Page Range | 42441-42577 | |
FR Document |
Page and Subject | |
---|---|
82 FR 42563 - Sunshine Act Meeting Notice | |
82 FR 42550 - Valero Energy Corporation; Valero Marketing and Supply Company; Notice of Emergency Request for Temporary Waiver | |
82 FR 42550 - Colonial Pipeline Company; Notice of Emergency Petition for Waiver | |
82 FR 42568 - Grand Elk Railroad, Inc.-Acquisition Exemption-Norfolk Southern Railway Company | |
82 FR 42551 - Sunshine Act Meeting; Farm Credit Administration Board | |
82 FR 42562 - Certain Electronic Devices, Including Mobile Phones, Tablet Computers, and Components Thereof; Notice of a Commission Determination Not To Review an Initial Determination Granting a Joint Motion To Terminate the Investigation; Termination of the Investigation | |
82 FR 42545 - Procurement List; Additions and Deletions | |
82 FR 42546 - Procurement List; Proposed Additions and Deletions | |
82 FR 42541 - Building the Foundations for Quantum Industry | |
82 FR 42540 - National Construction Safety Team Advisory Committee Meeting | |
82 FR 42567 - Administrative Declaration of an Economic Injury Disaster for the State of California | |
82 FR 42559 - Proposed Collection; 30-Day Comment Request; Application To Participate in the National Institutes of Health Technical Assistance Programs: Commercialization Accelerator Program (CAP) | |
82 FR 42563 - Advisory Committee for Education and Human Resources; Notice of Meeting | |
82 FR 42566 - Proposed Collection; Comment Request | |
82 FR 42565 - Submission for OMB Review; Comment Request | |
82 FR 42564 - Proposed Collection; Comment Request | |
82 FR 42552 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
82 FR 42547 - Intent To Prepare an Environmental Impact Statement for the Combined Operational Plan, Broward, Miami-Dade Counties, Florida | |
82 FR 42551 - Notice of Request for Comment on the Exposure Draft of a Proposed Technical Bulletin, Intragovernmental Exchange Transactions | |
82 FR 42556 - Submission for OMB Review; Comment Request | |
82 FR 42555 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
82 FR 42551 - Environmental Impact Statements; Notice of Availability | |
82 FR 42543 - North Pacific Fishery Management Council; Notice of Public Meeting | |
82 FR 42542 - New England Fishery Management Council; Public Meeting | |
82 FR 42544 - Fisheries of the South Atlantic, Gulf of Mexico, and Caribbean; Southeast Data, Assessment, and Review (SEDAR) Public Meeting | |
82 FR 42544 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings | |
82 FR 42561 - Great Lakes Pilotage Advisory Committee | |
82 FR 42549 - International Energy Agency Meetings | |
82 FR 42569 - Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders | |
82 FR 42506 - Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration | |
82 FR 42569 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel SILVER MAMA; Invitation for Public Comments | |
82 FR 42552 - Mars, Incorporated and VCA Inc.; Analysis To Aid Public Comment | |
82 FR 42577 - Advisory Committee on Disability Compensation; Notice of Meeting Cancellation | |
82 FR 42560 - Navigation and Vessel Inspection Circular (NVIC) 05-17; Guidelines for Addressing Cyber Risks at Maritime Transportation Security Act (MTSA) Regulated Facilities | |
82 FR 42447 - Drawbridge Operation Regulation; Upper Mississippi River, Rock Island, IL | |
82 FR 42501 - Review of Existing Center for Tobacco Products Regulatory and Information Collection Requirements | |
82 FR 42494 - Review of Existing Center for Devices and Radiological Health Regulatory and Information Collection Requirements | |
82 FR 42499 - Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements | |
82 FR 42492 - Review of Existing Center for Biologics Evaluation and Research Regulatory and Information Collection Requirements | |
82 FR 42497 - Review of Existing Center for Veterinary Medicine Regulatory and Information Collection Requirements | |
82 FR 42503 - Review of Existing Center for Food Safety and Applied Nutrition Regulatory and Information Collection Requirements | |
82 FR 42557 - Self-Collection Devices for Pap Test; Public Workshop; Request for Comments | |
82 FR 42559 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
82 FR 42559 - National Cancer Institute; Notice of Closed Meetings | |
82 FR 42554 - The Presidential Commission on Election Integrity (PCEI); Upcoming Public Advisory Meeting; Extension of Comment Period | |
82 FR 42555 - Statement of Organization, Functions, and Delegations of Authority | |
82 FR 42567 - Presidential Declaration Amendment of a Major Disaster for the State of Texas | |
82 FR 42568 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Iowa | |
82 FR 42568 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Idaho | |
82 FR 42572 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42573 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42571 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42570 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42576 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42575 - Reports, Forms, and Recordkeeping Requirements | |
82 FR 42548 - Notice of Intent To Prepare an Integrated Environmental Impact Statement for the Lower Columbia River Federal Navigation Channel Maintenance Plan | |
82 FR 42487 - Airworthiness Directives; Airbus Helicopters | |
82 FR 42441 - Airworthiness Directives; Agusta S.p.A. Helicopters | |
82 FR 42545 - Notice of Meeting | |
82 FR 42454 - Approval and Promulgation of Implementation Plans; Texas; El Paso Carbon Monoxide Limited Maintenance Plan | |
82 FR 42445 - Amendment of Class E Airspace; Falls City, NE | |
82 FR 42443 - Airworthiness Directives; Rolls-Royce Corporation Turboshaft Engines | |
82 FR 42489 - Airworthiness Directives; Viking Air Limited Airplanes | |
82 FR 42447 - Attainment Date Extensions for the Logan, Utah-Idaho 2006 24-Hour Fine Particulate Matter Nonattainment Area | |
82 FR 42451 - Air Plan Approval; Ohio; Volatile Organic Compound Control Rules | |
82 FR 42561 - Endangered and Threatened Wildlife and Plants; Incidental Take Permit Application; Draft R-Project Transmission Line Habitat Conservation Plan for the American Burying Beetle and Draft Environmental Impact Statement | |
82 FR 42531 - Aluminum tris (O-ethylphosphonate), Carbon disulfide, p-Chlorophenoxyacetic acid, Cyromazine, Dichlobenil, et al.; Proposed Tolerance and Tolerance Exemption Actions | |
82 FR 42457 - Air Plan Approval; AK, Fairbanks North Star Borough; 2006 PM2.5 | |
82 FR 42508 - Method 202-Dry Impinger Method for Determining Condensable Particulate Emissions From Stationary Sources | |
82 FR 42473 - Connect America Fund; Universal Service Reform-Mobility Fund |
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Fish and Wildlife Service
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Maritime Administration
National Highway Traffic Safety Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are superseding Airworthiness Directive (AD) 2015-22-51 for Agusta S.p.A. (Agusta) Model A109A and A109A II helicopters. AD 2015-22-51 required pre-flight checking and inspecting each main rotor blade (blade) for a crack and replacing any cracked blade. This new AD removes the check and requires inspecting each blade more frequently. This AD is prompted by a crack that was not detected during any of the pre-flight checks. The actions of this AD are intended to address the unsafe condition on these products.
This AD becomes effective September 25, 2017.
We must receive comments on this AD by November 7, 2017.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046; or at
Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.
We issued Emergency AD 2015-22-51, which was published in the
AD 2015-22-51 was prompted by AD No. 2015-0190-E, dated September 18, 2015, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition for Agusta Model A109A and A109A II helicopters. EASA advised that abnormal vibrations were reported during a flight on a Model A109A II helicopter. During a post-flight inspection, a crack was found on a P/N 109-0103-01-9 blade. EASA AD No. 2015-0190-E required pre-flight inspections and repetitive inspections of each blade. EASA advised that due to similarity of design, the inspections also applied to P/N 109-0103-01-7 and P/N 109-0103-01-115 blades. EASA further advised that a cracked blade, if not detected and corrected, could affect the structural integrity of the blade, possibly resulting in blade failure and loss of control of the helicopter. EASA revised its AD and issued AD No. 2015-0190R1, dated October 23, 2015, to extend the interval of the repetitive inspections to 10 flight hours.
Since we issued AD 2015-22-51, Leonardo Helicopters (previously Agusta) issued Alert Bollettino Tecnico (BT) No. 109-150, Revision B, dated October 21, 2016, and EASA superseded AD 2015-0190R1 by issuing AD No. 2016-0213, dated October 26, 2016. EASA AD No. 2016-0213 was prompted by a crack in a blade P/N 109-0103-01-9 on a Model A109A II helicopter that was not detected during any of the pre-flight inspections. Upon a subsequent review of data, it was determined that the pre-flight inspections were ineffective to address the unsafe condition and that a shorter interval of the repetitive inspection is necessary. For these reasons, EASA AD 2016-0213 requires inspecting the blades for a crack at intervals not exceeding five flight hours.
Additionally, the FAA is in the process of updating Agusta's name change to Leonardo Helicopters on its FAA type certificate. Because this name change is not yet effective, this AD specifies Agusta.
After our Final rule; request for comments was published, we received comments from one commenter.
The commenter stated the AD's cost estimate for a new blade is erroneous, and while the AD identifies the cost of a single inspection, it does not account for the cumulative cost of the daily inspection over time.
We agree. We have revised the cost of the blade in this final rule. As far as a cumulative cost of the repetitive inspections, this new AD changes the compliance interval to every 5 hours TIS. Since the cumulative cost would be different for every operator, we have made no change to the estimated costs in this regard.
The commenter also requested the FAA require Agusta to design and provide a new blade to operators at no charge. The commenter stated the actual cost of the AD is financially devastating to operators and renders the helicopter worthless.
We do not have the authority to direct manufacturers to provide parts or repairs to operators at no charge. We can only require repair or replacement of defective components that are installed on the helicopter. In light of this, we have made no change to the AD in this regard.
These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.
We reviewed Leonardo Helicopters Alert BT No. 109-150, Revision B, dated October 21, 2016. This service information specifies inspecting the top and bottom surfaces of each blade for a crack in the area between station 1550 (the station at the end of the doublers) and station 3100 (the station at the beginning of the abrasion strip) for a crack every 5 flight hours and replacing a cracked blade.
This AD requires, before further flight, unless done within the last 5 hours TIS, and thereafter at intervals not to exceed 5 hours TIS, visually inspecting the top and bottom surface of each blade for a crack in the area between stations 1550 and 3100 using a 3X or higher power magnifying glass. If there is a crack, this AD requires replacing the blade.
The EASA AD requires a type II dye penetrant inspection if in doubt about whether there is a crack, while this AD does not. The EASA AD also includes warning the pilot regarding cracked blades resulting in possible vibration, while this AD does not.
We consider this AD interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this AD affects 33 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour. We estimate 8 work-hours to inspect a set of four blades at a cost of $680 per helicopter and $22,440 for the fleet per inspection cycle. We estimate 4 work-hours to replace a blade and the required parts will cost $124,000, for a replacement cost of $124,340 per blade.
According to Leonardo Helicopter's service information, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Leonardo Helicopter. Accordingly, we have included all costs in our cost estimate.
Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we find that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the required corrective actions must be completed before further flight or within 5 hours TIS after the effective date of this AD.
Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in less than 30 days.
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 AD will not have federalism implications under Executive Order 13132. This AD 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.
For the reasons discussed, I certify that this AD:
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);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model A109A and A109A II helicopters with a main rotor blade (blade) part number (P/N) 109-0103-01-7, P/N 109-0103-01-9, or P/N 109-0103-01-115 that has 500 or more hours time-in-service (TIS) installed, certificated in any category.
This AD defines the unsafe condition as a crack in a blade. This condition could result in failure of a blade and subsequent loss of control of the helicopter.
This AD supersedes AD 2015-22-51, Amendment 39-18386 (81 FR 5037, February 1, 2016).
This AD becomes effective September 25, 2017.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Before further flight, unless already done within the last 5 hours TIS, and thereafter at intervals not to exceed 5 hours TIS:
(1) Using a 3X or higher power magnifying glass, visually inspect the top and bottom surface of each blade for a crack in the area between the station at the end of the doublers (station 1550) and the station at the beginning of the abrasion strip (station 3100).
(2) If there is a crack, replace the blade before further flight. Replacing the blade with blade P/N 109-0103-01-7, P/N 109-0103-01-9, or P/N 109-0103-01-115 does not constitute terminating action for the repetitive inspections required by this AD.
Special flight permits are prohibited.
(1) The Manager, Safety Management Section, FAA, may approve AMOCs for this AD. Send your proposal to: Matt Fuller, Senior Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
(1) Leonardo Helicopters Alert Bollettino Tecnico No. 109-150, Revision B, dated October 21, 2016, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness, Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-711756; fax +39-0331-229046; or at
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2016-0213, dated October 26, 2016. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 6210, Main Rotor Blade.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are superseding Airworthiness Directive (AD) 2015-02-22 for certain Rolls-Royce Corporation (RRC) model 250 turboprop and turboshaft engines. AD 2015-02-22 required repetitive visual inspections and fluorescent-penetrant inspection (FPIs) on certain 3rd-stage and 4th-stage turbine wheels for cracks in the turbine wheel blades. This AD requires repetitive visual inspections and FPIs of 3rd-stage turbine wheels while removing from service 4th-stage turbine wheels. We are also revising the applicability to remove all RRC turboprop engines and add additional turboshaft engines. This AD was prompted by our finding that it is necessary to remove the 4th-stage wheels at the next inspection. We are issuing this AD to address the unsafe condition on these products.
This AD is effective October 13, 2017.
See the
You may examine the AD docket on the Internet at
John Tallarovic, Aerospace Engineer, FAA, Chicago ACO Branch, Compliance and Airworthiness Division, 2300 E. Devon Ave., Des Plaines, IL 60018; phone:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2015-02-22, Amendment 39-18090 (80 FR 5452, February 2, 2015), (“AD 2015-02-22”). AD 2015-02-22 applied to certain RRC 250-B17, -B17B, -B17C, -B17D, -B17E, -B17F, -B17F/1, -B17F/2, turboprop engines; and 250-C20, -C20B, -C20F, -C20J, -C20R, -C20R/1, -C20R/2, -C20R/4, -C20S, and -C20W turboshaft engines. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
RRC requested that we remove references in this AD to the 3rd stage turbine wheel, part number (P/N) RR30000236, installed on the RRC 250-C300/A1 and 250-C300/B1 turboshaft engines. RRC indicated that 3rd stage turbine wheels, P/N RR30000236, are not susceptible to cracks. RRC noted that there have been no cracks observed on 3rd stage wheels installed on RRC 250-C300/A1 or 250-C300B/1 engines.
We agree. The 3rd stage turbine wheel, P/N RR30000236, installed on RRC 250-C300/A1 and 250-C300/B1 engines does not require inspections. They are subject to less severe operating conditions and are not susceptible to this type of failure. We removed references to the 3rd stage turbine wheel, P/N RR30000236, from this AD.
RRC requested that we change references in this AD from “power turbine” to “turbine.” RRC noted that this AD should refer to the entire turbine module rather than just to the power turbine. RRC also commented that the risk analysis for this AD is based on changing the parts anytime the turbine is being serviced, not just the power turbine. Revising the reference in this AD to “turbine” would remove the affected 4th stage turbine wheels from the fleet in a shorter time period since the actions specified in this AD are to be complied with whenever the turbine is at the shop and is dissembled for any reason, or at the next turbine wheel replacement, whichever occurs first.
We agree. We changed the reference in the Compliance section of this AD from “power turbine” to “turbine.”
RRC also commented that changing the references to “turbine” would allow for removal of the Definition section from this AD.
We disagree. The term “engine shop visit” is used as one of the criteria in this AD to determine when an inspection of affected applicable turbine wheels is required. Given that “engine shop visit” may be interpreted in different ways, we provide a definition for this term in this AD. We did not change this AD.
RRC requested that we revise the Compliance section of this AD so that it does not require removal from service all turbine wheels found with cracks. RRC commented that only certain cracks are related to this AD and are a safety concern.
We agree. The intent of this AD is to address cracks at the trailing edge of the turbine wheel blades, near the fillet at the rim. The maintenance manuals for these engines allow certain cracks in areas of the turbine wheels not subject to this AD. Engines may still operate safety with turbine wheels that have allowable cracks. We revised paragraph (f)(3) of this AD to refer to cracks found at the trailing edge, near the fillet at the rim, of the turbine blades.
We reduced the estimated cost of inspection of 3rd stage wheels from $320,365 to $288,320 since we removed the 3rd stage wheel, P/N RR30000236, from the applicability of this AD. As noted in our previous comment response, these P/N 3rd stage wheels are not subject to the unsafe condition identified in this AD.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We estimate that this AD affects 3,769 engines installed on airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
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,
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.
For the reasons discussed above, I certify that this AD:
(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),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, 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 amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective October 13, 2017.
This AD replaces Airworthiness Directive (AD) 2015-02-22, Amendment 39-18090 (80 FR 5452, February 2, 2015).
This AD applies to Rolls-Royce Corporation (RRC) 250-C20, -C20B, -C20F, -C20J, -C20R, -C20R/1, -C20R/2, -C20R/4, -C20W, -C300/A1, and -C300/B1 turboshaft engines with either a 3rd-stage turbine wheel, part number (P/N) 23065818, or a 4th-stage turbine wheel, P/N 23055944 or RR30000240, installed.
Joint Aircraft System Component (JASC) Code 7250, Turbine Section.
This AD was prompted by in-service turbine wheel blade failures that revealed the need for changes to the inspections of certain 3rd-stage turbine wheels and removal from service of certain 4th-stage turbine wheels. We are issuing this AD to prevent failure of the 3rd-stage and 4th-stage turbine wheel blades, damage to the engine, and damage to the aircraft.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 1,775 hours since last visual inspection and fluorescent-penetrant inspection (FPI) or before the next flight after the effective date of this AD, whichever occurs later:
(i) Remove 3rd-stage turbine wheels, P/N 23065818, and perform a visual inspection and an FPI on the removed turbine wheels for cracks at the trailing edge of the turbine blades, near the fillet at the rim.
(ii) Thereafter, re-inspect the affected turbine wheels every 1,775 hours since last inspection (HSLI).
(2) Any time the turbine is disassembled, perform a visual inspection and an FPI on 3rd-stage turbine wheels, P/N 23065818, for cracks at the trailing edge of the turbine blades, near the fillet at the rim.
(3) Do not return to service any turbine wheels found to have cracks at the trailing edge, near the fillet at the rim, of the turbine blades.
(4) Within 1,775 HSLI, or at the next engine shop visit, whichever occurs later, remove 4th-stage turbine wheels, P/N 23055944, from service.
(5) Within 2,025 HSLI, or at the next engine shop visit, whichever occurs later, remove 4th-stage turbine wheels, P/N RR30000240, from service.
For the purpose of this AD, an “engine shop visit” is the induction of an engine into the shop for maintenance involving the separation of pairs of major mating engine flanges, except that the separation of engine flanges solely for the purposes of transportation without subsequent engine maintenance does not constitute an engine shop visit.
(1) The Manager, FAA, Chicago ACO Branch, Compliance and Airworthiness Division, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO Branch, send it to the attention of the person identified in paragraph (i) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact John Tallarovic, Aerospace Engineer, FAA, Chicago ACO Branch, Compliance and Airworthiness Division, 2300 E. Devon Ave., Des Plaines, IL 60018; phone: 847-294-8180; fax: 847-294-7834; email:
None.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace extending upward from 700 feet above the surface at Brenner Field
Effective 0901 UTC, December 7, 2017. 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 7400.11 and publication of conforming amendments.
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Walter Tweedy, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5900.
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 would modify Class E airspace extending upward from 700 feet above the surface area at Brenner Field Airport, Falls City, NE, in support of standard instrument approach procedures for IFR operations at the airport.
The FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, 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 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A 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 within a 6.5-mile radius (increased from 6.4 miles) of Brenner Field and cancels the NDB approach due to the decommissioning of the Brenner NDB. This action enhances the safety and management of the standard instrument approach procedures for 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 will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would 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 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. 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 6.5-mile radius of Brenner Field.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Rock Island Railroad and Highway Drawbridge across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois. The deviation is necessary to facilitate the Quad Cities Marathon. This deviation allows the bridge to remain in the closed-to-navigation position for approximately four and a half (4.5) hours on one day until the race is completed.
This deviation is effective from 7 a.m. through 11:30 a.m. on September 24, 2017.
The docket for this deviation, (USCG-2017-0840) is available at
If you have questions on this temporary deviation, call or email Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email
The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois. The bridge has a vertical clearance of 23.8 feet above normal pool in the closed-to-navigation position. This bridge is governed by 33 CFR 117.5.
This deviation allows the bridge to remain in the closed-to-navigation position from 7 a.m. through 11:30 a.m. on September 24, 2017. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received.
The bridge will not be able to open for emergencies and there are no alternate routes for vessels transiting this section of the Upper Mississippi River. The Coast Guard will inform users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so the vessel operators 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 effective period of this temporary deviation. 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 granting two one-year extensions to the Moderate attainment date for the 2006 24-hour fine particulate matter (PM
This final rule is effective on October 10, 2017.
The EPA has established two dockets for this action under Docket ID No. EPA-R08-OAR-2017-0216 and EPA-R10-OAR-2017-0193. All documents in the dockets are listed on
Crystal Ostigaard, Air Program, EPA, Region 8, Mailcode 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6602,
In early June of this year, the EPA proposed to grant two one-year extensions to the Moderate attainment date for the 2006 24-hour PM
On August 24, 2016, the EPA finalized the Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements (“PM
On June 6, 2017 (82 FR 25992), the EPA Region 8 Regional Administrator, and on June 8, 2017 (82 FR 26638), the EPA Region 10 Regional Administrator proposed to grant two one-year extensions to the Moderate area attainment date for the 2006 24-hour PM
The EPA received two public comments on the proposed actions. One was submitted anonymously and the second was submitted by Western Resource Advocates (WRA).
As discussed in the proposed approval of the extension requests, and in the response to the comment from WRA below, the Logan, UT-ID nonattainment area has met the CAA section 188(d) requirements for granting the two one-year extensions. Accordingly, the EPA is finalizing approval of the two one-year extension requests to the Moderate area attainment date as proposed.
WRA further states that air quality monitoring data indicates that the extensions are inappropriate. The commenter provides air quality data representing the 98th percentile values for the Logan PM
Regarding the first criterion for granting an attainment date extension under CAA Section 188(d)(1), the preamble of the PM
The regulatory requirements for extensions of the Moderate area attainment date that the EPA promulgated in the PM
The EPA has acted on certain aspects of the State of Utah's SIP in separate actions, as described in the proposed action to grant the two one-year attainment date extensions.
For the second criterion in CAA Section 188(d)(2), the EPA interprets the requirement to demonstrate that the area had “no more than one exceedance” of the 24-hour PM
As noted in the proposal,
The comment does not dispute that the area has met the criterion set forth in 40 CFR 51.1005(a)(1)(ii). Instead, the comment cites other monitoring data from previous years. Again, the EPA established its interpretation in the PM
To the extent the comment also argues that the EPA should deny the extension requests in our discretion, we decline to do so. As explained in our proposal and restated above, we have reviewed the requests from the states and accompanying data, and we find that they support granting two one-year extensions of the attainment date for this area. Thus, we do not agree that the EPA must necessarily consider all aspects of air quality (such as the other data the comment presents) in addition to our evaluation of the extension year air quality data under the second criterion. We also do not agree that the EPA must necessarily consider the concerns the comment raises regarding reasonable further progress and quantitative milestones in addition to our evaluation under the first criterion of the state's compliance with commitments and requirements in the submitted Moderate area plan.
However, even if the EPA were to consider the other information presented in the comment, we would still grant the extension requests. First, we note that Utah's submitted Moderate
If we were to consider the other air quality data presented by the comment, we would note that, as the comment states, there is variability from year to year.
In response to requests from the State of Utah on May 2, 2017, and from the Idaho Department of Environmental Quality (IDEQ) on December 15, 2015, February 26, 2016, and April 25, 2017, the EPA is granting two one-year attainment date extensions to the Moderate attainment date for the 2006 24-hour PM
This action is not a redesignation to attainment under CAA section 107(d)(3)(E). The State of Utah and the State of Idaho are not currently attaining the PM
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and therefore is not subject to review by the Office of Management and Budget (OMB). This final action merely approves a state request as meeting federal requirements and imposes no new requirements.
This action does not impose any additional information collection burden under the provisions of the PRA, 44 U.S.C. 3501
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law. Approval of a state's request for an attainment date extension does not create any new requirements and does not directly regulate any entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to state, local, or tribal governments, or to the private sector, will result from this action.
This action does not have federalism implications. It will not 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. Pursuant to the CAA, this action merely approves a state request for an attainment date extension.
This action does not have tribal implications, as specified in Executive Order 13175. No tribal areas are located in the nonattainment area that will be receiving an attainment date extension. The CAA and the Tribal Authority Rule establish the relationship of the federal government and tribes in developing plans to attain the NAAQS, and this rule does nothing to modify that relationship. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe any environmental health or safety risks addressed by this action present a disproportionate risk to children. This action merely approves a state request for an attainment date extension and it does not impose additional requirements beyond those imposed by state law.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards. This action merely approves a state request for an attainment date extension.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). This action approves a state request for an attainment date extension based on the state's compliance with requirements and commitments in its plan and recent air quality monitoring data that meets requirements for an extension.
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 7, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).
Environmental protection, Air pollution control, Ammonia, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving under the Clean Air Act (CAA), a November 18, 2015, State Implementation Plan (SIP) submittal from the Ohio Environmental Protection Agency consisting of adjustments and additions to volatile organic compound (VOC) rules in the Ohio Administrative Code (OAC). The changes to these rules are based on an Ohio-initiated five-year periodic review of its VOC rules and a new rule to update the VOC reasonably available control technology (RACT) requirements for the miscellaneous metal and plastic parts coatings source category for the Cleveland-Akron-Lorain area (“Cleveland area”) consisting of Ashtabula, Cuyahoga, Geauga, Lake, Lorain, Medina, Portage, and Summit counties. Additionally, EPA is approving into the Ohio SIP an oxides of nitrogen (NO
This final rule is effective on October 10, 2017.
EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2015-0802. All documents in the docket are listed on the
Jenny Liljegren, Physical Scientist, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6832,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
EPA is approving a November 18, 2015, Ohio SIP submittal consisting of adjustments and additions to OAC Chapter 3745-21. Specifically, this includes amended OAC rules 3745-21-01, 3745-21-03, 3745-21-04, 3745-21-08, 3745-21-09, 3745-21-10, 3745-21-12, 3745-21-13, 3745-21-14, 3745-21-15, 3745-21-16, 3745-21-17, 3745-21-18, 3745-21-19, 3745-21-20, 3745-21-21, 3745-21-22, 3745-21-23, 3745-21-25, 3745-21-27, 3745-21-28, 3745-21-29; rescission of existing OAC rule 3745-21-24, and adoption of new OAC rules 3745-21-24 and 3745-21-26.
Except for OAC rule 3745-21-26, the changes to the Chapter 3745-21 rules are based on an Ohio-initiated five-year periodic review of its VOC rules. When Ohio reviews a rule and amends greater than fifty percent of that rule, Ohio issues the entire rule as a new replacement rule. This is the case with OAC 3745-21-24. OAC rule 3745-21-26 is an entirely new rule, the purpose of which is to update the VOC RACT requirements for the Cleveland area for the miscellaneous metal and plastic parts coatings source category. Additionally, EPA is approving into the Ohio SIP the NO
Many of Ohio's amendments to the rules in Chapter 3745-21 are not significant. These amendments include: Updates to items incorporated by reference; minor typographical changes to conform to new state preferences on style and formatting; updates to correct typographical and format errors; updates to reflect source name and/or address changes; the removal of references to sources which have been permanently shut down; updates to replace deadlines associated with previous rule effective dates with actual dates (
More significant amendments, those amendments requiring more explanation, and the addition of OAC rule 3745-21-26 were discussed in detail in the May 11, 2017, proposed rulemaking (82 FR 21960). These amendments pertain to catalytic incinerator requirements, references to operating permits, VOC recordkeeping requirements, solvent cleaning operations requirements, the addition of OAC rule 3745-21-26 surface coating of miscellaneous metal and plastic parts, and updates to the following rules: OAC rule 3745-21-24 flat wood paneling coatings and OAC rule 3745-21-28 miscellaneous industrial adhesives and sealants. EPA reviewed these amendments and is approving them for the reasons explained in detail in the May 11, 2017, proposed rulemaking (82 FR 21960) which can be found in the docket to this final rule.
EPA is approving into the Ohio SIP adjustments and additions to VOC RACT rules in OAC Chapter 3745-21. Additionally, EPA is incorporating into the Ohio SIP the NO
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Ohio Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, 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 7, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions and additions read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving the required second carbon monoxide (CO) maintenance plan as a revision to the Texas State Implementation Plan (SIP). The El Paso, Texas CO maintenance area (El Paso Area) has been demonstrating consistent air quality monitoring at or below 85% of the CO National Ambient Air Quality Standard (NAAQS or standard). Because of this, the State of Texas, through its designee, submitted the required second maintenance plan for the El Paso Area as a Limited Maintenance Plan (LMP).
This final rule is effective on October 10, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2016-0550. All documents in the docket are listed on the
Jeff Riley, 214-665-8542,
Throughout this document “we,” “us,” and “our” means the EPA.
The factual background for this action is discussed in detail in our March 21, 2017 direct final rule and proposal (82 FR 14442, 82 FR 14499). Originally, we issued a direct final rule to approve the required second CO maintenance plan for the El Paso, Texas CO maintenance area as a revision to the Texas SIP.
However, the direct final rule and proposal stated that if any relevant adverse comments were received by the end of the public comment period on April 20, 2017, the direct final rule would be withdrawn and we would respond to the comments in a subsequent final action. Relevant adverse comments were received during the comment period, and the direct final rule was withdrawn on May 22, 2017 (82 FR 23148). The background information found in the direct final is still relevant and our March 21, 2017 proposal provides the basis for this final action.
We received comments on our proposal from one commenter. Our response to the comments are below.
We further note that 40 CFR 58.10(a)(1) requires that beginning July 1, 2007, the State shall adopt and submit to the Regional Administrator an annual monitoring network plan, and that this annual monitoring network plan must be made available for public inspection for at least 30 days prior to submission to EPA. This public inspection period of annual monitoring network plans has been provided by the State for all submittals since July 1, 2007, and no adverse comments have been received pertaining to the El Paso Area CO monitoring network in this time.
In the September 21, 2016 limited maintenance plan SIP submission, the State provided data showing monitored CO values from 2006-2015, reflecting a 2015 8-hour CO design value of 2.8 ppm. Thus, the design value represented for the 8-hour standard was less than 31% of the CO NAAQS. Only 1 CO monitor is currently required for El Paso, the Chamizal monitor (AQS #48-141-0044) required for NCore (National Core monitoring network) monitoring. This is a neighborhood-scale, high CO concentration site for the city and it recorded a 2.3 ppm 8-hour CO design value for 2016, similar to the 2.4 ppm 8-hour CO design value for 2016 recorded at the nearby Ascarate Park monitor to the southeast of Chamizal. The 2.3 ppm and 2.4 ppm 8-hour CO design values are significantly below the 8-hour CO NAAQS of 9.4 ppm, representing ambient concentrations 24% and 26%, respectively, of the 8-hour CO NAAQS. Both of these monitors are located in the CO maintenance area, and we note that these design values also represent a continued downward trend of CO ambient concentrations beyond the 2015 design value provided in the State's September 21, 2016 submittal.
The Commenter also states that the El Paso CO LMP should include a commitment to collocate at least one near-road nitrogen dioxide (NO
The 40 CFR part 58, Appendix D standard for population data is considered to be U.S. Census Bureau data. Based on U.S. Census data, El Paso will most likely not reach 1,000,000 in population by 2028. The current population growth estimate rate per year for El Paso is 5,811/year based upon U.S. Census estimates from 2010-2016.
To EPA's knowledge, no such statements have been made concerning implementation of the Tier 3 Motor Vehicle Emission and Fuel Standards, and therefore the state's reliance upon these standards as valid Federal control measures is appropriate for this SIP action. At this time, we see no legal requirement for the state to revise the LMP with an explicit commitment to reevaluate its reliance thereof in the speculative chance that a Federal measure could be weakened or removed some time in the future. We note that in any case of Federal measures being repealed or weakened, pursuant to 42 U.S.C. 7410(k)(5), the EPA has Clean Air Act authority to require a state to revise an approved SIP if it finds that it has become substantially inadequate to maintain the NAAQS. Moreover, CAA section 175A provides the EPA discretion to require the state to submit a revised SIP should the area fail to maintain the NAAQS.
EPA disagrees with the Commenter's contention that the maintenance plan's implementation schedules for contingency measures fail to satisfy the “prompt response” requirement in CAA section 175A(d). This section of the CAA requires that a maintenance plan include such contingency provisions as the Administrator deems necessary to assure that the state “will promptly correct any violation” of the NAAQS that occurs after redesignation of an area. Thus, Congress gave EPA discretion to evaluate and determine the contingency measures that EPA “deems necessary” to assure that the state will “promptly correct” any subsequent violation.
Section 175A does not establish any deadlines for implementation of contingency measures after redesignation to attainment. It also provides far more latitude than does Section 172(c)(9), which applies to a different set of contingency measures applicable to nonattainment areas. Section 172(c)(9) contingency measures must “take effect . . . without further action by the State or [EPA].” By contrast, section 175A(d) allows EPA to take into account the need of a state to assess, adopt, and implement contingency measures if and when a violation occurs after an area's redesignation to attainment. As noted by the U.S. Court of Appeals for the Sixth Circuit in
In the case of the El Paso Area, EPA believes that the contingency measures set forth in the submittal, combined with the State's commitment to implement contingency measures as expeditiously as practicable but no later than 18 months of a trigger, provide assurance that the State will “promptly” correct a future NAAQS CO violation. Given the uncertainty regarding the nature of the contingency measures required to address a violation, a State may need up to 24 months to enact new statutes; develop new or modified regulations and complete notice and comment rulemaking; or take actions authorized by current state law that require the purchase and installation of equipment (
We are approving the CO LMP for the El Paso Area submitted by the TCEQ on September 21, 2016 as a revision to the Texas SIP because the State adequately demonstrates that the El Paso Area will maintain the CO NAAQS and meet all the criteria of a LMP through the second 10-year maintenance period.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. 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, 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 7, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
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 approving state implementation plan (SIP) revisions submitted by the State of Alaska (Alaska or the State) to address Clean Air Act (CAA or Act) requirements for the 2006 24-hour fine particulate matter (PM
This action is effective on October 10, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2015-0131. All documents in the docket are listed on the
Claudia Vaupel at 206-553-6121, or
Throughout this document, wherever “we”, “us” or “our” are used, it is intended to refer to the EPA.
On February 2, 2017, the EPA published its proposal to approve the FNSB Moderate Plan submitted by Alaska to address CAA requirements for the 2006 24-hour PM
The EPA provided a 30-day period for the public to comment on our proposed action on the FNSB Moderate Plan which ended on March 3, 2017. During this comment period, we received five public comment letters. The public comments can be found in the docket for this action. Two commenters were supportive of efforts to improve air quality in general. One commenter expressed appreciation for the “strong standards implemented in 2006 that strengthened the 24-hour PM
The EPA notes that the commenter may have believed that Alaska did not adequately evaluate the use of low sulfur fuel because Alaska did not separately consider both mandatory requirements to use such fuel and incentive programs to encourage the voluntary use of such fuel. Upon reviewing Alaska's analysis, however, we believe that the economic feasibility analysis for this control measure applies to both a mandatory requirement, as well as to incentives to use low-sulfur fuel. We note that while the subheading in the economic incentives section refers to “incentives,” the analysis is not limited to only providing incentives and more broadly analyzes the costs of low-sulfur fuel, whether implemented through a requirement or with incentives. The EPA acknowledges that the “incentives” subheading is somewhat confusing given the broader analysis that follows it, but we do not agree that Alaska failed to consider requirements to use low-sulfur fuel adequately for purposes of the FNSB Moderate Plan.
Alaska concluded that switching to low sulfur fuels would not be economically feasible; this conclusion would apply to both incentive-based and mandatory measures. We note that the FNSB NAA has been reclassified from Moderate to Serious, and Alaska will be required to prepare and submit for EPA review a Serious area attainment plan. 82 FR 21711, May 10, 2017. We anticipate that Alaska will thoroughly evaluate such control measures again, with updated economic data and in light of the longer Serious area attainment deadline, in developing the Serious area attainment plan for this area which requires analysis and implementation of Best Available Control Measures/Technologies (BACM/BACT).
In addition, we note that for a specific category of wood-heating devices, hydronic heaters, Alaska evaluated and implemented a setback requirement that prohibits new installations that are less than 330 feet from the property line. One purpose of this requirement is to restrict these sources, which typically emit larger amounts of pollutants, to less densely populated areas. In the 2017 Clarification, Alaska describes the effect of this control measure as limiting “the installation of hydronic heaters to large lots which are unlikely to exist in more densely populated areas.” 2017 Clarification, p. 7. The hydronic heater setback requirement is thus a density-based requirement that is tailored to address a specific type of heating device.
As discussed in the 1989 RWC Guidance, the effectiveness of an installer certification program depends in part on the extent to which installers and consumers participate in the programs. 1989 RWC Guidance p. 3-12. During development of the FNSB Moderate Plan, Alaska considered and responded to public comments about installation and certification programs by explaining that it had added to its outreach materials for users of wood stoves the EPA's recommendation for consumers to use certified installers.
Significantly, however, the situation about which the commenter was concerned has changed because the referendum no longer applies and Alaska has evaluated additional control measures for inclusion in the FNSB Moderate Plan. Alaska provided supplemental SIP submissions, supported by clarifying information, that analyzed the control measures that it previously considered infeasible due to the citizen's referendum, including the control measures identified by the commenter. Based on this revised analysis, Alaska adopted some additional control measures, such as the mandatory solid-fuel heating device curtailment program, but continued to find some control measures infeasible for reasons unrelated to the expired referendum, such as the ban on green wood sales.
Alaska's supplemental submissions provided additional control measures and an updated and revised analysis for certain components of the FNSB Moderate Plan to ensure that the EPA could evaluate and act on the current plan. As a result, and as the commenter notes, there is some information in the original submission that is outdated and that was made extraneous by the supplemental submissions. However, the supplemental submissions clearly identify the portions of the original submission that were updated and revised and we do not believe that the extraneous material that remains in the original submission is a basis for disapproving the FNSB Moderate Plan. As explained in response to comments concerning specific potential control measures, we have concluded that Alaska's evaluation of the measures is adequate for purposes of the FNSB Moderate Plan.
Regarding Alaska's statement that the benefits are assumed to be small for requiring alternate sources of heat in rental units, we believe that Alaska made reasonable assumptions based on the latest information available at the time. For example, Alaska explained that surveys from 2011-2015 indicated that only 5.6% of households surveyed had wood as a sole source of heat.
As explained in our proposed approval of the FNSB Moderate Plan with respect to this issue, Alaska conducted a technical and economic feasibility analysis of RACT-level SO
Additionally, the commenter did not identify any specific deficiencies with respect to Alaska's RACT analysis for SO
In November 2014, the EPA approved Alaska's infrastructure SIP for the 2006 24-hour PM
We also disagree with the comment suggesting that ADEC must justify the absence of administrative enforcement authorities. The commenter argues that AS 46.14.030 generally grants authority to ADEC to adopt regulations to implement the SIP which could be read to include administrative enforcement authority. As noted previously, ADEC has authority to pursue civil and criminal judicial actions to enforce violations of the SIP and the EPA has already determined that ADEC has adequate authority to enforce the SIP, including the FNSB Moderate Plan. If the commenter believes ADEC should have additional enforcement authority, the appropriate venue to pursue such a concern is with ADEC and the Alaska State Legislature. Furthermore, as noted by the commenter, the Borough has authority to issue warnings and citations to enforce key control measures adopted at the local level, such as the solid-fuel heating device curtailment program. The Borough control measures are included in Alaska's FNSB Moderate Plan submission and will become a part of the federally-approved SIP.
Another commenter contended that Alaska claimed it lacks the resources to implement and enforce regulations. The EPA is unaware of any such statement attributable to Alaska submitted as part of the FNSB Moderate Plan, and the commenter provided no reference or citation for the EPA to evaluate this claim. Accordingly, the EPA has no information suggesting that Alaska has stopped funding, or lacks resources to make progress in improving air quality in the FNSB NAA. In fact, ADEC currently is devoting resources to the development of a Serious area attainment plan and the Borough is implementing local control measures incorporated into the SIP. In addition, as indicated previously, the EPA found that in its infrastructure SIP for the 2006 24-hour PM
Second, the EPA disagrees with the commenter's view that the low temperature limitation on the applicability of the mandatory solid-fuel heating device curtailment requirement necessarily constitutes an impermissible exemption in the emissions limitation, because the curtailment requirement works in conjunction with other specific control measures in the SIP that continue to apply and limit emissions from this source category even during those low temperature events. It is important to clarify how Alaska is combining control measures in order to assure that the SIP imposes continuous emission limits on solid fuel heating devices, even when the curtailment requirement is suspended during extreme cold events.
Alaska is aware of the public health concerns associated with ambient PM
To address these competing concerns, Alaska and the Borough structured the stage 3 alert requirements to allow the continued use of certain devices during periods of extreme cold. When temperatures are below −15 °F during stage 3 alerts, the prohibition on the use of all solid-fuel heating devices, masonry heaters, pellet fuel burning appliances, cook stoves, fireplaces, or waste oil burning appliances does not apply. However, the stage 2 prohibition on the use of uncertified solid-fuel heating devices and hydronic heaters that are not EPA Phase II qualified continues to apply. In addition, even when the temperature limitation on the applicability of stage 3 alerts applies, the users of solid-fuel heating devices must continue to meet the applicable opacity emission limitation and continue to comply with the requirement to burn only dry, properly seasoned wood (with a moisture content of 20% or less). Thus, the EPA believes that the opacity limit and dry wood
The EPA notes that Alaska is currently in the process of developing the Serious area plan for the FNSB NAA, and is reevaluating the need for additional emission reductions to attain the 2006 24-hour PM
Finally, the EPA agrees with the commenter that state and local control measures in the SIP need to be legally and practically enforceable. A core principal of the CAA is that the EPA's approval of a control measure into a SIP makes the measure a federally-enforceable component of the SIP that the State, the EPA or citizens can enforce in the event of violations. In this final action, the EPA is approving into the Alaska SIP, among other control measures, the mandatory solid-fuel heating device curtailment program, the 20% opacity emission limitation, and the dry wood requirement, and these measures will become federally-enforceable elements of the SIP for the FNSB NAA.
We also disagree with the commenter's assertion that the amendments to 18 AAC 50.065(f) are a relaxation of existing SIP measures. The dates of the open burning prohibition remain the same as when the EPA last approved 18 AAC 50.065(f) into the Alaska SIP in 1998. 63 FR 63983, November 18, 1998. More importantly, the amendments to 18 AAC 50.065(f) make the open burning prohibition applicable to PM
Similarly, we disagree with the commenter's view that inclusion of the language contemplating a potential future open burn permit program to replace the current open burning prohibition is a relaxation of the existing Alaska SIP. First, as stated previously, the current SIP-approved regulation applies only to PM
Regarding the commenter's concern that the amendment is vague and does not provide limits or specify a process for state approval of a local open burn permit program, we note that the provision does not itself constitute an approval of any such local open burn permit program. The provision merely contemplates such a permitting program in the future, and one that would have to meet certain requirements. For example, the condition in 18 AAC
With respect to the commenter's concern that the language in the FNSB Moderate Plan that contemplates potential future open burn permit programs in lieu of the prohibition on open burning is vaguely worded and provides no indication of “what constitutes a lawful local air quality open burn permit program and no limit to the range of activities that might be authorized . . .” the EPA agrees that the amendment leaves unaddressed many aspects of a local open burn permit program that would need further development and clarification. Also, as noted previously, any future local open burn permit program that is developed to operate in lieu of the open burning prohibition must be submitted to Alaska for incorporation into the
Finally, we disagree with the commenter's suggestion that a future open burn permit program would have to address the process for variances related to ceremonial and recreational fires. We note that ceremonial and recreational fires are specifically excluded from Alaska's amended definition of open burning in 18 AAC 50.990(65)(B). Because these activities are not subject to the open burning prohibition, there would not be a need for future variances related to such fires. We agree, however, that to the extent a future permitting program may include a process for seeking variances for activities subject to the burn ban, provisions related to such variances should provide adequate definitions and specifications to allow for necessary implementation and enforcement, as well as evaluation by Alaska and the EPA before approval as a revision to the current SIP.
However, we believe the commenter raised valid concerns with the waiver provisions in 18 AAC 50.075(d)(2). The EPA is not taking final action on these waiver provisions because they are no longer part of the submitted FNSB Moderate Plan. On July 26, 2017, Alaska withdrew 18 AAC 50.075(d)(2) from its SIP submission. The withdrawal letter is included in the docket for this action.
With respect to the comments about the type of curtailment program and the suggestion that state and local officials provide a fuel oil subsidy, we note that states have discretion in formulating their attainment plans, so long as they meet the applicable requirements of the Act. In the FNSB NAA, Alaska has adopted a number of control measures
Regarding the commenter's suggestion that Alaska use a more simplified wood moisture labeling system for this program, such as “dry” or “wet,” we note that states have discretion in formulating their attainment plans, so long as they meet the applicable requirements of the Act. In this instance, we believe that the method of labeling moisture content adopted by Alaska adequately conveys the necessary information to wood users to facilitate the related requirement to burn only dry wood, and thus the alternative form of labelling suggested by the commenter is not required. We are therefore approving Alaska's regulations, including the requirement that wood sellers document three moisture content measurements on the moisture content disclosure. The EPA notes that the mandatory component of Alaska's wood seller registration program was implemented on August 15, 2017.
We disagree with the comment that Alaska did not establish emission standards for new coal-burning device installations in the FNSB Moderate Plan. Although the commenter is correct that 18 AAC 50.077 does not establish such emission standards, the emission standards for “Borough listed appliances” in section 020 of Borough code chapter 21.28 apply to coal heating devices. Additionally, section 030.A prohibits the installation of a solid fuel burning appliance in the FNSB NAA if the appliance is not listed by the Borough. We note that “solid fuel burning appliance” is defined in section 010 to include coal stoves, coal-fired hydronic heaters, and coal-fired furnaces. Alaska adopted Borough code chapter 21.28 sections 010, 020, and 030 into the FNSB Moderate Plan that was submitted to the EPA on November 23, 2016. Upon the effective date of this action, these Borough provisions will be adopted into the federally-approved SIP. Thus, Alaska has imposed emission controls on coal fired stoves in the FNSB NAA sufficient for purposes of the FNSB Moderate Plan. Alaska acknowledged the public health concerns associated with emissions from coal fired stoves in the FNSB Moderate Plan and the EPA anticipates that Alaska will further evaluate potential controls for these sources in
We also disagree with the commenter regarding the need to revise the written confirmation requirements in 18 AAC 50.077(f) for sales of wood-fired heating devices to be installed outside of the FNSB NAA to include additional requirements such as notarization and retention of forms. The requirements of 18 AAC 50.077(f) specify that all new wood-fired heating devices to be installed or used in the FNSB NAA must meet certain emission standards and provides that a person who intends to sell or otherwise convey a wood-fired heating device that does not meet those standards must receive written confirmation from the buyer or operator that the device will not be installed or used in the FNSB NAA. The EPA believes that this provision provides sufficient notice (in addition to the regulatory text of 18 AAC 50.077 and other education and outreach efforts conducted by ADEC and the Borough) to potential buyers of the prohibition on such installations in the FNSB NAA and adequately documents their awareness and agreement to comply. Although the additional requirements suggested by the commenter may be helpful, we believe the current requirements devised by Alaska are sufficient.
With respect to the comment that Alaska should implement immediately the requirement for replacing uncertified wood stoves at the time of home sale, rather than implement it as a future contingency measure, the EPA notes that the measure has been implemented. The requirement became effective on June 9, 2017, the effective date of reclassification of the area to Serious. 82 FR 21711, May 10, 2017.
Second, we acknowledge that under 18 AAC 50.246(c)(1), curtailments are voluntary “from any person issued a permit under this chapter whose stationary source's emissions might impact the area subject to the advisory.” Thus, the commenter is correct that compliance with the curtailment contemplated in this provision is voluntary for the affected stationary sources (Alaska defines “stationary source” in AS 46.14.990 as “any building, structure, facility, or installation which emits or may emit a regulated NSR pollutant”). However, we note that 18 AAC 50.246(c)(1) applies only to permitted stationary sources and it applies statewide.
By contrast, Alaska has adopted a mandatory curtailment program for the FNSB NAA that applies to all solid-fuel heating devices in the event that Alaska or the Borough issues an alert based on high ambient PM
We also believe that the requirements of AS 46.14.400(d) address the commenter's concern that Alaska should not delegate authority to a local air quality control program that is unwilling or unable to fully implement regulatory requirements. The cooperative agreement must specify the respective enforcement responsibilities of the local air quality district and ADEC. According to the ADEC-FNSB MOU, ADEC has enforcement responsibility for all currently permitted facilities that are under ADEC authority. ADEC and the Borough have joint responsibility for responding to public complaints about air pollution within the Borough. The ADEC-FNSB MOU provides a flow chart for identifying appropriate enforcement actions for the Borough to take, for ADEC to take, or for joint enforcement actions.
In response to the comments about air quality monitors, we affirm that the North Pole Fire Station monitor continues to operate as a regulatory monitor and that it is a neighborhood scale monitor. As discussed in our proposal, the EPA expects that Alaska will include the data from the North Pole Fire Station monitor in the analyses for the development of a Serious area attainment plan for the FNSB NAA. 82 FR 9037, February 2, 2017. Regarding the comment about the removal of the special purpose monitor, the EPA is aware that high concentrations of PM
With respect to the commenter's question concerning whether this approval was influenced by the timing of the action, the EPA acknowledges that our final action is outside of the timeline prescribed by the CAA. The EPA's inability to take timely action was the result of a number of factors including our ongoing work with Alaska to supplement the FNSB Moderate Plan. However, as noted previously, the EPA's decision to approve the FNSB Moderate Plan in this action is based on the content of the plan and its consistency with applicable statutory and regulatory requirements, and was not influenced by the timing of our final action.
Under CAA section 110(k), the EPA is approving the FNSB Moderate Plan for the 2006 24-hour PM
The EPA is approving the
With respect to local rules, we are incorporating by reference Fairbanks North Star Borough Code chapter 21.28 sections 010, 020, 030 (except J), 050, and 060. We are approving, but not incorporating by reference, Fairbanks North Star Borough Code chapter 21.28 section 030.J because it relates to penalty provisions that if incorporated by reference may conflict with the EPA's independent authorities. We are also approving, but not incorporating by reference Fairbanks North Star Borough Code chapter 21.28 sections 040 and 070 because they relate to funding for voluntary initiatives being undertaken by the Borough to reduce emissions of PM
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of state and local regulations for solid-fuel heaters and open burning, as set forth in the amendments to 40 CFR part 52. The EPA has made, and will continue to make, these materials generally available through
Therefore, these materials have been approved by the EPA for inclusion in the State implementation plan, have been incorporated by reference by the EPA into that plan, are fully federally-enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond
• 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 the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and it 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 7, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The additions and revisions read as follows:
(c) * * *
(e) * * *
Federal Communications Commission.
Final rule; petition for reconsideration.
In this Order on Reconsideration and Second Report and Order, the Commission adopts the parameters for the Mobility Fund Phase II challenge process, which will enable the Commission to resolve eligible-area disputes expeditiously. The challenge process will begin with a new, one-time collection of standardized, up-to-date 4G LTE coverage data from mobile wireless providers. Interested parties will then have an opportunity to contest an initial determination that an area is ineligible for MF-II support, and providers will then have an opportunity to response to challenges.
The Commission adopted this Order on Reconsideration and Second Report and Order on August 3, 2017, and the parameters set forth therein for the Mobility Fund Phase II challenge process, along with all associated requirements also set forth therein, go into effect October 10, 2017, except for the new or modified information collection requirements in the challenge process that require approval by the Office of Management and Budget (OMB). The Commission will publish a document in the
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Wireless Telecommunications Bureau, Auction and Spectrum Access Division, Jonathan McCormack or Audra Hale-Maddox, at (202) 418-0660. For further information concerning the Paperwork Reduction Act information collection requirements contained in this document, contact Cathy Williams at (202) 418-2918 or via the Internet at
This is a summary of the Order on Reconsideration and Second Report and Order (
As required by the Regulatory Flexibility Act of 1980, the Commission has prepared a Final Regulatory Flexibility Analysis (FRFA) of the possible significant economic impact on small entities of the policies and rules adopted in this document. The FRFA is set forth in an appendix to the
The
The Commission will send a copy of this
1. In the MF-II Challenge Process Order, the Commission takes the next step to extend mobile opportunities to rural America by fulfilling its commitment to design a robust challenge process that will direct Mobility Fund Phase II (MF-II) support to primarily rural areas that lack unsubsidized 4G Long Term Evolution (LTE) service. The MF-II challenge process the Commission establishes will be administratively efficient, fiscally responsible, and will enable it to resolve eligible area disputes quickly and expeditiously. This challenge process will begin with a new, one-time collection of standardized, up-to-date 4G LTE coverage data from mobile wireless providers. Interested parties will then have an opportunity to contest an initial determination that an area is ineligible for MF-II support, and providers will then have an opportunity to respond to challenges.
2. In February 2017, the Commission adopted rules to move forward expeditiously to an MF-II auction. The Commission established a budget of $4.53 billion over a term of ten years to provide ongoing support for the provision of service in areas that lack adequate mobile voice and broadband coverage absent subsidies. The Commission further decided that geographic areas lacking unsubsidized, qualified 4G LTE service would be deemed “eligible areas” for MF-II support, and that it would use a competitive bidding process (specifically, a reverse auction) to distribute funding to providers to serve those areas. For the purposes of MF-II, the Commission defined “qualified 4G LTE service” as mobile wireless service provided using 4G LTE technology with download speeds of at least 5 Mbps. The Commission also decided that, prior to an MF-II auction, it would compile a list of areas that were presumptively eligible for MF-II support based on information derived from the Form 477 data submissions and high-cost support disbursement data available from the Universal Service Administrative Company (USAC), and it would provide a limited timeframe for challenges to those initial determinations during the pre-auction process.
3. In order to make more informed decisions on the challenge process, the Commission deferred deciding the specific parameters of the challenge process and instead sought additional comment. Among other things, the Commission sought comment in the
4. As necessary starting points for the challenge process, the Commission first resolves certain issues raised in petitions for reconsideration of the
5. The Commission reconsiders its decision to use Form 477 data as the basis for determining deployment of qualified 4G LTE for the map of areas presumptively eligible for MF-II. At the time of the
6. A trade association now seeks reconsideration of the Commission's decision to use Form 477 data to determine what areas are covered by qualified 4G LTE for purposes of identifying areas presumptively eligible for MF-II support. The trade association instead offers an industry consensus proposal asking that the Commission undertakes a new, one-time data collection with specified data parameters tailored to MF-II, thus addressing the lack of a better-tailored data source than Form 477.
7. After consideration of petitioner's industry consensus proposal, as well as the record gathered in response to this issue, the Commission reconsiders its decision to use Form 477 data as the basis for determining deployment of qualified 4G LTE for the map of areas presumptively eligible for MF-II support. The Commission instead grants, in part, petitioner's petition for reconsideration proposing a new, one-time collection of data to determine the deployment of qualified 4G LTE for the purposes of MF-II.
8. The Commission observes at the outset that the mobile deployment data collected on Form 477 represent a dramatic improvement over the deployment data previously available on a national scale. On reconsideration, the Commission acknowledges the concerns of commenters, and finds that the use of Form 477 data as the baseline, as currently filed, is likely to result in a significantly longer MF-II challenge process than if the Commission collected data consistent with the petitioner's consensus proposal as the baseline for establishing which areas are presumptively eligible for support.
9. Given the negative impact that using Form 477 data could have in prolonging the MF-II challenge process, and after considering the possibility of quickly acquiring a better-tailored data source than Form 477, the Commission is persuaded by the weight of the record to adopt petitioner's consensus proposal to undertake a new, one-time data collection of 4G LTE coverage maps based on the specific parameters the Commission adopts in the
10. To reduce the burden on these providers, the Commission requires only those providers that have previously reported 4G LTE coverage in Form 477 and have qualified 4G LTE coverage based on the data specification described below to submit MF-II coverage data. Form 477 filers that do not provide qualified 4G LTE service at the speed benchmark and parameters for MF-II eligibility are not required to submit coverage data as part of the MF-II challenge process collection. Filers that provide service at the benchmark and parameters for MF-II eligibility must submit coverage data. The Commission will use these new coverage data, in conjunction with subsidy data from USAC, to create the map of areas presumptively eligible for MF-II support.
11. In reaching its decision to undertake this effort, the Commission finds that on balance the new coverage data it is collecting should reduce the need for challengers to perform more in-depth testing in certain areas or to file extensive challenges to large geographic areas. Thus, it should reduce the burden on challengers and providers that respond to challenges and allow the Commission to commence the MF-II auction more quickly. In addition, current 4G LTE providers have the best information concerning their coverage footprints based on their propagation models, spectrum, and network infrastructure, and thus are in the best position to provide the Wireless Telecommunications Bureau and the Wireline Competition Bureau (the Bureaus) with data already in their possession, tailored to the purposes of MF-II. This approach also allows the Commission to simplify the challenge process by allowing only challenges that qualified LTE coverage is overstated and not also challenges that such coverage is understated. This approach also permits the Commission to establish various bright line rules for evaluation of the new coverage submissions and of certain challenges that should expedite the final resolution of areas eligible for MF-II support.
12. The Commission also wishes to make clear that only the extent of qualified 4G LTE coverage can be challenged in the challenge process; its decision in the
13. The Commission affirms that it will use a 5 Mbps download speed benchmark to determine what coverage counts as qualified 4G LTE for the purpose of identifying areas eligible for MF-II support. Using a download speed benchmark of 5 Mbps supports the Commission's primary policy goal of directing its limited MF-II funds to address 4G LTE coverage gaps and expanding 4G LTE coverage to areas that the private sector will not serve without government subsidies.
14. Four petitioners seek reconsideration of some aspect of the Commission's decision to use a 5 Mbps download speed as the benchmark to determine what coverage counts as qualified 4G LTE for the purpose of identifying areas eligible for MF-II support.
15. Despite the fact that providers have used different standards and methodologies to report coverage in their Form 477 data, the nationwide carriers are all generally reporting minimum advertised download speeds of 5 Mbps for their 4G LTE network coverage. Carriers' advertised speeds demonstrate that a consumer can reasonably expect to receive 4G LTE service at a download speed of 5 Mbps in both rural and urban areas. The Commission previously noted that “commenters generally did not discuss the technical requirements of 4G LTE service” but did cite multiple comments on the performance requirement for MF-II recipients. Commenters consistently cited 5 Mbps download as consistent with 4G LTE service but differed on whether a 10/1 Mbps requirement was too aggressive. Similarly, the
16. The purpose of the eligibility benchmark is to determine at the outset of MF-II which areas lack service reasonably comparable to current service because they are uneconomic to serve and require subsidies to achieve 4G LTE service. In contrast, the performance benchmark for an MF-II recipient ensures that the Commission's limited universal service funds are used in a fiscally responsible manner to assure that service in eligible areas is reasonably comparable to urban offerings in the future. Setting the eligibility benchmark the same as the performance benchmark would have the counterproductive effect of directing subsidies to areas that are already receiving high levels of service, and consequently providers in those areas could potentially achieve the performance objective in the first year of a ten-year support program. Different eligibility and buildout requirements are consistent with past Commission decisions in the universal service context, and they serve “our objective of ensuring that we target our finite budget to where it is most needed.” To accomplish this objective, the Commission must exercise its discretion to balance competing universal service principles of promoting nationwide deployment of high-speed mobile broadband and spending limited universal service funds in a cost-effective manner.
17. The Commission also rejects petitioners' assertions that it did not provide sufficient analysis to justify using the 5 Mbps download speeds as the eligibility benchmark in light of its expectation that areas found to be ineligible for MF-II support are likely to see improvements in the coming years. The Commission's objective in MF-II, in accordance with the
18. Lastly, the Commission declines to adopt an upload speed benchmark to identify areas eligible for MF-II support. Given the nature of mobile wireless deployment and the interplay between download and upload speeds when designing and optimizing an LTE network, there is no single upload edge speed that corresponds to a 5 Mbps download speed. One party, however, has submitted recent LTE speed measurement results showing that with 1 Mbps as the 10th percentile of the upload speed distribution, the standard national compliance, at the non-MSA (metropolitan statistical area) and MSA level, only ranges from approximately 5 percent to 12 percent. This suggests that a cell edge 1 Mbps upload speed standard requirement would exceed the upload speeds of most current LTE service areas. Thus, including a 1 Mbps upload speed benchmark could make eligible for support most areas with current LTE service at download speeds of 5 Mbps. Finally, the Commission also finds that the additional upload speed standard would add unnecessary complexity to the already complex challenge process. The Commission concludes that including a 1 Mbps upload speed benchmark for
19. The Commission affirms the conclusion it reached in the
20. Two petitioners now seek reconsideration of this issue; they argue that areas that do not have both GSM and CDMA coverage by unsubsidized providers should be eligible for MF-II support. The Commission denies the petitions for reconsideration of this issue. Efficiently distributing MF-II funds and expanding coverage are the Commission's priorities, and it must balance these policy goals against an issue that even one petitioner notes “is one that time and ubiquitous VoLTE deployment will eventually solve.” In the face of a diminishing technological issue, the Commission directs MF-II support in a fiscally-responsible manner by focusing on areas that lack unsubsidized, qualified 4G LTE coverage without considering whether older technologies are compatible. The Commission's gradual phase down of legacy support will provide consumers and carriers with time to complete the transition to newer technologies.
21. The Commission also denies a petitioner's request that it reconsider the basis on which it determines whether qualified 4G LTE deployed in an area is subsidized or unsubsidized. Consistent with the Commission's earlier conclusion, the Commission affirms that it will determine whether a provider that deploys qualified 4G LTE in an area is subsidized or unsubsidized based only on whether it receives high-cost support for that area using USAC high-cost disbursement data, as described in the
22. The Commission also notes that the Commission has not collected and does not intend to collect the tower-by-tower data that would be necessary to conduct the analysis proposed by the petitioner because the possible benefits of collecting that data appear small compared to the significant costs of collection and analysis. As part of their Form 477 data filings, mobile wireless carriers submit maps that depict coverage without distinguishing between carrier-owned and collocated facilities. As discussed in the
23. Consistent with the Commission's overarching objective to transition quickly away from the legacy CETC support system, it adopts a streamlined challenge process that will efficiently resolve disputes about areas deemed presumptively ineligible for MF-II support. Based on the Commission's review of the record and its comprehensive evaluation of the advantages and disadvantages of the various proposals, the Commission concludes that the approach it adopts will both promote fairness and minimize burdens on interested parties.
24. Under the adopted approach, the Commission will begin with a new, one-time collection of 4G LTE coverage data, which will be used to establish the map of areas presumptively eligible for MF-II support. Specifically, the Commission will require providers to file propagation maps and model details with the Commission indicating their current 4G LTE coverage, as defined by download speeds of 5 Mbps at the cell edge with 80 percent probability and a 30 percent cell loading factor.
25. An interested party (the challenger) will have 150 days to initiate a challenge of one or more of the areas initially deemed ineligible in the Commission's map of areas presumptively eligible for MF-II support (the challenge window). Prior to the close of the challenge window, a challenger may use USAC's online challenge portal (the USAC portal) to (1) access confidential provider-specific information for areas it wishes to challenge; (2) identify the area(s) it wants to challenge; (3) submit evidence supporting the challenge; and (4) certify its challenge for the specified area(s). After agreeing to treat the data as confidential, challengers will be able to access via the USAC portal (a) the underlying provider-specific coverage maps submitted as part of the new data collection; (b) the list of pre-approved provider-specified handsets with which to conduct speed measurements; and (c) any other propagation model details collected as part of the new data collection. To certify a challenge, a challenger will be required to identify the area(s) within each state that it wishes to challenge and submit actual outdoor speed test data collected using standardized parameters. Challengers will submit their challenges via the USAC portal. The Commission directs the Bureaus to work with USAC to establish the USAC portal through which a challenger will be able to access the confidential provider-specific information that is pertinent to the challenge, as well as submit its challenge, including all supporting evidence and required certifications.
26. Once a challenger submits its evidence in the USAC portal, the system will conduct an automatic validation to determine whether the challenger provided sufficient evidence to justify proceeding with each submitted challenge. In the event the data fail automatic validation for an area, the system will flag the problem for the challenger. If the failure occurs while the challenge window is still open, the challenger may submit additional or modified data, or modify its challenged area contours, as required, to resolve the problem. Once the challenge window closes, however, the challenger will have no further opportunity to correct existing, or provide additional, data in support of its challenge. Only those challenges to areas that are certified by a challenger at the close of the window will proceed.
27. A challenged party will have an opportunity to submit additional data via the USAC portal in response to a certified challenge (the response window). If a challenged party does not oppose the challenge, it does not need to submit any information. After the response window closes, Commission staff will adjudicate certified challenges and responses.
28. The Commission finds that, in conjunction with the new data collection, this framework for the MF-II challenge process appropriately balances the need for accuracy against the burdens imposed on interested parties. The Commission anticipates that using standardized new coverage data as the basis for its initial eligibility map will improve the accuracy and reliability of the information available to potential challengers, which should result in fewer, more targeted challenges and should reduce the administrative burdens on Commission staff, challengers, providers, and other stakeholders. Requiring challengers to submit proof of lack of unsubsidized, qualified 4G LTE coverage should deter frivolous challenges based on anecdotal evidence and, thereby, expedite the challenge process. Moreover, allowing, but not requiring, challenged parties to submit data in response to a challenge will both promote fairness and minimize burdens on interested parties.
29. The Commission directs the Bureaus to issue a public notice or order (following the Bureaus' issuance of a notice and opportunity for comment) detailing instructions, deadlines, and requirements for filing a valid challenge, including file formats, parameters, and other specifications for conducting speed tests.
30. In the new, one-time MF-II data collection, the Commission will require providers to file propagation maps and model details with the Commission indicating their current 4G LTE coverage, as defined by download speeds of 5 Mbps at the cell edge with 80 percent probability and a 30 percent cell loading factor. The Commission finds that a download speed of 5 Mbps with 80 percent cell edge probability, which is equivalent to approximately 92 percent cell area probability, and a 30 percent cell loading factor, strikes a reasonable balance between expanding LTE into unserved areas and enhancing existing suboptimal LTE service areas, which promotes the optimal use of limited public funds.
31. The Commission acknowledges that the 80 percent cell edge probability and 30 percent cell loading factor parameters required for the data collection are lower than those proposed in the industry consensus proposal. Adopting the higher cell edge probability and cell loading factor parameters in the industry consensus proposal, however, would increase the likelihood that MF-II funds would be directed to areas that already meet the MF-II performance requirement of a 10 Mbps median download speed. One wireless provider submitted recent LTE speed measurement data analysis based upon nationwide wireless provider performance in specific states. The analysis showed that in some cases less than 2 percent of the data points achieved a 5 Mbps download speed 90 percent of the time. Indeed, the Commission estimates that the cell area median download speed in the cell areas associated with the industry consensus proposal's proposed parameters would be significantly in excess of 10 Mbps and therefore higher than the MF-II performance requirement. In fact, the Commission estimates that areas larger than industry consensus proposal's proposed cell areas would have median download speeds in excess of 10 Mbps. The Commission's analysis shows that the 80 percent cell edge probability it adopts corresponds with a 92 percent cell area probability, which means users would have a greater than 90 percent chance of achieving a download speed of at least 5 Mbps across the entire coverage area of a cell. In addition, these parameters exceed the parameters that wireless operators typically use when deploying networks into previously-unserved areas (greenfield builds) of 75 percent cell edge probability and 90 percent cell area probability. In light of the difficulties of precisely determining the coverage areas where service with a minimum download speed of 5 Mbps is available, the Commission finds that a cell edge probability of 80 percent and a cell area probability of 92 percent appropriately balance the concern of misrepresenting coverage with its priority of directing its limited universal service funds on areas most in need of support. Further, adoption of the industry consensus proposal's proposed parameters would likely result in MF-II support being used to upgrade or over-build current 4G LTE networks rather than to expand 4G LTE coverage to unserved areas.
32. In addition, the Commission believes that a 30 percent cell loading factor in rural areas is more appropriate for MF-II purposes than the industry consensus proposal's proposed 50 percent cell loading factor, which is more typical in non-rural areas where there is more uniform traffic. Typical cell site density in rural areas is much lower than in urban areas, resulting in an overall lower interference environment. Additionally, when compared to urban and suburban areas, rural areas typically have lower amounts of uniform traffic among cells because of the varied population distribution across cells, lower numbers of simultaneous users, and lower overall demands on the network over time. As such, cell loading is typically lower in rural areas than in urban and suburban areas. The lower cell edge probability and cell loading factor parameters for the data collection will likely decrease the eligible areas and target the limited MF-II funds to more areas that are currently unserved or served by 4G LTE networks with a median download speed below 10 Mbps. If the Commission was to adopt a lower cell edge probability, it would unnecessarily risk focusing funds on the costliest to serve areas, thus decreasing the square miles receiving support in the auction and consequently reducing the cost effectiveness of the MF-II program. A lower cell edge probability requirement would likely decrease the eligible areas with marginal LTE coverage. Thus, using its predictive judgment, the Commission finds that these parameters meet its standards for the availability of coverage and are best suited to advancing its goals for MF-II.
33. The Commission recognizes that some may have concerns about the effect of the parameters it adopts on the availability of certain mobile applications, for instance telemedicine and precision agriculture, in rural areas. The Commission believes those concerns are misplaced. Remote monitoring and diagnosing of medical conditions and precision agriculture, which uses satellite GPS positioning and remote sensors in farming operations, are typically lower-bandwidth, machine-to-machine applications and should not significantly increase the overall cell loading or require speeds greater than 5 Mbps. Further, the Commission believes that focusing its limited funds on expanding service to the areas that currently lack 4G LTE service is the best way to increase the availability of these services in rural areas. Applying a higher cell loading factor more typical of an urban or suburban area or increasing the cell edge probability even further is more likely to direct funds to more areas that already have coverage
34. As one party proposed, filers shall report an outdoor level of coverage. The coverage boundaries shall have a resolution of 100 meters (approximately three arc-seconds) or better, and shall likewise use an appropriate clutter factor and terrain model with a resolution of 100 meters or better. In addition, filers shall use the optimized RF propagation models and parameters used in their normal course of business. The Commission directs the Bureaus to specify what other propagation model details and parameters must be filed alongside such propagation maps in a subsequent public notice. In addition to submitting propagation maps and model details of 4G LTE coverage, providers shall report the signal strength (RSRP) and clutter factor categories used to generate their coverage maps. If the signal strength in the coverage maps varies regionally, then such variations must be reported. The providers must report the loss value associated with each clutter factor category used in their coverage maps. Additionally, providers shall submit a list of at least three readily-available handsets that challengers can use to conduct speed tests, as well as a certification, under penalty of perjury, by a qualified engineer that the propagation maps and model details reflect the filer's coverage as of the generation date of the map in accordance with all other parameters. The Commission clarifies that the handsets identified by providers must include at least one compatible with industry-standard drive test software. The Bureaus will issue further guidance or requirements on the handsets that may be used for speed tests in a subsequent public notice.
35. The Commission finds that requiring a specific signal strength benchmark, as sought by several commenters, is not necessary for these propagation maps because the cell edge speed threshold requirement subsumes a specific signal strength value depending on specific operating signal bandwidth and the network deployment configurations. A 10 MHz bandwidth has double the noise power of the 5 MHz bandwidth; thus, it requires higher signal strengths for the same signal quality (SNR) requirement. The thermal noise power equation indicates that noise power is directly proportional to the bandwidth. The Commission's analysis comparing results of theoretical propagation models and actual speed test data indicates that the signal strength parameter in propagation models may not be closely correlated with actual on-the-ground data in a particular geographic area. As a result, and in light of the differing technical characteristics of service providers' LTE deployments, the Commission decides to benchmark download speed, which is what the customer receives, rather than signal strength, to determine whether a particular geographic area is eligible or not for MF-II support. With this in mind, the Commission sets the download speed at 5 Mbps at 80 percent probability, and will evaluate challenges on the basis of measured download speeds. In other words, the topography of an area as well as summer foliage may lead to differences between expected signal strength and the actual experienced speed of consumers. Thus, the Commission's cell edge speed threshold requirement should result in more accurate data in America's deserts, prairies, rolling hills, mountains, and forests than an across-the-board signal strength parameter. The Commission is mindful, however, of the concerns of some providers regarding signal strengths, and the Commission will, as noted above, require providers to report signal strength with their coverage maps. The signal strength information will be available to challengers. When issuing filing instructions, the Commission directs the Bureaus to explain what additional parameters (such as signal strength and clutter categories) and information must be included with coverage map filings, and subsequently disclosed to challengers in the challenge process.
36. In a public notice to be released later in the MF-II process, the Commission directs the Bureaus to provide instructions for how to file the data submission, including a data specification, formatting information, and any other technical parameters that may be necessary for such filings. In order to provide ample time for carriers to generate data in accordance with these parameters, the Commission directs the Bureaus to set the deadline for carriers to submit data for the one-time data collection at least 90 days after the release of the filing instructions public notice.
37. Based on the Commission's experience in the challenge processes for MF-I and CAF-II, and after carefully weighing the record on this issue, the Commission concludes that government entities (state, local, and Tribal) and all service providers required to file Form 477 data with the Commission are best suited to participate as challengers in the MF-II challenge process. Allowing these interested parties to participate in the challenge process satisfies the Commission's policy goal of administrative efficiency because they are most likely to be able to acquire the requisite data sufficient to support a valid challenge and, in many cases, are already familiar with filing data with USAC. Many Form 477 filers have a pre-existing relationship (
38. As a practical matter, the Commission does not expect that an individual consumer would have the time, ability, or resources to file a valid challenge. Instead, the Commission anticipates that an individual consumer will be best served by participating in the MF-II challenge process through his or her state, local, or Tribal government entity. This expectation is supported by past practice before the agency, as individual consumers did not file challenges in either the MF-I or CAF proceedings. If, however, a consumer, organization, or business believes that its interests cannot be met through its state, local, or Tribal government entity, and it wishes to participate in the process as a challenger, it is free to file a waiver with the Commission for good cause shown, either on its own or with the assistance of an organization. Waivers may be submitted by email to
39. Moreover, given the improvements the Commission expects to see in the standardized information
40. Because the Commission is undertaking a new collection of standardized, more reliable, and more recent 4G LTE coverage data, it will only permit challenges for areas that the Bureaus identify as ineligible for MF-II support. The Commission anticipates that a party that submits a challenge for an eligible area will likely be the unsubsidized service provider that submitted and certified the data used to make the initial eligibility determination for the challenged area. As such, the challenge would consist of nothing more than an update to or correction of the coverage data submitted by the unsubsidized service provider during the new data collection in compliance with the Commission's new requirements. Since, under the framework the Commission adopts, service providers will be required to update their coverage data shortly before the start of the challenge process, permitting such “corrections” within the challenge process would be administratively inefficient and unnecessarily delay the deployment of MF-II support. The Commission is confident that the new data collection will give providers ample opportunity to correct and/or update the coverage data previously provided via Form 477. Therefore, the Commission will not permit challenges for areas that the Bureaus identify as eligible for MF-II support.
41. As part of the framework the Commission adopts for the MF-II challenge process, it will limit challenges to
42. The Commission finds that a challenger must submit detailed proof of lack of unsubsidized, qualified 4G LTE coverage in support of its challenge. For each state, a challenger must identify the specific area(s) it wants to challenge and submit actual outdoor speed test data that satisfy the parameters the Commission adopts in the
43. These requirements strengthen the Commission's ability to design an administratively efficient challenge process that does not impede implementation of MF-II. The Commission finds that requiring challengers to submit detailed proof of lack of unsubsidized, qualified 4G LTE coverage instead of “anecdotal evidence” is fair, minimizes the burden on providers and Commission staff, and should help deter excessive and unfounded challenges that could delay the deployment of MF-II support. The Commission agrees with several commenters that requiring actual speed test data will not impose an excessive burden on challengers, including small carriers. The Commission expects that challenged areas will be sufficiently circumscribed that challengers will not need to collect speed test data over unnecessarily large areas. Further, the Commission expects that small carriers are likely to already own drive test equipment. To the extent they do not, the Commission's decision to allow application-based tests provides a less expensive and more mobile means of collecting data. Thus, the Commission declines to allow a challenger to initiate the challenge process with an unsubstantiated good-faith assertion of lack of unsubsidized, qualified 4G LTE coverage.
44. Although the Commission agrees with commenters that some flexibility with testing standards is warranted, it finds it necessary to adopt clear guidance and parameters on speed test data to ensure that the evidence submitted by challengers is reliable, accurately reflects consumer experience in the challenged area, and can be analyzed quickly and efficiently. As a preliminary matter, the Commission will allow challengers to submit speed data from hardware- or software-based drive tests or application-based tests that cover the challenged area. To minimize the burdens on challengers, the Commission will not require that an independent third party conduct the speed tests. The Commission will require that all speed tests be conducted pursuant to standard parameters using Commission-approved testing methods on pre-approved handset models. Accordingly, the Commission expects that it would be difficult to manipulate the data collected regardless of whether a challenger uses drive-based or application-based tests as both types of tests can automatically generate data reports that can conform to the specifications for the data submission. The Commission will, however, require that the speed test data be substantiated by the certification of a qualified engineer or official under penalty of perjury. For challengers that are governmental entities and do not have a qualified engineer available to certify, the Commission will allow certification by a government official authorized to act on behalf of the organization and
45. A challenger must provide proof of lack of unsubsidized, qualified 4G LTE coverage in the form of measured download throughput test data for each of the unsubsidized providers claiming qualified 4G LTE coverage in the challenged area. As part of the new MF-II data collection, the Commission will require service providers with qualified 4G LTE coverage to identify at least three readily available handset models appropriate for testing those providers' coverage. The Commission will require providers to specify at least one handset that is compatible with industry-standard drive test software. The Commission directs the Bureaus to propose and adopt further guidance on the types of devices that may be used for speed tests in the subsequent public notices. Challengers electing to use application-based tests and software-based drive tests must use the applicable handsets specified by each unsubsidized service provider with coverage in the challenged area. In addition, to accurately reflect consumer experience in the challenged area, the challenger must purchase an appropriate service plan from each unsubsidized service provider in the challenged area. An appropriate service plan would allow for speed tests of full network performance,
46. All speed tests must be conducted between the hours of 06:00 a.m. and 12:00 a.m. local time, when consumers are most likely to use mobile broadband data. To ensure that the speed test data reflect consumer experience throughout the entire challenged area, a challenger must take speed measurements that are no more than a fixed distance apart from one another within the challenged area, and which substantially cover the entire area. The Commission directs the Bureaus to adopt the specific value for the maximum distance between speed tests after seeking comment in a subsequent public notice. This value will be no greater than one mile. This requirement serves as an upper bound, and a challenger will be free to submit measurements taken more frequently. While the Commission declines to adopt the specific parameter here, it is convinced that a value within this range will strike the correct balance between the benefits of increased accuracy, and the harms of burdens on small carriers and to the efficient administration of challenges. The Commission also agrees with one commenter that the data should reflect recent performance. However, given upcoming, expected deployment of new 4G LTE service in conjunction with the Commission's decision to perform a new data collection, the Commission is concerned that speed measurements taken before the submission of updated coverage maps may not reflect the current consumer experience. Thus, the Commission will only accept data that were collected after the publication of the initial eligibility map and within six months of the scheduled close of the challenge window.
47. The Commission directs the Bureaus to seek comment on and to implement any additional parameters and/or to require the submission of additional types of relevant data, such as signal strength tests, and then to implement any such parameters or requirements as appropriate to ensure that speed tests accurately reflect consumer experience in the challenged area, by issuing an order or public notice providing detailed instructions, guidance, and specifications for conducting speed tests.
48. The Commission adopts a general framework for automatic system validation of a challenger's evidence, and it directs the Bureaus to work with USAC to implement specific parameters for the validation process. Using an automated process is the most efficient way to evaluate the data submitted by a challenger because it ensures that the objective validation criteria are applied consistently across every challenge.
49. Under this approach, at the outset the USAC system will superimpose each identified challenged area on the initial eligibility map and will remove any portions that overlap eligible areas. If a challenged area meets the
50. Next, the USAC system will analyze the geographic coordinates of the points at which the challenger conducted the speed tests and will validate that the data associated with each speed test point meet the specifications for speed tests. To be counted towards a valid challenge, the speed test must record a download speed less than 5 Mbps (counted speed tests) and meet all other standard parameters. In order to implement the requirement that the tests substantially cover the entire challenged area and that each point is no more than a fixed distance apart, the system will create a buffer (
51. The USAC system will require speed tests to substantially cover the entire challenged area (
52. Each challenged area that meets the
53. The Commission will provide challenged parties a limited opportunity to submit additional data in response to a challenge. The Commission finds that this approach promotes its goals of a fair and fiscally responsible MF-II program while minimizing the burdens on challenged parties. Giving challenged parties an opportunity to contest a challenge and submit more detailed coverage data to supplement the information provided during the initial data collection will help to ensure that only areas truly lacking unsubsidized, qualified 4G LTE coverage will receive MF-II support.
54. After the challenge window closes, the response window will open. Using the USAC portal, challenged parties will have 30 days after the opening of the response window to: (1) Access and review the data submitted by the challenger with respect to the challenged area; and (2) submit additional data/information to oppose the challenge (
55. The Commission declines to require a specific level of response from challenged parties. The Commission will accept certain technical information that is probative regarding the validity of a challenger's speed tests including speed test data and other device-specific data collected from transmitter monitoring software. If a challenged party chooses to submit its own speed test data, the data must conform to the same standards and requirements the Commission adopts in the
56. Although the Commission is willing to accept certain technical data that are probative regarding the validity of a challenger's speed tests, the data must be reliable and credible to be useful during the adjudication process. Specifically, technical data other than speed tests submitted by a challenged party, including data from transmitter monitoring software, should include geolocated, device-specific throughput measurements or other device-specific information (rather than generalized key performance indicator statistics for a cell-site) in order to be useful to help refute a challenge. The Commission agrees with commenters that “on the ground” data collected using standardized parameters are a reliable form of evidence because they simulate what consumers actually experience. Thus, the Commission expects that speed test data would be particularly persuasive evidence for challenged parties to submit to refute a challenge, especially since it will be easier for the Bureaus to compare equivalent data. While the system will not validate a challenged party's response data, to be probative in order to refute a challenge, speed tests must record a download speed of at least 5 Mbps and meet all other standard parameters.
57. The Commission directs the Bureaus to issue an order or public notice implementing any additional requirements that may be necessary or appropriate for data submitted by a challenged party in response to a challenge. Such order or notice will contain any further detailed instructions, guidance, and specifications for responding to a challenge.
58. Consistent with the standard of review adopted in the
59. With respect to the evidentiary standard, comments submitted in the record support a preponderance of the evidence standard, and no commenters supported the higher standard of clear and convincing evidence. The preponderance of the evidence standard of review is consistent with the CAF challenge processes, as well as with a wide body of Commission precedent. A more demanding standard would impose an evidentiary burden that is in tension with the Commission's overall goal of making the most accurate determinations based on the evidence of record. The Commission finds that applying a preponderance of the evidence standard strikes the appropriate balance, potentially reducing the number of disputed areas and ensuring that the Commission has the data necessary to evaluate the merits of any challenges, while not unduly burdening smaller providers.
60. The
61. The Commission will send a copy of the
62. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), an Initial Regulatory Flexibility Analysis (IRFA) was incorporated in the Further Notice section of the
63. Rural and high-cost areas of the United States trail significantly behind urban areas in the growth of 4G LTE service. The Mobility Fund Phase II (MF-II) will use a market-based, multi-round reverse auction and allow the Commission to redirect its limited resources to those areas of the country lacking unsubsidized, qualified 4G LTE service.
64. In the
65. The Commission received one comment, one reply comment, and one written
66. The Commission is sensitive to the burden on small entities and other providers associated with the new data collection. However, the benefits of standardized, reliable data on which to base eligibility determinations outweigh the costs associated with their collection. Moreover, the use of newly collected data enables the Commission to adopt a streamlined challenge process that will reduce the burden on challengers and providers that respond to challenges. Fewer small providers will be forced to bring a challenge, and challenges will be more directed, more accurate, and less onerous because the Commission will have the best-available starting point of standardized data. The Commission also eases the burden of the new data collection on small entities by limiting the one-time data collection to providers who have previously reported 4G LTE coverage in Form 477 and have qualified 4G LTE coverage. The limited scope of the collection addresses the concerns of some of the smaller providers who objected to the potential burden of a universal new filing. The Commission has eased the burden of the collection by only requiring a filing from those who have easy access to the necessary data. Additional steps taken to minimize the burden of the challenge process on small entities are discussed below.
67. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule(s) and to provide a detailed statement of any change made to the proposed rule(s) as a result of those comments.
68. The Chief Counsel did not file any comments in response to the proposed procedures in this proceeding.
69. The RFA directs agencies to provide a description of, and where feasible, an estimate of the number of small entities that may be affected by the rules adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A “small-business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
70.
71.
72. The Commission's own data—available in its Universal Licensing System—indicate that, as of October 25, 2016, there are 280 Cellular licensees that will be affected by its actions. The Commission does not know how many of these licensees are small, as the Commission does not collect that information for these types of entities. Similarly, according to internally developed Commission data, 413 carriers reported that they were engaged in the provision of wireless telephony, including cellular service, Personal Communications Service, and Specialized Mobile Radio Telephony services. Of this total, an estimated 261 have 1,500 or fewer employees, and 152 have more than 1,500 employees. Thus, using available data, the Commission estimates that the majority of wireless firms can be considered small.
73.
74. In the
75. To establish the map of areas presumptively eligible for MF-II support, all current Form 477 filers that have previously reported qualified 4G LTE coverage and have qualified 4G LTE coverage based on the data specification set forth in
76. In conjunction with submitting propagation maps, model details, and signal strength of 4G LTE coverage, providers will submit a list of at least three readily-available handset models appropriate for challengers wishing to conduct a speed test of the providers' coverage in a particular area, and a certification, under penalty of perjury, by a qualified engineer or government official that the propagation map and model details reflect the filer's coverage as of the generation date of the map in accordance with all other parameters. For challengers that are governmental entities and do not have a qualified engineer available to certify, the Commission will allow certification by a government official authorized to act on behalf of the organization and with actual knowledge of the accuracy of the underlying data.
77. To initiate a challenge, a challenger must, within the 150-day challenge window: (1) Access confidential, provider-specific information for areas it wishes to challenge; (2) identify the areas(s) it wishes to challenge; (3) submit evidence supporting the challenge; and (4) certify its challenge for the specified area(s). Only service providers required to file Form 477 data and government entities (state, local, and Tribal) have standing to initiate a challenge. Challengers other than government entities and service providers required to file Form 477 data with the Commission, who are not already represented by another interested party, may file a waiver request with the Commission to participate in the MF-II challenge process for good cause shown. Only challenges for areas that the Bureaus identify as presumptively ineligible for MF-II support will be permitted.
78. Challengers must submit their challenges to areas identified as ineligible for support via an online challenge portal to be operated by the Universal Service Administrative Company (USAC). A challenger will be required to identify the area(s) that it wishes to challenge for each state. The Commission will require that any challenge be of a minimum size of at least one square kilometer.
79. Challengers will also be required to submit actual outdoor speed test data that satisfy the parameters outlined below and any others the Commission or Bureaus may implement. Speed test data must be collected using provider-specified handsets, and substantiated by the certification of a qualified engineer or, in the case of a government entity, a government official under penalty of perjury.
80. A challenger must provide detailed proof of lack of unsubsidized, qualified 4G LTE coverage in support of its challenge with speed test data for each of the providers claiming qualified 4G LTE coverage in the challenged area. The Commission will allow challengers to submit speed data from hardware or software-based drive tests or application-based tests that spatially cover the challenged area. All speed tests must be conducted between the hours of 06:00 a.m. and 12:00 a.m. local time, when consumers are likely to use mobile broadband data. A challenger must take speed measurements that are no more than a fixed distance apart from one another within the challenged area, and which substantially cover the entire challenged area. This fixed distance parameter will be a value no greater than one mile, and will be set by the Bureaus in a subsequent public notice. The Commission will only accept data that were collected after the publication of the initial eligibility map and within six months of the scheduled close of the challenge window.
81. Challengers electing to use application-based tests must use the applicable handsets specified by each service provider servicing any portion of the challenged area. The challenger must purchase a service plan from each unsubsidized service provider in the challenged area. If there are multiple unsubsidized service providers in the challenge area, the challenger must purchase service plans that are comparable (
82. Once a challenger has submitted its evidence in the USAC MF-II portal, the system will automatically conduct a validation to determine whether the evidence is sufficient to justify proceeding with the challenge. The USAC system will superimpose each challenger's identified challenged area on the initial eligibility map and will remove any portions that overlap eligible areas. A challenged ineligible area must meet the
83. Once the challenge window closes, challenged parties will have a limited opportunity to submit additional data in response to a challenge. Using the USAC portal, a challenged party will have 30 days after the opening of the response window to: (1) Access and review the data submitted by the challenger with respect to the challenged area; and (2) submit additional data/information to oppose the challenge. The Commission will accept certain technical information that is probative to the validity of a challenger's speed tests, including, but not limited to speed test data and device-specific data collected from transmitter monitoring software. If a respondent chooses to respond, it need only conduct speed tests of its own network (or gather its own geolocated, device-specific data from network monitoring software) in the disputed
84. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its approach, which may include the following four alternatives, among others: “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.”
85. The Commission has considered the economic impact on small entities in reaching its final conclusions and taking action through this proceeding. In the
86. In the
87. “Option A” allowed a challenge to be made on a good-faith belief, based on actual knowledge or past data collection, that 4G LTE coverage was not available in an area as depicted by Form 477 filings. Carriers and state and local governments would be eligible to participate. The Commission sought comment on what evidence, if any, should be required in support of a challenge, whether or not it should require a challenged area to reach a minimum size threshold, whether challenges should be allowed for areas marked as eligible, and how and when challenged providers could respond and with what evidence of coverage.
88. “Option B” gave challenging parties 60 days following the Commission's release of a list of eligible areas to submit evidence, which would include speed test data and shapefile maps and be filed in the public record, contesting the eligibility status of an area. Service providers and governmental entities located in or near the relevant areas would be eligible to participate. Challenged providers would then have 30 days to respond with their own speed tests and shapefile maps. The Commission sought comment on what requirements should be imposed for speed tests and on the burden of requiring such a level of response from challenged providers.
89. The Commission explained that it intended to assemble a “best in class structure” from the proposed options and made it clear the Commission did not intend to adopt either option wholesale. The Commission believes the challenge process procedures adopted today are the “best in class” and will both promote fairness and minimize burdens on small entities and other interested parties.
90. Given the concerns voiced in the comments regarding the lack of standardization and the reliability of using Form 477 data for MF-II purposes, a collection of new data will ultimately lead to a less onerous and more efficient challenge process for small entities and other MF-II participants. The challenge process will be streamlined using universal, standardized coverage data. These data are already in the possession of current providers who are therefore in the best position to provide data to the Bureaus. Current providers of unsubsidized, qualified 4G LTE coverage, including small businesses, will benefit by filing their coverage data under the standardized parameters adopted in the
91. Use of newly collected data enables the Commission to adopt a streamlined challenge process that will ease the burden of submission and resolution of challenges to the map of presumptively eligible areas. Because the map of presumptively eligible areas will be established using current, standardized data, challengers will be able to target fewer areas to challenge and reduce the need for more in-depth testing in certain areas. This in turn should reduce the burden on challengers and providers that respond to challenges. The Commission also limited the new, one-time data collection to providers who have previously reported 4G LTE coverage in Form 477 and have qualified 4G LTE coverage. The limited scope for the collection eases the burden by only requiring a filing from those who have easy access to the necessary data.
92. The Commission has taken a number of steps to reduce the burden on small entities and other parties participating in the challenge process while also collecting the information required to target areas without qualified 4G LTE coverage. For example, the Commission limits the types of challenges and will only accept challenges for areas identified by the Bureaus as ineligible for MF-II support. Because the data for the map of presumptively eligible areas are supplied by service providers, the Commission believes a challenge to an eligible area would likely be a correction by the service provider who supplied the initial data. The Commission will not require challengers to match up their challenged areas to census blocks or census block groups as proposed in the
93. The Commission also requires that challenges be a minimum size of at least one square kilometer. By including a minimum size requirement for challenges, the Commission believe small businesses and all interested parties will benefit from a streamlined challenge process. The Commission rejected smaller alternatives to the size of the minimum challenge area. Making the minimum zone smaller than one square kilometer would make the area so small as to be inconsequential for improving efficiency for the challenge process. Ineligible areas of less than one square kilometer can be subject to challenge insofar as they are part of a challenge where the total size of the areas being challenged exceeds the
94. The
95. The Commission will send a copy of the
96. The Commission orders the following, pursuant to the authority contained in sections 1, 2, 4(i), 5, 10, 201-206, 214, 219-220, 251, 254, 256, 303(r), 332, 403, 405, and 503 of the Communications Act of 1934, as amended, and section 706 of the Telecommunications Act of 1996, 47 U.S.C. 151, 152, 154(i), 155, 160, 201-206, 214, 219-220, 251, 254, 256, 303(r), 332, 403, 405, 503, 1302, and sections 1.1 and 1.429 of the Commission's rules, 47 CFR 1.1 and 1.429:
• The Order on Reconsideration and Second Report and Order is adopted. It is the Commission's intention in adopting these procedures that if any of the procedures that the Commission retains, modifies, or adopts herein, or the application thereof to any person or circumstance, are held to be unlawful, the remaining portions of the procedures not deemed unlawful, and the application of such procedures to other persons or circumstances, shall remain in effect to the fullest extent permitted by law.
• The parameters set forth in the Order on Reconsideration and Second Report and Order for the Mobility Fund Phase II challenge process, along with all associated requirements also set forth therein, go into effect October 10, 2017, except for the new or modified information collection requirements in the challenge process that require approval by the Office of Management and Budget (OMB). The Commission will publish a document in the
• The Petition for Reconsideration and Comments filed by CTIA on April 26, 2017, is granted in part to the extent described herein.
• The Petition for Reconsideration and/or Clarification filed by the Rural Wireless Association, Inc. on April 12, 2017, is denied as described herein.
• The Petition for Reconsideration filed by Panhandle Telephone Cooperative, Inc. and Pine Belt Cellular, Inc. on April 27, 2017, is denied as described herein.
• The Petition for Reconsideration and Clarification filed by Rural Wireless Carriers (
• The Petition for Reconsideration and/or Clarification filed by the Blooston Rural Carriers on April 27, 2017, is denied as described herein.
• The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of the Order on Reconsideration and Second Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede airworthiness directive (AD) 2015-22-53 for Airbus Helicopters (Airbus) Model AS350B3 helicopters. AD 2015-22-53 requires revising the rotorcraft flight manual (RFM) to perform the yaw load compensator check after rotor shut-down and to state that the yaw servo hydraulic switch must be in the “ON” position before taking off. Since we issued AD 2015-22-53, Airbus developed a modification of the ACCU TST switch. This proposed AD would retain the requirements of AD 2015-22-53 and require modifying the yaw servo hydraulic switch (collective switch) and replacing the ACCU TST button. The actions of this proposed AD are intended to address an unsafe condition on these products.
We must receive comments on this proposed AD by November 7, 2017.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this proposed rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
George Schwab, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
On November 13, 2015, we issued AD 2015-22-53, Amendment 39-18331 (80 FR 74982, December 1, 2015), which was sent previously as an emergency AD to all known U.S. owners and operators of Airbus Helicopters Model AS350B3 helicopters. AD 2015-22-53 requires revising the pre-flight and post-flight procedures in the RFM to perform the yaw load compensator check (ACCU TST switch) after rotor shut-down instead of during preflight procedures and to state that the yaw servo hydraulic switch (collective switch) must be in the “ON” (forward) position before taking off. AD 2015-22-53 was prompted by two accidents and one incident of Model AS350B3 helicopters with a dual hydraulic system installed, and which also prompted EASA, which is the Technical Agent for the Member States of the European Union, to issue EASA AD No. 2015-0178, dated August 26, 2015. EASA advised these occurrences may have resulted from improperly performing the T/R hydraulic preflight check (a pilot forgetting to put the yaw servo hydraulic switch (collective switch) in the “ON” position or put the ACCU TST switch in the “OFF” position before flight)—and not from equipment failure. According to EASA, these conditions significantly increase the control load necessary to generate sufficient tail rotor thrust for take-off.
Since we issued AD 2015-22-53, Airbus Helicopters issued SB No. AS350-67.00.65, Revision 0, dated August 25, 2016, which specifies procedures to alter the ACCU TST switch. Subsequently, EASA issued AD No. 2016-0220, dated November 4, 2016. EASA advises that further
These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other products of the same type design.
We reviewed Airbus Helicopters SB No. AS350-67.00.64, Revision 0, dated February 25, 2015, which specifies procedures to install a timer relay and an additional indicator light on the caution and warning panel. This modification provides an “OFF” status indication of the yaw servo hydraulic switch (collective switch) by flashing a newly installed “HYD2” indicator light on the caution and warning panel. Airbus Helicopters identifies performance of this SB as modification 074622. This modification was available when AD 2015-22-53 was issued; however, it was determined unnecessary to address the unsafe condition at that time.
We also reviewed Airbus Helicopters SB No. AS350-67.00.65, Revision 0, dated August 25, 2016, which specifies procedures to replace the bistable push button ACCU TST switch with a monostable push button switch. Airbus Helicopters identifies performance of this SB as modification 074719.
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
We reviewed Airbus SB No. AS350-67.00.66, Revision 1, dated October 22, 2015, which specifies inserting specific pages of the SB into the rotorcraft flight manual. These pages revise the preflight and post-flight hydraulic checks by moving the tail rotor yaw load compensator check from preflight to post-flight. These pages also revise terminology within the flight manuals for the different engine configurations.
This proposed AD would retain the RFM revision that moves the yaw load compensator check (ACCU TST switch) from preflight procedures to post-flight procedures after rotor shut-down. This proposed AD would also retain the RFM revision that requires the yaw servo hydraulic switch (collective switch) to be in the “ON” (forward) position before taking off.
Additionally, this proposed AD would require, within 350 hours time-in-service, installing a timer relay for the yaw servo hydraulic switch (collective switch) and installing an additional light on the caution and warning panel. This proposed AD would also require replacing the bistable ACCU TST button with a monostable button.
We estimate that this proposed AD would affect 86 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.
Revising an RFM would take about 0.5 work-hour for a cost of $43 per helicopter and $3,698 for the U.S. fleet. Installing a timer relay for the yaw servo hydraulic switch (collective switch) and an indicator light would take about 9 work-hours and parts would cost about $2,224. Replacing the ACCU TST button would take about 1 work-hour and parts would cost about $2,244.
Based on these figures, we estimate a total cost of $5,361 per helicopter and $461,046 for the U.S. fleet.
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, 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 to the extent that it justifies making a regulatory distinction; 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.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
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.
This AD applies to Model AS350B3 helicopters with a dual hydraulic system installed, certificated in any category.
The dual hydraulic system for Model AS350B3 helicopters is referred to as Airbus modification OP 3082 or OP 3346.
This AD defines the unsafe condition as lack of hydraulic pressure in a tail rotor (T/R) hydraulic system. This condition could result in loss of T/R flight control and subsequent loss of control of the helicopter.
This AD supersedes AD 2015-22-53, Amendment 39-18331 (80 FR 74982, December 1, 2015).
We must receive comments by November 7, 2017.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Before further flight, insert a copy of this AD into the rotorcraft flight manual, Section 4 Normal Operating Procedures, or make pen and ink changes to the preflight and post-flight procedures as follows:
(i) Stop performing the yaw load compensator check (ACCU TST switch) during preflight procedures, and instead perform the yaw load compensator check during post-flight procedures after rotor shut-down.
(ii) The yaw servo hydraulic switch (collective switch) must be in the “ON” (forward) position before takeoff.
The yaw servo hydraulic switch is also called the hydraulic pressure switch or hydraulic cut off switch in various Airbus Helicopters rotorcraft flight manuals.
(2) Within 350 hours time-in-service:
(i) Install a timer relay for the yaw servo hydraulic switch (collective switch) by following the Accomplishment Instructions, paragraph 3.B.2.b.1, 3.B.2.b.2, 3.B.2.b.3, 3.B.2.b.4, 3.B.2.b.5, or 3.B.2.b.6, as applicable to the configuration of your helicopter, of Airbus Helicopters Service Bulletin (SB) No. AS350-67.00.64, Revision 0, dated February 25, 2015 (AS350-67.00.64). If your helicopter has an automatic pilot system, also comply with paragraph 3.B.2.b.7 of AS350-67.00.64.
(ii) Install an indicator light on the caution and warning panel by following the Accomplishment Instructions, paragraph 3.B.2.c.1 or 3.B.2.c.2, as applicable to the configuration of your helicopter, of AS350-67.00.64.
(iii) Replace the bistable ACCU TST button on the control panel with a monostable button as depicted in Figure 1 or Figure 3, as applicable to the configuration of your helicopter, of Airbus Helicopters SB No. AS350-67.00.65, Revision 0, dated August 25, 2016.
(3) After the effective date of this AD, do not install a bistable ACCU TST button on any helicopter.
A special flight permit may be issued for paragraph (f)(2) of this AD only.
(1) The Manager, Safety Management Section, FAA, may approve AMOCs for this AD. Send your proposal to: George Schwab, Aviation Safety Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
(1) Airbus Helicopters SB No. AS350-67.00.66, Revision 1, dated October 22, 2015, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2016-0220, dated November 4, 2016. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 2910, Main Hydraulic System.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracking found in the wing rear spar web at the wing station where the flap outboard hinge is attached. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by October 23, 2017.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (800) 663-8444; fax: (250) 656-0673; email:
You may examine the AD docket on the Internet at
Aziz Ahmed, Aerospace Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 228-7329; fax: (516) 794-5531; email:
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 Transport Canada, which is the aviation authority for Canada, has issued AD Number CF-2017-17, dated May 18, 2017 (referred to after this as “the MCAI”), to correct an unsafe condition for all Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes and was based on mandatory continuing airworthiness information originated by an aviation authority of another country. The MCAI states:
It was reported that a crack was found in the wing rear spar web, part number C2W1007, at wing station 123.5 where the flap outboard hinge is attached. An aileron hinge bracket has also been found cracked. Viking Air Ltd. analysis shows that similar cracks may develop on the wing rear spar web and flap/aileron hinge arm support brackets at the other flap/aileron hinge attachment locations.
Undetected cracking of the wing rear spar or flap/aileron hinge bracket may lead to the failure of the component with consequent loss of aeroplane control.
The MCAI requires inspecting the left-hand and right-hand wing rear spar and the flap/aileron hinge air support brackets for cracks, damage, or discrepancy and repairing or replacing any cracked, damaged, or discrepant parts. You may examine the MCAI on the Internet at
Viking Air Limited has issued DHC-2 Beaver Service Bulletin Number: V2/0009, Revision A, dated February 10, 2017. The service information describes procedures for inspecting the left-hand and right-hand wing rear spars, the flap/aileron hinge brackets, and the exterior store support bracket for cracks, damage, and discrepancies and specifies repairing or replacing any cracked, damaged, or discrepant parts. 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 this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We consider this proposed AD interim action. The inspection report required by this proposed AD allows us to obtain better information into the nature, cause, and extent of the damage to the wing rear spars and flap/aileron hinge arm support brackets and to develop final action to address the unsafe condition. Once final action has been identified, we may consider further rulemaking.
We estimate that this proposed AD will affect 140 products of U.S. registry. We also estimate that it would take about 11work-hours per product to comply with the basic inspection requirements of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the basic cost of this proposed AD on U.S. operators to be $130,900, or $935 per product.
In addition, the following is an estimate of possible necessary follow-on replacement actions. We have no way of determining the number of products that may need these actions.
To replace all four wing spar sections per wing takes 240 work-hours.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information Collection Clearance Officer, AES-2000.
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.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes and domestic business jet transport airplanes to the Director of the Policy and Innovation Division.
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 October 23, 2017.
None.
This AD applies to Viking Air Limited Models DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes, all serial numbers, certificated in any category.
Air Transport Association of America (ATA) Code 57: Wings.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracking found in the wing rear spar web at the wing station (WS) where the flap outboard hinge is attached. We are issuing this AD to detect and correct cracks in the wing rear spars and the flap/aileron hinge arm support brackets, which could cause these parts to fail. Failure of the wing rear spars and the flap/aileron hinge arm support brackets could result in loss of control.
Unless already done, do the actions in paragraphs (f)(1) through (5) of this AD:
(1) Within the next 400 hours time-in-service (TIS) after the effective date of this AD, visually inspect the left-hand and right-hand wing rear spar and flap/aileron hinge arm support brackets following the Accomplishment Instructions of Viking DHC-2 Beaver Service Bulletin Number: V2/0009, Revision A, dated February 10, 2017 (SB V2/0009, Revision A).
(2) For airplanes with agricultural configuration installed (SOO Mod 2/984), within the next 400 hours TIS after the effective date of this AD, inspect the exterior store support arm bracket at wing station (WS) 101.24 following the Accomplishment Instructions of SB V2/0009, Revision A.
(3) If any discrepancies are found during the inspections required in paragraphs (f)(1) and (2) of this AD, before further flight, repair or replace using a method approved by the Manager, New York ACO Branch, FAA; or Transport Canada; or Viking Air Limited's Transport Canada Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(4) Within 30 days after completing the inspections required in paragraphs (f)(1) and (2) of this AD, using the Operator Reply Form on page 7 of SB V2/0009, Revision A, report the inspection results to Viking Air Limited at the address specified in paragraph (h) of this AD.
(5) As of the effective date of this AD, do not install a wing on any airplane affected by this AD unless it has been inspected as specified in paragraph (f)(1) of this AD and paragraph (f)(2) of this AD, as applicable, and is found free of any discrepancies.
The following provisions also apply to this AD:
(1)
(2)
(3)
Refer to MCAI Transport Canada AD Number CF-2017-17, dated May 18, 2017, for related information. You may examine the MCAI on the Internet at
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Biologics Evaluation and Research (CBER).
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
FDA's CBER regulates a wide range of biological products and related products including: Allergenics, blood and blood products, certain medical devices for blood and tissues, gene therapies, human cells, tissues, and cellular and tissue-based products, vaccines, and xenotransplantation products. This document is seeking comments and information solely on regulations and approved information collections related to these product areas.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff Office (see
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Devices and Radiological Health (CDRH).
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Erica Blake Payne, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-3999,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
FDA's CDRH regulates medical devices from simple tongue depressors to complex programmable pacemakers and laser-based surgical devices. Medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. CDRH also regulates radiation emitting electronic products. Electronic products include certain medical devices (
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff office (see
1. Executive Order 13771 (January 30, 2017); available at
2. Executive Order 13777 (February 24, 2017); available at
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Veterinary Medicine (CVM).
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-5692,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most
FDA's CVM regulates the manufacture and distribution of food, food additives, and drugs that will be given to animals, including animals from which human foods are derived, as well as companion animals, and takes enforcement action against unsafe veterinary devices. This document is seeking comments and information solely on regulations and approved information collections related to these product areas.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, health care institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff Office (see
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Drug Evaluation and Research (CDER).
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the
Christine Kirk, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-2465,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
FDA's CDER regulates over-the-counter and prescription drugs, including therapeutic biological products and generic drugs. This document is seeking comments and information solely on regulations and approved information collections related to these product areas.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff Office (see
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to the products regulated by the Center for Tobacco Products (CTP).
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Gerie Voss, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-CTP-1373,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
FDA's CTP regulates the manufacture, marketing, and distribution of tobacco products. This document is seeking comments and information solely on regulations and approved information collections related to this product area.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff Office (see
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Karen Strambler, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
FDA's CFSAN regulates human food (including dietary supplements) and cosmetics. This document is seeking comments and information solely on regulations and approved information collections related to these product areas.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, health care institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff Office (see
Food and Drug Administration, HHS.
Request for comments and information.
As part of the implementation of Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” and Executive Order 13777 entitled, “Enforcing the Regulatory Reform Agenda,” the Food and Drug Administration (FDA, Agency, or we) is seeking comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. This document relates to general regulatory and information collection requirements that affect multiple FDA Centers and/or Offices.
Submit either electronic or written comments on this document by December 7, 2017.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 7, 2017. The
Submit electronic comments in the following way:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Megan Velez, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-4830,
FDA is responsible for protecting the public health by: (1) Ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; (2) ensuring the safety, security, and appropriate labeling of our nation's food supply, products that emit radiation, and cosmetics; and (3) regulating the manufacture, marketing, and distribution of tobacco products. Equally important, FDA promotes the public health by fostering and supporting innovative approaches and solutions for some of our nation's most compelling health and medical challenges.
This document is seeking comments and information solely on general regulations and approved information collections affecting multiple FDA Centers and/or Offices.
On January 30, 2017, President Trump issued Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs” (Ref. 1). This Executive Order states that the policy of the Executive Branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources, and that it is essential to manage the costs associated with complying with Federal regulations. On February 24, 2017, President Trump issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda” (Ref. 2). The purpose of this Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 directs each Agency to establish a Regulatory Reform Task Force (RRTF) to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Executive Order provides that, at a minimum, each RRTF must attempt to identify regulations that:
• Eliminate jobs, or inhibit job creation;
• Are outdated, unnecessary, or ineffective;
• Impose costs that exceed benefits;
• Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
• Are inconsistent with the requirements of the Information Quality Act, or the guidance issued pursuant to that Act, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
• Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
To assist with our implementation of Executive Orders 13771 and 13777 and support the work of the RRTF of the Department of Health and Human Services, FDA is issuing this Request for Information soliciting broad public comment on ways we can change our regulations to achieve meaningful burden reduction while continuing to achieve our public health mission and fulfill statutory obligations. We request comment, including supporting technical, scientific, economic, or other data, from all persons and entities significantly affected by FDA regulations, including consumers, patients and caregivers, researchers, healthcare institutions, the regulated industry, trade associations, public interest organizations, academia, and State, local, and tribal governments, as well as any other interested stakeholder. These comments and data will supplement and inform our own ongoing, systematic review of our regulations.
The following list of questions includes those that FDA is using to guide our initial review of our regulations. This list is intended to help the public in providing comments, not to restrict the issues that may be addressed.
• Is the regulation still current, or is it outdated or unnecessary in some way?
○ Have there been advancements and innovations in science, technology, or FDA or industry practice, or any other changes that suggest repeal of or modification to the regulation may be warranted or appropriate?
○ Has the regulation been superseded or made irrelevant or unenforceable by statute, another FDA regulation or guidance, a regulation by another Federal Agency, or controlling legal authority? If yes, identify the statute, regulation, guidance, or legal precedent and explain what FDA regulation is affected and in what way it is affected.
○ Is this regulation duplicative of requirements in other FDA regulations or other Federal Agency regulations? If yes, identify the overlapping regulation(s) and responsible Federal Agency and describe the way(s) in which the regulations overlap, as well as any suggestions with respect to how best to resolve the duplication.
• Have regulated entities had difficulties complying with the regulation? If yes, identify what entity or entities have had such difficulties and the nature of the difficulties.
• Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations (
• Does the regulation contain redundant, outdated, or unnecessary collections of information or retention of records,
• Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection? If yes, provide examples of alternatives that may reduce costs to industry while retaining the same level of public health protection.
• What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?
The most current version of FDA regulations may be found at
In addition, in order to enable us to more efficiently review and consider comments, we ask that the comments be submitted in the format shown in table 1 of this document.
The following references are on display in the Dockets Management Staff office (see
Environmental Protection Agency (EPA).
Proposed rule.
In this action, the Environmental Protection Agency (EPA) proposes editorial and technical revisions to the EPA's Method 202—Dry Impinger Method for Determining Condensable Particulate Emissions from Stationary Sources to improve the consistency in results achieved across the testing community.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0456, to the Federal eRulemaking Portal at
Mr. Ned Shappley, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Measurement Technology Group (E143-02), Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-5225; fax number: (919) 541-0516; email address:
The following topics are discussed in this preamble.
This action applies to you if you operate a stationary source that is subject to applicable requirements to control or measure condensable particulate matter (CPM) emissions where EPA Method 202 is incorporated as a component of the applicable test method. In addition, this action applies to you if federal, state, tribal, or local agencies take certain additional independent actions. For example, this action applies to sources through actions by state and local agencies that implement CPM control measures to attain the National Ambient Air Quality Standards (NAAQS) for particles less than 2.5 micrometers in diameter (PM
The source categories and entities potentially affected include, but are not limited to, the following:
If you have any questions regarding the applicability of the proposed changes to Method 202, contact the person listed in the preceding
Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.
Do not submit information that you consider to be CBI or otherwise protected through
If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the
The docket number for the Method 202 revisions is Docket ID No. EPA-HQ-OAR-2016-0456.
Section 110 of the Clean Air Act, as amended (42 U.S.C. 7410), requires state and local air pollution control agencies to develop, and submit for EPA approval, State Implementation Plans (SIPs) that provide for the attainment, maintenance, and enforcement of the NAAQS in each air quality control region (or portion thereof) within each state. The emissions inventory and analyses used in the state's attainment demonstrations must consider PM
Subpart A of 40 CFR part 51 (Requirements for Preparation, Adoption, and Submittal of Implementation Plans) defines primary PM
Specifically, on December 17, 1991 (56 FR 65433), the EPA first promulgated Method 202 to provide a test method for measuring CPM from stationary sources. Method 202, as promulgated in 1991, used water-filled impingers to cool, condense, and collect materials that are vaporous at stack conditions and become solid or liquid PM at ambient air temperatures. Method 202, as promulgated in 1991, contains several optional procedures that were intended to accommodate the various test methods in use by state and local regulatory entities at the time Method 202 was being developed.
When conducted consistently and carefully, this version of the method provided improved precision for most emission sources, and has been successfully implemented in regulatory programs where the emission limits and compliance demonstrations are established based on a consistent application of Method 202 and its associated options. However, when the same emission source is tested using different combinations of the optional procedures within the method, there were variations in the measured CPM emissions. Additionally, during validation of the method, we determined that sulfur dioxide (SO
In 2010, the EPA promulgated amendments to Method 202 (75 FR 80118) to improve the measurement of fine PM emissions. The final amendments revised the sample collection and recovery procedures of the method to: (1) Reduce the potential for CPM formation due to oxidation of dissolved SO
On April 8, 2014, the EPA issued interim guidance on the treatment of CPM results in the Prevention of Significant Deterioration (PSD) and Nonattainment NSR Permitting Programs. The purpose of this guidance was to address concerns that CPM test results obtained with the method could include a positive bias that results in the overestimation of emissions due to the potential for blank contamination associated with the implementation of Method 202. In this interim guidance, we recommend to air agencies and permit applicants that it is appropriate on an interim basis to allow major source permit applicants to depart from one aspect of Method 202, specifically the current upper limit of 2.0 milligrams (mg) for the field train recovery blank. Consistent with this guidance, during the prescribed interim period, air agencies may allow permit applicants to use field train proof blanks, in lieu of the field train recovery blanks, and blank values as high as 5.1 mg can then
On March 10, 2016, the EPA released the EPA Method 202 Best Practices Handbook. This handbook provides quality control procedures for evaluating the cause of blank contamination and practices to reduce contamination, so that testers may achieve the expected results when using Method 202. A copy of this handbook is available in the docket as EPA-HQ-OAR-2016-0456-004 and on the EMC Web site at
In this action, we are proposing technical revisions and editorial changes to clarify and update the requirements and procedures specified in Method 202. Proposed editorial changes include correcting inconsistent terminology, improving readability, and simplifying text to aid in consistent implementation of the method. Proposed technical revisions are discussed below.
In this action, we propose to replace the field train recovery blank requirement used to determine the blank correction (up to 2.0 mg) with a field train proof blank requirement. In the current version of Method 202, the result of the field train recovery blank is used as the basis for the blank correction (up to 2.0 mg). Specifically, we propose to revise section 8.5.4.10 (and renumber as section 8.5.5.8) to require conducting a field train proof blank to demonstrate the cleanliness of the sampling train. We propose to revise sections 9.9, 12.1, and 12.2.2, and Figures 4, 5, and 6 to replace the field train recovery blank with the field train proof blank. We also propose to remove the field train recovery blank requirement and the associated text in section 9.10 from the method.
The EPA received technical information and recommendations from the National Council on Air and Stream Improvement (NCASI) supporting the use of a field train proof blank to evaluate method blank correction. The EPA believes the updated field train proof blank is a better indicator of the total systematic blank error for Method 202 sample runs. Under the proposed amendments, a clean and prepared sampling train is transported and fully assembled at the sampling location, leak checked, left in place without collecting a sample, purged with nitrogen, and recovered in the same manner as a sample collection train. All components of the Method 202 sampling train must be included in the field train proof blank to properly quantify the blank value. The field train proof blank represents the systematic bias associated with all of the uncertainty from the reagents, sampling media, glassware preparation, recovery and analysis procedures, environmental contamination, leak checks, and test crew sample handling.
In the current version of Method 202, the setup and recovery procedures for the field train proof blank are incomplete. We are proposing the following revisions for the field train proof blank setup and recovery procedures specified in sections 8.5.5.8, 8.5.5.8.1, 8.5.5.8.2, and 9.9:
• Adding a full sampling train setup including the front half of the train for collecting filterable PM, probe extension and/or transfer line, condenser, impingers, and filter used to collect the CPM.
• Requiring that the entire filterable PM and CPM sampling train is transported to and assembled at the sampling location.
• Adding pre- and post-test leak checks.
• Exposing the assembled field train proof blank sampling train to the sampling environment for the same duration as the test runs to be conducted.
• Performing a post-test nitrogen purge of the field train proof blank.
• Requiring recovery of the sampling train components identical to how field samples are recovered.
In this action, we are also proposing to add section 8.5.5.8.3 to include procedures for handling the CPM filter from the field train proof blank. We believe that the proposed revisions will generate blank samples that duplicate sources of possible contamination experienced by the field samples.
Currently, Method 202 does not specify the orientation of the moisture condenser located before the first impinger of the sampling train. Although the sampling trains depicted in Figures 1 through 3 show the placement of the condenser, the incline of the condenser in the figures is not specified.
When the condenser is installed horizontally or at an angle, condensed moisture may pool in the condenser coils, increasing the potential for SO
In this action, we propose revisions to sections 2.1.2, 6.1.2, and 8.4.1 to require that the moisture condenser be installed in a vertical orientation. We propose to revise Figures 1 through 3 to depict the condenser in the vertical position consistent with the changes to the method text. We also propose to revise section 6.1.4 (and renumber as section 6.1.3) to allow other equipment options to purge the water in the dropout impinger.
Currently, Method 202 allows the use of a graduated cylinder to measure the volume of moisture collected in the impingers and the silica gel trap for the purpose of calculating the moisture content of the effluent gas. We believe that using a graduated cylinder to measure the accumulated water is not sensitive enough to measure the moisture and potentially adds an unnecessary additional source for potential loss of condensable particulate residual mass in samples measured by Method 202. Therefore, we propose to revise section 8.5.3.4 (and renumber as section 8.5.3) to remove the option to use graduated cylinders and to require use of a balance to determine the mass of each impinger for the purpose of measuring the moisture collected during sampling. Instructions to weigh each impinger before testing, which is a necessary step for determining the amount of moisture collected when using a balance, are proposed for relocation to section 8.4.5. We also propose to make accompanying
High moisture in the sampled gas stream can result in the accumulation of SO
Section 8.5.1.1 of Method 202 recommends removing moisture from the sampling train during the test run when the amount of moisture collected is greater than half the capacity of the water dropout impinger or the moisture level of the back-up impinger is above the impinger tip.
Longer sampling run times also delay the start of the post-test nitrogen purge. The post-test nitrogen purge is designed to remove dissolved gasses from the accumulated moisture and thus reduce the potential chemical reactions. In this action, we propose to amend Method 202 by adding a recommendation in section 1.5 to limit the sampling time to 2 hours for Method 202 testing when excessive moisture collection is expected. We also propose revisions to section 8.5.1.1 to specify that if accumulated water exceeds half of the capacity of the water dropout impinger, or if water accumulates in the back-up impinger sufficient to cover the impinger tip, the impinger(s) must be removed and replaced with new pre-weighed impingers and all resulting impingers must be weighed, purged and recovered following the procedures of the method.
The current version of Method 202 also prohibits the use of certain filterable particulate test methods in conjunction with Method 202. In this action, we propose revisions to section 1.4 to state only the acceptable filterable particulate test methods and to include a note that you must maintain the gas filtration temperature as specified in the filterable PM test method unless otherwise specified by an applicable subpart.
Condensable PM is formed from gaseous materials that condense and/or react upon cooling and dilution in the ambient air. Method 202 requires the use of a particulate sampling method (
Filterable PM methods that collect particulate out-of-stack have specified filter temperature requirements and require the addition of a Method 202 sampling train to collect CPM. Filterable PM methods that employ in-stack filters collect particulate material at the source gas temperature.
If the temperature of the filterable PM sampling equipment, including the filter, meets Method 202 temperature requirements (
In this action, we propose to revise section 1.2 to clearly state that, if the sample gas filtration temperature never exceeds 30 °C (85 °F), then Method 202 is not required to measure total primary PM because the CPM would be collected with the filterable PM.
Currently, section 6.2.1(d) of Method 202 specifies the use of amber glass sample bottles for sample recovery. In this action, we propose to revise section 6.2.1(d) to allow the use of sample containers made from other non-reactive materials (
Although we are proposing to revise the method to allow use of polymer or glass sample containers for inorganic samples, we continue to require glass containers for organic samples. The proposed revisions would provide testers with an alternative for storing inorganic samples to avoid this potential source of contamination.
Currently, section 6.2.2(b) of Method 202 specifies that glass evaporation vials, fluoropolymer beaker liners, or aluminum weighing tins can be used for final sample evaporation and weighing. In this action, we propose to include a list of acceptable weighing containers that includes fluoropolymer beaker liners and other vessels that have low mass and are unreactive to the sample and the atmosphere. Laboratories have reported that aluminum weighing tins may oxidize in contact with some sample matrices. The heavier weight of some glass beakers or containers may cause difficulty with measurement of trace amounts of residual mass. We propose to revise sections 6.2.2(b), 11.2.2.3, 11.2.3, 11.2.4, 11.2.5, and 11.2.6 to remove the connotation of sampling “tin” as an implicit approval of aluminum tins.
We propose additional quality control requirements for analytical balance use. Currently, section 9.6 of Method 202 requires calibration of the analytical balance on each day that samples are weighed, and section 10.3 of the Method 202 Best Practices Handbook provides additional steps that stack testers can use to improve consistency in analytical balance measurements. In this action, we propose to amend section 9.6 to specify the correct mass standard to use for the Analytical Calibration Check, specifications for the temperature and humidity control in weighing areas and requirements for balance calibration checks that approximately match the sample measurements to include the following requirements:
• The laboratory analytical balance must be maintained at a constant temperature of 20 °C ± 3 °C (68 °F ± 5 °F).
• The relative humidity at the location of the laboratory analytical balance must be maintained at 35 to 50 percent, with the exception that if the relative humidity is lower than 35 percent, the relative humidity must be maintained within ±10 percent during sample weighing.
• The results of the calibration check of the laboratory analytical balance must be within 0.05 percent of the applicable certified weight.
• The laboratory analytical balance must be checked each day it is used for gravimetric measurements by weighing at least one ASTM E617-13 Class 2 tolerance (or better) calibration weight that corresponds to 50 to 150 percent of the weight of one filter or between 1 gram (g) and 5 g. If the scale cannot reproduce the value of the calibration weight to within 0.5 mg of the certified mass, perform corrective measures and
In this action, we propose to correct section 9.4 to specify the mass standard with which to conduct the field balance calibration check. We believe that this additional requirement is necessary to increase consistency of Method 202 moisture sample measurements. We propose the requirement that the field balance calibration check be performed daily with an ASTM E617-13 Class 6 (or better) weight.
In sections 6.2.2(h) and 11.2.2.2 of the current method, pH measurement by pH meter or colorimetric pH indicator is allowable for the titration procedure. While the use of a colorimetric (
In this action, we propose to amend sections 6.2.2(h) and 11.2.2.2 to remove the option of using a colorimetric pH indicator and require the use of a pH meter whose calibration has been checked immediately prior to the titration step. We also propose to correct the CPM Sample Processing Flow Chart for sample analysis (Figure 8). We believe these revisions will increase the consistency and comparability of Method 202 results between source tests.
To obtain reliable CPM data using Method 202 for PSD and NSR permits, residual mass from sampling and analysis equipment must be minimized.
In this action, we propose the following amendments to clarify equipment and glassware cleaning in section 8.4 of Method 202, including:
• Adding a specification that all glassware used in the implementation of Method 202, including the impinger train and sample containers, should be cleaned sufficiently to meet the blank correction maximum limit of 2.0 mg in section 9.9.
• Removing the statement referencing cleaning silicone grease so that it is not mistakenly viewed as acceptable to use such grease in Method 202 sampling trains.
• Removing the requirement that glassware must be baked after cleaning (although the EPA is proposing to remove the baking requirement, we highly recommended baking of glassware as discussed in the EPA Method 202 Best Practices Handbook).
• Removing the option to use the field train proof blank as an alternative to baking since the field train proof blank is being proposed as a requirement of Method 202.
• Adding a recommended procedure for cleaning the probe liners by heating for a period of at least 3 hours at the maximum practical temperature.
These proposed revisions make the glassware cleaning procedures performance-based, clarify the requirements, and provide testers with an additional method for ensuring cleanliness of the probe liners.
Currently, Method 202 specifies a volume of 150 milliliters (mL) for performing reagent blank analyses and specifies that field reagent blanks are optional. In this action, we propose to revise section 9.7 to specify a minimum volume of 200 mL for these field reagent blank volumes and to revise section 9.8 to require analysis of field reagent blanks in the performance of Method 202. We also propose to make accompanying revisions to sections 8.5.5.5, 8.5.5.6, 8.5.5.7, 11.2.4, 11.2.5, and 11.2.6.
The original solvent blank volume was intended to represent amounts typically used during sample recovery. A larger reagent blank volume is necessary to quantify residual mass using the analytical balance specified in Method 202 with a sensitivity of 0.0001 g (0.1 mg). These proposed revisions are based on recommendations received from state agencies. This change to the method quality control quantifies any addition to the sample mass from gross contamination originating from the use of reagents in the field.
Method 202, as promulgated in 2010, includes two approaches for performing the post-test nitrogen purge: (1) A negative pressure purge using the pump and meter box from the sampling train or (2) a positive pressure purge using the gas cylinder pressure to propel the nitrogen gas through the CPM collection components.
The intent of the multiple purge options was to allow the testing contractors to either purge the sampling train on or near the sampling location or to transport the train components to a controlled environment less susceptible to sources of contamination. We now believe that a post-test nitrogen purge of the sampling train using the meter box and a vacuum pump adds steps that could potentially contaminate samples and outweigh the advantages of train purges done immediately following the sampling. In this action, we propose to revise section 8.5.4 to eliminate the option for performing the post-test nitrogen purge using the meter box and vacuum pump. We also propose to make accompanying revisions in sections 8.5.4.1, 8.5.4.2, 8.5.4.4 and 8.5.4.5.
In this action, we propose the following amendments to Method 202 sections to record and report test information that were either absent or undefined in the current promulgated method:
• Record the pre- and post-test weights of the impingers, as well as the color of the indicating silica gel, at the completion of sampling (sections 8.4.5 and 8.5.3).
• Record the results of the pre- and post-test leak checks of the sampling train (sections 8.4.6 and 8.5.2).
• Record the time (hh:mm), nitrogen flowrate, CPM filter temperature, and moisture trap temperature (if applicable) during the post-test nitrogen purge (section 8.5.4.4).
• Record the results of the field and laboratory analytical balance calibration checks (sections 9.4 and 9.6.4).
• Record the temperature and relative humidity conditions of the laboratory analytical balance (section 9.6.3).
In this action, we propose to revise section 13.0 regarding method performance. We updated method detection limit values based on a formal study submitted to the EPA by NCASI that evaluated the zero bias of Method 202 when Method 202 Best Practices were implemented. A copy of this study titled, “Method 202 Zero Bias Study When Incorporating Draft Best Practices Developed by the US EPA,” (NCASI 2017) is available in the docket (EPA-HQ-OAR-2016-0456-005).
While the EPA believes that field train proof blank results of 2.0 mg or less are achievable, we recognize there may be certain instances when the environment surrounding the sampling location may significantly contribute to the systematic bias of the method results as measured by the field train proof blank. This proposed alternative procedure would account for the uncontrollable environmental bias associated with measurements collected in problematic sampling locations.
In this action, we are proposing to amend section 16.1 of Method 202 to allow the combined results from multiple field train proof blanks to be used as the basis for blank correction up to 3.9 mg when approved by the regulatory authority. The 3.9 mg value is based on the Upper Prediction Limit (UPL) of the NCASI field study used to update the method detection limit (NCASI 2017). In this procedure, we have included conditions and criteria that a facility must satisfy in order to demonstrate need for the alternative procedure.
The EPA is requesting public comments on all of the proposed editorial and technical amendments to Method 202. For the convenience of the reader, we include in this notice the entire text of Method 202, including proposed revisions, but the scope of this rulemaking is limited to the proposed revisions and does not include any unchanged provisions.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action is not expected to be an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.
This action does not impose an information collection burden under the PRA. The revisions being proposed in this action do not add information collection requirements, but make corrections and updates to existing testing methodology.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. The proposed revisions to Method 202 neither impose any requirements on regulated entities beyond those specified in the current regulations, nor do they change any emission standard.
This action does not contain any unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not 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.
This action does not have tribal implications, as specified in Executive Order 13175. This action proposes corrections and updates to the existing procedures specified in Method 202. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This action makes corrections and updates to existing testing methodology and does not have any impact on human health or the environment.
Administrative practice and procedure, Air pollution control, EPA Method 202, Incorporation by reference, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide.
For the reasons stated in the preamble, the Environmental Protection Agency proposes to amend title 40, chapter I of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
(a) If you are required to measure total primary (direct) PM
If Method 17 of appendix A-6 to part 60 is attempted in conjunction with Method 202 to measure total primary PM, and the constant weight requirements for the filterable fractions cannot be met, it may be necessary to conduct additional test runs using an applicable filterable PM method that requires a heated filter temperature.
(b) If the gas filtration temperature of the filterable PM method used does not exceed 30 °C (85 °F), then use of this method is not necessary to measure primary PM, as the CPM is collected as filterable PM.
For those methods that require in-stack filtration (
(a) Method 1—Sample and velocity traverses for stationary sources.
(b) Method 2—Determination of stack gas velocity and volumetric flow rate (Type S pitot tube).
(c) Method 3—Gas analysis for the determination of dry molecular weight.
(d) Method 4—Determination of moisture content in stack gases.
(e) Method 5—Determination of particulate matter emissions from stationary sources.
(f) Method 17—Determination of particulate matter emissions from stationary sources (in-stack filtration method).
(g) Method 201A—Determination of PM
(h) In addition to Method 5, it is also acceptable to use Method 5A, 5D or 5I to collect filterable PM from stationary sources.
You must maintain the gas filtration temperature of the filterable PM method as specified in the method, unless otherwise specified by an applicable subpart.
The EPA recommends that under these conditions or any other conditions, when moisture collection is expected to be in excess of 2 percent, the testing periods be limited to no greater than 2 hours.
[Reserved]
The equipment used in the filterable particulate portion of the sampling train is described in Methods 5 and 17 of appendix A-1 through A-3 and A-6 to part 60 and Method 201A of appendix M to this part. The equipment used in the CPM portion of the train is described in this section.
(a) Nitrogen purge line. You must use inert tubing and fittings capable of delivering at least 14 liters/min of nitrogen gas to the impinger train from a standard gas cylinder (
(b) Rotameter. You must use a rotameter capable of measuring gas flow up to 20 liters/min. The rotameter must be accurate to five percent of full scale.
(c) Nitrogen gas purging system. Compressed ultra-pure nitrogen, regulator, and filter must be capable of providing at least 14 liters/min purge gas for one hour through the sampling train.
(d) Sample bottles (500 ml). You must use amber glass bottles or other non-reactive bottles (
(a) Separatory Funnel. Glass, 1 liter.
(b) Weighing Containers. Fluoropolymer beaker liners or other low-mass vessels which are unreactive to the sample or atmosphere.
The use of an anti-static device(s) during gravimetric analysis to prevent static from interfering with the analysis is recommended when using Fluoropolymer or similar beaker liners.
(c) Glass Beakers. 300 to 500 ml.
(d) Drying Equipment. A desiccator containing anhydrous calcium sulfate that is maintained below 10 percent relative humidity, and a hot plate or oven equipped with temperature control.
(e) Glass Pipets. 5 ml.
(f) Burette. Glass, 0 to 100 ml in 0.1 ml graduations.
(g) Analytical Balance. Analytical balance capable of weighing at least 0.0001 g (0.1 mg).
(h) pH Meter. The pH meter must be capable of determining the acidity of liquid within 0.1 pH units.
(i) Sonication Device. The device must have a minimum sonication frequency of 20 kHz and be approximately four to six inches deep to accommodate the sample extractor tube.
(j) Leak-Proof Sample Containers. Containers used for sample and blank recovery must not contribute more than 0.05 mg of residual mass to the CPM measurements.
(k) Wash bottles. Any container material is acceptable, but wash bottles used for sample and blank recovery must not contribute more than 0.1 mg of residual mass to the CPM measurements.
(a) Determining the sampling site location and traverse points.
(b) Calculating probe/cyclone blockage (as appropriate).
(c) Verifying the absence of cyclonic flow.
(d) Completing a preliminary velocity profile, and selecting a nozzle(s) and sampling rate.
Due the length of most probes, it is not practical to heat them in an oven. After cleaning the probe liners, it is recommended to heat the probe to the maximum temperature practical for the probe sheath for a period of at least 3 hours. Then rinse thoroughly with acetone, hexane, and deionized, ultra-filtered water.
You should also note the color of the indicating silica gel to determine whether it has been completely spent, and record its condition on the CPM Impinger Data Sheet.
Maintain a field log notebook of all condensable particulate sampling and analysis calibrations. Include copies of the relevant portions of the calibration and field logs in the final test report.
(a) Record the filterable particulate field data on the appropriate (
(b) Visually inspect the liquid level mark on each sample container and record on the CPM Work Table whether leakage occurred during transport. If a noticeable amount of leakage has occurred, either void the sample or use methods, subject to the approval of the Administrator, to correct the final results.
12.2.3
A field evaluation (NCASI 2017) of Method 202 incorporating Best Practices showed that the detection limit was 1.6 for total CPM; consisting of approximately 1.0 mg for organic CPM and approximately 0.6 mg for inorganic CPM. This field evaluation also demonstrated that the expected blank value of the field train proof blank was less than 1.8 mg.
Solvent and water are evaporated in a laboratory hood during analysis. No liquid waste is generated in the performance of this method. Organic solvents used to clean sampling equipment should be managed as Resource Conservation and Recovery Act organic waste.
(1) Documented adherence to the Best Practices for Method 202 by the tester. This documentation may include:
(a) Tester's Method 202 standard operating procedure (SOP);
(b) Residual mass of the laboratory reagent blanks (Reagent ID, Manufacturer, Lot Number);
(c) Tester-specific Method Detection Limit;
(d) Training records.
(2) Justification by the facility that the environment around the sampling location is likely to bias the CPM results. This justification may include:
(a) Schematic of the facility identifying locations that may contribute to environmental bias;
(b) Ambient PM concentration (mg/m
(c) Previous test results (
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to revoke certain tolerances for aluminum tris (
Comments must be received on or before November 7, 2017.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2017-0128, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Joseph Nevola, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8037; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
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This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the
EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.
EPA is proposing, in follow-up to canceled product registrations or uses, to revoke certain tolerances for carbon disulfide (degradate of sodium tetrathiocarbonate), dichlobenil, oxydemeton-methyl, propachlor, and thiodicarb; and to revoke a tolerance exemption for insecticidal uses of
As part of registration review, EPA will harmonize U.S. tolerances with international Maximum Residue Limits (MRLs) where possible. Therefore, EPA is proposing to modify certain tolerances for aluminum tris (
In a series of planned crop group updates, EPA has revised crop groupings to promote the greater use of crop groupings for tolerance-setting purposes and, in particular, to assist in making available lower risk pesticides for minor crops. EPA plans to eventually convert tolerances for any pre-existing crop group to tolerances with coverage under the revised crop group. This conversion will occur through the registration review process
Also, EPA is proposing to modify certain tolerances for aluminum tris (
Detailed explanations for proposed modifications or establishments of tolerances or tolerance exemptions, or tolerance expression changes other than minor revisions in accordance with current Agency practice, can be found in the Human Health Risk Assessment for Registration Review and the Interim Registration Review Decision for the following: aluminum tris (
The selection of an individual tolerance level is based on crop field residue studies designed to produce the maximum residues under the existing or proposed product label. Generally, the level selected for a tolerance is a value slightly above the maximum residue found in such studies, provided that the tolerance is safe. The evaluation of whether a tolerance is safe is a separate inquiry. EPA favors raising a tolerance when data show that:
1. Lawful use (sometimes through a label change) may result in a higher residue level on the commodity; and
2. The tolerance remains safe, notwithstanding increased residue level allowed under the tolerance.
EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.
EPA has found that the tolerances that are proposed in this document to be modified, are safe;
Also, in accordance with current Agency practice to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to make minor revisions to the introductory text for dichlobenil. The revisions to the tolerance expression do not substantively change the tolerance or, in any way, modify the permissible level of residues permitted by the tolerances.
In addition, EPA is proposing to revoke certain specific tolerances because either they are no longer needed or are associated with food uses that are no longer registered under FIFRA. Those instances where registrations were canceled were because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily requested cancellation of one or more registered uses of the pesticide. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or legally treated domestic commodities.
1.
Also, in accordance with current Agency practice to list significant figures for tolerance values, EPA is proposing to list existing tolerances in 180.415(a) for pineapple at 0.10 ppm, pea, succulent at 0.30 ppm, onion, bulb at 0.50 ppm, tomato at 3.0 ppm, and onion, green at 10 ppm.
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Also, EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 346a(e), in order to harmonize with certain higher Codex MRLs (defined as cyromazine residues), believes the tolerances in 40 CFR 180.414(a)(1) for cyromazine residues in or on “kidney” of cattle, goats, hogs, horses, and sheep should be increased from 0.2 to 0.30 ppm; and “meat byproducts, except kidney” of cattle, goats, hogs, horses, and sheep should be increased from 0.05 to 0.30 ppm. Because tolerances for “kidney” and “meat byproducts, except kidney” for cattle, goats, hogs, horses, and sheep would be revised to the same tolerance levels at 0.30 ppm, EPA is proposing to revoke the existing tolerances in 40 CFR 180.414(a)(1) for cyromazine residues in or on cattle, kidney; goat, kidney; hog, kidney; horse, kidney; sheep, kidney; cattle, meat byproducts, except kidney; goat, meat byproducts, except kidney; hog, meat byproducts, except kidney; horse, meat byproducts, except kidney; and sheep, meat byproducts, except kidney and to concomitantly establish tolerances at 0.30 ppm for cattle, meat byproducts; goat, meat byproducts; hog, meat byproducts; horse, meat byproducts; and sheep, meat byproducts.
In addition, EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 346a(e), in order to harmonize with Codex MRLs, is proposing to increase tolerances in 40 CFR 180.414(a)(1) for cyromazine residues in or on egg from 0.25 to 0.30 ppm; cattle, meat; goat, meat; hog, meat; horse, meat; and sheep, meat from 0.05 to 0.30 ppm; mango from 0.3 to 0.50 ppm; poultry, meat (from chicken layer hens and chicken breeder hens only) from 0.05 to 0.10 ppm; poultry, meat byproducts (from chicken layer hens and chicken breeder hens only) from 0.05 to 0.20 ppm; and vegetable, cucurbit, group 9 from 1.0 to 2.0 ppm.
Also, registrations exist for use of cyromazine for fly control in mushroom compost and as a feed-through fly control agent for chicken manure, and such cyromazine-treated manure from chickens may be used as a soil fertilizer supplement. A greenhouse rotational crop study showed a maximum cyromazine residue level of 0.08 ppm in spring wheat straw from an application rate of 0.05 lb active ingredient (ai) per acre (A). Data from a magnitude of residue study in poultry excreta topically treated with cyromazine showed residues of 40 ppm in manure at day 24. At 40 ppm (40 mg ai/kg manure or 18.2 mg ai/pound (lb) manure), the maximum label application rate of 4 tons treated manure per acre (8000 lb manure/A) is calculated to result in residues of cyromazine of 0.15 kg ai/A or 0.33 lb ai/A, which is 7X (0.33 lb ai/A vs. 0.05 lb ai/A) the rate used in the greenhouse study. Therefore, to support current registrations, the Agency determined that at the maximum application rate, indirect or inadvertent residue tolerances at 0.60 ppm (7 × 0.08 ppm) were needed for crops that do not have current tolerances established based on direct application of cyromazine. Consequently, EPA is proposing to re-designate 40 CFR 180.414(d) into § 180.414(d)(1), establish § 180.414(d)(2), and in newly designated 40 CFR 180.414(d)(2) to add introductory text and establish tolerances for indirect and inadvertent residues of cyromazine resulting from crops grown in soil amended with cyromazine treated fertilizer at 0.60 ppm for the following: grain, cereal, forage, fodder and straw, group 16; grain, cereal, group 15; herbs and spices, group 19; oilseed, group 20; onion, bulb, subgroup 3-07A; strawberry; vegetable, foliage of legume, group 7; vegetable, fruiting, group 8-10; vegetable, leaves of root and tuber, group 2; vegetable, legume, group 6; and vegetable, root and tuber, group 1.
Also, in accordance with current Agency practice to list significant figures for tolerance values, EPA is proposing to list existing tolerances in 40 CFR 180.414(a)(1) for garlic; garlic, great-headed, bulb; rakkyo, bulb; and shallot, bulb at 0.20 ppm, potato at 0.80 ppm, and cabbage, abyssinian; cabbage, seakale; hanover salad, leaves; and turnip, greens at 10 ppm, and tolerances in newly designated 40 CFR 180.414(d)(1) for cotton, undelinted seed at 0.10 ppm, and corn, sweet, kernel plus cob with husks removed; corn, sweet, forage; corn, sweet, stover; radish, roots; and radish, tops at 0.50 ppm.
5.
In accordance with current Agency practice to describe more clearly the measurement and scope or coverage of tolerances, EPA is proposing to revise
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Also, in accordance with current Agency practice to list significant figures for tolerance values, EPA is proposing to list existing tolerances in § 180.330(a)(1) for bean, lima; melon; and pumpkin at 0.20 ppm, beet, sugar, roots and squash, winter at 0.30 ppm, and beet, sugar, tops and corn, sweet, kernel plus cob with husks removed at 0.50 ppm, and alfalfa, hay at 11 ppm.
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A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce, 21 U.S.C. 331(a). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA, 7 U.S.C. 136
EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.
Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under FFDCA section 408, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops uses for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities.
Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue.
EPA is proposing that the actions herein become effective 6 months after the date of publication of the final rule in the
Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:
1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and
2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with
The Codex has not established a MRL for aluminum tris (
The Codex has established MRLs for cyromazine in or on [cucumber at 2 mg/kg; edible offal (mammalian) and eggs at 0.3 mg/kg; mango at 0.5 mg/kg; poultry meat at 0.1 mg/kg; and poultry, edible offal at 0.2 mg/kg. These MRLs are currently different, but the same as certain proposed U.S. tolerances (to harmonize with Codex MRLs) for cyromazine in the United States.
The Codex has established MRLs for oxydemeton-methyl in or on various commodities, including cauliflower and sugar beet at 0.01 mg/kg; fat of cattle, poultry, and sheep, meat of cattle, hogs, sheep, and poultry, and cotton seed at 0.05 mg/kg; and lemon at 0.2 mg/kg. These MRLs are different than the tolerances, proposed for revocation, for oxydemeton-methyl in the United States because of differences in use patterns, and/or good agricultural practices.
In this proposed rule, EPA is proposing to establish tolerances under FFDCA section 408(e), and also modify and revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions (
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR part 180 be amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a)
(a)
(a) * * *
(1) * * *
(2) * * *
(c) * * *
(a) * * *
(1) * * *
(d)(1)
(2)
(a) * * *
(a) * * *
(2) * * *
(d) * * *
(a) * * *
(a) An exemption from the requirement of a tolerance is established for residues of
(b) A exemption from the requirement of a tolerance is established for residues of
An exemption from the requirement of a tolerance is established for residues of tartrazine (F.D.&C. Yellow No. 5 or Acid Yellow 23), in or on all food commodities when used as an aquatic plant control agent.
National Institute of Standards and Technology, Department of Commerce.
Notice of open meeting.
The National Construction Safety Team (NCST) Advisory Committee (Committee) will meet in person and via teleconference on Thursday, September 28, 2017 from 8:30 a.m. to 5:00 p.m. Eastern Time. The primary purpose of this meeting is to update the Committee on the progress of the implementation of the recommendations made as a result of the National Institute of Standards and Technology (NIST) Joplin tornado investigation, provide the Committee an overview of ongoing work focused on enhancing the readiness and effectiveness of future National Construction Safety Teams in the field, and provide NIST's response to the Committee's 2016 Annual Report and recommendations. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site at
The NCST Advisory Committee will meet on Thursday, September 28, 2017 from 8:30 a.m. until 5:00 p.m. Eastern Time. The meeting will be open to the public.
The meeting will be held in the Heritage Room of Building 101, NIST, 100 Bureau Drive, Gaithersburg, Maryland 20899. For instructions on how to participate in the meeting, please see the
Benjamin Davis, Management and Program Analyst, Community Resilience Program, Engineering Laboratory, NIST, 100 Bureau Drive, Mail Stop 8615, Gaithersburg, Maryland 20899-8604. Mr. Davis' email address is
The Committee was established pursuant to Section 11 of the NCST Act (Pub. L. 107-231, codified at 15 U.S.C. 7301
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the NCST Advisory Committee will meet on Thursday, September 28, 2017, from 8:30 a.m. until 5:00 p.m. Eastern Time. The meeting will be open to the public. The meeting will be held in the Heritage Room of Building 101, NIST, 100 Bureau Drive, Gaithersburg, Maryland 20899. The primary purpose of this meeting is to update the Committee on the progress of the implementation of the NIST Joplin Tornado Investigation Report's recommendations, available at
Individuals and representatives of organizations who would like to offer comments and suggestions related to items on the Committee's agenda for this meeting are invited to request a place on the agenda. On September 28, 2017, approximately fifteen minutes will be reserved from 1:05 p.m. to 1:20 p.m. Eastern Time for public comments. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received, but is likely to be three minutes each. Questions from the public will not be considered during this period. All those wishing to speak must submit their request by email to the attention of Mr. Benjamin Davis,
Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend are invited to submit written statements to the NCST, National Institute of Standards and Technology, 100 Bureau Drive, MS 8604, Gaithersburg, Maryland 20899-8604, or electronically by email to
To participate in the teleconference, please submit your first and last name, email address, and phone number to Benjamin Davis at
National Institute of Standards and Technology, Department of Commerce.
Notice; request for information (RFI).
The National Institute of Standards and Technology (NIST) requests information about the broader needs of the industrial community in the area of quantum information science (QIS). NIST seeks input from stakeholders regarding opportunities for research and development, means and methods of inducing interaction and collaboration, providing support for emerging market areas, identifying barriers to near-term and future applications, and understanding workforce needs. As part of this effort, NIST will hold a workshop on Thursday, October 5, 2017. The information received in response to this RFI and during the workshop will inform recommendations for the development and coordination of U.S. Government policies, programs, and budgets to advance U.S. competitiveness in QIS.
Kimberly Emswiler, Jacob Taylor, or Carl Williams by email at
NIST seeks input from stakeholders regarding opportunities for research and development, emerging market areas, barriers to near-term and future applications, and workforce needs. The objective of this RFI is to gather facts that will assist the IWG's formation of recommendations for the development and coordination of U.S. Government policies, programs, and budgets to advance U.S. competitiveness in QIS. The questions below are intended to assist in the formulation of comments and should not be construed as a limitation on the number of comments that interested persons may submit or the issues that may be addressed in such comments. Comments containing references, studies, research, and other empirical data that are not widely published should include copies of the referenced materials. As noted above, all comments will be made publicly available as submitted; therefore proprietary or confidential information should not be included. NIST is specifically interested in receiving input pertaining to one or more of the following questions:
QIS includes, for example, quantum computing and processing, quantum algorithms and programming languages, quantum communications, quantum sensors, quantum devices, single photon sources, and detectors. What areas of pre-competitive QIS research and development appear most promising? What areas should be the highest priorities for Federal investment? What are the emerging frontiers? What methods of monitoring new developments are most effective? What market areas are well-positioned to benefit from new developments in QIS? Where will a technology perspective study help most? Where are roadmaps useful for coordination?
The 2016 report “Advancing Quantum Information Science: National Challenges and Opportunities”
Uncertain market needs, imperfect investment levels and mechanisms, undeveloped technology, challenges in dissemination of information, and technology transfer are some of the potential barriers to adoption of QIS technology. What are the greatest technical and organizational barriers to advancing important near-term and future applications of QIS and what should be done to address these barriers? What methods might be adopted to encourage both small and large efforts to provide a healthy industrial base? Which areas are underfunded, inconsistently funded, or need better funding clarity from the government for progress of the industry as a whole? At what level of knowledge or development should intellectual property move from being freely available to exclusive? How can industry or government address these concerns?
The purpose of the workshop is to convene stakeholders in the development and commercialization of quantum technologies to address the identified key challenges via industrial, academic, and governmental means. Topics to be discussed include opportunities for research and development and means and methods of facilitating interaction and collaboration such as creation of consortia, providing support for emerging market areas, identifying barriers to near-term and future applications, and understanding workforce needs. Information gathered at this workshop will be used in the development and coordination of U.S. Government policies, programs, and budgets to advance U.S. competitiveness in QIS. Furthermore, this workshop will provide a discussion place for industry to consider methods of collaboration in a neutral setting, including the potential benefits of developing a technology perspective study as well as other helpful organizing elements, including consortia and future roadmap development for subfields.
This workshop will focus on addressing the key challenges described above under “Request for Information.” It will include invited presentations by leading experts from academia, industry, and government; time for group discussion; and breakout sessions for discussing subfields, potential consortia frameworks, and the role of technology perspective studies.
There is no cost for participating in the workshop. No proprietary information will be accepted, presented or discussed as part of the workshop, and all information accepted, presented or discussed at the workshop will be in the public domain.
All workshop participants must pre-register at the following web address to be admitted:
15 U.S.C. 272(b)(1), (4), (11) & 15 U.S.C. 272(c)(12).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council, NEFMC) will hold a three-day meeting to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
The meeting will be held on Tuesday, Wednesday, and Thursday, September 26, 27, and 28, 2017, beginning at 9 a.m. on September 26, 8:30 a.m. on September 27, and 8:30 a.m. on September 28.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492, ext. 113.
After introductions and brief announcements, the meeting will begin with the swearing-in of reappointed Council members, followed by the election of 2017-2018 officers. The Council then will hear reports from the Council Chairman and Executive Director, NMFS's Regional Administrator for the Greater Atlantic Regional Fisheries Office (GARFO), liaisons from the Northeast Fisheries Science Center (NEFSC) and Mid-Atlantic Fishery Management Council, representatives from NOAA General Counsel and the Office of Law Enforcement, and staff from the Atlantic States Marine Fisheries Commission and U.S. Coast Guard. In addition, the Northeast Trawl Advisory Panel will provide a report. Next, the Council will hear from its Whiting Committee, which will cover three items of business. The first involves Amendment 22 to the Northeast Multispecies Fishery Management Plan (FMP). The amendment is being developed to potentially limit access to the small-mesh multispecies fishery, which includes red, silver, and offshore hakes. The Council is expected to select limited access, permitting, and possession limit preferred alternatives for Amendment 22 to send to public hearing. Next, the Whiting Plan Development Team (PDT) will present the Annual Monitoring Report, which summarizes 2016 fishing year activity and contains an assessment update and specification recommendations. Finally, the Council will initiate an action to develop 2018-20 specifications for the small-mesh multispecies fishery.
Following the lunch break, the Council will resume the whiting discussion if necessary. Otherwise, it will move on to the Atlantic Herring Committee report and address three items related to Draft Amendment 8 to the Atlantic Herring FMP. First, the
The second day of the meeting will begin with a report from the Transboundary Resource Assessment Committee (TRAC) summarizing results from the 2017 stock assessments for Eastern Georges Bank cod, Eastern Georges Bank haddock, and Georges Bank yellowtail flounder. The Scientific and Statistical Committee (SSC) will report next with 2018-19 overfishing limit (OFL) and ABC recommendations for Georges Bank yellowtail flounder and the Northeast skate complex. A short SSC working group update will follow. Next, the Council will hear from U.S. representatives to the Transboundary Management Guidance Committee (TMGC) and potentially approve TMGC recommendations for 2018 total allowable catches (TACs) for shared U.S./Canada groundfish stocks on Georges Bank. The TMGC considers TRAC advice when formulating recommendations. Members of the public then will be able to speak during an open comment period on issues that relate to Council business but are not included on the published agenda for this meeting. The Council asks the public to limit remarks to 3-5 minutes. Following the public comment period, the Council will receive a Groundfish Committee report, beginning with an update on Framework Adjustment 57 to the Northeast Multispecies FMP. The framework includes: (1) 2018-2020 Fishery specifications; (2) 2018 TACs for U.S./Canada stocks; (3) Atlantic halibut accountability measures (AMs); (4) recreational management measures; (5) common pool trimester TAC adjustments; and (6) southern windowpane flounder AMs. During the Groundfish Committee report, the Council also will receive and potentially further discuss the TMGC's TAC recommendations for U.S./Canada shared stocks and the SSC's OFL and ABC recommendations for Georges Bank yellowtail flounder. Finally, the Committee will present a progress report on Groundfish Monitoring Amendment 23.
After a lunch break, the Groundfish Committee report will continue until related business is concluded. The Skate Committee Report will follow. The Council will receive the Annual Monitoring Report on fishing year 2016 activity and then discuss Framework Adjustment 5 to the Northeast Skate Complex FMP. The Council may consider final action on the framework, which was initiated to develop fishing year 2018-2019 specifications and allow the landing of barndoor skates. The Council also will receive an update on Amendment 5 to potentially develop a limited access program for skates. At the conclusion of the skate discussion, the Council will adjourn for the day.
The third day of the meeting will begin with a preliminary discussion of 2018 Council priorities. Here, the Council will review and discuss a draft list of possible actions and tasks for further development in 2018 covering all committees. The Council will not take final action on priorities until its December meeting. Next, the Council will hear from its Scallop Committee, beginning with a summary of 2017 scallop survey results. The Council then will receive a progress report on Framework Adjustment 29 to the Atlantic Sea Scallop FMP. This framework contains: (1) Fishery specifications for the 2018 fishing year and default specifications for 2019; (2) scallop fishery AMs for yellowtail flounder and windowpane flounder; (3) Northern Gulf of Maine Management Area modifications; and (4) Closed Area I Scallop Access Area changes to be consistent with pending habitat area revisions. The Ecosystem-Based Fishery Management (EBFM) Committee then will provide a progress report on developing an example Fishery Ecosystem Plan for Georges Bank. The EBFM PDT will report on the application of operating models for a Georges Bank Ecosystem Production Unit, describing how the models could be used to support a Management Strategy Evaluation. Next, the Council will receive three brief habitat-related updates: One on the Omnibus Deep-Sea Coral Amendment; another on the Clam Dredge Framework; and a third on wind energy development.
Following a lunch break, the Council will receive an update on the status of the Council Program Review. The Research Steering Committee will report next on three issues: (1) Developing a process to prioritize Council research priorities; (2) providing input to the Northeast Cooperative Research Program; and (3) reviewing collaborative research projects. The Council then will discuss two issues related to Standardized Bycatch Reporting Methodology (SBRM). First the Council is expected to take final action on the SBRM Omnibus Framework Adjustment to address assigning at-sea observers to the lobster pot fleet in an unbiased manner through the Northeast Fishery Observer Program. It then will receive an update on the SBRM Three-Year Report. The Council will close out the meeting with “other business” and then potentially go into closed session to discuss ongoing litigation.
Although non-emergency issues not contained on this agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council 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. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
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 (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings of the North Pacific Fishery Management Council Ecosystem Committee.
The North Pacific Fishery Management Council (Council) Ecosystem Committee will meet in Seatte, WA. The meeting will be available via web delivery and
The meeting will be held on September 22, 2017, from 9 a.m. to 5 p.m., Pacific Time (PST).
The meeting will be held at the Alaska Fisheries Science Center, 7600 Sand Point Way NE., Seattle, WA, USA.
Steve MacLean, Council staff, phone: (907) 271-2809.
The purpose of the Ecosystem Committee meeting is to review the draft Bering Sea Fishery Ecosystem Plan being developed by Council committee. Resources will be available on the Council's Ecosystem Committee Web page at
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting of the SEDAR Steering Committee.
The SEDAR Steering Committee will meet to discuss the SEDAR process and assessment schedule. See
The SEDAR Steering Committee will meet Tuesday, September 26, 2017, from 1 p.m. until 6 p.m. and Wednesday, September 27, 2017, from 8:30 a.m. until 1 p.m.
John Carmichael, Deputy Executive Director, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free 866/SAFMC-10; fax: (843) 769-4520; email:
The items of discussion are as follows:
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 identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The South Atlantic Fishery Management Council (Council) will hold a meeting of its Citizen Science Advisory Panel Communication/Outreach/Education Action Team via webinar.
The meeting will be held Friday, September 22, 2017 at 10 a.m. The meeting is scheduled to last approximately 90 minutes. Additional Action Team webinar and plenary webinar dates and times will publish in a subsequent issue in the
Amber Von Harten, Citizen Science Program Manager, SAFMC; phone: (843) 302-8433 or toll free: (866) SAFMC-10; fax: (843) 769-4520; email:
The South Atlantic Fishery Management Council created a Citizen Science Advisory Panel Pool in June 2017. The Council appointed members of the Citizen Science Advisory Panel Pool to five Action Teams in the areas of
The Communication/Outreach/Education Action Team will meet to continue work on developing recommendations on program policies and operations to be reviewed by the Council's Citizen Science Committee.
Items to be addressed during these meetings:
These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
The next meeting of the U.S. Commission of Fine Arts is scheduled for 20 September 2017, at 9:00 a.m. in the Commission offices at the National Building Museum, Suite 312, Judiciary Square, 401 F Street NW., Washington, DC 20001-2728. Items of discussion may include buildings, parks and memorials.
Draft agendas and additional information regarding the Commission are available on our Web site:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the Procurement List.
This action adds product(s) and/or service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes product(s) and/or service(s) from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 7/28/2017 (82 FR 35187-35188) and 8/7/2017 (82 FR 36753-36754), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and a service and impact of the additions on the current or most recent contractors, the Committee has determined that the products and service listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and service to the Government.
2. The action will result in authorizing small entities to furnish the products and service to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products and service proposed for addition to the Procurement List.
Accordingly, the following products and service are added to the Procurement List:
On 7/21/2017 (82 FR 33872-33873), 7/28/2017 (82 FR 35187-35188), and 8/7/2017 (82 FR 36753-36754), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the product(s) and/or service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the product(s) and/or service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and/or service(s) deleted from the Procurement List.
Accordingly, the following products and services are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add product(s) and/or service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes product(s) and/or service(s) previously furnished by such agencies.
Comments must be received on or before October 8, 2017.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia 22202-4149.
For further information or to submit comments contact: Amy B. Jensen, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed additions, the entities of the Federal Government identified in this notice will be required to procure the products listed below from nonprofit agencies employing persons who are blind or have other severe disabilities.
The following products are proposed for addition to the Procurement List for
The following products and services are proposed for deletion from the Procurement List
Department of the Army, U.S. Army Corps of Engineers, DOD.
Notice of intent.
The Jacksonville District, U.S. Army Corps of Engineers (Corps) is beginning preparation of a National Environmental Policy Act (NEPA) assessment for the Combined Operational Plan (COP). The purpose of the COP is to define operations for the constructed features of the Modified Water Deliveries to Everglades National Park (MWD) and Canal 111 (C-111) South Dade Projects, while maintaining the congressionally authorized purposes of the Central and Southern Florida (C&SF) Project to include flood control; water supply for agricultural irrigation, municipalities and industry; regional groundwater control and prevention of saltwater intrusion; enhancement of fish and wildlife; and recreation.
U.S. Army Corps of Engineers, Planning and Policy Division, Environmental Branch, P.O. Box 4970, Jacksonville, FL 32232-0019.
Melissa Nasuti at 904-232-1368 or email at
a. The COP will result in a comprehensive integrated water control plan for the operation of water management infrastructure associated with the MWD and C-111 South Dade Projects in Miami Dade County, Florida. Development of the COP will be informed by a series of operational field tests previously conducted under the authority of the MWD Project that include incremental increases in water delivered from Water Conservation Area 3 (WCA 3) to Everglades National Park (ENP). Information gained from water management actions taken by the Corps in response to unseasonable high water levels within the WCAs in 2016 and 2017 will also be utilized to inform development of the COP.
b. Implementation of the COP is anticipated to increase the availability of water deliveries from WCA 3A to ENP through Northeast Shark River Slough and improve hydrologic conditions in Taylor Slough, the Rocky Glades, and the eastern panhandle of ENP.
c. Water management operating criteria defined during development of the COP will be incorporated into the 2012 WCAs, ENP, and ENP to South Dade Conveyance system Water Control Plan following completion of NEPA.
d. A scoping letter will be used to invite comments from Federal, State, and local agencies, affected Indian tribes, and other interested private organizations and individuals.
e. All alternative plans will be reviewed under provisions of appropriate laws and regulations, including the Endangered Species Act, Fish and Wildlife Coordination Act, Clean Water Act, and Farmland Protection Policy Act.
f. The Draft Environmental Impact Assessment is expected to be available for public review in 2019.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of intent.
The Portland District, U.S. Army Corps of Engineers (Corps) intends to prepare an integrated Environmental Impact Statement (EIS) and Federal Navigation Channel (FNC) Maintenance Plan, hereafter referred to as the Plan. The purpose of this Plan is to ensure the continued maintenance of the 43-foot deep Lower Columbia River FNC for the next 20 years. The Port of Longview, Port of Kalama, Port of Woodland, Port of Vancouver, and the Port of Portland (collectively the Sponsor Ports) are non-federal sponsors of the project, who will have Oregon and Washington State permitting requirements to execute on the Plan. The Corps will serve as the lead federal agency for purposes of the National Environmental Policy Act (NEPA). The Sponsor Ports will serve as cooperating agencies for purposes of NEPA. The Washington ports' activities in support of the proposed project will be subject to environmental review under chapter 43.21C Revised Code of Washington (RCW), the Washington State Environmental Policy Act (SEPA). The Washington Sponsor Ports will be co-lead agencies under SEPA, and the Port of Longview will serve as the nominal SEPA lead agency for purposes of SEPA compliance. To satisfy the requirements of NEPA and SEPA, the Corps and Sponsor Ports will be jointly preparing an integrated EIS for the Plan.
Written comments for consideration in the development of the scope of the joint NEPA/SEPA EIS are due to the addresses below no later than Thursday, November 16, 2017. Comments may also be made at the public scoping meetings listed in this notice. Additional information related to the public scoping process will be provided through advertisements placed in regional newspapers of general circulation, Public Notice, and on the project Web site at
Mailed comments may be sent to: U.S. Army Corps of Engineers, Portland District, P.O. Box 2946, Attn: CENWP-PM-E, Portland, Oregon 97208-2946. Email comments to:
For questions regarding the Plan, the EIS, or special accommodations for scoping process participation, please contact Kate Wells, Environmental Resources Specialist; Attn: CENWP-PM-E, P.O. Box 2946, Portland, Oregon 97208-2946; (503) 808-4664;
• Monday, October 2, 2017, 4:00 p.m. to 7:00 p.m., Cowlitz County Event Center, 1900 7th Avenue, Longview, Washington.
• Thursday, October 5, 2017, 4:00 p.m. to 7:00 p.m., Marshall Community Center, 1009 East McLoughlin Boulevard, Vancouver, Washington.
• Friday, October 6, 2017, 4:00 p.m. to 7:00 p.m., Charles Jordan Community Center, 9009 North Foss Avenue, Portland, Oregon.
• Monday, October 16, 2017, 4:00 p.m. to 7:00 p.m., Meriwether Place, 1070 Columbia Boulevard, St. Helens, Oregon.
• Tuesday, October 17, 2017, 4:00 p.m. to 7:00 p.m., Columbia River Maritime Museum Barbey Maritime Center, 1792 Marine Drive, Astoria, Oregon.
• Thursday, October 19, 2017, 4:00 p.m. to 7:00 p.m., Norse Hall, 444 State Route 4, Puget Island, Cathlamet, Washington.
Upon completion of the scoping process, the Draft Plan/Draft EIS will be developed. The DEIS will then be circulated for public review and comment. The Corps and Sponsor Ports expect to release the Draft EIS for public review and comment in 2018. The Corps will issue a Notice of Availability in the
Department of Energy.
Notice of meetings.
The Industry Advisory Board (IAB) to the International Energy Agency (IEA) will meet on September 13, 2017, at the Conference Centre of the French Ministry of Foreign Affairs, 27, Rue de la Convention, 75015 Paris, France, in connection with a joint meeting of the IEA's Standing Group on Emergency Questions (SEQ) and the IEA's Standing Group on the Oil Market (SOM) on September 14, 2017, in connection with a meeting of the SEQ on that day.
September 13, 14, 2017.
27, Rue de la Convention, 75015 Paris, France.
Thomas Reilly, Assistant General Counsel for International and National Security Programs, Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, 202-586-5000.
In accordance with section 252(c)(1)(A)(i) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(i)) (EPCA), the following notice of meetings is provided:
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held at the Centre de Conférence Ministériel of the French Ministry of Foreign Affairs Building, 27 Rue de la Convention, 75015 Paris, France, commencing at 9:30 a.m. on September 13, 2017. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a meeting of the IEA's Standing Group on Emergency Questions (SEQ), which is scheduled to be held at the same location and time. The IAB will also hold a preparatory meeting among company representatives at the same location at 8:30 a.m. on September 13. The agenda for this preparatory meeting is to review the agenda for the SEQ meeting.
The agenda of the SEQ meeting is under the control of the SEQ. It is expected that the SEQ will adopt the following agenda:
Draft Agenda of the 152nd Meeting of the SEQ to be held at the Centre de Conférence Ministériel of the French Ministry of Foreign Affairs Building, 27 Rue de la Convention, 75015 Paris, France, 13 September 2017, beginning at 9:30 a.m.
A meeting of the Industry Advisory Board (IAB) to the International Energy Agency (IEA) will be held at the Conference Centre of the French Ministry of Foreign Affairs, 27 Rue de la Convention, 75015 Paris, France, commencing at 10:00 on September 14, 2017. The purpose of this notice is to permit attendance by representatives of U.S. company members of the IAB at a joint meeting of the IEA's Standing Group on Emergency Questions (SEQ) and the IEA's Standing Group on the Oil Market (SOM), which is scheduled to be held at the same location and time.
The agenda of the meeting is under the control of the SEQ and the SOM. It is expected that the SEQ and the SOM will adopt the following agenda:
Draft Agenda of the Joint Session of the SEQ and the SOM to be held at the Conference Centre of the French Ministry of Foreign Affairs, 27 Rue de la Convention, 75015 Paris, France, 14 September 2017, beginning at 10:00.
As provided in section 252(c)(1)(A)(ii) of the Energy Policy and Conservation Act (42 U.S.C. 6272(c)(1)(A)(ii)), the meetings of the IAB are open to representatives of members of the IAB and their counsel; representatives of members of the IEA's Standing Group on Emergency Questions and the IEA's Standing Group on the Oil Markets; representatives of the Departments of Energy, Justice, and State, the Federal Trade Commission, the General Accounting Office, Committees of Congress, the IEA, and the European Commission; and invitees of the IAB, the SEQ, the SOM, or the IEA.
Take notice that on September 5, 2017, Valero Energy Corporation and Valero Marketing and Supply Company, filed a request that the Federal Energy Regulatory Commission (Commission), under its emergency powers pursuant to section 1(15) of the Interstate Commerce Act, 49 U.S.C. App. 1(15), allow, or if necessary direct, Colonial Pipeline Company to temporarily waive any and all RVP product specifications for conventional and reformulated gasoline that are inconsistent with the Environmental Protection Agency's August 31, 2017 Fuel Waiver, as more fully explained in the petition.
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 and 385.214. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Take notice that on September 5, 2017, pursuant to Rule 207(a)(5) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385. 207(a)(5) (2017), Colonial Pipeline Company filed an emergency petition for waiver of certain requirements of its tariffs for petroleum products transportation service between origin points in the Gulf Coast region and destination points on its pipeline system throughout the Southern and Eastern Seaboard states, consistent with the Environmental Protection Agency's August 31, 2017 Fuel Waiver, as more fully explained in the petition.
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 and 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at
This filing is accessible on-line at
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
Farm Credit Administration.
Notice, regular meeting.
Notice is hereby given, pursuant to the Government in the Sunshine Act, of the regular meeting of the Farm Credit Administration Board (Board).
The regular meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on September 14, 2017, from 9:00 a.m. until such time as the Board concludes its business.
Farm Credit Administration, 1501 Farm Credit Drive, McLean, Virginia 22102-5090. Submit attendance requests via email to
Dale L. Aultman, Secretary to the Farm Credit Administration Board, (703) 883-4009, TTY (703) 883-4056.
Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to
* Session Closed-Exempt pursuant to 5 U.S.C. Section 552b(c)(8) and (9).
Federal Accounting Standards Advisory Board.
Notice.
The exposure draft is available on the FASAB Web site at
Respondents are encouraged to comment on any part of the exposure draft. Written comments are requested by October 5, 2017, and should be sent to
Ms. Wendy M. Payne, Executive Director, 441 G Street NW., Mailstop 6H19, Washington, DC 20548, or call (202) 512-7350.
Federal Advisory Committee Act, Pub. L. 92-463.
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 4, 2017.
1.
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent orders—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before September 29, 2017.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Michael Barnett (202-326-2362), Bureau of Competition, 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for August 30, 2017), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before September 29, 2017. Write “In the Matter of Mars, Incorporated and VCA Inc., File No. 171-0057” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you prefer to file your comment on paper, write “In the Matter of Mars, Incorporated and VCA Inc., File No. 171-0057” 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
Because your comment will be placed on the publicly accessible FTC Web site at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC Web site at
The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) with Mars, Incorporated (“Mars”), which is designed to remedy the anticompetitive effects that would result from Mars' proposed acquisition of VCA Inc. (“VCA”).
Pursuant to an Agreement and Plan of Merger announced January 9, 2017, Mars proposes to acquire all of the assets of VCA in a transaction valued at approximately $9.1 billion (the “Acquisition”). Both parties provide specialty and emergency veterinary services in clinics they operate in cities across the United States. The Commission alleges in its Complaint that the Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by lessening competition in the markets for certain specialty and emergency veterinary services in ten different localities in the United States. The proposed Consent Agreement will remedy the alleged violations by preserving the competition that would otherwise be eliminated by the Acquisition. Specifically, under the terms of the Consent Agreement, Mars is required to divest twelve clinics. Mars and VCA have proposed National Veterinary Associates (“NVA”), PetVet Care Centers (“PetVet”), and Pathway Partners Vet Management Company (“Pathway”) as buyers of these clinics.
The proposed Consent Agreement has been placed on the public record for 30 days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review proposed Consent Agreement and comments received, and decide whether it should withdraw, modify, or make the Consent Agreement final.
The relevant lines of commerce in which to analyze the Acquisition are individual specialty and off-hours emergency veterinary services. Specialty veterinary services are required in cases that a general practitioner veterinarian cannot treat properly. General practitioner veterinarians commonly refer such cases to a specialist, typically a doctor of veterinary medicine board certified in the required specialty. Individual veterinary specialties include cardiology, critical care, internal medicine, neurology, oncology, ophthalmology, and surgery. Emergency veterinary services are used in acute situations where a general practice veterinarian is not available or in some cases not trained or equipped to treat the animal's medical problem.
The relevant areas for the provision of specialty and off-hours emergency veterinary services are local, delineated by the distance and time that pet owners travel to receive treatment. The distance and time customers travel for specialty services are highly dependent on local factors such as the proximity of a clinic offering the required specialty service, population density, population demographics, traffic congestion, or specific local geographic barriers. The markets affected by the transaction differ by area. The localities and services at issue are:
a. Oncology in western suburbs of Chicago, IL;
b. Emergency in Corpus Christi, TX;
c. Critical Care, Emergency, Internal Medicine, and Surgery in Kansas City, MO;
d. Critical Care and Emergency in Mesa, AZ;
e. Critical Care and Oncology in northern New York City, NY and its northern suburbs;
f. Critical Care, Internal Medicine, Neurology, Oncology, and Ophthalmology in Portland, OR;
g. Emergency, Internal Medicine, and Oncology in Rockville, MD;
h. Emergency in San Antonio, TX;
i. Cardiology, Critical Care, Emergency, Internal Medicine, and Neurology in Seattle, WA; and
j. Emergency, Internal Medicine, Oncology, and Ophthalmology in Vienna, VA.
In each locality listed above, the relevant market is highly concentrated. In a number of these markets, the combined firm would be the only provider following the transaction. In other markets, consumers would only have one remaining alternative to the combined firm following the transaction. In all of these markets, the Acquisition would substantially increase concentration within the described localities.
Entry into the relevant markets described above would not be timely, likely, or sufficient in magnitude, character, and scope to deter or
The Acquisition, if consummated, may substantially lessen competition and tend to create a monopoly in the relevant markets by eliminating head-to-head competition between Mars and VCA in the provision of specialty and emergency veterinary services; increasing the likelihood that Mars would unilaterally exercise market power; and increasing the likelihood that customers would be forced to pay higher prices for and degraded quality of the relevant services.
The proposed Consent Agreement effectively remedies the Acquisition's anticompetitive effects in ten markets where both Mars and VCA operate specialty or emergency veterinary clinics by requiring the parties to divest 12 facilities. Clinics in Kansas City, New York, and Phoenix are to be divested to NVA. Clinics in Portland, Rockville, and Vienna are to be divested to PetVet. Clinics in Chicago, Corpus Christi, San Antonio, and Seattle are to be divested to Pathway. The divestitures will preserve competition between the divested clinics and Mars' BluePearl or VCA's clinics that offer the same specialty or emergency services within each locality. NVA, PetVet, and Pathway are qualified acquirers of the divested assets. Each firm has significant experience acquiring, integrating, and operating specialty and emergency veterinary clinics.
The divestiture includes all regulatory permits and approvals, confidential business information, including customer information, related to the divested clinics, and other assets associated with providing specialty and emergency veterinary care at the divested clinics. To ensure the divestiture is successful, the Order requires Mars and VCA to secure all third-party consents, assignments, releases, and waivers required to permit the buyers to conduct business at the divested clinics.
As part of these divestitures, Mars and VCA are required to provide reasonable financial incentives to certain employees to continue in their positions. Such incentives may include, but are not limited to, guaranteeing a retention bonus for the specialty veterinarians at the divestiture clinics to assure their continued employment at such clinic, a continuation of all employee benefits, including the funding of regularly scheduled raises and bonuses, and the vesting of pension benefits (as permitted by law and for those Relevant Employees covered by a pension plan), offered by the parties. These provisions ensure that the buyers will have the assets necessary to operate the divested clinics in a competitive manner.
The Consent Agreement contains several additional provisions designed to ensure that the divestitures are successful. First, the Consent Agreement prevents Mars for a period of one year from contracting with any specialty or emergency veterinarian affiliated with a divested clinic. This provides the buyers with sufficient time to build goodwill and working relationships with the veterinarians before Mars could capitalize on its prior relationships in soliciting their services. Second, to ensure continuity of patient care and records as the buyers implement their own quality care, billing, and supply systems, Mars will provide transitional services for a period of one year. Finally, the Consent Agreement requires Mars for a period of ten years from the date the Commission issues the Order to provide prior notice to the Commission of its planned acquisitions of specialty or emergency veterinary clinics in certain geographic areas.
The Order requires Mars and VCA to divest the clinics no later than ten business days after the consummation of the Acquisition.
The Commission has appointed Thomas A. Carpenter, D.V.M. as Interim Monitor to ensure that Mars and VCA comply with all of their obligations pursuant to the Consent Agreement and to keep the Commission informed about the status of the transfer of the rights and assets to NVA, Pathway, and PetVet. Dr. Carpenter assists client companies undergoing regulator-mandated ownership transitions and has experience with the purchase and sale of veterinary clinics.
If the Commission determines that NVA, Pathway, and PetVet are not acceptable acquirers of the divested assets, or that the manner of the divestitures is not acceptable, the parties must unwind the sale of rights and assets to NVA, Pathway, and PetVet and divest them to a Commission-approved acquirer within six months of the date the Order becomes final. In that circumstance, the Commission may appoint a trustee to divest the rights and assets if the parties fail to divest them as required.
The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement, and it is not intended to constitute an official interpretation of the proposed Decision and Order or to modify its terms in any way.
By direction of the Commission.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Meeting notice with request for comments; extension of comment period.
GSA and OGP issued a notice on August 25, 2017, seeking input on an upcoming public advisory meeting, held by the PCEI. The comment period is extended to provide additional time for interested parties to review and submit comments on the notice.
The comment period for the notice published in the
Individuals who wish to submit written comments for the Commission's consideration may do so by either of the following methods:
•
•
Written comments not received by 5:00 p.m., EST, on Tuesday, September 12, 2017 may be submitted but will not be considered for the meeting held on Tuesday, September 12, 2017.
For questions, please contact Mr. Ron Williams, Policy Advisor, Presidential Advisory Commission on Election Integrity, via email at
GSA and OGP issued a notice on August 25, 2017, seeking input on an upcoming public advisory meeting, held by the PCEI. The comment period is extended to provide additional time for interested parties to review and submit comments on the notice.
Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 75 FR 6677, dated February 10, 2010) is amended to reflect the Order of Succession for the Centers for Disease Control and Prevention.
Section C-C, Order of Succession, is hereby amended as follows:
Delete in its entirety Section C-C, Order of Succession, and insert the following:
During the absence or disability of the Director, Centers for Disease Control and Prevention (CDC), or in the event of a vacancy in that office, the first official listed below who is available shall act as Director, except that during a planned period of absence, the Director may specify a different order of succession:
Part J (Agency for Toxic Substances and Disease Registry) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (50 FR 25129-25130, dated June 17, 1985, as amended most recently at 80 FR 61424, dated October 13, 2015) is amended to reflect the Order of Succession for the Agency for Toxic Substances and Disease Registry.
Section J-C, Order of Succession:
Delete in its entirety the Section C-C, Order of Succession, and insert the following:
During the absence or disability of the Administrator, Agency for Toxic Substances and Disease Registry (ATSDR), or in the event of a vacancy in that office, the first official listed below who is available shall act as Administrator, except during a planned period of absence, the Administrator may specify a different order of succession:
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by November 7, 2017.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
William Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
Administration for Native Americans (ANA) On-Going Progress Report (OPR) and Objective Work Plan (OWP).
The information in the OPR is collected on a semi-annual basis to monitor the performance of grantees and better gauge grantee progress. The semi-annual data collection replaces the previous quarterly filing requirement of the OPR.
The Objective Work Plan information collection is conducted in accordance with 42 U.S.C. of the Native American Programs Act of 1972, as amended. This collection is necessary to evaluate applications for financial assistance and determine the relative merits of the projects for which such assistance is requested, as set forth in Sec. 806 [42 U.S.C. 2991d-1](a)(1).
The Ongoing Progress Report information collection is conducted in accordance with Sec. 811 [42 U.S.C. 2992] of the Native American Programs Act and will allow ANA to report quantifiable results across all program areas. It also provides grantees with parameters for reporting their progress and helps ANA better monitor and determine the effectiveness of their projects.
Food and Drug Administration, HHS.
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled “Self-Collection Devices for Pap Test.” The purpose of the public workshop is to obtain feedback about the feasibility, benefits, risks, impact on current standard of care, and least burdensome validation approaches for self-collection devices for cervical samples for the purpose of cervical cancer screening by Pap testing. Comments and suggestions generated through this workshop will guide the development of an appropriate least burdensome regulatory framework for the evaluation of cervical sample self-collection devices to be used for cervical cancer screening of patients.
The public workshop will be held on January 11, 2018, from 9 a.m. to 4 p.m. Submit either electronic or written comments on this public workshop by February 14, 2018.
The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 14, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Shyam Kalavar (Rm. 5660, 301-796-6807,
Cervical cancer is a disease that results from uncontrolled, or abnormal, growth of cells in the cervix. Cervical cancer is generally considered as a consequence of a long-term infection with human papillomavirus (HPV), especially with high-risk strains such as HPV16 and 18. Through regular screening and early detection, cervical cancer can often be prevented. According to the National Cancer Institute, routine screening with Pap Test (or Pap smear) and HPV Test in the United States has decreased the incidence of cervical cancer, based on an estimated 12,820 new cases and 4,210 deaths (0.7 percent of all cancer deaths) in 2017 (Ref. 1).
The standard of care for cervical cancer screening has been well-established in the United States over the past several decades. Automated liquid-based Pap Test has largely replaced conventional Pap smear method. Liquid-based cervical specimens can be used for both Pap Test and HPV Test. By using specimen collection devices such as a cervical broom or cervical spatula and brush combination, cervical specimens are collected by healthcare professionals and sent to a Clinical Laboratory Improvement Amendments certified laboratory for processing for Pap Test and HPV Test. The results of these tests are then returned to the ordering clinician who conveys the results to the patient and initiates appropriate treatment.
Despite the established standard of care for cervical cancer screening in the United States, gaps in cervical cancer screening exist. Barriers to cervical cancer screening may include limited access to such services in rural areas, socioeconomic status, etc. As a result, in certain populations and geographic areas of the United States, cervical cancer incidence and death rate are still high, due in large part to limited access to cervical cancer screening (Refs. 2-3).
The role of self-sampling in overcoming these barriers is unclear. Careful evaluation of risks and benefits, and impact to current standard of care is needed to better understand issues concerning how such devices should be dispensed to end users for self-collection, proper use of the device to ensure patient safety, the collection of adequate samples for testing, the use of these test results in patient care, and the impact on the current regulatory framework. FDA is holding this public workshop to solicit input from stakeholders about the self-collection of cervical specimens for cancer screening, including its feasibility, benefits, risks, current attitudes, and impact on current standard of care.
This public workshop will consist of both morning and afternoon sessions. Each session will include brief presentations followed by an interactive panel discussion. The presentations will provide information to outline the goals of the workshop and help promote interactive discussions. Following the presentations, there will be a moderated discussion where speakers and additional panelists will be asked to provide their individual perspectives.
The presentations and discussions will focus on several related topics. The morning session will involve scientific considerations, focusing on the current status of cervical cancer screening and the feasibility, benefits, and risks of self-collection of cervical specimens for Pap Test. The afternoon session will involve validation and regulatory considerations, focusing on the impact of self-collection of cervical samples on the current standard of care and the regulatory environment for supporting self-collection for Pap Test. A detailed agenda will be posted on the following Web site in advance of the workshop:
Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by January 3, 2018, 4 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public workshop.
If you need special accommodations due to a disability, please contact Susan Monahan, 301-796-5661 or email
If you have never attended a Connect Pro event before, test your connection at
The following references are on display in the Dockets Management Staff (see
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the NHLBI Special Emphasis Panel.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: J. P. Kim, NIH SBIR/STTR Program Manager & NIH Extramural Data Sharing Policy Officer, Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Office, Office of Extramural Programs (OEP)/Office of Extramural Research (OER), Office of the Director (OD)/National Institutes of Health (NIH), 6705 Rockledge Drive, Suite 350; Bethesda, Maryland 20892-7963 or call non-toll-free number (301) 435-0189 or Email your request, including your address to:
The Commercialization Accelerator Program (CAP), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 150.
Coast Guard, DHS.
Notice of availability and request for comments; extension of comment period.
The Coast Guard is extending the comment period for its notice of availability and request for comments, published on July 12, 2017. The notice announced the availability of the draft Navigation and Vessel Inspection Circular (NVIC) 05-17 entitled Guidelines for Addressing Cyber Risks at Maritime Transportation Security Act (MTSA) Regulated Facilities, and requested public comments on the draft. The comment period was set to close on September 11, 2017. The Coast Guard has received requests to extend the comment period by 30 days due to the conditions caused by hurricane Harvey, which prevent some members of the public from submitting comments by the original deadline.
Comments and related material must reach the Coast Guard on or before October 11, 2017.
You may submit comments identified by docket number USCG-2016-1084 using the Federal eRulemaking Portal at
If you have questions on this notice, call or email, Jason Warren, Coast Guard; telephone 202-372-1106, email
U.S. Coast Guard, Department of Homeland Security.
Notice of Federal Advisory Committee meeting.
The Great Lakes Pilotage Advisory Committee will meet in Martinsburg, West Virginia, at the U.S. Coast Guard National Maritime Center to discuss Committee matters relating to Great Lakes pilotage, including review of proposed Great Lakes pilotage regulations and policies. The meeting will be open to the public.
The Great Lakes Pilotage Advisory Committee will meet on Tuesday, September 26, 2017, from 8 a.m. to 5:30 p.m. EDT, and on Wednesday, September 27, 2017 from 8 a.m. to 5:30 p.m. EDT. Please note that this meeting may adjourn early if the Committee has completed its business.
The meeting will be held at the Coast Guard National Maritime Center, 100 Forbes Drive, Martinsburg, West Virginia, 25404-0001.
All attendees will be required to provide a government-issued picture identification card in order to gain admittance to the building.
For additional information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the individual listed in the
Ms. Michelle Birchfield, Alternate Designated Federal Officer of the Great Lakes Pilotage Advisory Committee, telephone (202) 372-1533, or email
Notice of this meeting is in compliance with the Federal Advisory Committee Act, (Title 5 U.S.C. Appendix). The Great Lakes Pilotage Advisory Committee is established under the authority of 46 U.S.C. 9307, and makes recommendations to the Secretary of Homeland Security and the Coast Guard on matters relating to Great Lakes pilotage, including review of proposed Great Lakes pilotage regulations and policies.
A copy of all meeting materials will be made available at
The Great Lakes Pilotage Advisory Committee will meet on Tuesday, September 26, and Wednesday, September 27, 2017 to review, discuss, deliberate and formulate recommendations, as appropriate, on the following topics:
1. Reports:
a. Change Point Review Subcommittee and;
b. Input to Support Regulatory Reform of Coast Guard Regulations-Executive Orders 13771 and 13783 Subcommittee;
2. Coast Guard contracted studies;
3. Individual pilot compensation;
4. Staffing and dispatch;
5. Use of the 10-year rolling average of traffic;
6. Weighting factors;
7. Authorized pilotage charges;
8. Audits;
9. Working capital fund;
10. Coast Guard communications with external stakeholders;
11. Reports and updates on ongoing association and Pilotage Office projects; and
12. Public comment period.
Public comments or questions will be taken throughout the meeting as the Committee discusses the issues and prior to deliberations and voting. There will also be a public comment period at the end of the meeting. Speakers are requested to limit their comments to 5 minutes. Please note that the public comment period will end following the last call for comments. Contact the individual listed in the
Fish and Wildlife Service, Interior.
Notice; reopening of public comment period.
We, the U.S. Fish and Wildlife Service (Service), are reopening the comment period for the public to review the draft Habitat Conservation Plan for the R-Project Transmission Line in Nebraska (HCP), draft Environment Impact Statement of the R-Project HCP (DEIS), draft Migratory Bird Conservation Plan (MBCP); and draft Restoration Management Plan. The HCP identifies conservation measures to minimize and mitigate the potential effects of incidental take of the American burying beetle from the construction, operations, and maintenance of the R-Project transmission line. If you previously submitted comments, you need not resubmit them; we have already incorporated them into the public record and will fully consider them in finalizing these documents.
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•
Eliza Hines, at 308-382-6468, extension 204 (phone), or
We, the U.S. Fish and Wildlife Service (Service), are reopening the comment period for the public to review the draft Habitat Conservation Plan for the R-Project Transmission Line in Nebraska (HCP), draft Environment Impact Statement of the R-Project HCP (DEIS), draft Migratory Bird Conservation Plan (MBCP), and draft Restoration Management Plan. The HCP identifies conservation measures to minimize and mitigate the potential effects of incidental take of the American burying beetle. As of July 3, 2017, we received requests from over 60 individuals and organizations to provide a longer comment period. In response to these requests, we are reopening the comment period. If you previously submitted comments, you need not resubmit them; we have already incorporated them into the public record and will fully consider them in finalizing these documents.
On May 12, 2017, we opened a 60-day public comment period via a
For background information, see our May 12, 2017, notice (82 FR 22153).
The draft HCP, DEIS, draft MBCP, and draft Restoration Management Plan are available via the Internet at the Federal eRulemaking Portal (
• North Platte Public Library, 120 West 4th Street, North Platte, Nebraska.
• Logan County Library, 317 Main Street, Stapleton, Nebraska.
• Hooker County Library, 102 North Cleveland Avenue, Mullen, Nebraska.
• Garfield County Library, 217 G Street, Burwell, Nebraska.
• Ewing Township Library, 202 East Nebraska, Ewing, Nebraska.
• Ainsworth Public Library, 455 North Main Street, Ainsworth, Nebraska.
• Valentine Public Library, 324 North Main Street, Valentine, Nebraska.
• Thomas County Library, 501 Main Street, Thedford, Nebraska.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 26) of the presiding administrative law judge (“ALJ”) granting a joint motion to terminate the investigation based on settlement.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2737. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on January 27, 2017, based on a complaint and supplements, filed on behalf of Nokia Technologies Oy of Espoo, Finland (“complainant”). 82 FR 8626-27 (Jan. 27, 2017). The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic devices, including mobile phones, tablet computers, and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 7,415,247 (“the '247 patent”); 9,270,301 (“the '301 patent”); 6,393,260 (“the '260 patent”); 6,826,391 (“the '391 patent”); 6,480,700; 9,473,602; 7,653,366; and 8,036,619. The Notice of Investigation named Apple Inc., a/k/a Apple Computer, Inc. of Cupertino, California (“respondent”) as a respondent. The Office of Unfair Import Investigations (“OUII”) was named as a party. On January 26, 2017, the ALJ severed the investigation into two investigations. The '301, '391, '260 and '247 patents are now asserted in Inv. No. 337-TA-1039.
On June 7, 2017, complainant and respondent filed a joint motion to
On August 8, 2017, the ALJ issued an order (Order No. 26) granting the joint motion to terminate the investigation. The ALJ found that no public interest concerns are implicated by this settlement. No petitions for review were filed.
The Commission has determined not to review the ID and terminates the investigation.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
Operated assisted teleconference is available for this meeting. Call 888-677-2612 with password EHRAC and you will be connected to the audio portion of the meeting.
Meeting materials and minutes will also be available on the EHR Advisory Committee Web site at
Weeks of September 11, 18, 25, October 2, 9, 16, 2017.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of September 11, 2017.
There are no meetings scheduled for the week of September 18, 2017.
There are no meetings scheduled for the week of September 25, 2017.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of October 9, 2017.
There are no meetings scheduled for the week of October 16, 2017.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17f-2(d) requires that records created pursuant to the fingerprinting requirements of Section 17(f)(2) of the Act be maintained and preserved by every member of a national securities exchange, broker, dealer, registered transfer agent and registered clearing agency (“covered entities” or “respondents”); permits, under certain circumstances, the records required to be maintained and preserved by a member of a national securities exchange, broker, or dealer to be maintained and preserved by a self-regulatory organization that is also the designated examining authority for that member, broker or dealer; and permits the required records to be preserved on microfilm. The general purpose for Rule 17f-2 is to: (i) Identify security risk personnel; (ii) provide criminal record information so that employers can make fully informed employment decisions; and (iii) deter persons with criminal records from seeking employment or association with covered entities. The rule enables the Commission or other examining authority to ascertain whether all required persons are being fingerprinted and whether proper procedures regarding fingerprinting are being followed. Retention of these records for a period of not less than three years after termination of a covered person's employment or relationship with a covered entity ensures that law enforcement officials will have easy access to fingerprint cards on a timely basis. This in turn acts as an effective deterrent to employee misconduct.
Approximately 4,200 respondents are subject to the recordkeeping requirements of the rule. Each respondent maintains approximately 68 new records per year, each of which takes approximately 2 minutes per record to maintain, for an annual burden of approximately 2.2666667 hours (68 records times 2 minutes). The total annual burden for all respondents is approximately 9,520 (4,200 respondents times 2.2666667 hours). As noted above, all records maintained subject to the rule must be retained for a period of not less than three years after termination of a covered person's employment or relationship with a covered entity. In addition, we estimate the total cost to respondents is approximately $42,000 in third party storage costs.
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
Section 19(a) (15 U.S.C. 80a-19(a)) of the Investment Company Act of 1940 (the “Act”)
Rule 19a-1 (17 CFR 270.19a-1) under the Act, entitled “Written Statement to Accompany Dividend Payments by Management Companies,” sets forth specific requirements for the information that must be included in statements made pursuant to section 19(a) by or on behalf of management companies.
The purpose of rule 19a-1 is to afford fund shareholders adequate disclosure of the sources from which distribution payments are made. The rule is intended to prevent shareholders from confusing income dividends with distributions made from capital sources. Absent rule 19a-1, shareholders might receive a false impression of fund gains.
Based on a review of filings made with the Commission, the staff estimates that approximately 11,818 series of registered investment companies that are management companies may be subject to rule 19a-1 each year,
The staff estimates that approximately one-third of the total annual burden (7,879 hours) would be incurred by a paralegal with an average hourly wage rate of approximately $205 per hour,
To comply with state law, many investment companies already must distinguish the different sources from which a shareholder distribution is paid and disclose that information to shareholders. Thus, many investment companies would be required to distinguish the sources of shareholder dividends whether or not the Commission required them to do so under rule 19a-1.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Compliance with the collection of information required by rule 19a-1 is mandatory for management companies that make statements to shareholders pursuant to section 19(a) of the Act. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
Written comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17Ad-3(b) requires registered transfer agents to send a copy of the written notice required under Rules 17Ad-2(c), (d), and (h) to the chief executive officer of each issuer for which the transfer agent acts when it has failed to turnaround at least 75% of all routine items in accordance with the requirements of Rule 17Ad-2(a), or to process at least 75% of all items in accordance with the requirements of Rule 17Ad-2(b), for two consecutive months. The issuer may use the information contained in the notices: (1) As an early warning of the transfer agent's non-compliance with the Commission's minimum performance standards regarding registered transfer agents; and (2) to become aware of certain problems and poor performances with respect to the transfer agents that are servicing the issuer's issues. If the issuer does not receive notice of a registered transfer agent's failure to comply with the Commission's minimum performance standards then the issuer will be unable to take remedial action to correct the problem or to find another registered transfer agent. Pursuant to Rule 17Ad-3(b), a transfer agent that has already filed a Notice of Non-Compliance with the Commission pursuant to Rule 17Ad-2 will only be required to send a copy of that notice to issuers for which it acts when that transfer agent fails to turnaround 75% of all routine items or to process 75% of all items.
The Commission estimates that only one transfer agent will meet the requirements of Rule 17Ad-3(b) each year. If a transfer agent fails to meet those turnaround and processing performance requirements under 17Ad-3(b), it would simply send a copy of the notice to its issuer-clients that had already been produced for the Commission pursuant to Rule 17Ad-2(c) or (d). The Commission estimates
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l
The Investment Company Act of 1940 (the “Act”)
In one of its first releases, the Commission exercised its rulemaking authority pursuant to sections 38(a) and 40(b) of the Act by adopting rule 0-1 (17 CFR 270.0-1).
The Commission amended rule 0-1 to include the definition of the term “independent legal counsel” in 2001.
If the board's counsel has represented the fund's investment adviser, principal underwriter, administrator (collectively, “management organizations”) or their “control persons”
Any fund that relies on one of the exemptive rules must comply with the requirements in the definition of “independent legal counsel” under rule 0-1. We assume that approximately 3,108 funds rely on at least one of the exemptive rules annually.
These burden hour estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
Written comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to:
U.S. Small Business Administration.
Notice.
This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of California, dated 08/30/2017.
Issued on 08/30/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's EIDL declaration, applications for economic injury disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for economic injury is 152760.
The State which received an EIDL Declaration # is California.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4332-DR), dated 08/25/2017.
Issued on 08/30/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Texas, dated 08/25/2017, is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Iowa (FEMA-4334-DR), dated 08/27/2017.
Issued on 08/27/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 08/27/2017, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 15286B and for economic injury is 152870.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Idaho (FEMA-4333-DR), dated 08/27/2017.
Issued on 08/27/2017.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 08/27/2017, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 152846 and for economic injury is 152850.
By petition filed on June 12, 2017, Grand Elk Railroad, Inc. (GDLK), seeks an exemption under 49 U.S.C. 10502 from the requirements of 49 U.S.C. 10902 to acquire trackage rights currently held by Norfolk Southern Railway Company over 3.3 miles of track in Grand Rapids, Mich. owned by CSX Transportation, Inc. (CSXT).
The Board will institute a proceeding. The Board is aware of GDLK's request for expedited consideration of this petition and GDLK's related petition in Docket No. FD 36127 (Sub-No. 1) and anticipates issuing a decision addressing these matters in the near
1. Under 49 U.S.C. 10502(b), a proceeding is instituted.
2. Notice of the Board's action will be published in the
3. This decision is effective on its service date.
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of denials.
FMCSA announces its decision to deny applications from 24 individuals who requested an exemption from the Federal Motor Carrier Safety Regulations (FMCSRs) prohibiting persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a commercial motor vehicle (CMV) from operating CMVs in interstate commerce.
Ms. Christine A. Hydock, Chief, Medical Programs Division, (202) 366-4001,
You may see all the comments online through the Federal Document Management System (FDMS) at:
FMCSA received applications from 24 individuals who requested an exemption from the FMCSRs prohibiting persons with a clinical diagnosis of epilepsy or any other condition that is likely to cause a loss of consciousness or any loss of ability to operate a CMV from operating CMVs in interstate commerce.
FMCSA has evaluated the eligibility of these applicants and concluded that granting these exemptions would not provide a level of safety that would be equivalent to or greater than, the level of safety that would be obtained by complying with the regulation 49 CFR 391.41(b)(8).
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for two years if it finds “such an exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such an exemption.”
The Agency's decision regarding these exemption applications is based on the eligibility criteria, the terms and conditions for Federal exemptions, and an individualized assessment of each applicant's medical information provided by the applicant.
The Agency has determined that these applicants do not satisfy the criteria eligibility or meet the terms and conditions of the Federal exemption and granting these exemptions would not provide a level of safety that would be equivalent to or greater than, the level of safety that would be obtained by complying with the regulation 49 CFR 391.41(b)(8). Therefore, the 24 applicants in this notice have been denied exemptions from the physical qualification standards in 49 CFR 391.41(b)(8).
Each applicant has, prior to this notice, received a letter of final disposition regarding his/her exemption request. Those decision letters fully outlined the basis for the denial and constitutes final action by the Agency. This notice summarizes the Agency's recent denials as required under 49 U.S.C. 31315(b)(4) by periodically publishing names and reasons for denial.
The following 24 applicants do not meet the minimum time requirement for being seizure-free, either on or off of anti-seizure medication:
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 10, 2017.
Comments should refer to docket number MARAD-2017-0149. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel SILVER MAMA is:
The complete application is given in DOT docket MARAD-2017-0149 at
In accordance with 5 U.S.C. 553(c), DOT/MARAD solicits comments from the public to better inform its rulemaking process. DOT/MARAD posts these comments, without edit, to
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Request for public comment on proposed collection of information.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.
Comments must be received on or before November 7, 2017.
You may submit comments identified by docket number at the heading of this notice by any of the following methods:
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For additional information or access to background documents, contact Wayne McKenzie, Office of Crash Avoidance Standards (NVS-121), National Highway Traffic Safety Administration, West Building W43-462, 1200 New Jersey Avenue SE., Washington, DC 20590. Mr. McKenzie can be reached at (202) 366-1810.
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must publish a document in the
(i) 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) 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) How to enhance the quality, utility, and clarity of the information to be collected; and
(iv) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In compliance with these requirements, NHTSA asks public comment on the following proposed collection of information:
Issued in Washington, DC.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Request for public comment on an extension of a currently approved collection.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
This document describes one collection of information for which NHTSA intends to seek OMB approval.
Comments must be received on or before November 7, 2017.
Comments must refer to the docket notice numbers cited at the beginning of this notice and be submitted to Docket Management, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590 by any of the following methods.
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Complete copies of each request for collection of information may be obtained at no charge from Hisham Mohamed or Carlita Ballard, NHTSA, 1200 New Jersey Ave. SE., Room W43-437, NRM-310, Washington, DC 20590. Mr. Mohamed's telephone number is (202) 366-0307 and Ms. Ballard's telephone number is (202) 366-5222. Please identify the relevant collection of information by referring to its OMB Control Number.
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must first publish a document in the
(i.) 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.) 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.) How to enhance the quality, utility, and clarity of the information to be collected and;
(iv.) How to minimize the burden of the collection of information on those
In compliance with these requirements, NHTSA asks for public comments on the following proposed collections of information:
NHTSA estimates that the vehicle manufacturers will incur a total reporting annual hour burden and cost burden of 50,440 hours and $3,716,740 respectively. The amount includes annual burden hours incurred by multi-stage manufacturers and motor vehicle equipment suppliers.
Issued in Washington, DC, under authority delegated in 49 CFR 1.95.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for public comment on extension of a currently approved collection of information.
The Department of Transportation (DOT) invites public comments about our intention to request the Office of Management and Budget (OMB) renewed approval for an existing information collection. The collection involves labeling information from manufacturers of brake hoses, end fittings, and brake hose assemblies. The information to be collected will be used to and/or is necessary to satisfy the requirements of Federal Motor Vehicle Safety Standard (FMVSS) No. 106, Brake Hoses. Under procedures established by the Paperwork Reduction Act of 1995 (Pub. L. 104-13), before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
Written comments should be submitted by November 7, 2017.
You may submit comments [identified by Docket No. DOT-NHTSA-2017-0047] through one of the following methods:
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Joshua Fikentscher, Office of Crash Avoidance Standards, Vehicle Dynamics Division (NRM-220), National Highway Traffic Safety Administration, West Building, Fourth Floor, Room W43-467, 1200 New Jersey Avenue SE., Washington, DC 20590. Mr. Fikentscher's phone number is (202) 366-1688.
Prior to assembling or selling brake hoses, these entities must register their identification marks with NHTSA to comply with the labeling requirements of this standard. In accordance with the Paperwork Reduction Act, the agency must obtain OMB approval to continue collecting labeling information. Currently, there are 2,418 manufacturers of brake hoses and end fittings, and brake hose assemblers, registered with NHTSA. However, about 60 respondents annually (annual average from 2014-2016) request to have their identification marks added to or removed from the NHTSA database. To comply with this standard, each brake hose manufacturer or assembler must contact NHTSA and state that they want to be added to or removed from the NHTSA database of registered brake hose manufacturers. This action is usually initiated by the manufacturer with a brief written request via U.S. mail, facsimile, an email message, or a telephone call. Since September 1, 2015, the request can be submitted via the Manufacturer Portal: Online Web-based Submittal Center (
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1:48.
Issued in Washington, DC.
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Request for public comment on extension of a currently approved collection of information.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes an existing collection of information for an existing regulation for the aftermarket modification of vehicles to accommodate people with disabilities, for which NHTSA intends to seek renewed OMB approval.
Comments must be received on or before November 7, 2017.
Comments must refer to the docket number cited at the beginning of this notice, and may be submitted by any of the following methods:
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Mr. Christopher J. Wiacek, NHTSA, 1200 New Jersey Avenue SE., Room W43-474, NVS-122, Washington, DC 20590. Mr. Wiacek's telephone number is (202) 366-4801.
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must first publish a document in the
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) How to enhance the quality, utility, and clarity of the information to be collected;
(4) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In compliance with these requirements, NHTSA asks for public
This final rule included two new “collections of information,” as that term is defined in 5 CFR part 1320 “Controlling Paperwork Burdens on the Public”: Modifier identification and a document to be provided to the owner of the modified vehicle stating the exemptions used for that vehicle and any reduction in load carrying capacity of the vehicle of more than 100 kg (220 lbs).
Modifiers who take advantage of the exemption created by this rule are required to furnish NHTSA with a written document providing the modifier's name, address, and telephone number, and a statement that the modifier is availing itself of the exemption. The rule requires:
(a) Any motor vehicle repair business that modifies a motor vehicle to enable a person with a disability to operate, or ride as a passenger in, the motor vehicle and intends to avail itself of the exemption provided in 49 CFR 595.7 shall furnish the information specified in paragraphs (a)(1) through (3) of this section to: Administrator, National Highway Traffic Safety Administration, 400 Seventh Street SW., Washington, DC 20590.
(1) Full individual, partnership, or corporate name of the motor vehicle repair business.
(2) Residence address of the motor vehicle repair business and State of incorporation if applicable.
(3) A statement that the motor vehicle repair business modifies a motor vehicle to enable a person with a disability to operate, or ride as a passenger in, the motor vehicle and intends to avail itself of the exemption provided in 49 CFR 595.7.
(b) Each motor vehicle repair business required to submit information under paragraph (a) of this section shall submit the information not later than August 27, 2001. After that date, each motor vehicle repair business that modifies a motor vehicle to enable a person with a disability to operate, or ride as a passenger in, the motor vehicle and intends to avail itself of the exemption provided in 49 CFR 595.7 shall submit the information required under paragraph (a) not later than 30 days after it first modifies a motor vehicle to enable a person with a disability to operate, or ride as a passenger in, the motor vehicle. Each motor vehicle repair business who has submitted required information shall keep its entry current, accurate and complete by submitting revised information not later than 30 days after the relevant changes in the business occur.”
This requirement is a one-time submission unless changes are made to the business as described in paragraph (b). NHTSA estimates that there are currently 900 businesses making modifications to motor vehicles to accommodate persons with disabilities. Of those 900, we estimate 85 percent will need to use the exemptions provided by 49 CFR 595.7 (595 businesses). The initial registration of modifiers wishing to use the exemptions occurred in 2001. Based on letters received since then, we estimate that 90 businesses currently modifying vehicles will need to change their information or new registrants will elect to use the exemptions annually. We estimate the burden of new or changed registrations from 90 businesses each year of:
We estimate the material cost associated with each submission to be 56 cents per responding business, or $50.04 nationwide annually.
Burden means the total time, effort, or financial resources expended by a person to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instruction; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; and transmit or otherwise disclose the information.
We seek comment on:
1. Is our estimate of 900 businesses engaged in vehicle modification to accommodate people with disabilities correct?
2. Are we correct in assuming that a maximum of 85 percent of those 900 businesses, or 765 businesses, will need to use the exemptions provided by 49 CFR 595.7?
3. Are our estimates of the burden hours and material cost of compliance with 49 CFR 595.6 reasonable?
Modifiers who avail themselves of the exemptions in 49 CFR 595.7 are required to keep a record, for each applicable vehicle, listing which standards, or portions thereof, no longer comply with the Federal motor vehicle safety standards and to provide a copy to the owner of the vehicle modified (see 49 CFR 595.7(b) and (e) as published in the final rule).
We estimate that:
1. There are approximately 5,000 vehicles modified for persons with disabilities per year by 900 businesses;
2. If 85 percent of the 900 businesses use the exemptions provided by 49 CFR 595.7, those 765 businesses will modify 4,383 vehicles annually; and
3. The burden for producing the record required by 49 CFR 595.7 in accordance with paragraph (e) for those vehicles will be 1,460 hours per year nationwide.
In the final rule we anticipated that the least costly way for a repair business to comply with this portion of the new rule would be to annotate the vehicle modification invoice as to the exemption, if any, involved with each item on the invoice. The cost of preparing the invoice is not a portion of our burden calculation, as that preparation would be done in the normal course of business. The time needed to annotate the invoice, we estimate, is 20 minutes. Therefore, the burden hours for a full year are calculated as:
This burden includes the calculation required by 49 CFR 595.7(e), but not the gathering of the information required for the calculation. That information would be gathered in the normal course of the vehicle modification. The only extra burden required by the rule is the calculation of the reduction in loading carrying capacity and conveying this information to the vehicle owner. Again, we are assuming that annotation on the invoice is the least burdensome way to accomplish this customer notification.
There will be no additional material cost associated with compliance with this requirement since no additional materials need be used above those used to prepare the invoice in the normal course of business. We are assuming it is normal and customary in the course of vehicle modification business to prepare an invoice, to provide a copy of the invoice to the vehicle owner, and to keep a copy of the invoice for five years after the vehicle is delivered to the owner in finished form.
We seek comment on whether our assumptions about the following are accurate:
1. The document required by 49 CFR 595.7(b) and specified in paragraph (e) will need to be prepared for approximately 4,383 vehicles modified nationwide per year,
2. Annotation of each vehicle modification invoice as to which exemptions were used will take an average of 20 minutes, and
3. It is normal in the course of vehicle modification business to prepare an invoice, to provide a copy of the invoice to the vehicle owner, and to keep a copy of the invoice for five years after the vehicle is delivered to the owner in finished form.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Request for extension of a currently approved collection of information.
This notice solicits public comments on continuation of the requirements for the collection of information on safety standards. Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections.
This document describes a collection of labeling information on four Federal motor vehicle safety standards, for which NHTSA intends to seek OMB approval. The labeling requirements include brake fluid warning, glazing labeling, and safety belt labeling.
Comments must be received on or before November 7, 2017.
You may submit comments (identified by the DOT Docket ID Number above) by any of the following methods:
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Regardless of how you submit your comments, you should mention the docket number of this document. You may call the Docket at (202) 366-9324. Please identify the proposed collection of information for which a comment is provided, by referencing its OMB clearance Number. It is requested, but not required, that two copies of the comment be provided.
Note that all comments received will be posted without change to
Complete copies of each request for collection of information may be obtained at no charge from Ms. Lori Summers, U.S. Department of Transportation, NHTSA, Room W43-320, 1200 New Jersey Avenue SE., Washington, DC 20590. Mrs. Summers' telephone number is (202) 366-4917 and fax number is (202) 366-7002.
Under the Paperwork Reduction Act of 1995, before a proposed collection of information is submitted to OMB for approval, Federal agencies must first publish a document in the
(i) 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) 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) How to enhance the quality, utility, and clarity of the information to be collected;
(iv) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In compliance with these requirements, NHTSA asks for public comments on the following proposed collection of information:
The Secretary is authorized to invoke such rules, as deemed necessary to carry out these requirements. Using this authority, the agency issued the following FMVSS, specifying labeling requirements to aid the agency in achieving many of its safety goals:
FMVSS No. 105, “Hydraulic and electric brake systems,”
FMVSS No. 135, “Light vehicle brake systems,”
FMVSS No. 205, “Glazing materials,” and
FMVSS No. 209, “Seat belt assemblies.”
This notice requests comments on the labeling requirements of these FMVSS.
FMVSS No. 105, “Hydraulic and electric brake systems,” and FMVSS No. 135, “Light vehicle brake systems,” require that each vehicle shall have a brake fluid warning statement in letters at least one-eighth of an inch high on the master cylinder reservoirs. The lettering shall be permanently affixed, engraved or embossed; located so as to be visible by direct view; and of a color that contrasts with its background, if it not engraved or embossed.
FMVSS No. 205, “Glazing materials,” provides labeling requirements for glazing and motor vehicle manufacturers. In accordance with the standard, NHTSA requires each new motor vehicle glazing manufacturer to request and be assigned a unique mark or number. This number is then used by the manufacturer as their unique company identification on their self-certification label on each piece of motor vehicle glazing. As part of that certification label, the company must identify with the simple two or three-digit number assigned by the agency and the model of the glazing. In addition to these requirements, which apply to all glazing, certain specialty glazing items, such as standee windows in buses, roof openings, and interior partitions made of plastic require that the manufacturer affix a removable label to each item. The label specifies cleaning instructions, which will minimize the loss of transparency. Other information may be provided by the manufacturer but is not required.
FMVSS No. 209, “Seat belt assemblies,” requires safety belts to be labeled with the year of manufacture, the model, and the name or trademark of the manufacturer (S4.1(j)). Additionally, replacement safety belts that are for use only in specifically stated motor vehicles must have labels or accompanying instruction sheets to specify the applicable vehicle models and seating positions (S4.1(k)). Seat belt assemblies installed as original equipment in new motor vehicles need not be required to be labeled with position/model information.
44 U.S.C. 3506(c); delegation of authority at 49 CFR 1.50.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Request for public comment on proposed collection of information.
Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.
Comments must be received on or before November 7, 2017.
You may submit comments identified by docket number at the heading of this notice by any of the following methods:
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For additional information or access to background documents, contact Wayne McKenzie, Office of Crash Avoidance Standards (NVS-121), National Highway Traffic Safety Administration, West Building, 4th Floor, Room W43-462, 1200 New Jersey Avenue SE., Washington, DC 20590. Mr. McKenzie can be reached at (202) 366-1810.
Under the Paperwork Reduction Act of 1995, before an agency submits a proposed collection of information to OMB for approval, it must publish a document in the
(i) 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) 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) How to enhance the quality, utility, and clarity of the information to be collected; and
(iv) How to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
In compliance with these requirements, NHTSA asks public comment on the following proposed collection of information:
Issued in Washington, DC on:
The Department of Veterans Affairs gives notice under the Federal Advisory Committee Act that the meeting of the Advisory Committee on Disability Compensation, previously scheduled to be held at the Department of Veterans Affairs, 1800 G. Street NW., Conference Room 870, Washington, DC 20006, on September 12-13, 2017,
For more information, please contact Stacy Boyd, Designated Federal Officer, Department of Veterans Affairs, Veterans Benefits Administration, Compensation Service, Policy Staff at (202) 461-9580 or via email at
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |