excessive loss of life rather than for the purpose of initiating fault clearing or mitigating an abnormal system condition to support reliable operation of the Bulk-Power System.”
22. As proposed in the NOPR, we approve Reliability Standard PRC-005-4 without any directives or modifications. As we stated in the NOPR, we find the proposed addition to the standard of those sudden pressure relays identified by the SPCS Report as potentially having an impact on the reliability of the Bulk-Power System sufficient to address the concerns we raised in Order No. 758 at this time.
23. We decline to make any further findings, as EEI suggests, as to the comprehensiveness of the SPCS Report or otherwise take a position on whether a maintenance reliability gap currently exists with respect to non-electrical sensing devices. Instead, we acknowledge NERC's agreement to continue to work with Commission staff to explore and assess the misoperations of particular types of non-electrical sensing relays or devices in relation to the reliable operation of the Bulk-Power System. As with any aspect of NERC's and the Commission's reliability oversight obligations, we expect that when reliability gaps are identified, NERC would seek to address each gap through modification of a Reliability Standard or other appropriate means.
24. In the NOPR, the Commission proposed to approve NERC's implementation plan for PRC-005-4, which incorporates the phased-in implementation period approved for PRC-005-2, with additional compliance dates for applicable sudden pressure relays. The Commission also proposed
25. NRECA, Southern Companies, TVA, and Ameren, who otherwise support approval of PRC-005-4, ask the Commission to consider rejecting NERC's proposed implementation plan for the revised standard, and to instead consider postponing the start dates for this and earlier versions of the standard. These commenters explain that several versions of PRC-005 have recently been approved or are under development, and that, as a result, “implementation of the various versions of PRC-005 will burden the industry in the continued need to modify associated maintenance and testing programs.”
26. NRECA asks the Commission to consider two proposed approaches to allow for the alignment of implementation schedules for the revised version of PRC-005:
1. Postpone implementation of PRC-005-3, PRC-005-3(i), PRC-005-4 and PRC-005-5 to coincide with the beginning of implementation of PRC-005-6.
2. Defer action on PRC-005-3(i), PRC-005-3(ii), PRC-005-4 and PRC-005-5 to be considered concurrently with PRC-005-6.
Both TVA and Southern Companies support NRECA's proposal to postpone implementation of all yet-to-be implemented versions of PRC-005 to align with the beginning of implementation of PRC-005-6 (
27. We decline, without prejudice, to postpone the proposed start date for implementation of PRC-005-4, or to alter the already-approved implementation plans and start dates for PRC-005-3. While we are sympathetic to commenters' concerns about the several versions of PRC-005 that have been or may be going into effect in a relatively short period, we are reluctant to consider postponing implementation of an approved standard (PRC-005-3) or deferring consideration of an otherwise beneficial standard (PRC-005-4) based on prospective versions of the standard that have yet to be filed. Thus, while we are aware that additional versions of the standard are being developed,
28. The following collection of information contained in this Final Rule is subject to review by the Office of Management and Budget (OMB) under Section 3507(d) of the Paperwork Reduction Act of 1995 (PRA).
29. The Commission solicited comments on the need for and purpose of the information contained in Reliability Standard PRC-005-4, including whether the information will have practical utility, the accuracy of the burden estimates, ways to enhance the quality, utility, and clarity of the information to be collected or retained, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques. The Commission received no comments regarding the need for the information collection or the burden estimates associated with PRC-005-4 as described in the Notice of Proposed Rulemaking.
30. The Final Rule approves Reliability Standard PRC-005-4, which will replace PRC-005-3 (Protection System and Automatic Reclosing Maintenance). The Reliability Standard expands the existing standard to cover sudden pressure relays that meet certain criteria, thereby imposing mandatory minimum maintenance activities and maximum maintenance intervals for the applicable relays. Because the specific requirements were designed to reflect common industry practice, entities are not expected to experience a meaningful change in actual maintenance and documentation practices. However, each applicable entity will have to perform a one-time review of sudden pressure relays that detect rapid changes in gas pressure, oil pressure, or oil flow that are indicative of faults within transformer equipment, and, if it has applicable sudden pressure relay devices, review current maintenance programs to ensure that they meet the requirements of proposed standard PRC-005-4. Accordingly, all additional information collection costs are expected to be limited to the first year of implementation of the revised standard.
31. Reliability Standard PRC-005-4 reduces the evidence retention requirements approved in previously-approved versions of the standard, and now requires entities to maintain documentation of maintenance activities for only one maintenance cycle (a maximum of twelve years) if the maintenance interval is longer than the audit cycle. For maintenance activities where the interval is shorter than the audit cycle, documentation is to be retained for all maintenance activities since the previous audit. While the potential data retention requirement exceeds the three-year period that is routinely allowed for regulations requiring record retention under the OMB regulations implementing the PRA,
32.
33. Our estimate below assumes that the number of unique applicable entities (distribution providers, generator owners and transmission owners, or a combination of those) in the United States is approximately 1,287
34.
35. Interested persons may obtain information on the reporting requirements by contacting the Federal Energy Regulatory Commission, Office of the Executive Director, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, email:
36. Comments concerning the information collections approved in this Final Rule and the associated burden estimates should be sent to the Commission in this docket and may also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs [Attention: Desk Officer for the Federal Energy Regulatory Commission]. For security reasons, comments should be sent by email to OMB at the following email address:
37. The Regulatory Flexibility Act of 1980 (RFA)
38. On average, each small entity affected may have a one-time cost of $523, representing a one-time review of the program for each entity, consisting of 8 man-hours at $65.34/hour, as explained above in the information collection statement. We do not consider this cost to be a significant economic impact for small entities. Accordingly, the Commission certifies that Reliability Standard PRC-005-4 will not have a significant economic impact on a substantial number of small entities. Accordingly, no regulatory flexibility analysis is required.
39. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
40. In addition to publishing the full text of this document in the
41. From the Commission's home page on the internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number of this document excluding the last three digits in the docket number field.
42. User assistance is available for eLibrary and the Commission's Web site during normal business hours from the Commission's online support at 202-502-6652 (toll free at 1-866-208-3676) or email at
By the Commission.
Food and Drug Administration, HHS.
Final rule.
In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.
This rule is effective October 26, 2015.
Gerie Voss or Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373;
This final rule will allow certain classes of actions on tobacco product marketing applications to be excluded from the requirements to prepare an environmental assessment (EA) or an environmental impact statement (EIS). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act (Pub. L. 111-31).
FDA is issuing this final rule under NEPA and CEQ regulations (42 U.S.C. 4332(2); 40 CFR parts 1500 to 1508) requiring FDA to assess, as an integral part of its decisionmaking process, the environmental impacts of any proposed Federal action to ascertain the environmental consequences of that action on the quality of the human environment and to ensure that the interested and affected public is appropriately informed. FDA regulations governing its responsibilities under NEPA are codified at part 25 (21 CFR part 25), and CEQ regulations are codified at 40 CFR parts 1500 to 1508.
This final rule applies to certain classes of tobacco product-related actions including: (1) Issuance of an order finding a tobacco product substantially equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 387j(a)(2)(B)); (2) issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the FD&C Act, denial of a request for an exemption under 21 CFR part 1107 (part 1107) from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(c) of the FD&C Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the FD&C Act (21 U.S.C. 387k) that a modified risk tobacco product (MRTP) may not be introduced or delivered for introduction into interstate commerce; (3) rescission (order withdrawing an order) or temporary suspension of an order authorizing the marketing of a new tobacco product under section 910 of the FD&C Act; (4) rescission of an order authorizing the marketing of a MRTP under section 911 of the FD&C Act; and (5) rescission of an order granting an exemption request under § 1107.1 (21 CFR 1107.1).
This final rule provides that certain classes of actions are categorically excluded from the requirement to prepare an EA or EIS unless extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment. The rule also amends FDA's NEPA implementing regulations to include tobacco products in sections dealing with statements about disclosure regarding certain FDA actions and preparation of an EIS.
NEPA and CEQ regulations require each Federal Agency to assess, as an integral part of its decisionmaking process, the environmental impacts of any proposed Federal action to ascertain the environmental consequences of that action on the quality of the human environment and to ensure that the interested and affected public is appropriately informed (42 U.S.C. 4332(2); 40 CFR 1506.6). CEQ is responsible for CEQ regulations and for overseeing Federal efforts to comply with NEPA. Both FDA and CEQ have issued regulations governing Agency obligations and responsibilities under NEPA. FDA regulations are codified at part 25 and CEQ regulations are codified at 40 CFR parts 1500 to 1508.
CEQ regulations, which are binding on all Federal Agencies, establish
FDA regulations state that for major Federal actions that may “significantly affect the quality of the human environment,” FDA must prepare an EIS (§ 25.22 (21 CFR 25.22); see also 40 CFR 1501.4). The term “significantly,” as used in NEPA, requires considerations of both “context” (
Categorically excluded actions refer to a category of actions that have been found not to individually or cumulatively have a significant effect on the quality of the human environment and which do not normally require the preparation of an EA or EIS (40 CFR 1508.4). However, as required under § 25.21 and 40 CFR 1508.4, FDA will require preparation of at least an EA for any specific action that normally would be excluded if extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment.
If a submitter elects to request a categorical exclusion for a proposed action, a claim of categorical exclusion must be submitted in accordance with § 25.15. Section 25.15 requires that the claim of categorical exclusion include: (1) A statement of compliance with the categorical exclusion criteria and (2) a statement that, to the submitter's knowledge, no extraordinary circumstances exist.
In November 2010, CEQ issued a final guidance on categorical exclusions including the process Federal Agencies should use to establish new categorical exclusions. The guidance states that Agencies can establish new categorical exclusions to reduce paperwork and delay where the Agency has developed a record illustrating that the proposed categorical exclusion covers a category of action that, on the basis of past experience, does not normally have the potential to cause significant environmental effects (Ref. 1 at pp. 2 and 16; 40 CFR 1508.4). In addition, when Agencies acquire new responsibilities through legislation or administrative restructuring, they should propose new categorical exclusions after they, or other Agencies, gain sufficient experience with the new activities to make a reasoned determination that any resulting environmental impacts are not significant (Ref. 1 at p. 18).
FDA is issuing new categorical exclusions in accordance with NEPA, FDA, and CEQ regulations, and the CEQ November 2010 categorical exclusion guidance. In the
The final rule is issued under 42 U.S.C. 4332(2) and 40 CFR 1507.3, which requires FDA to assess, as an integral part of its decisionmaking process, the environmental impacts of any proposed Federal action to ascertain the environmental consequences of that action on the quality of the human environment and to ensure that the interested and affected public is appropriately informed (42 U.S.C. 4332(2); 40 CFR 1506.6).
FDA considered all of the comments it received regarding the proposed rule and is finalizing it with three changes. We have changed the text of § 25.20(o) in the final rule to clarify that granting a request for an exemption under part 1107 from the requirement of demonstrating substantial equivalence normally requires the preparation of an EA, unless it is subject to a categorical exclusion. Similarly, we have changed the text of § 25.35(b) to clarify that denial of a request for an exemption under part 1107 from the requirement of demonstrating substantial equivalence is categorically excluded and, therefore, normally does not require the preparation of an EA or an EIS. We have also made a technical change by replacing the term “ordinarily” with “normally” in §§ 25.20 and 25.35 to conform with 40 CFR 1508.4. The Agency considers these terms, as used in these regulations, to be synonymous. FDA will continue to evaluate the need for this conforming amendment to other FDA regulations in part 25 as the FDA regulations are updated.
In addition, § 25.20(o) in the final rule replaces proposed § 25.20(p) (Issuance of an order finding a tobacco product substantially equivalent under the FD&C Act, unless categorically excluded under § 25.35) and§ 25.20(p) replaces § 25.20(q) (Issuance of an order authorizing marketing of a new tobacco product under section 910 of the FD&C Act or an order authorizing marketing of a modified risk tobacco product under section 911 of the FD&C Act, unless categorically excluded under § 25.35).
The Agency has prepared EAs for many Agency-initiated actions and has reviewed hundreds of EAs for a variety of industry requests for Agency action on foods, drugs, and medical devices for human consumption and use, and foods and drugs given to animals. In accordance with § 25.40(a), these EAs have focused on the potential environmental effects related to the use and disposal from use of FDA-regulated articles. Based on FDA's experience reviewing EAs for actions involving foods, drugs, and medical devices for human consumption and use, and food and drugs given to animals, and its evaluation and knowledge of other relevant environmental science, FDA has determined that certain classes of actions related to tobacco products normally do not cause significant environmental effects and, therefore, should be added to the list of actions that are excluded from the requirement to prepare an EA or an EIS. In addition, FDA has gained sufficient experience from its responsibilities under the Tobacco Control Act to determine that certain actions on tobacco-related applications do not result in significant environmental impacts to the quality of the human environment. Accordingly, FDA is adding several new categorical exclusions for tobacco product-related actions.
With this final rule, FDA is adding the following classes of tobacco product-related actions that qualify for categorical exclusions: (1) Issuance of an order finding a tobacco product substantially equivalent to a tobacco
FDA received 10 comments on the proposed rule. Comments were received from tobacco product manufacturers, environmental groups, and individuals. To make it easier to identify comments and our responses, the word “Comment,” in parentheses, will appear before each comment, and the word “Response,” in parentheses, will appear before each response. We have numbered the comments to make it easier to distinguish between comments; the numbers are for organizational purposes only and do not reflect the order in which we received the comments or any value associated with them. We have combined similar comments under one numbered comment. In addition to the comments specific to this rulemaking that we address in the following paragraphs, we received five general comments: (1) One expressing a view that all tobacco products should be prohibited; (2) another providing reasons why FDA should regulate tobacco products and tobacco marketing; (3) one opposing any regulation that decreases FDA authority; (4) one supporting another comment; and (5) one that stated general disagreement with FDA proposing rules for this policy. These comments express broad policy views and do not address specific points related to this rulemaking. Because these general comments fall outside the scope of the proposed rule, we do not address them here. The remaining comments and FDA's responses follow.
(Comment 1) Multiple comments addressed the classes of tobacco actions FDA proposed to qualify for categorical exclusions. Several comments did not want FDA to categorically exclude any class of actions from the requirement to prepare an EA or EIS. These comments stated that the tobacco industry has misrepresented facts and relevant information regarding adverse impacts of its tobacco products and cannot be trusted to determine whether extraordinary circumstances are present such that the specific proposed action may have the potential to significantly affect the quality of the human environment.
(Response) We disagree with these comments. FDA is categorically excluding those actions that FDA has determined, based on experience, will not significantly affect the quality of the human environment. Additionally, this final rule will require a person submitting a tobacco product application to certify that the application qualifies for a categorical exclusion. FDA may deny the application if the submitter makes a false certification. In addition, under section 1001 of title 18 of the United States Code, anyone who makes a materially false, fictitious, or fraudulent statement to the Government of the United States is subject to criminal penalties. FDA, therefore, will continue to have appropriate oversight of the environmental impacts of tobacco product applications that are the subject of this final rule.
(Comment 2) Other comments expressed support for the rule and recommended that FDA add additional categorical exclusions for marketing authorizations for products that are the subject of SE reports under section 910(a)(2)(A) (nonprovisional SE reports) and SE exemption requests under section 905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)). These comments stated that FDA's analysis in support of the proposed rule should apply to these actions as well.
(Response) We disagree. As we stated in the proposed rule, FDA expects that any new tobacco product that receives marketing authorization through any of the available premarket pathways will have less—or no more—environmental impact than do tobacco products currently on the market. However, FDA does not yet have data to determine whether these actions, in the aggregate, will significantly impact the environment. Actions on provisional SE reports, by contrast, will relate only to products already on the market. Therefore, FDA is not proposing to add such categorical exclusions at this time.
(Comment 3) Comments provided several reasons why they believe categorically excluding nonprovisional SE reports and SE exemption requests from the requirement to develop an EA or EIS for tobacco products will not significantly affect the quality of the human environment. First, comments stated that marketing authorizations for products that are the subject of nonprovisional SE reports and SE exemption requests will not lead to a larger overall tobacco product market or expand tobacco product consumption; and tobacco products found SE or exempt from SE will compete with or replace tobacco products currently on the market. In addition, comments estimated that the number of new tobacco products for which FDA issues SE orders (for nonprovisional SE reports under section 910(a)(2)(A) of the FD&C Act) or grants SE exemptions would be relatively small.
Second, comments urged FDA to categorically exclude the granting of SE exemption requests because they believe the foreseeable environmental effects are even less significant for SE exemptions than for nonprovisional SE reports, based upon the more limited circumstances in which a product would be eligible for a request for an SE exemption.
Third, comments stated that authorizing categorical exclusions for marketing authorizations for products that are the subject of nonprovisional SE reports and SE exemption requests would be consistent with FDA's regulatory approach to premarket clearances and approvals for other product categories regulated by the Agency. Comments also maintained that the tobacco industry's previous experience with EAs for tobacco product applications demonstrates that these tobacco products are unlikely to significantly affect environment.
Fourth, a comment suggested that the extraordinary circumstances provision of the proposed rule supports inclusion of other classes of tobacco actions because it provides a mechanism by which to prevent any SE report or SE exemption request from resulting in the exposure of substances harmful to some biological mechanisms or systems in the environment or cause harm to a protected or endangered species.
(Response) We disagree with these comments. CEQ has provided guidance to Federal Agencies for substantiating a new or revised categorical exclusion. In this guidance, CEQ explains that
(Comment 4) One comment stated that FDA should revise the examples provided in the preamble of the proposed rule regarding circumstances where a categorical exclusion would not be appropriate for tobacco products. This comment stated that FDA paraphrases two extraordinary circumstances examples provided in the regulations (at § 25.21(a) and (b)) and unnecessarily expands the scope of these provisions.
(Response) We disagree with this comment's characterization of FDA's discussion of extraordinary circumstances. FDA's description in the preamble provided circumstances for which EA or EIS preparation may be required for tobacco product applications. The descriptions were not intended to expand the existing regulations on extraordinary circumstances (§ 25.21
(Comment 5) Two comments questioned FDA's assertion that tobacco product waste is “individually and cumulatively trivial” and asserted that FDA did not review a sufficient number of studies. These comments urged FDA to not finalize the proposed rule based on the environmental impact of tobacco product waste. They noted that the growing of tobacco and manufacturing of cigarettes may result in a variety of pesticides, herbicides, insecticides, fungicides, and rodenticides being deposited into the environment, and 4,000 chemicals may be introduced to the environment via tobacco product waste, thirdhand, and secondhand smoke. One comment stated that the environmental impacts of tobacco product manufacture and disposal are best addressed by having FDA retain the lead role in preparing any necessary EISs or EAs.
(Response) FDA disagrees with comments stating that it did not adequately consider the environmental impact of tobacco product waste. FDA reviewed the 2011 Toxics Release Inventory National Analysis to determine that the amount of waste released, recycled, and treated due to the manufacturer of all tobacco products currently on the market is a fraction of the total toxic waste released from and managed by industrial facilities in the United States. The classes of actions that FDA proposed for categorical exclusions do not result in additional tobacco products being marketed because those exclusions represent either the marketing authorization of tobacco products already on the market (provisional SE reports), or the rescission, suspension, or denial of authorization for a new tobacco product. As mentioned in the proposed rule, FDA also reviewed the effect on the environment due to the use (including secondhand and thirdhand smoke) and disposal of tobacco products (including cigarette butts) currently on the market. FDA acknowledged that currently marketed tobacco products contribute to pollution on beaches and streets and affect wildlife and marine and freshwater fish. FDA concluded from its review that the effects of keeping tobacco products on the market are individually and cumulatively trivial compared to the existing environmental effects due to toxic waste released from and managed in industrial facilities in the United States and the existing environmental effects due to the use and disposal from use of the tobacco products in the country (79 FR 3742 at 3745). FDA has carefully considered the information available in order to conclude that these tobacco product actions qualify for categorical exclusion under NEPA.
The amendment of FDA's NEPA regulations (part 25) concerns NEPA documentation for certain actions on tobacco product submission. CEQ does not direct Federal Agencies to prepare a NEPA analysis or document before establishing Agency procedures that supplement CEQ regulations for implementing NEPA. Agencies are required to adopt NEPA procedures that establish specific criteria for, and identification of, three classes of actions: (1) Those that require preparation of an EIS; (2) those that require preparation of an EA; (3) and those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). Categorical exclusions are one part of those Agency procedures; therefore, establishing categorical exclusions does not require preparation of a NEPA analysis or document. Agency NEPA procedures, such as FDA's EPA regulations, assist FDA in the fulfillment of Agency responsibilities under NEPA, but are not FDA's final determination of what level of NEPA analysis is required for a particular proposed action on a tobacco product submission. The requirements for establishing Agency NEPA procedures are set forth at 40 CFR 1505.1 and 1507.3. Furthermore, the Agency has also determined under § 25.30(h) that this rulemaking does not individually or cumulatively have a significant effect on the quality of the human environment.
The final regulatory impact analysis is available as Reference 2 in Docket No. FDA-2013-N-1282 (Ref. 2) and at
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 is not required.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the final 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, the Agency has concluded 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 have been placed on display in the Division of Dockets Management (see
Environmental impact statements, Foreign relations, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and authority delegated to the Commissioner of Food and Drugs, 21 CFR part 25 is amended as follows:
21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.
Any proposed action of a type specified in this section normally requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35:
(o) Issuance of an order finding a tobacco product substantially equivalent under the Federal Food, Drug, and Cosmetic Act, or granting of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, unless categorically excluded under § 25.35.
(p) Issuance of an order authorizing marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act or an order authorizing marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act, unless categorically excluded under § 25.35.
The classes of actions listed in this section are categorically excluded and, therefore, normally do not require the preparation of an EA or an EIS:
(a) Issuance of an order finding a tobacco product substantially equivalent under section 910(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act;
(b) Issuance of an order finding a tobacco product not substantially equivalent under section 910(a) of the Federal Food, Drug, and Cosmetic Act, denial of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, issuance of an order under section 910(c) of the Federal Food, Drug, and Cosmetic Act that a new tobacco product may not be introduced or delivered for introduction into interstate commerce, or issuance of an order under section 911 of the Federal Food, Drug, and Cosmetic Act that a modified risk tobacco product may not be introduced or delivered for introduction into interstate commerce;
(c) Rescission or temporary suspension of an order authorizing the marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act;
(d) Rescission of an order authorizing the marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act; and
(e) Rescission of an order granting an exemption request under § 1107.1 of this chapter.
(b) Many FDA actions involving investigations, review, and approval or market authorization of applications, and premarket notifications for human drugs, animal drugs, biologic products, devices, and tobacco products are protected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic Act. * * * Even the existence of applications for human drugs, animal drugs, biologic products, devices, and tobacco products is protected from disclosure under these regulations. Therefore, unless the existence of applications for human drugs, animal drugs, biologic products, tobacco products, or premarket notification for devices has been made publicly available, the release of the environmental document before approval or authorization of human drugs, animal drugs, biologic products, devices and tobacco products is inconsistent with statutory requirements imposed on FDA. Appropriate environmental documents, comments, and responses will be included in the administrative record to the extent allowed by applicable laws.
(a) If FDA determines that an EIS is necessary for an action involving investigations, approvals, or market authorizations for drugs, animal drugs, biologic products, devices, or tobacco products, an EIS will be prepared but will become available only at the time
(b) Comments on the EIS may be submitted after the approval or market authorization of the drug, animal drug, biologic product, device, or tobacco product. Those comments can form the basis for the Agency to consider beginning an action to withdraw the approval or market authorization of applications for a drug, animal drug, biologic product, or tobacco product, or to withdraw premarket notifications or premarket approval applications for devices.
(c) In those cases where the existence of applications and premarket notifications for drugs, animal drugs, biologic products, devices, or tobacco products has already been disclosed before the Agency approves the action, the Agency will ensure appropriate public involvement consistent with 40 CFR 1506.6 and part 1503 in preparing and implementing the NEPA procedures related to preparing EISs while following its own disclosure requirements including those listed in part 20 and §§ 312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge across the Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The Montlake Bridge is a double leaf bascule bridge. The deviation is necessary to allow the bridge to operate in single leaf mode during day light hours, and a full closure (both bascule leafs in the closed-to-navigation position) during night time hours while work crews replace bridge decking. This deviation allows a single leaf opening with a one hour advance notice during the day, and remains in the closed-to-navigation position at night.
This deviation is effective from 7 a.m. on October 3, 2015 to 7 a.m. on October 26, 2015.
The docket for this deviation, [USCG-2015-0888] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Washington Department of Transportation has requested a temporary deviation from the operating schedule for the Montlake Bridge across the Lake Washington Ship Canal, at mile 5.2, at Seattle, WA. The deviation is necessary to accommodate work crews to conduct timely bridge deck repairs.
The Montlake Bridge in the closed position provides 30 feet of vertical clearance throughout the navigation channel, and 46 feet of vertical clearance throughout the center 60 feet of the bridge; vertical clearance references to the Mean Water Level of Lake Washington. When half the span is open, single leaf, 46 feet of vertical clearance will be reduced throughout the center to 30 feet of the bridge.
To facilitate this event, the south half of the bridge span, or single leaf, will open with at least a one hour advance notice provided to the bridge operator from 7 a.m. to 7 p.m. From 7 p.m. to 7 a.m., the Montlake Bridge span will remain in the closed-to-navigation position, or full closure.
The normal operating schedule for the Montlake Bridge operates in accordance with 33 CFR 117.1051(e) which requires the bridge to open on signal, except that the bridge need not open for vessels less than 1,000 gross tons between 7 a.m. and 9 a.m. and 3:30 p.m. and 6:30 p.m. Monday through Friday, except Federal Holidays from April 30 to September 1, and from 7 a.m. to 10 a.m. and from 3:30 p.m. to 7 p.m. from September 1 to April 30. The draw need open only on the hour and half hour from 12:30 p.m. to 3:30 p.m. and from 6 p.m. to 6:30 p.m.
The deviation period is from 7 a.m. on October 3, 2015 until 7 p.m. on October 3, 2015 (south single leaf opening if a one hour notice is given); from 7 p.m. on October 3, 2015 until 7 a.m. on October 4, 2015 (remain in the closed-to-navigation position); from 7 a.m. on October 4, 2015 until 7 p.m. on October 4, 2015 (south single leaf opening if a one hour notice is given); from 7 p.m. on October 4, 2015 until 7 a.m. on October 5, 2015 (remain in the closed-to-navigation position); from 7 a.m. on October 24, 2015 until 7 p.m. on October 24, 2015 (south single leaf opening if a one hour notice is given); from 7 p.m. on October 24, 2015 until 7 a.m. on October 25, 2015 (remain in the closed-to-navigation position); from 7 a.m. on October 25, 2015 until 7 p.m. on October 25, 2015 (south single leaf opening if a one hour notice is given); from 7 p.m. on October 25, 2015 until 7 a.m. on October 26, 2015 (remain in the closed-to-navigation position).
Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass through the bridge in the closed-to-navigation position may do so at anytime. The bridge will be able to open for emergency vessels in route to a call when an hour notice is given to the bridge operator, and a single leaf opening will be provided. The Lake Washington Ship Canal has no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving changes to the Georgia State Implementation Plan (SIP) that were submitted by the State of Georgia, through the Georgia Environmental Protection Division (GA EPD), on January 22, 2015, for the purpose of moving the Clean Fuel Fleet Program (CFFP) from the active portion of the Georgia SIP to the contingency measures portion of the maintenance plan for the Atlanta Area for the 1997 8-hour ozone national ambient air quality standards (NAAQS). EPA has determined that Georgia's January 22, 2015, SIP revision regarding the CFFP is approvable because it is consistent with the Clean Air Act (CAA or Act).
This rule will be effective October 26, 2015.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0114. All documents in the docket are listed on the
Kelly Sheckler, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Sheckler's phone number is (404) 562-9222. She can also be reached via electronic mail at
On January 22, 2015, GA EPD submitted a SIP revision to EPA with a request to move Georgia's CFFP rules (Georgia Rules 391-3-22-.01 through .11)
On July 24, 2015, EPA published a proposed rulemaking to approve Georgia's January 22, 2015, SIP revision related to the CFFP based, in part, on EPA's preliminary finding that the SIP revision satisfies the anti-backsliding requirements of EPA's ozone implementation rules and the CAA section 110(l) requirements. The details of Georgia's submittal and the rationale for EPA's action are explained in that notice of proposed rulemaking.
EPA is taking final action to approve the SIP revision submitted by Georgia on January 22, 2015, to move Georgia's CFFP rules (Georgia Rules 391-3-22-.01 through .11) from the active portion of Georgia SIP to the contingency measures portion of Georgia's maintenance plan in the SIP for the 1997 Atlanta 8-hour ozone area. EPA has determined that Georgia's January 22, 2015, SIP revision related to the State's CFFP is consistent with the CAA and EPA's regulations and guidance.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 23, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve portions of the October 14, 2011, State Implementation Plan (SIP) submission, provided by the State of Florida, through the Department of Environmental Protection (FL DEP) for inclusion into the Florida SIP. This final submission pertains to the Clean Air Act (CAA or the Act) infrastructure requirements for the 2008 Lead national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP. FL DEP certified that the Florida SIP contains provisions that ensure the 2008 Lead NAAQS is implemented, enforced, and maintained in Florida. With the exception of provisions pertaining to prevention of significant deterioration (PSD) permitting which EPA has already approved, EPA is taking final action to approve Florida's infrastructure submission, provided to EPA on October 14, 2011, as satisfying the required infrastructure elements for the 2008 Lead NAAQS.
This rule will be effective October 26, 2015
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2013-0040. All documents in the docket are listed on the
Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9152. Mr. Farngalo can be reached via electronic mail at
Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. Section 110(a) of the CAA generally requires states to make a SIP submission to meet applicable requirements in order to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. For additional information on the infrastructure SIP requirements, see the proposed rulemaking published on May 22, 2015 (80 FR 29592).
On May 22, 2015, EPA proposed to approve portions of Florida's October 14, 2011, 2008 Lead NAAQS infrastructure SIP submission with the exception of provisions pertaining to PSD permitting in sections 110(a)(2)(C), prong 3 of D(i) and (J). EPA did not receive any comments, adverse or otherwise, on the May 22, 2015, proposed rule. EPA took final action to approve the PSD permitting requirements in sections 110(a)(2)(C), prong 3 of D(i) and (J) on March 18, 2015 (80 FR 14019). EPA is taking final action to approve the remaining portions of Florida's infrastructure submission as demonstrating that the State meets the applicable requirements of sections 110(a)(1) and (2) of the CAA for the 2008 Lead NAAQS.
With the exception of provisions pertaining to PSD permitting requirements, EPA is taking final action to approve Florida's October 14, 2011, infrastructure submission because it addresses the required infrastructure elements for the 2008 Lead NAAQS. FL DEP has addressed the elements of the CAA 110(a)(1) and (2) SIP requirements pursuant to section 110 of the CAA to ensure that the 2008 Lead NAAQS is implemented, enforced, and maintained in Florida.
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, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 23, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to approve the September 20, 2011, State Implementation Plan (SIP) submission, provided by the South Carolina Department of Health and Environmental Control (SC DHEC) for inclusion into the South Carolina SIP. This final action pertains to the Clean Air Act (CAA or the Act) infrastructure requirements for the 2008 Lead national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP. SC DHEC certified that the South Carolina SIP contains provisions to ensure the 2008 Lead NAAQS is implemented, enforced, and maintained in South Carolina. With the exception of provisions pertaining to prevention of significant deterioration (PSD) permitting which EPA has already approved, EPA is taking final action to approve South Carolina's infrastructure SIP submission, provided to EPA on September 20, 2011.
This rule will be effective October 26, 2015.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2012-0852. All documents in the docket are listed on the
Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9152. Mr. Farngalo can be reached via electronic mail at
Upon promulgation of a new or revised NAAQS, sections 110(a)(1) and (2) of the CAA require states to address basic SIP requirements, including emissions inventories, monitoring, and modeling to assure attainment and maintenance for that new NAAQS. Section 110(a) of the CAA generally requires states to make a SIP submission to meet applicable requirements in order to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. For additional information on the infrastructure SIP requirements, see the proposed rulemaking published on June 8, 2015. (80 FR 32324)
On June 8, 2015, EPA proposed to approve portions of South Carolina's September 20, 2011, 2008 Lead NAAQS infrastructure SIP submission with the exception of provisions pertaining to PSD permitting in sections 110(a)(2)(C), prong 3 of D(i) and (J).
In this rulemaking, EPA is taking final action to approve the remaining portions of South Carolina's infrastructure submission as demonstrating that the State meets the applicable requirements of sections 110(a)(1) and (2) of the CAA for the
With the exception of provisions pertaining to PSD permitting requirements in sections 110(a)(2)(C), prong 3 of D(i), and (J), EPA is taking final action to approve South Carolina's September 20, 2011, infrastructure submission because it addresses the required infrastructure elements for the 2008 Lead NAAQS. SC DHEC has addressed the elements of the CAA 110(a)(1) and (2) SIP requirements pursuant to section 110 of the CAA to ensure that the 2008 Lead NAAQS is implemented, enforced, and maintained in South Carolina.
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, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this action for the state of South Carolina does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). The Catawba Indian Nation Reservation is located within the State of South Carolina. Pursuant to the Catawba Indian Claims Settlement Act, S.C. Code Ann. 27-16-120, “all state and local environmental laws and regulations apply to the [Catawba Indian Nation] and Reservation and are fully enforceable by all relevant state and local agencies and authorities.” However, EPA has determined that because this rule does not have substantial direct effects on an Indian Tribe because, as noted above, this action is not approving any specific rule, but rather proposing that South Carolina's already approved SIP meets certain CAA requirements. EPA notes this action will not impose substantial direct costs on Tribal governments or preempt Tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 23, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations Lead, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2014-20-01, for certain Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. AD 2014-20-01 currently requires repetitive inspections for any fuel leak in the right-hand landing lights compartment, and related investigative and corrective actions if necessary. AD 2014-20-01 also provides for an optional replacement of the connector of the fuel boost pump canister of the auxiliary power unit (APU), which terminates the repetitive inspections. Since we issued AD 2014-20-01, we have determined that a terminating action for the repetitive inspections is necessary. This proposed AD would retain the repetitive inspections for any fuel leak in the right-hand landing lights compartment and the related investigative and corrective actions, and would require replacing the connector of the fuel boost pump canister of the APU. We are proposing this AD to detect and correct fuel leaks in the right-hand landing lights compartment, which, in combination with the heat generated by the taxi lights and landing lights on the ground reaching the auto-ignition temperature of the fuel, could result in ignition of any fuel or fumes present in the right-hand landing lights compartment.
We must receive comments on this proposed AD by November 9, 2015.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
You may examine the AD docket on the Internet at
Assata Dessaline, Aerospace Engineer, Avionics and Services Branch, ANE-172, FAA, New York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7301; fax 516-794-5531.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On September 19, 2014, we issued AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014). AD 2014-20-01 requires actions intended to address an unsafe condition on certain Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The preamble of AD 2014-20-01 specified that we considered the actions an interim action and that we were considering requiring “a replacement of the connector of the fuel boost pump canister of the APU, and applicable corrective actions, which would constitute terminating action for the repetitive inspections required by this AD action.”
Since we issued AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014), we have determined that further rulemaking is indeed necessary; this proposed AD follows from that determination.
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2014-21, dated July 10, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. The MCAI states:
Bombardier, Inc. has discovered fuel leakage in the auxiliary power unit (APU) fuel Boost Pump (BP) canister connector cavity. On some of those aeroplanes, leakage was also noticed at the APU fuel BP electrical conduit connection in the right hand landing light compartment. The root cause of the subject fuel leak is identified to be the
Available data indicates that on a hot day, due to the heat generated by the taxi light and/or landing lights on the ground, temperature in the landing light compartment can reach the fuel auto ignition temperature. Therefore, presence of any fuel in the right hand landing light compartment is considered to be a safety hazard [fuel or fumes present in the right-side landing lights compartment might ignite] that warrants mitigating action.
In order to help mitigate the potential safety hazard precipitated by any fuel leakage in the right hand landing light compartment, Bombardier, Inc., has revised the Aircraft Flight Manual (AFM) through Temporary Revisions (TRs) 604/38 and 605/20 dated 16 June 2014 to restrict the operation of Taxi and Landing lights on the ground. Transport Canada issued Emergency [Canadian] AD CF-2014-17 [(
To address the root cause of the subject fuel leakage from the APU fuel boost pump canister wiring conduit, Bombardier, Inc. issued Alert Service Bulletin (ASB) A605-28-008 that requires periodic [repetitive general visual] inspection[s] for fuel leaks and [applicable related investigative and corrective actions and] eventual the replacement of the discrepant fuel BP canister connectors [including related investigative and corrective actions] on affected aeroplanes. The ASB has been revised to include an additional inspection of the new connector wiring for damage and this [Canadian] AD is issued to mandate the compliance with ASB A605-28-008 Revision 2 requirements.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 92 airplanes of U.S. registry.
The actions required by AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014), and retained in this proposed AD take about 2 work-hours per product, at an average labor rate of $85 per work-hour. Required parts cost $0 per product. Based on these figures, the estimated cost of the actions that are required by AD 2014-20-01 is $170 per product.
We also estimate that it would take about 22 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost $0 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $172,040, or $1,870 per product.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979).
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by November 9, 2015.
This AD replaces AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014).
This AD applies to Bombardier, Inc. Model CL-600-2B16 (CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes, certificated in any category, serial numbers 5906, 5910, 5912, 5917, 5919 through 5932 inclusive, 5934, 5935, 5939, 5940, 5942, and 5948.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by a report of fuel leaks in the auxiliary power unit (APU) fuel boost pump canister connector cavity and in the right-hand landing lights compartment from the APU fuel boost pump electrical conduit connection and by a determination that terminating action for the repetitive inspections is necessary. We are issuing this AD to detect and correct fuel leaks in the right-hand landing lights compartment,
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014) with no changes. Within 25 flight hours after October 20, 2014, (the effective date of AD 2014-20-01): Do a general visual inspection for any fuel leak in the right-hand landing lights compartment, and do all applicable related investigative and corrective actions, in accordance with Part A of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014, except as required by paragraph (h) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 8 flight hours until the replacement specified in paragraph (j) of this AD has been accomplished.
This paragraph restates the requirements of paragraph (h) of AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014) with no changes. If any fuel leak is found during the related investigative actions required by paragraph (g) of this AD: Before further flight, do the terminating action specified in paragraph (j) of this AD, or do corrective actions using a method approved by the Manager, New York Aircraft Certification Office (ACO), ANE-170, FAA; or Transport Canada Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If approved by the DAO, the approval must include the DAO-authorized signature.
This paragraph restates the requirements of paragraph (j) of AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014) with no changes. For airplanes having new connectors installed, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, dated April 21, 2014: Within 6 months or 150 flight hours after October 20, 2014, (the effective date of AD 2014-20-01), whichever occurs first, do a detailed inspection for damage (cuts) of the connector wiring, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014. If any damage (cuts) is found on the wires, before further flight, replace the wire with a new wire identified in kit 605K28-008A, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014.
Within 5 months, or 150 flight hours after the effective date of this AD, replace the connector of the fuel boost pump canister of the APU and do all applicable related investigative actions, in accordance with Part B of the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014. Accomplishing this replacement terminates the repetitive actions required by paragraph (g) of this AD provided that the following actions are done, as applicable.
(1) If any damage (cuts) is found on the wires, before further flight, replace the wire with a new wire identified in kit 605K28-008A, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014.
(2) If any damage is found on an O-ring, before further flight, replace the O-ring with a new O-ring, in accordance with the Accomplishment Instructions of Bombardier Alert Service Bulletin A605-28-008, Revision 02, dated July 9, 2014.
(3) If any fuel leak is found, before further flight, do corrective actions using a method approved by the Manager, New York ACO, ANE-170, FAA; or TCCA; or Bombardier, Inc.'s TCCA DAO. If approved by the DAO, the approval must include the DAO-authorized signature.
This paragraph restates paragraph (k) of AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014) with a redesignated paragraph. This paragraph provides credit for actions required by paragraph (j) of this AD, if those actions were performed before October 20, 2014, (the effective date of AD 2014-20-01, Amendment 39-17974 (79 FR 59640, October 3, 2014) using Bombardier Alert Service Bulletin A605-28-008, Revision 01, dated May 28, 2014, which is not incorporated by reference in this AD.
The following provisions also apply to this AD:
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2014-21, dated July 10, 2014, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-5000; fax 514-855-7401; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. This proposed AD was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip that caused severe damage and induced the loss of some airplane functions. This proposed AD would require modification of the anti-collision light bonding. We are
We must receive comments on this proposed AD by November 9, 2015.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
For service information identified in this proposed AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; Internet
You may examine the AD docket on the Internet at
Tom Rodriguez, Aerospace Engineer, ANM 116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1137; fax 425-227-1139.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0006, dated January 15, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Dassault Aviation Model MYSTERE-FALCON 50, MYSTERE-FALCON 900, FALCON 900EX, FALCON 2000, and FALCON 2000EX airplanes. The MCAI states:
An occurrence was reported where a Falcon 2000 aeroplane experienced an in-flight lightning strike, which caused severe damage and induced the loss of some aeroplane functions. The investigation results revealed that the entering point of the lightning was at the WHELEN anti-collision light located on the top of the vertical fin tip.
When the lightning strike hit the anti-collision light, an electric arc occurred between the aeroplane structure and the anti-collision light and created a conductive path by which the lightning current entered inside the aeroplane. Further analysis has determined that the electrical bonding between the WHELEN anti-collision light, Part Number (P/N) 01-0790044-09, and the fin tip fairing or the No. 2 engine air intake cover is insufficient to withstand a lightning strike.
In case of severe lightning, this condition, if not corrected, could lead to an unsafe condition (loss of electrical power and/or of essential functions) possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Dassault Aviation developed a modification (mod) to improve the WHELEN anti-collision light bonding when the anti-collision light is located on top of the vertical fin tip or on No. 2 engine air intake cover, and issued several Service Bulletins (SB) to modify all affected aeroplanes in service.
For the reasons described above, this [EASA] AD requires modification of the anti- collision light bonding.
You may examine the MCAI in the AD docket on the Internet at
We reviewed the following Dassault Aviation service information:
• Dassault Service Bulletin F50-481, dated August 22, 2007.
• Dassault Service Bulletin F900-372, dated August 22, 2007.
• Dassault Service Bulletin F900-378, dated September 19, 2007.
• Dassault Service Bulletin F900EX-285, dated July 18, 2007.
• Dassault Service Bulletin F900EX-305, dated September 19, 2007.
• Dassault Service Bulletin F2000-337, dated July 25, 2007.
• Dassault Service Bulletin F2000EX-108, dated July 25, 2007.
The service information describes procedures to correct the electrical bonding of the WHELEN anti-collision light located at the vertical fin tip of the airplane. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type designs.
We estimate that this proposed AD affects 778 airplanes of U.S. registry.
We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $801 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $1,416,738, or $1,821 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII:
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have 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.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by November 9, 2015.
None.
This AD applies to Dassault Aviation airplanes, certificated in any category, identified in table 1 to paragraph (c) of this AD.
Air Transport Association (ATA) of America Code 33, Lights.
This AD was prompted by a report of an in-flight lightning strike to the WHELEN anti-collision light located on the top of the vertical fin tip of a Falcon 2000 airplane that caused severe damage and induced the loss of some airplane functions. We are issuing this AD to prevent loss of electrical power
Comply with this AD within the compliance times specified, unless already done.
Within 24 months after the effective date of this AD, modify the anti-collision light bonding, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraphs (g)(1) through (g)(7) of this AD.
(1) For Model MYSTERE-FALCON 50 airplanes: Dassault Service Bulletin F50-481, dated August 22, 2007.
(2) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900-372, dated August 22, 2007.
(3) For Model MYSTERE-FALCON 900 airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900-378, dated September 19, 2007.
(4) For Model FALCON 900EX airplanes with the WHELEN system installed on the fin tip: Dassault Service Bulletin F900EX-285, dated July 18, 2007.
(5) For Model FALCON 900EX airplanes with the WHELEN system installed on the S-duct cowl: Dassault Service Bulletin F900EX-305, dated September 19, 2007.
(6) For Model FALCON 2000 airplanes: Dassault Service Bulletin F2000-337, dated July 25, 2007.
(7) For Model FALCON 2000EX airplanes: Dassault Service Bulletin F2000EX-108, dated July 25, 2007.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) European Aviation Safety Agency Airworthiness Directive 2015-0006, dated January 15, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For service information identified in this AD, contact Dassault Falcon Jet, P.O. Box 2000, South Hackensack, NJ 07606; telephone 201-440-6700; Internet
Consumer Product Safety Commission.
Proposed rule.
On September 8, 2015, the federal departments and agencies that are subject to the Federal Policy for the Protection of Human Subjects (referred to as the “Common Rule”) published a notice of proposed rulemaking (“NPR”) amending the Common Rule. Through this proposed rule, the Consumer Product Safety Commission (“CPSC” or “Commission”) proposes to adopt the Common Rule NPR and solicits public comment on the proposal.
Comments must be received no later than 5 p.m. on December 7, 2015.
You may submit comments, identified by docket ID number HHS-OPHS-2015-0008, by one of the following methods:
•
•
Hope E.J. Nesteruk, Human Factors Engineer, Division of Human Factors, Directorate for Engineering Sciences, Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301-987-2579; email:
On June 18, 1991, the Department of Health and Human Services (“HHS”) issued a rule setting forth the Common Rule requirements for the protection of human subjects. (56 FR 28003). The HHS regulations are codified at 45 CFR part 46. At that time, 14 other agencies, including the CPSC, joined HHS in adopting a uniform set of rules for the protection of human subjects identical to subpart A of 45 CFR part 46. The Common Rule is codified in the CPSC's regulations at 16 CFR part 1028. The basic provisions of the Common Rule include, among other things, requirements related to the review of human subjects research by an institutional review board, obtaining and documenting informed consent of human subjects, and submitting a written assurance of institutional compliance with the Common Rule.
On September 8, 2015, (80 FR 53933), HHS, on behalf of many of the same agencies that were signatories to the original Common Rule, proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The Common Rule NPR seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The participating departments and agencies proposed these revisions to the regulations because they believe these changes would strengthen protections for research subjects while facilitating important research.
The full description of the proposed revisions to the Common Rule is provided in the Common Rule NPR at 80 FR 53933. Although the CPSC is a signatory to the original Common Rule, the CPSC's procedural requirements require Commission deliberation and vote on new rulemaking matters. Due to HHS's expedited schedule regarding publication of the Common Rule NPR in the
CPSC's current regulations on the protection of human subjects are the regulations promulgated by all of the departments and agencies subject to the Common Rule, as codified under the CPSC's regulations at 16 CFR part 1028. For the reasons provided in the Common Rule NPR (80 FR 53933), the CPSC would adopt the amended regulatory text provided in the Common Rule NPR. Because the CPSC follows the HHS regulations in 45 CFR part 46, subpart A, the CPSC proposes to amend the Commission regulations at 16 CFR part 1028 to cross-reference the HHS regulations in 45 CFR part 46, subpart A.
Human research subjects, Reporting and recordkeeping requirements, Research.
For the reasons stated in the preamble, the Consumer Product Safety Commission proposes to revise 16 CFR part 1028 to read as follows:
5 U.S.C. 301; 42 U.S.C. 300v-1(b).
The provisions set forth at 45 CFR part 46, subpart A, concerning the protection of human research subjects, apply to all research conducted, supported, or otherwise subject to regulation by the CPSC.
Federal Energy Regulatory Commission.
Notice of proposed rulemaking.
The Federal Energy Regulatory Commission proposes to approve Reliability Standard PRC-026-1 (Relay Performance During Stable Power Swings), submitted by the North American Electric Reliability Corporation. The proposed Reliability Standard is designed to ensure that applicable entities use protective relay systems that can differentiate between faults and stable power swings. In addition, the Commission requests comment regarding the potential burden of modifying the applicability of proposed Reliability Standard PRC-026-1 to include relays with a time delay of 15 cycles or greater in instances where either (1) an element has been identified by a Planning Coordinator as potentially susceptible to power swings or (2) an entity becomes aware of a bulk electric system element that tripped in response to a stable or unstable power swing due to the operation of its protective relay(s), even if the element was not previously identified by the planning coordinator.
Comments are due November 23, 2015.
Comments, identified by docket number, may be filed in the following ways:
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1. Pursuant to section 215 of the Federal Power Act (FPA),
2. Consistent with directives issued in Order No. 733,
3. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval.
4. On March 18, 2010, in Order No. 733, the Commission approved Reliability Standard PRC-023-1 (Transmission Relay Loadability) and directed NERC to develop a new Reliability Standard that requires the use of protective relay systems that can differentiate between faults and stable power swings and, when necessary, retirement of protective relay systems that cannot meet this requirement.
5. On February 17, 2011, in Order No. 733-A, the Commission denied rehearing of Order No. 733 and clarified that “[w]e continue to believe that not addressing stable power swings constitutes a gap in the current Reliability Standards and must be addressed.”
6. On December 31, 2014, NERC submitted a petition seeking approval of proposed Reliability Standard PRC-026-1, as well as the associated implementation plan, and violation risk factors and violation severity levels.
7. According to NERC, the proposed Reliability Standard is “directly responsive” to the Order No. 733 directive that NERC develop a standard addressing undesirable relay operation due to stable power swings.
8. Proposed Reliability Standard PRC-026-1 has four requirements and two attachments. NERC explains that Attachment A “provides clarity on which load-responsive protective relay functions are applicable” under the standard.
According to NERC, the 15 cycle time delay “is representative of an expected power swing having a slow slip rate of 0.67 Hertz (Hz) and is the average time that a stable power swing with that slip rate would enter the relays' characteristic, reverse direction, and then exit the characteristic before the time delay expired.”
9. According to NERC, Requirement R1 of the proposed Reliability Standard requires the planning coordinator to identify bulk electric system elements that meet one or more of four criteria and subsequently notify, at least once each calendar year, the respective generator owners and transmission owners of the identified at-risk elements.
10. NERC states that, upon such notification, Requirement R2 obligates the generator owners and transmission owners to determine whether the relays applied to the identified bulk electric system elements meet the two criteria outlined in Attachment B to proposed Reliability Standard PRC-026-1. NERC notes that Requirement R2 requires a generator owner or transmission owner to conduct the same analysis where the entity becomes aware of a bulk electric system element that tripped in response to a stable or unstable power swing due to the operations of its protective relay(s), even if the element was not previously identified by the planning coordinator.
11. NERC explains that Requirement R3 requires an applicable generator owner or transmission owner to develop a corrective action plan for any protective system that does not meet the Attachment B criteria. Under the corrective action plan, a generator owner or transmission owner is required to modify the relevant protection system to meet the Attachment B criteria. Requirement R4 obligates a generator owner or transmission owner to implement a corrective action plan developed under Requirement R3 and to update the plan when either the content of the plan or associated timetables change until the plan has been fully executed.
12. NERC proposes an implementation plan for PRC-026-1 under which Requirement R1 is to become effective 12 months after Commission approval, and Requirements R2, R3, and R4 become effective 36 months after Commission approval.
13. Pursuant to section 215(d)(2) of the FPA, we propose to approve Reliability Standard PRC-026-1 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. We also propose to approve NERC's proposed implementation plan, and the proposed violation risk factors and violation severity levels. Generally, the proposed Reliability Standard appears to adequately address the Commission's directive from Order No. 733 by helping to prevent the unnecessary tripping of bulk electric system elements in response to stable power swings. We propose to accept NERC's approach as an equally effective and efficient method to achieve the reliability goal underlying the Commission's Order No. 733 directive.
14. However, we are concerned that NERC's proposed exclusion of load responsive relays with a time delay of 15 cycles or greater as proposed in Attachment A could result in a gap in reliability. As mentioned above, pursuant to Attachment A, the Reliability Standard applies to “any protective functions which could trip instantaneously or with a time delay of less than 15 cycles on load current (
15. Therefore, we seek comment on the potential burden of modifying the applicability of proposed Reliability Standard PRC-026-1 to include relays with a time delay of 15 cycles or greater in instances where either (1) an element has been identified by a Planning Coordinator as potentially susceptible to power swings or (2) an entity becomes aware of a bulk electric system element that tripped in response to a stable or unstable power swing due to the operation of its protective relay(s), even if the element was not previously identified by the planning coordinator. Depending on the response, the Commission may direct that NERC develop modifications to the proposed Reliability Standard.
16. The collection of information contained in this Notice of Proposed Rulemaking is subject to review by the Office of Management and Budget (OMB) regulations under section 3507(d) of the Paperwork Reduction Act of 1995 (PRA).
17. Upon approval of a collection(s) of information, OMB will assign an OMB control number and an expiration date. Respondents subject to the filing requirements of a rule will not be penalized for failing to respond to these collections of information unless the collections of information display a valid OMB control number.
18. We solicit comments on the need for this information, whether the information will have practical utility, the accuracy of the burden estimates, ways to enhance the quality, utility, and clarity of the information to be collected or retained, and any suggested methods for minimizing respondents' burden, including the use of automated information techniques. Specifically, the Commission asks that any revised
Average Burden Hours per Response * $60.66 per Hour = Average Cost per Response. The hourly average of $60.66 assumes equal time is spent by the manager, electrical engineer, and information and record clerk. The average hourly cost (salary plus benefits) is: $37.50 for information and record clerks (occupation code 43-4199), $78.04 for a manager (occupation code 11-0000), and $66.45 for an electrical engineer (occupation code 17-2071). (The figures are taken from the Bureau of Labor Statistics, May 2014 figures at
19.
20. Interested persons may obtain information on the reporting requirements by contacting the Federal Energy Regulatory Commission, Office of the Executive Director, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, email:
21. Comments concerning the information collections proposed in this NOPR and the associated burden estimates, should be sent to the Commission in this docket and may also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs [Attention: Desk Officer for the Federal Energy Regulatory Commission]. For security reasons, comments should be sent by email to OMB at the following email address:
22. The Regulatory Flexibility Act of 1980 (RFA)
23. As discussed above, proposed Reliability Standard PRC-026-1 will serve to enhance reliability by imposing mandatory requirements governing generator relay loadability, thereby reducing the likelihood of premature or unnecessary tripping of generators during system disturbances. The Commission estimates that each of the small entities to whom the proposed Reliability Standard PRC-026-1 applies will incur paperwork and record retention costs of $935.28 per entity (annual ongoing).
24. The Commission does not consider the estimated costs per small entity to have a significant economic impact on a substantial number of small entities. Accordingly, the Commission certifies that proposed Reliability Standard PRC-026-1 will not have a significant economic impact on a substantial number of small entities. The Commission seeks comment on this certification.
25. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
26. The Commission invites interested persons to submit comments on the matters and issues proposed in this notice to be adopted, including any related matters or alternative proposals that commenters may wish to discuss. Comments are due November 23, 2015. Comments must refer to Docket No. RM15-8-000, and must include the commenter's name, the organization they represent, if applicable, and address.
27. The Commission encourages comments to be filed electronically via the eFiling link on the Commission's Web site at
28. Commenters that are not able to file comments electronically must send an original of their comments to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street NE., Washington, DC 20426.
29. All comments will be placed in the Commission's public files and may be viewed, printed, or downloaded remotely as described in the Document Availability section below. Commenters on this proposal are not required to serve copies of their comments on other commenters.
30. In addition to publishing the full text of this document in the
31. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number of this document, excluding the last three digits, in the docket number field.
32. User assistance is available for eLibrary and the Commission's Web site during normal business hours from the Commission's Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
By direction of the Commission.
International Trade Commission.
Notice of proposed rulemaking.
The United States International Trade Commission (“Commission”) proposes to amend its Rules of Practice and Procedure concerning rules of general application, adjudication, and enforcement. The amendments are necessary to make certain technical corrections, to clarify certain provisions, to harmonize different parts of the Commission's rules, and to address concerns that have arisen in Commission practice. The intended effect of the proposed amendments is to facilitate compliance with the Commission's Rules and improve the administration of agency proceedings.
To be assured of consideration, written comments must be received by 5:15 p.m.
You may submit comments, identified by docket number MISC-045, by any of the following methods:
Megan M. Valentine, telephone 202-708-2301, Office of the General Counsel, United States International Trade Commission. Hearing-impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal at 202-205-1810. General information concerning the Commission may also be obtained by accessing its Internet server at
The preamble below is designed to assist readers in understanding these proposed amendments to the Commission Rules. This preamble provides background information, a regulatory analysis of the proposed amendments, a section-by-section explanation of the proposed amendments to parts 201 and 210, and a description of the proposed amendments to the rules. The Commission encourages members of the public to comment on whether the language of the proposed amendments is sufficiently clear for users to understand, in addition to any other comments they wish to make on the proposed amendments.
If the Commission decides to proceed with this rulemaking after reviewing the comments filed in response to this notice, the proposed rule revisions will be promulgated in accordance with the applicable requirements of the Administrative Procedure Act (“APA”) (5 U.S.C. 553), and will be codified in 19 CFR parts 201 and 210.
Section 335 of the Tariff Act of 1930 (19 U.S.C. 1335) authorizes the Commission to adopt such reasonable procedures, rules, and regulations as it deems necessary to carry out its functions and duties. This rulemaking seeks to improve provisions of the Commission's existing Rules of Practice and Procedure. The Commission proposes amendments to its rules covering investigations under section 337 of the Tariff Act of 1930 (19 U.S.C. 1337), as amended (“section 337”), in order to increase the efficiency of its section 337 investigations.
This rulemaking was undertaken to make certain technical corrections, to clarify certain provisions, to harmonize different parts of the Commission's rules, and to address concerns that have arisen in Commission practice. The intended effect of the proposed amendments is to facilitate compliance with the Commission's Rules and improve the administration of agency proceedings.
On February 14, 2012, at 77 FR 8114, the Commission published a Plan for Retrospective Analysis of Existing Rules. This plan was issued in response to Executive Order 13579 of July 11, 2011, and established a process under which the Commission will periodically review its significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving regulatory objectives. This process will include a general review of existing regulations in 19 CFR parts 201, 207, and 210. The current notice of proposed rulemaking is consistent with the plan to ensure that the Commission's rules are effective.
The Commission invites the public to comment on all of these proposed rules amendments. In any comments, please consider addressing whether the language of the proposed amendments is sufficiently clear for users to understand. In addition please consider addressing how the proposed rules amendments could be improved, and offering specific constructive alternatives where appropriate.
Consistent with its ordinary practice, the Commission is issuing these proposed amendments in accordance with the applicable requirements of section 553 of the APA. This procedure entails the following steps: (1) Publication of a notice of proposed rulemaking; (2) solicitation of public comments on the proposed amendments; (3) Commission review of public comments on the proposed amendments; and (4) publication of final amendments at least thirty days prior to their effective date.
The Commission has determined that the proposed rules do not meet the criteria described in section 3(f) of Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and thus do not constitute a significant regulatory action for purposes of the Executive Order.
The Regulatory Flexibility Act (5 U.S.C. 601
These proposed rules do not contain federalism implications warranting the preparation of a federalism summary impact statement pursuant to Executive Order 13132 (64 FR 43255, Aug. 4, 1999).
No actions are necessary under the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501
The proposed rules are not major rules as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
The amendments are not subject to section 3504(h) of the Paperwork Reduction Act (44 U.S.C. 3504(h)).
Section 201.16 provides the general provisions for service of process and other documents. In particular, section 201.16(a)(1) provides that the Commission may effect service by mailing or delivering a copy of the document to be served to the person to be served or to certain persons affiliated with the organization to be served or to
In addition, subsection 201.16(f) authorizes parties to serve documents by electronic means. The proposed rule would amend subsection 201.16(f) to require parties serving documents by electronic means to ensure that any such document containing confidential business information subject to an administrative protective order be securely transmitted, in addition to being securely stored, to prevent unauthorized access and/or receipt by individuals or organizations not authorized to view the specified confidential business information.
Section 337(b)(1) states that the “Commission shall investigate any alleged violation of this section on complaint under oath or upon its initiative.” 19 U.S.C. 1337(b)(1). Accordingly, section 210.10 provides for institution of section 337 investigations by the Commission based upon a properly filed complaint.
In addition, subsection 210.10(b) provides that, when instituting an investigation, the Commission shall issue a notice defining the scope of the investigation, including whether the Commission has ordered the presiding administrative law judge to take evidence and to issue an initial determination concerning the public interest. The proposed rule would add subsection 210.10(b)(1) to provide that the notice of institution will specify in plain language the accused products that will be within the scope of the investigation in order to avoid disputes between the parties concerning the scope of the investigation at the outset. Comments regarding this proposed rule should address, in particular, whether the proposed rule would be useful in clarifying the scope of the investigation. The Commission welcomes alternate language that captures the Commission's intent with respect to the proposed rule. New subsection 210.10(b)(2) contains the existing language in subsection 210.10(b), which provides that the Commission may order the presiding administrative law judge to take evidence concerning the public interest.
The Commission has established a “100-Day” proceeding to provide for the disposition of potentially dispositive issues within a specified time frame following institution of an investigation. The proposed rule would accordingly add subsection 210.10(b)(3) to authorize the Commission to direct the presiding administrative law judge to issue an initial determination pursuant to new subsection 210.42(a)(3), as described below, on a potentially dispositive issue as set forth in the notice of investigation. The specified time frame for issuance of the initial determination is subject to an extension of time for good cause shown. As set forth in the pilot program, the presiding administrative law judge will have discretion to stay discovery during the pendency of the 100-Day proceeding.
Section 210.11—in particular, subsection 210.11(a)—provides that the Commission will, upon institution of an investigation, serve copies of the nonconfidential version of the complaint and the notice of investigation upon the respondent(s), the embassy in Washington, DC of the country in which each respondent is located, and various government agencies. Subsection 210.11(a)(2) concerns service by the Commission when it has instituted temporary relief proceedings. The proposed rule would amend subsection 210.11(a)(2)(i) to clarify that the Commission will serve on each respondent a copy of the nonconfidential version of the motion for temporary relief, in addition to the nonconfidential version of the complaint and the notice of investigation.
Section 210.12 specifies the information that a complainant must include in a complaint requesting institution of an investigation under Part 210. In particular, subsection 210.12(a)(9) details the information a complainant is required to include when alleging a violation of section 337 with respect to the infringement of a valid and enforceable U.S. patent. The proposed rule would amend subsection 210.12(a)(9) by adding the requirement that complaints include the expiration date of each asserted patent.
Section 210.14 provides for various pre- and post-institution actions, including amending the complaint and notice of investigation, making supplemental submissions, introducing counterclaims, providing submissions on the public interest, and consolidating investigations. The proposed rule would amend section 210.14 to add subsection 210.14(h), allowing the administrative law judge to sever an investigation into two or more investigations at any time prior to or upon issuance of the procedural schedule, based upon either a motion or upon the administrative law judge's judgment that severance is necessary to allow efficient adjudication. The Commission is seeking in particular comments regarding whether the administrative law judge's decision to sever should be in the form of an initial determination pursuant to new subsection 210.42(c)(3) or an order.
The proposed rule would also add subsection 210.14(i), authorizing the administrative law judge to issue an order designating a potentially dispositive issue for an early ruling. The proposed rule would also provide authority for the presiding administrative law judge to hold expedited hearings on such dispositive issues in accordance with section 210.36.
Section 210.15 provides the procedure and requirements for motions during the pendency of an investigation and related proceedings, whether before an administrative law judge or before the Commission. The proposed rule would amend subsection 210.15(a)(2) to clarify that this provision does not allow
Section 210.19 provides for intervention in an investigation or related proceeding. The proposed rule would amend section 210.19 to clarify that motions to intervene may be filed only after institution of an investigation or a related proceeding.
Subsections 210.21(b)(2) and (c)(2) authorize the presiding administrative law judge to grant by initial determination motions to terminate an investigation due to settlement or consent order, respectively. The subsections further provide that the Commission shall notify certain agencies of the initial determination and the settlement agreement or consent order. Those agencies include the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service (now U.S. Customs and Border Protection), and such other departments and agencies as the Commission deems appropriate.
Currently, the Commission effects such notice through various electronic means, including posting a public version of the initial determination and public versions of any related settlement agreements or consent orders on its Web site. The proposed rule would amend subsections 210.21(b)(2) and (c)(2) to clarify that the Commission need not specifically notify the listed agencies regarding any such initial determination and related settlement agreements or consent orders. This change is intended to conserve Commission resources and does not relieve the Commission of its obligation under section 337(b)(2) to consult with and seek advice and information from the indicated agencies as the Commission considers appropriate during the course of a section 337 investigation.
In addition, subsection 210.21(c)(3) sets out the required contents of a consent order stipulation while subsection 210.21(c)(4) sets out the required contents of the consent order. The proposed rule would amend subsection 210.21(c)(3)(ii)(A) to conform to subsection 210.21(c)(4)(x), which requires that the consent order stipulation and consent order contain a statement that a consent order shall not apply to any intellectual property right that has been held invalid or unenforceable or to any adjudicated article found not to infringe the asserted right or no longer in violation by the Commission or a court or agency of competent jurisdiction in a final, nonreviewable decision. The proposed rule would also amend subsection 210.21(c)(4)(viii) to add “any asserted patent claims,” delete “the claims of the asserted patent,” delete the second occurrence of the word “claims,” and add the word “claim” after “unfair trade practice” in the phrase “validity or enforceability of the claims of the asserted patent claims . . . unfair trade practice in any administrative or judicial proceeding to enforce the Consent Order[.]” The proposed rule would further amend subsection 210.21(c)(4)(x) to add “asserted” before “claim of the patent. . . .” and to add “claim” after “or unfair trade practice. . . .” The proposed rule also would add new subsection 210.21(c)(4)(xi) to require in the consent order an admission of all jurisdictional facts, similar to the provision requiring such a statement in the consent order stipulation (210.21(c)(3)(i)(A)).
The proposed rule would add new section 210.22 to allow parties to file a motion within 30 days of institution of the investigation requesting the presiding administrative law judge to issue an order designating a potentially dispositive issue for an early ruling. The proposed rule would also provide authority for the presiding administrative law judge to hold expedited hearings on such issues in accordance with section 210.36.
Section 210.25 provides for the process by which a party may request and the presiding administrative law judge or the Commission may grant sanctions. In particular, subsection 210.25(a)(1) states the grounds for which a party may file a motion for sanctions. The proposed rule would amend subsection 210.25(a)(1) to clarify that a motion for sanctions may be filed for abuse of discovery under subsection 210.27(g)(3).
In addition, subsection 210.25(a)(2) provides that a presiding administrative law judge or the Commission may raise sanctions issues as appropriate. The proposed rule would amend subsection 210.25(a)(2) to clarify that the subsection regarding sanctions for abuse of discovery is subsection 210.27(g)(3).
Section 210.27 contains the general provisions governing discovery during a section 337 investigation or related proceeding. The proposed rule would add section 210.27(e)(5) to add language consistent with Federal Rule of Civil Procedure 26 concerning the preservation of privilege between counsel and expert witnesses. In particular, the proposed rule specifies that privilege applies to communications between a party's counsel and any expert witness retained on behalf of that party and to any draft reports or disclosures that the expert prepares at counsel's behest.
Subsection 210.27(g) details the requirements of providing appropriate signatures with every discovery request, response, and objection, and the consequences for failing to do so. The proposed rule would amend subsection 210.27(g)(3) to clarify that a presiding administrative law judge or the Commission may impose sanctions if, without substantial justification, a party certifies a discovery request, response, or objection in violation of subsection 210.27(g)(2).
Section 210.28 provides for the taking, admissibility, and use of party and witness depositions. In particular, subsection 210.28(h)(3) provides that the deposition of a witness, whether or not a party, may be used for any purpose if the presiding administrative law judge finds certain circumstances exist. The proposed rule would add subsection 210.28(h)(3)(vi) to allow, within the discretion of the presiding administrative law judge, the use of agreed-upon designated deposition testimony in lieu of live witness testimony absent the circumstances enumerated in subsection 210.28(h)(3).
Section 210.32 provides for the use of subpoenas during the discovery phase of a section 337 investigation. In particular, subsection 210.32(d) provides for the filing of motions to quash a subpoena that the presiding administrative law judge has issued. The proposed rule would amend subsection 210.32(d) to clarify that a party upon which a subpoena has been served may file an objection to the subpoena within ten days of receipt of the subpoena, with the possibility of requesting an extension of time for filing objections for good cause shown. The proposed rule would also amend
In addition, subsection 210.32(f) authorizes the payment of fees to deponents or witnesses that are subpoenaed. The proposed rule would amend subsection 210.32(f)(1) to clarify that such deponents and witnesses are entitled to receive both fees and mileage in conformance with Federal Rule of Civil Procedure 45(b)(1) and to correct the antecedent basis for “fees and mileage” as recited in subsection 210.32(f)(2).
Section 210.34 provides for the issuance of protective orders and for the remedies and sanctions the Commission may impose in the event of a breach of a Commission-issued administrative protective order. Subsection 210.34(c)(1) provides that the Commission shall treat the identity of any alleged breacher as confidential business information unless the Commission determines to issue a public sanction. Subsection 210.34(c)(1) also requires the Commission and the administrative law judge to allow parties to make submissions concerning these matters. The proposed rule would amend subsection 210.34(c)(1) to remove the mandatory provision requiring the Commission or the administrative law judge to allow the parties to make written submissions or present oral arguments bearing on the issue of violation of a protective order and the appropriate sanctions therefor. The Commission and the administrative law judge continue to have discretion to permit written submissions or oral argument bearing on administrative protective order violations and sanctions therefor. In the interest of preserving the confidentiality of the process, the Commission has decided that notification of all parties in an investigation regarding breach of a protective order may be inappropriate in many cases. Submissions from relevant persons will be requested as necessary and appropriate.
Section 210.42 provides for the issuance of initial determinations by the presiding administrative law judge concerning specific issues, including violation of section 337 under subsection 210.42(a)(1)(i), on motions to declassify information under subsection 210.42(a)(2), on issues concerning temporary relief or forfeiture of temporary relief bonds under subsection 210.42(b), or on other matters as specified in subsection 210.42(c).
The proposed rule would add subsection 210.42(a)(3) authorizing the presiding administrative law judge to issue an initial determination ruling on a potentially dispositive issue in accordance with a Commission order under new subsection 210.10(b)(3) or the administrative law judge's order issued pursuant to new section 210.22. In addition, the proposed rule would require the administrative law judge to certify the record to the Commission and issue the initial determination within 100 days of when the issue is designated by the Commission pursuant to 210.10(b)(3) or by the administrative law judge pursuant to 210.14(i) or 210.22. The 100-day period for certification may be extended for good cause shown. This procedure differs from a summary determination proceeding in that the administrative law judge's ruling pursuant to this section is made following an evidentiary hearing. These changes are intended to provide a procedure for the early disposition of potentially dispositive issues identified by the Commission at institution of an investigation or by the administrative law judge early in procedural schedule for the investigation. This procedure is not intended to affect summary determination practice under section 210.18 whereby the ALJ may dispose of one or more issues in the investigation when there is no genuine issue as to material facts and the moving party is entitled to summary determination as a matter of law.
The proposed rule would also add subsection 210.42(c)(3), authorizing the presiding administrative law judge to issue an initial determination severing an investigation into two or more investigations pursuant to new subsection 210.14(h).
In addition, subsection 210.42(e) provides that the Commission shall notify certain agencies of each initial determination granting a motion for termination of an investigation in whole or part on the basis of a consent order or settlement, licensing, or other agreement pursuant to section 210.21, and notice of such other initial determinations as the Commission may order. Those agencies include the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service (now U.S. Customs and Border Protection), and such other departments and agencies as the Commission deems appropriate. The rule further states that the indicated agencies have 10 days after service of any such initial determinations to submit comments. Currently, the Commission effects such notice through various electronic means, including posting a public version of the initial determination on its Web site so that paper service is unnecessary. The proposed rule would amend section 210.42(e) to remove the explicit requirement that the Commission provide any specific notice of or directly serve any initial determinations concerning terminations under section 210.21 on the listed agencies. This change is intended to conserve Commission resources and does not relieve the Commission of its obligation under section 337(b)(2) to consult with and seek advice and information from the indicated agencies as the Commission considers appropriate during the course of a section 337 investigation.
Section 210.43 provides for the process by which a party may request and the Commission may consider petitions for review of initial determinations on matters other than temporary relief. In particular, subsection 210.43(a)(1) specifies when parties must file petitions for review based on the nature of the initial determination, and subsection 210.43(c) specifies when parties must file responses to any petitions for review. The proposed rule would amend subsection 210.43(a)(1) to specify when parties must file petitions for review of an initial determination ruling on a potentially dispositive issue pursuant to new subsection 210.42(a)(3). The proposed rule would further amend subsection 210.43(c) to specify when the parties must file responses to any such petitions for review. Under the proposed rule, parties are required to file a petition for review within five calendar days after service of the initial determination and any responses to the petitions within three business days after service of a petition.
Subsection 210.43(d)(1) provides for the length of time the Commission has
In addition, subsection 210.43(d)(3) provides that, if the Commission determines to grant a petition for review, in whole or in part, and solicits written submissions on the issues of remedy, the public interest, and bonding, the Secretary of the Commission shall serve the notice of review on all parties, the U.S. Department of Health and Human Services, the U.S. Department of Justice, the Federal Trade Commission, the U.S. Customs Service (now U.S. Customs and Border Protection), and such other departments and agencies as the Commission deems appropriate. Currently, the Commission effects such notice through various electronic means, including posting a public version of the notice on its Web site such that paper service is unnecessary. The proposed rule would amend subsection 210.43(d)(3) to remove the explicit requirement that the Commission provide by way of direct service any such notice to the indicated agencies, thus conserving Commission resources. This proposed rule does not affect the Commission's obligation under section 337(b)(2) to consult with and seek advice and information from the indicated agencies as the Commission considers appropriate during the course of a section 337 investigation.
Section 210.47 provides the procedure by which a party may petition the Commission for reconsideration of a Commission determination. The proposed rule would amend section 210.47 to make explicit the Commission's authority to reconsider a determination on its own initiative.
Section 210.50, and in particular subsection 210.50(a)(4), requires the Commission to receive submissions from the parties to an investigation, interested persons, and other Government agencies and departments considering remedy, bonding, and the public interest. Subsection 210.50(a)(4) further requests the parties to submit comments concerning the public interest within 30 days of issuance of the presiding administrative law judge's recommended determination. It has come to our attention that members of the public are confused as to whether subsection 210.50(a)(4) applies to them since the post-recommended determination provision is stated immediately after the provision requesting comments from “interested persons.” The proposed rule would amend subsection 210.50(a)(4) to clarify that the rule concerns post-recommended determination submissions from the parties. Given the variability of the dates for issuance of the public version of the recommended determinations, post-recommended determination submissions from the public are solicited via a notice published in the
Section 210.75 provides for the enforcement of remedial orders issued by the Commission, including exclusion orders, cease and desist orders, and consent orders. Subsection 210.75(a) provides for informal enforcement proceedings, which are not subject to the adjudication procedures described in subsection 210.75(b) for formal enforcement proceedings. In
Subsection 210.75(b) currently provides that the Commission may institute a formal enforcement proceeding upon the filing of a complaint setting forth alleged violations of any exclusion order, cease and desist order, or consent order. The proposed rule would amend subsection 210.75(b)(1), redesignated as 210.75(a)(1), to provide that the Commission shall determine whether to institute the requested enforcement proceeding within 30 days of the filing of the enforcement complaint, similar to the provisions recited in section 210.10(a), barring exceptional circumstances, a request for postponement of institution, or withdrawal of the enforcement complaint.
Moreover, when the Commission has found a violation of an exclusion order, the Commission has issued cease and desist orders as appropriate. The proposed rule would amend subsection 210.75(b)(4), redesignated as 210.75(a)(4), to explicitly provide that the Commission may issue cease and desist orders pursuant to section 337(f) at the conclusion of a formal enforcement proceeding. The proposed rule would also amend subsection 210.75(b)(5), redesignated as 210.75(a)(5), to include issuance of new cease and desist orders pursuant to new subsection 210.75(a)(4).
Section 210.76 provides the method by which a party to a section 337 investigation may seek modification or rescission of exclusion orders, cease and desist orders, and consent orders issued by the Commission. The proposed rule would modify section 210.76(a) to clarify that this section is in accordance with section 337(k)(1) and allows any person to request the Commission to make a determination that the conditions which led to the issuance of a remedial or consent order no longer exist. The proposed rule would also add subsection 210.76(a)(3) to require that, when the requested modification or rescission is due to a settlement agreement, the petition must include copies of the agreements, any supplemental agreements, any documents referenced in the petition or attached agreements, and a statement that there are no other agreements, consistent with rule 210.21(b)(1).
In addition, subsection 210.76(b) specifies that the Commission may institute such a modification or rescission proceeding by issuing a notice. The proposed rule would amend subsection 210.76(b) to provide that the Commission shall determine whether to institute the requested modification or rescission proceeding within 30 days of receiving the request, similar to the provisions recited in section 210.10(a), barring exceptional circumstances, a request for postponement of institution, or withdrawal of the petition for
Section 210.77 provides for the Commission to take temporary emergency action pending a formal enforcement proceeding under subsection 210.75(b) by immediately and without hearing or notice modify or revoke the remedial order under review and, if revoked, to replace the order with an appropriate exclusion order. As noted above, the Federal Circuit held in
Section 210.79 provides that the Commission will, upon request, issue advisory opinions concerning whether any person's proposed course of action or conduct would violate a Commission remedial order, including an exclusion order, cease and desist order, or consent order. The proposed rule would amend subsection 210.79(a) to provide that any responses to requests for advisory opinions shall be filed within 10 days of service. The proposed rule would also amend subsection 210.79(a) to provide that the Commission shall institute the advisory proceeding by notice, which may be amended by leave of the Commission, and shall determine whether to institute within 30 days of receiving the request barring exceptional circumstances, a request for postponement of institution, or withdrawal of the request for an advisory opinion.
Administration practice and procedure, Reporting and recordkeeping requirements.
Administration practice and procedure, Business and industry, Customs duties and inspection, Imports, Investigations.
For the reasons stated in the preamble, the United States International Trade Commission proposes to amend 19 CFR parts 201 and 210 as follows:
Sec. 335 of the Tariff Act of 1930 (19 U.S.C. 1335), and sec. 603 of the Trade Act of 1974 (19 U.S.C. 2482), unless otherwise noted.
(a) * * *
(1) By mailing, delivering, or serving by electronic means a copy of the document to the person to be served, to a member of the partnership to be served, to the president, secretary, other executive officer, or member of the board of directors of the corporation, association, or other organization to be served, or, if an attorney represents any of the above before the Commission, by mailing, delivering, or serving by electronic means a copy to such attorney; or
(4) When service is by mail, it is complete upon mailing of the document. When service is by an express service, service is complete upon submitting the document to the express delivery service or depositing it in the appropriate container for pick-up by the express delivery service. When service is by electronic means, service is complete upon transmission of a notification that the document has been placed in an appropriate repository for retrieval by the person, organization, representative, or attorney being served, unless the Commission is notified that the notification was not received by the party served.
(f)
19 U.S.C. 1333, 1335, and 1337.
(a) * * *
(6) The Commission may determine to institute multiple investigations based on a single complaint where necessary to limit the number of technologies and/or unrelated patents asserted in a single investigation.
(b)(1) An investigation shall be instituted by the publication of a notice in the
(2) The Commission may order the administrative law judge to take evidence and to issue a recommended determination on the public interest based generally on the submissions of the parties and the public under § 210.8(b) and (c). If the Commission orders the administrative law judge to take evidence with respect to the public interest, the administrative law judge will limit public interest discovery appropriately, with particular consideration for third parties, and will ensure that such discovery will not delay the investigation or be used improperly. Public interest issues will not be within the scope of discovery unless the administrative law judge is specifically ordered by the Commission to take evidence on these issues.
(3) The Commission may order the administrative law judge to issue an initial determination as provided in
(a) * * *
(2) * * *
(i) Copies of the nonconfidential version of motion for temporary relief, the nonconfidential version of the complaint, and the notice of investigation upon each respondent; and
(a) * * *
(9) * * *
(xi) The expiration date of each patent asserted.
(h)
(i)
(a) * * *
(2) When an investigation or related proceeding, not including a preinstitution proceeding except as otherwise prescribed by § 210.52, is before the Commission, all motions shall be addressed to the Chairman of the Commission. All motions shall be filed with the Secretary and shall be served upon each party.
Any person desiring to intervene in an investigation or a related proceeding under this part shall make a written motion after institution of the investigation or related proceeding. * * *
The revisions and addition read as follows:
(b) * * *
(2) The motion and agreement(s) shall be certified by the administrative law judge to the Commission with an initial determination if the motion for termination is granted. If the licensing or other agreement or the initial determination contains confidential business information, copies of the agreement and initial determination with confidential business information deleted shall be certified to the Commission simultaneously with the confidential versions of such documents. If the Commission's final disposition of the initial determination results in termination of the investigation in its entirety, a notice will be published in the
(c) * * *
(2)
(3) * * *
(ii) * * *
(A) A statement that if any claim of the patent, copyright, trademark, mask work, boat hull design, or unfair trade practice claim that has expired or is held invalid or unenforceable by a court or agency of competent jurisdiction or if any article has been found or adjudicated not to infringe the asserted right in a final decision, no longer subject to appeal, this Consent Order shall become null and void as to such expired, invalid, or unenforceable claim or as to any adjudicated article;
(4) * * *
(viii) A statement that Respondent and its officers, directors, employees, agents, and any entity or individual acting on its behalf and with its authority shall not seek to challenge the validity or enforceability of any asserted patent claims, copyright, trademark, mask work, boat hull design, or unfair trade practice claim in any administrative or judicial proceeding to enforce the Consent Order;
(x) A statement that if any asserted claim of the patent, copyright, trademark, mask work, boat hull design, or unfair trade practice claim is held invalid or unenforceable by a court or agency of competent jurisdiction or if any article has been found or adjudicated not to infringe the asserted right in a final decision, no longer subject to appeal, this Consent Order shall become null and void as to such invalid or unenforceable claim or adjudicated article;
(xi) An admission of all jurisdictional facts; and
Any party may move within 30 days of institution of the investigation to request that the presiding administrative law judge issue an order designating a potentially dispositive issue for an early ruling. The presiding administrative law judge is authorized, in accordance with
(a)(1) Any party may file a motion for sanctions for abuse of process under § 210.4(d)(1), abuse of discovery under § 210.27(g)(3), failure to make or cooperate in discovery under § 210.33 (b) or (c), or violation of a protective order under § 210.34(c). * * *
(2) The administrative law judge (when the investigation or related proceeding is before the administrative law judge) or the Commission (when the investigation or related proceeding is before it) also may raise the sanctions issue
(e) * * *
(5)(i) The provisions of paragraphs (e)(1) through (4) of this section protect drafts of expert reports, regardless of the form in which the draft is recorded.
(ii) The provisions of paragraphs (e)(1) through (4) of this section protect communications between the party's attorney and expert witnesses concerning trial preparation, regardless of the form of the communications, except to the extent that the communications:
(A) Relate to compensation for the expert's study or testimony;
(B) Identify facts or data that the party's attorney provided and that the expert considered in forming the opinions to be expressed; or
(iii) Identify assumptions that the party's attorney provided and that the expert relied on in forming the opinions to be expressed.
(g) * * *
(3) If without substantial justification a request, response, or objection is certified in violation of paragraph (g)(2) of this section, the administrative law judge or the Commission, upon motion or sua sponte under § 210.25 of this part, may impose an appropriate sanction upon the person who made the certification, the party on whose behalf the request, response, or objection was made, or both.
(h) * * *
(3) * * *
(v) Upon application and notice, that such exceptional circumstances exist as to make it desirable in the interest of justice and with due regard to the importance of presenting the oral testimony of witnesses at a hearing, to allow the deposition to be used; or
(vi) Upon agreement of the parties and within the administrative law judge's discretion, the use of designated deposition testimony in lieu of live witness testimony absent the circumstances otherwise enumerated in this paragraph is permitted.
(d)
(2) Any motion to quash a subpoena shall be filed within 10 days after receipt of the subpoena. The administrative law judge may, for good cause shown, extend the time in which motions to quash may be filed.
(f) * * *
(1)
(c)
The additions and revision read as follows:
(a) * * *
(3)
(c) * * *
(3) A determination pursuant to § 210.14(h) severing an investigation into two or more investigation shall be in the form of an initial determination.
(e)
The revisions read as follows:
(a) * * *
(1) * * * A petition for review of an initial determination issued under § 210.42(a)(3) must be filed within five (5) calendar days after service of the initial determination. * * *
(c)
(d) * * *
(1) The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(a)(2) or § 210.42(c), which grants a motion for summary determination that would terminate the investigation in its entirety if it becomes the final determination of the Commission, § 210.50(d)(3), or § 210.70(c) within 45 days after the service of the initial determination on the parties, or by such other time as the Commission may order. The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(a)(3) within 30 days after the service of the initial determination on the parties, or by such other time as the Commission may order. The Commission shall decide whether to grant, in whole or in part, a petition for review of an initial determination filed pursuant to § 210.42(c), except as noted above, within 30 days after the service of the initial determination on the parties, or by such other time as the Commission may order.
(3) The Commission shall grant a petition for review and order review of an initial determination or certain issues therein when at least one of the participating Commissioners votes for ordering review. In its notice, the Commission shall establish the scope of the review and the issues that will be considered and make provisions for filing of briefs and oral argument if deemed appropriate by the Commission.
Within 14 days after service of a Commission determination, any party may file with the Commission a petition for reconsideration of such determination or any action ordered to be taken thereunder, setting forth the relief desired and the grounds in support thereof. Any petition filed under this section must be confined to new questions raised by the determination or action ordered to be taken thereunder and upon which the petitioner had no opportunity to submit arguments. Any party desiring to oppose such a petition shall file an answer thereto within five days after service of the petition upon such party. The Commission on its own initiative may order reconsideration of a Commission determination or any action ordered to be taken thereunder. The filing of a petition for reconsideration shall not stay the effective date of the determination or action ordered to be taken thereunder or toll the running of any statutory time period affecting such determination or action ordered to be taken thereunder unless specifically so ordered by the Commission.
The revision and additions read as follows:
(a) * * *
(4) Receive submissions from the parties, interested persons, and other Government agencies and departments with respect to the subject matter of paragraphs (a)(1), (a)(2), and (a)(3) of this section.
(i) After a recommended determination on remedy is issued by the presiding administrative law judge, the parties may submit to the Commission, within 30 days from service of the recommended determination, information relating to the public interest, including any updates to the information supplied under §§ 210.8(b) and (c) and 210.14(f). Submissions by the parties in response to the recommended determination are limited to 5 pages, inclusive of attachments. This provision does not apply to the public. Dates for submissions from the public are announced in the
The additions and revision read as follows:
(a) * * *
(1) * * *
(i) The determination of whether to institute shall be made within 30 days after the complaint is filed, unless—
(A) Exceptional circumstances preclude adherence to a 30-day deadline;
(B) The filing party requests that the Commission postpone the determination on whether to institute an investigation; or
(C) The filing party withdraws the complaint.
(ii) If exceptional circumstances preclude Commission adherence to the 30-day deadline for determining whether to institute an investigation on the basis of the complaint, the determination will be made as soon after that deadline as possible.
(iii) If the filing party desires to have the Commission postpone making a determination on whether to institute an investigation in response to the complaint, the filing party must file a written request with the Secretary. If the request is granted, the determination will be rescheduled for whatever date is appropriate in light of the facts.
(iv) The filing party may withdraw the complaint as a matter of right at any time before the Commission votes on
(4) * * *
(iv) Issue a new cease and desist order as necessary to prevent the unfair practices that were the basis for originally issuing the cease and desist order, consent order, and/or exclusion order subject to the enforcement proceeding.
(5) Prior to effecting any issuance, modification, revocation, or exclusion under this section, the Commission shall consider the effect of such action upon the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, and U.S. consumers.
The revisions and additions read as follows:
(a)
(3) If the petition requests modification or rescission of an order issued pursuant to section 337 (d), (e), (f), (g), or (i) of the Tariff Act of 1930 on the basis of a licensing or other settlement agreement, the petition shall contain copies of the licensing or other settlement agreements, any supplemental agreements, any documents referenced in the petition or attached agreements, and a statement that there are no other agreements, written or oral, express or implied between the parties concerning the subject matter of the investigation. If the licensing or other settlement agreement contains confidential business information within the meaning of § 201.6(a) of this chapter, a copy of the agreement with such information deleted shall accompany the motion. On motion for good cause shown, the administrative law judge or the Commission may limit the service of the agreements to the settling parties and the Commission investigative attorney.
(b) * * *
(1) The determination of whether to institute shall be made within 30 days after the petition is filed, unless—
(i) Exceptional circumstances preclude adherence to a 30-day deadline;
(ii) The petitioner requests that the Commission postpone the determination on whether to institute a modification or rescission proceeding;
(iii) The petitioner withdraws the petition; or
(2) If exceptional circumstances preclude Commission adherence to the 30-day deadline for determining whether to institute a modification or rescission proceeding on the basis of the petition, the determination will be made as soon after that deadline as possible.
(3) If the petitioner desires to have the Commission postpone making a determination on whether to institute a modification or rescission proceeding in response to the petition, the petitioner must file a written request with the Secretary. If the request is granted, the determination will be rescheduled for a date that is appropriate in light of the facts.
(4) The petitioner may withdraw the complaint as a matter of right at any time before the Commission votes on whether to institute a modification or rescission proceeding. To effect such withdrawal, the petitioner must file a written notice with the Commission.
(5) The Commission shall institute a modification or rescission proceeding by publication of a notice in the
(a)
(1) The determination of whether to issue and advisory opinion shall be made within 30 days after the petition is filed, unless—
(i) Exceptional circumstances preclude adherence to a 30-day deadline;
(ii) The requester asks the Commission to postpone the determination on whether to institute an advisory proceeding; or
(iii) The petitioner withdraws the request.
(2) If exceptional circumstances preclude Commission adherence to the 30-day deadline for determining whether to institute an advisory proceeding on the basis of the request, the determination will be made as soon after that deadline as possible.
(3) If the requester desires that the Commission postpone making a determination on whether to institute an advisory proceeding in response to its request, the requester must file a written request with the Secretary. If the request is granted, the determination will be rescheduled for whatever date is appropriate in light of the facts.
(4) The requester may withdraw the request as a matter of right at any time before the Commission votes on whether to institute an advisory proceeding. To effect such withdrawal,
(5) The Commission shall institute an advisory proceeding by publication of a notice in the
By order of the Commission.
Federal Highway Administration (FHWA), National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of regulatory review.
Consistent with Executive Order 13563, Improving Regulation and Regulatory Review, and in particular its emphasis on burden-reduction and on retrospective analysis of existing rules, a Request for Comments was published on November 28, 2014, to solicit input on State highway safety plan development and reporting requirements, which specifically refers to the development of the State Highway Safety Plan (HSP) and Strategic Highway Safety Plan (SHSP), and the reporting requirements of the Highway Safety Improvement Program (HSIP) and HSP. Thirty-eight unique letters were received and this document provides a summary of the input from these letters. Given the lack of support for any significant changes in the highway safety plan development and reporting requirements, neither the FHWA nor NHTSA will change the HSP or SHSP development requirements nor change the HSIP or HSP reporting requirements at this time. However, the FHWA and NHTSA will consider the valuable information offered in the responses to inform the agencies' decisions on their respective highway safety programs.
September 24, 2015.
For questions about the program discussed herein, contact Melonie Barrington, FHWA Office of Safety, (202) 366-8029, or via email at
This document, all comments, and the request for comments notice may be viewed on line through the Federal eRulemaking portal at:
On November 28, 2014, FHWA and NHTSA published a Request for Comments at 79 FR 70914 soliciting input on actions FHWA and NHTSA could take to address potentially duplicative State highway safety planning and reporting requirements in order to streamline and harmonize these programs, to the extent possible, in view of the separate statutory authority and focus of the two programs.
The FHWA's HSIP and NHTSA's State Highway Safety Grant Programs share a common goal—to save lives on our Nation's roadways—and have three common performance measures. These programs have complementary but distinctly different focus areas and administrative and operational procedures and requirements. The FHWA's HSIP primarily addresses infrastructure-related projects and strategies. The NHTSA's State Highway Safety Grant Programs primarily focus on driver behavior projects and strategies. One notable distinction is that the statute governing the NHTSA grant program requires State highway safety activities to be under the direct auspices of the Governor. In contrast to the NHTSA grant program, the HSIP is administered by the State Department of Transportation.
Both the HSIP projects and the HSP must be coordinated with the SHSP and both programs contribute to the goals and objectives of the SHSP, but they do so in different ways based on different statutory authority.
The funding for individual project and strategy implementation is contained in the Statewide Transportation Improvement Program for the HSIP and the annual HSP for NHTSA's State Highway Safety Grant Programs. Following the implementation period, the State then reports on progress to implement the projects and strategies and the extent to which they contribute to achieving the State's safety goals and targets. The HSIP report is submitted to FHWA by August 31st each year, while the HSP report is submitted to NHTSA by the end of each calendar year.
The FHWA received comments from 28 State DOT representatives, 7 State Offices of Highway Safety (or similar-named agencies), and 5 associations. The following sections indicate the specific question as stated in the Request for Comments and provide a summary of the associated docket comments.
The responses indicated that the means for collecting and reporting data are unique and often tailored by each State. Several States use a combination of national reporting databases, such as the Fatality Analysis Reporting System (FARS), and their own database(s) specifically developed for their State. According to the Governor's Highway Safety Association (GHSA), most States have created comprehensive, tailored, complex programs that capture the most reliable, relevant data for their own requirements. Many States indicated that data was collected by various departments, yet was available to other
Connecticut, Maine, Pennsylvania, and Rhode Island DOTs, as well as the Minnesota and Washington State Highway Safety Offices stated that reporting on three safety performance measures (number and rate of fatalities, number of severe injuries) was potentially duplicative. Those three performance measures are currently part of the HSP and are proposed for inclusion in the HSIP as noted in NPRM RIN 2125-AF56. Though there is some duplication in reporting, several States, including Missouri and Oregon DOTs, the Arizona Governor's Office of Highway Safety, the California Office of Traffic Safety, and the American Association of State Highway and Transportation Officials (AASHTO) indicated that each report serves a different purpose, and therefore should remain separate. While each report focuses on the efforts of its program, these reports support the overall safety efforts described in the SHSP.
Alaska and Washington State DOTs indicated that behavioral questions on the HSIP online reporting tool are duplicative of HSP reporting requirements. The FHWA would like to clarify that only funds programed and obligated for HSIP projects should be reported in the HSIP online reporting tool.
Regarding streamlining, Delaware, Kentucky, Montana, Oregon, Pennsylvania, and Wisconsin DOT as well as the GHSA specifically stated that streamlining efforts should not be pursued, because duplication is minimal and efforts to change the reporting process would likely increase costs and administrative burden. Some States did offer suggestions for streamlining; the AASHTO, Maine, New Jersey, Rhode Island, and Texas DOTs suggested aligning the reporting periods and submission deadlines for HSIP and HSP reports. The HSP is by statute due to NHTSA by July 1 of each year and a report due December 31. The HSIP annual report is, by regulation, due August 31. The Connecticut DOT, Utah Highway Safety Office, and Washington Traffic Safety Commission suggested that there be a common performance measure reporting tool for both agencies.
As indicated by the responses, data collection is unique to each State. States have developed partnerships and working agreements that allow the collection of data necessary for State highway safety planning. Although a few States indicate there is some repetition in reporting, the majority believe the reports should remain separate. Changes to this process would not provide efficiencies or improve the current practices.
Fourteen State DOTs, four State Offices of Highway Safety, and one association suggested that the existing processes remain unchanged. Only Vermont DOT supported consolidating the HSP for NHTSA and the HSIP for FHWA into a single report. Although Vermont DOT's comment does not specify, FHWA and NHTSA assume that Vermont is referring to the HSP report and the HSIP report. The remainder of the comments on this question suggested minor modifications to the existing processes. New York's State DOT and Governor's Traffic Safety Committee suggested that the plans be combined, yet the reporting remains separate. Eight commenters, including AASHTO, GHSA, Connecticut, Montana, New Jersey, North Dakota, Oregon, and Pennsylvania DOTs suggested that the reports be submitted biannually (every 2 years) rather than annually. Alaska, Rhode Island, Tennessee, and Texas DOTs suggested that the reporting periods and deadlines be aligned between the two reports to reduce burdens and conserve resources.
Rhode Island DOT further suggested that the submission requirements for the HSIP report, HSP and HSP report be the same and that the HSP and HSP report be consolidated. Wisconsin DOT also suggested eliminating duplicate information between the previous fiscal year report and the upcoming fiscal year application for the HSP and HSP report. Rhode Island and Texas DOT suggested improvements related to the HSIP online reporting tools, and creating an online reporting tool for the HSP. Pennsylvania recommended a uniform online reporting format for common performance measures.
To ensure that the HSIP and HSP are being implemented as intended and their programs are achieving their purpose, FHWA and NHTSA will continue to require yearly reporting. However, due to the limited interest in aligning the deadlines of these two reports, the FHWA and NHTSA will not pursue that action. The FHWA and NHTSA will continue to identify opportunities to streamline the reporting and planning process and explore providing additional guidance to assist States in coordinating their safety plans. The FHWA realizes the importance of the online reporting tool and will continue to solicit input on system enhancements from users. The NHTSA is considering developing an online tool for the HSP and HSP report in the future.
Only Vermont suggested combining the HSIP and HSP reports. Twenty-five State DOTs, five State offices of Highway Safety, and three associations (92 percent of the responders) expressed disagreement with combining the plans and reports for HSIP and HSP into a single report. Commenters indicated that combining the reports would lead to increasing the burdens on the States due to more layers of review and approval, thus increasing cost and additional time requirements for coordination above and beyond what is needed. Some States indicated that a combined document would be more difficult to interpret by the intended audiences and that it would also likely increase the review time by FHWA and NHTSA thus potentially delaying program funding and implementation. Based on the overwhelming response against combining the plans and reports, the current planning and reporting structure will be maintained.
While there was quite strong opposition to combining the HSIP and HSP reports, only eight commenters (Michigan, Minnesota, and Washington State DOTs and California, Minnesota, and Washington Offices of Highway Safety, AASHTO and GHSA) indicated that there were organizational barriers to combining the plans and reports. Washington Traffic Safety Commission indicated that combining more reports with Washington State DOT would be an additional burden due to the differences in organizational structure between the two independent agencies. California Office of Traffic Safety indicated that California's organizational structure would make it difficult to combine the plans. Five State DOTs and three State offices of Highway Safety did not specifically state that there were legal or organizational barriers, yet some provided comments indicating how the agencies within the State already work together or comments against combining the plans due to the additional coordination/approval process that would be required beyond what is already being done. Wisconsin DOT stated that “efforts to combine reporting would be cumbersome, time-consuming, disruptive, and costly.” Fourteen State DOTs and one State Office of Highway Safety specifically indicated that there were no legal or organizational barriers to combining the plans and reports. However, several commenters, including Alaska, New Hampshire, North Dakota, and Missouri DOTs acknowledged combining plans or reports would be burdensome and not add any efficiencies or improvements to the process. Furthermore, combining plans would also be unproductive as the SHSP is the State's comprehensive highway safety plan and already coordinates highway safety efforts and builds consensus on safety goals and strategies. These efforts are then implemented though the HSIP and HSP. The responses on organizational or State legal barriers to combining plans or reports further indicates there is not support or a strong desire for a change to the current processes.
Nineteen State DOTs and 4 State Offices of Highway Safety indicated that the SHSP costs do not outweigh the benefits. Responding to ways to improve or eliminate requirements, the Arizona Governor's Office of Highway Safety indicated that requirements related to data collection in general have higher costs than benefits which can essentially reduce the State's ability to satisfy other requirements under MAP-21.
Oregon DOT suggested that FHWA consider eliminating the individual strategy evaluation requirement, and instead focus on data collection to evaluate overall performance on key transportation safety metrics such as fatal and injury crashes over an extended period. The FHWA would like to clarify that evaluation of individual SHSP strategies is not an SHSP requirement; rather State's should assess whether the strategies are being implemented as planned, and review their progress in meeting SHSP goals and objectives, such as reductions in the number of fatalities and serious injuries. Both AASHTO, through its discussions with member States, and GHSA indicated that over time the SHSP principles and process have been embraced and integrated by the State DOTs and Highway Safety Offices, resulting in a safety culture through the planning and programming processes. The AASHTO cautioned against the promulgation of additional guidance on reporting that could disrupt the existing working arrangements and reporting systems currently in place. Similarly, GHSA indicated that because the SHSP process has been incorporated into the planning process already, there were not likely to be improvements that would greatly reduce costs.
Very few commenters provided input related to changes that FHWA should make to the SHSP guidance to promote coordination among State agencies responsible for highway safety. The AASHTO indicated that it would not object to guidance that may encourage State agencies to collaborate and coordinate in the further development of their safety plans, but that any additional mandates to require the collaboration and coordination is unwarranted. Iowa DOT suggested FHWA provide a template for a memorandum of understanding or other type of agreement to institutionalize the collaborative process which outlines the shared and separate responsibilities included in the development of a State's SHSP. Oregon DOT indicated that the current requirements are sufficient, yet there is no enforcement mechanism in place requiring all parties to participate with the FHWA and NHTSA funded State agencies, which are compelled by financing to work together. Rhode Island DOT suggested that FHWA mandate States to designate a full-time employee as the State's SHSP Program Coordinator. The FHWA in coordination with NHTSA will promote noteworthy practices on collaboration and coordination of safety stakeholders in the development and implementation of the SHSP. The FHWA will continue to endorse flexibility in how the States choose to develop their SHSP and HSIP in accordance with MAP-21.
Given the lack of support from State DOTs and Offices of Highway Safety for significant change in the highway safety plan development and reporting requirements process, FHWA and NHTSA will retain the current State highway safety plan development and reporting requirements. The DOT will use the valuable information offered in the responses to streamline and harmonize FHWA and NHTSA highway safety programs.
Agricultural Research Service, USDA.
Notice of intent.
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Oregon State University of Corvallis, Oregon, an exclusive license to the variety of blueberry described in U.S. Plant Patent Application Serial No. 14/545,561, “BLUEBERRY PLANT NAMED `BABY BLUES',” filed on May 21, 2015.
Comments must be received on or before October 26, 2015.
Send comments to: USDA, ARS, Office of Technology Transfer, 5601 Sunnyside Avenue, Rm. 4-1174, Beltsville, Maryland 20705-5131.
Mojdeh Bahar of the Office of Technology Transfer at the Beltsville address given above; telephone: 301-504-5989.
The Federal Government's patent rights in this plant variety are assigned to the United States of America, as represented by the Secretary of Agriculture. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Salmon-Challis National Forest will prepare an environmental impact statement to analyze the potential effects of geothermal development on approximately 5,600 acres. The decision will be whether to proceed with geothermal leasing and, if so, under what stipulations.
Comments concerning the scope of the analysis must be received by October 26, 2015. The draft environmental impact statement is expected in May, 2016 and the final environmental impact statement is expected in September, 2016.
Send written comments to Big Creek Geothermal EIS Project, Salmon-Challis National Forest, 1206 South Challis Street, Salmon, ID 83467. Comments may also be sent via email to
Julie Hopkins, Minerals Program Manager, via email at
The Bureau of Land Management (BLM) received applications for leasing approximately 5,600 acres of Salmon-Challis National Forest (SCNF) lands for exploration and development for geothermal energy production. The SCNF must decide whether these lands are available for leasing by the BLM and, if so, under what stipulations for protection of surface resources. The entire area plus an additional approximately 100 acres for power transmission will be considered in the analysis in the event of future similar interest.
Approximately 5,600 acres of the SCNF lands within the project area would be allocated as open to geothermal leasing subject to existing laws, regulations, formal orders and stipulations attached to the lease form, and the terms and conditions of the standard lease form. Stipulations proposed include: No surface occupancy; controlled surface use; and timing limitations.
The Forest Service, Salmon-Challis National Forest, is the lead agency in this analysis.
The responsible official is the Forest Supervisor of the Salmon-Challis National Forest.
The decision will be whether to implement the action as proposed, implement an alternative which allows leasing under different stipulations or conditions, or not to implement the action. If the decision is to authorize leasing, that decision with associated stipulations and conditions will become an amendment to the Salmon-Challis National Forest Plan or will become a part of the Revised Forest Plan.
This notice of intent initiates the scoping process, which guides the development of the environmental impact statement. The complete Proposed Action, with accompanying maps and descriptions of proposed stipulations, will be posted at:
It is important that reviewers provide their comments at such times and in such manner that they are useful to the agency's preparation of the environmental impact statement. Therefore, comments should be provided prior to the close of the comment period and should clearly
Comments received in response to this solicitation, including names and addresses of those who comment, will be part of the public record for this proposed action. Comments submitted anonymously will be accepted and considered, however.
Agricultural Research Service, National Agricultural Library, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR part 1320 (60 FR 44978, August 29, 1995), this notice announces the National Agricultural Library's intent to request renewal of an approved electronic mailing list subscription form from those whose who work in the field of nutrition.
Comments on this notice must be received by November 23, 2015 to be assured of consideration.
Address all comments concerning this notice to Wendy Davis, Program Leader, Nutrition and Food Safety, U.S. Department of Agriculture National Agricultural Library, 10301 Baltimore Avenue, Beltsville, Maryland 20705. Comments may be sent by fax to (301) 504-6409, or email to
Wendy Davis, telephone (301) 504-6369.
Comments are invited on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and the assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who respond, including the use of appropriate automated, electronic, mechanical, or other technology. Comments should be sent to the address in the preamble. All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the United States Department of Agriculture (USDA) Rural Utilities Service (RUS) invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.
Comments on this notice must be received by November 23, 2015.
Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. Fax: (202) 720-8435 or email
The Office of Management and Budget's (OMB) regulation (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d)). This notice identifies an information collection that RUS is submitting to OMB for extension.
Comments are invited on: (a) 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; (b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP 1522, Washington, DC 20250-1522. Telephone: (202) 690-4492. FAX: (202)720-8435 or email:
The collection will require only that information which is essential for determining: The need for debt settlement; the amount of relief that is needed; the amount of debt that can be repaid; the scheduling of debt repayment; and, the range of opportunities for enhancing the amount of debt that can be recovered. The information to be collected will be similar to that which any prudent lender would require to determine whether debt settlement is required and the amount of relief that is needed. Since the need for relief is expected to vary substantially from case to case, so will the required information collection.
Copies of this information collection can be obtained from Rebecca Hunt, Program Development and Regulatory Analysis at (202) 205-3660. FAX: (202) 720-8435.
All responses to this notice will be summarized and included in the request for OMB approval.
All comments will also become a matter of public record.
September 30, 2015, 6:00 p.m. CDT.
Hilton Americas—Houston, 1600 Lamar Street, Houston, Texas 77010
Open to the public.
The Chemical Safety and Hazard Investigation Board (CSB) will convene a public meeting on September 30, 2015, starting at 6:00 p.m. CDT at the Hilton Americas—Houston, 1600 Lamar Street, Houston, Texas 77010. The Board will discuss its investigation of the incident at the DuPont LaPorte facility that claimed four lives. CSB Staff will present interim findings and proposed recommendations for the Board's review and approval.
The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the “Contact Person for Further Information,” at least three business days prior to the meeting.
This meeting will be webcast for those who cannot attend in person. Please visit
The CSB is an independent federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.
The time provided for public statements will depend upon the number of people who wish to speak. Speakers should assume that their presentations will be limited to five minutes or less, but commenters may submit written statements for the record.
Shauna Lawhorne, Public Affairs Specialist,
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
Estimates from the SAS are essential to a better understanding and higher quality estimates of economic growth, real output, prices, and productivity for our nation's economy. A broad spectrum of government and private stakeholders use these estimates in analyzing business and economic sectors; developing statistics on services; forecasting economic growth; and compiling data on productivity, prices, and the gross domestic product
Annual Services Report is the collection instrument for the SAS. The key inquiries for the SAS are total revenue, total expenses, and general expense detail items. For some sectors, we also collect revenue detail items that are specific to a particular industry. The availability of these data greatly improves the quality of the intermediate-inputs and value-added estimates in BEA's annual input-output and GDP by industry accounts.
A new sample will be introduced with the 2016 SAS survey year. In order to link estimates from the new and prior samples, we will be asking companies to provide data for 2016 and 2015. The 2017 SAS and subsequent years will request one year of data until a new sample is once again introduced.
The estimates produced in the SAS are critical to the accurate measurement of total economic activity.
• The Bureau of Economic Analysis (BEA), the primary Federal user, uses the estimates to develop the national income and product accounts, compile benchmark and annual input-output tables, and compute GDP by industry.
• The Bureau of Labor Statistics (BLS) uses the estimates as inputs to its Producer Price Indexes and in developing productivity measurements.
• The Centers for Medicare and Medicaid Services (CMS) use the estimates for program planning and development of the National Health Expenditure Accounts.
• The Federal Communications Commission (FCC) uses the estimates to assess the impact of regulatory policies.
• International agencies use the estimates to compare total domestic output to changing international activity.
• Private industry also uses the estimates as a tool for marketing analysis.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The MOPS was first collected in 2010, and no subsequent MOPS have been collected. The 2010 MOPS results had the significant benefit of being linked to the Census Bureau's data sets on plant level outcomes. Since every establishment in the MOPS sample is also in the ASM, the results of MOPS 2010 were linked with certainty to annual performance data at the plant level, including outcomes on sales, shipments, payroll, employment, inventories, capital expenditure, and more for the period 2009-2013. Furthermore, the existence of the Longitudinal Business Dataset (LBD) enables future longitudinal research on establishment-level management practices and allows researchers to link MOPS data to the Manufacturing component of the quinquennial Economic Census (sent to all manufacturers with paid employees for years ending in `2' or `7').
Understanding the determinants of productivity growth is essential to understanding the dynamics of the U.S. economy. The MOPS provides information on whether the large and persistent differences in productivity across establishments (even within the same industry) are partly driven by differences in management and organizational practices. In addition to increasing our understanding of the dynamics of the economy, MOPS data provides policymakers with some guidance while they attempt to raise aggregate productivity levels. Policymakers, such as the Federal Reserve Board and the Department of Commerce can use MOPS data to gain a greater understanding of the current state and evolution of management and organizational practices, which can in turn aid the policymakers in forecasting future productivity growth.
The MOPS provides information on differences in manufacturing management and organizational practices by region, industry, and firm size. Since the MOPS data are also connected with annual performance data, the MOPS results directly aid policy discussion about the potential impact of programs. As a result, the MOPS data are also particularly important for understanding what policymakers can do to assist U.S. manufacturing companies as they react to a changing economy.
Further, the 2015 MOPS include two new modules that were not included in the 2010 MOPS. Reflecting the increasing use of data to make production decisions, the MOPS expanded the information collected on this subject (relative to 2010) into a module on “Data and Decisions Making”. Understanding the characteristics of businesses that rely upon data in making decisions helps businesses and policymakers understand the decision-making process
Policymakers and businesses are also increasingly aware of the impact of uncertainty on decisions such as hiring and investing in capital. The 2015 MOPS also has a new module on “Uncertainty” that will help researchers better understand the effects of uncertainty on management decisions.
A notice published in the
From the 2010 MOPS, the Census Bureau created a press release, “Census Bureau Offers First-Ever Large Scale Look at American Management Practices”. Pending an Internal Revenue Service review of the file, the Census Bureau intends to release a Public Use Microdata File from the 2010 collected responses.
The 2015 MOPS will be conducted under authority of title 13, United States Code, sections 131, and 182. The collection is mandatory under the provisions of title 13, United Sates Code, sections 224, and 225.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
The information collected in the 2017 CFS Advance Questionnaire will be used to: Improve the quality of the information the Census Bureau has on the 2017 CFS universe with associated improvements in sampling efficiency, and to provide contact information for the selected establishments, reducing the cost and improving the timeliness of data collection for the 2017 CFS.
The CFS, a component of the Economic Census, is the only comprehensive source of multi-modal, system-wide data on the volume and pattern of goods movement in the United States. The CFS is conducted in partnership with the Bureau of Transportation Statistics (BTS), Office of the Assistant Secretary for Research and Technology, U.S. Department of Transportation.
An advance letter will be mailed to a sample from U.S. manufacturing, mining, and wholesale establishments, enterprise support establishments, electronic shopping, mail-order houses, and publishing establishments, and establishments expected to be selected with certainty in the 2017 CFS. Selected small establishments from industries with a high incidence of non-shipping activity will also receive the letter. The Census Bureau is streamlining operations to conserve taxpayer time and money. This includes moving from paper-based data collection operations to on-line-based data collection operations. The letter will direct the selected establishments to complete the on-line 2017 CFS Advance Questionnaire. No paper questionnaires were created for mailing. Respondents will have the opportunity to print what they report on the on-line questionnaire at the time of data submission for their records.
The six items on the on-line questionnaire attempt the following for each establishment/location:
All information collected in the 2017 CFS Advance Questionnaire will be used internally to improve the 2017 CFS universe and mail-out processing.
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Economic and Statistics Administration, Commerce.
Notice of public meeting.
The Economic and Statistics Administration (ESA) is giving notice of the third meeting of the Commerce Data Advisory Council (CDAC). The CDAC will discuss environmental data, workforce capabilities to improve data operations, data protection, and other Council matters. The CDAC will meet in a plenary session on October 29-30,
October 29-30, 2015. On October 29th, the meeting will begin at approximately 9 a.m. and end at approximately 5 p.m. (MT). On October 30th, the meeting will begin at approximately 9 a.m. and end at approximately 1 p.m. (MT).
The meeting will be held at National Oceanic and Atmospheric Administration's David Skaggs Research Center, 325 Broadway, Boulder, CO 80305.
The meeting is open to the public (See “ENTRY REQUIRMENTS”). Members of the public are welcome to observe the business of the meeting in person or via webcast on the CDAC Web site linked to
1. First and Last name;
2. Organization (if applicable);
3. Email address;
4. State of ID (if applicable),
5. Indicate if you are a U.S. Citizen or a Foreign National; and
6. If you are a not a citizen, please indicate your country of citizenship.
Alternatively, forms of acceptable ID are:
Please visit the “Security Procedure for Visitors” on the Boulder Labs Web site
The meeting is physically accessible to persons with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Director of External Communication as soon as possible, preferably two weeks prior to the meeting.
Seating is available to the public on a first-come, first-served basis.
Burton Reist,
The CDAC is comprised of 19 members, the Commerce Chief Data Officer, and the Economic and Statistics Administration. The Council provides an organized and continuing channel of communication between recognized experts in the data industry (collection, compilation, analysis, dissemination and privacy protection) and the Department of Commerce. The CDAC provides advice and recommendations, to include process and infrastructure improvements, to the Secretary, DOC and the DOC data-bureau leadership on ways to make Commerce data easier to find, access, use, combine and disseminate. The aim of this advice shall be to maximize the value of Commerce data to all users including governments, businesses, communities, academia, and individuals.
The Committee is established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2, Section 10(a)(b)).
In the Matter of:
The Bureau of Industry and Security, U.S. Department of Commerce (“BIS”), has notified Aiman Ammar a/k/a Ayman Ammar (“Ammar”), of Dubai, United Arab Emirates (“U.A.E.”), Rashid Albuni (“Albuni”), of Dubai, U.A.E., Engineering Construction & Contracting Co. (“ECC”), of Damascus, Syria, Advanced Technology Solutions a/k/a Advanced Tech Solutions (“ATS”), of Damascus, Syria, and iT
1. Ammar, Albuni, ECC, ATS, and iT-Wave conspired and acted in concert with others, known and unknown, to bring about or do an act that constitutes a violation of the Regulations. The conspiracy was formed by and among Ammar, Albuni, ECC, and ATS in or about October 2010. iT-Wave joined the conspiracy by no later than in or about January 2013, and the conspiracy continued through at least in or about March 2013. The purpose of the conspiracy was to bring about exports and reexports without the required U.S. Government authorization to Syria, including the Syrian Telecommunications Establishment (“STE”), of computer equipment and software designed for use in monitoring and controlling Web traffic and of other associated equipment. All of these items were subject to the Regulations, and nearly all of them were classified under Export Control Classification Number (“ECCN”) 5A002 and controlled for National Security and Anti-Terrorism reasons and as Encryption Items.
2. The United States has a long-standing and widely-known trade embargo against Syria. With the exception of certain medicines and food, no item subject to the Regulations may be exported or reexported to Syria without a Department of Commerce license, as set forth at all times pertinent hereto in General Order No. 2, codified in Supplement No. 1 to part 736 of the Regulations.
3. In furtherance of the conspiracy, Ammar and Albuni directed activities in and/or from the U.A.E. and Syria in a scheme to export or reexport U.S.-origin or U.S.-controlled equipment and software for use in Syria and in several instances to fulfill contracts with the state-run STE. As set forth in further detail below, Albuni negotiated sales, submitted purchase orders, and served as the end user contact for shipments of controlled items while identifying himself as General Manager of ATS, a Syrian company that has been in operations in the U.A.E., and as Manager of iT-Wave, which identifies itself as an internet computer technology company based in the U.A.E. with operations in Syria. Ammar directed payments for the unlawful exports and reexports to Syria from personal and business bank accounts, including payments from the accounts of ECC, a company based in Damascus, Syria. ECC and ATS share the same P.O. Box address in Damascus, Syria, and upon information and belief are related companies. Ammar also identified himself as the Chief Executive Officer of iT-Wave.
4. Both directly and through regional resellers, Ammar, Albuni, ECC, ATS, and iT-Wave arranged for the procurement of U.S.-origin or U.S.-controlled items for use in Syria. Through various entities, these individuals falsely represented, directly and indirectly, to U.S. companies or their authorized distributors or resellers that the items were intended for end users in such locations as Iraq, Afghanistan, Turkey, Egypt and U.A.E, when they actually were intended for Syria, primarily STE.
5. In or about August 2010, Albuni, holding himself out as General Manager of ATS of Damascus, Syria, requested pricing information from a regional reseller for products produced by Blue Coat Systems, Inc., of Sunnyvale, California (“Blue Coat”). The regional reseller provided the order to Computerlinks FZCO, the authorized distributor in the Middle East for Blue Coat. On or about October 29, 2010, Computerlinks FZCO placed with Blue Coat an order for eight devices used to monitor and control web traffic along with accompanying equipment and software. In order to evade the Regulations, Albuni concealed the fact that the items were destined for Syria, by falsely representing to Blue Coat, through Computerlinks FZCO and the regional reseller, that the items were intended for the Iraq Ministry of Telecom, and provided his personal email address as the end user contact, which also did not indicate a Syrian location. Upon receiving the order, Blue Coat reexported the items from its facility in the Netherlands to Computerlinks FZCO in the U.A.E. On or about December 15, 2010, Computerlinks FZCO directed the items' transfer within the U.A.E. for their subsequent shipment to ECC in Damascus, Syria, for use by the state-run STE. A shipping request notice identified Ammar as the point of contact at ECC for the shipment.
6. On or about December 31, 2010, using the same reseller and distributor channel as for the October 29, 2010 order, a second order was placed for six of the same Blue Coat devices, again with false information being provided indicating that the items were intended for the Iraq Ministry of Telecom and listing the end user contact as Albuni, when the items were in fact destined for Syria. Upon receiving the order, Blue Coat shipped the items from the United States to Computerlinks FZCO in the U.A.E. On or about February 9, 2011, Computerlinks FZCO directed that three of the six devices be transferred within the U.A.E. for their subsequent shipment to ECC in Damascus, Syria. In an air waybill dated February 10, 2011, the freight forwarder identified Ammar as the point of contact for ECC in Damascus, Syria.
7. To satisfy outstanding bills to Computerlinks FZCO for the items for which they falsely stated were for use in
8. On or about May 15, 2011, using a similar reseller and distribution channel, an order was placed for five more devices, along with accompanying equipment and software, from Blue Coat, this time falsely stating that the items were intended for Liwalnet, an Internet service provider in Afghanistan, when in fact the items were again destined for Syria. After the items arrived in the U.A.E. from the Netherlands, on or about May 26, 2011, Computerlinks FZCO directed its freight forwarder to consolidate the remaining three of the six devices and software from the December 31, 2010 order, along with the five devices and software from the May 15, 2011 order, and transfer the ownership of all eight devices and the accompanying equipment within the U.A.E. After the transfer of ownership, Albuni, identifying himself as General Manager of ATS, directed the subsequent shipment of the items to Syria.
9. Finally, on or about June 5, 2011, an order was placed for three additional Blue Coat devices, along with accompanying equipment and software, this time falsely stating that the items were destined purportedly for Turkey for a company named Turkish Marine Services, when the items were in fact destined for Syria. After the items arrived in the U.A.E. from the Netherlands, on or about June 27, 2011, Computerlinks FZCO directed its freight forwarders to transfer ownership of the items within the U.A.E. Albuni in his capacity as General Manager of ATS directed the freight forwarder to ship to him at ATS, which has the same address as ECC in Syria.
10. ECC paid for the May and June orders by two wire transfers dated, respectively, July 12 and 14, 2011.
11. On or about March 24, 2011, Albuni, through his ATS email account, notified a different regional reseller that ATS had received an STE contract and needed assistance in placing orders for the Brocade ServerIron ADX 1000 and related items. These items distribute network or application traffic (load balance) across a number of servers to increase capacity and reliability of applications for networks and large enterprise data centers. On March 27, 2011, an employee of this regional reseller responded that he was negotiating about the order with Mindware, Brocade's authorized reseller in the Middle East, and that he had requested that the reseller ask Brocade to start the manufacturing process so that the items could be delivered in six weeks. After receiving the regional reseller's invoice, Albuni secured payment for the items from Ammar, who, on or about May 10, 2011, directed payment to the regional reseller for the order from ECC's bank account.
12. When Brocade, the U.S. manufacturer, requested end user information in conjunction with its approval of the order on or about April 11, 2011, false information was provided indicating that the end user was a company in Egypt, when in fact the items were destined for STE in Syria. When the order arrived in the U.A.E. in early May 2011, a co-conspirator traveled from Damascus to Dubai to inspect the shipment and found the shipment to be acceptable. Emails received by Albuni indicate that the shipment was eventually delivered to Syria on or about May 17, 2011.
13. Subsequently, in emails and other correspondence among STE and Albuni at ATS and iT-Wave, STE identified hard drive issues relating to three products, some of which were items exported or reexported in 2010-2011 as part of the conspiracy. On or about January 29, 2013, Albuni, identifying himself as a representative of iT-Wave, placed orders with a U.S. company for three hard drives, falsely stating that the items were intended for iT-Wave in Dubai, U.A.E., when in fact the items were destined for STE in Syria. On or about January 30, 2013, the hard drives were shipped from the United States to the U.A.E. to a ship to and bill to address for iT-Wave in Dubai, U.A.E., and transshipped to Syria after their arrival in Dubai. Emails indicate that the hard drives arrived in Damascus, Syria, in early March 2013.
14. Following the failure of additional hard drives, STE sought to acquire more hard drives through Albuni. On or about March 6, 2013, Albuni, holding himself out as a representative of iT-Wave, placed another order with the same U.S. company for the same type of hard drives, again falsely stating that the items were intended for iT-Wave in Dubai, U.A.E., when in fact the items were destined for STE in Syria. On or about the same day, the hard drives were shipped from the United States to iT-Wave in Dubai and transshipped to Syria after their arrival in the U.A.E. Financial records maintained by Ammar, who served both as CEO of iT-Wave and Managing Director of ECC, indicate that ECC paid for the transport of the hard drives from Dubai to Damascus, Syria, for use by STE.
15. As set forth above, Respondents knew at all pertinent times hereto that the items were destined for end users in Syria, as evidenced by, inter alia, email discussions among and between Respondents, the resellers and the forwarders that indicated the final destination was Syria, shipping documents showing Syria as the ultimate destination, and wire transfer payment made from Syria for the items.
16. Respondents also knew at all times pertinent hereto that exports and reexports of the items to Syria were prohibited by the United States' trade embargo against Syria and related export control laws. For example, in an interview with BIS and the Department of Homeland Security special agents on or about August 6, 2013, Ammar admitted that he was “one hundred percent” aware of U.S. sanctions on Syria and stated that “[b]efore the sanctions started, I worked for this American company . . . and when the sanctions started, they told me to Syria we cannot ship.” During this interview, he had a business card that identified him as the managing director of ECC. Based on emails, Albuni, in turn, was aware of U.S. sanctions on Syria, which prevented U.S. companies from having registered partners in Syria, as early as in or about October 2009. Moreover, in correspondence dated November 29, 2010, Albuni indicated that he knew that there were problems shipping to Syria and suggested placing STE orders through a regional reseller, falsely stating that the items were for an Iraq project.
17. As also set forth above, Ammar and Albuni managed and/or controlled ECC, ATS, and iT-Wave, through which
18. In so doing, Ammar, Albuni, ECC, ATS, and iT-Wave each violated Section 764.2(d) of the Regulations.
19. As set forth in Paragraphs 1-10 and 15-17,
20. In so doing, Ammar, Albuni, ECC, and ATS committed four violations of Section 764.2(h) of the Regulations and are jointly and severally liable for those violations.
21. As set forth in Paragraphs 1-4, 11-12, and 15-17,
22. In so doing, Ammar, Albuni, ECC, and ATS committed one violation of Section 764.2(h) of the Regulations and are jointly and severally liable for that violation.
23. As set forth in Paragraphs 1-4 and 13-17,
24. In so doing, Ammar, Albuni, ECC, and iT-Wave committed two violations of Section 764.2(h) of the Regulations and are jointly and severally liable for those violations.
WHEREAS, BIS and Respondents have entered into a Settlement Agreement pursuant to Section 766.18(b) of the Regulations, whereby they agreed to settle this matter in accordance with the terms and conditions set forth therein; and
WHEREAS, I have approved of the terms of such Settlement Agreement; IT IS THEREFORE ORDERED:
FIRST, Respondents shall be assessed a civil penalty in the amount of $7,000,000. Respondents are jointly and severally liable for the payment of this civil penalty. Payment of $250,000 shall be made to the U.S. Department of Commerce in four installments as follows: $62,500 not later than March 1, 2016; $62,500 not later than September 1, 2016; $62,500 not later than March 1, 2017; and $62,500 not later than September 1, 2017. Payment shall be made in the manner specified in the attached instructions. Payment of the remaining $6,750,000 shall be suspended for a period of two years from the date of this Order, and thereafter shall be waived, provided that during this two-year payment probationary period under this Order, Respondent has committed no violation of the Act, or any regulation, order, license or authorization issued thereunder and has made full and timely payment of $250,000 as set forth above. If any of the four installment payments is not fully and timely made, any remaining scheduled installment payments and any suspended penalty may become due and owing immediately.
SECOND, pursuant to the Debt Collection Act of 1982, as amended (31 U.S.C. 3701-3720E (2000)), the civil penalty owed under this Order accrues interest as more fully described in the attached Notice, and if payment is not made by the due date specified herein, Respondents will be assessed, in addition to the full amount of the civil penalty and interest, a penalty charge and an administrative charge, as more fully described in the attached Notice.
THIRD, for the applicable time periods, starting from the date of this Order, that are set forth in Paragraph Sixth below, Aiman Ammar a/k/a Ayman Ammar, with last known addresses of Princess Tower, Apartment 3803, Al Sufouh Street, Dubai Marina, Dubai, U.A.E., and 1265 Camden Way, Yuba City, CA 95991; Rashid Albuni, with last known addresses of The Gardens Building 65, Apartment 12, Dubai, U.A.E., and Dubai Silicon Oasis, Office #AG 05-2, Dubai, U.A.E.; Engineering Construction & Contracting Co., with last known addresses of P.O. Box 25858, Damascus, Syria, and Abu Romana Area, Shahin Building, Ground Floor, Damascus, Syria; Advanced Tech Solutions a/k/a Advanced Technology Solutions, with last known addresses of P.O. Box 25858, Damascus, Syria, and Moasa Square, Takriti Building, Fourth Floor, Damascus, Syria; and iT Wave FZCO a/k/a iT-Wave a/k/a ITEX-Wave FZCO, with last known addresses of Dubai Silicon Oasis, Office #AG 05-2, Dubai, U.A.E., and The Gardens Building 65, Apartment 12, Dubai, U.A.E., and when acting for or on their behalf, their successors, assigns, directors, officers, employees, representatives, or agents (hereinafter each a “Denied Person” and collectively the “Denied Persons”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations, including, but not limited to:
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in
FOURTH, for the applicable time periods, starting from the date of this Order, that are set forth in Paragraph Sixth below, no person may, directly or indirectly, do any of the following:
A. Export or reexport to or on behalf of a Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by a Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby a Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from a Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from a Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by a Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by a Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
FIFTH, after notice and opportunity for comment as provided in section 766.23 of the Regulations, any person, firm, corporation, or business organization related to a Denied Person by affiliation, ownership, control, or position of responsibility in the conduct of trade or related services may also be made subject to the provisions of this Order for the applicable time periods, starting from the date of this Order, that are set forth in Paragraph Sixth, below.
SIXTH, that the provisions of Paragraphs Third, Fourth, and Fifth, above, shall apply for the following periods of time:
A. As to Engineering Construction & Contracting Co., and when acting for or on its behalf, its successors, assigns, directors, officers, employees, representatives, or agents, for a period of seven (7) years from the date of this Order;
B. As to Advanced Tech Solutions a/k/a Advanced Technology Solutions, and when acting for or on its behalf, its successors, assigns, directors, officers, employees, representatives, or agents, for a period of seven (7) years from the date of this Order;
C. As to Rashid Albuni, and when acting for or on his behalf, his successors, assigns, representatives, agents, or employees, for a period of six (6) years from the date of this Order;
D. As to Aiman Ammar a/k/a Ayman Ammar, and when acting for or on his behalf, his successors, assigns, representatives, agents, or employees, for a period of five (5) years from the date of this Order; and
E. As to iT Wave FZCO a/k/a iT-Wave a/k/a ITEX-Wave FZCO, and when acting for or on its behalf, its successors, assigns, directors, officers, employees, representatives, or agents, for a period of four (4) years from the date of this Order.
SEVENTH, Respondents shall not take any action or make or permit to be made any public statement, directly or indirectly, denying the allegations in the Charging Letter or this Order. The foregoing does not affect Respondents' testimonial obligations in any proceeding, nor does it affect its right to take legal or factual positions in civil litigation or other civil proceedings in which the U.S. Department of Commerce is not a party.
EIGHTH, that the Charging Letter, the Settlement Agreement, and this Order shall be made available to the public.
NINTH, that this Order shall be served on Respondents, and shall be published in the
This Order, which constitutes the final agency action in this matter, is effective immediately.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On March 13, 2015, the Department of Commerce (the “Department”) initiated a changed circumstance review (“CCR”) of the antidumping duty (“AD”) order on multilayered wood flooring from the People's Republic of China (“PRC”) in response to a request from Sino-Maple (JiangSu) Co., Ltd. (“Sino-Maple”), an exporter of subject merchandise to the United States.
Krisha Hill, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4037.
On December 23, 2014, Sino-Maple requested that the Department initiate an expedited CCR to confirm that Sino-Maple is the successor-in-interest to Jiafeng for purposes of determining AD liabilities.
Based on this information, the Department initiated this CCR on March 13, 2015, explaining that, while there was sufficient evidence to initiate a CCR, the Department determined not to conduct its review on an expedited basis by publishing the preliminary results in conjunction with its notice of initiation. Specifically, we noted that the purported predecessor company, Jiafeng, was still in a 180-day liquidation period. We stated that we intended to issue additional questionnaires to Sino-Maple, as authorized by 19 CFR 351.221(b)(2), upon completion of the 180-day liquidation period, seeking evidence that Jiafeng has been terminated and that Jiafeng's liquidation was completed.
The merchandise covered by the order includes multilayered wood flooring, subject to certain exceptions. Imports of the subject merchandise are provided for under the following subheadings of the Harmonized Tariff Schedule of the United States (“HTSUS”): 4412.31.0520; 4412.31.0540; 4412.31.0560; 4412.31.2510; 4412.31.2520; 4412.31.4040; 4412.31.4050; 4412.31.4060; 4412.31.4070; 4412.31.5125; 4412.31.5135; 4412.31.5155; 4412.31.5165; 4412.31.3175; 4412.31.6000; 4412.31.9100; 4412.32.0520; 4412.32.0540; 4412.32.0560; 4412.32.2510; 4412.32.2520; 4412.32.3125; 4412.32.3135; 4412.32.3155; 4412.32.3165; 4412.32.3175; 4412.32.3185; 4412.32.5600; 4412.39.1000; 4412.39.3000; 4412.39.4011; 4412.39.4012; 4412.39.4019; 4412.39.4031; 4412.39.4032; 4412.39.4039; 4412.39.4051; 4412.39.4052; 4412.39.4059; 4412.39.4061; 4412.39.4062; 4412.39.4069; 4412.39.5010; 4412.39.5030; 4412.39.5050; 4412.94.1030; 4412.94.1050; 4412.94.3105; 4412.94.3111; 4412.94.3121; 4412.94.3131; 4412.94.3141; 4412.94.3160; 4412.94.3171; 4412.94.4100; 4412.94.5100; 4412.94.6000; 4412.94.7000; 4412.94.8000; 4412.94.9000; 4412.94.9500; 4412.99.0600; 4412.99.1020; 4412.99.1030; 4412.99.1040; 4412.99.3110; 4412.99.3120; 4412.99.3130; 4412.99.3140; 4412.99.3150; 4412.99.3160; 4412.99.3170; 4412.99.4100; 4412.99.5100; 4412.99.5710; 4412.99.6000; 4412.99.7000; 4412.99.8000; 4412.99.9000; 4412.99.9500; 4418.71.2000; 4418.71.9000; 4418.72.2000; 4418.72.9500; and 9801.00.2500.
While HTSUS subheadings are provided for convenience and customs purposes, the written description of the subject merchandise is dispositive.
A complete description of the scope of the order is contained in the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
In accordance with section 751(b)(1) of the Act, we are conducting this CCR based upon the information contained in Sino-Maple's submissions. In making a successor-in-interest determination, the Department typically examines several factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.
Based on the record evidence, we preliminarily determine that Sino-Maple is the successor-in-interest to Jiafeng because Sino-Maple operates materially the same as Jiafeng with respect to the subject merchandise, albeit in a new location. Specifically, we find that any changes that may have occurred after Jiafeng became Sino-Maple did not constitute material changes to management, supplier relationships, customer relationships, or ownership/legal structure with respect to the production and sale of the subject merchandise. A list of topics discussed in the Preliminary Decision Memorandum appears in the Appendix to this notice.
If the Department upholds these preliminary results in the final results, Sino-Maple will be assigned the cash deposit rate currently assigned to Jiafeng with respect to the subject merchandise (
Interested parties may submit written comments by no later than 30 days after the date of publication of these preliminary results of review in the
Any interested party may request a hearing to the Assistant Secretary of Enforcement and Compliance using ACCESS within 30 days of publication of this notice in the
In accordance with 19 CFR 351.216(e), the Department intends to issue the final results of this CCR not later than 270 days after the date on which this review was initiated.
The Department is issuing and publishing these preliminary results in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.221.
Enforcement & Compliance, International Trade Administration, Commerce.
Invitation for Comment on Antidumping Suspension Agreement on Certain Cut-to-Length Carbon Steel Plate from the Russian Federation.
On May 5, 2015, ArcelorMittal USA, Inc., Nucor Corporation, and SSAB North America Division (collectively, “domestic interested parties”), filed with the U.S. Department of Commerce (“Department”) a request to terminate the 2003 Agreement Suspending the Antidumping Investigation of Certain Cut-to-Length Carbon Steel Plate from the Russian Federation (“Agreement”) (“request to terminate”). For the reasons stated in this notice, the Department is requesting comments on whether suspension of the investigation is no longer in the “public interest” under sections 734(d) and 734(i) of the Tariff Act of 1930, as amended (“Act”).
Sally C. Gannon or Julie H. Santoboni, Enforcement & Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, telephone: (202) 482-0162 or (202) 482-3063, respectively.
In January 2003, the non-market economy suspension agreement signed in October 1997 on cut-to-length carbon steel plate (“CTL plate”) from the Russian Federation was replaced with a market-economy agreement with Russian producers under section 734(b) of the Act.
On May 5, 2015, the domestic interested parties filed a request that the Department terminate the Agreement because it is no longer in the public interest and because Severstal may have violated the Agreement. On May 14, 2015, the Ministry of Economic Development of the Russian Federation (“Economy Ministry”) filed a letter in response to the domestic interested parties' request to terminate the Agreement. On May 18, 2015, Severstal filed a letter in response to the domestic interested parties' request to terminate the Agreement.
The products covered by the Agreement are CTL plate from the Russian Federation. This merchandise is currently classified in the Harmonized Tariff Schedule of the United States (HTS) under item numbers 7208.40.3030, 7208.40.3060, 7208.51.0030, 7208.51.0045, 7208.51.0060, 7208.52.0000, 7208.53.0000, 7208.90.0000, 7210.70.3000, 7210.90.9000, 7211.13.0000, 7211.14.0030, 7211.14.0045, 7211.90.0000, 7212.40.1000, 7212.40.5000, and 7212.50.0000. Although the HTS subheadings are provided for convenience and customs purposes, our written description of the scope of the Agreement is dispositive. For a full description of the scope of this Agreement, see Appendix B of the Agreement.
As discussed above, the Department has received a request to terminate the Agreement from the domestic interested parties and is currently evaluating the request. The Agreement, at Section F, provides that “{i}f the Department determines that the Agreement is being or has been violated or no longer meets
Section 734(i) of the Act provides that where, as here, the investigation was completed, the Department shall publish a determination suspending liquidation and issue an antidumping order under section 736(a) of the Act if the Department determines that there has been a violation of the Agreement, or the Agreement no longer meets certain statutory requirements, including the “public interest” requirement under section 734(d)(1) of the Act. The Department's regulations at 19 CFR 351.209(c)(1) state that if the Department has reason to believe that a suspension agreement no longer meets the requirements of section 734(d) of the Act, including if suspension of the investigation is no longer in the “public interest,” it will publish a notice inviting comment on the suspension agreement. Based on the request to terminate, we find that the requirements of 19 CFR 351.209(c)(1) have been met, and as such, are issuing this notice to seek comments to determine if suspension of the investigation is no longer in the “public interest.” Although the domestic interested parties alleged that Severstal may have violated the terms of the Agreement, we are not soliciting comments on the alleged violation.
The Department will make its determination and if appropriate, take necessary action, in accordance with section 734(i) of the Act and 19 CFR 351.209(c). Further, in making our determination, the Department will consider imports into the United States from all sources of the merchandise, as described in Section A of the Agreement. We also will consider factors including, but not limited to, the following: volume of trade, pattern of trade, whether or not the reseller is an original equipment manufacturer, and the reseller's export price.
Interested parties may submit comments on whether the Agreement is in the public interest via Enforcement & Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”) no later than 30 days after the date of publication of this notice by 5 p.m. Eastern Daylight Time.
When submitting comments via ACCESS, interested parties must upload their submissions to the segment in ACCESS entitled “Suspension Agreement.” The Department intends to address any comments in its determination.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On June 30, 2015, the Department of Commerce (Department) published a notice of preliminary results of a changed circumstance review (CCR) of the antidumping duty (AD) order on fresh garlic from the People's Republic of China (PRC)
Effective September 24, 2015.
Hilary E. Sadler, Esq., AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4340.
For a complete description of the events following the publication of the
The products covered by the order are all grades of garlic, whole or separated into constituent cloves, whether or not peeled, fresh, chilled, frozen, water or other neutral substance, but not prepared or preserved by the addition of other ingredients or heat processing. The subject garlic is currently classifiable under subheadings: 0703.20.0000, 0703.20.0010, 0703.20.0015, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700, 2005.99.9700, and of the Harmonized Tariff Schedule of the United States (HTSUS). While the HTSUS subheadings are provided for convenience and customs purposes, the written description of the scope of the
All issues raised by the parties in the case briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed in the Issues and Decision Memorandum is appended to this notice.
Upon review of the comments received, the Department has determined that Shanfu II operates in most material respects as a different business entity than Shanfu I, as discussed in the
As a result of this determination, the Department finds that Yongjia and Shanfu II are subject to the cash deposit rate currently assigned to the PRC-wide entity with respect to the subject merchandise,
This notice is the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
We are issuing and publishing these final results in accordance with sections 751(b)(1) and 777(i)(1) and (2) of the Act, and 19 CFR 351.216.
National Institute of Standards and Technology (NIST), Commerce.
Notice.
This notice announces a modification to existing provisions of the National Institute of Standards and Technology's (NIST) Alternative Personnel Management System (APMS), changing the classification structure for the Administrative (ZA) career path, Pay Bands I through IV, based upon a classification review of the level of difficulty and responsibility associated with each Pay Band.
This notice is effective on September 24, 2015.
For further information, please contact Janet Hoffman, by telephone at (301) 975-3185 or by email at
In accordance with Public Law 99-574, the National Bureau of Standards Authorization Act for Fiscal Year 1987, the Office of Personnel Management (OPM) approved a demonstration project plan, “Alternative Personnel Management System (APMS) at the National Institute of Standards and Technology (NIST),” and published the plan in the
The plan provides for modifications to be made as experience is gained, results are analyzed, and conclusions are reached on how the system is working. This notice modifies the classification structure for the Administrative (ZA) career path, Pay Bands I through IV, based upon a classification review of the level of difficulty and responsibility associated with each Pay Band.
The National Institute of Standards and Technology's (NIST) Alternative Personnel Management System (APMS) (62 FR 54604, October 21, 1997) is designed to (1) improve hiring and allow NIST to compete more effectively for high-quality researchers through direct hiring, selective use of higher entry salaries, and selective use of recruiting allowances; (2) motivate and retain staff through higher pay potential, pay-for-performance, more responsive personnel systems, and selective use of retention allowances; (3) strengthen the manager's role in personnel management through delegation of personnel authorities; and (4) increase the efficiency of personnel systems through installation of a simpler and more flexible classification system based on pay banding through reduction of guidelines, steps, and paperwork in classification, hiring, and other personnel systems, and through automation.
This amendment modifies the October 21, 1997
Modification of the APMS is based upon a change in the classification structure of the ZA career path. This new structural change will enable NIST to meet the intended design and objectives of the plan and increase the future vitality of the NIST workforce. The NIST APMS allows the NIST Director to make minor procedural modifications within already existing waivers of law or regulation with appropriate notice. Accordingly, NIST modifies the APMS to change the classification structure for the Administrative (ZA) career path, Pay Bands I through IV (set forth below).
The APMS at NIST, published in the
1. The chart titled “NIST Career Paths and Pay Bands” under the subsection titled “Position Classification” is replaced with:
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before November 23, 2015.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information should be directed to Allison Castellan, (301) 713-3155 ext. 125 or
This request is for revision and extension of a currently approved information collection.
In 1972, in response to intense pressure on United States (U.S.) coastal resources, and because of the importance of U.S. coastal areas, the U.S. Congress passed the Coastal Zone Management Act of 1972 (CZMA), 16 U.S.C. 1451
The coastal zone management grants provide funds to states and territories to: Implement federally-approved coastal management programs; complete information for the Coastal Zone Management Program (CZMP) Performance Management System; develop program assessments multi-year strategies to enhance their programs within priority areas under Section 309 of the CZMA; submit documentation as described in the CZMA Section 306a on the approved coastal zone management programs; submit requests to update their federally-approved programs through amendments or program changes; and develop and submit state coastal nonpoint pollution control programs (CNP) as required under Section 6217 of the Coastal Zone Act Reauthorization Amendments.
Revision: The CZMP Performance Measurement System has been revised to reduce the number of measures on which state programs are required to report, resulting in an overall decrease in reporting burden for the performance measurement system. The assessment process under CZMA Section 309 has also been refined to rely more on readily
Respondents have a choice of electronic or paper formats for submitting program documents, assessment and strategy documents, and other required materials. Grant applications are submitted electronically via Grants.gov and performance reports are submitted electronically through NOAA Grants Online. Performance measurement data is submitted through an online database. Methods of submittal for other program documents and required materials include electronic submittal via email, mail and facsimile transmission of paper forms, or submittal of electronic files on compact disc.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings and hearings.
The Western Pacific Fishery Management Council (Council) will hold meetings of its 121st Scientific and Statistical Committee (SSC), American Samoa Regional Ecosystem Advisory Committee (REAC), Fishing Industry Advisory Committee (FIAC), American Samoa Advisory Panel (AP) and its 164th Council meeting to take actions on fishery management issues in the Western Pacific Region. The Council will also convene meetings of the Pelagic and International Standing Committee, Program Planning and Research Standing Committee, and Executive and Budget Standing Committee.
The meetings will be held between October 13 and October 22, 2015. For specific times and agendas, see
The 121st SSC will be held at the Council office, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, phone: (808) 522-8220. The REAC, FIAC, American Samoa AP, Pelagic and International Standing Committee and 164th Council meetings will be held at the Rex Lee Auditorium, Department of Commerce, Pago Pago, American Samoa; phone: (684) 633-5155. The Program Planning and Research Standing Committee and Executive and Budget Standing Committee will be held at the Sadies by the Sea conference room in Pago Pago, American Samoa; phone: (684) 633-5981. The Fishers Forum will be held at Fagatogo Marina, Fagatogo, American Samoa.
Kitty M. Simonds, Executive Director, phone: (808) 522-8220.
The 121st SSC meeting will be held between 8:30 a.m. and 5 p.m. on October 13-14, 2015. The Council's REAC will be held between 8:30 a.m. and 1 p.m., FIAC between 2 p.m. and 5 p.m. and AP between 6 p.m. and 9 p.m. on October 19, 2015. The Council's Pelagic and International Standing Committee will be held between 9 a.m. and 12 noon, Program Planning and Research Standing Committee between 1 p.m. and 3 p.m., and Executive and Budget Standing Committee between 3 p.m. and 5 p.m. on October 20, 2015. The 164th Council meeting will be held between 8:30 a.m. and 5 p.m. on October 21-22, 2015. In addition, the Council will host a Fishers Forum on October 17, 2015, between 10 a.m. and 3 p.m.
In addition to the agenda items listed here, the SSC and Council will hear recommendations from Council advisory groups. Public comment periods will be provided throughout the agendas. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business. Background documents will be available from, and written comments should be sent to, Mr. Edwin Ebisui, Chair, Western Pacific Fishery Management Council, 1164 Bishop Street, Suite 1400, Honolulu, HI 96813, phone: (808) 522-8220 or fax: (808) 522-8226.
Non-emergency issues not contained in this agenda may come before the Council for discussion and formal Council action during its 163rd meeting. However, Council action on regulatory issues will be restricted to those issues specifically listed in this document and any regulatory issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of an incidental take authorization.
In accordance with the Marine Mammal Protection Act (MMPA) regulations, notification is hereby given that NMFS has issued an Incidental Harassment Authorization (IHA) to the California Department of Transportation (CALTRANS) to take, by harassment, small numbers of four species of marine mammals incidental to the San Francisco-Oakland Bay Bridge (SFOBB) Pier E3 demolition via controlled implosion in San Francisco Bay (SFB or Bay), between October 1 and December 30, 2015.
Effective October 1, 2015, through December 30, 2015.
Requests for information on the incidental take authorization should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910. A copy of the application containing a list of the references used in this document, NMFS' Environmental Assessment (EA), Finding of No Significant Impact (FONSI), and the IHA may be obtained by writing to the address specified above or visiting the Internet at:
Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as “. . . an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.”
Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for a one-year authorization to incidentally take small numbers of marine mammals by harassment, provided that there is no potential for serious injury or mortality to result from the activity. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization.
On March 3, 2015, CALTRANS submitted a request to NMFS for the potential harassment of small numbers of marine mammals incidental to the dismantling of Pier E3 of the East Span of the original SFOBB in SFB, California, in fall 2015. CALTRANS is proposing to remove the Pier E3 via highly controlled implosion with detonations. On April 16, 2015, CALTRANS submitted a revision of its request with an inclusion of a test implosion before the bridge demolition. NMFS determined that the IHA application was complete on May 1, 2015.
A detailed description of the CALTRANS SFOBB East Span Pier E3 demolition via controlled implosion is provided in the
A notice of NMFS' proposal to issue an IHA to CALTRANS was published in the
The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area include Pacific harbor seal (
General information on the marine mammal species found in the San Francisco Bay can be found in Caretta
The underwater impulse noise from controlled implosion for SFOBB Pier E9 demolition in San Francisco Bay has the potential to result in Level B harassment of marine mammal species and stocks from behavioral disturbances and temporary hearing threshold shift (TTS) in the vicinity of the action area. The Notice of Proposed IHA included a discussion of the effects of anthropogenic noise on marine mammals, which is not repeated here. No instances of injury (including permanent hearing threshold shift, or PTS), serious injury, or mortality are
The primary potential impacts to marine mammals and other marine species are associated with overpressure generated from the controlled underwater implosion, such that some fish in the immediate vicinity of the demolition site could be killed. These potential effects are discussed in detail in the
In order to issue an incidental take authorization under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.
For CALTRANS' proposed Pier E3 controlled implosion, NMFS is requiring CALTRANS to implement the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the controlled underwater implosion. In addition to the measures contained in the
Implosion of Pier E3 will only be conducted during daylight hours and with enough time for pre and post implosion monitoring, and with good visibility when the largest exclusion zone can be visually monitored.
Prior to the Pier E3 demolition, CALTRANS should install a Blast Attenuation System (BAS) as described above to reduce the shockwave from the implosion.
Due to the different hearing sensitivities among different taxa of marine mammals, NMFS has established a series of take thresholds from underwater explosions for marine mammals belonging to different functional hearing groups (Table 2). Under these criteria, marine mammals from different taxa will have different impact zones (exclusion zones and zones of influence).
CALTRANS will establish an exclusion zone for both the mortality and Level A harassment zone (permanent hearing threshold shift or PTS, GI track injury, and slight lung injury) using the largest radius estimated harbor and northern elephant seals. Estimates are that the isopleth for PTS would extend out to a radius of 1,160 ft (354 m) for harbor and northern elephant seals to 5,800 ft (1,768 m) for harbor porpoise; covering the entire areas for both Level A harassment and mortality. As harbor porpoises are unlikely to be in the area in November, the exclusion zone boundaries would be set around the calculated distance to Level A harassment for harbor and northern elephant seals. However, real-time acoustic monitoring (
Adherence to calculated distances to Level A harassment for pinnipeds indicates that the radius of the exclusion zone would be 1,160 ft (354 m). The exclusion zone will be monitored by protected species observers (PSOs) and if any marine mammals are observed inside the exclusion, the implosion will be delayed until the animal leaves the area or at least 30 minutes have passed since the last observation of the marine mammal. Hearing group specific exclusion zone ranges for the controlled implosion are provided in Table 3.
There is no exclusion zone for the test implosion because of the small charge to be used.
As shown in Table 2, for harbor and northern elephant seals, this will cover the area out to 212 dB peak SPL or 177 dB SEL, whichever extends out the furthest. Hydroacoustic modeling indicates this isopleth would extend out to 5,700 ft (1,737 m) from Pier E3. For harbor porpoises, this will cover the area out to 195 dB peak SPL or 146 dB SEL, whichever extends out the furthest. Hydroacoustic modeling indicates this isopleth would extend out to 26,500 ft (8,077 m) from Pier E3. As discussed previously, the presence of harbor porpoises in this area is unlikely but monitoring (including real-time acoustic monitoring) will be employed to confirm their absence. For California sea lions, the distance to the Level B TTS zone of influence will cover the area out to 212 dB peak SPL or 200 dB SEL. This distance was calculated at 470 ft (143 m) from Pier E3, well within the exclusion zone previously described. Hearing group specific Level B TTS zone of influence ranges for the controlled implosion are provided in Table 3.
Hearing group specific Level B TTS zone of influence ranges for the test implosion are provided in Table 4.
As shown in Table 2, for harbor seals and northern elephant seals, this will cover the area out to 172 dB SEL. Hydroacoustic modeling indicates this isopleth would extend out to 9,700 ft (2,957 m) from Pier E3. For harbor porpoises, this will cover the area out to 141 dB SEL. Hydroacoustic modeling indicates this isopleth would extend out to 44,500 ft (13,564 m) from Pier E3. As discussed previously, the presence of harbor porpoises in this area is unlikely but monitoring (including real-time acoustic monitoring) will be employed to confirm their absence. For California sea lions, the distance to the Level B behavioral harassment ZOI will cover the area out to 195 dB SEL. This distance was calculated at 800 ft (244 m) from Pier E3, well within the exclusion zone previously described. Hearing group specific Level B behavioral zone of influence ranges for the controlled implosion are provided in Table 3. There is no Level B behavioral ZOI for the test implosion because there would only be one detonation.
If any marine mammal is observed inside the exclusion zone of controlled implosion, the implosion will be delayed until the animal leaves the area or at least 30 minutes have passed since the last observation of the marine mammal.
If any marine mammal is observed inside the Level B ZOIs during the test implosion, the test implosion will be delayed until the animal leaves the area or at least 30 minutes have passed since the last observation of the marine mammal.
If harbor porpoise clicks are detected during passive acoustic monitoring, the implosion will be delayed for 30 minutes after the clicks are ceased.
All PSOs will be equipped with mobile phones and a VHF radio as a backup. One person will be designated as the Lead PSO and will be in constant contact with the Resident Engineer on site and the blasting crew. The Lead PSO will coordinate marine mammal sightings with the other PSOs and the real time acoustic monitor. PSOs will contact the other PSOs when a sighting is made within the exclusion zone or near the exclusion zone so that the PSOs within overlapping areas of responsibility can continue to track the animal and the Lead PSO is aware of the animal. If it is within 30 minutes of blasting and an animal has entered the exclusion zone or is near it, the Lead PSO will notify the Resident Engineer and blasting crew. The Lead PSO will keep them informed of the disposition of the animal.
NMFS has carefully evaluated the mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:
• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals
• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned
• The practicability of the measure for applicant implementation.
Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:
(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).
(2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving and pile removal or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving and pile removal, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).
(4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).
(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.
(6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.
Based on our evaluation of the mitigation measures, as well as other measures considered by NMFS, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an incidental take authorization (ITA) for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. CALTRANS submitted a marine mammal monitoring plan as part of the IHA application. It can be found at
Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:
(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;
(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;
(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:
Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);
Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;
(4) An increased knowledge of the affected species; and
(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.
Monitoring for implosion impacts to marine mammals will be based on the SFOBB pile driving monitoring protocol. Pile driving has been conducted for the SFOBB construction project since 2000 with development of several NMFS-approved marine mammal monitoring plans (CALTRANS 2004; 2013). Most elements of these marine mammal monitoring plans are similar to what would be required for underwater implosions. These monitoring plans would include monitoring an exclusion zone and ZOIs for TTS and behavioral harassment described above. In addition, CALTRANS shall implement passive acoustic monitoring. All monitoring will be conducted by NMFS-approved PSOs. A change is made from the
A minimum of 8-10 PSOs would be required during the Pier E3 controlled implosion so that the exclusion zone, Level B Harassment TTS and Behavioral ZOIs, and surrounding area can be monitored. One PSO would be designated as the Lead PSO and would receive updates from other PSOs on the presence or absence of marine mammals within the exclusion zone and would notify the Blasting Supervisor of a cleared exclusion zone to the implosion.
PSOs shall be positioned near the edge of each of the threshold criteria zones and shall utilize boats, barges, bridge piers and roadway, and sites on Yerba Buena Island and Treasure Island,
The Lead PSO will be in contact with other PSOs and the acoustic monitors. As the time for the implosion approaches, any marine mammal sightings would be discussed between the Lead PSO, the Resident Engineer, and the Blasting Supervisor. If any marine mammals enter the exclusion zone within 30 minutes of blasting, the Lead PSO will notify the Resident Engineer and Blasting Supervisor that the implosion may need to be delayed. The Lead PSO will keep them informed of the disposition of the animal. If the animal remains in the exclusion zone, blasting will be delayed until it has left the exclusion zone. If the animal dives and is not seen again, blasting will be delayed at least 30 minutes. Once the implosion has occurred, the PSOs will continue to monitor the area for at least 60 minutes.
Although any injury or mortality from the implosion of Pier E3 is very unlikely, boat or shore surveys will be conducted for the three days following the event to determine if there are any injured or stranded marine mammals in the area. If an injured or dead animal is discovered during these surveys or by other means, the NMFS-designated stranding team will be contacted to pick up the animal. Veterinarians will treat the animal or conduct a necropsy to attempt to determine if it stranded was a result of the Pier E3 implosion.
Each PSO will record their observation position, start and end times of observations, and weather conditions (sunny/cloudy, wind speed, fog, visibility). For each marine mammal sighting, the following will be recorded, if possible:
While harbor porpoises are not expected to be within the CALTRANS' Pier E3 implosion Level B TTS ZOI (within 26,500 ft [8,077 ms]) in November, real time acoustic monitoring to confirm species absence shallow be implemented as an added measure in addition to active monitoring by trained visual PSOs. Harbor porpoises vocalize frequently with other animals within their group, and use echolocation to navigate and to locate prey. Therefore, as an additional monitoring tool, a real time acoustic monitoring system will be used to detect the presence or absence of harbor porpoises as a supplement to visual monitoring.
The system would involve two bio-acousticians monitoring the site in real time, likely near the north end of Treasure Island as most harbor porpoises appear to pass through the area north of Treasure Island before heading south toward the East Span of the SFOBB. A calibrated hydrophone or towed array would be suspended from a boat and/or several sonobuoys (acoustic information is sent via telemetry to the acoustic boat) or a hydrophone moored offshore with a cable leading to a shore based acoustic station will be deployed outside of the monitoring area of Pier E3. All equipment will be calibrated and tested prior to the implosion to ensure functionality. This system would not be able to give an accurate distance to the animal but would either determine that no cetaceans are in the area or would provide a relative distance and direction so that PSOs could search for the cetaceans and determine if those animals have entered or may enter the Pier E3 implosion area. The bio-acousticians would be in communication with the Lead PSO and would alert the crew to the presence of any cetacean approaching the monitoring area. It would also provide further confirmation that there are no cetaceans around Pier E3 in addition to the visual observations documenting no observations.
The purpose of hydroacoustic monitoring during the controlled implosion of Pier E3 is twofold: (1) To evaluate distances to marine mammal impact noise criteria; and (2) to improve the prediction of underwater noise for assessing the impact of the demolition of the remaining piers through future controlled implosions.
Monitoring of the implosion is specific to two regions around Pier E3 with unique methods, approaches, and plans for each of these regions. These regions include the “near field” and the “far field”. For Pier E3, the near field will comprise measurements taken within 500 ft of the pier while the far field will comprise measurements taken at 500 feet and all greater distances.
Measurements inside the BAS will be made with near and far field systems using PCB 138A01 transducers. At the 100-ft distance, the near field system will use another PCB 138A01 transducer while the far field system will use both a PCB 138A01 transducer and a Reson TC4013 hydrophone. Prior to activating the BAS, ambient noise levels will be measured. While the BAS is operating and before the test implosion, background noise measurements will also be made. After the test implosion, the results will be evaluated to determine if any final adjustments are needed in the measurement systems prior to the Pier E3 controlled implosion. Pressure signals will be analyzed for peak pressure and SEL values prior to the scheduled time of the Pire E3 controlled implosion.
CALTRANS is required to submit a draft monitoring report within 90 days after completion of the construction work or the expiration of the IHA, whichever comes earlier. This draft report would detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS would have an opportunity to provide comments on the draft report within 30 days, and if NMFS has comments, CALTRANS would address the comments and submit a final report to NMFS within 30 days. If no comments are provided by NMFS after 30 days receiving the report, the draft report is considered to be final.
In addition, a stranding plan will be prepared in cooperation with the local NMFS-designated marine mammal stranding, rescue, and rehabilitation center. Although mitigation measures would likely prevent any injuries, preparations will be made in the unlikely event that marine mammals are injured. Elements of that plan would include the following:
1. The stranding crew would prepare treatment areas at the NMFS-designated facility for cetaceans or pinnipeds that
2. A stranding crew and a veterinarian would be on call near the Pier E3 site at the time of the implosion to quickly recover any injured marine mammals, provide emergency veterinary care, stabilize the animal's condition, and transport individuals to the NMFS-designated facility. If an injured or dead animal is found, NMFS (both the regional office and headquarters) will be notified immediately even if the animal appears to be sick or injured from other than blasting.
3. Post-implosion surveys would be conducted immediately after the event and over the following three days to determine if there are any injured or dead marine mammals in the area.
4. Any veterinarian procedures, euthanasia, rehabilitation decisions and time of release or disposition of the animal will be at the discretion of the NMFS-designated facility staff and the veterinarians treating the animals. Any necropsies to determine if the injuries or death of an animal was the result of the blast or other anthropogenic or natural causes will be conducted at the NMFS-designated facility by the stranding crew and veterinarians. The results will be communicated to both CALTRANS and to NMFS as soon as possible with a written report within a month.
Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild [Level A harassment]; or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering [Level B harassment].
Numbers of marine mammals within the Bay may be incidentally taken during demolition using controlled charges (impulse sound) related to the demolition of the original East Span of the SFOBB were calculated based on acoustic propagation models for each functional hearing group and the estimated density of each species in the project vicinity. Specifically, the takes estimates are calculated by multiplying the ensonified areas that are specific to each functional hearing group by the density of the marine mammal species.
There are no systematic line transect surveys of marine mammals within San Francisco Bay, therefore, the in water densities of harbor seals, California sea lions, and harbor porpoises were calculated from 14 years of observations during monitoring for the SFOBB construction and demolition. During the 210 days of monitoring (including 15 days of baseline monitoring in 2003), 657 harbor seals, 69 California sea lions and three harbor porpoises were observed within the waters of the east span of the SFOBB. Density estimates for other species were made from stranding data provided by the MMC (Sausalito, CA; Northern elephant seal).
Most data on harbor seal populations are collected while the seals are hauled out. This is because it is much easier to count individuals when they are out of the water. In-water density estimates rely on haul-out counts, the percentage of seals not on shore based on radio telemetry studies, and the size of the foraging range of the population. Harbor seal density in the water can vary greatly depending on weather conditions or the availability of prey. For example, during Pacific herring runs further north in the Bay (near Richardson Bay, outside of the Pier E3 hydroacoustic zone) in February 2014, very few harbor seals were observed foraging near Yerba Buena Island (YBI) or transiting through the SFOBB area for approximately two weeks. Sightings went from a high of 16 harbor seal individuals foraging or in transit in one day to 0-2 seals per day in transit or foraging through the SFOBB area (CALTRANS 2014). Calculated harbor seal density is a per day estimate of harbor seals in a 1 km
Harbor seal density for the proposed project was calculated from all observations during SFOBB Project monitoring from 2000 to 2014. These observations included data from baseline, pre, during and post pile driving and onshore implosion activities. During this time, the population of harbor seals within the Bay has remained stable (Manugian 2013), therefore, we do not anticipate significant differences in numbers or behaviors of seals hauling out, foraging or in their movements over that 15 year period. All harbor seal observations within a km
Density of harbor seals was highest near YBI and Treasure Island, probably due to the haul-out site and nearby foraging areas in the Coast Guard and Clipper coves. Therefore, density estimates were calculated for a higher density area within 3,936 ft (1,200 m) west of Pier E3, which includes these two foraging coves. A lower density estimate was calculated from the area east of Pier E3 and beyond 3,936 ft (1,200 m) to the north and south of Pier E3.
These density estimates were then extrapolated to the threshold criteria areas delineated by the hydroacoustic models to calculate the number of harbor seals likely to be exposed.
Most data on California sea lion populations are collected while the seals are hauled out as it is much easier to count individuals when they are out of the water. In-water density estimates rely on haul-out counts, the percentage of sea lions not on shore based on radio telemetry studies, and the size of the foraging range of the population. Sea lion density, like harbor seal densities, in the water can vary greatly depending on weather conditions, the availability of prey, and the season. For example, sea lion density increases during the summer and fall after the end of the breeding season at the Southern California rookeries.
For the proposed project, California sea lion density was calculated from all observations during SFOBB monitoring from 2000 to 2014. These observations included data from baseline, pre, during and post pile driving and onshore implosion activities. During this time, the population of sea lions within the Bay has remained stable as have the numbers observed near the SFOBB (Manugian 2013). As a result, we do not anticipate significant differences in the number of sea lion or their movements over that 15 year period. All sea lion observations within a km
Northern elephant seal density around Pier E3 was calculated from the stranding records of the MMC from 2004 to 2014. These data included both injured or sick seals and healthy seals. Approximately 100 elephant seals were reported within the Bay during this time, most of these hauled out and were likely sick or starving. The actual number of individuals within the Bay may be higher as not all individuals would necessarily have hauled out. Some individuals may have simply left the Bay soon after entering. Data from the MMC show several elephant seals stranding on Treasure Island and one healthy elephant seal was observed resting on the beach in Clipper Cove in 2012. Elephant seal pups or juveniles also may strand after weaning in the spring and when they return to California in the fall (September through November).
Harbor porpoise density was calculated from all observations during SFOBB monitoring from 2000 to 2014. These observations included data from baseline, pre, during and post pile driving and onshore implosion activities. Over this period, the number of harbor porpoises that were observed entering and using the Bay increased. During the fifteen years of observational data around the SFOBB Project, only four harbor porpoises were observed and all occurred from 2006 to 2014 (including two in 2014). All harbor porpoise observations within a km
A summary of marine mammal density information is provided in Table 5.
Since the proposed Pier E3 controlled implosion would be carried as a confined explosion, certain elements were taken into the modeling process beyond a simple open-water blast model. Confinement is a concept in blasting that predicts the amount of blast energy that is expected to be absorbed by the surrounding structural material, resulting in the fracturing necessary for demolition. The energy beyond that absorbed by the material is the energy that produces the pressure wave propagating away from the source. NMFS has determined that modeling with confinement was appropriate for the proposed Pier E3 blast by evaluating blast results from case study data for underwater implosions similar to the SFOBB Pier E3 implosion. In addition, the NMFS worked with CALTRANS and compared case study results to published blast models that incorporate a degree of confinement.
Data from 39 comparable underwater concrete blasts were used by CALTRANS to evaluate potential equations for modeling blast-induced peak pressures and subsequent effects to marine mammals (Kiewit-Mason, pers. Comm 2015 in CALTRANS 2015). All 39 blasts occurred in approximately 55 ft (16.8 m) of water, similar to the maximum water depth around Pier E3. In addition, all blasts had burdens (
Using these data, appropriate equations for modeling the associated hydroacoustic impacts are established for the Pier E3 controlled implosion. Cole's unconfined equation greatly overestimated peak pressures for all blasts while Cole's confined equation appeared to most accurately predict observed peak pressures. Oriard's conservative concrete equation overestimated peak pressures, but not as dramatically as under Cole's unconfined equation. NMFS and CALTRANS have opted to use more conservative methods to ensure an additional level of safety when predicting the monitoring zone and potential impact areas to marine mammals from the proposed controlled implosion project.
The applicable metrics discussed are the peak pressure (P
The blast event will consist of a total of 588 individual delays of varying charge weight; the largest is 35 pounds/delay and the smallest is 21 pounds/delay. The blasting sequence is rather complex. On the full height walls, 30 pound weights will be used for the portion below mud line, 35 pound weights will be used in the lower structure immediately above mud line, 29.6 pounds in the midstructure, and 21 pounds in the upper structure. Full details on the delay weights and locations can be found in the Blast Plan (CALTRANS 2015). Blasts will start in several interior webs of the southern portion of the structure followed by the outer walls of the south side. The blasts in the inner walls will occur just prior to the adjacent outer walls. The interior first, exterior second blast sequence will continue across the structure moving from south to north. The time for the 588 detonations is 5.3 seconds with a minimum delay time of 9 milliseconds (ms) between detonations. As the blasting progresses, locations to east, north, and west of the pier will be shielded from the blasting on the interior of the structure from the still-standing exterior walls of the pier. However, towards the conclusion of the blast, each direction will experience blasts from the outer walls that are not shielded.
To estimate
In the calculations, it was also assumed that there would be no self-shielding of the pier as the explosions progress. From the above discussion of the blast sequence, some shielding of the blasts along the interior of the pier will occur. However, the blasts that occur in outer wall (towards the end of the implosion) will not be shielded for all blasts. A blast in the outer wall that has a direct line of sight to the receptor calculation point will not be shielded and will generate the highest peak
Based on the Blast Plan (CALTRANS 2015), the delays are to be placed in 2
Another assumption was to consider only the direct wave from an individual blast. In shallow water, the signal at the receiver point could consist of the direct wave, surface-relief wave generated by the water/air interface, a reflected wave from the bottom, and a wave transmitted through the bottom material (USACE 1991). For estimating
Peak pressures were estimated by following the modified version of the Cole Equation for prediction of blasts in open, deep water (Cole 1948). The peak pressure is determined by:
Estimating the weighted SEL values for the different groups/species is a multiple step process. The first step is to estimate SEL values as a function of distance from the blast pressure versus time histories for each of the six charge weights as a function of distance. The open-water equation used for this calculation was that modified by the USACE (1991) based on methods pioneered by Cole (1948). Pressure as a function of time is given by:
These calculations were then extended to distances out to 160,000 ft (48.8 km).
As discussed previously, there are other wave components that could be considered in the SEL estimation, including the surface relief wave, reflection from the bottom, and transmission through and re-radiation from the bottom. Little or no contribution is expected from the bottom based on its sedimentary nature and previous experiences from measuring noise from underwater pile driving in the area around Pier E3. The
For each of the marine mammal groupings included in Table 2, specific filter shapes apply to each functional hearing group. To apply this weighting, the Fast Fourier Transform (FFT) was calculated for the time histories at each analysis distance. Each FFT was then filtered using the frequency weighted specified for each group. Filter factors were then determined for each distance by subtracting the filtered result from the unfiltered FFT data and determining the overall noise reduction in decibels. These filter factors were applied to the accumulated SEL determined for the entire blast event for each distance from the Pier.
The BAS of the Blast Plan will have an effect on the wave once a blast passes through it. In a research report by USACE in 1964, the performance of a BAS was examined in detail (USACE 1964). It has also been found that for an energy metric such as SEL, the reduction produced by the BAS was equal to or greater than the reduction of the peak pressure (USACE 1991; Rude 2002; Rude and Lee 2007; Rivey 2011). To estimate the reduction for SEL values due to the BAS installed in the Blast Plan (CALTRANS 2015), SEL was reduced by 80%. Effectively, this was done by reducing the SEL by 20 Log (0.20), or 14 dB. Delays below the mudline, which will be located below the BAS, were also reduced by 80% based on an assumption that the outside pier walls here (which will not be removed) and Bay mud sediments will provide a similar level of attenuation. These SEL values and those without the BAS were then compared to the appropriate criteria for each marine mammal group. Because the calculation of SEL is based on the peak pressure, these estimates for the direct wave component are expected to be conservative for the same reasons as described for the peak pressures.
To estimate positive impulse values, the expression originally developed by Cole for open water was used (Cole 1948). This expression includes only contributions from the direct wave neglecting any contribution from the surface relief, bottom reflected, and bottom transmitted consistent with the assumptions used to estimate SEL. In this case, impulse is given by:
Unlike P
The estimated distances (Table 3) to the marine mammal criteria for peak pressure, SEL, and impulse are based on established relationships between charge weight and distance from the literature. The estimated distances were determined assuming unconfined open water blasts from the original Cole equations or the Cole equations modified by USACE. The assumption of open water neglects several effects that could produce lower levels than estimated. These include no shielding by the pier structure prior a specific blast, confining of the individual delays in the holes drilled into the pier structure, and longer distances to individual blasts than assumed by closest distance between the pier and the receptor point. For SEL, the assumption of open water blasts neglects the surface relief wave which at longer distances from the pier, would tend to reduce the SEL due to interference with the direct wave. Although the estimated levels and distances may be conservative, there is sufficient uncertainty in the blast event and its propagation such that further, less conservative adjustments would not be appropriate.
Estimated exposure numbers are subsequently calculated based on modeled ensonified areas and marine mammal density information. However, since many marine mammals are expected to occur in groups, the estimated exposure numbers are adjusted upward by a factor of 2 to provide estimated take numbers. In addition, although modeling shows that no California sea lion would be exposure to noise levels that would result in a take, its presence in the vicinity of SFOBB has been documented. Therefore, take of 2 of California sea lion is assessed. A summary of estimated takes and exposures of marine mammals that could result from CALTRANS' Pier E3 controlled implosion is provided in Table 6.
Negligible impact is “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival” (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, this introductory discussion of our analyses applies to all the species listed in Table 5, given that the anticipated effects of CALTRANS' Pier E3 controlled implosion on marine mammals are expected to be relatively similar in nature. There is no information about the nature or severity of the impacts, or the size, status, or structure of any species or stock that would lead to a different analysis for this activity.
No injuries or mortalities are anticipated to occur as a result of CALTRANS' controlled implosion to demolish Pier E3, and none are authorized. The relatively low marine mammal density and small Level A exclusion zones make injury takes of marine mammals unlikely, based on take calculation described above. In addition, the Level A exclusion zones would be thoroughly monitored before the proposed implosion, and detonation activity would be postponed if an marine mammal is sighted within the exclusion.
The takes that are anticipated and authorized are expected to be limited to short-term Level B harassment (behavioral and TTS). Marine mammals (Pacific harbor seal, northern elephant seal, California sea lion, and harbor porpoise) present in the vicinity of the action area and taken by Level B harassment would most likely show overt brief disturbance (startle reaction) and avoidance of the area from the implosion noise. A few Pacific harbor seals could experience TTS if they occur within the Level B TTS ZOI. However, TTS is a temporary loss of hearing sensitivity when exposed to loud sound, and the hearing threshold is expected to recover completely within minutes to hours. In addition, even if an animal receives a TTS, the TTS would just be a one-time event from a brief impulse noise (about 5 seconds), making it unlikely that the TTS would evolve into PTS. Finally, there is no critical habitat and other biologically important areas in the vicinity of CALTRANS' proposed Pier E3 controlled implosion area (John Calambokidis
The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may kill some fish and cause other fish to leave the area temporarily, thus impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the prescribed monitoring and mitigation measures, NMFS finds that the total marine mammal take from CALTRANS's Pier E3 demolition via controlled implosion will not adversely affect annual rates of recruitment or survival; accordingly we conclude the taking will have a negligible impact on the affected marine mammal species or stocks.
The requested takes represent less than 0.06% of all populations or stocks potentially impacted (see Table 6 in this document). These take estimates represent the percentage of each species or stock that could be taken by Level B behavioral harassment and TTS (Level B harassment). The numbers of marine mammals estimated to be taken are small proportions of the total populations of the affected species or stocks. In addition, the mitigation and monitoring measures (described previously in this document) prescribed in the IHA are expected to reduce even further any potential disturbance to marine mammals.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the mitigation and monitoring measures, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.
There are no subsistence uses of marine mammals in the project area; and, thus, no subsistence uses impacted by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
NMFS has determined that issuance of the IHA will have no effect on listed marine mammals, as none are known to occur in the action area.
NMFS prepared an Environmental Assessment (EA) and a Supplemental Environmental Assessment (SEA) for the take of marine mammals incidental to construction of the East Span of the SF-OBB and made Findings of No Significant Impact (FONSIs) on November 4, 2003 and August 5, 2009. Due to the modification of part of the demolition of the original SFOBB using controlled implosion and the associated mitigation and monitoring measures, NMFS prepared an SEA and analyzed the potential impacts to marine mammals that would result from the modification. A Finding of No Significant Impact (FONSI) was signed in September 2015. A copy of the EA and FONSI is available upon request (see
NMFS has issued an IHA to CALTRANS for the potential harassment of small numbers of four marine mammal species incidental to the SFOBB Pier E3 demolition via controlled implosion in San Francisco Bay, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting and hearing.
The Western Pacific Fishery Management Council (Council) will hold a meeting of its Guam Mariana Archipelago Fishery Ecosystem Plan (FEP) Advisory Panel (AP) to discuss and make recommendations on fishery management issues in the Western Pacific Region.
The Guam Mariana Archipelago FEP AP will meet on Friday, October 9, 2015, between 6 p.m. and 7:30 p.m. All times listed are local island times. For specific times and agendas, see
The Guam Mariana Archipelago FEP AP will meet at the Guam Fishermen's Cooperative Association Lanai in Hagatna, Guam.
Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522-8220.
Public comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific & Statistical Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held Tuesday, October 13, 2015, beginning at 9 a.m. and Wednesday, October 14, 2015, beginning at 9 a.m.
The meeting will be held at the Providence Biltmore Hotel, 11 Dorrance Street, Providence, RI 02903; phone: (401) 421-0700; fax: (401) 455-3050.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee will review information provided by the Council's Scallop PDT and recommend the overfishing levels (OFLs) and acceptable biological catches (ABC) for Atlantic sea scallops for fishing years 2016 and 2017.
The Committee will also review recent stock assessment information from the 2015 Groundfish Operational Assessments updates and information provided by the Council's Groundfish Plan Development Team (PDT) and recommend the overfishing levels (OFLs) and acceptable biological catches (ABCs) for all groundfish stocks (except for Georges Bank yellowtail flounder) managed under the Northeast Multispecies Fishery Management Plan for fishing years 2016-18.
The Committee will continue to review information on and develop
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
Department of the Navy, DoD.
Notice.
Pursuant to the provisions of The Federal Advisory Committee Act (Pub. L. 92-463, as amended), notice is hereby given that the following meeting of the Board of Advisors to the Presidents of the Naval Postgraduate School and the Naval War College and its two subcommittees will be held. This meeting will be open to the public.
The meeting will be held on Wednesday, October 14, 2015, from 10:00 a.m. to 4:30 p.m. and on Thursday, October 15, 2015 from 9:00 a.m. to 3:00 p.m. Eastern Time Zone.
The meeting will be held at 3003 Washington Boulevard, Arlington, VA.
Ms. Jaye Panza, Naval Postgraduate School, Monterey, CA, 93943-5001, telephone number 831-656-2514.
The Committee examines the effectiveness with which the NPS and the NWC are accomplishing its missions. The agenda is as follows:
1. October 14, 2015: General deliberations and inquiry by the NWC BOA Subcommittee and its parent committee NPS/NWC BOA into its programs and mission priorities; re-accreditation review; administration; military construction; leader development continuum; defense planning guidance efforts; and any other matters relating to the operations of the NWC as the board considers pertinent.
2. October 15, 2015: The purpose of the meeting is to elicit the advice of the NPS BOA subcommittee on the Naval Service's Postgraduate Education Program. With its parent committee NPS/NWC BOA, the board will inquire into programs and curricula; instruction; administration; state of morale of the student body, faculty, and staff; fiscal affairs. The committee will review any other matters relating to the operations of the NPS as the board considers pertinent. Individuals without a DoD Government Common Access Card require an escort at the meeting location. For access, information, or to send written statements for consideration at the committee meeting must contact Ms. Jaye Panza, Naval Postgraduate School, 1 University Circle, Monterey, CA 93943-5001 or by fax 831-656-3145 by October 7, 2015.
Department of Energy.
Notice of Open Meeting.
This notice announces a teleconference call of the Commission to Review the Effectiveness of the National Energy Laboratories (Commission). The Commission was created pursuant to section 319 of the Consolidated Appropriations Act, 2014, Public Law 113-76, and in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C., App. 2. This notice is provided in accordance with the Act.
Friday, October 23, 2015 from 1:00 p.m.-2:00 p.m. (ET). To receive the call-in number and passcode, please contact the Commission's Designated Federal Officer (DFO) at the address or phone number listed below.
Karen Gibson, Designated Federal Officer, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585; telephone: (202) 586-3787; email:
The Commission was established to provide advice to the Secretary on the Department's national laboratories. The Commission will review the DOE national laboratories for alignment with the Department's strategic priorities, clear and balanced missions, unique capabilities to meet current energy and national security challenges, appropriate size to meet the Department's energy and national security missions, and support of other Federal agencies. The Commission will also look for opportunities to more effectively and efficiently use the capabilities of the national laboratories and review the use of laboratory directed research and development (LDRD) to meet the Department's science, energy, and national security goals. The Commission will report its findings and conclusions to the Secretary of Energy and the Committees on Appropriations of the House of Representatives and the Senate.
The draft Final Report of the Lab Commission has been posted to the Commission's Web site (
Purpose of the Meeting: This meeting is the final public meeting of the Commission.
Tentative Agenda: The meeting will start at 1:00 p.m. on October 23, 2015. The tentative meeting agenda includes discussion on the draft Final Report of the Commission. The Commissioners will address comments they have received on the report and hear any additional comments from members of the public on the Conference Call. The meeting will conclude at 2:00 p.m. Agenda updates or changes will be posted on the Lab Commission's Web site:
Public Participation: The meeting is open to the public. Individuals who would like to participate in the
Individuals and representatives of organizations who would like to offer comments may do so in writing by emailing:
Minutes: The minutes of the meeting will be available on the Commission's Web site at:
Office of Science, Department of Energy.
Notice of Open Meeting.
This notice announces a meeting of the DOE/NSF Nuclear Science Advisory Committee (NSAC). Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Thursday, October 15, 2015; 9:00 a.m. to 5:30 p.m. Friday, October 16, 2015; 9:00 a.m. to 11:30 a.m.
American Geophysical Union Conference Center, 2000 Florida Avenue NW., Washington, DC 20009, (202) 777-7433.
Brenda L. May, U.S. Department of Energy; SC-26/Germantown Building, 1000 Independence Avenue SW., Washington, DC 20585-1290; Telephone: (301) 903-0536 or email:
To provide advice and guidance on a continuing basis to the Department of Energy and the National Science Foundation on scientific priorities within the field of basic nuclear science research.
Agenda will include discussions of the following:
• Perspectives from Department of Energy and National Science Foundation
• Updates from the Department of Energy and National Science Foundation's Nuclear Physics Office
• Presentation of the 2015 NSAC Long Range Plan Report
• NSAC Discussion of the 2015 Long Range Plan Report
• Presentation of the Charge for the DOE Office of Nuclear Physics Committee of Visitors
• Presentation of the NSAC Subcommittee Report on Neutrinoless Double Beta Decay Report
• Continued NSAC discussion of the Neutrinoless Double Beta Decay Report
• Discussion of Transmittal Letters for the Long Range Plan and Neutrinoless Double Beta Decay Reports
• Public Comment
The NSAC Meeting will be broadcast live on the Internet. You may access the broadcast by going to the following site prior to the start of the meeting. A video record of the meeting, including the presentations that are made, will be archived at this site after the meeting ends:
Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Brenda L. May, at (301) 903-0536 or by email
Minutes: The minutes of the meeting will be available for review on the U.S. Department of Energy's Office of Nuclear Physics Web site at
Department of Energy.
Notice of open meeting.
This notice announces a combined meeting of the Environmental Monitoring and Remediation Committee and Waste Management Committee of the Environmental Management Site-Specific Advisory Board (EM SSAB), Northern New Mexico (known locally as the Northern New Mexico Citizens' Advisory Board [NNMCAB]). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the
Wednesday, October 14, 2015; 2:00 p.m.-4:00 p.m.
NNMCAB Office, 94 Cities of Gold Road, Santa Fe, NM 87506.
Menice Santistevan, Northern New Mexico Citizens' Advisory Board, 94 Cities of Gold Road, Santa Fe, NM 87506. Phone (505) 995-0393; Fax (505) 989-1752 or Email:
Tentative Agenda:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on September 17, 2015, the Southeastern Power Administration submitted a tariff filing: Kerr-Philpott 2015 Rate Adjustment to be effective 10/1/2015.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214).
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, protests, and recommendations is 30 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that the Commission received the following electric rate filings:
ER11-2037-007; ER12-2227-007;ER10-1852-011;
ER10-1887-007; ER10-1920-009;ER10-1928-009;
ER10-1952-007; ER12-1228-009;ER10-1961-007;
ER14-2707-004; ER10-2720-009;ER11-4428-009;
ER12-1880-008; ER12-895-007;ER10-1971-021;
ER14-2710-004; ER15-58-002;ER15-30-002;
ER14-2708-005; ER14-2709-004;ER13-2474-003
Take notice that the Commission received the following electric securities filings:
Take notice that the Commission received the following electric reliability filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
With this notice, we are initiating informal consultation with: (a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under section 7 of the Endangered Species Act and the joint agency regulations thereunder at 50 CFR part 402 and (b) the State Historic Preservation Officer, as required by section 106, National Historic Preservation Act, and the implementing regulations of the Advisory Council on Historic Preservation at 36 CFR 800.2.
With this notice, we are designating the City of Gonzales, Texas as the Commission's non-federal representative for carrying out informal consultation, pursuant to section 7 of the Endangered Species Act and section 106 of the National Historic Preservation Act.
The City of Gonzales, Texas filed with the Commission a Pre-Application Document (PAD; including a proposed process plan and schedule), pursuant to 18 CFR 5.6 of the Commission's regulations.
A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
Register online at
With this notice, we are soliciting comments on the PAD and Commission's staff Scoping Document 1 (SD1), as well as study requests. All comments on the PAD and SD1, and study requests should be sent to the address above in paragraph h. In addition, all comments on the PAD and SD1, study requests, requests for cooperating agency status, and all communications to and from Commission staff related to the merits of the potential application must be filed with the Commission.
The Commission strongly encourages electronic filing. Please file all documents using the Commission's eFiling system at
All filings with the Commission must bear the appropriate heading: “Comments on Pre-Application Document,” “Study Requests,” “Comments on Scoping Document 1,” “Request for Cooperating Agency Status,” or “Communications to and from Commission Staff.” Any individual or entity interested in submitting study requests, commenting on the PAD or SD1, and any agency requesting cooperating status must do so by November 21, 2015.
Although our current intent is to prepare an environmental assessment (EA), there is the possibility that an Environmental Impact Statement (EIS) will be required. Nevertheless, this meeting will satisfy the NEPA scoping requirements, irrespective of whether an EA or EIS is issued by the Commission.
Commission staff will hold two scoping meetings in the vicinity of the project at the time and place noted below. The daytime meeting will focus on resource agency, Indian tribes, and non-governmental organization concerns, while the evening meeting is primarily for receiving input from the public. We invite all interested individuals, organizations, and agencies to attend one or both of the meetings, and to assist staff in identifying particular study needs, as well as the scope of environmental issues to be addressed in the environmental document. The times and locations of these meetings are as follows:
Scoping Document 1 (SD1), which outlines the subject areas to be addressed in the environmental document, was mailed to the individuals and entities on the Commission's mailing list. Copies of SD1 will be available at the scoping meetings, or may be viewed on the web at
The potential applicant and Commission staff will conduct an Environmental Site Review of the project on Thursday, October 22, 2015, starting at 1:00 p.m. All participants should meet at the Gonzales Project Powerhouse, located at 201 Water Street, Gonzales, Texas 78629. All participants are responsible for their own transportation. Anyone planning to attend the site visit should contact Ms. Charlotte Garraway at (830) 249-3887 on or before October 15, 2015.
At the scoping meetings, staff will: (1) Initiate scoping of the issues; (2) review and discuss existing conditions and resource management objectives; (3) review and discuss existing information and identify preliminary information and study needs; (4) review and discuss the process plan and schedule for pre-filing activity that incorporates the time frames provided for in Part 5 of the Commission's regulations and, to the extent possible, maximizes coordination of federal, state, and tribal permitting and certification processes; and (5) discuss the appropriateness of any federal or state agency or Indian tribe acting as a cooperating agency for development of an environmental document.
Meeting participants should come prepared to discuss their issues and/or concerns. Please review the PAD in preparation for the scoping meetings. Directions on how to obtain a copy of the PAD and SD1 are included in item n. of this document.
The meetings will be recorded by a stenographer and will be placed in the public records of the project.
Take notice that on September 4, 2015, Venture Global Calcasieu Pass, LLC (Venture Global) and TransCameron Pipeline, LLC (TransCameron), 2200 Pennsylvania Ave. NW., Suite 600 West, Washington, DC 20037, filed in Docket Nos. CP15-550-000 and CP15-551-000 a joint application pursuant to sections 3 and 7(c) of the Natural Gas Act (NGA), for authorization to construct, install, own, operate, and maintain certain pipeline and liquefied natural gas (LNG) facilities entirely located in Cameron Parish, Louisiana, that comprise the Venture Global Calcasieu Pass Terminal and TransCameron Pipeline Project (Project). In the application TransCameron also request a Part 284, Subpart G blanket certificate and Part 157, Subpart F blanket certificate per regulations of the Federal Energy Regulatory Commission (FERC or Commission) all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may also be viewed on the web at
Any questions concerning this application may be directed to Fory Musser, Senior Vice President, Corporate Development, Venture Global LNG, Inc., 2200 Pennsylvania Ave. NW., Suite 600 West, Washington, DC 20037.
Specifically, Venture Global and TransCameron propose to site, construct, own, and operate a new LNG export terminal and to construct, own, and operate the 23.5-mile-long East Lateral and 19.2-mile-long West Lateral. The pipelines are designed to deliver approximately 1,900,000 Dth/d of firm transportation service. Project cost for the pipelines is estimated at $344.5 million and negotiated rates are proposed. The requested order date and proposed pre-commercial in-service date are September 1, 2016 and July 1, 2019 respectively.
On October 7, 2014, the Commission staff granted Venture Global and TransCameron request to utilize the Pre-Filing Process and assigned Docket No. PF15-2-000 to staff activities involved in the above referenced projects. Now, as of the filing of the September 4, 2015 application, the Pre-Filing Process for this project has ended. From this time forward, this proceeding will be conducted in Docket Nos. CP15-550-000 and CP15-551-000, as noted in the caption of this Notice.
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice, the Commission staff will issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) for this proposal. The issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below, file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit five copies of filings made with the Commission and must mail a copy to the applicant and to every other party in
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Environmental Protection Agency (EPA).
Notice; extension of comment period.
The Environmental Protection Agency (EPA) is extending the comment period for the Agency's draft recommended aquatic life water quality chronic criterion for selenium in freshwater. The draft criterion was announced in a July 27, 2015 notice entitled “Request for Scientific Views: Draft Recommended Aquatic Life Ambient Water Quality Chronic Criterion for Selenium—Freshwater 2015.” In response to stakeholder requests, EPA is extending the period of time in which the Agency will accept scientific views for an additional 15 days.
Comments must be received on or before October 10, 2015. Scientific views postmarked after this date may not receive the same consideration. The comment period was originally scheduled to end on September 25, 2015.
Written comments on the notice may be submitted to the EPA electronically, by mail, by facsimile or through hand delivery/courier. Please refer to the proposal (80 FR 44350-44354) for the addresses and detailed instructions.
Kathryn Gallagher at U.S. EPA, Office of Water, Health and Ecological Criteria Division (4304T), 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: (202) 564-1398; or email:
On July 27, 2015, EPA announced the availability of the draft recommended aquatic life water quality criterion for selenium in a previous notice entitled “Request for Scientific Views: Draft Recommended Aquatic Life Ambient Water Quality Chronic Criterion for Selenium—Freshwater 2015” in the
EPA is extending the public comment period for the Draft Aquatic Life Ambient Water Quality Criterion for Selenium—Freshwater 2015 (EPA-822-P-15-001). The original comment deadline was September 25, 2015. This action extends the comment period for 15 days. Written scientific views must now be received by October 10, 2015.
Following closure of the public comment period, EPA will consider the public comments and revise the document as necessary. EPA will then publish a
Environmental Protection Agency (EPA).
Notice.
The U.S. Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Safe Drinking Water Act State Revolving Fund Program” (EPA ICR No. 1803.07, OMB Control No. 2040-0185) to the Office of Management and Budget (OMB) for review and approval in accordance with the
Comments must be submitted on or before November 23, 2015.
Submit your comments, referencing Docket ID No. EPA-HQ-OW-2002-0059, online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Nick Chamberlain, Drinking Water Protection Division, Office of Ground Water and Drinking Water, 4606M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-1871; fax number: 202-564-3754; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) 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; (ii) 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; (iii) enhance the quality, utility and clarity of the information to be collected; and (iv) 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) Capitalization Grant Application and Agreement/State Intended Use Plan: The state must prepare a Capitalization Grant Application that includes an Intended Use Plan (IUP) outlining in detail how it will use all the funds covered by the capitalization grant. The state may, as an alternative, develop the IUP in a two part process, with one part identifying the distribution and uses of the funds among the various set-asides in the DWSRF program and the other part dealing with project assistance from the Fund.
(2) Biennial Report: The state must agree to complete and submit a Biennial Report on the uses of the capitalization grant. The scope of the report must cover assistance provided by the Fund and all other set-aside activities included under the Capital Grant Agreement. States which jointly administer the DWSRF and the Clean Water State Revolving Fund (CWSRF) programs, in accordance with section 1452(g)(1), may submit reports (according to the schedule specified for each program) which cover both programs.
(3) Annual Audit: A state must comply with the provisions of the Single Audit Act Amendments of 1996. Best management practices suggest and EPA recommends that a state conduct an annual independent audit of its DWSRF program. The scope of the report must cover the DWSRF Fund and all other set-aside activities included in the Capitalization Grant Agreement. States which jointly administer the DWSRF and the CWSRF programs, in accordance with SDWA section 1452(g)(1), may submit audits that cover both programs but which report financial information for each program separately.
(4) Assistance Application Review: Local applicants seeking financial assistance must prepare and submit DWSRF loan applications. States then review completed loan applications and verify that proposed projects will comply with applicable federal and state requirements.
(5) DWSRF National Information Management System (DWNIMS) and the Projects and Benefits Reporting System (PBR): To ensure that funds are being used in an expeditious and timely manner for eligible projects and expenses, states must annually enter state-level financial data into DWNIMS and quarterly enter project-level data into PBR.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board to advise the Agency on the ethical and scientific reviews of EPA research with human subjects.
A public virtual meeting will be held on October 19-20, 2015, from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A separate teleconference meeting is planned for Monday, December 7, 2015, from 1:00 p.m. to approximately 2:30 p.m. for the HSRB to finalize its Final Report of the October 19-20, 2015 meeting.
Both of these meetings will be conducted entirely on the Internet using Adobe Connect. Registration is required to attend this meeting. Please visit the HSRB Web site:
Any member of the public who wishes to receive further information should contact Jim Downing on telephone number (202) 564-2468; fax number: (202) 564-2070; email address:
Meeting access: Access to these Internet meetings are open to all by following the information provided above.
Procedures for providing public input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Section I, “Public Meeting” under subsection D. “How May I Participate in this Meeting?” of this notice.
This action is directed to the public in general. This Notice may, however, be of particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, Fungicide, and Rodenticide Act. This notice might also be of special interest to participants of studies involving human subjects, or representatives of study participants or experts on community engagement. The Agency has not attempted to describe all the specific entities that may have interest in human subjects research. If you have any questions regarding this notice, consult Jim Downing listed under
In addition to using regulations.gov, you may access this
Docket: All documents in the docket are listed in the
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data that you used to support your views.
4. Provide specific examples to illustrate your concerns and suggest alternatives.
5. To ensure proper receipt by the EPA, be sure to identify the Docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
You may participate in these meetings by following the instructions in this section. To ensure proper receipt by the EPA, it is imperative that you identify Docket ID number EPA-HQ-ORD-2015-0588 in the subject line on the first page of your request.
1. Oral comments. Requests to present oral comments during either conference call will be accepted up to Noon Eastern Time on Wednesday, October 14, 2015, for the October 19-20 meeting and up to Noon Eastern Time on Wednesday, December 2, 2015, for the December 7, 2015 conference call. To the extent that time permits, interested persons who have not pre-registered may be permitted by the Chair of the HSRB to present oral comments during either call. Individuals or groups wishing to make brief oral comments to the HSRB on October 19 or 20, 2015, are strongly advised to submit their request (preferably via email) to Jim Downing, listed under
2. Written comments. Submit your written comments prior to the meetings. For the Board to have the best opportunity to review and consider your comments as it deliberates, you should submit your comments by Noon Eastern Time on Wednesday, October 14, 2015, for the October 19-20 meeting, and by noon Eastern Time on Wednesday, December 2, 2015, for the December 7, 2015 teleconference. If you submit comments after these dates, those comments will be provided to the HSRB members, but you should recognize that the HSRB members may not have adequate time to consider your comments prior to their discussion. You should submit your comments using the instructions in Section I., under subsection C., “What Should I Consider as I Prepare My Comments for the EPA?” In addition, the agency also requests that persons submitting comments directly to the docket also provide a copy of their comments to Jim Downing listed under
The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S.C. App.2 § 9. The HSRB provides advice, information, and recommendations to the EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA's programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through the Agency's Science Advisor.
1. Topics for discussion. On Monday, October 19, 2015, EPA's Human Studies Review Board will consider scientific and ethical issues surrounding:
2. Then on Monday, December 7, 2015 the HSRB will finalize its Final Report for the October 19-20, 2015 meeting.
2. Meeting minutes and reports. Minutes of these meetings, summarizing the matters discussed and recommendations, if any, made by the advisory committee regarding such matters, will be released within 90 calendar days of the meeting. Such minutes will be available at
Environmental Protection Agency (EPA).
Notification of public teleconference meeting and public comment.
Pursuant to the Federal Advisory Committee Act, Public Law 92-463, the U.S. Environmental Protection Agency hereby provides notice that the Board of Scientific Counselors (BOSC) Homeland Security Subcommittee will host a public teleconference meeting on Thursday, October 1, 2015, from 1:00 p.m. to 3:00 p.m. Eastern Time. The primary discussion will focus on the draft report summarizing recommendations from the August 25-27, 2015 meeting. There will be a public comment period from 2:45 p.m. to 3:00 p.m. Eastern Time. Members of the public are encouraged to provide comments relevant to the topics of the meeting.
For additional information about registering to attend the meeting or to provide public comment, please see the REGISTRATION and
The BOSC Homeland Security Subcommittee teleconference meeting on Thursday, October 1, 2015, will begin promptly at 1:00 p.m. Eastern Time. Registration: In order to participate on the teleconference you must register at the following site:
Questions or correspondence concerning the teleconference meeting should be directed to Tom Tracy, Designated Federal Officer, Environmental Protection Agency, by mail at 1200 Pennsylvania Avenue NW., (MC 8104 R), Washington, DC 20460; by telephone at 202-564-6518; or via email at
The Charter of the BOSC states that the advisory committee shall provide independent advice to the Administrator on technical and management aspects of the Office of Research and Development's research program. Additional information about the BOSC is available at:
Information about Services for Individuals with Disabilities: For information about access or services for individuals with disabilities, please contact Tom Tracy, at 202-564-6518 or via email at
Environmental Protection Agency (EPA).
Notice of delegation of authority.
On June 24, 2015, the Environmental Protection Agency (EPA) sent the State of West Virginia (West Virginia) a letter acknowledging that West Virginia's delegation of authority to implement and enforce National Emissions Standards for Hazardous Air Pollutants (NESHAP) and New Source Performance Standards (NSPS) had been updated, as provided for under previously approved delegation mechanisms. To inform regulated facilities and the public of West Virginia's updated delegation of authority to implement and enforce NESHAP and NSPS, EPA is making available a copy of EPA's letter to West Virginia through this notice.
On June 24, 2015, EPA sent West Virginia a letter acknowledging that West Virginia's delegation of authority to implement and enforce NESHAP and NSPS had been updated.
Copies of documents pertaining to this action are available for public inspection during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103-2029. Copies of West Virginia's submittal are also available at the West Virginia Department of Environmental Protection, Division of Air Quality, 601 57th Street SE., Charleston, West Virginia 25304.
Ray Chalmers, (215) 814-2061, or by email at
On June 8, 2015, West Virginia notified EPA that West Virginia had updated its incorporation by reference of federal NESHAP and NSPS to include many such standards, as found in the Code of Federal Regulations (CFR), parts 60, 61, and 63, as of June 1, 2014. On June 24, 2015, EPA sent West Virginia a letter acknowledging that West Virginia now has the authority to implement and enforce the NESHAP and NSPS as specified by West Virginia in its notice
The United States Environmental Protection Agency (EPA) has previously delegated to the State of West Virginia (West Virginia) the authority to implement and enforce various federal National Emissions Standards for Hazardous Air Pollutants (NESHAP) and New Source Performance Standards (NSPS), which are found at 40 CFR parts 60, 61 and 63.
In a letter dated June 8, 2015, West Virginia informed EPA that West Virginia had updated its incorporation by reference of federal NESHAP and NSPS to include many such standards as found in 40 CFR parts 60, 61, and 63 as of June 1, 2014. West Virginia noted that it understood that it was automatically delegated the authority to implement these standards. West Virginia committed to enforcing the standards in conformance with the terms of EPA's previous delegations of authority. West Virginia made only allowed wording changes.
West Virginia provided copies of the revised West Virginia Legislative Rules which specify the NESHAP and NSPS which West Virginia has adopted by reference. These revised Legislative Rules are entitled 45 CSR 34—“Emission Standards for Hazardous Air Pollutants,” and 45 CSR 16—“Standards of Performance for New Stationary Sources.” These revised Rules have an effective date of June 1, 2015.
Accordingly, EPA acknowledges that West Virginia now has the authority, as provided for under the terms of EPA's previous delegation actions, to implement and enforce the NESHAP and NSPS standards which West Virginia has adopted by reference in West Virginia's revised Legislative Rules 45 CSR 34 and 45 CSR 16, both effective on June 1, 2015.
Please note that on December 19, 2008 in
Accordingly, EPA no longer allows sources the SSM exemption as provided for in the vacated provisions at 40 CFR part 63, § 63.6(f)(1) and (h)(1), even though EPA has not yet formally removed the SSM exemption provisions from the General Provisions of 40 CFR part 63. Because West Virginia incorporated 40 CFR part 63 by reference, West Virginia should also no longer allow sources to use the former SSM exemption from the General Provisions of 40 CFR part 63 due to the Court's ruling in
EPA appreciates West Virginia's continuing NESHAP and NSPS enforcement efforts, and also West Virginia's decision to take automatic delegation of additional and more recent NESHAP and NSPS by adopting them by reference.
This notice acknowledges the update of West Virginia's delegation of authority to implement and enforce NESHAP and NSPS.
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 Communication Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before October 26, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
The Commission has in place the following policy and procedures for records retention and disposal: Records will be actively maintained as long as the entity remains a tower owner. Paper records will be archived after being keyed or scanned into the Antenna Structure Registration (ASR) database and destroyed when twelve (12) years old.
The purpose of the FCC Form 854 is to register antenna structures (radio towers) that are used for communication services regulated by the Commission; to make changes to existing antenna structure registrations or pending applications for registration; or to notify the Commission of the completion of construction or dismantlement of such structures, as required by Title 47 of the Code of Federal Regulations (CFR), chapter 1. In addition, for proposed new antenna structures, the FCC Form 854 is used to facilitate a pre-application public notification process, including a required 30-day period of local and national notice to provide members of the public with a meaningful opportunity to comment on the environmental effects of proposed antenna structures that require registration with the Commission.
The Commission is revising this current information collection due to the adoption of a Report and Order, FCC 14-117, which streamlined and eliminated outdated provisions of the Commission's part 17 rules governing the construction, marking, and lighting of antenna structures. The changes to this collection are necessary to implement two of the updates adopted in the Report and Order. The first change, to section 17.4(j), requires owners of certain antenna structures to file FCC Form 854 with the Commission if there is any change or correction in the overall height of one foot or greater or in the coordinates of one second or greater in longitude or latitude of a registered antenna structure. The second change, to section 17.4(b), requires owners to note on FCC Form 854 that the registration is voluntary, if the antenna structure is otherwise not required to be registered under section 17.4.
As a result, there will be a small increase in the number of FCC Form 854s filed each year, as well as an additional question added to the form itself which will permit qualified applicants to indicate that they are voluntarily registering their antenna structures. These changes will enable the Commission to further modernize its rules while adhering to its statutory responsibility to prevent antenna structures from being hazards to air navigation.
The following Consent Agenda has been deleted from the list of Agenda items scheduled for consideration at the Thursday, September 17, 2015, Open Meeting and previously listed in the Commission's Notice of September 10, 2015. Items 1, 2, 3, 4, 5, 6, 7, 8, 10, and 11 have been adopted by the Commission.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before November 23, 2015. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email to
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Election Commission.
Thursday, October 1, 2015 at 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202)694-1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Federal Election Commission.
Tuesday, September 29, 2015 At 10:00 a.m. And Thursday, October 1, 2015 At The Conclusion Of The Open Meeting.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109. Internal personnel rules and internal rules and practices. Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 19, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
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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 October 9, 2015.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
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Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached
Comments must be received on or before October 19, 2015.
Interested parties may file a comment at
Karen Mandel, Bureau of Consumer Protection, (202) 326-2491, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 17, 2015), on the World Wide Web at:
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 19, 2015. Write “Carrot Neurotechnology, Inc.—Consent Agreement; File No. 1423132” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Carrot Neurotechnology, Inc.—Consent Agreement; File No. 1423132” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an agreement containing a consent order as to Carrot Neurotechnology, Inc., Adam Goldberg, and Aaron Seitz (hereafter “respondents”).
The proposed consent order (“order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the order and the comments received, and will decide whether it should withdraw the order or make it final.
This matter involves the respondents' advertising for the Ultimeyes software application. The Commission's complaint alleges that the respondents violated Sections 5(a) and 12 of the Federal Trade Commission Act (“FTC Act”), 15 U.S.C. 45(a), 52, by representing, either falsely or without adequate substantiation, that Ultimeyes substantially improves users' vision, including that it: improves the vision of users, including people of all ages, genders, and visual abilities; improves vision with real world benefits,
The order includes injunctive relief that prohibits these alleged violations and fences in similar and related violations. The order applies to marketing claims for any Covered Product or Service, defined as any Device within the meaning of Sections 12 and 15 of the FTC Act, 15 U.S.C. 52, 55, or any program or service that is: (1) Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or (2) intended to affect the structure or any function of the body of man or other animals; and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. As additional fencing-in relief, the order requires the respondents to follow appropriate recordkeeping and compliance reporting requirements, as well as document preservation requirements for human clinical studies that it conducts or sponsors on any Covered Product or Service.
Part I prohibits any representation that a Covered Product or Service improves users' vision, unless it is non-misleading and supported by competent and reliable scientific evidence. Such evidence must consist of human clinical testing of the Covered Product or Service that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall (1) be randomized, double-blind, and adequately controlled; and (2) be conducted by researchers qualified by training and experience to conduct such testing. In addition, the respondents must maintain all underlying or supporting data that experts in the relevant field generally would accept as relevant to an assessment of such testing.
Part II prohibits any representation about the health benefits, performance, efficacy, safety, or side effects of any Covered Product or Service, unless it is non-misleading and supported by competent and reliable scientific evidence that is sufficient in quality and quantity based on standards generally accepted in the relevant scientific fields, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. For purposes of this Part, competent and reliable scientific evidence means tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by qualified persons; and that are generally accepted in the profession to yield accurate and reliable results. When that evidence consists of human clinical tests or studies, the respondents must maintain all underlying or supporting data and documents that experts in the relevant field generally would accept as relevant to an assessment of such testing.
Part III, triggered when the human clinical testing requirement in Parts I or II applies, requires the respondents to secure and preserve all underlying or supporting data and documents generally accepted by experts in the relevant field as relevant to an assessment of the test, such as protocols, instructions, participant-specific data, statistical analyses, and contracts with the test's researchers. There is an exception for a “Reliably Reported” test, defined as a test that is published in a peer-reviewed journal and that was not conducted, controlled, or sponsored by any respondent or by any supplier of the respondents. Also, the published report must provide sufficient information about the test for experts in the relevant field to assess the reliability of the results.
Part IV prohibits the respondents from misrepresenting, including through the use of a name, endorsement, depiction, or illustration, the existence, contents, validity, results, conclusions, or interpretations of any test, study, or research, or that any benefits of a product, program, or service are scientifically proven.
Part V requires the respondents to disclose, when triggered by certain representations as to scientific support or endorsements in connection with the advertisement or sale of any product, program, or service, any material connections to any person that has conducted, authored, or participated in any test, study, or research of the product, program, or service; and all material connections between a person providing an endorsement and respondents or any other person manufacturing, labeling, advertising, promoting, offering for sale, selling, or distributing such product, program, or service.
Part VI provides the respondents will pay an equitable monetary payment of $150,000 and contains other provisions related to the payment.
Part VII requires the respondents to provide sufficient customer information to administer redress.
Part VIII contains recordkeeping requirements for advertisements and substantiation relevant to representations covered by Parts I through III, as well as order acknowledgments covered by Part IX.
Parts IX through XI require the respondents to deliver a copy of the order to officers, employees, and representatives having managerial responsibilities with respect to the order's subject matter, notify the Commission of changes in corporate structure that might affect compliance obligations, and file compliance reports with the Commission.
Part XII provides that, with exceptions, the order will terminate in twenty years.
The purpose of this analysis is to facilitate public comment on the order, and it is not intended to constitute an official interpretation of the complaint or order, or to modify the order's terms in any way.
By direction of the Commission.
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
Comments on the collection(s) of information must be received by the OMB desk officer by October 26, 2015.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 or Email:
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.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. 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 records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
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Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
This notice announces a meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.
Abigail Huffman, Designated Federal Official, Office of Communications, CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email
The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Act (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).
The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education
The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. We have had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.
In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits.
The Affordable Care Act (Patient Protection and Affordable Care Act, Public Law 111-148, and Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and the Children's Health Insurance Program (CHIP). Qualified individuals and qualified employers are now able to purchase private health insurance coverage through competitive marketplaces, called Affordable Insurance Exchanges (also called the Health Insurance Marketplace, and “Marketplace”). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace. The APOE (the Panel) allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act.
The scope of this panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA).
On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 21, 2015, and will terminate on January 21, 2017 unless renewed by appropriate action.
Under the current charter, the APOE will advise the Secretary and the Administrator on optimal strategies for the following:
• Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP), or coverage available through the Health Insurance Marketplace.
• Enhancing the federal government's effectiveness in informing Health Insurance Marketplace, Medicare, Medicaid, and CHIP consumers, issuers, providers, and stakeholders, through education and outreach programs, on issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, and stakeholders.
• Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Health Insurance Marketplace, Medicare, Medicaid, and CHIP education programs.
• Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.
• Building and leveraging existing community infrastructures for information, counseling, and assistance.
• Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating
The current members of the Panel are: Kellan Baker, Associate Director, Center for American Progress; Phillip Bergquist, Manager, Health Center Operations, Children's Health Insurance Program Reauthorization Act (CHIPRA) Outreach & Enrollment Project and Director, Michigan Primary Care Association; Robert Blancato, President, Matz, Blancato & Associates; Dale Blasier, Professor of Orthopaedic Surgery, Department of Orthopaedics, Arkansas Children's Hospital; Deborah Britt, Executive Director of Community & Public Relations, Piedmont Fayette Hospital; Deena Chisolm, Associate Professor of Pediatrics & Public Health, The Ohio State University, Nationwide Children's Hospital; Josephine DeLeon, Director, Anti-Poverty Initiatives, Catholic Charities of California; Robert Espinoza, Vice President of Policy, Paraprofessional Healthcare Institute; Amy Jones, Director of Health & Social Services, Southeast Asian Mutual Assistance Associations Coalition (SEAMAAC, Inc.); Louise Scherer Knight, Director, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Miriam Mobley-Smith, Dean, Chicago State University, College of Pharmacy; Roanne Osborne-Gaskin, M.D., Associate Medical Director, Neighborhood Health Plan of Rhode Island; Kamila Pickett, Litigation Support, Independent Contractor; Jeanne Ryer, Director, New Hampshire Citizens Health Initiative, University of New Hampshire; Alvia Siddiqi, Medicaid Managed Care Community Network (MCCN) Medical Director, Advocate Physician Partners, Carla Smith, Executive Vice President, Healthcare Information and Management Systems Society (HIMSS); Paula Villescaz, Senior Consultant, Assembly Health Committee; and Darlene Yee-Melichar, Professor & Coordinator, San Francisco State University.
In accordance with Section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the October 7, 2015 meeting will include the following:
Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the
Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3).
Centers for Medicare & Medicaid Services, HHS.
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 November 23, 2015.
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:
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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
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The Office of Child Care (OCC) has given thoughtful consideration to the comments received during the 60-day Public Comment Period. The Plan has been revised to incorporate public comments, better align the Plan with the new program requirements of the CCDBG Act of 2014 and includes additional guidance and clarification where appropriate in order to improve the quality of information that is being collected. This 30-day second Public Comment Period provides an opportunity for the public to submit comments to the Office of Management and Budget (OMB). The Tribal Plan (ACF-118a) will be addressed under a separate notice.
OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the
Food and Drug Administration, HHS.
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.
The interim report will be released on September 24, 2015, and will be available at
Submit electronic comments on the interim report to
Mark Ascione, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993-0002, 301-796-7652, FAX: 301-847-8443.
The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by BsUFA (Title IV of the Food and Drug Administration Safety and Innovation Act, Pub. L. 112-144), authorizes FDA to assess and collect fees for biosimilar biological products from October 2012 through September 2017. FDA uses these fees to expedite the review process for biosimilar biological products. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient. BsUFA facilitates the development of safe and effective biosimilar products for the American public.
As part of BsUFA, FDA is required to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. This notice solicits comments on the interim report, and the final report is due no later than September 30, 2016. The interim report is described in section 744I(d) of the FD&C Act (21 U.S.C. 379j-53(d)) (
FDA is issuing this notice to request public comment on the interim report. Interested persons may submit either electronic comments to
The interim report can be accessed at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by October 26, 2015.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277, title XVII), was signed into law on October 21, 1998. GPEA requires Federal Agencies to allow individuals or entities that deal with the Agencies the option to submit information or transact business with the Agency electronically, when practicable, and to maintain records electronically, when practicable. Its goal is to encourage Agencies to incorporate technologically improved respondent reporting, as this process typically lowers the burden on the respondent. GPEA allows FDA to collect information relating to a user fee payment refund request and transfer request.
Form FDA 3913, User Fee Payment Refund Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment refund. The information collected includes the organization, contact, and payment information. The information is used to determine the reason for the refund, the refund amount, and who to contact if there are any questions regarding the refund request. A submission of the User Fee Payment Refund Request form does not guarantee that a refund will be issued. FDA estimates an average of 0.40 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. The estimated hours are based on past FDA experience with the user fee payment refund request.
In fiscal year 2014, approximately 1,741 user fee refunds were processed for cover sheets and invoices including 27 for Animal Drug User Fee Act, 5 for Animal Generic Drug User Fee Act, 3 for Biosimilar Drug User Fee Act, 1 for a Center for Tobacco Products Civil Money Penalties, 216 for Export Certificate Program, 79 for Freedom of Information Act requests, 523 for Generic Drug User Fee Amendments, 539 for Medical Device User Fee Amendments, 266 for Mammography inspection fee, 81 for Prescription Drug User Fee Act, and 1 for a Tobacco product fee.
Form FDA 3914, User Fee Payment Transfer Request, is designed to provide the minimum necessary information for FDA to review and process a user fee payment transfer request. The information collected includes payment and organization information. The information is used to determine the reason for the transfer, how the transfer should be performed, and who to contact if there are any questions regarding the transfer request. A submission of the User Fee Payment Transfer Request form does not guarantee that a transfer will be performed. FDA estimates an average of 0.25 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. FDA estimated hours are based on past FDA experience with the user fee payment transfer request.
In fiscal year 2014, approximately 1,291 user fee payment transfers were processed for cover sheets and invoices including 21 for Animal Drug User Fee Act, 2 for Animal Generic Drug User Fee Act, 544 for Generic Drug User Fee Amendments, 627 for Medical Device User Fee Amendments, and 97 for Prescription Drug User Fee Act.
Respondents for the electronic request forms include domestic and foreign firms (including pharmaceutical, medical device, etc.). Specifically, refund request forms target respondents who submitted a duplicate payment or overpayment for a user fee cover sheet or invoice. Respondents may also include firms that withdrew an application or submission. Transfer request forms target respondents who submitted payment for a user fee cover sheet or invoice and need that payment to be re-applied to another cover sheet or invoice (transfer of funds).
The electronic user fee payment request forms will streamline the refund and transfer processes, facilitate processing, and improve the tracking of requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Customers will be able to request a user fee payment refund and transfer online at
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and investigators entitled “Use of Investigational Tobacco Products.” The draft guidance, when finalized, will describe FDA's current thinking regarding the definition of “investigational tobacco product” and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft by November 23, 2015. Submit either electronic or written comments on the proposed collection of information by November 23, 2015.
Submit written requests for single copies of the draft guidance to the Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the draft guidance may be sent. See the
Submit electronic comments on the draft guidance, including comments on the proposed collection of information, to
FDA is announcing the availability of a draft guidance for industry and investigators entitled “Use of Investigational Tobacco Products.” This draft guidance, when finalized, will describe FDA's current thinking regarding the definition of “investigational tobacco product” and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy. It is intended to provide guidance not only to persons who currently intend to submit study information to FDA, but to all persons who conduct “nonclinical laboratory studies,” as that term is used in the draft guidance, and “clinical investigations,” as that term is used in the draft guidance, using investigational tobacco products.
The draft guidance also discusses that for clinical investigations, a sponsor (as defined in the guidance) may submit information regarding a proposed use of an investigational tobacco product to FDA for review prior to enrolling subjects. As discussed in the guidance, FDA encourages this type of voluntary submission because it will allow FDA to work with a sponsor to help ensure that the factors FDA considers in making enforcement decisions are appropriately accounted for. FDA has created a form to assist sponsors in submitting information. While use of the form is voluntary, it will help ensure that complete information is provided for FDA's consideration and will facilitate FDA's processing and review. A copy of the form is attached as Appendix A to this guidance.
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act) into law. The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors.
To introduce or deliver for introduction into interstate commerce a new tobacco product, there must be in effect a marketing authorization order issued by FDA for the tobacco product under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. 387j(c)(1)(A)(i)) unless, in brief:
• A substantial equivalence order under section 910(a)(2)(A)(i) of the FD&C Act is in effect for the tobacco product;
• FDA has granted a request for an exemption of the tobacco product from the requirement to obtain a substantial equivalence order and the manufacturer has made the required submission under section 905(j)(1)(A)(ii) of the FD&C Act and waited 90 days before introducing its product to the market; or
• The manufacturer has submitted a substantial equivalence report in accordance with section 910(a)(2)(B) of the FD&C Act and there is no order finding that the tobacco product is not substantially equivalent.
To introduce or deliver for introduction into interstate commerce a modified risk tobacco product, there must be in effect an order under section 911(g) of the FD&C Act (21 U.S.C. 387k(g)) and the applicant must satisfy any applicable premarket review requirements under section 910 of the FD&C Act.
Further, a tobacco product must conform in all respects with applicable tobacco product standards established under section 907 of the FD&C Act (21 U.S.C. 387g).
Persons intending to file submissions with FDA to demonstrate that a tobacco product meets the criteria for marketing set forth in section 910 or 911 of the FD&C Act, and other researchers seeking to study tobacco products, may need to conduct or sponsor studies involving tobacco products that do not have marketing authorization or that do not comply with an applicable tobacco product standard.
Section 910(g) of the FD&C Act gives FDA the authority to issue regulations to exempt tobacco products intended for investigational use from the provisions of chapter IX of the FD&C Act, including premarket submission requirements. FDA intends to propose regulations establishing conditions for exempting investigational tobacco products from certain FD&C Act requirements. Until then, investigational tobacco products are not exempt from applicable FD&C Act requirements, including premarket submission requirements and tobacco product standards. This draft guidance discusses the factors FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products in both nonclinical laboratory studies and clinical investigations until regulations become effective or FDA provides written notice of its intent to change its enforcement policy.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on “Use of Investigational Tobacco Products.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA is announcing the availability of the draft guidance entitled “Use of Investigational Tobacco Products.” This guidance, when finalized, will describe FDA's current thinking regarding the definition of “investigational tobacco product” and discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations become effective or FDA provides written notice of its intent to change its enforcement policy. When finalized, it is intended to provide guidance, not only to persons who currently intend to submit study information to FDA, but to all persons who conduct nonclinical laboratory studies and clinical investigations using investigational tobacco products. Such persons may include sponsors, investigators, sponsor-investigators, contract research organizations (CROs),
We have identified the following recommendations in the draft guidance as collections of information.
In the draft guidance, FDA provides examples of information that may help FDA to evaluate specific proposed uses of investigational tobacco products, and encourages persons who intend to study investigational tobacco products to meet with FDA to discuss certain topics in connection with nonclinical laboratory studies and clinical investigations.
For clinical investigations, FDA encourages sponsors to submit information regarding a proposed use of an investigational tobacco product to FDA for review prior to enrolling subjects in the planned investigation. FDA has created a form to assist sponsors in submitting information. While use of this form is voluntary, its use will likely reduce the burden hours and will help ensure that sponsors provide complete information for FDA's consideration, processing, and review.
Furthermore, to ensure that studies are conducted in a manner that protects human subjects, the draft guidance contains recommendations as to how sponsors should put procedures in place to keep FDA and the committee or group formally designated to oversee research involving human subjects informed about any changes relating to the conduct of, and issues that arise during, the study. In the draft guidance, FDA further recommends that sponsors, CROs, sponsor-investigators, and clinical investigators maintain documentation to permit evaluation of the conduct of a clinical investigation, including assessing the quality and integrity of the study data and protection of human subjects.
In the draft guidance, FDA also recommends that sponsors consult with the Agency, clinical investigators, and any committee or group formally designated to oversee research involving human subjects when certain events occur during the conduct of a clinical investigation, including adverse experiences. In addition, FDA recommends that sponsors notify FDA if they choose to terminate a study (or withdraw or inactivate a protocol or want to withdraw all studies of a product) before completion and in the notification include certain information. Moreover, in the draft guidance, FDA recommends that under certain circumstances, sponsors also should inform any clinical investigators who participated in the discontinued investigation of the reason(s) for discontinuing the clinical investigation.
FDA also makes recommendations related to nonclinical laboratory studies and clinical investigations of using investigational tobacco products conducted outside of the United States (U.S.), but intended for submission to FDA, and refers to section 801(e) of the FD&C Act with respect to exported tobacco products intended for investigational use. The guidance also recommends that sponsors should prepare and maintain certain records and reports, for studies conducted outside of the U.S. but intended for submission to FDA to permit FDA to evaluate the conduct of a clinical investigation, including assessing the quality and integrity of the study data and protection of human subjects.
FDA estimates the burden of this collection of information as follows:
Table 1 describes the annual reporting burden as a result of respondents submitting information regarding the use of investigational tobacco products in certain clinical investigations. FDA estimates that 30 respondents will submit study information to FDA annually. FDA estimates that it will take each respondent approximately 40 hours to prepare the study information necessary for FDA to issue a response to the proposed use of an investigational tobacco product in these clinical investigations. FDA's estimate includes the anticipated burden for completing the form for the initial submission, which will include the initial protocol, time for intra-company edits and approvals, as well as the burden for assembling additional information, as described in the draft guidance.
The initial submission should include an initial study protocol, which should in turn include certain information and call for recordkeeping or other steps that may involve the submission of information to others. In addition, sponsors may wish to provide protocol amendments to reflect certain changes to a protocol. FDA estimates that 10 respondents will submit a new protocol. The estimated time for submitting a new protocol is 20 hours per response. Only 4 respondents are estimated to submit information amendments. Since this may take a little less than half the time of an initial submission, FDA estimates information amendments taking around 15 hours.
FDA estimates that it could take respondents 30 minutes to prepare protocol amendments and that about 5 respondents submitting study information will submit protocol amendments.
FDA estimates that respondents will infrequently need to report administrative amendments. The total number of respondents of this type of information is estimated to be 1. FDA estimates that this submission is estimated to take 30 minutes per respondent.
FDA estimates that approximately 3 respondents will report other types of submissions. This submission is estimated to take 30 minutes per response.
FDA estimates that 4 respondents will report serious or unexpected adverse experiences. This submission will take an average of 2 hours per respondent. FDA estimates that setting up an account in safety reporting portal for submission of serious or unexpected experiences will take 20 minutes per response.
As referenced in the guidance, FDA allows for three ways of submission but strongly encourages the use of electronic format for submission. The submitter should first set up an account with WebTrader to go through the Electronic Submissions Gateway (ESG). FDA estimates from past experience with the ESG system, WebTrader, that the first year to set up the account and to receive the verification certificate takes approximately 40 hours. This burden may be minimized if the respondent already has an established account in WebTrader for other electronic submissions to FDA, but FDA is assuming that all respondents for these products will be setting up a WebTrader account for the first time in the first year. In subsequent years, the burden hours are estimated at 1 hour to renew the yearly required Verification Certification.
FDA further estimates that the gathering, scanning, and submission of information and related correspondence would take approximately 2 hours utilizing the eSubmitter system.
Therefore, the first year will include 40 hours for the WebTrader system plus 2 hours for the eSubmitter submission process, resulting in 42 hours per response for the first year. For subsequent years, it is estimated that only 1 hour will be necessary for the WebTrader system plus the 2 hours for the eSubmitter submission process, resulting in 3 hours per response each year thereafter.
Additionally, there are capital and operating or maintenance costs associated with this information collection. The costs are $30 per year to establish and maintain the ESG verification certificate. The total cost may be lower if the respondents already have a verification certificate for that year for other electronic submissions to FDA. However, for purposes of this estimate, FDA is assuming that all respondents for these products will be
The total reporting burden for this collection of information is estimated to be 2,840 hours. These burden estimates were computed using FDA staff expertise and by reviewing comments received from recent FDA information collections for other tobacco-related initiatives.
Table 2 describes the annual recordkeeping burden of maintaining records relating to the investigational use of tobacco products. FDA anticipates that 50 sponsors will maintain records relating to the use of investigational tobacco products in clinical investigations. FDA estimates that it will take each of them approximately 10 hours annually to maintain these records. FDA anticipates that there will generally be one investigator per investigation. FDA anticipates there will be a total of 120 sponsors, sponsor-investigators, investigators, and CROs who will maintain records relating to the use of investigational tobacco products in clinical investigations. FDA estimates that it will take each sponsor approximately 10 hours annually to maintain these records. FDA estimates that it will take each sponsor-investigator approximately 20 hours annually to maintain these records. FDA estimates that it will take each of these investigators and CROs approximately 15 hours annually to maintain these records. The total reporting burden for recordkeeping is estimated to be 1,650 hours (500 hours for sponsors + 400 hours for sponsor-investigators + 750 for investigators and CROs.)
Table 3 describes the annual third party disclosure burden.
FDA estimates that disclosing information to investigators will take 1 hour per disclosure. FDA estimates that disclosing information to any committee or group formally designated to oversee research involving human subjects will average 10 minutes per disclosure.
The guidance also references examples of disclosing information to study subjects such as informed consent. On average, two disclosures per respondent will be provided to study subjects. FDA estimates this will take 30 minutes per disclosure.
The total burden for the collection of information under this draft guidance is estimated to be 4,455 hours.
This draft guidance also refers to previously approved collections of information. The draft guidance includes a recommendation that persons who intend to study tobacco products meet with FDA to discuss research plans. Additional information about how to request meetings with FDA's Center for Tobacco Products can be found in FDA's guidance: “Meetings with Industry and Investigators on the Research and Development of Tobacco Products.” The collections of information in the guidance referenced have been approved under OMB control number 0910-0731. The collections of information in section 801(e) of the FD&C Act and 21 CFR 1.101(b) have been approved under OMB control number 0910-0482; the collections of information for the Safety Reporting Portal have been approved under OMB control number 0910-0645; the collections of information in section 905(j) of the FD&C Act have been approved under OMB control number 0910-0673.
Interested persons may submit either electronic comments regarding this document to
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Please note that your name, contact information, and other information identifying you will be posted on
Persons with access to the Internet may obtain an electronic version of this guidance document at
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
Pursuant to Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at:
The meeting will be held on Wednesday, October 21, 2015, from 8:30 a.m. until 5:00 p.m. and Thursday, October 22, 2015, from 8:30 a.m. until 4:30 p.m.
Fishers Lane Conference Center, Terrace Level, 5635 Fishers Lane, Rockville, Maryland 20852.
Jerry Menikoff, M.D., J.D., Director, Office for Human Research Protections (OHRP), or Julia Gorey, J.D., Executive Director, SACHRP; U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-453-8141; fax: 240-453-6909; email address:
Under the authority of 42 U.S.C. 217a, Section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects.
The meeting will open to the public at 8:30 a.m., on Wednesday, October 21, followed by opening remarks from Dr. Jerry Menikoff, Executive Secretary of SACHRP and OHRP Director, and Dr. Jeffrey Botkin, SACHRP Chair. The Committee will hear the Subpart A Subcommittee (SAS) and Subcommittee on Harmonization (SOH) reports on the recent Notice of Proposed Rulemaking (NPRM) titled Federal Policy for the Protection of Human Subjects (80 FR 53933, Sep. 8, 2015). Both days will be devoted to the discussion of the NPRM.
SAS was established by SACHRP in October 2006 and is charged with developing recommendations for consideration by SACHRP regarding the application of subpart A of 45 CFR part 46 in the current research environment.
SOH was established by SACHRP at its July 2009 meeting and charged with identifying and prioritizing areas in which regulations and/or guidelines for human subjects research adopted by various agencies or offices within HHS would benefit from harmonization, consistency, clarity, simplification and/or coordination.
The meeting will adjourn at 4:30 p.m. October 22, 2015. Time for public comment sessions will be allotted both days.
Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify one of the designated SACHRP points of contact at the address/phone number listed above at least one week prior to the meeting. Pre-registration is required for participation in the on-site public comment session; individuals may pre-register the day of the meeting. Individuals who would like to submit written statements should email or fax their comments to SACHRP at
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
The Substance Abuse and Mental Health Services Administration's (SAMHSA), Center for Mental Health Services (CMHS) will conduct an evaluation to assess the impact of crisis center follow-up with patients admitted to emergency departments following a suicide attempt.
The overarching purpose of the Hospital Data Abstraction Form, formerly entitled Evaluation of Emergency Department Crisis Center Follow-up, is to examine the impact of crisis center follow-up with patients admitted to emergency departments or inpatient behavioral health units following a suicide attempt or serious suicidal ideation on subsequent readmissions for suicidal behavior. This effort assesses the capacity of follow-up to save both lives and critical hospital resources. This evaluation effort includes one data collection activity. Clearance is being requested for the continuation and expansion of the already-approved abstraction form of hospital data on patients admitted to emergency departments or inpatient behavioral health units following a suicide attempt or serious ideation. This effort will continue to examine the impact of crisis center follow-up on readmissions for suicidal behavior. The data collected through this project will ultimately help SAMHSA to understand and direct crisis center follow-up lifesaving initiatives. The data collection activity is described below.
Hospitals collaborating with two cohorts (cohorts IV and V) of Lifeline crisis centers will participate in this expanded initiative. Fifteen hospitals per cohort will participate for a total of 30. Patient data will be collected for patients admitted for a suicide attempt in the two years prior to collaboration between the hospital and crisis center and for patients admitted for a suicide attempt for the two-year period after collaboration.
The Hospital Data Abstraction Form will be utilized to collect systematic patient data for patients seen in the 30 participating hospitals' emergency departments or inpatient behavioral health units. Information to be abstracted from patient data include: Demographic data, historical data, and subsequent suicidal behavioral and admission data. Data will be de-identified. Hospital staff will review patient data for qualifying (
This revision involves an increase in the number of participating hospital respondents and burden associated with the continuation/expansion of the already-approved Hospital Data Abstraction Form (OMB No. 0930-0337; Expiration 09/30/2016), as well as the discontinuation of data collection and burden associated with the Crisis Center Data Abstraction Form.
The estimated response burden to collect this information is as follows annualized over the requested three-year clearance period is presented below:
Written comments and recommendations concerning the proposed information collection should be sent by October 26, 2015 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to:
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of AmSpec Services, LLC, as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that AmSpec Services, LLC, 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 April 29, 2015.
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 AmSpec Services, LLC, 100 Wheeler St., Unit G, New Haven, CT 06512, 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. AmSpec Services, LLC is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
AmSpec Services, LLC 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
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of final determination.
This document provides notice that U.S. Customs and Border Protection (“CBP”) has issued a final determination concerning the country of origin of certain analytical-grade acetonitrile. Based upon the facts presented, CBP has concluded that the country of origin of the analytical-grade acetonitrile is the country of origin of the crude acetonitrile for purposes of U.S. Government procurement.
The final determination was issued on September 18, 2015. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 26, 2015.
Ross Cunningham, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-0034.
Notice is hereby given that on September 18, 2015 pursuant to subpart B of Part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain analytical-grade acetonitrile, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H265712, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that the processing in the United States does not result in a substantial transformation. Therefore, the country of origin of the analytical-grade acetonitrile is the country of origin of the crude acetonitrile for purposes of U.S. Government procurement.
Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the
Dear Mr. Stepp: This is in response to your letter dated April 1, 2015, requesting a country-of-origin determination on behalf of the Sigma-Aldrich Corporation (“Sigma-Aldrich”). You state that Sigma-Aldrich wishes to sell “analytical-grade acetonitrile” to the U.S. Government and thus seeks a determination that the country of origin of its product will be the United States.
Analytical-grade acetonitrile is a purified chemical that Sigma-Aldrich plans to manufacture in the United States from crude, commercial-grade acetonitrile imported from China and other countries. You state that commercial-grade acetonitrile is most useful as an industrial-grade solvent. Because it is produced as a byproduct of other industrial processes, you state that it contains a relatively low level of “pure acetonitrile.” You state that commercial-grade acetonitrile “can be less than 95%” and that it contains contaminants such as water.
As its name suggests, purified analytical-grade acetonitrile contains fewer contaminants and may be up to 99.5% pure. In its purified, analytical grades, acetonitrile is suitable for use in chemical testing instruments such as Liquid Chromatography-Mass Spectrometry and Ultra-Performance Liquid Chromatography. These instruments are used for analyzing chemicals for pharmaceutical drug development and production, food safety, medical clinical testing, and environmental testing. You state that commercial-grade acetonitrile is unsuitable for these applications because its impurities would cause false readings and damage the testing equipment.
Sigma-Aldrich produces several analytical grades of purified acetonitrile, including CHROMASOLV® Plus for HPLC; MC-MS CHROMASOLV®; LC-MS Ultra CHROMASOLV®, tested for UHPLC-MS; and CHROMASOLV® Plus, for HPLC. Sigma-Aldrich will purify the imported commercial-grade acetonitrile using the following processes. The steps are set forth in general terms in accordance with your request to exclude confidential information:
1. Freezing the crude product;
2. Extracting the pure acetonitrile from the frozen mass;
3. Analyzing the purified acetonitrile output product and the correct purity level for the grade being produced;
4. Packaging the purified acetonitrile, which requires:
a. Special glass bottles
b. Rinsing the bottles
c. Filling the bottles
You state that the process is lengthy and requires sophisticated, expensive equipment and highly educated personnel. The steps described above take about four days for a “typical batch” of 20,000 liters. Scientists, all of whom possess at least a Bachelor of Science degree, perform or oversee the production process which uses a specialized unit and precision testing equipment.
Whether the purification process described above will “substantially transform” the product such that the country of origin of the finished analytical-grade acetonitrile will be the United States for U.S. Government procurement purposes.
Pursuant to Subpart B of Part 177, 19 CFR 177.21
In rendering final determinations for purposes of U.S. Government procurement, CBP applies the provisions of Subpart B of Part 177 consistent with the Federal Procurement Regulations.
You argue that the imported commercial-grade acetonitrile will be substantially transformed when Sigma-Aldrich purifies it into analytical-grade acetonitrile. Therefore, in your view, the finished product will be eligible for U.S. Government procurement because its country of origin will be the United States.
A substantial transformation occurs when an article is used in a manufacturing process that results in a new article that has a new name, character or use different from that of the original imported article. In previous rulings, “CBP has consistently held that refining or purification of a crude substance does not generally effect a substantial transformation that results in a different article of commerce with a new name, character, or use”. Headquarters Ruling Letter (“HQ”) H113256, dated December 27, 2010. For example, CBP has held that refining linseed oil, in H554664, dated October 29, 1987, and Octamine (an aviation lubricant), in HQ 556143, dated March 2, 1992, did not result in an article with a new name, use, or character.
You argue that the acetonitrile purification processes will result in a substantial transformation because the finished product will have a new name, character, and use. Although a change in a product's name is the weakest evidence of a substantial transformation, as noted in
You also argue that the processed acetonitrile has a new character compared to the crude acetonitrile. You state that the imported crude acetonitrile has the character of an industrial manufacturing byproduct, whereas the purified product has the character of a laboratory reagent. CBP's examination of character, however, focuses on the chemical and physical properties of the product itself.
While the finished product will not have a different name or character, it will have a different use. The imported crude product can be used as a solvent for industrial processes but not in precision testing applications because impurities can damage the testing equipment or produce measurement errors. Although the finished product could also be used as a solvent, you
In support of your argument that a substantial transformation will take place when the crude acetonitrile is purified into analytical-grade acetonitrile, you analogize to rulings HQ 563301, dated August 26, 2005 and HQ 731731, dated February 23, 1989. In HQ 731731, we found that a substantial transformation occurred when raw powdered vancomycin hydrochloride was processed into a finished antibiotic drug capable of intravenous use. As imported, the raw chemical was unfit for medical use. Applying the three substantial transformation factors, we found that the name changed to “sterile” vancomycin hydrochloride, the use changed to an injectable antibiotic, and the character changed to a purified solution of uniform potency levels. Accordingly, we found that the chemical was substantially transformed. Similarly, in HQ 563301 we found that a substantial transformation occurred when bulk parathormone was processed into finished parathormone cartridges. We held that the “extensive processing transforms the raw parathormone from an unstable, non-sterile, frozen material unsuitable for human use into a pharmaceutical agent ready for human use.”
A common theme in HQ 563301 and HQ 731731 is the production of a medicine from chemicals that were previously unfit for human consumption. In both cases, we found that—along with the required change in name and character—this conversion from raw chemicals to medication represented a significant change in use. Here, aside from the fact that no change in name or character will occur, the production of analytical-grade acetonitrile results in a less significant change in use, namely, from one type of industrial use to another.
We believe that this case is more analogous to cases involving the refining and purification of chemicals than to those involving the production of medicine. As noted above, CBP has consistently held that refining or purification of a crude substance does not generally effect a substantial transformation. You attempt to distinguish one of these cases, H566143, dated March 2, 1992, by pointing out that there was no substantial transformation because “both the precursor and purified substances had the same essential character as aviation lubricants of merely different grades and were therefore not different articles of commerce, and both substances had the same chemical structures.” Yet here too the crude and purified acetonitrile will have the same essential character as acetonitrile and you have provided no evidence that the substances will have a different chemical structure. Therefore, we are “bound to follow the well-settled principle of Customs law that the mere refining of a chemical does not result in a substantial transformation of the imported chemicals into a new and different article of commerce with a new name, character, and use.” HQ 556143, dated March 2, 1992.
The purification process described above will not substantially transform the acetonitrile, and the country of origin of the finished analytical-grade acetonitrile will not be the United States for U.S. Government procurement purposes.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Saybolt LP as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Saybolt LP 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 May 20, 2015.
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 Saybolt LP, 220 Texas Ave., Texas City, TX 77590, 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. Saybolt LP is approved for the following gauging procedures for petroleum and certain petroleum products from the American Petroleum Institute (API):
Saybolt LP 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
Bureau of Land Management, Interior.
Notice.
The United States Department of Agriculture, Forest Service (USFS) has filed an application with the Bureau of Land Management (BLM) requesting the Secretary of the Interior to withdraw approximately 17,486.90 acres of National Forest System lands from the mining laws to protect four Research Natural Areas and seven Botanical Areas within the Black Hills National Forest in South Dakota and Wyoming. This notice temporarily segregates the lands for up to 2 years from location and entry under the United States mining laws while the application is being processed. This notice also gives an opportunity to comment on the proposed withdrawal application, and announces dates, time and location of two public meetings.
The USFS must receive comments on or before December 23, 2015. The USFS will hold public meetings in connection with the proposed withdrawal on October 27, 2015 and October 28, 2015.
Comments should be sent to the Forest Supervisor, Black Hills National Forest, 1019 North 5th Street, Custer, South Dakota 57730 or the BLM Montana State Director, 5001 Southgate Drive, Billings, Montana 59101.
Valerie Hunt, USFS, Rocky Mountain Region, 303-275-5071,
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact either of the above individuals. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with either of the above individuals. You will receive a reply during normal business hours.
The USFS has filed an application with the BLM, pursuant to Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714 requesting that the Secretary of the Interior withdraw, for a 20-year period, subject to valid existing rights, the National Forest System lands within the Black Hills National Forest described below, from location and entry under the United States mining laws:
Black Hills Meridian
The areas described aggregate 5,342.08 acres in Lawrence County.
The areas described aggregate 1,618.38 acres in Pennington (909.42 acres) and Lawrence (708.96 acres) Counties.
The areas described aggregate 914.26 acres in Pennington County.
The area described contains 409.05 acres in Lawrence County.
The area described contains 853.41 acres in Custer County.
The area described contains 1,640.00 acres in Lawrence County.
The area described contains 239.60 acres in Pennington County.
The area described aggregates 1,681.72 acres in Pennington County.
The areas described in South Dakota aggregate approximately 12,698.50 acres in Custer, Lawrence, and Pennington Counties.
Sixth Principal Meridian
The area described aggregates 1,515.33 acres in Crook County.
The area described contains 1,080.00 acres in Crook County.
The area described contains 2,233.07 acres in Crook County.
The total areas described in Wyoming aggregate 4,828.40 acres in Crook County.
The purpose of the withdrawal is to protect the Research Natural Areas and Botanical Areas and allow the USFS to explore administrative alternatives in managing the lands.
The use of a right-of-way, interagency agreement, or cooperative agreement would not provide adequate protection for these areas due to the broad scope and nondiscretionary nature of the general mining laws.
No alternative sites are feasible due to the resource significance of the areas. No water will be needed to fulfill the purpose of the requested withdrawal.
Records relating to the application may be examined by contacting the USFS, Rocky Mountain Region at the above address and phone number.
For a period until December 23, 2015, all persons who wish to submit comments, suggestions, or objections in connection with the withdrawal application may present their views in writing to the Forest Supervisor, Black Hills National Forest at the address indicated above.
Comments, including names and street addresses of respondents, will be available for public review at the Forest Supervisor's Office, Black Hills National Forest, 1019 North 5th Street, Custer, South Dakota 57730, during regular business hours. Individual respondents may request confidentiality. Before including your address, phone number, email address, or other personal identifying information in your comment, be advised 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 from public review your personal identifying information, we cannot guarantee that we will be able to do so.
Notice is hereby given that public meetings in connection with the proposed withdrawal will be held at the Mystic Ranger District, 8221 South Hwy 16, Rapid City, South Dakota 67702 on October 27, 2015 at 6 p.m. and at the Sundance Community Center, Basement of the Crook County Courthouse, 309 Cleveland St., Sundance, Wyoming 82729 on October 28, 2015 at 6 p.m. The USFS will publish a notice of the time and place in a least one newspaper of general circulation no less than 30 days before the scheduled dates of the meetings.
For a period until September 25, 2017, subject to valid existing rights, the lands will be segregated from location and entry under the United States mining laws, unless the application is denied or canceled or the withdrawal is approved prior to that date. The lands will remain open to other uses within the statutory authority pertinent to National Forest lands and subject to discretionary approval.
The application will be processed in accordance with the regulations set forth in 43 CFR 2310.
Bureau of Land Management, Interior.
Notice of availability.
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) and Approved Resource Management Plan Amendments (ARMPAs) for the Great Basin Region Greater Sage-Grouse (GRSG) sub-regions of Idaho and Southwestern Montana, Nevada and Northeastern California, Oregon, and Utah. The Assistant Secretary for Land and Minerals Management of the U.S. Department of the Interior signed the ROD.
Copies of the ROD and ARMPAs are available upon request and are also available for public inspection at the addresses listed in the
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individuals during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
This ROD and the ARMPAs for the Great Basin Region GRSG sub-regions of Idaho and Southwestern Montana, Nevada and Northeastern California, Oregon, and Utah were developed through a collaborative planning process in order to incorporate land use plan level measures into existing BLM land use plans to protect, enhance, and restore GRSG and their habitat by reducing, eliminating, or minimizing threats to GRSG habitat in the context of the BLM's multiple-use and sustained yield mission under FLPMA.
The ARMPAs approved by the ROD include land use allocations that limit or eliminate new surface disturbance in GRSG Priority Habitat Management Areas (PHMA), while minimizing disturbance in GRSG General Habitat Management Areas (GHMA). The Idaho and Southwestern Montana ARMPA also includes Important Habitat Management Areas (IHMA) in Idaho, where management provides a buffer for PHMAs and connects patches of PHMAs. IHMAs encompass areas of generally moderate to high value habitat and/or populations, but that are not as important as PHMAs. The Nevada and Northeastern California ARMPA also includes Other Habitat Management Areas (OHMA), which is unmapped habitat that contains seasonal or connectivity habitat areas. BLM management of these areas is limited to the application of required design features (RDFs) for certain authorizations when applicable.
In addition to establishing protective land use allocations, the ARMPAs implement a suite of management decisions, such as the establishment of disturbance limits, GRSG habitat objectives, mitigation requirements, monitoring protocols, and adaptive management triggers and responses, as well as other conservation measures throughout the range.
The cumulative effect of these measures is to protect, improve, and restore GRSG habitat across the remaining range of the species in the Great Basin and provide greater certainty that BLM land and resource management activities in GRSG habitat will lead to conservation of the GRSG and other species associated with the sagebrush ecosystem in the region.
The ARMPAs approved by the ROD amend the following BLM Resource Management Plans (RMPs) and Management Framework Plans (MFPs), completed in the year indicated:
The Idaho and Southwestern Montana, Nevada and Northeastern California, and Utah Draft Land Use Plan Amendments (LUPAs)/Draft Environmental Impact Statements (EISs) and Proposed LUPAs/Final EISs included proposed GRSG management direction for National Forest System lands. However, the U.S. Forest Service (USFS) has completed a separate ROD and Land and Resource Management Plans under USFS planning authorities. Management decisions within the ROD and ARMPAs apply only to BLM-administered lands.
Across all four sub-regions in the Great Basin Region, the ROD and ARMPAs amend existing land use plan decisions on a total of approximately 90 million BLM-administered surface acres.
A Notice of Availability (NOA) for the Great Basin Region GRSG Proposed LUPAs and Final EISs for the Idaho and Southwestern Montana, Nevada and Northeastern California, Oregon, and Utah sub-regions was published in the
The BLM received 133 timely and valid protest submissions across all four Great Basin Proposed LUPAs/Final EISs. All protests have been resolved and/or dismissed. For a full description of the
The BLM received notifications of inconsistencies and recommendations as to how to resolve them during the Governor's consistency review period from the States of Idaho, Montana, Nevada, Oregon, and Utah. The BLM also received a concurrence letter of consistency from the State of California. On August 6, 2015, the BLM State Directors for Idaho, Montana, Nevada, Oregon, and Utah sent notification letters to their respective States as to whether they accepted or rejected their recommendations for consistency. The States were then given thirty days to appeal the State Directors' decisions. The States of Idaho, Nevada, and Utah appealed the BLM State Directors' decisions. The BLM Director affirmed the State Directors' decisions on these recommendations as the recommendations did not provide the balance required by 43 CFR 1610.3-2(e). The Director communicated his decisions on the appeals in writing to the Governors concurrently with the release of the RODS.
The Proposed LUPAs/Final EISs were selected in the ROD as the ARMPAs, with some minor modifications and clarifications based on protests received, the Governors' consistency reviews, and internal agency deliberations.
36 CFR 219.59, 40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2; 43 CFR 1610.5.
Bureau of Land Management, Interior.
Notice.
The Assistant Secretary of the Interior for Land and Minerals Management has approved an application to withdraw approximately 10 million acres of public and National Forest System lands identified as Sagebrush Focal Areas in Idaho, Montana, Nevada, Oregon, Utah, and Wyoming from location and entry under the United States mining laws to protect the Greater Sage-Grouse and its habitat from adverse effects of locatable mineral exploration and mining, subject to valid existing rights. This notice temporarily segregates the lands for up to 2 years while the application is processed. This notice also provides the public with an opportunity to comment on the proposed withdrawal application. In addition, this notice initiates the public scoping process for an Environmental Impact Statement (EIS) to analyze and disclose impacts of the proposed withdrawal.
Comments on the proposed withdrawal application or scoping comments on issues to be analyzed in the EIS must be received by December
Written comments should be sent to the BLM Director, 1849 C Street NW., (WO-200), Washington, DC 20240 or electronically to
Mark A. Mackiewicz, PMP, Senior National Project Manager BLM, by telephone at 435-636-3616, or by email at
The Bureau of Land Management (BLM) filed an application requesting the Assistant Secretary of the Interior for Land and Minerals Management to withdraw, subject to valid existing rights, approximately 10 million acres of public and National Forest System lands located in the States of Idaho, Montana, Nevada, Oregon, Utah and Wyoming from location and entry under the United States mining laws, but not from leasing under the mineral or geothermal leasing or mineral materials laws. Copies of the map entitled “BLM Petition/Application for Sagebrush Focal Areas Withdrawal” depicting the lands proposed for withdrawal are posted on our Web site at
The Sagebrush Focal Areas include all public and National Forest System lands identified in the townships below:
The areas described contain approximately 3,854,622 acres in Bingham, Blaine, Butte, Camas, Cassia, Clark, Custer, Elmore, Fremont, Gooding, Jefferson, Lemhi, Lincoln, Minidoka, Owyhee, Power, and Twin Falls Counties.
The areas described contain approximately 983,156 acres in Fergus, Garfield, Petroleum, Phillips, and Valley Counties.
The areas described contain approximately 2,797,399 acres in Elko, Humboldt, and Washoe Counties.
The areas described contain approximately 1,929,580 acres in Harney, Lake, and Malheur Counties.
The areas described contain approximately 230,808 acres in Box Elder, Cache, and Rich Counties.
The areas described contain approximately 252,162 acres in Fremont, Lincoln, Sublette, Sweetwater, and Uinta Counties.
The total areas described aggregate approximately 10 million acres of public and National Forest System lands in the six states and counties listed above.
The Assistant Secretary of the Interior for Land and Minerals Management has approved the BLM's application. Therefore, this document constitutes a withdrawal proposal of the Secretary of the Interior (43 CFR 2310.1-3(e)).
The purpose of the proposed withdrawal of the Sagebrush Focal Areas in Priority Habitat Management Areas is to protect the Greater Sage-Grouse and its habitat from adverse effects of locatable mineral exploration and mining subject to valid existing rights.
The use of a right-of-way, interagency or cooperative agreement, or surface management by the BLM under 43 CFR part 3715 or 43 CFR part 3809 regulations or by the Forest Service under 36 CFR part 228 would not adequately constrain nondiscretionary uses, which could result in loss of critical sage-grouse habitat.
There are no suitable alternative sites for the withdrawal.
No water rights would be needed to fulfill the purpose of the requested withdrawal.
Records relating to the application may be examined by contacting the BLM offices listed above.
For a period until December 23, 2015, all persons who wish to submit comments, suggestions, or objections in connection with the proposed withdrawal may present their views in writing to the BLM Director, 1849 C Street NW., (WO-210), Washington, DC 20240, or electronically to
All comments received will be considered before any final action is taken on the proposed withdrawal.
The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including alternatives, and guide the process for developing the EIS. At present, the BLM has identified the following preliminary issues: Air quality/climate, American Indian resources, cultural resources, wilderness, mineral resources, public health and safety, recreation, socio-economic conditions, soil resources, soundscapes, special status species, vegetation resources, visual resources, water resources, and fish and wildlife resources.
Because of the nature of a withdrawal of public lands from operation of the mining law, mitigation of its effects is not likely to be an issue requiring detailed analysis. However, consistent with Council on Environmental Quality regulations implementing NEPA (40 CFR 1502.14), the BLM will consider whether and what kind of mitigation measures may be appropriate to address the reasonably foreseeable impacts to resources from the approval of this proposed withdrawal.
The BLM will utilize and coordinate the NEPA scoping process to help fulfill the public involvement process under the National Historic Preservation Act (54 U.S.C. 306108) as provided in 36 CFR 800.2(d)(3). The information about historic and cultural resources within the area potentially affected by the proposed action will assist the BLM in identifying and evaluating impacts to such resources.
The BLM will consult with Indian tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including impacts to Indian trust assets and potential impacts to cultural resources, will be given due consideration. Federal, State, and local agencies, along with tribes and other stakeholders that may be interested in or affected by the proposed withdrawal that the BLM is evaluating, are invited to participate in the scoping process and, if eligible, may request or be requested by the BLM to participate in the development of the environmental analysis as a cooperating agency.
Comments including names and street addresses of respondents will be available for public review at the BLM Washington Office at the address noted above, during regular business hours Monday through Friday, except Federal holidays. 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.
For a period until September 24, 2017, subject to valid existing rights, the lands described in this notice will be segregated from location and entry under the United States mining laws, unless the application/proposal is denied or canceled or the withdrawal is approved prior to that date. Licenses, permits, cooperative agreements, or discretionary land use authorizations may be allowed during the temporary segregative period, but only with approval of the authorized officer of the BLM or the USFS.
The application will be processed in accordance with the regulations set forth in 43 CFR part 2300.
Bureau of Land Management, Interior.
30-day notice and request for comments.
The Bureau of Land Management (BLM) has submitted an information collection request to the Office of Management and Budget (OMB) to continue the collection of information from owners of surface estates who apply for title to underlying Federally-owned mineral estates. The Office of Management and Budget (OMB) previously approved this information collection activity, and assigned it control number 1004-0153.
The OMB is required to respond to this information collection request within 60 days but may respond after 30 days. For maximum consideration, written comments should be received on or before October 26, 2015.
Please submit comments directly to the Desk Officer for the Department of the Interior (OMB #1004-0153), Office of Management and Budget, Office of Information and Regulatory Affairs, fax 202-395-5806, or by electronic mail at
Please indicate “Attn: 1004-0153” regardless of the form of your comments.
Flora Bell, at 202-912-7347. Persons who use a telecommunication device for the deaf may call the Federal Information Relay Service at 1-800-877-8339, to leave a message for Ms. Bell. You may also review the information collection request online at
The Paperwork Reduction Act (44 U.S.C. 3501-3521) and OMB regulations at 5 CFR part 1320 provide that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information, you are not obligated to respond. In order to obtain and renew an OMB control number, Federal agencies are required to seek public comment on information collection and recordkeeping activities (see 5 CFR 1320.8(d) and 1320.12(a)).
As required at 5 CFR 1320.8(d), the BLM published a 60-day notice in the
1. Whether the collection of information is necessary for the proper functioning of the BLM, including whether the information will have practical utility;
2. The accuracy of the BLM's estimate of the burden of collecting the information, including the validity of the methodology and assumptions used;
3. The quality, utility and clarity of the information to be collected; and
4. How to minimize the information collection burden on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other forms of information technology.
Please send comments as directed under
The following information pertains to this request:
The estimated burdens are itemized in the following table:
Bureau of Land Management, Interior.
Notice of availability.
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD); and Approved Resource Management Plan Amendments (ARMPAs) for the Rocky Mountain Region Greater Sage-Grouse (GRSG) sub-regions of Lewistown, North Dakota, Northwest Colorado, and Wyoming; and Approved Resource Management Plans (ARMPs) for Billings, Buffalo, Cody, HiLine, Miles City, Pompeys Pillar National Monument, South Dakota, and Worland. The Assistant Secretary for Land and Minerals Management of the U.S. Department of the Interior signed the ROD.
Copies of the ROD, ARMPAs and ARMPs are available upon request and are also available for public inspection at the addresses listed in the
Contacts for each subregion for the GRSG ARMPAs and ARMPs are listed in the
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the listed individuals during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
This ROD; the ARMPAs for the Rocky Mountain Region GRSG sub-regions of Lewistown, North Dakota, Northwest Colorado, and Wyoming; and the ARMPs for Billings, Buffalo, Cody, HiLine, Miles City, Pompeys Pillar National Monument, South Dakota, and Worland were developed through a collaborative planning process in order to incorporate land use plan level measures into existing BLM land use plans to protect, enhance, and restore GRSG and their habitat by reducing, eliminating, or minimizing threats to GRSG habitat in the context of the BLM's multiple-use and sustained yield mission under FLPMA.
The ARMPAs and ARMPs approved by the ROD include land use allocations that limit or eliminate new surface disturbance in GRSG Priority Habitat Management Areas (PHMA), while minimizing disturbance in GRSG General Habitat Management Areas (GHMA). The Billings and Miles City ARMPs also include Restoration Habitat Management Areas (RHMA), where certain management actions in these areas provide for a balance between ongoing and future resource uses, so that habitat is maintained, while also allowing for residual populations in impacted areas to persist. The Northwest Colorado ARMPA also includes Linkage and Connectivity Habitat Management Areas (LCHMA), which have protections to facilitate the movement of GRSG and maintain ecological processes. In addition to establishing protective land use allocations, the ARMPAs and ARMPs implement a suite of management decisions, such as the establishment